foia results for phf's cmms audit

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IDENTIFICATION NUMBER:

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION

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PRINTED: 06/06/2011FORM APPROVED

(X2) MULTIPLE CONSTRUCTION

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391

054125 01/14/2011

SANTA BARBARA, CA 93110

STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER

SANTA BARBARA COUNTY PSYCHIATRIC HEALTH FACILITY315 CAMINO DEL REMEDIO

PROVIDER'S PLAN OF CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE

CROSS-REFERENCED TO THE APPROPRIATE

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SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

A 000 INITIAL COMMENTS A 000

The following reflects the findings of California

Department of Public Health Licensing and

Certification during a Recertification survey.

The following reflects the findings of the

Department of Public Health, Licensing and

Certification, during a RE-CERTIFICATION

survey.

Representing the Department of Public Health:

Pam Richardson, HFE-N

Susan Randolph, HFE-S

Alan Kratz, MD, Medical Consultant

Samual Obair II, PharmD, Pharmacist Consultant

Francia Trout, RHIA, Medical Records Consultant

Maxine McKaig, HFE II-S, Life Safety

Zeina Naser, HFE I, Life Safety

Shola Ayodele, MS, RD, Dietary Consultant

Lacie Rodrigues, MS, RD, Dietary Consultant

The facility's census was 14 patients.

Patient Records Sampled: 21 total.

Nursing: 11

Pharmacy: 5

Dietary: 3

Medicine: 1

Medical Records: 4

A 043 482.12 GOVERNING BODY

The hospital must have an effective governing

body legally responsible for the conduct of the

hospital as an institution. If a hospital does not

have an organized governing body, the persons

legally responsible for the conduct of the hospital

must carry out the functions specified in this part

A 043

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that

other safeguards provide sufficient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days

following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14

days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued

program participation.

FORM CMS-2567(02-99) Previous Versions Obsolete Q6M011Event ID: Facility ID: CA050000667 If continuation sheet of 145

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A 043 Continued From page 1 A 043

that pertain to the governing body.

This CONDITION is not met as evidenced by:

Based on observation, staff interview and review

of administrative records, policies and

procedures, contracts, infection control and

quality assurance documentation it was

determined that the hospital failed to have an

effective governing body responsible for the

conduct of the hospital as evidenced by;

The governing body failed to consider the

recommendations of the medical staff prior to

appointing members to the medical staff, failed to

ensure the governing body had approved the

medical staff bylaws, and failed to assure written

policies and procedure for the appraisal, initial

treatment, and referral of emergencies was

developed (Refer to A-046, A-048, A-093); the

governing body failed to ensure contracted

services, including but not limited to Dietary and

Pharmacy, were monitored, evaluated and

performed in a safe and effective manner (Refer

to A-083, A-084, A-085, A-490, A-618);

The governing body failed to failed to ensure

each patient's rights were protected and

promoted, including participation in the

development of plans of care, development of

advance directives, assuring that each patient's

personal belonging and monies were protected;

the governing body failed to ensure restraint and

seclusion orders were specific, complete and

comprehensive, failed to ensure the death of a

restrained, secluded patient was reported to CMS

as required, and failed to ensure the CMS

notification was documented in the patient's

medical record (Refer to A- 115, A-130. A-132,

A-142, A-164, A-214);

The governing body failed to ensure an organized


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nursing service was provided that met the needs

of the patients, and that was integrated into the

hospital's QAPI program; failed to ensure an

adequate number of nursing staff were provided

to meet the identified needs of the patients, failed

to ensure that medications were given as

prescribed, and that medication orders were

clarified to ensure medications were administered

as prescribed (A- 385, A-392, A-404);

The governing body failed to ensure that a

ongoing, comprehensive quality assessment and

performance improvement (QAPI) program was

implemented and maintained, reflecting the

complexity of the hospital services, focused on

improving patient care and health outcome, such

as Infection control, involving all departments,

including those services furnished under contract

or arrangement (Refer to A-263, A-490, A-385,

A-618, A-756);

The governing body failed to ensure that

Pharmaceutical Services met the needs of the

patients served, that pharmacy policies and

procedures, reflective of the hospitals services,

were approved and implemented, that accurate

accounting records of medications were kept and

maintained, that a drug formulary was

established, and that medication errors, including

lost/missing medications were investigated (Refer

to A-490, A-491, A-494, A-500, A-501, A-507,

A-508, A-509, A-511);

The governing body failed to ensure that Dietary

services were organized and staffed by adequate

numbers of qualified personnel, that a diet

manual and dietary policies and procedures were

developed and implemented, that the dietary

space and equipment was cleaned and

maintained, and that the dietary services provided

met the nutritional needs of the patients served


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(Refer to A-618, A-620, A-628,A-629, A-630,

A-631);

The governing body failed to ensure the physical

environment was maintained to ensure the safety

of the patients, and that the hospital met the

provisions of the Life Safety code of the the

National Fire Protection Association, due to the

potential for harm an immediate jeopardy was

called on 1/11/11 at 2:55 p.m.. The IJ was abated

on 1/12/11 at 9:08 a.m. (Refer to A-700, A-701,

A-710);

The governing body failed to ensure a

comprehensive on going, hospital wide infection

control program and plan was developed and

implemented to minimize infections and

communicable diseases, failed to ensure that the

assigned infection control officer was qualified,

that infection control policies and procedures

were reviewed, developed, and implemented, that

the designation of the infection control officer was

written into the infection control plan, and that a

comprehensive log of incidents of infections was

implemented, tracked and reviewed for

improvement of patient care and services. (Refer

to A-0747,A-748, A-749, A-750, A-756)

The cumulative effect of these systemic problems

resulted in the hospitals inability to provide safe,

quality patient care in a safe environment.

A 046 482.12(a)(2) MEDICAL STAFF -

APPOINTMENTS

[The governing body must] appoint members of

the medical staff after considering the

recommendations of the existing members of the

medical staff.

This STANDARD is not met as evidenced by:

A 046


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Based on interview with facility staff and review

of documents the hospital failed to ensure that

the governing body considered the

recommendations of the medical staff prior to

appointing members to the medical staff.

Findings:

Review of the current medical staff bylaws for the

hospital revealed appointments to the medical

staff were to be made by action of the governing

board only after recommendation from the

medical staff. In an interview on 1/12/11 at 10 a

m. the medical director stated the Medical

Practice Committee made recommendations for

appointment to the medical staff to the governing

body. However, review of the meeting minutes of

the Medical Practice Committee did not show any

documentation of their recommendations.

A 048 482.12(a)(4) MEDICAL STAFF - BYLAWS AND

RULES

[The governing body must] approve medical staff

bylaws and other medical staff rules and

regulations.


A 048

Based on review of documents and interview

with facility staff the hospital failed to ensure that

the governing body had approved the medical

staff bylaws.

Findings:

Review of the medical staff bylaws for the

hospital revealed they contained the statement

that they had been approved by the governing

board on 7/1/10. In an interview on 1/12/11 at 10


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a.m. the medical director stated the medical staff

bylaws had been approved by the governing

body, but was unable to provide documentation of

their approval.

A 083 482.12(e) CONTRACTED SERVICES

The governing body must be responsible for

services furnished in the hospital whether or not

they are furnished under contracts. The

governing body must ensure that a contractor of

services (including one for shared services and

joint ventures) furnishes services that permit the

hospital to comply with all applicable conditions of

participation and standards for the contracted

services.


A 083

Based on observation, staff interviews and

review of hospital documents, the governing body

failed to ensure that the food service and

consultant dietitian contracts were executed in a

manner that complied with conditions of

participation for dietary services.

Findings:

Review of the hospital's contract for dietary

services was done on 1/11/11. The contract was

initially entered into on 12/15/2004. An attached

"Exhibit A" which described the roles and

responsibilities of the contractor was also

reviewed. According to this document, the

contracted service was to maintain a policy and

procedure manual (P/P) that reflected the

contractor's practices indicating how the contract

would be executed.

According to the contract, meals were to be


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delivered at specified times. On 1/11/11 dinner

arrived and was served before 4:30 p.m.. Hospital

staff did not document the arrival time. The LN

who served the meal stated that it arrived early

and rather than let the food get cold he served it.

Review of the dietary services contract revealed

dinner was to be delivered at 4:45 p.m. and

served at 5:00 p.m.. In an interview with the

Program director on 1/11/11 at approximately

9:20 a.m., she identified the early delivery of

patient food as one of the many issues that they

have been working on with the contracted

services. She explained that on weekends, the

dinner meal is delivered about 1:00 p.m. because

the cafe kitchen which produces the food closes

at 12 (noon), and so they prepare cold

sandwiches and put it on ice. A result of this early

eating is that the patients are hungry and the

hospital provides them additional snacks other

than what is provided by the contracted service.

This observation on 1/11/11 and interview with

the program director revealed that this

requirement was not always met (cross refer

A630). These failures resulted in patients being

served exceeding the community standards of

the 14 hour span between dinner and breakfast

the following day.

A tour of the contractor's kitchen showed an

environment that was cluttered, and unsanitary.

There was food service equipment that was not

maintained in a working condition. Staff practices

including food storage, were not in compliance

with good food safety guidelines. There were

refrigerators that did not have thermometers.

Foods stored in all of the refrigerators were not

labeled or dated. Some refrigerator temperature

logs had not been maintained or checked since


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11/1/10.

Six containers were found in one of the walk-in

refrigerators on 1/10/11 at approximately 3:50

p.m.. According to the food service manager

(FSM), this item was cream of wheat prepared

ahead for the breakfast for another program. The

temperature of the items varied from 120.1

degrees Fahrenheit to 156 degrees Fahrenheit.

These items were not being monitored to ensure

that it cools down appropriately. Improperly

cooled foods left in the danger zone 41 to 135

degrees Fahrenheit for over 4 hours could result

in food borne microorganisms that could cause

food borne illness. The kitchen closes at about

5:00 p.m.; therefore no monitoring was done

when the kitchen was closed.

Staff knowledge was inadequate in terms of dish

washing and sanitizer testing. Two different staff

members were interviewed on how they ensured

that the dishes were properly sanitized. The

contracted dietary services employee washing

pots and pans in the three compartment sink, did

not accurately identify the correct level of sanitizer

in the sanitizing compartment of the sink.

Although the strip read between 100 - 200 ppm

(parts per million), he circled 200 on the log. The

recommended level is 200 ppm or above.

The dietary services employee operating the dish

machine on 1/10/11, at approximately 4:20 p.m.

did not have the proper test strips to check the

concentration of the sanitizer. The FSM stated at

this time, his staff did not monitor the dish

machine and only the service company who

services the machine and sells them chemicals

will check it when they come out once a month.


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Review of the county environmental health

department inspection report dated 2/2/10,

showed that the appropriate chemical test strips

were not available during the inspection.

The hospital served meals at temperatures that

were not palatable. It could not be determined

whether the food was delivered at low

temperatures or if the hospital staff were not

maintaining the food at the proper temperature

after delivery due to malfunctioning steam table

(Cross refer A 620). The contracted dietary

services staff stated that they do not record food

temperatures prior to delivery at the facility.

The menu provided by dietary contracted service

was posted in the kitchen in the hospital. There

was no evidence that it was approved. An

interview with the dietary contracted services RD

could not be conducted for verification of her role

in menu planning and approval. The January

2011 menu did have portion sizes. Hospital staff

was sent serving utensils without instructions on

how much to serve. The nutrition adequacy of the

diet served could not be validated.

Review of the hospital menu for the month of

January 2011 was reviewed. According to the

menu, breakfast burrito and orange were items to

have been served for breakfast on 1/10/11. But,

the menu did not have portion sizes listed next to

the items. Further review showed that none of the

menu items for all three meals for the month had

any portion sizes listed. Review of the lunch

menu dated 1/10/11, showed BBQ chicken,

macaroni and cheese, mixed vegetables, an

orange, and milk for the lunch meal. The menu

did not show portion sizes or scoop sizes. On


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1/10/11, at approximately 11:50 a.m., on the

steam table were BBQ chicken, green salad,

macaroni and cheese, and cooked carrots and

peas. The green salad was being served with a

spaghetti spoon/server, macaroni and cheese

and cooked carrots and peas were being both

served with a six ounce (oz) spoodle, and the

BBQ chicken was being served with a spatula.

The nutrition adequacy was unable to be

validated due to lack of stated portion sizes of the

meal items. No oranges were observed in the

serving area. The menu did not state there would

be a green salad served. A green salad would

not be an equal substitute for an orange, on the

basis of the green salad containing less vitamin

C. The menu for the lunch meal on 1/11/11,

showed pork loin, rice pilaf, mixed vegetables,

dinner roll, fruit mix, and milk. The patients

received lima beans instead of mixed vegetables

and they did not receive a dinner roll. Patients

also received the green salad that was not listed

on the menu. The substitutions were made

without being posted on the menu. There was no

substitute provided for the missing dinner roll.

RA1 served lima beans and rice pilaf with a six oz

spoodle, pork loin (pre-sliced) with tongs. The

portion sizes were not consistent for all the

patients served. Some patients were served

spoodle that was half-full; others were served

3/4th full. There were no cardex or patient diet

cards instructing RA1 on what amount to serve

each patient. It was unclear why each patient was

not consistently served the same amount.

Concerns regarding a lack of portion sizes were

shared with the contracted meal service provider

manager (FSM). In an interview on 1/10/11, at


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approximately 2:30 p.m. he stated that in addition

to the hospital's contract, the dietary contracted

service also provides meals for children's

program and a senior nutrition program. He

indicated that the hospital menu is planned by a

registered dietitian who was not housed in the

office he was located. He further stated that the

menu had a nutrient analysis. A call was placed

to the dietary contracted services RD however,

was not returned until after the surveyor had

exited the hospital. (Cross refer 630)

The dietary contracted service did not

consistently provide the hospital with all items as

planned on the menu or made substitutions that

were not documented prior to meal service.

Meals were also delivered prior to scheduled

meal times resulting in patients eating dinner very

early requiring the hospital staff to provide snacks

outside of the snacks provided by dietary

contracted services. (Cross refer A629, A630)

There were refrigerators that were not working,

thermometer gauges on warming carts that were

not working, broken light fixtures above food

preparation areas, roof leaks, walls and door of

freezer with dark brown, black material etc.

Interview with the FSM on 1/10/11 and 1/11/11

revealed attempts to resolve some of the issues

with malfunctioning equipment. The FSM

provided a copy of the emails dated 11/5/10

through 11/22/10 sent to the General Services

Department requesting help in submitting work

order request for repairs of kitchen equipment.

He indicated that these issues had not been

resolved.

In an interview with the registered dietitian (RD1)


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on 1/10/11 at approximately 4:30 p.m. revealed

that she did not have any role in the food service

operation. In a subsequent interview with RD1 on

1/13/11 she indicated that she did not monitor any

quality improvement measures and does not

generate any kind of report. Review of the RD1 ' s

contract shows that she was contracted to assess

the nutritional needs of patients at nutritional risk.

There was no requirement for performance

improvement in her contract. The current

contract with RD1 was signed in 12/04.

There was no evidence that the county or hospital

governing body ensured that the contracted meal

provider met the requirements of the condition of

participation.

A 084 482.12(e)(1) CONTRACTED SERVICES

The governing body must ensure that the

services performed under a contract are provided

in a safe and effective manner.


A 084

Based on review of the hospital's Pharmacy and

Therapeutic Committee (P&T) minutes, Medical

Practice Committee minutes, and Quality

Assurance Committee minutes the facility failed

to evaluate the services which were being

provided by the contractor Pharmacy.

Findings:

Review of the facility's Pharmacy and Therapeutic

Committee (P&T) minutes, Medical Practice

Committee minutes, and Quality Assurance

Committee minutes on 1/12/11 revealed that

none of the hospital's Committees had reviewed

or assessed the quality of services which were


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being provided by the facility's contracted

Pharmacy. No indication of the hospital's

satisfaction or disapproval with the Pharmacy's

services could be found in any of the Committees

minutes. No recommendations for change or

modification of Pharmacy services were ever

discussed in any of the above Committee

minutes.

A 085 482.12(e)(2) CONTRACTED SERVICES

The hospital must maintain a list of all contracted

services, including the scope and nature of the

services provided.


A 085


with facility staff the hospital failed to ensure a list

of all contracted services was maintained.

Findings:

During an interview on 1/11/11 at 12:00 p.m. the

medical director stated patients could be

transferred to another facility through an

agreement. Review of the list of contracted

services revealed this agreement was not

included on the list. In an interview on 1/12/11 at

10:30 a.m. the medical director discussed a

contract for the purchase of medications,

however, this contract was not included on the list

of contracted services provided by the facility.

A 093 482.12(f)(2) EMERGENCY SERVICES

If emergency services are not provided at the

hospital, the governing body must assure that the

medical staff has written policies and procedures

for appraisal of emergencies, initial treatment,

and referral when appropriate.

A 093


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with facility staff the governing body failed to

ensure that the medical staff had written policies

and procedures for the appraisal of emergencies,

initial treatment, and referral.

Findings:

The facility policy titled " Emergency Medical

Policy " stated in case of emergency the facility

staff was to call 911 for ambulance transport to

an emergency room. The policy did not provide

any guidance for appraisal or initial treatment of

the patient. In an interview on 1/12/11 the DON

stated it was the only policy for emergencies.

A 115 482.13 PATIENT RIGHTS

A hospital must protect and promote each

patient's rights.


A 115

Based on observation, record and document

review and staff interview the hospital failed to

protect and promote patient rights. The hospital

failed to ensure each patient was included in the

development and implementation of their plans

of care (Refer to A- 130). The hospital failed to

ensure advanced directives were discussed and

documented in the medical record for 2 of 11

patients reviewed (Refer to A-0132). The hospital

failed to ensure patient's personal valuables were

inventoried, monitored, and returned to patients

timely, following their discharge. The facility failed

to have a system in place to ensure patient

monies were tracked, safe guarded and

protected. (Refer to A-0142). The facility failed to


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ensure restraint and seclusion orders were

comprehensive, complete and in compliance with

facility policy and procedures (Refer to A-0164).

The facility failed to report the death of a patient

who expired while in restraints and seclusion to

CMS, and to ensure this notification was

documented in the patient's health record (Refer

to A-214).


resulted in the hospital's inability to protect and

promote patient's rights, and to provide quality

patient care in a safe environment.

A 130 482.13(b)(1) PATIENT RIGHTS:PARTICIPATION

IN CARE PLANNING

The patient has the right to participate in the

development and implementation of his or her

plan of care.


A 130

Based on interview and record review the

hospital failed to ensure the right of 1 of 11

sampled patients (N3) to participate in the

development and implementation of her plans of

care.

Findings;

Review of N3's medical record on 1/11/11 at

12:10 p.m. revealed the patient was admitted on

5/3/10. Per the record the patient's medical

problems included asthma, and the medication

Flovent was ordered twice a day for the patient.

On 5/6/10 a multidisciplinary treatment plan was

developed and implemented for the patient's

medical problem of asthma, however there was

no documentation to indicate that the patient was


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involved in the development of her plan of care.

Interview with LN 1 on 1/12/11 at 3:15 p.m.

revealed that when a treatment plan is developed

by the interdisciplinary team the identified

problems are addressed with the patient by a

member of the team.

There was no documentation to indicate the

patient was involved in the development and

implementation of her plans of care. This

information was verified in an interview with staff

on 1/11/11.

A 132 482.13(b)(3) PATIENT RIGHTS: ADVANCED

DIRECTIVES

The patient has the right to formulate advance

directives and to have hospital staff and

practitioners who provide care in the hospital

comply with these directives, in accordance with

§489.100 of this part (Definition), §489.102 of this

part (Requirements for providers), and §489.104

of this part (Effective dates).


A 132

Based on policy and procedure review, medical

record review and interview, the hospital failed to

ensure that advanced directives were discussed

and documented in the record for 2 of 11

sampled residents reviewed (N3, N4)

Findings:

Review of the policy and procedure titled" Patient

Self-Determination Act" reflected the following, "

When a patient is admitted to..., in such condition

that it is not practical to provide information

regarding advance directives at the time of

admission, such information will be provided as


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soon as is reasonable after admission.

When a patient who lacks present decision

making capacity (as determined by the admitting

physician in consultation with the patient's family

members and/or close friends) is admitted..., the

person responsible for documenting the

admission shall provide information regarding

advance directives and ask for direct questions

regarding the existence of an advance directive to

a relative or friend accompanying the patient, if

such a person is present. If the patient is

unaccompanied, information on advance

directives and inquiry into the existence of an

advance directive shall be forwarded to the

patient's surrogate decision maker, once a

surrogate decision maker has been identified by

the attending physician.

The admitting physician will decide whether a

patient who is being admitted will be questioned

regarding the existence of an advance directive. If

the Patient's state of mental disability will be

adversely impacted by the questioning then such

questioning should not occur.

The person responsible for documenting the

admission of the patient shall provide information

regarding advance directives, and direct

questions to a relative or friend accompanying the

patient, if such a person is present. If the patient

is unaccompanied, information on advance

directives and inquiry into the existence of an

advance directive shall be directed to the patient's

surrogate decision maker."

