quality management in hc

Quality Management System in HC

Good Afternoon…Standards talk again?talk again?

20110202 TQM Systems 1


How to Implement a Robust (Quality) Management System (Quality) Management System

Based on ISO 9001 and the B ld i N ti l Q lit A d Baldrige National Quality Award

Healthcare Criteria

byMickey Christensen, MSME, P.E. Retired

President

TQM Systems®

Baton Rouge, LA USA


Quality Management System in HCQuality Management in HC

Why a Quality Management System for HC organizations?System for HC organizations?– To lead and operate an

organization successfully, it is necessary to direct and control it in a systematic and transparent manner.a spa e a e• Manage the whole system and

not just tasks• More consistency in processes• More consistency in processes• More effective use of resources• Focus on achievement of results• Better patient safety when the

system is well managed• Continual improvement over time


p


Everyday there is news about medical errors, with a recent one b i th OIG t M dibeing the OIG report on Medicare Adverse Events published Dec. 1, 2010 that stated that Medicare beneficiaries experienced adversebeneficiaries experienced adverse events that contributed to at least 15,000 deaths in a single month.

Patient Care, Patient Safety, Research

A new study examining safety– A new study examining safety practices at 10 hospitals found no reduction in patient harm attributable to medical care overattributable to medical care over a five-year period.

November 28, 2010



"You can't solve a problem with the same kind of thinking thatthe same kind of thinking that created it."

- Albert EinsteinAlbert Einstein



“Hospital chief executive officers should adopt enterprise wideshould adopt enterprise-wide operations management and related strategies to improverelated strategies to improve the quality and efficiency of emergency care.”

— Institute of Medicine report, "Hospital-Based Emergency Care: At the Breaking Point"



“We have to bring the science of managementscience of management back into health care.”

Donald M Berwick MD MPPDonald M. Berwick, MD, MPP, President and CEO, Institute for Healthcare Improvement (Director of CMS 20110202)

To help achieve what he calledTo help achieve what he called “systemic change” in healthcare, CMS Administrator Dr. Donald Berwick said hospital trusteesBerwick said hospital trustees and C-suite leaders should make quality a strategy and consider it when they think about their b d tbudgets.



Baldrige and ISO 9001 fit like a glovea glove– System designed to control all

work processesp– System focuses on customer

(patient) requirements– Both are results oriented– Data driven decisions

Continual improvement of– Continual improvement of processes required



Pop Quiz!In 50 words or less describe– In 50 words or less, describe your management system.

• How is clinical handled?H ill t• How are ancillary supports handled?

• How is safety handled?H i i t l h dl d?• How is environmental handled?

• How is financial handled?

You have 5 minutes to jot the answer down

Save this to take some notes relative to requirements mentioned in next slides


mentioned in next slides.


Jot your management system notes here.



Why ISO 9001 Criteria?(International Quality Management System Criteria)(International Quality Management System Criteria)

– To direct and control the organization with regard for

li i ALLquality in ALL processes.• Basic clinical protocols • Basic financial standards• Basic ancillary processes• Basic monitoring and measurement

of processes and the resultsof processes and the results• Basic analysis of data to generate

information to manage and continually improvecontinually improve

• Basic patient and employee safety



Why Baldrige Award Healthcare Criteria?Healthcare Criteria?– Results oriented system– Enables financial successEnables financial success– Supplements CMS conditions for

participation– Recognition nationally if win

awardBetter patient care and safety– Better patient care and safety

– Reduce waste



ISO 9001:2008 (Quality Management System standard) & Baldrige supplements otherBaldrige supplements other requirements– Use of various tools and methods

• Lean (suggested by Joint Commission and others)

• Six Sigma (the hot item now)SPC• SPC

• FMEA (required by Joint Commission criteria)

Changes are institutionalized by– Changes are institutionalized by becoming part of the system so the gains are sustainedRe ie of s stem periodicall for– Review of system periodically for effectiveness

– Quality objectives

20110202 TQM Systems 1420100730 TQM Systems 14

• A stated goal to achieve in time


ISO 9001:2008 (Quality Management System standard) &Management System standard) & Baldrige supplements other requirements– Good fit with Centers for Medicare and

Medicaid Services (CMS) conditions of participation

– Blends with various award criteria– Generic and provides a basic system

for any organization– Does not tell clinicians how to practice

medicine– Does prescribe some processesDoes prescribe some processes

necessary to implement a good management system



Consider where Six Sigma (or Lean) could be applied in yourLean) could be applied in your organization as we go through the next slides discussingthe next slides discussing system requirements– What needs improving?– How will it be improved?– When will it be improved?– How will improvements be

institutionalized?– What assures this will becomeWhat assures this will become

the new culture?



