(fIJ) P00501308242017 1803

CALIFORNIA HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

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STATEMENT OF oEFICIENCIES (X1) PROVlDERISUPPLIEACLIA (X2) MUrnPLE CONSTRUCTION (X3) DATE SURVEYCOMPLETEDlNO PLAN Or CORruCllON IDENTIFICATION NUMEER

A BUILDING

050107 BWING 08112017

NAMS OF PROVIOeR OR $UPPLlcR STREETADORESS CITY STAT ZIP cooe Marian Regional Medical Center 1400 E Church St Santa Marla CA 93454-l906 SANTA BARBARA COU~TY

SUMMARY STATEMENT OF OElICIENCIES ID PRDVID~RS PLAN OF CORRECTION (X6) (X4)10 PREFIX (EACH DEFICIENCY MUST BE PRECEEDEO ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSshy COMPLETE

TAI REGULATORY OR ~SCIOlNTIFYING INFORMAllON) TAG f(ElERcNGED TO THE APROPRIATE DEFICIENCY) CATE

The following reflects the findings of the Department of Public Health during an Inspection visit

Complaint Intake Number CA00479796 Substantiated

Representing the Department of Public Health Surveyor ID 2895 HFEN

The inspection was limited to the specific facility event investigated and does not represent the findings of a full inspection of the facility

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Health and Safety Code Section 12803(g) For shy~ purposes of this section immediate jeopardy means a situation in which the licensees noncompliance with one or more requirements of llcensure has caused or is likely to cause serious ~ injury or death to the patient ~ 12791 (b)1)(D) For purposes of this section adverse event includes any of the following shy(1 ) Surgical events including the following

[ (D) Retention of a foreign object in a patient after ~ surgery or other procedure excluding objects Intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained 3 middot California Codes Health amp Safety Code Section 12791 (c) (c) The faclllty shall inform the patient or the party responsible for the patient of the adverse event by the time the report was made

The CDPH verified that the facility Informed the

Event ID4QWOi 1 8112017 103547AM

LABORATORY~~pound)ROVIDERSUPPLl~R REPRESENTATIVES SIGNATURE TITlE ) GI

~rrr~ Lampf1()pound4 r ~ By signing this document I am acknowledging receipt ol thamp lntlre citation packilt PRga(sJ 1 rna1 9

Any deficiency statement ending with on asterisk () denote~ 3 defleicney which the Institution msy be exeu~cMl ~om correcting providing it is determined that other saregwards provide sufficient protecien to the patien~ Except for m1rslng homes the findings above are dlsclosabla 90 days mllmvlng the date

of survey whether or note plan of correction Is provided For nursing homes the above flndlngearicl plane of correction are dlsolosabla 14 days ronowlng the dlt11amp these documents are made available to the facility If deficiencies are cited in ~pproved plan of correction la requlelte 10 continued plOgnlm partlci auon

Page 1 of9Stitemiddot2567

08242017 1803 P006013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMtNT OF UEFICIENCIES (X1) PROVIOeiRJSUPPLlERCLIA (X2) MULTIPLE CONSTRUCTION (XS) DATE SURVEY

ANO PlAfl OF CORRECTION IDENTIFICATIONNUMBER COMPLETEO

A BUILDING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Medical Center 1400 E Ch4rch St Santa Marla CA 93454-i906 SANTA BARBARA COUNTY

(X4) ID SUMMARY STATEMENT OF o iFICllONCIES ID PROVIDERS PLAN O~ CORRECTION (X5)

PREFIX (eACH DEFICIENCY MUST SE PRECEEDEO SY FULL PREFIX (EACH cORllECIWE ACTION SHOULO BE CROSSmiddot COMPLETE

TAG REGULATORY OR LSC IOENTIFYING INFORMATION) TAG REfERENCEO tOIHEAPPROPRIATE DEFICIENCY) DATE

patient or the party responsible for the patient of the adverse event by the time the report was made

Title 22 California Code of Regulations Division 5 Chapter 1 Article 3 Section 70223 (b)(2) Surgical Service General Requlrements (b) A committee of thlj medical staff shall be middot assigned responsibility fur (2) Development maintenance and implementation of written policies and procedures In consultation with other appropriate health professlonals and administration Policies shall be approved by the governing body Procedures shall be approved by the administration and medical staff where such is appropriate

middot This rule Is not met as evidenced by Based on Interview and record review the facility

felled to eniure surgical counts for sponges were performed according to professional standards of practice and the fadlitys policies and procedures This failure resulted In leaving a surglcal sponge inside one patient (Patient A) during open heart surgery