1. Medical record review beginning on 1/11/11 at


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11:45 a.m. reflected that N4 was admitted on

10/22/10. The nursing admission assessment

dated 10/22/10, included an area for information

regarding the patient's advanced directives,

however, this area was blank.

Interview with LN 2 (licensed nurse) on 1/12/11 at

8 a.m. revealed that N4 was unable to answer the

question on advance directives at the time of

admission. The facility had no system in place to

ensure this information was re-addressed with the

patient once she was stabilized. The area was

blank.


12:10 p.m. revealed N3 was admitted on 5/3/10.

The information regarding the patient's advanced

directives on the nursing admission assessment

was blank.

A 142 482.13(c) PATIENT RIGHTS: PRIVACY AND

SAFETY

Patient Rights: Privacy and Safety


A 142

Based on policy and procedure review, medical

record review, staff interviews, facility inventory

log and review of valuables in the lock box and

safe, the hospital failed to ensure that each

patient's personal valuables were consistently

inventoried and monitored. Patient personal

inventory lists were not consistently completed

and signed by the patients and facility staff, for 2

of 11 patients (N1 and N4). Personal items,

belonging to two patients N10 and N11, were not

returned to the patients upon discharge and

remained in the facility's lock box. Patient

valuables exceeding $20, were found in the lock


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box, yet facility policy and procedure states that

sums greater than $20.00 will be locked in the

safe. (N6, N7, N8, N9). Personal items stored in

sealed envelopes, for a patient who was

transferred from another facility, were not verified

and inventoried by the facility upon admission.

(N5) There was no tracking or monitoring of

personal monies that were locked in the lock box

or the safe. There was no policy and procedure in

place that addressed the use of a single key lock

box in the medicine room.

Findings:

Review of the policy and procedure titled "Unit

Safe", reflected the following," All sums of money

greater than $20, credit cards, expensive jewelry,

or other valuables, will be locked in the Unit safe.

The Unit safe is located in the Medications

Closet. 1. The safe lock requires two keys to

enter. The team leader will have one key, and the

Unit secretary will have the other key. At no time

is one person to enter the safe. 2. Each time the

safe is entered, an entry will be made in the safe

logbook, with the day, time, purpose and

signatures of the persons entering. 3. The safe

will be checked daily by the Unit secretary."


2:10 p.m. reflected that the N1 was admitted on

1/3/11. The Patient Property List listed various

articles of clothing, grooming items and a black

billfold. The bottom of the form had a space for

the patient's and staff signature. In addition it

stated " I certify that the above is a correct list of

my property and I assume entire responsibility for

any articles I have retained in my possession"

There was also a space that stated "If patient is


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unable to sign, please provide an explanation".

There were two spaces for witnesses to sign.

However, there were no signatures anywhere on

the form.

N4 was admitted on 10/22/10. The Patient

Property List dated 10/22/10 had four items of

clothing listed. There was a staff signature dated

10/22/10, but, no patient signature, nor any

explanation as to why there was no signature. On

11/23/10 and 1/6/11 there were additional items

of clothing listed, however, there was no

signature by staff or the patient which indicated

that these valuables had been accepted by the

patient.

2. Concurrent interview with LN6 ( licensed

nurse) and a review of the valuables located in

the lock box, stored in the medicine room, on

1/13/11 at 8:30 a.m., revealed two envelopes for

patients N10 and N11. The envelope for N10 was

blank. There was no information that indicated

what was inside the envelope. Upon further

inspection of the contents of the envelope, a

wallet was found. LN6 stated that N10 was no

longer a patient and had been discharged a few

weeks ago. LN6 reviewed the safe log that was

kept at the nursing station, there was no

information to confirm the discharge of N10.

Further review of discharge dates reflected that

N10 was discharged on 12/16/10.

The envelope for N11 had a written note

indicating that a case worker was to pick up the

items on 7/9/10. Inside the envelope was a wallet

and various credit and medical cards. N11 was

discharged on 5/9/10, over 8 months ago.


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3. Additional envelopes stored in the single key

lock box contained the following:

Patient N6: A SSI check for $620.34.

Patient N7: A $25 gift card

Patient N8: A $100 paycheck

Patient N9: $54.12 cash

LN 6 stated that this lock box is for items or

monies that are valued at $20 or less. The safe

log is usually filled out and the monies are tallied

daily. But, review of the log reflected it had not

been done since 12/26/10. LN 6 confirmed that it

was not being done. He stated that any staff can

have access to keys for the lock box and safe.

There was no single point person.

Inspection of the double key safe revealed two

sealed envelopes labeled with another facility's

name, and containing items that belonging to N5.

LN 6 confirmed that the items were from a

different facility, and that they (the facility) had not

opened the contents of the envelopes to identify

the contents and inventory N5's personal items.

Interview with the program director on 1/13/11 at

9:25 a.m. revealed that the contents in the single

key lock box should be in the double key safe due

to the amounts of the checks, credit cards and

money that were found. The facility had no

policies and procedure for the use of the single

key lock box, and inventory lists. The current

practice for the inventory lists, safe list and

money tallies was inconsistent.

A 164 482.13(e)(2) PATIENT RIGHTS: RESTRAINT

OR SECLUSION

Restraint or seclusion may only be used when

less restrictive interventions have been

A 164


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determined to be ineffective to protect the patient,

a staff member, or others from harm.


Based on observation, staff interview and record

and document review, the hospital failed to

ensure that the orders written for the use of

restraints and/or seclusion, for 2 of 11 patients

(N2 and N3), were comprehensive, complete and

in compliance with the facility's policies and

procedures. The restraint and seclusion orders

written for N2 failed to describe, in specific

behavioral terms, the patient's dangerous

behavior justifying the intervention; failed to

specify the type of restraint to be implemented;

and failed to ensure the order for the use of the

restraints was time limited. The restraint and

seclusion orders written for patient N3 failed to

specify the type of restraint to be implemented

and failed to be time limited.

Findings;

A review of the facility's policy and procedures on

1/11/11 beginning at 9:00 a.m. revealed a policy

entitled "Restraint and Seclusion" dated 12/5/04.

"Part 1. Definitions of terms .Mechanical restraint;

Cuffs and belts which are well padded or soft ties

consisting of cloth. Patient must be afforded the

least restrictive restraint and the maximum

freedom of movement while ensuring the physical

safety of the person and other, and shall use the

least number of restraint points."

" Part 4. "Environmental safeties and equipment..

5-point locked leather restraint with padding, in

secluding room with door locked under continuos

one of one observation and monitoring. 4-point


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locked leather restraints walking ankle and waist

restraints and in seclusion room with door locked

under continuos one to one observation and

monitoring.

The facility's policy failed to include a definition of

"5 point" locked, leather restraints.

Within the policy under Part 6 was "Procedures

for Mechanical Restraint (cuffs and belts) and/or

Seclusion.".....

"Physician"

1. RN/Physician assess that the patient is

displaying behavior that presents a risk of great

bodily harm to the patient or others and that less

restrictive interventions have failed or are not

feasible.

2. LNS/Physician (licensed nursing staff)

documents any less restrictive intervention that

were attempted but not effective on R (restraint)

& S (seclusion) use form

3. Provide order R & S which includes time, date,

and signature:describes in specific behavioral

terms the dangerous behavior justifying

intervention, specifies the types of restraints if

applicable. Document this and orders on the R &

S use form

5. Physician writes or RN obtains order for R & S.

Describe in specific behavioral terms the

dangerous behavior on the R & S Physician's

orders form.....

6. Patient must be afforded the least restrictive

restraint, and the maximum freedom of

movement, while ensuring the physical safety of

the person and others, and shall use the least

number of restraint points.

Interview with three licensed nursing staff ( LN5,

LN 2 and LN6) on 1/12/10 at 11:30 a.m. revealed


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that "an order" to place a patient in "restraints"

means the patient is placed in 5 point locked

leather restraints, in a bed, in the seclusion room.

The seclusion room(s) are equipped with a

surveillance camera, to facilitate observations of

the patient by a staff person via a monitor located

in the nursing station. Staff demonstrated that the

placement of 5 point leather restraints consists of

restraining the patient at the waist, and at each

ankle and at each wrist.

1. Review of the medical record for N2 on 1/11/11

beginning at 11:35 a.m. revealed the patient was

admitted to the hospital on an involuntary hold, at

4/28/10 at 21:45 (9:45 p.m.). The physician's

orders of 4/28/10 at 2145 stated "may put pt.

(patient) in seclusion and restraint."

The order for the use of "seclusion and restraints"

was incomplete and did not reflect the facility's

policy and procedure. The order failed to specify

the dangerous behavior that justified the use of

the most restrictive restraint intervention and the

seclusion, failed to specify the type of the

restraint(s) to be used, and failed to specify the

use of the restraints and seclusion was time

limited. There was no documentation to indicate

the patient was afforded the least restrictive

restraint and the maximum freedom of

movement. There was no documentation in the

patients record that identified that the patient

required the use of 5 point locked leather

restraints. There was no documentation in the

record that identified the type of restraints that

were used for the patient.

2. Review of the medical record for N3 on 1/11/11

beginning at 12:10 p.m. revealed the patient was


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admitted to the facility on 5/3/10. At 23:15 (11:15

p.m.) an order was written for "S (seclusion) & R

(restraints) for SIB (self injurious behavior) pt's

(patient's) safety." The order for the use of

restraints and seclusion was incomplete. The

order failed to describe in specific behavioral

terms the dangerous behavior the patient was

exhibiting that presented a risk of great bodily

harm justifying this most restrictive intervention,

failed to specify the type of restraint to be used

and failed to specify that the use of the restraints

and seclusion was time limited.

Further review of the patient's record revealed on

5/5/10 at 8:15 a.m. an order was written to "place

pt. (patient) in seclusion and restraint for

DTS/DTO (danger to self/danger to others)." The

order for the use of restraints and seclusion failed

to describe in specific behavioral terms the

dangerous behavior that presented a risk of great

bodily harm justifying the this most restrictive

intervention, failed to specify the type of

restraint(s) to be used and failed to specify the

duration of the restraints and the seclusion.

A 214 482.13(g) PATIENT RIGHTS: SECLUSION OR

RESTRAINT

Death Reporting Requirements: Hospitals must

report deaths associated with the use of seclusion

or restraint.

(1) The hospital must report the following

information to CMS:

Each death that occurs while a patient is in

restraint or seclusion.

Each death that occurs within 24 hours after the

A 214


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patient has been removed from restraint or

seclusion.

Each death known to the hospital that occurs

within 1 week after restraint or seclusion where it

is reasonable to assume that use of restraint or

placement in seclusion contributed directly or

indirectly to a patient's death. "Reasonable to

assume" in this context includes, but is not limited

to, deaths related to restrictions of movement for

prolonged periods of time, or death related to

chest compression, restriction of breathing or

asphyxiation.

(2) Each death referenced in this paragraph must

be reported to CMS by telephone no later than

the close of business the next business day

following knowledge of the patient ' s death.

(3) Staff must document in the patient's medical

record the date and time the death was reported

to CMS.


Based on record and document review and staff

interview, the hospital failed to report the death of

a patient (N2), who expired while in restraints and

seclusion on 4/29/10 to CMS, and failed to

document the notification in the patient's medical

record. Patient N2 was admitted to the facility on

4/28/10 at 21:45 (9:45 p.m.). Documentation

indicates the patient was placed in restraints and

seclusion at 21:45 (9:45 p.m.) upon admission to

the facility, and remained in restraints and

seclusion until the time of the patients death on

4/29/10 at 1:15 a.m., 3 hours and 15 minutes

later. According to the IDN the patient was "noted

to have no respirations at 0115" (on 4/29/10). "


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911 called, CPR started. Paramedics arrived. Pt

expired." There was no documentation to indicate

CMS was notified of the patient's death, that

occurred while the patient was in restraints and

seclusion, and there was no documentation in the

patients record to reflect that CMS was notified,

as required.

Findings;

Review of the facility's "Restraint and Seclusion"

policy and procedure dated 12/5/04, provided on

1/11/11 beginning at 9:00 a.m. revealed under

Part 8 "Monitoring and Reporting".."Reporting

Patient Death".. "Centers for Medicare and

Medicaid (CMS) 42 CFR, Section 482.13(f)(7)

requires that all certified hospitals report to CMS

any patient death that occurs while a patient is

restrained or in seclusion for behavior

management..".

Interview with three licensed nursing staff (LN5,

LN2, LN6) on 1/12/10 at 11:30 a.m. revealed that

when patients are placed in "restraints" they are

placed in 5 point locked leather restraints, in a

bed, in the seclusion room. The seclusion

room(s) have a camera mounted in the room so

the patient can be constantly observed by staff,

who are observing the camera monitor, which is

located in the nursing station.

Review of N2's record on 1/11/11 beginning at

11:35 a.m. revealed the patient was admitted to

the facility on 4/28/10 at 21:45 (9:45 p.m.) from

the emergency room of an acute hospital, on an

involuntary hold. The patient, who had been

restrained while at the emergency room,

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ambulance to the hospital for admission. The

patient was admitted in restraints, and due to

agitation, yelling, and uncooperative behaviors,

the patient was placed in restraints (unspecified

type), on a bed, in a seclusion room.

According to the restraint and seclusion flow

sheet documentation, completed every 15

minutes, the patient continued to be agitated, to

scream and yell at staff, and to pull at the

restraints (unspecified type). At 22:30 (10:30

p.m.) the physician completed a face to face

assessment of the patient, and the use of the

restraints and seclusion continued. According to

the medication administration record the patient

received Zyprexa 10 mg IM for agitation and

screaming at 22:15 (10:15 p.m.). with "no effect."

At 24:10 (12:10 a.m.) the patient received

Zyprexa 10 mg IM and Ativan 2 mg. IM for

agitation again with "no effect." The final entry on

the restraint and seclusion flow sheet was written

at 01:00 (not dated). The entry states the patient

was "pulling on restraints."

A review of the interdisciplinary progress notes in

the record revealed a single entry dated 4/28/10

and timed as "admit 2145" (9:45 p.m.). According

to the progress note the patient was admitted

from an emergency room (ER) via ambulance on

a gurney with restraints in place. The patient had

been in restraints in the ER with 1:1 security. The

patient was agitated, screaming, aggressive and

combative to staff during the transfer from the

gurney to the bed. Orders were received to admit

the patient, to place the patient in seclusion and

restraints, and to administer an antipsychotic

medication (Zyprexa 10 mg.) IM (intramuscular).

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agitated and uncooperative, and was pulling at

the restraints.

The physician was contacted and additional

medication orders were received for Ativan (an

antianxiety) and Zyprexa IM (intramuscular). The

patient was offered water but refused. Attempts

to provide care to the patient were unsuccessful

due to the patient's refusal and agitation. The

note continues stating the "Pt (patient) noted to

have no respirations at + - 0115. 911 called, CPR

started. Paramedics arrived. Pt expired.

Supervisor notified." The note indicated that

physician(s) were notified.

There was no documentation in the record to

indicate CMS was notified of the patient's death

that occurred while the patient was in restraints

and in seclusion, as required.

A review of all of the hospital's documentation

provided for review (related to the patient's death)

on 1/11/11 at 12:00 p.m. revealed no

documentation to indicate that CMS was notified

of the restrained patient's death. Interview with

the DON and LN5 on 1/11/11 at 2:00 p.m. verified

that the hospital had not contacted CMS

regarding the death of the restrained patient.

A 263 482.21 QAPI

The hospital must develop, implement and

maintain an effective, ongoing, hospital-wide,

data-driven quality assessment and performance

improvement program.

The hospital's governing body must ensure that

the program reflects the complexity of the

hospital's organization and services; involves all

A 263


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hospital departments and services (including

those services furnished under contract or

arrangement); and focuses on indicators related

to improved health outcomes and the prevention

and reduction of medical errors.

The hospital must maintain and demonstrate

evidence of its QAPI program for review by CMS.


Based on staff interview and review of

administrative records, policies and procedures,

contracts, infection control and quality assurance

documentation, the hospital failed to develop,

implement and maintain an effective, ongoing,

data driven, hospital wide quality assessment and

performance improvement (QAPI) program, that

incorporated infection control issues, and that

measured, analyzed and tracked quality

indicators, including adverse patient events

(Refer to A-264, A-265, A-267, A-273, A-747).

The hospital failed to have a QAPI program that

included quality indicator data, focusing on high

risk, high volume or problem prone areas; the

hospital failed to ensure that results, summaries

and trends of incident reports were shared with

administrative hospital staff, and the facility failed

to have system in place to implement

improvement actions, and track performances;

the hospital failed to ensure that ongoing

performance improvement projects were

conducted (Refer to A-283, A-288, A-291, A-297).

The governing body failed to ensure the QAPI

program reflected the hospital's services,

involved all departments, including the contracted

services of Pharmacy and Dietary, and focused

on indicators to improve health outcome and

provide quality patient care and services. (Refer


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to A-115, A-309, A-385, A-490, A-618, A-385,

A-700)


resulted in the hospitals inability to ensure the

provision of quality health care in a safe

environment.

A 264 482.21(a) QAPI PROGRAM SCOPE

Standard: Program Scope


A 264

Based on interview and policy and procedure

review, the hospital failed to ensure that an

active, on going, comprehensive, facility wide,

quality assessment and performance

improvement program (QAPI) was enacted.

There was no documentation to reflect that

infection control issues were incorporated into a

hospital wide QAPI program.

Findings:


9:45 a.m. revealed that the infection control

committee had not been reporting to the quality

committee.

Review of the Infection Control Manual, policy

and procedures, reflected no current approval

date of the policies. The Medical Director,

Infection Control Practitioner and the facility

Internist had not signed off on the policies. The

form indicated that policies were reviewed

annually for revision. The last revision date was

noted to be in 5/2007. There was no mention of

what infection control guidelines were to be

utilized. The Infection Control Committee


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consisted of the Medical Director, Program

Manager, Nurse Manager, Quality Improvement

Manager, Infection Control Practitioner and the

Internist.

Interview with the quality manager on 1/13/11 at

3:30 p.m. revealed that the infection control

policies and procedures had not been reviewed

recently nor were there any recent approval

dates. The quality committee had not been

proactively involved with the infection control

process.

A 265 482.21(a)(1) QAPI HEALTH OUTCOMES

The program must include, but not be limited to,

an ongoing program that shows measurable

improvement in indicators for which there is

evidence that it will improve health outcomes and


A 265

Based on interview with facility staff and review

of documents the hospital failed to ensure that

there was an ongoing quality assessment and

performance improvement (QAPI) program.

Findings:

Review of the Compliance Committee (formerly

the Utilization Review Committee) meeting

minutes revealed the material reviewed at the

meetings was related to utilization review not

QAPI activities. In an interview on 1/11/11 at 11

a.m. the QA Manager stated medical care

evaluation studies as required by Department of

Mental Health were ongoing. In an interview on

1/12/11 at 3:15 p.m. a department business

analyst stated there were two studies currently

ongoing. One study was the re-hospitalization


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rates of the hospitals clients and the other was

the utilization of hospital's bed days by jail clients.

Review of the studies revealed both were

utilization review studies concerned with length of

stay at the hospital. There was no documentation

of studies which used quality indicators for the

improvement of health outcomes or the reduction

of medical errors.

A 267 482.21(a)(2) QAPI QUALITY INDICATORS

The hospital must measure, analyze, and track

quality indicators, including adverse patient

events, and other aspects of performance that

assess processes of care, hospital services and

operations.


A 267

Based on document and medical record review

the hospital failed to measure, analyze and track

quality indicator, including adverse patient events

and other aspects of performance that assess

care and services. (Refer to A-164, A-747)

Findings;

Review of the documentation provided by the

facility revealed there were no performance

improvement activities which tracked medical

errors and adverse patient events, analyzed their

causes, and implemented preventative actions.

Document review revealed a patient expired while

in restraints and seclusion on 4/29/10. There was

no performance improvement documentation to

indicate this adverse patient event was analyzed

and/or tracked to assess care provided, and to

identify improvement actions.


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Review of the Infection Control Report dated

12/09-6/10 reflected three areas that were

targeted: Employee Health, Environment and

Infections. Under Infections there was a tally of

50 reported infections over a six month period. 40

were skin related, five were respiratory and five

were for urinary tract infections. There was no

breakdown of the data to ascertain what type of

infections had been contacted, treatments

utilized, treatment effectiveness, antibiotic

choices based on the organism nor any analysis

of the application/administration of ordered

medications by facility staff.

Interview with LN 1, on 1/11/11 at 9:50 a.m.

revealed that he has never attended an infection

control meeting. He submits data that he collects

and does not hear any more information. He has

never had any input on any revisions to the

policies and procedures. He had not attended an

infection control committee meeting. He does

not do any personal surveillance of employees,

including handwashing techniques. He collects

data on a quarterly basis and submits to the

charge nurse. He did not know of any outcomes

or decisions with the information that he

submitted.



committee had not been reporting to the

governing board or the quality committee. She

agreed that there was a lack of communication

between committees and staff. Data collection,

surveillance and monitoring had not been done

on a proactive daily basis.