DMAIC is the structured Six Sigma approach for processSigma approach for process improvement: – Define (Part of “PLAN”)Define, (Part of PLAN )– Measure, (Part of “PLAN”)– Analyze, (Part of “CHECK”)– Improve, (Part of “DO & ACT”)– Control. (Part of “DO & ACT”)

How do results from this get to b t f th tbe part of the management system?



DMADV: D fi– Define

– Measure – Analyze– Analyze – Design – Verify y

DMADV strives to generate a gnew process where none existed, or where an existing

i d d t bprocess is deemed to be inadequate and in need of replacement


replacement.


How do results from DMAIC or DMADV get to be part of theDMADV get to be part of the management system?

How are the gains maintained?

How do you prevent entropy?– In thermodynamics the second– In thermodynamics, the second

law basically says all energy evolves to the lowest level.



Some requirements associated with ISO 9001 &associated with ISO 9001 & Baldrige– Identify processes and describeIdentify processes and describe

interaction and sequence– Control outsourced products and

services• Products and services you have

someone else do that you could doy– Example: Sears washer is made by

Whirlpool– Example: ER docs are contracted to

id i ERprovide care in ER



Some requirements associated with ISO 9001 &associated with ISO 9001 & Baldrige– Control documentsControl documents

• internal documents reviewed and approved prior to useexternal documents version and• external documents -- version and distribution controlled

– PDR, Nurses guide to medicinesFire Marshall Life Safety Code– Fire Marshall, Life Safety Code

– CMS documentation

• Records are evidence of work performedperformed

– Evidence the work was done– Supports coding and billing



Use the KISS process:KeepKeep

It

Simple &Simple &

Sufficient

Bureaucracy:yA fool proof method of converting pure energy...

... into solid waste.



Some requirements – cont’dM l f li i d– Manuals for policies and procedures controlled

• reviewed and approved prior to usepp p• revised as necessary and

reapprovedManagement committed and– Management committed and customer (patient) focused

• patient centered care?• accountable care organization?• Patient medical home



Patient Centered CareDesign of patient care wherein– Design of patient care wherein institutional resources and personnel are organized around patients rather than around specialized departmentsthan around specialized departments.

From Reference.MD web site 20101108

HC’s New Golden Rule:Don't do unto others as you'dDon t do unto others as you d like done unto you,Do unto others as they'd like done nto themdone unto them.



Patient Centered Care Addresses:

Creativity, Self-Development,

Self-ExpressionTraining, Innovation, Motivation

G th Fill d b Ch iSelf

ActualizationSelf Respect,

Respect ofRewards Recognition

Growth - - Filled by Choice

Social Needs

Esteem NeedsRespect of Others

Association w/

GroupFamily, Church, Clubs

Rewards, Recognition,

Value

Safety & Security NeedsFinancial, Health

Deprivation - -Must be filled needs

M l ' Hi h

Physiological NeedsProtection from

dangerFood, Water, Air


Maslow's Hierarchy


Some requirements – cont’dR ibiliti d th it f– Responsibilities and authority for all are defined and understood

• job descriptions,j p• procedures defining competencies

– Management reviews the system periodically for improvementperiodically for improvement

– Adequate resources are providedp

• Competent personnel– for all jobs that impact meeting

customer (patient) requirements(p ) q

• Appropriate infrastructure and work environment



Some requirements – cont’d– Adequate business results to aid q

sustainability:• Correct billing to receive

appropriate feesappropriate fees– monitor returned and rejected claims– concerned about fraud and abuse

billingg

• Proper collection procedures are in place to minimize accounts receivable daysy

• Patient demographics can be developed and analyzed

– care plans fit the patient needscare plans fit the patient needs

• Financial planning is tied to operational planning.