On 3916 an entity reported event (ERi) was submitted by the faclllty to the CDPH Licensing and Certification Indicating retention of a foreign object was discovered Inside Patient As chest According to the facmty Patient Awas recently hospitalized for unrelated chronic Issues a chest xray was performed and the foreign body was identified on the chest x-ray dated 21316

70223 (b)() -

Accountability ChiefNurse Executive Officer

Immediate Action 1 Implemented CDllCtuTent observations and

auditing performed by the Director of middot Surgical Services and leadership team to verify the Prevention ofRctained Surgical Items policy was fully implemented The concurrent audit process included a review of documentation in the patient record to verifyal I required counts were recorded During the month of March 100 of cases were observed and verified the tasks and requirements ofthe policy were completed as required

2 A site visit was conducted on 31016 by the Qignity Health surgeon expert consultant responsible for the No Thing Left Behind project The surgeon observed procedures and conducted an independent evaluation of key processes During the site visit the consultant met with surgeons surgical staff administrative and physician leaders and provided on-site education regarding Prevention of Retained Surgical Items Dignity Health policy and standardization of safety processes as outlined in policy expectations Recommendations were made and immediately implemented following the site visit

3 Additional sponge holders were ordered and placed in all procedure rooms Verification of the use ofsponge holders oil A- Abull Abull bullAA~ O bull bull bull bull bull AA-~IAhJ

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Event ID4QW011 8112017 103547AM

State-2587 Pago 2 of9

08242017 1803 P006013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMtNT OF UEFICIENCIES (X1) PROVIOeiRJSUPPLlERCLIA (X2) MULTIPLE CONSTRUCTION (XS) DATE SURVEY

ANO PlAfl OF CORRECTION IDENTIFICATIONNUMBER COMPLETEO

A BUILDING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Medical Center 1400 E Ch4rch St Santa Marla CA 93454-i906 SANTA BARBARA COUNTY

(X4) ID SUMMARY STATEMENT OF o iFICllONCIES ID PROVIDERS PLAN O~ CORRECTION (X5)

PREFIX (eACH DEFICIENCY MUST SE PRECEEDEO SY FULL PREFIX (EACH cORllECIWE ACTION SHOULO BE CROSSmiddot COMPLETE

TAG REGULATORY OR LSC IOENTIFYING INFORMATION) TAG REfERENCEO tOIHEAPPROPRIATE DEFICIENCY) DATE

patient or the party responsible for the patient of the adverse event by the time the report was made

Title 22 California Code of Regulations Division 5 Chapter 1 Article 3 Section 70223 (b)(2) Surgical Service General Requlrements (b) A committee of thlj medical staff shall be middot assigned responsibility fur (2) Development maintenance and implementation of written policies and procedures In consultation with other appropriate health professlonals and administration Policies shall be approved by the governing body Procedures shall be approved by the administration and medical staff where such is appropriate

middot This rule Is not met as evidenced by Based on Interview and record review the facility

felled to eniure surgical counts for sponges were performed according to professional standards of practice and the fadlitys policies and procedures This failure resulted In leaving a surglcal sponge inside one patient (Patient A) during open heart surgery

On 3916 an entity reported event (ERi) was submitted by the faclllty to the CDPH Licensing and Certification Indicating retention of a foreign object was discovered Inside Patient As chest According to the facmty Patient Awas recently hospitalized for unrelated chronic Issues a chest xray was performed and the foreign body was identified on the chest x-ray dated 21316

70223 (b)() -

Accountability ChiefNurse Executive Officer

Immediate Action 1 Implemented CDllCtuTent observations and

auditing performed by the Director of middot Surgical Services and leadership team to verify the Prevention ofRctained Surgical Items policy was fully implemented The concurrent audit process included a review of documentation in the patient record to verifyal I required counts were recorded During the month of March 100 of cases were observed and verified the tasks and requirements ofthe policy were completed as required

2 A site visit was conducted on 31016 by the Qignity Health surgeon expert consultant responsible for the No Thing Left Behind project The surgeon observed procedures and conducted an independent evaluation of key processes During the site visit the consultant met with surgeons surgical staff administrative and physician leaders and provided on-site education regarding Prevention of Retained Surgical Items Dignity Health policy and standardization of safety processes as outlined in policy expectations Recommendations were made and immediately implemented following the site visit