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Based on document review, interview and policy

and procedure review, the hospital failed to

develop quality indicators for performance

improvement in infection control, pharmacy

services,, nursing services and dietary services

through out the hospital.

Findings:

1. Review of the Infection Control Report dated

























submitted.


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A 273 482.21(b) QAPI PROGRAM DATA

Standard: Program Data


A 273

Based on review of documents the facility failed

to ensure that the QAPI program included quality

indicator data such as patient care data.

Findings:


facility revealed there was no data collection used

to monitor the effectiveness and safety of

services and quality of care.

A 274 482.21(b)(1) QAPI PROGRAM DATA

The program must incorporate quality indicator

data including patient care data, and other

relevant data, for example, information submitted

to, or received from the hospital's Quality

Improvement Organization.


A 274

Based on document review, the hospital failed to

ensure that the QAPI program developed and

incorporated quality indicators, including patient

care data.

Findings:


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facility revealed there was no data collection used

to monitor the effectiveness and safety of

services and quality of care.

A 276 482.21(b)(2)(ii) QAPI IDENTIFY IMPROVEMENT

[The hospital must use the data collected to--]

(ii) Identify opportunities for improvement and

changes that will lead to improvement.


A 276

Based on interview, the hospital failed to identify

problem prone areas for improvement. There was

no identification of issues related to patient rights,

nursing services, pharmacy services, dietary

services, life safety or infection control.

(Cross reference: A-0115, A-0385, A-0490,

A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with

the medical director, program director and the

DON the hospital had not identified any trends or

problem prone areas for improvement related to

patient rights, nursing services, pharmacy

services, dietary services, life safety or infection

control.

A 277 482.21(b)(3) QAPI PROGRAM DATA

FREQUENCY

The frequency and detail of data collection must

be specified by the hospital's governing body


A 277

Based on interview, the hospital failed to specify


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the frequency and detail of hospital wide data

collection. There was no identification of specific

data collection frequencies related to patient

rights, nursing services, pharmacy services,

dietary services, life safety or infection control.

(Cross reference: A-0115, A-0385, A-0490,

A-0618, A-0700, A-0747)

Findings:

Interviews conducted the week of 1/10/11 with

the medical director, program director and the

DON revealed that the hospital had not specified

the frequency nor details of the data to be

collected on a hospital wide basis.

A 283 482.21(c) QAPI PROGRAM ACTIVITIES

Standard: Program Activities


A 283


to ensure that the QAPI program focused on

high-risk, high-volume, or problem-prone areas.

Findings:


facility revealed there were no performance

improvement activities which tracked medical

errors and adverse patient events analyzed their

causes, and implemented preventative actions.

A 285 482.21(c)(1) QAPI PATIENT SAFETY

The hospital must set priorities for its

performance improvement activities that --

Focus on high-risk, high-volume, or

A 285


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problem-prone areas;

Consider the incidence, prevalence, and severity

of problems in those areas; and

Affect health outcomes, patient safety, and

quality of care.


Based on document and record review and staff

interview, the hospital failed to ensure that

performance improvement activities focused on

high risk, high volume problem prone areas, that

affect patient safety and quality of care. A review

of the hospitals patient acuity system, which

identifies staffing needs based on an assessment

of the patients needs, and review of staffing

records, revealed adequate numbers of licensed

staff was not consistently provided to meet the

needs of the patients, placing the patients and

staff at risk for harm. There was no

documentation to indicate the hospital had

evaluated the effectiveness of their current

patient acuity system. (Refer to A- 0392).

Findings;

A review of the facility's patient acuity/staffing

policy and procedures on 1/11/11 at 10:00 a.m.

revealed... " Nursing general policies. Acuity

NG-2-0," effective 1/1/2000 and revised May

2006. According the policy the "daily nursing staff

and requirement based on patient acuity as

identified by levels of care. Patient acuity

determination will be identified daily to identify,

justify and guide the assignment of nursing staff.

The total staffing requires the scheduling of at

least one (1) registered nurse on each shift to


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provide assess, assign, direct, and/or supervise

the care rendered by other nursing staff."

The facility utilizes patient criteria levels of 0

through 3.

A level 0 requires a 1:1 staff, patient is a high risk,

in restraints or seclusion, or the patient continues

to escalate despite frequent staff intervention.

A level 1 requires every 30 minutes observation

and includes; a new admit within 24 hours, patient

requires constant re-direction and limit setting.

A level 2 patient requires moderate assistance.

may have a special medical treatment, seizure

precautions, and may be verbally threatening or

provocative but no physical threats.

A level 3 patient requires only minimal prompts,

and is generally stable.

Interview with the Director of Nurses on 1/12/11

at 2:00 p.m. revealed that patient acuity

assessments are completed daily at 11:30 a.m.,

and based on the assessment of each patient

staffing needs are determined for the day. Most

staff work 12 hour shifts ( 7a.m.-p.m. and 7 p.m.

to 7 a.m.), but at times there is a staff who would

work a variation of different hours, such as 1 p.m.

-11 p.m. or 7 a.m.- 5 p.m..

The patient acuity assessments/staffing sheets

for 4/26, 4/27,4/28, 4/29, 5/1, and 5/2/2010 were

requested for review. A review of the six days

revealed the facility failed to have an adequate

number of staff to meet the patient needs, as

identified on the acuity/staffing records, for all six

of the days reviewed. The shortage of staff

ranged from 1 to 4 staff.

On 4/26/10 the patient census was 16; (-2 staff)


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1 patient was assessed at a level 0 and required

a 1:1 staff;

2 patients were assessed at a level 1, and

required constant redirection and every 30 minute

observations.

13 patients were assessed at a level 2.

According to the staffing record although 12 staff

were required to meet the acuti needs of the

patients, only 10 staff were scheduled/provided

for the 24 hours.

On 4/27/10 patient census was 17; (-4 staff)

2 two patients were assessed at a level 0, both

requiring a 1:1 staff;

2 patients were assessed at level 1 and required

every 30 minutes observations;

12 patients were at a level 2 (moderate assist);

and

1 patient was a level 3 (stable).

According to the staffing record 14 staff were

required to meet the needs of the patients,

however, only 10 staff were scheduled/provided

for the 24 hours.


1 patient was a level 0 (1:1)

4 patients were assessed at a level 1, this

included 2 new admissions and 2 potential

admissions coming in ( require every 30 minutes

observations);

9 patients at a level 2 (moderate assist); and


According to staffing/acuity records 11.92 staff

were required to meet the needs of the patients,


for the 24 hours.

A review of the assignment sheets for 4/28/10


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with LN5 verified that 3 staff worked the second

shift (p.m.-a.m.). One of the 3 staff would be

assigned to do the 1:1 patient observations,

leaving the other two staff to complete the every

30 observations, and the other duties assigned to

the shift, including the two new admissions. Staff

interview on 1/12/11 at 2:30 p.m. with LN5 and

LN2 verified that only 3 staff was not an adequate

number of staff to meet all of the patients care

needs and complete all of the duties required for

the second shift.

On 4/29/10 patient census was 16;(-2 staff)

1 patient at a level 0;

2 patients were a level 1

12 patients were level 2

1 patient was a level 3. Per the daily acuity

system 12 staff were needed for the patient's

needs, however only 10 staff were

scheduled/provided for the 24 hours.

On 5/1/10 patient census was 15; ( - 1.5 staff)

1 patient at a level 0

1 patient at a level 1 (new admit)

13 patients at a level 2. per the daily acuity

system rating 10.66 staff were required, however

only 9.41 staff were scheduled/provided for the

24 period.

On 5/2/10 patient census was 16; (-2.29 staff)

2 patients at a level 0 required 1:1


12 patients at a level 2 and

1 patient at a level 3. Per the daily acuity 12.42

staff were required to meet the needs of the

patients, however, on 10.13 staff were

scheduled/provided for the 24 hour period.


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Interview with two licensed nursing staff (LN5

and Ln 2) on 1/12/11 at 2:00 p.m. verified that the

acuity rating of the patients is done only once a

day and if a patient's condition becomes more

acute and the acuity changes additional staff can

be called in. Both nurses verified that they are

"frequently" asked to do overtime.

When asked if the current acuity/staffing system

has been evaluated to ascertain if the system

was still effective both nurses stated that there

has been no evaluation or revision of the current

system "for as long as I have been here" (over 8

years). Staff interview verified that no data was

collected or analyzed to evaluate the current

patient classification system/staffing to ensure it

was effective in meeting the needs of the

patients.

A 288 482.21(c)(2) QAPI FEEDBACK AND LEARNING

[Performance improvement activities must track

medical errors and adverse patient events,

analyze their causes and] implement preventive

actions and mechanisms that include feedback

and learning throughout the hospital.


A 288

Based on hospital staff interview and review of

the facility's Quality Assurance/ Utilization

Committee minutes the hospital failed to ensure

that the results and summaries and trends of

reports were shared with administrative hospital

staff. The sharing of this information would allow

administrative staff to incorporate the information

into opportunities for modifying the way that the

hospital provides patient care.

Findings:


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Review of the hospital's Quality Assurance/

Utilization Committee minutes on 1/13/11

revealed 15 to 20 reports that had been provided

to the Committee, by the Acute Hospital during

the 2010 year. No trending of the 15 to 20

specific incidents, could be found in the Quality

Assurance/ Utilization Committee minutes, which

required any type of action to be taken by the

hospital. Interview with the Acute Hospital's DON

(Director of Nursing Services) on 1/13/11 at 9:30

a.m. revealed that the reports for the Hospital,

were collected by her and the Program Manager

and then forwarded to Quality Assurance (QA) for

analysis and trending. The DON also stated that

unless QA brings back specific trends of events

to the DON or the Program Manager, the DON

and the Program Manager receive no information

to assist them in modifying the way that the

Hospital provides patient care. The hospital's

DON and Program Manager confirmed that no

information about the incidents which they send

to QA have ever been brought back or shared

with them by QA to assist with the modification in

the way that patient care has been provided by

the hospital.

A 291 482.21(c)(3) QAPI SUSTAINED IMPROVEMENT

[The hospital must take actions aimed at

performance improvement and, after

implementing those actions, the hospital must

measure its success, and] track performance to

ensure that improvements are sustained.


A 291

Based on hospital staff interview, review of the

facility's Quality Assurance/ Utilization Committee

minutes and review of the facility's Medical


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Practice Committee minutes the hospital failed to

ensure that the results,trends, and summaries of

the incident reports were shared with

administrative hospital staff. The hospital had no

system in place to implement improvement

actions, measure it's success and track

performance to ensure improvements were

maintained as a result of the data from the

reports which had been gathered.

Findings:

Review of the hospital's Quality Assurance/

Utilization Committee minutes, Medical Practice

Committee and administrative staff interview on

1/13/11 revealed that the facility had no system

in place to implement improvement actions,

measure any of it's success and track

performance to ensure improvements as a result

of the hospital's reports. Interview with the Acute

Hospital's DON on 1/13/11 at 9:30 a.m. revealed

that the reports for the Hospital are collected by

her and the Program Manager and then

forwarded to Quality Assurance (QA). The DON

also stated that unless QA brings back specific

trends or issues to the DON or the Program

Manager, the DON and the Program Manager

receive no information to assist them with

modifying the way that the Hospital provides

patient care. The hospital's DON and Program

Manager confirmed that no information about the

incidents that are sent to QA have ever been

brought back or shared with them by QA.

Interview with the QA Manager on 1/12/11 at 3:00

p.m. and again on 1/13/11 at 5:11 p.m. revealed

that the hospital had not be aware of it's need to

implement improvement actions, measure it's

success with any system changes that had been


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implemented from the QA reports. The QA

Manager also indicated that the hospital did not

track performance improvements and ensure that

any changes were maintained.

A 297 482.21(d) QAPI PERFORMANCE

IMPROVEMENT PROJECTS

As part of its quality assessment and

performance improvement program, the hospital

must conduct performance improvement projects.


A 297


to ensure that performance improvement projects

were conducted.

Findings:

Review of documents provided by the facility

revealed the facility did not have documentation

of quality improvement projects being conducted,

reasons for conducting projects, or measurable

progress from the projects.

A 300 482.21(d)(3) QAPI PROJECT

DOCUMENTATION

The hospital must document what quality

improvement projects are being conducted, ...


A 300

Based on review of documents the hospital failed


were conducted.

Findings:




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DOCUMENTATION

[The hospital must document what quality

improvement projects are being conducted,] the

reasons for conducting these projects and...


A 301



were conducted.

Findings:







DOCUMENTATION

[The hospital must document what quality

improvement projects are being conducted the

reasons for conducting these projects, and] the

measurable progress achieved on these projects.


A 302



were conducted.

Findings:



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A 309 482.21(e) EXECUTIVE RESPONSIBILITIES

The hospital's governing body (or organized

group or individual who assumes full legal

authority and responsibility for operations of the

hospital), medical staff, and administrative

officials are responsible and accountable for

ensuring the following:


A 309


to ensure that the governing body, medical staff,

and administrative officials were responsible and

accountable for an ongoing Quality Assessment

and Performance Improvement (QAPI) program

to improve patient safety and patient care.

Findings:


revealed there was no documentation that an

ongoing program for quality improvement was

defined, implemented, or maintained. There was

no facility-wide QAPI program which addressed

priorities for improved quality of care and patient

safety including the reduction of medical errors.

A 340 482.22(a)(1) MEDICAL STAFF PERIODIC

APPRAISALS

The medical staff must periodically conduct

appraisals of its members.


A 340



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the medical staff periodically conducted

appraisals of its members.

Findings:

In an interview on 1/11/11 at 10 a.m. the medical

director stated that the medical staff conducted

peer review of its members. The medical director

also stated that as part of the appraisal

performance evaluations and chart reviews were

performed. However, no documentation of these

activities was provided.

A 341 482.22(a)(2) MEDICAL STAFF CREDENTIALING

The medical staff must examine credentials of

candidates for medical staff membership and

make recommendations to the governing body on

the appointment of the candidates.


A 341



the medical staff made recommendations to the

governing body on the appointment of

candidates.

Findings:


director stated that the medical staff made

recommendations to the governing body

regarding the appointment of candidates.

However, review of the Medical Practice

Committee meeting minutes did not disclose any

recommendations and no other documentation

was provided.

A 353 482.22(c) MEDICAL STAFF BYLAWS A 353


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The medical staff must adopt and enforce bylaws

to carry out its responsibilities. The bylaws must:


Based on observation, document review and

staff interview, the hospital failed to ensure that

the medical staff enforced its bylaws by

suspending members' privileges when medical

records were not completed within the prescribed

time period.

Findings:

The Medical Staff Bylaws, approved 7/1/10, were

reviewed on 1/11/11. Section 6.3.5 states in part:

"....A limited suspension in the form of withdrawal

of admitting and other related privileges until

medical records are completed, shall be imposed

by the Chief of Staff...."

During an interview with medical records staff 1

(MR) on 1/10/11 beginning at 2:10 p.m., she

stated that physicians are not suspended due to

delinquent records (those not completed within 30

days after discharge). The medical records staff

simply keep reminding physicians that records

need to be completed. During a concurrent tour

of the medical records office, a counter with a

wire basket full of records and 3-4 stacks of

records were observed. MR Staff 1 & 2 explained

that these were records waiting for medical,

nursing and allied health staff to complete.

An audit of the delinquent records was done on

1/11/11 and reviewed with MR Staff 1 on 1/12/11

at 9 a.m. There were 6 records lacking discharge

summaries that needed to be completed by a


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member of the medical staff, dating back to

11/29/10 discharge date. There were a total of

60 delinquent records lacking signatures by other

staff.

A 354 482.22(c)(1) APPROVAL OF MEDICAL STAFF

BYLAWS

[The bylaws must:]

(1) Be approved by the governing body.


A 354



the medical staff bylaws were approved by the

governing body.

Findings:


director stated that the medical staff bylaws had

been approved by the governing body. However,

no documentation of their approval was provided.

A 358 482.22(c)(5) MEDICAL STAFF

RESPONSIBILITIES

[ The bylaws must:]

Include a requirement that--

(i) A medical history and physical examination be

completed and documented for each patient no

more than 30 days before or 24 hours after

admission or registration, but prior to surgery or a

procedure requiring anesthesia services. The

medical history and physical examination must be

completed and documented by a physician (as

defined in section 1861(r) of the Act), an

A 358


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oromaxillofacial surgeon, or other qualified

individual in accordance with State law and

hospital policy.



to ensure that the medical staff bylaws contained

a requirement that a medical history and physical

examination be completed and documented for

each patient no more than 30 days before or 24

hours after admission.

Findings:

Review of the medical staff bylaws revealed no

documentation to indicate a requirement for the

completion of a medical history and physical

examination of each patient within the prescribed

timeframe.

A 359 482.22(c)(5) MEDICAL STAFF

RESPONSIBILITIES

[The bylaws must:]

[Include a requirement that --]

(ii) An updated examination of the patient,

including any changes in the patient's condition,

be completed and documented within 24 hours

after admission or registration, but prior to surgery

or a procedure requiring anesthesia services,

when the medical history and physical

examination are completed within 30 days before

admission or registration. The updated

examination of the patient, including any changes

in the patient's condition, must be completed and

documented by a physician (as defined in section

1861(r) of the Act), an oromaxillofacial surgeon,

A 359


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or other qualified licensed individual in

accordance with State law and hospital policy.



to ensure that the medical staff bylaws contained

a requirement that an updated examination of the

patient be completed, within 24 hours after

admission, when the medical history and physical

examination were completed within 30 days

before admission.

Findings:

Review of the medical staff bylaws revealed that

they did not contain a requirement for the

completion of an updated examination of the

patient within 24 hours after admission.

A 385 482.23 NURSING SERVICES

The hospital must have an organized nursing

service that provides 24-hour nursing services.

The nursing services must be furnished or

supervised by a registered nurse.


A 385

Based on staff interview and review of

administrative records, policies and procedures,

and quality assurance documentation it was

determined that the hospital failed to ensure the

hospital had an organized nursing service that

had an adequate number of licensed registered

nurses and other personnel to provide the

necessary care and services to meet the

identified needs of the patients, failed to ensure

nursing services were integrated into a hospital

wide QAPI program (Refer to A-392, A-263); the

hospital failed to ensure an ongoing assessment


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of N3's was completed by a registered nurse

(RN), and failed to ensure nursing plans of care

were developed for N4 Refer to A-395, A-396).;

the hospital failed to ensure that a licensed nurse

clarified stat (to be given now) medication orders

for (N4, and failed to ensure the physician was

notified by nursing or other authorized personnel,

that a prescribed medication was not available for

administration for N3 and N4 (Refer to A-405).

The hospital failed to ensure all nursing care and

treatments provided to N2 were accurately

documented on the patient's medical record

(Refer to A-438); and failed to ensure

medications were transcribed accurately and

administered as prescribed (Refer to 494).


resulted in the hospital's inability to ensure the

musing needs of the patients were consistently

met, and the provision of quality health care in a

safe environment.

A 392 482.23(b) STAFFING AND DELIVERY OF CARE

The nursing service must have adequate

numbers of licensed registered nurses, licensed

practical (vocational) nurses, and other personnel

to provide nursing care to all patients as needed.

There must be supervisory and staff personnel for

each department or nursing unit to ensure, when

needed, the immediate availability of a registered

nurse for bedside care of any patient.


A 392

Based on staff interview, document and record

review, the hospital failed to ensure an adequate

number of licensed nursing staff were

consistently available to provide the necessary

care and services to meet the needs of the


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patients.

Findings;

A review of the facility's patient acuity/staffing

policy and procedures on 1/11/11 at 10:00 a.m.

revealed... " Nursing general policies. Acuity

NG-2-0," effective 1/1/2000 and revised May

2006. According the policy the "daily nursing staff

and requirement based on patient acuity as

identified by levels of care. Patient acuity

determination will be identified daily to identify,

justify and guide the assignment of nursing staff.

The total staffing requires the scheduling of at

least one (1) registered nurse on each shift to

provide assess, assign, direct, and/or supervise

the care rendered by other nursing staff."

The facility utilizes patient criteria levels of 0

through 3.

A level 0 requires a 1:1 staff, patient is a high risk,

in restraints or seclusion, or the patient continues

to escalate despite frequent staff intervention.

A level 1 requires every 30 minutes observation

and includes; a new admit within 24 hours, patient

requires constant re-direction and limit setting.

A level 2 patient requires moderate assistance.

may have a special medical treatment, seizure

precautions, and may be verbally threatening or

provocative but no physical threats.

A level 3 patient requires only minimal prompts,

and is generally stable.

Interview with the Director of Nurses on 1/12/11

at 2:00 p.m. revealed that patient acuity

assessments are completed once a day at 11:30

a.m., and based on the assessment of each

patient, staffing needs are determined for the day.


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Most staff work 12 hour shifts ( 7a.m.-7p.m. and

7 p.m. to 7 a.m.), but at various times there is a

staff who works a variation of different hours,

such as 1 p.m. -11 p.m. or 7 a.m.- 5 p.m..