Some requirements – cont’d– Customer (patient and others)Customer (patient and others)

requirements are understood and met• includes regulatory and statutory• includes those not specified by the

customer, but are necessary• includes those of payers• communications are appropriate

Design of product (care plan) or– Design of product (care plan) or service is managed and meets the requirements

• Best in class protocols adoptedp p• Protocols revised based on analysis of

results achieved• Five rights honored:

right patient right drug right time right– right patient, right drug, right time, right dose, and right route

• Utilizing international standards for providing care (Ex: WHO hand washing)



COMMUNICATING (CAJUN MEDICAL TERMS)

– Artery-- Study of Paintingy y g– Barium-- What you do when CPR fails– Caesarian Section-- A district in Rome– Colic-- A sheep dog– Coma-- A punctuation markComa A punctuation mark– Congenital-- Friendly– Dilate-- To live longer– G.I. Series-- A baseball game between soldiers

Medical Staff Doctor’s cane– Medical Staff-- Doctor s cane– Morbid-- A higher offer– Nitrate-- Lower than the day rate– Outpatient-- A person who fainted

P i I f f l– Protein-- In favor of young people– Secretion-- Hiding everything– Serology-- The study of English Knights– Tablet-- A small table– Tumor-- An extra pair– Urine-- Opposite of “Your out”– Varicose Veins--Veins which are too close together



Example of design of care: (Hand washing)(Hand washing)

The five components of the WHO Multimodal Hand Hygiene Improvement StrategyHand Hygiene Improvement Strategy

1a. System change –alcohol-based handrub at point of care

++1b. System change – access to safe,continuous water supply, soap and

towels+

3. Evaluation and feedback+

2. Training and educationg+

4. Reminders in the workplace+

5 Institutional safety climate


5. Institutional safety climate


FIVE MOMENTS FOR HAND HYGIENE IN HEALTH CARE

1. BEFORE TOUCHING A PATIENT

HYGIENE IN HEALTH CARE

2. BEFORE CLEAN/ASEPTIC PROCEDURE

3. AFTER BODY FLUID RISK EXPOSURE

4. AFTER TOUCHING A PATIENT

5. AFTER TOUCHING PATIENT SURROUNDINGS

Placement of hand hygiene products (soap and handrubs) should be aligned(soap and handrubs) should be aligned with promoting hand hygiene in accordance with the concept of the “Five moments for hand hygiene”


moments for hand hygiene .


Some requirements –t’dcont’d

– Purchasing of products and services managedservices managed

• Suppliers are evaluated and re-evaluatedOrders describe product or service• Orders describe product or service correctly

• Suppliers deliver what was ordered tion time

– Partial shipments waste resources (unless specified in the order as acceptable)acceptable)

– Late deliveries may cause problems– Wrong items waste resources



Some requirements – cont’dW k t ll d t– Work processes are controlled to provide results expected

• Suitable work instructions, equipment, measuring and monitoring, etc.

• Infections are targeted with goal of g gzero

• Assure proper coding and billingProper identification and– Proper identification and traceability of product, service, and patient

• Recalled products identified and traced easily to prevent patient harm



Some requirements – cont’dq– Control of customer property

• Meds, jewelry, clothing, aids (eye glasses hearing aids teethglasses, hearing aids, teeth, walkers, canes)

• Medical records, images, labs– Control of monitoring and

measuring equipment• maintained and calibrated tomaintained and calibrated to

National or International standards



Some requirements – cont’dC t ti f ti– Customer perception of meeting their requirements is to be monitored

• Not a measure of dis-satisfaction– System to have internal audits

periodicallyperiodically• Internal by employees, but not their

own work area• Use of third party auditors if needed



Some requirements – cont’dM it d– Monitor and measure processes for effectiveness

• Are patient results as expected?p p• Are costs monitored and managed?

– Control of non-conforming product or service throughoutproduct or service throughout

• wrong product, wrong patient, wrong quantity, wrong time, wrong ddose

• Procedures not being followed, results not expected (allergic reactions, infections)



Some requirements – cont’d– Collect and analyze data about the– Collect and analyze data about the

system• turn data into information to aid in

managing the processesg g p

– Take corrective/preventive actions• Corrective actions to prevent recurrence of

issue (may use Lean or Six Sigma here)( y g )– root cause– action plan and implemented– verify effectiveness of action taken

• Preventive actions to prevent the occurrence of an issue (may use Lean or Six Sigma here)

root cause– root cause– action plan and implemented– verify effectiveness of action taken



Break time15 i t d th t t– 15 minutes and then we start again.



Before collecting data, sharpen your observationsharpen your observation skills:

1. Count the number of “F’s” in the following slide’s text. (The F’s are not case sensitive for this exercise.))

2. Record your count for scoring.3. You only have a max. of TWO (2) minutes to

count.



The Necessity of Training Farm Hands for First Class Farms in the Fatherly yHandling of Farm Livestock is Foremost in the Minds of Farm Owners. Since the Forefathers of the Farm Owners Trained the Farm Hands for First Class Farms in the Fatherly Handling of Farm Livestock, the Farm Owners Feel they should carry on with the Family Tradition of Training Farm Hands of First Class Farms in the Fatherly Handling of Farm Livestock B th b li it i th B i fBecause they believe it is the Basis of Good Fundamental Farm Management.