3 Additional sponge holders were ordered and placed in all procedure rooms Verification of the use ofsponge holders oil A- Abull Abull bullAA~ O bull bull bull bull bull AA-~IAhJ

3916 shy33116

3l O l6 shy311 16

31811 6

Event ID4QW011 8112017 103547AM

State-2587 Pago 2 of9

08242017 1803 P007013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARMENT OF PUBLIC HEALTH

STATEMeNT OF~iFIC lNCIES (X1) PROVIDlRSUPPLIERCLA (X2) MULTIPLE CONSTRUCTION (X3) OATE SURlleY ~ND PLAN OF CORRlCTION IOENTIFICATION NUMBER COMPLETED

A BUILDING

050107 a WING 08112017

Nllgt1E Of PROVlOER OR SUPPLIER STREET ADD~S CITY STATE ZIP CODE

Marian Regional Medlcat center 1400 E Church St Santa Marla CA 93454-5906 SANTA BAR6ARA COUNTY

(X4) ID SUMMARY STATIOMENT OF oeFICIENCIES ID PROVIDERS PLAN OF CORRcCTION (XS)

PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PR5FIX (EACH CORRECilVE ACTION SHOULOBE CROSSmiddot COMPLETE TAG REGULATORY OR LSC 1011NTIFYING INFORMATION) TAG middot RElERENCEO ro lHE APPROPRIATE DEFICIENCY) DATE

According to the Association of Perl-Operative Registered Nurses (2014) standards and best practices for prevention of retained surgical Items (RSI) The final count should not be considered complete until ALL of the sharps broken parts sponges equlpment used In the surgical procedure are returned to the scrub person A multidisciplinary system Bpproach should be used so that all team members can verify that all Items are ~ccounted for and be sure that a surgical item is not 1eft in the patient at the end of a procedure Team members need to use standardized and reliable counting practices that ensure all surgical ltems are accounted for or are reconciled at the end of the procedure Burlingame B et al Guldeine Summary Prevention of Retained Surgical Items AORN Journal 1041 (2016) 49-53

A review of the facilitys policy and procedure entitled Preventlqn of Retained Surgical Itemsbull undated Indicated the purpose of the policy is (A) To provide safety rules for pertoperatlve registered nurses andsurgical technologist in the performance of spongecounts (B) To provide safety rules for surgeons In the performance of a methodical wound exam and actions to prevent unintentional retention of surgical Items (F) To assists in accounting for all surgical items

According to the same policy the facility uses the Sponge Accounting System (SAS a standardized transparent m~nual accountirig system that requires visible verllication of the free surgical sponges used in an operation Using the

70223 (b)(2) Systemic Action l A sponge management competency is 32516

mandatory fo1middot all Circulators and Scrub and Technicians The competency includes On-going the following elements

a Viewing ofa 21 minute video demonstration of the Sponge Accounting process Demonstration of knowledge and understanding ofthe safety process is verified with a Test and requires a passing grade of l 00

b All Circulator and Scrub Technicians (existing and newly onboarded) are required to read agree and sign an attestationcommitment to follow the safety processes outlined in the Prevention of Retained Surgical Items policy

c The Just Culture policy process and accountability for safety in the Surgical Services department will be followed as

routine expectation and part of operational processes Just

Cultme (human e1Tor at risk and reckless behavior) will be utilized for potential and actual breaches in implementation of the Prevention of Retained Surgical Items policy

middot Event ID4QW011 811112017 103547AM

Stste-2567 Pagll 3 of 9

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(fAX) P008101308242017 1803

CALIFORNIA HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIDERSUPPLIERICLlt1 (X2) MULTIPU~ CONSTRUCTION (X3) DATE SURVEY

igtND PAtl OF CORRECTION IDEN11FICATION NUMBER COMPLETED

A au1LblNG

050107 8WING 081112017

NAME Oi PROVIDER OR SUPPLIER STREET ADDFlESS CITY STATE ZIP CODE

Marian Regional Meatcal Centor 1400 E Church St Santa Merla CA 9~4-5906 SANTA BARBARA COUNTY

(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (XS)

PREFIX (EACH DEFICIENCY MUST ae PRECEEDEO BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS COMPLETE TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCEO TO THE APPROPRIATE OelICIENCY) DATE