The patient acuity assessments/staffing sheets

for 4/26, 4/27,4/28, 4/29, 5/1, and 5/2/2010 were

requested for review. A review of the six days

revealed the facility failed to have an adequate

number of staff to meet the patient needs, as

identified on the acuity/staffing records, for all six

of the days reviewed.

On 4/26/10 the patient census was 16; (-2 staff)

1 patient was assessed at a level 0 and required

a 1:1 staff;

2 patients were assessed at a level 1, and

required constant redirection and every 30 minute

observations.

13 patients were assessed at a level 2.

According to the staffing record, although 12 staff

were required to meet the acuity needs of the 16

patients, only 10 staff were scheduled/provided

for the 24 hours.


2 two patients were assessed at a level 0, both

requiring a 1:1 staff;

2 patients were assessed at level 1 and required

every 30 minutes observations;

12 patients were at a level 2 (moderate assist);

and


According to the staffing record 14 staff were

required to meet the needs of the patients,


for the 24 hours.


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1 patient was a level 0 (1:1)

4 patients were assessed at a level 1, this

included 2 new admissions and 2 potential

admissions coming in ( require every 30 minutes

observations);

9 patients at a level 2 (moderate assist); and


According to staffing/acuity records 11.92 staff

were required to meet the needs of the patients,


for the 24 hours.

A review of the assignment sheets for 4/28/10

with LN 5 verified that 3 staff worked the second

shift (p.m.-a.m.). One of the 3 staff was assigned

the 1:1 patient observations, leaving the other two

staff to complete the every 30 observations (on 4

patients), and the other patient care duties as

assigned. Staff interviews on 1/12/11 at 2:30 p.m.

with LN 5 and LN 2 revealed that 3 staff was not

an adequate number of staff to meet all of the

patient care needs, and complete all of the duties

necessary for the second shift.

On 4/29/10 patient census was 16;(-2 staff)

1 patient at a level 0; required 1:1

2 patients were a level 1

12 patients were level 2

1 patient was a level 3. Per the daily acuity

system 12 staff were needed for the identified

patients needs, however, only 10 staff were

scheduled/provided for the 24 hours.

On 5/1/10 patient census was 15; ( - 1.5 staff)

1 patient at a level 0; required 1:1


13 patients at a level 2. Per the daily acuity


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system rating 10.66 staff were required, however

only 9.41 staff were scheduled/provided for the

24 period.

On 5/2/10 patient census was 16; (-2.29 staff)

2 patients at a level 0; required 1:1


12 patients at a level 2 and

1 patient at a level 3. Per the daily acuity 12.42

staff were required to meet the needs of the

patients, however, on 10.13 staff were

scheduled/provided for the 24 hour period.

Interview with two licensed nursing staff (LN 5

and LN 2) on 1/12/11 at 2:00 p.m. verified that the

acuity rating of the patients is done only once a

day, and if a patient's condition becomes more

acute and the acuity changes, additional staff can

be called in. Both nurses verified that they are

"frequently" asked to do overtime.

A review of the acuity/staffing sheets for an

additional 15 days with LN 5 on 1/12/11 at 3:00

p.m. (including 12/21, 12/22,12/23, 12/27, 12/28,

12/30/2010 and 1/2,1/4, 1/5,1/6, 1/7, 1/8, 1/9,

1/10 and 1/11/2011) revealed that on 7 of the 15

days reviewed the facility failed to have an

adequate number of staff on duty to meet the

needs of the patients. The staff shortage ranged

from 1 to 3.5 staff.

When asked if the current acuity/staffing system

had been evaluated to ascertain if the system

was still effective, both nurses stated that there

has been no evaluation or revision of the current

system "for as long as I have been here" (over 8

years). Staff interview verified that no data was

collected or analyzed to evaluate the current


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patient classification system/staffing to ensure it

was effective in meeting the needs of the

patients.

A 395 482.23(b)(3) RN SUPERVISION OF NURSING

CARE

A registered nurse must supervise and evaluate

the nursing care for each patient.


A 395

Based on record review and staff interview, the

hospital failed to ensure an assessment of N3's

medical problems was completed on an ongoing

basis by a registered nurse (RN) to ensure the

patient's needs were being met. (1 of 11 sampled

patients).

Findings;

A review of the medical record for patient N3 on

1/11/11 beginning at 12:10 p.m. revealed the

patient was admitted to the hospital on 5/3/10 at

3:16 p.m.. The patient's diagnoses included

asthma and orthostatic hypotension (postural

hypotension). The admission physician's orders

included an order for Flovent twice a day (a

medication given in the maintenance treatment of

asthma), and an order for a prn (as needed)

Albuterol inhaler (used to treat bronchial spasms).

Although the patient's asthma and orthostatic

hypotension were identified identified medical

problems for the patient there was no

documentation in the record to indicate an

ongoing assessment and evaluation of the

patient's identified medical problems was

completed. Interview with LN 1 on 1/12/11 at

10:30 a.m. revealed that an assessment of the


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patient's current medical problems should be

documented in the the interdisciplinary progress

notes. Review of the medical record with LN1

verified that the record contained no

documentation to indicate the patient's medical

conditions were assessed and evaluated on an

ongoing basis.

A 396 482.23(b)(4) NURSING CARE PLAN

The hospital must ensure that the nursing staff

develops, and keeps current, a nursing care plan

for each patient.


A 396

Based on observation, document and record

review and staff interview the hospital failed to

ensure nursing plans of care were developed for

N4 (1 of 11 sampled patients).

Findings

Medical record review beginning on 1/11/11 at

11:45 a.m. reflected N4 was admitted on

10/22/10. Admitting diagnoses included altered

thought process, mood lability, bilateral leg

edema, high blood pressure, hypothyroidism ,

history of breast cancer and a right mastectomy.

The nursing admission assessment dated

10/22/10 reflected that N4 had a "red" rash on

both legs, poor nutrition, pain, high blood

pressure, edema, and numbness and tingling in

feet and hands.

There were no careplans initiated upon admission

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8 a.m. revealed that N4 was admitted with a

compression sleeve on her arm to assist with her

arm edema. This information was not captured on

any careplan nor documented in any progress

notes. She did not have edema on her arm when

admitted. N4 lost the compression sleeve, but,

there was no way to determine the length of time

the compression sleeve was lost, as there was no

documentation . Over time N4 developed right

arm lymphadema. A new compression sleeve

was applied on 1/8/11. LN 2 agreed there were

no care plans initiated upon admission that

addressed the medical needs for N4. There was

a lack of documentation and assessment of N4's

right arm upon admission.

A 405 482.23(c)(1) ADMINISTRATION OF DRUGS

All drugs and biologicals must be administered

by, or under supervision of, nursing or other

personnel in accordance with Federal and State

laws and regulations, including applicable

licensing requirements, and in accordance with

the approved medical staff policies and

procedures.


A 405

Based on medical record review, interview and

policy and procedure review, the hospital failed to

ensure that the licensed nurse clarified stat (to be

given now) medication orders for 1 of 11 sampled

patients (N4), and failed to ensure the physician

was notified by nursing or other authorized

personnel, that a prescribed medication was not

available for administration and was not given as

prescribed for 2 of 11 sampled patients (N3 and

N4). (Refer to A-501)

Findings:


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Review of the facility's policy and procedure titled

"Drug Availability" reflected the following, in part,:"

The Pharmacy Service shall be available 24

hours a day, seven days a week. If a physician

orders a drug that is not available in the facility's

Medication Room, the following procedure is to

be observed:

Notify the attending physician or contact the

on-call physician to see if an alternate medication

can be used. If an alternate medication is

acceptable the physician should give a new

medication order. this mediation order must be

signed by a physician within 24 hours. The

decision to change medications should be

documented in the nursing progress notes..."

1. Review of the the medical record for Patient N3

beginning on 1/11/11 beginning at 12:10 p.m.

revealed the patient was admitted to the hospital

on 5/3/10 with diagnoses including asthma and

hypertension. The patient's admission physician's

orders, written at 6:00 p.m., included the

medication Flovent ( used in the maintenance

treatment of asthma) to be given twice a day.

The order was noted by nursing personnel, along

with a notation that the Flovent medication would

be delivered "tomorrow."

A review of the patients medication administration

record revealed a notation that the Flovent was

'not available." There was no documentation to

indicate the physician was notified that the

patient's asthma medication was not available for

administration as ordered.

2. Review of medical record for Patient N4


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beginning on 1/11/11 at 11:45 a.m. reflected an

admission date of 10/22/10. Admitting diagnoses

included altered thought process, mood lability,

bilateral leg edema, high blood pressure,

hypothyroidism , history of breast cancer and a

right mastectomy.

Physician orders dated 10/27/10 reflected " Give

Ativan (anti-anxiety) 2 mg (milligram) and Abilify

(antipsychotic) 15 mg IM (intramuscularly) Stat

(right away)". The order was noted by nursing

personnel and a notation reflected that the Abilify

medication was not available from pharmacy.

The medication administration record (MAR)

reflected that the Ativan was given at 2:50 p.m.

However, a notation on the MAR indicated the

Abilify was not available. There was no

documentation to indicate the Abilify was ever

administered or that communication with the

physician took place to clarify the order and

inform the physician the Abilify was not available.


8 a.m. revealed that there was no indication that

the order was ever clarified. Since the medication

was not available, there should have been

communication with the physician along with

documentation to reflect the clarification.

Review of the policy and procedure titled "Drug

Availability" reflected the following, in part,:" The

Pharmacy Service shall be available 24 hours a

day, seven days a week. If a physician orders a

drug that is not available in the facility's

Medication Room, the following procedure is to

be observed:


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Notify the attending physician or contact the

on-call physician to see if an alternate medication

can be used. If an alternate medication is

acceptable the physician should give a new

medication order. this mediation order must be

signed by a physician within 24 hours. The

decision to change medications should be

documented in the nursing progress notes..."

A 432 482.24(a) ORGANIZATION AND STAFFING

The organization of the medical record service

must be appropriate to the scope and complexity

of the services performed. The hospital must

employ adequate personnel to ensure prompt

completion, filing, and retrieval of records.


A 432

Based on document review and staff interview,

the hospital failed to ensure that the Medical

Record Administrator had the qualifications as

required by the job description; and that the

medical record service's policies and procedures

were approved and an accurate description of the

current services.

Findings:

1. The job description for the Medical Record

Administrator was reviewed on 1/11/11. The

position requires either a Registered Health

Information Administrator (RHIA) or a Registered

Health Information Technician (RHIT) credential.

During an interview with MR Staff 1 on 1/10/11

beginning at 2:10 p.m., she stated that she was

an RHIT and she was asked for her most recent

credential validation certificate. This certificate is

evidence that an individual has obtained the

minimum required number of hours of continuing


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education (CE) credits in a 2-year cycle, and it is

required in order to retain the RHIT credential.

The personnel file of MR Staff 1 was reviewed on

1/11/11 and no evidence of a current CE

validation was in the file. On the afternoon of

1/12/11, she explained that she had not

submitted her CE report for the last two cycles,

resulting in a need to reinstate her credential.

2. The Medical Records Policy and Procedure

(P&P) Manual was reviewed on 1/11/11. There

was no evidence of annual approvals, as required

by the administrative policy, "Review and

Approval of Psychiatric Health Facility Policy and

Procedures" (effective 6/4/08). The majority of

the P&Ps were last reviewed in October, 2000

and were not reflective of current practices. For

example, medical records were no longer stored

with the off-site company as stated and there was

no mention of the current record archives area.

On 1/12/11 beginning at 9:30 a.m., during an

interview with MR Staff 1, she stated that the P&P

Manual had been reviewed and approved

annually; however, no evidence was provided by

the end of the survey.

A 438 482.24(b) FORM AND RETENTION OF

RECORDS

The hospital must maintain a medical record for

each inpatient and outpatient. Medical records

must be accurately written, promptly completed,

properly filed and retained, and accessible. The

hospital must use a system of author

identification and record maintenance that

ensures the integrity of the authentication and

protects the security of all record entries.


A 438


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Based on record review and staff interview the

hospital failed to maintain accurately

documented, and complete medical records for

N2 and N3 (2 of 11 sampled patients) .

Findings;

1. A review of the medical record for patient N2

on 1/11/11 beginning at 11:35 a.m. revealed the

patient was admitted to the hospital on 4/28/10 at

9:45 p.m. and expired on 4/29/10 at 1:45 a.m..

There was no primary admission diagnosis

documented on the "Psychiatric admission

orders" dated 4/28/10 at 2145 (9:45 p.m.).

A review of N2's "Routine assessment of Patient

Progress", an assessment to be completed upon

admission, revealed the assessment was

incomplete. The assessment was not dated or

signed by the person who completed the

assessment.

2. A review of the facility's policy and procedure

titled "Restraint and Seclusion" dated 12/5/04

included the use of "emergency involuntary

medications." According to the facility policy and

procedure.."the use of emergency involuntary

medication" requires a physician's order. "The

order is to include the symptoms for which the

medication is to be given", and a "statement" that

the patient is a "danger to self and/or others."

According to medical record documentation N2

was admitted to the hospital in restraints on

4/28/10 at 2145 (9:45 p.m.). Physician's orders

received at that time stated.."put pt (patient) in

seclusion and restraints", and "Give Zyprexa 10

mg IM now." A subsequent physician's order


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written on 4/28/10 at 2355 (11:55 p.m.) stated,

"Give Zyprexa 10 mg IM now, one time order"

and "Give Ativan 2 mg. IM now one time order."

The two orders written for the use of emergency

medications were incomplete, and did not reflect

the facility's policy and procedures. The orders

failed to specify the symptoms for which the

medications were to be given, and failed to

identify whether the patient was a danger to self

and/or others.

3. According to facility's policy and procedure

titled "Event of Patient Death" effective Feb.

1998, Revised May 2006.....

#1. Only a physician may pronounce a patient

deceased.

#2. The physician should notify the deceased

patient's family of the patient death, and

determine from them which mortuary is to be

called.

#3. When an autopsy is desired, the physician or

social worker must obtain consent.

#9. The nursing observation should include the

time respiration ceased, the time the physician

pronounced the patient dead, which physician,

which member of the family was notified, the

disposition of the body, the property and the

valuables. If resuscitation was attempted, include

all measures taken.

The patient's record contained one

interdisciplinary progress note (IDT)dated

"4/28/10" and timed only as "admit 2145."

According to the documentation the patient was

admitted from an acute hospital emergency room

(ER), on an involuntary hold, via ambulance. The

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restraints and remained in restraints (type was

not specified) and seclusion following admission

to the facility. The patient was described as

"agitated and screaming at staff." The patient

remained restraints, in seclusion, in an

observation room. The nursing interdisciplinary

progress notes described the patient as "yelling"

and "screaming" at staff and "pulling at the

restraints." Per the notes the patient was

uncooperative with staff during attempts to

provide personal care.

The interdisciplinary progress note

documentation states "4/28/10 admit. Pt (patient)

noted to have O (no) respiration at + - 0115. 911

called, CPR started, Paramedics arrived. Pt.

expired. Supervisor notified. Dr. M.., Dr. F... LZ

notified."

The record contained no documentation

describing what "CPR" interventions were

implemented, what care was provided to the

patient, when and by whom. There was no

documentation to reflect the patient's responses

to the interventions and care provided.

The record stated "paramedics arrived."

However, there was no documentation to indicate

when they arrived and what care, treatment and

interventions were initiated. There was no

documentation in the patients record to indicate

what the patient's response was, if any, to

interventions implemented by the paramedics.

Per the IDT documentation by the licensed

nurse... "Pt. (patient) expired." The

documentation was incomplete, not timed and

failed to reflect the facility's policy and procedure.


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There was no documentation in the patients

record that a physician pronounced the patient

deceased, per policy. The record contained no

documentation to indicate a physician attempted

to notify the deceased patient's family of the

patient death, and determine from them which

mortuary is to be called. There was no

documentation in the record to indicate if an

autopsy was desired, or if the physician or social

worker obtained consent. The nursing

observations failed to include the time respiration

ceased, the time the physician pronounced the

patient dead, which physician, which member of

the family was notified, the disposition of the

body, the property and the valuables. If

resuscitation was attempted, there was no

documentation to include all the measures taken.

4. A review of the medical record for patient N3

on 1/11/11 at 12:10 p.m. revealed the patient was

admitted on 5/3/10 at 3:16 p.m.. A review of the

admission record, completed by the on-call

psychiatrist, revealed the form was incomplete.

The form was not dated, timed, or signed. The

history and physical, completed on the patient on

5/4/10 indicated the patient had "no allergies",

yet the admission physicians orders state the

patient has allergies to "Ativan, latex, codeine,

demerol, geodon and allerall."

A 450 482.24(c)(1) MEDICAL RECORD SERVICES

All patient medical record entries must be legible,

complete, dated, timed, and authenticated in

written or electronic form by the person

responsible for providing or evaluating the service

provided, consistent with hospital policies and

procedures.

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Based on medical record review and staff

interview, the facility failed to ensure that medical

record entries were complete (with time, date and

patient identifier) in 4 of 4 records reviewed

(R1,R2, R3, R4).

Findings:

Records R1 through R4 were reviewed 1/12/11.

The following findings were confirmed with MR

Staff 1 on1/12/11 beginning at 9:30 a.m.:

1. Physician progress notes that did not

document the time the notes were written, as

required by the pre-printed area on the form (R 1,

2, 3, 4). Physician orders were not timed (R1, 3,

4).

2. The Admission Evaluations did not state the

date the evaluation was performed (R2, 3, 4).

3. The Informed Consent for Psychotropic

Medications was not dated when signed by the

physician (R1); and not dated when signed by the

patient (R2).

4. The Psychiatric Admission Assessment

contained abbreviations (DTS, OD, CPT, SA) that

were not on the approved list (RI).

5. The Daily Nursing Assessment Flowsheet did

not contain any patient identification on the back

sides of the forms (R1, 2, 3, 4).

6. A discharge summary had been electronically

signed by the physician; however the facility did

not have an acknowledgement statement signed

by the physician to ensure that the individual is

indeed the one who electronically authenticated

the report. (R1).

7. The Admission Evaluation did not document

the actual date the evaluation was performed


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(R2, 4).

8. A telephone order was not dated and timed

when the physician signed it (R2).

A 490 482.25 PHARMACEUTICAL SERVICES

The hospital must have pharmaceutical services

that meet the needs of the patients. The

institution must have a pharmacy directed by a

registered pharmacist or a drug storage area

under competent supervision. The medical staff

is responsible for developing policies and

procedures that minimize drug errors. This

function may be delegated to the hospital's

organized pharmaceutical service.


A 490

Based on observation, interview, and document

review the hospital failed to ensure that

Pharmaceutical Services met the needs of all of

it's patients as evidenced by failure to:

1. To ensure that the Pharmacy services were

administered in accordance with the facility's

policy and procedures and that the facility's

Medical Staff Committees had approved the

facility's Pharmacy policy and procedure manual.

(Refer to A-491).

2. To ensure that the facility administered drugs

and biologicals in accordance with Federal and

State laws and regulation, and inaccordance with

approved medical staff policies and procedures.

(Refer to A-405)

3. To ensure patient safety with the distribution of

drugs in accordance with standards of practice

(including the facility's own policies and

procedures). (Refer to A-500).


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4. To ensure that medications were dispensed

under the supervision of a pharmacist and

consistent with Federal laws. (Refer to A-501).

5. To ensure that outdated and mislabeled drugs

were not available for patient use. (Refer to

A-505).

6. To ensure that medications were renewed in

compliance with the facility's stop order policies

and procedures. (Refer to A 507).

7. To ensure that all medication errors were

reported to the attending physician and the

hospital-wide quality assurance program. (Refer

to A-508).

8. To ensure that any losses of controlled

substances were reported to the individual

responsible for pharmaceutical service and to the

chief executive officer. (Refer to A-509).

9. To ensure that the facility had established a

formulary system for the hospital and it's staff to

use. (Refer to A-511).

10. Evaluate the services that were being

provided by the facility's contracted Pharmacy

service. (Refer to A- 84).

11. To analyze medication errors, to implement

preventive actions, and mechanisms which

included feedback and learning for the hospital

and it's employees. (Refer to A-288).

12. To ensure that systems were in place to

implement improvement actions, measure the


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success of these improvement actions, measure

success, track performance, and to ensure that

any success obtained as a result, were

maintained. (Refer to A-291).


resulted in the inability of the hospital to provide

pharmaceutical services and ensure client safety

in such a manner that the pharmaceutical needs

of the patients were met in accordance with the

facility's own policies and procedures, Federal

law, and applicable standards of practice.

A 491 482.25(a) PHARMACY ADMINISTRATION

The pharmacy or drug storage area must be

administered in accordance with accepted

professional principles.