Total Number of F’s ___________.



A good (Quality) Management System yields benefits:System yields benefits:– Customers (Patients & Doctors)

• ExternalExternal • Internal

– Employees– Financial– Suppliers



Benefits to hospitals(Data from several hospitals)

M i t t h t idi– More consistent approach to providing care, less confusion

– Saved approx. $130,000 per year by b tt i li ( 130better managing suppliers (approx 130 bed hospital)

– Doctors feel data from calibrateddevices are more accurate & reliable

– Reduced number of forms and documents

– Improved overall efficiency– Patient satisfaction improved– Quality objectives drive continualQuality objectives drive continual

improvement




Floyd Memorial Hospital in New Albany, IN


Some bumps in the road for HC to implementHC to implement– New terminology to learn– Not all people wanted theNot all people wanted the

change– Doctors concerned about

someone telling them how to practice medicine (IWA-1, ISO 9001 & Baldrige do not do this.)9001 & Baldrige do not do this.)

– Resources to get system in place and then maintain

– How to prioritize relative to all other things going on



From Hippocratic Oath: primum non nocere, a Latin p ,phrase that means "First, do no harm." . For MDs now: secundus nonFor MDs now: secundus non attero, a Latin phrase that means “Second, not waste”

Ricardo Leano, MD MBA

If you think health care is i it tilexpensive now, wait until

you see what it costs when it's free!

P. J. O'Rourke



INPUT •1.Patients Admitting Diagnosis

•2.Procedures Ordered •3. Materials Needed for Care

System Approach

to ManagementNo

•Work Continues

•No Corrective Actions Necessary•Preventive Actions•Continual Improvement• may take place

YesNo

•PLAN

•ASSESS

g Be

gins

• may take place

•IMPLEMENT•EVALUATE

C M t

• Performance Equivalentto Standards

•PLAN

•IMPLEMENT

•Con

trollin

g

•Performance Significantly Different from Standards

•Compare Measurement• to Standards •Measure Performance

•EVALUATE

•Take Corrective Actions:

•Change Plans, Organization

•Influencing Methods

•New Work Situation Begins

• OUTPUT

•1. Patient discharged

•2. Procedures done correctly


•3.Correct materials supplied


Get out your note describing your management systemyour management system.

Spend the next few minutesSpend the next few minutes developing a plan on how you could improve that system.

Pi k l t f– Pick a couple processes to focus on that give the most ROI

• Use the Pareto principle

Take the plan back to the ffi d k hoffice and make some changes

that are value-added for the organization.


g


Crossing the Quality Chasm

“ ’ b f id k“Don’t be afraid to take a big step when one is indicatedindicated.You can’t cross a chasm in two small steps.”p

-David Loyd George



Process Flow Charts

Example of process to be analyzed.

Pt. Start w/ Dr. Tube

labeledw/ request

Specimento correct Lab area

OrderBloodTest

End

No

Yes

Tube(s) to Lab

Recv’d & t d i

Blood testdone

Results to Dr.

Doctor orderstype of test

(Care Plan)

Signed ff

entered in lab system

No

Results reviewed & verified

Results Printed/faxed

to ER

RequestTranscribed

& printed

offby RN

Notify Collection S i

No

No

Results called to ER

Yes

Yes

qAccepta

ble?ResultsAccepta

ble?

CriticalValues?

Notify RN/Phleb

to draw bloodof blood inright tube

SpecimenProcessed/

CentrifugedResults entered

in computer

Yes



Other systems (USA related)– Baldrige National Quality Award Healthcare

criteria [included in AIAG document Businesscriteria [included in AIAG document, Business Operating Systems (BOS) for health care organizations]

– DNV Healthcare, Inc. system that includes CMS conditions of participation and ISO 9001CMS conditions of participation and ISO 9001 (CMS deeming authority granted in 2008)

– Joint Commission that includes CMS conditions of participation and JC added criteria (CMS Deeming authority)

– AOA system (HFAP) that includes CMS conditions of participation and AOA added criteria (CMS Deeming authority)

– NCQA [National Committee for Quality Assurance] (Health Plan accreditation)Assurance] (Health Plan accreditation)

– URAC (health plans and preferred provider organizations)

– ACHC [Accreditation Commission for Health Care] (CMS Deeming authority for homeCare] (CMS Deeming authority for home care), ACHC is certified to ISO 9001.