SAS all of the used and unused sponges during a surgical procedure must be In the sponge holders at the end of the case (surgery) to have a correct final count and to be able to perform a team verification step (show me)

Further review of the policy speclflcally under subpart (VI) (A) entitled Surgery Count the policy provisions indicate that during a surgery there are IN Countsbull In Counts according to the policy are counts performed of surgical sponges to establish the baseline number of items (sponges) being used during the case Additionally the policy also provides for OUT Counts which consist of the following bull Cavity count- performed before closure of a cavity within a cavity and Closing count- performed before wound closure begins and

bull FINAL Count- performed after skin closure when surgical items are no longer in use and ALL are passed off the field

Section 111 (C) of the policy Indicates the following Surgical counts must be performed in procedures In which an Incision is made or a wound is rested and surgical items are used

Section V (A) of the policy indicates the following A registered nurse Is responsible for medical

documentatfonmiddotSection (C) sets forth Counts and other required Information should be entered concurrently with ah occurrence or at the end of the case Documentation In the medical record serves

70223 (b)(2) 2 An ongoing monitoring system was implemented including observation and verification by the Director ofSurgical Services and the Surgical Services leadership team Documentation in the patient record of surgical counts is observed and evaluated The immediate action taken ongoing monitoring of the safety system was presented and accepted by the Surgical Services Committee Quality Improvement Committee Patient Safoty Committee Medical Executive Committee and Governing Board

There have been no retainid surgical item events identified since the occurrence in

March 2016

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EvMt 104QW011 B112017 103547AM

St11tE1-2S6T Pege 4of9

08242017 1803 P009013

CALI FORNIA HEAL TH AND HUMAN SlRVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DeuroFICIENCIES (X 1) PROVIDERSUPPLIERCtIA (X2l MULTIPLE CONSTRUCTION (X3) DATE SURVEY

ANO PLAN 0 1 CORRECTION IDENTIFCATION NtJMBER COMPLETED

A EIUILDING

050107 S WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET APOR5$$ CITY STATE ZIP cooe Marian Regional Medical Center 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNlY

(X6) ID SUMMARY STATEMElT OF DEFICIENCIES 10 PROVIDERS PlAN OF CORRECTION r-lt6gt PREFIX (EACH DSFICIENCY MUST BE FAECEEDED av FULL PREFIX (EACH CORRE CTNEACTION SHOULD BE CROSS COMPLETE

TAG REGULATOIW OR LSC IOENTIFYING INFORMATION) TAG RE1FERENCEO TO THE AlPROPRIATC DEFICIENCY) DATE

is legal evidence of what practices were performed

In section V1 B (2) (e) (13) the policy sets forth At the time of the final count ALL sponges (used and unused sponges) MUST be In the sponge holders and two people viewing the sponge holders must make the final verification The preference Is to have the clinician who closes the skin verify with the circulating nurse that tl1e number of sponges In the holders agrees with the number of sponges documented on the dry erase board If this not possible the anesthesiologist a charge nurse or RN who was not involved in the case may substitute The requirement Is to have new eyes look at the holders and the dry erase board to minimize confirmation bias between the scrub person who counted in the sponges and the circulating nurse

During a review of the clinical record for Patient A the Operative Reportbull dated 7fT15at1206 pm revealed Patient A had an Aortic (largest artery in the body) Root replacement with an aortic valve and tube graft using the Cabtol technique (tension-free re-implantation of the coronary arte(J es) on 7 7 1 5

During an interview with MO 1 on 41 41 6 at 1056 am bull he explained that toward the and of the surgery Patient A started bleedlng fromiddotm the surgical holes MD 1 stated I packed the bleeding area with thrombln facilitates blood clotting) gel foam (absorbable foam to aid in clotting) and a Ray-Tee (Xmiddotray detectable) sponge behind his Aorta and applied pressure to achieve hemostasis (blood clotting )

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08242017 1804 P010013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) fROVIOERSUPPUERCLIA (X2) MULTIPLE CONSTRUCTION (X3) DAtE SURVEY

ANO PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED

A ElU ILOING

0~0107 B WING 08112017

NAME Of PROVIDER OR SUPPLIER STREET AODRESS crrY STATE ZIP CODE

Marian Regional Medlcal center 1400 E Church St Santa Marla CA 93454--5906 SANTA BARBARA COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (XS) PREFIX (eACH OEFICl~NCY MUST BE PReCEE05D SY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD ae CROSSshy COMPLETE