A 491

Based on review of the hospital's Medical Staff

Committee minutes, interview with the hospital's

Medical Director, and the Program Manager, the

hospital failed to ensure that the hospital's

Pharmacy Policy and Procedure manual was

approved by any of the hospital's medical staff

committees. The hospital failed to ensure that the

contracted Pharmacy provider was able to

provide all the necessary services which are

required for an Acute Care Hospital. The hospital

failed to ensure that policies and procedures

which are outlined in this manual were being

implemented into the hospital's practices. Review

of the hospital's only medication refrigerator log,

the Pharmacist medication regimen review and

facility staff interview revealed that the hospital

failed to ensure that the medication refrigerator

was maintained between 36 and 46 degrees

Fahrenheit, and that actions were taken by staff


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when the refrigerator was out of range. The

facility's administrative staff also failed to take

corrective actions when this issue of refrigerator

temperatures being maintained out of range, was

brought to administrations attention on several

occasions by the hospital's Pharmacist, this could

alter the integrety of the refrigerated drugs.

Findings:

1. Inspection of the hospital's Pharmacy Policy

and Procedure manual on 1/11/11, which was

labeled: "Nursing Care Center Pharmacy Policy

and Procedure Manual", contained a document

entitled:" Pharmacy Policies and Procedures

Annual Authorization". The document read: "The

nursing care center's Pharmacy Services

Subcommittee/Pharmaceutical Services

Committee/Quality Assessment and Assurance

Committee/ or its equivalent, on this the day

of...hereby approve and adopt the following

policies and procedures as amended by the

nursing care center in accordance with nursing

care center standards and state and federal

regulations. The hospital's failure to address

these out of range refrigerator temperatures may

have altered the integrety of all of the facility's

refrigerated drugs and biologicals.

All medical, nursing and pharmacy staff shall be

inserviced on and have access to this manual."

Not only does this facility not have any of the

Committees identified above, but the facility's

Medical Staff Committees had no oversight on

any approval of this Pharmacy policy and

procedure manual. The remainder of the


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Authorization page had signature lines for the

following administrative staff: Administrator,

Director of Nursing, Medical Director or physician

designee, and the Consultant Pharmacist. This

page was completely blank, indicating that this

policy and procedure had not been reviewed by

the facility's administrative staff or the Consultant

Pharmacist. Interview with the hospital's Program

manager on 1/11/11 at 10:35 a.m. revealed that

this manual was the hospital's official Pharmacy

policy and procedure manual. Interview with the

hospital's Medical Director on 1/12/11 at 11:15

a.m. revealed that no one could provide proof that

this policy and procedure had been reviewed by

any of the hospital's administrative staff or any of

the facility's Medical Staff Committee's prior to its'

use in the facility. The blank copy of the facility's

"Pharmacy Policies and Procedures Annual

Authorization form had accurately reflected the

hospital's failure to approve this Pharmacy policy

and procedure manual.

2. Review of the hospital's Pharmacy policy and

procedure manual introduction page stated the

following information indicating that this

Pharmacy provider only services "Long Term

Care" facilities: "XXXX (the Pharmacy's name

was removed) Corporation specializes in

long-term care pharmacy, providing medications,

consulting programs, regulatory assistance and

related services to long-term care residents in

skilled nursing, sub-acute and assisted living

settings nationwide....XXXXX (the Pharmacy's

name was removed) Corporation has compiled

this collection of policies and procedures as a

basic practice guideline for pharmaceutical

services for the professional nurse in a long-term

care setting....The responsibility for ensuring the


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accuracy of any provision and updating of the

procedures for compliance within your nursing

care center remains with you."

The introduction in this manual confirms that this

Pharmacy does not provide services for a facility

certified as an Acute Care Hospitals, which this

hospital is currently certified as and has been

certified as for many years. As a result of this

information, the hospital's Pharmaceutical

services were not the same as the

Pharmaceutical services which are being

provided at other Acute Hospitals. Interview with

the facility's Program Manager and the facility's

Director of Nurses on 1/13/11 at 5:10 p.m.

confirmed that the services that the facility was

receiving from the Pharmacy provider above,

were not meeting the hospital's expectations and

needs.

3. Review of the hospital's Pharmacy policy and

procedure manual on 1/13/11 at 2:00 p.m.

revealed a policy and procedure entitled:"Black

Box Warning Medications". The policy states:"...1.

Nursing Staff shall refer to "Black Box" Warning

Monitoring Guidelines...". No such monitoring

guidelines could be provided by the facility.

Interview with LN5 on 1/13/11 at 2:15 p.m.

revealed that about one year ago, nursing staff

were provided with medication side effect and

other important drug information documents

which could be given to patients who were being

discharged from the facility. LN5 went on to say

during the interview that she would provide any

patient with the information that she remembered

about each drug.

Interview with LN2 on 1/13/11 at 2:18 p.m.

revealed that she too would do the same, in


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regards to providing her patient drug information

based on her memory of the drugs which were

being dispensed. Nursing staff indicated that the

information about the drugs which was shared

with the patients at the time of discharge, would

not always be consistent from nurse to nurse.

LN5 indicated that the facility's Pharmacy use to

send the facility standardized drug information

sheets for reference and to be provided to the

discharge patient for the sake of consistency.

Both Nursing staff indicated that they missed the

fact that Pharmacy was no longer providing them

with these standardized drug information sheets,

for the nurses to share this information with the

patients at discharge for consistency.

4. Review of the facility's Pharmacy policy and

procedure manual on 1/12/11 revealed a policy

and procedure entitled: "Emergency Pharmacy

Service and Emergency Kits", which

read:"....Emergency needs for medication are met

by using the nursing care center's approved

emergency medication supply or by special order

from the provider pharmacy...". The hospital did

not have an approved list of emergency drugs for

use. The same Pharmacy policy and procedure

goes on to say:" 3. The provider pharmacy

supplies emergency or "stat" medications/items

according to the provider pharmacy

agreement...".

The hospital's pharmacy agreement

states:"Services to be provided by Contractor: A.

Check and replenish "stock" medications and

emergency box". Interview on 1/12/11 at 3:50

p.m. with one of the hospital staff nurses revealed

that the only emergency supplies that the facility

had for Diabetic emergencies was oral glucose


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tubes which could not be administered for an

unconscious patient. The pharmacies policy and

procedure manual did not indicate what

emergency drugs should be present in the facility.

5. The hospital's Nursing policy and procedure

entitled: "Nursing -Medications", reads: "A

refrigerator will be housed in the Medication

Room for the storage of medications. The

temperature of the refrigerator will be maintained

between 2.2 degrees C (36 degrees F) and 7.7

degrees C (46 degrees F)....B. The refrigerator

will be defrosted and cleaned monthly by the

evening shift. C. The temperature of the

medication refrigerator will be checked daily and

a log maintained of daily temperatures noted. The

log will be kept on top of the medication

refrigerator. The refrigerator temperature shall be

between 2.2 degrees C (36 degrees F) and 7.7

degrees C (46 degrees F)."

Review of the hospital's Pharmacy policy and

procedure entitled: "Medication Storage", reads:

"...11. Medications requiring "refrigeration" or

"temperatures between 2 degrees C (36 degrees

F) and 8 degrees C (46 degrees F)" are kept in a

refrigerator with a thermometer to allow

temperature monitoring....".

Review of the hospital's refrigerator temperature

log on 1/12/11 at 4:00 p.m. revealed that following

recorded temperatures below 36 degrees

Fahrenheit between April 2010 to January 2011:

1) on 4/4/10 and 4/5/10 the temperature was

recorded as 34 degrees Fahrenheit without any

corrective action being documented on the log, 2)

on 4/9/10 the temperature was recorded as 34

degrees Fahrenheit without any corrective action


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being recorded on the log, 3) on 4/10/10, 4/11/10,

4/14/10, 4/19/10, 4/24/10 and 4/28/10 no

refrigerator temperatures were recorded on the

log, 4) between 4/21/10 to 4/26/10 (for at least 5

days) the refrigerator temperatures were

documented as 34 degrees Fahrenheit, 5) on

5/1/10, 5/4/10, 5/6/10, 5/15/10, and 5/17/10 no

refrigerator temperatures were recorded on the

medication refrigerator's temperature log, 6) on

5/3/10 and 5/10/10 the temperature was recorded

as 35 degrees Fahrenheit and on 5/5/10 the

refrigerator temperature was recorded as 32

degrees Fahrenheit (which is freezing), 7) for the

remainder of 5/10, the refrigerator temperature

was recorded at 34 degrees Fahrenheit for 8

days, 8) for 6/10 the refrigerator temperature was

recorded below 36 degrees Fahrenheit for 5

days, 9) for 7/10, the refrigerator temperature was

recorded below 36 degrees Fahrenheit for 6 days

and no temperature was documented during this

month for an additional 5 days that month, 10) for

8/10, the refrigerator temperature was recorded

below 36 degrees Fahrenheit for 8 days and no

temperature was documented on the refrigerator

log for an additional 6 days that month,11) for




log for an additional 10 days that month, 12) for











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below 36 degrees Fahrenheit for 4 days (with

temperatures documented as low as 30 degrees)

and no temperatures were documented on the

refrigerator log for numerous days that month,

and 15) for 1/1/11 to 1/12/11 the refrigerator

temperature was recorded below 36 degrees

Fahrenheit for 2 of 12 days and no temperature

was documented on the refrigerator log for an

additional 4 of 12 days that month.

Nursing staff failed to ensure that the medication

refrigerator temperatures were maintained in

accordance with the hospital's policies and

procedures. Hospital staff failed to document on

the refrigerator temperature log daily, as indicated

in the facility's policy and procedure. Review of

the facility's Pharmacy and Nursing polices or

procedures, provided the facility staff with

direction or guidance as to what they should do

when refrigerator temperatures were not

maintained between 36 F to 46 F. Interview with

at least three of the facility's day shift nursing staff

on 1/12/11 at 4:00 p.m. revealed that none of the

staff knew how to adjust the medication

refrigerator's temperature or what to do when the

refrigerator might be in need of repair.

Review of the hospital's Pharmacist monthly

medication report on 1/13/11 at 3:00 p.m.

revealed that the Pharmacist had reported to the

facility in 4/10 that there was ice in the Insulin (a

drug used to treat diabetes) storage box, in the

same report the Pharmacist reported that the

refrigerator temperature was 32 degrees

Fahrenheit and that she had asked the hospital's

administrative staff to correct the refrigerator's

freezing temperature.


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Again in 8/10, the hospital's Pharmacist reported

that the insulin 70/30 (which had been stored

inside the refrigerator) was encased in ice. The

Pharmacist also noted at that time that there was

ice build up in the refrigerator for a second time,

and requested that administrative staff take

action to correct this issue. In the Pharmacist's

report dated 9/10, the Pharmacist stated that the

refrigerator temperature was again 32 degrees

Fahrenheit and that this was her second time in

the last month for requesting administrative staff

to correct the freezing temperature of the

medication refrigerator. The freezing

temperatures of this medication refrigerator

continued into 1/11 without any correction, or

action being taken by the hospital's administrative

staff.

A 494 482.25(a)(3) PHARMACY DRUG RECORDS

Current and accurate records must be kept of the

receipt and distribution of all scheduled drugs.


A 494

Based on review of the hospital's Narcotic

Control form, review of the hospital's unusual

occurrence reports, and interview with facility

administrative staff, the hospital failed to use its

medication error data from their reports, to

change or modify the way that the hospital

provides services.

Findings:

Review of a hospital report on 1/12/11 involving

Vicodin (a scheduled narcotic) revealed that the

facility had concluded that the loss of a tablet was

due to "Overcrowding" in the narcotic storage


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area and because medications were being

stored inside of large bubble packs. Interview with

facility nursing staff on 1/12/11 at 2:10 p.m.

revealed that the facility has had a difficult time

with controlled drugs falling out of the backs of

the narcotic bubble packs for a while. Facility staff

also indicated that the loss of narcotics from this

supply (the narcotic cabinet), had occurred on a

regular frequency. Review of the hospital's

reports did not reveal any trends with the facility's

loss of controlled substances. Review of the

facility's monthly Consultant Pharmacist report

also failed to identify any concerns about the

facility's loss of controlled substances. A Narcotic

Control form was reviewed on 1/12/11 for Vicodin

(a scheduled narcotic) and the sheet indicated

that on 12/23/10 at 4:40 p.m. a dose of Vicodin

was going to be administered to a patient, but it

was wasted. The dose of Vicodin which had been

wasted only had one signature on the narcotic

control form, contrary to the hospital's policy and

procedure. Interview with one of the medication

nurses on 1/12/11 at 2:05 p.m. revealed that the

facilities policy and procedure was for two

different nurses to sign the Narcotic Control form

when a dose of a controlled substance was to be

wasted.

A 500 482.25(b) DELIVERY OF DRUGS

In order to provide patient safety, drugs and

biologicals must be controlled and distributed in

accordance with applicable standards of practice,

consistent with Federal and State law.


A 500

Based on clinical record review, document

review, and hospital staff interview the facility

failed to ensure that all patient discharge orders


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were written clearly and did not clarify these

discharge orders. The Pharmacy provider was

unable to provide discharge medications for all

the hospital's patients in a timely manner. The

hospital also failed to ensure that all drugs and

biologicals were accurately accounted for. The

hospital staff provided patients with discharge

medications, house stock medications were not

approved by the hospital's P&T Committee, the

list of house supply medications was incomplete,

the facility failed to develop a system for the

tracking of its house supply medications.

Findings:

1. Inspection of the facility's Drug Room and

drug storage area on 1/12/11 at 2:15 p.m.

revealed that the facility had established an

unapproved list of drugs which the facility referred

to as "House Supply". This "House Supply" was

for Controlled drugs as well as non-controlled

prescription and nonprescription medications.

This included injectable drug and consisted of

more than 70 different types of medications. The

list of drugs in both "House Supplies", had never

been approved for use by any of the facilities

Medical Staff oversight committees. Facility staff

and the DON indicated that the DON had decided

at some point in time, which medications the

facility would need to have in stock. For the

non-controlled prescription and over the counter

drugs the quantities on hand did not match the

quantities which were indicated on the master

"House Stock" medication list. Facility staff

indicated that any one who had access to this


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drug supply could walk out of the building and go

home with pockets full of these medications and

no one would miss them because the quantities

were not being monitored. Review of the

Controlled "House Supply" on 1/12/11 at 2:15

revealed the following drugs were not on the

facility's "House Supply" list, but despite not being

on the facility's list, they were still present in the

facility's narcotic locker: 1) Ambien 5 mg, 9

tablets, 2) Xanax 0.5 mg, 16 tablets, 3)

Phenobarbital (which on the facility's list

stated:"Do not Order", 32.4 mg 4 tablets, 4)

Norco 10-325 mg, 13 tablets, 5) Darvocet N-100,

13 tablets, 6) Dalmane 30 mg, 6 tablets, 7)

Tylenol #3, 16 tablets, and 8) Librium 10 mg, 10

tablets. The facility also had Chloral Hydrate 500

mg Softgels 10, on the facility's list, but none

were available for administration in the narcotic

cabinet.

2. Review of the hospital's controlled substance

drug storage area on 1/12/11 at 4:15 p.m.

revealed that almost 1/3 of the all of the

controlled substance bubble packs had tape on

the back of them. During an interview with LN 5

on 1/12/11 at 4:15 p.m. the nurse was asked why

so many of the bubble packs had tape on the

back of them. LN 5 responded that nursing staff

would find the medication hanging out of the back

of the card (almost ready to fall out of the card),

or the medication had already fallen out of the

bubble pack and into a bin or the counter space

inside the narcotic cabinet. Nursing staff would

put these tablets back into the bubble packs and

resealing the medications back into the bubble

packs using tape. The use of the tape to reseal

the bubble packs did not conform with standards

of professional practice.


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A 501 482.25(b)(1) PHARMACIST SUPERVISION OF

SERVICES

All compounding, packaging, and dispensing of

drugs and biologicals must be under the

supervision of a pharmacist and performed

consistent with State and Federal laws.


A 501

Based on review of the hospital's policy and

procedure and interview with the facility's Medical

Director, the facility failed to establish policies and

procedures which were reflective of the facility's

operational practices. The hospital staff provided

patients with discharge medications, house stock

medications were not approved by the hospital's

P&T Committee, the list of house supply

medications was incomplete, the facility failed to

develop a system for the tracking of its house

supply medications and the distribution of these

medications for 1 of 5 patients (P-5).

Findings:

1. Review of the clinical record for patient P-5 on

1/13/11 at 11:00 a.m. revealed the following

physician's order written on 12/30/10 at 10:05

a.m. :"Discharge home with own medications and

house stock medications". This medication order

was never clarified by nursing. Interview with

hospital nursing staff on 1/13/11 at 10:30 a.m.

revealed that when a patient is discharged from

the facility, the patient is provided (not directly

unless they are being discharged home) with a 7

day supply of the current medications that they

were receiving during the patient's stay in the

hospital. Several facility nursing staff also


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indicated that they have been asked to provide

the patients with the patient's own bubble pack of

medications which may have been mislabeled,

(as the directions for use on the label of the

bubble pack may not reflect the directions for use

that the patient is currently taking). Facility

nursing staff also indicated that they have had to

give patients "House Supply" medications on

discharge in order to ensure that patients are able

to take with them a 7 day supply of medications

on discharge from the hospital.

Facility nursing staff also indicated that patients

are usually discharged from the facility around

"Probable Cause Hearings", which usually take

place between 1:30 p.m. and 2:30 p.m. during

any given date. Based on the outcome of these

hearings, the facility may need to fax the patient's

medication orders for discharge to the Pharmacy.

The Pharmacy's location is in Ventura, which is

about 40 miles south of the hospital's Goleta

location. Delivery of the patient's medications

from the Pharmacy has taken up to 4 hours (6:00

p.m. in the evening) after the orders have been

faxed to the Pharmacy by the hospital. By the

time that the ordered medications arrives at the

facility (6:00 p.m. in the evening), almost 90% of

the patients who have been discharged as a

result of the "Probable Cause Hearings" have

already left the facility without the medications,

and there is usually no sure way for these

medications to get to the patients or their

caregivers once the patients have left. Nurses

were dispensing medications outside of their

scope of practice.

2. Review of the hospital's policies and


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procedures on 1/12/11 revealed a policy and

procedure entitled: "#50 Dispensing Sample

Medications". The policy and procedure reads as

follows: "It is the policy of the Santa Barbara

County Mental Health Plan (SBCMHP) that

sample medications will be recorded, stored and

dispensed in accordance with relevant State and

Federal requirements as well as standards of

clinical practice." The policy goes on to say:

"Pharmaceutical samples will only be dispensed

by Medical Staff to a patient as directed by a

written prescription or other order signed by a

Physician. 2. A single dose of a sample

medication may be dispensed to a patient by

Medical Staff....".

Interview with the facility's Medical Director on

1/13/11 at 3:10 p.m. revealed that this policy did

indeed pertain to the hospital, but in practice, the

hospital did not permit sample medications to be

dispensed to the hospital's patient's. During the

interview, the Medical Director indicated that he

understood how someone reviewing the facility's

policy and procedure, could accept this policy as

being a part of the hospital's every day practice.

The Medical Director also indicated that many of

the facility's policies and procedures had not been

reviewed by any of the hospital's administrative

staff in order to determine if this policy and

procedure reflected the hospital's everyday

practices.

A 505 482.25(b)(3) UNUSABLE DRUGS NOT USED

Outdated, mislabeled, or otherwise unusable

drugs and biologicals must not be available for

patient use.


A 505

Based on inspection of the facility's Drug Room


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the facility and it's Pharmacist also failed to

ensure that expiration dates could be found on all

bubble packs and that expired medications were

not available for administration.

Findings:

Review of the facility's Pharmacy policy and

procedure manual states under the section

entitled:" House Supplied (Floor Stock)

Medications:"...4. The manufacturer's or

pharmacy's label shall include the following

elements: ....f. expiration date."

Inspection of the facility's "House Supply" on

1/12/11 at 2:30 p.m. revealed the following

expired drugs that were available for

administration and had not been removed from

the facility' drug supply by the facility's

Pharmacist: 1) Provigil 100 mg, 16 tablets with an

expiration date of 12/10 and 2) Ambien 12.5 mg,

7 tablets with an expiration date of 12/10.

Inspection of the same drug supply revealed one

bubble pack of Ativan 1 mg tablets 10, without an

expiration date being provided by the facility's

Pharmacy, contrary to the facility's Pharmacy

contract which states in Exhibit D under

compliance requirements J: "All drugs obtained

by prescription are labeled in compliance with all

pertinent State and Federal standards,

specifically: 1. All drugs obtained by prescription

are labeled in compliance with Federal and State

laws....". California Business and Professions

Code section 4076 states: "A pharmacist shall not

dispense an prescription except in a container

that meets the requirements of state and federal

law and is correctly labeled with all of the

following:.....9. The expiration date of


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effectiveness of the drug dispensed.....".

A 507 482.25(b)(5) STOP-ORDERS FOR DRUGS

Drugs and biologicals not specifically prescribed

as to time or number of doses must automatically

be stopped after a reasonable time that is

predetermined by the medical staff.


A 507

Based on review of the hospital's clinical records,

review of the hospital's Pharmacy policy and

procedure manual, and interview with the Medical

Director, the facility failed to ensure that the

facility's medication stop order policy was being

implemented for 1 of 5 patients (P-2).