– SGS-SSC system that includes CMS conditions of participation and ISO 9001 (CMS deeming authority to be requested)


g y q )


Some references that may be helpful

IOM b h d f N i l– IOM reports can be purchased from National Academy Press at www.nap.edu

– The USA Dept of State has headquarters clinic certified to ISO 9001 and will do all embassy clinics soon

– About 20 hospitals and a total of about 45 HC organizations are certified to ISO 9001 in the USA. About 4500 in Europe.

– NCQA and URAC are at: www.ncqa.org and www.urac.org

– Accreditation Commission for Health Care (ACHC) which accredits DME and Home care(ACHC) which accredits DME and Home care is certified to ISO 9001 www.achc.org

– SGS-SCS registrar [email protected]– DNV Healthcare, Inc. has deeming authority to

accredit hospitals and is a registrar:accredit hospitals and is a registrar: www.dnv.com

– AIAG for BOS document at: www.aiag.com



Questions?



Contact information:Mickey Christensen MSME P E retiredMickey Christensen, MSME, P.E. retired

TQM Systems12382 Mollylea DriveyBaton Rouge, LA 70815 USAPhone: 225-273-4972Email: [email protected]



Mickey Christensen, President of TQM Systems will focus on the ISO 9001 criteria and the healthcare aid document, IWA-1, as used in a hospital. The use of the Business Operating Systems (BOS) for Health Care Organizations document combines the ISO 9001 and Baldrige Health Care criteria. He will also discuss other programs and the information covered will be applicable to any healthcare organization. The presentation will also include a quick review of helpful reference informationhelpful reference information.

Answer is 38 letters “F” on the previous slide for counting F’sAnswer is 38 letters F on the previous slide for counting F s.



Be beyond where you are Be the signature of your work Be notorious for bringing value Be a knowledge source for those seeking help Be accepting of differing views Be adamant about the stuff that counts Be willing to change yourself Be an animator in life Be open to what is not known -- yet Be aware of communication styles Be more wise than wordy Be flexible on the non essential, firm on the non negotiable Be appealing to the customer’s basic instinctcustomer s basic instinct Be aware of the value of your original equipment Be different Be up on what is coming Be better at change than your competition Be more hopeful than doubtful Be a variation watcher more than a mean watcherBe a variation watcher more than a mean watcher Be an originator of tools for others Be an example of efficiency Be in line with the strategic goals Be a means for others’ success Be a bragger of that success Be a sponge that likes! fun p gBe a pro at what you do Be ethical, truthful Be ROI oriented Be prompt Be anti arrogant Be positive is not just a blood type (gotcha) B li h h f i l dBe a lighthouse of potential danger Be real Be outrageous in your thinking Be profoundly simple in your insight Be sharp, but not pointed Be the best in something Be available


Be available Be a mediocre eradicator Be so good they can’t do without you


Berwick urges emphasis on quality

By Jessica ZigmondPosted: March 2, 2011 - 1:45 pm ET

T h l hi h t h ll d “ t i h ” i h lthTo help achieve what he called “systemic change” in healthcare, CMS Administrator Dr. Donald Berwick said hospital trustees and C-suite leaders should make quality a strategy and consider it when they think about their budgets.

“We built in fragments so we pay in fragments ” Berwick toldWe built in fragments, so we pay in fragments, Berwick told attendees Wednesday at the National Journal's health policy summit on the effect of healthcare-associated infections on costs and quality. “So we're not really paying for what we want: outcomes.”

In his interview with moderator Marilyn Werber Serafini of the K i F il F d ti B i k di d h A i b iltKaiser Family Foundation, Berwick discussed how America built its healthcare system in fragmented pieces—focusing on hospitals, physicians, nurses and other disciplines—and how that system no longer works as healthcare has evolved. The solution, he said, is quality.

Citing a recent success in the quality arena, Berwick mentioned g q y ,the Center for Disease Control and Prevention's report that said rates of central line infections among intensive-care unit patients fell 58% to 18,000 in 2009 from 43,000 in 2001, which the CDC said has saved some 27,000 lives and about $1.8 billion in excess healthcare costs.

Berwick also described steps CMS has taken and will take toBerwick also described steps CMS has taken, and will take, to improve quality, such as rolling out the Center for Medicare and Medicaid Innovation; making improvements to the agency's Hospital Compare website; and changing payments to reward quality and penalize high re-admissions and HAIs.


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