TM REGULATORY OR ~SC IDENTIFYING INFORMATION) TAG R~FERENCED TO THE AP)ROPRIATE DEFICIENCY) DATE

A review of Patient As Surgical Document Final Report elated 7 f15 at 11 20 am revealed the initial count (IN Count) was performed by registered nurse (RN 1) and (RN 2) at approximately 752 am There was no other documentation of any of the OUT counts (cavity closing or final)

During an interview with the r~lstered nurse (RN 1) on 32316 at 305 pmbull he reviewed the Surgical Document Final Report dated 717115 at 11 20 am to locate Patient As sponge counts RN 1 acknowledged the closing and final sponge counts were not documented on the final report Furthermore RN 1 acknowledged that If the closing and final count were not documented on the surgical final report that meant The closing and final middot sponge counts were not donebull

During an Interview with registered nurse (RN 2) on 41 16 at 900 am she explained and recalled performing the Initial sponge count during Patient As surgical procedure with RN 1 but did not acknowledge or explain any other counts during Patient As surgical procedure According to RN 2 the Ray-Tee sponge was under all the items and used to produce clotting

During an Interview with the scrub technlcl~n (SCT 1) on 32316 at 405 pm he explained he did not do any sponge counts during Patient As surgical procedure A review of the document entitled Responsibilities Circulating Nurse (RN) and Scrub Penon revised 515 sets forth under Section 111 B the following During surgery the circulating RN will be

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Event ID4QW011 811 12017 103547AM

Stale-2567 Page 6 of9

08242017 1804 P011013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTf1ENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIOlRSUPP~ltRIC~IA (X2) MULTIPU CONSTRUCTION (X3) DATE SURVEY AND PLAbl OF CORRECTION IDENTIFICATION NUMaER COMPLETED

A ElUl~DING

0$0107 S WING 081 1Z017

NAME OF PROVIDER OR SUPPLIER smeer ADDRESS CITY STA-m ZIP CODE

Marian Reglom1l Medical c1mter 1400 E Church St Santa Maril CA 934545906 SANTA BARBARA COUNlY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES 10 - PROVIDERS PLAN OF CORRECTION (XS) PREFIX (EACH DEFICIENCY MUSI ee PRECEEOED ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TAG REGULAIORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED O THE APPROPRIATI DEFICIENCY) CATE

responsible for managing and coordinating ell aspects of patient care

In part B (1 of the policy the following is set forth The Circulating Registered Nurse (RN Is responsible for documenting allnursing care In the electronic medical record In SurgfnetPerloperatlve DocOperating Room lntraoperatlve Nursing Record

In part D of the policy the following is set forth The cfrcufatrng RN and scrub person share accountability for sponge sharp and instrument counts as well as patient safety and infection control

In section 1V A 1 0) of the policy a circulating nurse responsibilities is documented to Include the following Perform sponge sharp and instrument counts with scrub person per policy

A review of Patient As Computed Tomography CT chest (serial of X-rays dated 3416 at 455 pm revealed Small tangle of wires approximately 25 crn (centimeters) of the rnediastinum just above and anterior to the right pulmonary arteiy

The surgeon (MD 1) was inteNiewed on (41416 at 1056 am MD 1 stated the two X rays of the chest taken biifore Patient As discharge were underpenetrated and the sponge was not seen at that time_ After reviewing the GT the surgeon shared the sponge was Isolated between the graft and the patients old aorta

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Event ID4QW011 8112017 103547AM

State-2567 Pege 7 of 9

0812412017 1804 (fIJ) P0121013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEAL TH

STATEMENT ormiddotDEFICIENCIES (X1) PROVIDERSUPPLIERCtIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLA~ OF COFtRECTION IDEITTIFICATION NUMeER COMPLETED

A SUILOING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STAiE ZIP CODE

Marian Roglonal Medical Centar 1400 E Chur~h St Sant Marla CA 93454-5906 SANTA SARBARA COUNTY

(X4) ID SUMMMY SlAlEMENl OF OElICIENCIES 10 PROVIDERS PLAN OF CORRECTION (X5) PREFIX (EACH DEiICIENCY MUSf ee PRECEeoeo BY FJtl PREltFIX (EACH COAAEClNE ACTION SHOULD BE CROSSmiddot COMPl5T6