Findings:

Review of the hospital's Pharmacy policy and

procedure manual under section entitled: "Stop

Orders for Acute Conditions", reads:"...1. The

following classes of medications will not be

automatically refilled after the indicated number of

days, unless the prescriber specifies a different

number of doses or duration of therapy to be

given or in cases where the automatic

discontinuation of a medication may lead to an

adverse outcome....e. Steroids (10 days)...".

Review of the clinical record for patient P-2 on

1/12/11 at 10:15 a.m. revealed a physician's

order for Advair Diskus (a corticosteroid

combination drug) 250/50 one puff twice a day for

inhalation. The Advair Diskus was originally order

for this patient on 9/17/10 and it was reordered on

9/21/10 (4 days later). On 10/10/10 the Advair

was reordered 19 days after the last reorder, then

on 12/5/10 (55 days after the last reorder) the


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Advair Diskus was renewed. Then on 1/4/11 the

Advair Diskus inhaler was renewed again, 31

days after the last renewal of this medication.

The Advair was not renewed as outline in the

facility's Pharmacy policy and procedure.

A 508 482.25(b)(6) REPORTING ADVERSE EVENTS

Drug administration errors, adverse drug

reactions, and incompatibilities must be

immediately reported to the attending physician

and, if appropriate, to the hospital-wide quality

assurance program.


A 508

Based on review of the hospital's clinical records

and interview with hospital administrative staff the

facility failed to ensure that at least 1 of 5 patients

Discharge Summary was free from medication

error information. Further review of the facility's

clinical records revealed multiple medication

errors which had not been identified by the facility

staff and that all prescribed medications were

available for patient administration for 3 of 5

patients. Medications listed on the discharge

summary were inaccurate for P-3, medication for

P-1 was prescribed for twice daily but not

administered as ordered and no documentation

to show that medications were not given as

ordered. The facility was unable to provide

documentation that these medication errors were

identified and sent to QA. One unsampled patient

recieved an incorrect dose of medication that was

not reported to the attending physician.

Findings:

1. Review of the clinical record for P-3 on 1/11/11


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revealed that a Physician's Discharge Summary

had been created for this patient. The Discharge

Summary indicated that this patient had been

discharged from the hospital on an

anti-arrhythmic drug called Amiodarone at a dose

of 800 mg by mouth three times daily. Careful

review of th patient's clinical record revealed that

this patient was never on Amiodarone during her

stay at the facility.

The Discharge Summary is very important and

needs to be accurately completed for several

reasons. This Discharge Summary is sent out

with the patient to the next facility (or place of

discharge) with this patient, so that anyone who is

to provide subsequent care to this patient has

accurate information on what medications this

patient should be taking and the events which

took place during the patient's hospitalization.

The Discharge Summary is also used to obtain

medical information when the patient is

readmitted to the hospital and medical treatment

decisions need to be made on how to handle the

patient's medical care. Interview with the facility's

Medical Director on 1/11/11 at 11:00 a.m. and

review of the patient's medical record with the

Medical Director revealed that the Amiodarone

was not a medication that this patient had

received during any point of her hospitalized stay

at the hospital.


1/11/11 at 3:00 p.m. revealed a physician's order,

written on 1/7/11 about 6:45 p.m. for the patient

to receive Zydis (a behavior modifying

medication) 10 mg by mouth twice daily. The

medication nurse transcribed this order onto the

patient's Medication Administration Record


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(MAR) on 1/7/11 as Zydis 10 mg every evening

by mouth.

The first dose of this medication was given on

1/7/11 at 9:00 p.m. The next dose that was

attempted to be administered to the patient was

on 1/8/11 at 9:00 p.m. but the patient refused, so

no Zydis was given to this patient on 1/8/11. The

medication was ordered by the physician to be

offered at least twice daily, so a second dose

should have been offered to the patient at some

other point during 1/8/11. This second dose not

being offered to the patient resulted in a missed

dose. On 1/9/11, no dose at 9:00 a.m. was

administered as originally ordered by the patient's

physician, but the next dose was administered at

9:00 p.m. On 1/10/11, three days after the

physician's original order for this medication one

of the facility's nursing staff re-transcribed the

physician's order onto the MAR correctly for twice

daily administration and administered a 9:00 a.m.

dose on 1/10/11. No report was created for these

medication errors and the facility failed to capture

these errors in their medication error data.

3. Review of the same clinical record for P-1 on


written on 1/9/11 for Primidone (an anti-seizure

medication) 250 mg by mouth four times daily.

This medication was documented on the MAR as

needing to being administered to the patient at

the following times daily: 9:00 a.m., 1:00 p.m.,

5:00 p.m., and 9:00 p.m. Review of the hospital's

MAR for 1/10/11 revealed that the 5:00 p.m. dose

of this medication, which was suppose to have

been administered to the patient had not been

documented on the patient's MAR and the facility

was unable to provide documentation that this


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medication had been given to the patient as

ordered.



written on 11/18/10 about 7:00 p.m. for Zantac

(an ulcer medication) 150 mg by mouth twice

daily. According to documentation on the patient's

MAR, this medication was not available for

administration on 11/19/10 when the first dose

was due.

5. Review of a hospital report on 1/12/11 revealed

that a patient had been given Ativan 2 mg dose

rather than the 1 mg dose, which had been

ordered by the patient's physician. The only

corrective action identified in the hospital's

summary report indicated that the employee had

been counseled about the incident and the

patient's psychiatrist had not been contacted

about the medication error.

A 509 482.25(b)(7) REPORTING ABUSES/LOSSES OF

DRUGS

Abuses and losses of controlled substances must

be reported, in accordance with applicable

Federal and State laws, to the individual

responsible for the pharmaceutical service, and to

the chief executive officer, as appropriate.


A 509

Based on review of the facility's Narcotic Control

form, review of the hospital's unusual occurrence

report forms, and interview with facility

administrative staff, the hospital failed to provide

documentation that an incident involving a lost

controlled narcotic (Darvocet N-100) tablet had

been reported as an incident for documentation


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and investigation to facility administrative staff for

the purpose of tracking and trending of

medication related events. The hospital failed to

implement their policy and procedure for the loss

of controlled substances.

Findings:

1. Review of the hospital's policy and procedure

entitled: "Controlled Drug Storage", states: "Any

discrepancy in controlled substance medication

counts is reported to the director of nursing

immediately. The director of nursing or designee

investigates and makes every reasonable effort to

reconcile all reported discrepancies while nurses

remain on duty. The director of nursing, in a

report to the administrator, documents

irreconcilable discrepancies".

Review of the hospital's Narcotic Control form on

1/12/11 at 2:00 p.m. revealed that a controlled

drug (Darvocet N-100) came up missing on

9/3/10 during a shift count. Vicodin (a schedule IV

narcotic) had also come up missing on 11/12/10

according to one of the hospital's reports,

indicating that the facility had multiple incidents of

controlled drugs being lost in the facility. The

hospital was unable to provide documentation

that the Darvocet N-100 loss was ever reported

by staff to administration as an incident which

needed to be investigated. Review of the facility's

policy and procedure entitled: "Controlled Drug

Storage", states: "Any discrepancy in controlled

substance medication counts is reported to the

director of nursing immediately. The director of

nursing or designee investigates and makes

every reasonable effort to reconcile all reported


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discrepancies while nurses remain on duty. The

director of nursing, in a report to the

administrator, documents irreconcilable

discrepancies". Interview with the DON on

1/13/11 at 5:00p.m. revealed that the DON was

unable to remember this specific incident, she

was unable provide any documentation of any

action that had been taken, or provide any

evidence that a report had been generated and

sent to the facility administrator (Program

Manager).

A 511 482.25(b)(9) FORMULARY SYSTEM

A formulary system must be established by the

medical staff to assure quality pharmaceuticals at

reasonable costs.


A 511

Based on interview with hospital staff and review

of what the hospital thought was their drug

formulary the hospital failed to ensure that it had

established an actual drug formulary for the

hospital. The hospital's medical staff failed to

establish a drug formulary for the hospital.

Findings:

Interview with three of the hospital's nursing staff

on 1/13/11 at 10:00 a.m. revealed that none of

the three staff could find a copy of the hospital's

drug formulary. When no one could find a copy of

a drug formulary, one of the facility nurses went

to her computer and printed a copy of the

institutions formulary (not the hospital's formulary)

and brought it to me for review. After reviewing

the institution's formulary and identifying that

drugs which were being used by the hospital

(such as Risperdal and Zyprexa to mention a


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few), were not on the formulary which I had

received. One of the nursing staff members

involved in the interview had worked at the

hospital for over 16 years and indicated that he

had never called the facility's pharmacy and been

told that any drug of the drugs that he had

requested was not on the drug formulary. Further

interview with the three hospital nursing staff

revealed that the hospital did not have a drug

formulary. Interview with the facility's DON and

Medical Director on 1/13/11 at 5:10 p.m. revealed

that the Acute Hospital did not have a drug

formulary. The DON and Medical Director

confirmed that any drug which the facility ordered

from the Pharmacy would be sent to the facility

irregardless of its cost or availability. They also

confirmed that the hospital did not have any type

of official or unofficial drug formulary.

A 582 482.27(a) ADEQUACY OF LABORATORY

SERVICES

The hospital must have laboratory services

available, either directly or through a contractual

agreement with a certified laboratory that meets

the requirements of part 493 of this chapter.


A 582

Based on interview, the hospital failed to ensure

the application of a laboratory waiver (CLIA) for

the use of a glucometer (machine that checks

blood sugar level) in the facility.

Findings:

Interview with the program director on 1/11/11

revealed that the staff test patient blood sugars

with an accuchek (glucometer) machine. They

had not obtained a waiver for the testing of blood


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specimens with this machine within the hospital.

A 618 482.28 FOOD AND DIETETIC SERVICES

The hospital must have organized dietary

services that are directed and staffed by

adequate qualified personnel. However, a

hospital that has a contract with an outside food

management company may be found to meet this

Condition of Participation if the company has a

dietitian who serves the hospital on a full-time,

part-time, or consultant basis, and if the company

maintains at least the minimum standards

specified in this section and provides for constant

liaison with the hospital medical staff for

recommendations on dietetic policies affecting

patient treatment.


A 618

Based on observation, review of clinical records,

hospital documents and staff interviews, the

hospital failed to ensure that the dietary services

met the needs of all patients as evidenced by

failure to:

1. Provide organized dietetic services as

evidence by failure to hire a full-time employee

who was responsible for the daily management of

the dietary services, this resulted in a food

service operation that was unorganized, space

that was dirty and cluttered, and the use of dirty

food service equipment. Staff, that were

inadequately trained, a menu that was not

consistently followed, and food storage practices

that were not reflective of current community

standards, i.e.. poor food quality due to poor

dating and labeling practices (Refer to A-620).

2. Ensure that the contracted dietitian had


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adequate hours to meet the nutritional needs of

the patients and provide adequate oversight for

the food services. Failed to ensure the diet

manual and dietary policies and procedures were

approved and implemented. (Refer to A-621)

3. Ensure that menus met the needs of the

patients. This failure resulted in the inability of the

hospital to evaluate the nutritional adequacy of

meals provided (Refer to A- 628).

4. Ensure that the therapeutic diets of two of

three clinical records reviewed (D1, D2) were

ordered by their physicians. These failures

resulted in a delay of medical nutrition therapy

(Refer to A-629).

5. Ensure the nutritional needs of the patients

were met in accordance with recognized dietary

practices, and in accordance with the orders of

the physicians. This failure resulted in patients

not receiving therapeutic diets. Other patients

received food that may be inadequate or exceed

their nutrient needs, and meal times that were not

in accordance with accepted community

standards (Refer to A-630).

6. Ensure that a current diet manual was

maintained and was readily accessible to the

physician, nursing staff and food service

personnel. This failure had the potential of

patients being served diets not consistent with the

orders of the physician (Refer to A-631)

7. Develop performance improvement activities

that reflected the scope and nature of services

provided (Refer to A-263, A-276 ).

A 620 482.28(a)(1) DIRECTOR OF DIETARY A 620


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SERVICES

The hospital must have a full-time employee who-

(i) Serves as director of the food and dietetic

services;

(ii) Is responsible for daily management of the

dietary services; and

(iii) Is qualified by experience or training.


Based on observation, staff interviews and

review of hospital documents, the facility failed to

hire a full-time employee who is responsible for

the daily management of the dietary services.

This resulted in a food service operation that was

unorganized, space that was cluttered, unclean;

food service equipment that was dirty, food

storage practices that were below community

standards and could result in growth of

microorganisms that could result in food borne

illness; poor food quality due to poor dating and

labeling practices. In addition, these failures

resulted in staff that were inadequately trained, a

menu that was not consistently followed resulting

in patients not receiving adequate food as

planned on the menu.

Findings:

During the initial tour of the kitchen on 1/10/11 at

approximately 10:00 AM, the following

observations were made:

*Three breakfast burritos wrapped in foil and left

in the steam table which was not plugged in;


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*One toaster with a build up of bread crumbs

visible through top openings and in tray;

*One toaster oven with a build up of black burnt

material coated on rack and tray, bottom tray with

black hard coating along with discolored sesame

seeds. The window had a brown and yellowish

film covering it and up the top of toaster oven;

*Three drawers containing various food items

including: knives, spoons, were stored directly on

paper lined drawers that had visible food debris

and dark brown stains;

*On the top shelf of one the cupboards was a

silver metal container that was firmly stuck onto

shelf;

*Other cabinets were cluttered with various items

including: hairnets, gloves, condiments, aprons,

and low sodium packets;

*One cabinet with a stack of bowls, approximately

seven of the bowls were wet and contained

approximately one tablespoon of water in them;

*Freezer with no visible thermometer. A build up

of ice through out shelves and a solid build up on

door ice shute (outlet by which ice dispenses into

a container from the ice maker inside the freezer

to the dispenser on the exterior door);

*Refrigerator:

A 46 fluid ounce metal can of prune juice

with the side bent and bulging on top with

approximately one to two inch sliced opening with

old juice thick residue around the opening. There


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was no date on can of prune juice indicating

when it was opened;

Two, four ounce styrofoam containers filled

with mandarin oranges were stored in the

refrigerator with no date to indicate when it was

stored;

Approximately 10 by 10 inch metal pan

containing cottage cheese that showed evidence

of being previously served with no date to indicate

when it was stored or when it needed to be

discarded;

One plastic bag containing sliced meat which

was not sealed and contained no label to indicate

what kind of meat it was and no date to indicate

when it was placed in the refrigerator or when it

needed to be discarded;

One 10 ounce container of sliced white

mushrooms opened with rubber band wrapped

around package. The package contained a date

of packaging for 12/27.

Hand washing

On 1/11/11, at approximately 11:40 AM, RA 1

was observed entering kitchen. Next, she used a

hand sanitizer before putting on gloves prior to

serving the lunch meal. At the conclusion of the

meal, she returned to the hand sanitizer

dispenser after taking off her gloves.

Review of the basic kitchen policy and

procedures, showed to "always wash hands at

the beginning of a shift,...., before putting on

gloves, and at any time necessary to prevent the


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spread of food borne bacteria". The policy also

showed to wash hands whenever you change

gloves.

Meal observation

Review of the lunch menu dated 1/10/11, showed

BBQ chicken, macaroni and cheese, mixed

vegetables, an orange, and milk for the lunch

meal. The menu did not show portion sizes or

scoop sizes. On 1/10/11, at approximately 11:50

AM, the steam table contained BBQ chicken,

green salad, macaroni and cheese, and cooked

carrots and peas. The nutrition adequacy was

unable to be determined due to lack of stated

portion sizes of the meal items. The green salad

was being served with a spaghetti spoon/server,

macaroni and cheese and cooked carrots and

peas were being both served with a six-ounce

(oz) spoodle, and the BBQ chicken was being

served with a spatula.

No oranges were observed in the serving area.

The menu did not state there would be a green

salad served. A green salad would not be an

equal substitute for an orange, on the basis of the

green salad containing less Vitamin C.

Further observation revealed the steam table was

turned on; there were three knobs that controlled

the heat to each of the wells. The well where the

macaroni and cheese was placed, the knob was

turned to "2" (out of 10); the well where the

cooked carrots and peas were placed, the knob

was turned to "9"; and the well where the BBQ

chicken was placed, the knob was turned

between the 9 and 10.


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Review of the written instruction titled, Weekend

Standards for PHF Meal Delivery, showed staff

should "verify temperatures are at least at 160 for

hot food - 40 or below for cold food". Food

temperatures were taken by the surveyor which

revealed the macaroni and cheese was 90.4

degrees Fahrenheit (F), cooked carrots and peas

was 116.7 F, and the BBQ chicken was 128.5 F.

On 1/10/11 at approximately 12:05 PM an

interview was conducted with RA 2. RA 2 stated

temperatures should be taken prior to meal

service but she had forgotten to take today since

she has not worked in the kitchen in awhile.

Review of the daily temperature log dated

January 2011, showed no food temperatures

recorded for the lunch meal or the previous meal

on the 10th. Further review of the same log,

showed no temperatures (blanks) for the lunch

meal on the 2nd, blanks for the breakfast meal on

the 3rd, blanks for the dinner meal on the 4th,

blanks for the breakfast and dinner meal on the

7th, blanks for lunch and dinner meal on the 8th,

and blanks breakfast and lunch meal on the 9th.

The daily temperature log only accounts for one

food item for each meal. It is unclear what item

should be or had been recorded. This log did not

have instructions on what the procedure should

be and the facility did not have any policies or

procedures to direct the staff on the correct

procedures on the taking and recording of

temperatures.

On 1/11/11 at approximately 11:45 AM, the steam

table was observed containing pork loin, rice pilaf,

green salad (with tomatoes, red bell peppers, red

onions, and cucumbers), and cooked lima beans.

RA 1, who was the nurse responsible for meal


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service, took the temperature of pork loin which

read 124.1 F and took no other food

temperatures. The surveyor took the

temperatures of the lima beans and rice pilaf

which read 104.8 F and 128.2 F, respectively.

Review of the menu for the lunch meal on 1/11/11

showed, pork loin, rice pilaf, mixed vegetables,

dinner roll, fruit mix, and milk for the lunch meal.

The patients received lima beans instead of

mixed vegetables and they did not receive a

dinner roll. Patients also received the green salad

that was not listed on the menu. The substitutions

were made without being posted on the menu.

There was no substitute provided for the missing

dinner roll.

RA1 was observed on 1/11/11 serving lima beans

and rice pilaf with a six oz spoodle, and pork loin

(pre-sliced) with tongs. The portion sizes were not

consistent for all the patients served. Some

patients were served spoodle that was half-full;

others were served 3/4th full. There were no

cardex or patient diet cards instructing RA1 on

what amount to serve each patient. It was unclear

why each patient did not receive the same

amount.

An interview was conducted with RA1 on 1/11/11,

at approximately 11:55 AM. In a response to

concerns about food sufficiency, because some

food items were completely utilized for sixteen

patients with none leftover at the end of service

before patients had consumed their meals,

thereby leaving no opportunity for seconds when

requested. RA 1 stated that sometimes there is

not enough food for the patients. She stated that

they send enough food for 18 patients for the


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entree or meats and for other items they send a

pan.

On 1/11/11, at approximately 12:00 PM, after all

the patients had been served, an interview was

conducted with RA 1 regarding the missing dinner

roll and equivalent substitute. RA 1 stated she

did not notice the dinner rolls were missing since

they have not been provided for about the last

week. When one of the patients asked for a roll,

RA 1 preceded to hand him a slice of bread from

a loaf that had been stored in the cabinet.

Thereafter, other patients were observed asking

and receiving bread slices. RA 1 was not

observed to offer other patients a slice of bread

since the dinner roll was missing from the initial

meal served.

An observation at the end of meal service on

1/11/11, was of two plates with food, covered with

aluminum foil and placed in the pan on the steam

table well. An interview was conducted with RA1

at approximately 12:10 PM, reagrding these

items. RA1 stated that they were being saved for

two patients who did not want to eat at the time

lunch was being served. She further stated, these

plates will be saved for the patients with their

names written on it. It will stay in the kitchen

steam table until they request the meal because

the "steam table will keep the food warm". If the

food is not requested by snack time

(approximately 2-1/2 hours later) the food will be

discarded.

RA 1 was then asked why the food was not

stored in the refrigerator and reheated in the

microwave when the patients request for their

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in the refrigerator. This practice of storing food in

the steam table well at room temperature had

been observed the day before. Food stored at

room temperature (danger zone is 41 degrees

Fahrenheit to 135 degrees) could result in the

growth of microorganisms that could result in

food borne illness.

Training

RA 1 was interviewed on 1/11/11, at

approximately 12:00 PM, regarding the training

she had received for patient meal service. She

indicated that she was hired approximately a year

and half before and had "shadowed" (followed

and observed) another employee but had not

received any formal training from the registered

dietitian or contract food service operator.

Policies and Procedures

There were no policy and procedure manual in

the kitchen for use of the hospital staff. There

was only written instructions on the wall regarding

hand washing and taking food temperatures but

no other policies. A review of the food service

contract dated 12/15/04 was conducted. Included

in the responsibilities of the food service

contractor was "generate, maintain and distribute

a policy and procedure manual which defines

methods and practices by which the contractor

will comply with the terms of the agreement and

compliance with regulatory requirements. The

contractor shall ensure that the policy and

procedure manual is maintained in a current,

complete and timely manner reflecting actual

practices". The lack of a P/P resulted in staff

practices there were inconsistent and in some


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cases, had the potential to cause harm.

The program director (PD) of the hospital was

interviewed on 1/10/11, at approximately 9:20

AM, regarding the lack of a full time person

responsible for food service operation. She

acknowledged that the food temperatures were

an on-going problem and that the hospital does

not have anybody in the position to coordinate the

activities of the department because of food

production being contracted out. The PD stated

that there were not specific policies for dietary

services.

The failure of the hospital to have a full -time

person responsible for the operation of the dietary

services department has resulted in a food

service space that is cluttered, unclean; food

service equipment that was dirty, food storage

practices that were below community standards

and could result in poor food quality and growth of

microorganisms. In addition, these failures

resulted in staff that were inadequately trained,

menu that was not consistently followed resulting

in patients not receiving adequate food as

planned on the menu; there were also no policy

and procedure manual.

A 621 482.28(a)(2) QUALIFIED DIETITIAN

There must be a qualified dietitian, full-time,

part-time, or on a consultant basis.


A 621

Based on observation, review of hospital

documents, clinical record review and staff

interviews, the hospital failed to ensure that the

contracted dietitian had adequate hours to ensure

the nutritional needs of the patients were met and


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to provide oversight for the food services. The

limited frequency of consultation and lack of

oversight resulted in two patients not receiving

therapeutic diets and therefore the delay of

medical nutrition therapy. In addition, it resulted in

the lack of collaboration with medical staff,

unapproved diet manual and lack of performance

improvement activities in the dietary services

department.

Findings:

The contract with the registered dietitian (RD 1)

was effective 7/1/10 through 06/30/11. A review

of the contract, revealed RD 1 was contracted to

provide a 2 hour weekly visit to the facility to

assess the nutritional status of patients at

nutritional risk. The contract attachment

identified what these nutritional risks were

including malnutrition, diabetes, <80% or >130 %

of IBW (Ideal Body Weight), hypertension, etc

and how to refer to the RD. It stated that a daily

diet sheet would be faxed to the dietitian.

Review of the clinical records revealed the

hospital did not have a written policy and

procedure to screen patients to determine their

nutritional risk and referral to RD 1. The rationale

behind screening is that medical nutrition therapy

will be provided in a timely manner. None of the

patients reviewed were assessed sooner than RD

1's scheduled Monday visits to the hospital. There

was an average of five days lag time in nutrition

assessments for patients considered at high

nutritional risk.

Nutrition Care

1. Patient D1 was admitted to the hospital on


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8/11/10 with diagnoses including diabetes

mellitus, hypothyroidism and COPD (chronic

obstructive pulmonary disease). She was 5' 6"

tall and weighed 186 lbs on admission. A nutrition

assessment was conducted by the registered

dietitian (RD 1) on 8/16/10. RD 1 recommended a

DM diet (diabetic diet). There was no

documented evidence that this recommendation

was communicated to the patient's physician.

On 10/4/10, RD 1 conducted a follow up

assessment, she documented Patient D1 gained

16 lbs in six weeks, therefore weighed 202 lbs.

Patient D1 had developed a foot ulcer and RD1

recommended a DM high protein, no extra

portions except high protein food diet to promote

healing of foot ulcer. There was no documented

evidence that this recommendation was

communicated to the patient's physician.

On 11/15/10 after the foot ulcer had healed, RD 1

recommended "continue ADA hi protein diet to

prevent foot ulcer re-infection". Review of the

clinical record for Patient D1 did not show any

diet order for any of the diets recommended by

RD 1. There was no documented evidence that

this recommendation was communicated to the

patient's physician.

During meal observations on 1/10/11 and 1/11/11

all the patients were served the same foods.

There was a white board that had Patient D1's

name with the word "diabetic" next to it but there

was no observed change made specifically to her

plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11 at

approximately 3:40 p.m. she explained the


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process by which RD1's recommendations are

communicated to the hospital staff. She stated

that RD1 writes her recommendations and

nursing goals on the Consultant Dietitian Report.

She stated that the charge nurse or team leader

will make a copy of the report and give it to the

staff member working in the kitchen. That staff

member will then write the

recommendations/nursing goals on a white board

in the kitchen, for example if patients cannot have

seconds. Review of the Consultant Dietitian

Reports from 1/10 to 1/10/11 showed no

recommendations for Patient D1 during the

months that RD 1 made those recommendations.

Further review of Patient D1's clinical record

showed that on 1/1/11 hospital staff documented

on the interdisciplinary team Treatment Plan

problem list "Resistant to ADA diet". Patient D1

was not provided with the diet that was

recommended and RD 1 believed she was on it

and was not clear how she was resistant to a diet

that was never served.

2. Patient D2 was admitted on 1/5/11 with

diagnoses including hypertension, broken jaw,

and detached retina. He was 6'1" and weighed

300 lbs on admission and was placed on a

regular diet.

A nutrition assessment was conducted by RD 1

on 1/10/11. She recommended a weight loss diet,

secondary (due to) obesity. She did not however,

specify a caloric level. The nursing goals were

"no extra portions except vegetables and salads".

It is unclear how long it takes the hospital staff to

communicate diet recommendations to the

physician and when nursing plans are


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implemented when physicians concur with RD's

recommendations.

Policy and Procedures and Diet Manuals

The hospital did not have a dietary services policy

and procedure manual. The hospital staff was

observed not practicing proper food storage

procedures. Items in the refrigerator were not

properly labeled or dated. Dry food and storage

areas in which they were stored were not

maintained in a sanitary manner. The toaster and

toaster ovens were not cleaned. There were no

written policies to determine the frequency of

cleaning and who was responsible.

The diet manual had not been approved or used

by the hospital staff for an undermined length of

time. The program director stated, at

approximately 4:00 p.m. on 1/10/11, that they

could not find the diet manual, and would ask the

registered dietitian (RD) where it was located.

The hospital diet manual is a reference tool that

describes the different types of therapeutic diets

that is available to be ordered in the hospital. It

describes the framework (including definition and

nutrient adequacy) of all diets and under what

conditions all diets are ordered.

Observations during meal times on 1/10/11 and

1/11/11 and lack of portion sizes that resulted in

questions of nutrient adequacy could have been

verified using the diet manual. During interview

with the RD on 1/10/11 at approximately 4:30

p.m. she stated that the hospital had a diet

manual but does not remember the last time she

saw it. She indicated that she had not been

invited to any Pharmacy and Therapeutics

Committee (P & T) since been hired about 12


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years ago. The P & T committee or similar

committee is the avenue used in hospitals to

approve diet and patient care manuals, present or

resolve care issues that affect patients.

On 1/14/11, the program director found the diet

manual in a shelf in her office. The face sheet

was blank and therefore could be determined

whether it was ever approved by the dietitian or

medical staff. The length of the time that it took to

locate the diet manual and the fact that the RD

indicated that she could not remember the last

time she saw it, would result in the conclusion

that the hospital staff did not have access to it.

Food service

The RD had no role in ensuring that the

nutritional needs of the patients were met. She

stated in an interview that her role was clinical

and did not participate in menu planning. Review

of the contract with the meal service provider

revealed a provision stating that their registered

dietitian was to approve menus only. However,

there has been no communication between the

contracted meal service provider and RD 1. RD

1, who has had no responsibilities with the food

service, is unable to share concerns with

contracted dietary staff. Some of these concerns

include food palatability, improper food delivery

times, substitutions, and poor hand washing.

Review of the menu for the lunch meal on

1/11/11, showed pork loin, rice pilaf, mixed

vegetables, dinner roll, fruit mix, and milk for the

lunch meal. The patients received lima beans

instead of mixed vegetables and they did not

receive a dinner roll. Patients also received the

green salad that was not listed on the menu. The


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substitutions were made without being posted on

the menu. There was no substitute provided for

the missing dinner roll.

RA 1 was observed on 1/11/11 serving lima

beans and rice pilaf with a six ounce spoodle, and

pork loin (pre-sliced) with tongs. The portion sizes

were not consistent for all the patients served.

Some patients were served a spoodle that was

half-full; others were served 3/4th full. There were

no cardex or patient diet cards instructing RA 1

on what amount to serve each patient. It was

unclear why each patient did not receive the

same amount. During this meal several of the

patients asked for seconds but did not receive

any because the food had run out. Due to a lack

of a credible nutrient analysis and portion sizes

on the menu, it could not be determined whether

the menu was meeting the patients' needs.

Training

An interview was conducted with RA 1 on

1/11/11, at approximately 12:00 p.m. regarding

the training she had received for patient meal

service. She indicated that she was hired

approximately a year and half before and had

"shadowed" (followed and observed) another

employee but had not received any formal

training from the registered dietitian or contract

food service operator. RD 1 stated that she has

provided some training to nursing staff but did not

indicate the last time she had provided such

training.

At the end of the meal service, there were two

plates of food covered with aluminum foil placed

in the pan on the steam table well. RA 1 stated in

an interview conducted on 1/11/11 at


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approximately 12:10 p.m. they were being saved

for two patients who did not want to eat at the

time. She further stated at this time, these plates

will be saved for the patients with their names

written on it. It will stay in the kitchen steam table

until they request the meal because the "steam

table will keep the food warm". If the food is not

requested by snack time (approximately 2-1/2

hours later) the food will be discarded.

When RA 1 was asked why the food was not

stored in the refrigerator and reheated in the

microwave when the patients request for their

food, she stated she had not thought of putting it

in the refrigerator. This practice of storing food in

the steam table well at room temperature had

been observed the day before. Food stored at

room temperature (danger zone is 41 degrees

Fahrenheit to 135 degrees) could result in the

growth of microorganisms that could result in

food borne illness. There has been no training

provided to hospital staff on the proper storage of

food.

In the interview with RD 1 on 1/10/11 at 4:30 p.m.

she stated she felt the hours she was contracted

for was sufficient. These limited consultation

hours has resulted lapses observed in areas of

patient care and food service.

A 628 482.28(b) DIETS

Menus must meet the needs of the patients.


A 628

Based on observation, review of hospital menu

and staff interviews, the hospital failed to ensure

that menus met the needs of its patients. This

failure has resulted in the inability of the hospital


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to evaluate the nutritional adequacy

Findings:

Patient D1 was admitted to the hospital on



obstructive pulmonary disease). She weighed 186

lbs and was 5 ' 6 " tall. A nutrition assessment

was conducted by the registered dietitian (RD 1)

on 8/16/10. She recommended a DM diet. Patient

D1 weighed 202 lbs, gained 16 lbs in 6 weeks.

On 10/4/10, RD1 conducted a follow up

assessment and recommended a DM high

protein, no extra portions except high protein food

diet to promote healing of foot ulcer. On 11/15/10

after the foot ulcer had healed RD1

recommended continue ADA high protein diet to

prevent foot ulcer re-infection. Review of clinical

record for patient D1 did not show any diet order

for any of the diets recommended by RD1. The

copy of the posted menu did not include any

therapeutic diet or a diabetic or high protein diet.

Patient D1 was not provided with the diet that was

recommended and RD1 believed she was on.

A tour of the kitchen on 1/10/11 at approximately

9:47 a.m. revealed three large foil wrapped item

stored in an unheated steam table. The item was

later described as breakfast burrito left over from

breakfast. Each breakfast burrito was

approximately six inches long, weighing

approximately 12 ounces.

Review of the hospital for the month of January

2011 was reviewed. According to the menu,

breakfast burrito and orange were items to have


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been served for breakfast on 1/10/11. But, the

menu did not have portion sizes listed next to the

items. Further review showed that none of the

menu items for all three meals for the month had

any portion sizes listed.






a.m., on the steam table were BBQ chicken,

green salad, macaroni and cheese, and cooked

carrots and peas. The green salad was being

served with a spaghetti spoon/server, macaroni

and cheese and cooked carrots and peas were

being both served with a six ounce (oz) spoodle,

and the BBQ chicken was being served with a

spatula. The nutrition adequacy was unable to be

determined due to lack of stated portion sizes of

the meal items.





green salad containing less Vitamin C.

The menu for the lunch meal on 1/11/11, showed

pork loin, rice pilaf, mixed vegetables, dinner roll,

fruit mix, and milk. The patients received lima

beans instead of mixed vegetables and they did

not receive a dinner roll. Patients also received

the green salad that was not listed on the menu.

The substitutions were made without being

posted on the menu. There was no substitute

provided for the missing dinner roll.


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each patient. It was unclear why each patient did

not receive the same amount.

Concerns regarding the lack of portion sizes were


manager (FSM) in an interview on 1/10/11, at

approximately 2:30 p.m.. In addition to the

hospital's contract he stated, the contracted meal

service provider also provided meals for children '

s program and a senior nutrition program. He

indicated that the facility's menu is planned by a

registered dietitian who was not housed in the

office where he was located. He further stated

that the menu had a nutrient analysis. A call was

placed to the meal services providers RD at this

time, and was not returned until after the surveyor

had exited the hospital.

The FSM provided a document that he stated

was the nutrient analysis for hospital menus. The

document titled " Dec 1, 2010 thru Dec 31, 2010

Spreadsheet-Portion values " . The nutrient

analysis was for the previous month not for

January 2011. According to this spreadsheet the

breakfast burrito portion size was one and

contained 213 calories each. The breakfast

burrito was significantly large and would contain

more calories than was stated in the nutrient

analysis. Closer review of the spreadsheet

revealed that the analysis was conducted on a

program for children. The portion sizes analysis


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would therefore be based on children's not adult

daily requirements. For example, the total

calories for a meal that included breakfast burrito

were analyzed as 377 calories, and satisfying 68

% of the allocated need of 554 calories for

breakfast.

The information was based on the caloric

requirements of a School Breakfast Program, not

the recommended daily allowances (RDA) for an

adult. The nutrient analysis that was provided, did

not examine the nutrient adequacy of the meal for

adults. The FSM was asked for a copy of the

recipe used to prepare the breakfast burrito,

neither he nor the cook in the kitchen were able

to produce the recipe.

A 629 482.28(b)(1) THERAPEUTIC DIETS

Therapeutic diets must be prescribed by the

practitioner or practitioners responsible for the

care of the patients.


A 629

Based on observation, review of clinical records

and staff interview, the hospital failed to ensure

that the therapeutic diets of two of three clinical

records reviewed (D1, D2) were ordered by their

physicians. These failures resulted in a delay of

medical nutrition therapy.

Findings:








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dietitian (RD 1) on 8/16/10. RD1 recommended a





assessment she documented that Patient D1

gained 16 lbs in six weeks, therefore weighed

202 lbs. Patient D2 had developed a foot ulcer

and RD1 recommended a DM high protein, no

extra portions except high protein food diet to

promote healing of foot ulcer. There was no



On 11/15/10 after the foot ulcer had healed RD1

recommended, "continue ADA hi protein diet to

prevent foot ulcer re-infection". Review of the

clinical record for patient D1 did not show any diet

order for any of the diets recommended by RD1.

There was no documented evidence that this

recommendation was communicated to the


During meal observations on 1/10/11 and

1/11/11, all the patients were served the same

foods. There was a white board that had Patient

D1's name with the word "diabetic" next to it but

there was no observed change made specifically

to her plate in terms of amount or kind of food

served.

An interview was conducted with LN 7 on 1/11/11,

at approximately 3:40 p.m., she explained the






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months that RD1 made those recommendations.

An interview was conducted with the FSM on


production of special diets for the hospital. He

stated that he had been in his position for

approximately a year and a half and does not

remember sending any special diets to the facility

except vegetarian and vegan diets. The copy of

the posted menu did not include any therapeutic

diets, diabetic or high protein diet. There were no

special instructions on modifying the regular diet

to any special diet.


showed that on 1/1/11 hospital staff documented

in the interdisciplinary team Treatment Plan



recommended and RD1 believed she was on it

was not clear how she was resistant to a diet that

was never served. The hospital failed to provide a

therapeutic diet as recommended by the RD.

2. Patient D2 was admitted on 1/5/11 with

diagnoses including hypertension, broken jaw,

and detached retina. He was 6'1" and weighed

300 lbs on admission and was placed on a

regular diet.


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A nutrition assessment was conducted by RD1 on

1/10/11. She recommended a weight loss diet,

secondary (due to) obesity. She did not however,

specify a caloric level. The nursing goals were

"no extra portions except vegetables and salads".

It is unclear how long it takes the hospital staff to

communicate diet recommendations to the

physician and when nursing plans are

implemented when physicians concur with the

RD's recommendations.

During lunch on 1/11/11, Patient D2 was

observed asking for seconds, he was offered

bread because there was no more entree.

Patients D2's name was not observed on the

white board in the kitchen.

The hospital failed to ensure that its patients

receive therapeutic diets as recommended by the

RD.

A 630 482.28(b)(2) DIETS

Nutritional needs must be met in accordance with

recognized dietary practices and in accordance

with orders of the practitioner or practitioners

responsible for the care of the patients.


A 630

Based on observation, review of hospital

documents and staff interviews, the hospital failed

to ensure that nutritional needs were met in

accordance with recognized dietary practices and

in accordance with the orders of the physicians.

This failure resulted in patients not receiving

therapeutic diets, other patients receiving food

that may be inadequate or exceed their nutrient

needs and meal times that are in accordance with


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community standards.

Findings:







dietitian (RD1) on 8/16/10. RD1 recommended a





assessment she documented that Patient D1

gained 16 lbs in six weeks, therefore weighed

202 lbs. Patient D1 had developed a foot ulcer

and RD1 recommended a DM high protein, no

extra portions except high protein food diet to

promote healing of foot ulcer. There was no



On 11/15/10 after the foot ulcer had healed RD1

recommended, "continue ADA hi protein diet to

prevent foot ulcer re-infection". Review of clinical

record for patient D1 did not show any diet order

for any of the diets recommended by RD1. There

was no documented evidence that this

recommendation was communicated to the


During meal observations on 1/10/11 and 1/11/11

all the patients were served the same foods.

There was a white board that had Patient D1's

name with the word "diabetic" next to it but there


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was no observed change made specifically to her

plate in terms of amount or kind of food served.

In an interview with LN 7 on 1/11/11, at

approximately 3:40 p.m. she explained the














months that RD1 made those recommendations.

An interview was conducted with the FSM on


production of special diets for the hospital. He

stated that he had been in his position for

approximately a year and a half and does not

remember sending any special diets to the facility

except vegetarian and vegan diets. The copy of

the posted menu did not include any therapeutic

diets, diabetic or high protein diet. There were no

special instructions on modifying the regular diet

to any special diet.


showed, that on 1/1/11 hospital staff documented

in the interdisciplinary team Treatment Plan



recommended and RD1 believed she was on. It


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was not clear how Patient D1 was resistant to a

diet that was never served. The hospital failed to

provide a therapeutic diet as recommended by

the RD.

2. A tour of the kitchen on 1/10/11 at

approximately 9:47 AM revealed three large foil

wrapped item stored in an unheated steam table.

The item was later described as breakfast burrito

left over from breakfast. Each breakfast burrito

was approximately six inches long, weighing

approximately 12 ounces.

Review of the hospital menu for the month of

January 2011 showed, a breakfast burrito and

orange were items to have been served for

breakfast on 1/10/11. But, the menu did not have

portion sizes listed next to the items. Further

review showed that none of the menu items for all

three meals for the month had any portion sizes

listed.






AM, on the steam table were BBQ chicken, green

salad, macaroni and cheese, and cooked carrots

and peas. The green salad was being served with

a spaghetti spoon/server, macaroni and cheese

and cooked carrots and peas were being both

served with a six ounce (oz) spoodle, and the

BBQ chicken was being served with a spatula.

The nutrition adequacy was unable to be

validated due to lack of stated portion sizes of the

meal items.


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green salad containing less vitamin C.

The menu for the lunch meal on 1/11/11, showed

pork loin, rice pilaf, mixed vegetables, dinner roll,

fruit mix, and milk. The patients received lima

beans instead of mixed vegetables and they did

not receive a dinner roll. Patients also received

the green salad that was not listed on the menu.

The substitutions were made without being

posted on the menu. There was no substitute

provided for the missing dinner roll.








each patient. It was unclear why each patient was

not consistently served the same amount.

Concerns regarding a lack of portion sizes were


manager (FSM). In an interview on 1/10/11, at

approximately 2:30 PM, he stated that the in

addition to the hospital's contract, the contracted

meal service provider provides meals for

children's program and a senior nutrition

program. He indicated that the hospital's menu is

planned by a registered dietitian of the contracted

meal service provider who was not housed in the

office he was located. He further stated that the

menu had a nutrient analysis. A call was placed


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to the contracted meal service's RD however,

was not returned until after the surveyor had

exited the hospital.

The FSM provided a document that he stated

was the nutrient analysis for hospital's menus.

The document titled "Dec 1, 2010 thru Dec 31,

2010 Spreadsheet-Portion values". The nutrient

analysis was for the previous month not for

January 2011. According to this spreadsheet the

breakfast burrito portion size was one and

contained 213 calories each. The breakfast

burrito was significantly large and would contain

more calories than was stated in the nutrient

analysis. Closer review of the spreadsheet

revealed that the analysis was conducted on a

program for children. The FSM confirmed in an

interview on 1/10/11 at approximately 3:00 p.m.

that this was the program used for nutrient

analysis. The portion sizes analysis would

therefore be based on children's not adult's daily

requirements. For example, the total calories for

a meal that included breakfast burrito were

analyzed as 377 calories, and satisfying 68 % of

the allocated need of 554 calories for breakfast.

The information was based on the caloric

requirements of the School Breakfast Program

not the recommended daily allowances (RDA) for

an adult. The nutrient analysis provided did not

examine the nutrient adequacy of the meal for

adults. FSM was asked for a copy of the recipe

used to prepare the breakfast burrito, neither he

nor the cook in the kitchen were able to produce

the recipe.

3. The community standard is that no greater

than 14 hours lapse between dinner and


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breakfast the following day. On 1/11/11 dinner

arrived and was served before 4:30 p.m. Hospital

staff did not document the arrival time. The LN

who served the meal stated that it arrived early

and rather than let the food get cold he served it.

Review of the contract with the contracted meal

service revealed dinner was to be delivered at

4:45 p.m. and served at 5:00 p.m In an interview

with the Program director on 1/11/11, at

approximately 9:20 a.m. she identified the early

delivery of patient food as one of the many issues

that they have been working on with the

contracted service. She explained that on

weekends, the dinner meal is delivered about

1:00 p.m. because the cafe kitchen which

produces the food closes at 12 (noon) and so

they prepare cold sandwiches and put it on ice. A

result of this early eating is that the patients are

hungry and the hospital provides them additional

snacks other than what is provided by the

contracted meal service.

The program director further explained that some

of the medications cause weight gain and

diabetes. However, it is unclear what role the

added snacks and calories if any, may be

contributing to weight gain in some of the

patients. Patient D1 gained 16 lbs in six weeks

after her initial admission to the hospital. Patient

D2 already weighs over 300 lbs. The nutrient

analysis of the menu has been determined to be

incorrect (cross refer A629). The hospital failed to

provide patients' food according to community

standards due to early delivery of dinner meals

including weekends and poor functioning food

temperature maintenance equipment (steam

table). (Cross refer A620).


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A 631 482.28(b)(3) THERAPEUTIC DIET MANUAL

A current therapeutic diet manual approved by

the dietitian and medical staff must be readily

available to all medical, nursing, and food service

personnel.


A 631

Based on staff interview and review of hospital

diet manual, it was determined that the hospital

failed to ensure that it maintained a current diet

manual that was readily accessible to the

physician, nursing staff and food service

personnel. This failure had the potential of

patients being served dits not consistent with the

orders of the physician.

Finding;

during the entrance interview on 1/0/11 the diet

manual was one of the documents requested for

review. The program director stated, at

approximately 4:00 p.m. on 1/10/11 that they

could not find the diet manual and would ask the

registered dietician (RD) where it was located.

The hospital diet manual is a reference tool that

describes the different types of therapeutic diets

that is available to be ordered in the hospital. It

describes the framework (including definition and

nutrient adequacy) of all diets and under what

conditions all diets are ordered.

Observations during the meal times and lack of

portion sizes that resulted in questions of nutrient

adequacy could have been verified using th diet

manual. During interview with the RD on 1/10/11

at approximately 4:30 p.m. she stated that the

hospital had a diet manual but does not

remember the last time she saw it. She indicted


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that she had not been invited to any pharmacy

and therapeutic committee since she had been

hired about 12 years ago. The P & T committee

or similar committee is the avenue use in

hospitals to approve diet and patient care

manuals present or resolve care issues that

affect patients.

On 1/14/11 the program director found the diet

manual in a shelf in her office. The face sheet

was blank and therefore could not be determined

whether it was ever approved by the dietician or

medical staff. The length of the time that it took to

locate the diet manual and the fact that the RD

indicted that she could not remember the last

time she saw it, would result in the conclusion

that the hospital staff did not have access to it.

A 700 482.41 PHYSICAL ENVIRONMENT

The hospital must be constructed, arranged, and

maintained to ensure the safety of the patient,

and to provide facilities for diagnosis and

treatment and for special hospital services

appropriate to the needs of the community.


A 700

Based on observation, staff interview, and

inspection of the building, it was determined that

the hospital failed to be maintained to ensure the

safety of the patients. This was evidenced by no

records for testing the complete fire alarm

system, the failure of the tamper alarm, and by

the failure to test the generator under load as

required by NFPA 99 Health Care Facilities, and

NFPA 110, Standard for Emergency and Standby

Power Systems.

The Program Manager was notified that


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immediate jeopardy was identified on 1/11/11, at

2:55 p.m. The immediate jeopardy was due to no

records for required testing of the complete fire

alarm system, by the failure of the tamper alarm

to activate after closing the O S & Y valve, and by

the failure to test the generator under load. The

O S & Y valve controls the water supply to the

sprinkler system. The tamper alarm is activated

when the water supply is turned off. (See K52,

K61 and K144 of the Life Safety Code survey

document).

On 1/12/11 at 9:08 a.m., IJ was abated after

repairs and testing of the fire alarm system were

scheduled, a Fire Watch for the fire alarm system

was initiated and load testing of the generator

was successfully completed. The Program

Manager was notified that IJ had been abated.

NFPA (National Fire Protection Association)

manuals are the basis for the regulations and

standards for building construction, exits, and fire

safety features in various occupancies.

NFPA 99 Health Care Facilities - 1999 edition,

addresses fire related problems in and about

health care facilities.

NFPA 110 Standard for Emergency and Standby

Power Systems - 1999 edition, addresses the

installation, and performance of electrical power

systems to supply critical and essential needs

during outages.

The facility failed to ensure the facility is protected

from fire, and that all building construction, fire

protection systems and emergency electrical

sources are maintained and tested as required.

The results of the survey are cross referenced to

the CMS 2567 representing the K tags for the Life


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Safety Code. (Refer to A710 in the Health Survey

and K52, K61 and K144 of the LSC survey

document).

1. During record review and interview with staff

on 1/11/11, no current records for monthly

activation and annual inspection and testing of

the fire alarm system were provided.

2. During the facility tour and alarm testing on

1/11/11, the tamper alarm failed to activate when

the O S & Y valve was closed.


on 1/11/11, the facility failed to provide generator

records for 30 minute testing under load, and for

weekly inspections for 29 of 52 weeks.

During an interview at 10:07 a.m., Maintenance

Staff 2 reported the generator is not tested under

load.

The cumulative effect of the systemic problems

identified during the Life Safety Code (LSC)

portion of the recertification survey resulted in the

facility's inability to ensure the provision of quality

health care in a safe environment

A 701 482.41(a) MAINTENANCE OF PHYSICAL

PLANT

The condition of the physical plant and the overall

hospital environment must be developed and

maintained in such a manner that the safety and

well-being of patients are assured.


A 701

Based on observation and staff interview the

condition of the hospital physical environment

was not maintained in a manner that the safety


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and well being of the patient was assured.

Findings;

The hospital provides services to acute, inpatient

psychiatric patients on voluntary and involuntary

holds. The locked unit, where the safety of the

patients, is a concern. Observation rooms,

equipped with cameras, are used to monitor

patients who require the use of restraints and/or

seclusion. During an environmental tour of the

unit on 1/12/10 at 11:10 a.m. with nursing staff

the following safety concerns were observed.

A window in the hallway, outside room 111, was

cracked and broken at the top. Staff stated that

the broken window had been reported, but not yet

repaired.

An empty camera box was observed mounted on

the wall in patient room 134. The wooden box

was broken and could be used as a leverage tool

for a patient with suicidal ideations.

Throughout the unit patient rooms were equipped

with protruding stationary knobs that were not

break away, creating a possible leverage tool and

a safety concern for at risk suicidal patients.

A 710 482.41(b)(1)(2)(3) LIFE SAFETY FROM FIRE

(1) Except as otherwise provided in this section-

(i) The hospital must meet the applicable

provisions of the Life Safety Code of the National

Fire Protection Association. The Director of the

Office of the Federal Register has approved the

NFPA 101 2000 edition of the Life Safety Code,

issued January 14, 2000, for incorporation by

reference in accordance with 5 U.S.C. 552(a) and

A 710


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1 CFR Part 51. A copy of the Code is available for

inspection at the CMS Information Resource

Center, 7500 Security Boulevard, Baltimore, MD

or at the National Archives and Records

Administration (NARA). For information on the

availability of this material at NARA, call

202-741-6030, or go to:

http://www.archives.gov/federal_register/code_of

_federal_regulations/ibr_locations.html

Copies may be obtained from the National Fire

Protection Association, 1 Batterymarch Park,

Quincy, MA 02269. If any changes in this edition

of the Code are incorporated by reference, CMS

will publish notice in the Federal Register to

announce the changes.

(ii) Chapter 19.3.6.3.2, exception number 2 of

the adopted edition of the LSC does not apply to

hospitals.

(2) After consideration of State survey agency

findings, CMS may waive specific provisions of

the Life Safety Code which, if rigidly applied,

would result in unreasonable hardship upon the

facility, but only if the waiver does not adversely

affect the health and safety of the patients.

(3) The provisions of the Life Safety Code do not

apply in a State where CMS finds that a fire and

safety code imposed by State law adequately

protects patients in hospitals.


Based on observation, facility staff interviews,

document review and generator and fire alarm

system inspections, the facility did not meet the

provisions of the 2000 edition of the Life Safety

Code 101 of the National Fire Protection

Association. The facility failed to maintain and


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test the complete fire alarm system annually,

failed to inspect and test the generator in

accordance with NFPA 99 and NFPA 110, and

the facility failed to ensure the sprinkler system

tamper alarm initiated an alarm when the O S & Y

valve was closed. These failures affected 13 of

13 patients on 1/11/11 and 15 of 15 patients on

1/12/11. This could result in a failure of the fire

protection system, an increased risk of fire, or the

spread of smoke and fire.

Findings:

During the facility tour, facility staff interviews,

document review and the generator area

inspection, on 1/11/11 and 1/12/11, the facility

was found not to be in compliance with the 2000

edition of the Life Safety Code 101 of the National

Fire Protection Association. The results of the

survey are cross referenced to the CMS 2567

representing the K tags for the Life Safety Code.

The deficiencies written were as follows: K52,

K61, and K144.

1. During record review with staff on 1/11/11, no

current records for annual inspection and testing

of the fire alarm system were provided. The

records indicated the last inspection was

completed in 2008.

During the facility tour on 1/11/11, at 10:14 a.m.,

the fire alarm control panel, in the reception area,

indicated a Supervisory trouble signal. At 2:30

p.m., a faxed report, dated 1/11/11, provided a list

of fire alarm signals received during the last 12

months by the monitoring company. The report

"System Event Report," indicated the system had

been in Trouble since 12/10/10.


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2. During the facility tour and alarm testing with

facility staff on 1/11/11, the tamper alarm was

tested at the sprinkler system riser.

At 1:45 p.m., the O S & Y valve was closed.

There was no audible alarm or trouble signal

received at the fire alarm panel after the valve

was closed.

At 1:48 p.m., the O S & Y valve was closed.

There was no audible alarm or trouble signal

received at the fire alarm panel after the valve

was closed.

An alarm is required to activate at the panel when

the valve is closed.


on 1/11/11, the generator records were reviewed.

There were no records for 30 minute testing

under load for 12 of 12 months. There were no

records for weekly generator inspections for 4 of

4 weeks in January 2010 and in November 2010.

There were no records for weekly inspections for

2 of 4 weeks during the other 10 months in 2010.

During an interview on 1/11/11, at 10:07 a.m.,

Maintenance Staff 2 reported the generator is not

tested under load. He stated there were no other

records for generator inspection or testing.

A 747 482.42 INFECTION CONTROL

The hospital must provide a sanitary environment

to avoid sources and transmission of infections

and communicable diseases. There must be an

active program for the prevention, control, and

investigation of infections and communicable

diseases.


A 747


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Based on observation, staff interview and review

of facility documentation, the hospital failed to

develop, implement and maintain a

comprehensive on going infection control

program to minimize infections and

communicable diseases. The hospital failed to

ensure that the assigned infection control officer

was qualified in infection control. Policies and

procedures in infection control had not been

reviewed, developed nor implemented. The

designation of the infection control officer was not

written into the over all infection control plan.

(Refer to A-0748). The hospital failed to develop

a comprehensive infection control program for the

identification, investigation, reporting, prevention,

evaluation and control of infections. (Refer to

A-049) The hospital failed to maintain a

comprehensive log of infections and incidences

for patients and personnel. (Refer to A-0750)

The hospital failed to ensure infection control

issues were incorporated into the facility wide

quality assurance program and that training

programs were developed targeting infection

control issues. (Refer to A-0756).

The cumulative effect of these systemic failures

resulted in the hospital's inability to maintain an

ongoing infection control program to minimize

infections and communicable diseases and

provide quality patient care in a safe and sanitary

environment.

A 748 482.42(a) INFECTION CONTROL OFFICER(S)

A person or persons must be designated as

infection control officer or officers to develop and

implement policies governing control of infections

and communicable diseases.

A 748


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Based on interview, personnel file review and

facility forms review, the hospital failed to ensure

that the assigned infection control officer (LN 1)

was qualified in infection control. There were no

specific infection control responsibilities assigned

to LN 1. Policies and procedures in infection

control had not been reviewed, developed nor

implemented by LN 1. The designation of the

infection control officer was not written into the

over all infection control plan.

Findings:


9:50 a.m. revealed he had been the infection

control nurse for over 15 years. He had never

addressed the policy and procedures related to

infection control. He had not had any training in

infection control beyond what all employees

receive as a part of their job. He had never been

given a job description related to the infection

control duties.

Review of LN 1's personnel file on 1/13/11 at 9:30

a.m. revealed that he had worked at the facility

since 1997. An Annual performance report, dated

2/10/10 reflected part of the work objectives were

to "Continue to function as the Infection Control

Nurse". There was no further delineation as to

what that objective required.

Subsequent interview with the Director of

Nursing (DON), revealed that the work objective

related to being the infection control nurse had

been written into each of LN 1's performance

evaluations. There had never been specific duties

assigned that would encompass infection control


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issues. The designation of the infection control

nurse had not been addressed in writing as part

of the over all infection control plan, nor had it

been approved by any committee, including the

quality committee and the governing board.

Review of the facility's organizational chart

reflected no indication who had been designated

as the infection control officer.

A 749 482.42(a)(1) INFECTION CONTROL OFFICER

RESPONSIBILITIES

The infection control officer or officers must

develop a system for identifying, reporting,

investigating, and controlling infections and

communicable diseases of patients and

personnel.


A 749

Based on interview, policy and procedure review

and observation, the hospital failed to develop a

comprehensive infection control program for the

identification, investigation, reporting, prevention,

evaluation and control of infections. 1. Contracted

environmental cleaning services were not

included in the over all infection control plan. The

cleaning solutions and procedures had not been

adopted and approved by the facility. 2. There

was no on going active surveillance of personnel

in infection control practices, nor any current

areas identified for improvement. There was no

analysis of data collected. 3. The medicine room

had an air duct in the ceiling that was covered in

debris, resembling dust. The nurses station sink

had a faucet and handles with a build up of

gray/green sediment deposits. The counter tops

were discolored with a white coating. 4. There

was no monitoring of the cleaning of the


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accucheck machine (used for checking patient's

blood sugar). 5. Policies and procedures related

to infection control were not approved and did not

meet current standards of practice.

Findings:

1. Interview with LN 3 (licensed nurse) on 1/11/11

at 8:30 a.m. revealed that no licensed staff were

assigned to any custodial duties. Information

about infections is put on a white board and

sometimes they are available on-line as a part of

their yearly training. There have been no

employee staff meetings in many years.

Interview with the Job Coach on 1/11/11 at 9:30

a.m. revealed that he supervises the

housekeeping staff. They leave at around 4:15

p.m. weekdays, with an evening crew that comes

in at 5:30, but they clean multiple buildings, not

just this facility. On weekends the crews leave at

1:30 p.m. so, the next cleaning that is done is not

until Monday morning at 8:30 a.m. The crew

uses universal precautions. The nurses don't

always relay information regarding patient

conditions, so they will have to ask before they

enter rooms. They will clean rooms only when

they are not occupied. Linens are not changed

daily. Beds are cleaned when patient's are

discharged. The medicine room is cleaned now

and then. He did not know what the nurses do if

any cleaning needed to be done after they were

gone.


revealed that if staff needed to clean the rooms

after the cleaning crew left they would use bleach.

There was no policy and procedure for this


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scenario.


9:45 a.m. revealed that the contract for

environmental cleaning and subsequent cleaning

policy and procedures, had not been approved as

a part of the facility's infection control committee,

governing body or quality improvement.

2. Review of the Infection Control Report dated

























submitted.



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3. Observation of the handwashing sink in the

nurses station, on 1/12/11 at 9:30 a.m., revealed

a faucet and handles with a build up of gray/green

sediment deposits. The deposits were at the tip of

the faucet, where water pours out and at the base

of the faucet and the handles. The counter tops

were discolored with a white embedded coating.

Subsequent interview with LN 1 revealed that the

cleaning crew will clean the area when asked by

nursing. He agreed that the area did not look

clean and the sediment on the faucet was stuck

and unable to be removed.

Observations noted on 1/13/11 at 2:40 p.m. in the

medicine room revealed a ceiling vent with a build

up of material, resembling an accumulation of lint

and dust. Subsequent interview with LN 2

revealed she had no idea when it was last

cleaned. There was no documentation of cleaning

or monitoring of this area found.

4. Review of the policy and procedure titled "

Accuchek Machine Maintenance' reflected in

part,"..The machine will be checked nightly

comparing the "Check Strip". Record as Okay

with a check mark on the log sheet. Initial. The

machine will be checked weekly, (Sunday), using

HI and LO solutions to record variances. Initial...."

Review of the accuchek "Quality Control Log" for


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the year 2010 indicated the following number of

nights that nightly checks were missing for each

month:

January: 12

February: 19

March: 16

April 19

May: 14

June: 16

July: 17

August: 19

September: 23

October: 16

November: 21

December: 16

Subsequent interview with LN 1 revealed that no

one oversees this process. He agreed the log is

inconsistent and the policy was not being

followed.

5. Review of the Infection Control Manual, policy













Internist.


9:45 a.m. revealed that the policies and


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procedures had not been reviewed or revised

recently and there were no recent approval dates.

A 750 482.42(a)(2) INFECTION CONTROL LOG

The infection control officer or officers must

maintain a log of incidents related to infections

and communicable diseases.


A 750

Based on facility document review and interview,

the hospital failed to maintain a comprehensive

log of incidences of infections for patients and

personnel. The patient log utilized was incomplete

and did not allow for the tracking of diagnoses,

organisms, or even isolation precautions, if

required. No log of employee infections or

incidences had been developed or monitored by

the infection control designee.

Findings:

Review of the Infection Control Log dated 12/1/10

through 12/31/10, reflected a computerized print

out of patient names and antibiotics prescribed.

Subsequent interview with LN 1 (licensed nurse)

revealed that the list comes from pharmacy. He

concurred it was lacking in specific information

and there was no way of knowing the diagnoses.

He had not been tracking organisms or the

efficacy of the antibiotics that were prescribed. He

had not been tracking the number of times

isolation had been used or why. He does not get

information on employee illness. No log had been

developed that tracked employee infections or

incidences that could potentially be an infection

control concern.

A 756 482.42(b) LEADERSHIP RESPONSIBILITIES A 756


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Standard: Responsibilities of chief executive

officer, medical staff and director of nursing

services. The chief executive officer, the medical

staff, and the director of nursing must--

(1) Ensure that the hospital-wide quality

assurance program and training programs

address problems identified by the infection

control officer or officers; and

(2) Be responsible for the implementation of

successful corrective action plans in affected

problem areas.


Based on interview and policy and procedure

review the hospital failed to ensure infection

control issues were incorporated into the facility

wide quality assurance program. Training

programs for staff, targeting infection control,

were not developed, as there was no

identification of any infection control issues.

Findings:

Interview with LN 1 (licensed nurse), on 1/11/11

at 9:50 a.m. revealed that he has never attended

an infection control meeting. He submits data that

he collects and does not hear any more

information. He has never had any input on any

revisions to the policies and procedures. He had

not attended an infection control committee

meeting. He does not do any personal

surveillance of employees, including

handwashing techniques. He collects data on a

quarterly basis and submits to the charge nurse.

He did not know of any outcomes or decisions


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with the information that he submitted.




governing board or the quality committee.

Training specific to any infection control issues

had not been implemented.

Review of the Infection Control Manual, policy













Internist.

Interview with the quality manager on 1/13/11 at

3:30 p.m. revealed that the infection control

policies and procedures had not been reviewed

recently nor were there any recent approval

dates. The policies had not been approved by the

governing body. The Quality Improvement

committee had not been proactively involved with

the infection control process. As a result, there

had been no training programs developed

specific to any infection control issues.


foia results for phf's cmms audit

Documents