TAG REGUATORY OR ~SC IOENTIFYING INFORMATION TAG REFERENCED ro THE APPROPFUATE DEFICIENCY) DATE

During an Interview with the admlnistrator(Adrn 1 ) on 32316 at 205 pm she explained that when Patient A was bleeding the Ray-Tee sponge was used to apply pressure to the bleeding site Adm 1 stated the Ray-Tee sponge Is reactive and cannot be left Inside the patients [Patient AJ chest as it may causa an Inflammatory response an abscess (pus within the tissue) andormiddot a fistula (abnormal connection between two hollow spaces such eg blood vessels) According to Adm 1 these types of sponges are not meant to be retained inside the patients body Furthermore Adm 1 explained that during (Patient A) incident it was concluded that the surgical staff did not follow the [Prevention of Retained Surgical Items] policy and the SAS whioti were In place at the time of [Patient A] Incident to account for the sponge counting

During an interview with the surgeon (MD 1) on 41416 at 1056 am he shared he fell Patient A would probably not survive the surgery to remove the sponge and stated the surgery would be too risky According to MD 1 the patient was going to be evaluated for a heart transplant and at that point they could remove the spongeThe fai lure of the surgeon and the OR staff to follow the facilitys policies and procedures as it pertained to counting any and all Items entering the patient and ensuring the items came back out of the patient d11ring a surgical procedure resulted in the retention of a Ray-Tee surgical sponge In Patient A The facllltys failure to itnplement surgical care and serViCes in compliance with section 70223 (b) (2) for Patient A with a retained 1oreign object is a deficient practice that has caused or is likely to cause serious injurymiddot

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Event ID4QW011 6112017 103547AM

State-2567 Page 8 of g

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

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Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9

08242017 1803 P009013

CALI FORNIA HEAL TH AND HUMAN SlRVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DeuroFICIENCIES (X 1) PROVIDERSUPPLIERCtIA (X2l MULTIPLE CONSTRUCTION (X3) DATE SURVEY

ANO PLAN 0 1 CORRECTION IDENTIFCATION NtJMBER COMPLETED

A EIUILDING

050107 S WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET APOR5$$ CITY STATE ZIP cooe Marian Regional Medical Center 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNlY

(X6) ID SUMMARY STATEMElT OF DEFICIENCIES 10 PROVIDERS PlAN OF CORRECTION r-lt6gt PREFIX (EACH DSFICIENCY MUST BE FAECEEDED av FULL PREFIX (EACH CORRE CTNEACTION SHOULD BE CROSS COMPLETE

TAG REGULATOIW OR LSC IOENTIFYING INFORMATION) TAG RE1FERENCEO TO THE AlPROPRIATC DEFICIENCY) DATE

is legal evidence of what practices were performed

In section V1 B (2) (e) (13) the policy sets forth At the time of the final count ALL sponges (used and unused sponges) MUST be In the sponge holders and two people viewing the sponge holders must make the final verification The preference Is to have the clinician who closes the skin verify with the circulating nurse that tl1e number of sponges In the holders agrees with the number of sponges documented on the dry erase board If this not possible the anesthesiologist a charge nurse or RN who was not involved in the case may substitute The requirement Is to have new eyes look at the holders and the dry erase board to minimize confirmation bias between the scrub person who counted in the sponges and the circulating nurse

During a review of the clinical record for Patient A the Operative Reportbull dated 7fT15at1206 pm revealed Patient A had an Aortic (largest artery in the body) Root replacement with an aortic valve and tube graft using the Cabtol technique (tension-free re-implantation of the coronary arte(J es) on 7 7 1 5

During an interview with MO 1 on 41 41 6 at 1056 am bull he explained that toward the and of the surgery Patient A started bleedlng fromiddotm the surgical holes MD 1 stated I packed the bleeding area with thrombln facilitates blood clotting) gel foam (absorbable foam to aid in clotting) and a Ray-Tee (Xmiddotray detectable) sponge behind his Aorta and applied pressure to achieve hemostasis (blood clotting )

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Event 104QW011 811201 7 103547AM

State-2567 Page 5 of 9

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08242017 1804 P010013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) fROVIOERSUPPUERCLIA (X2) MULTIPLE CONSTRUCTION (X3) DAtE SURVEY

ANO PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED

A ElU ILOING

0~0107 B WING 08112017

NAME Of PROVIDER OR SUPPLIER STREET AODRESS crrY STATE ZIP CODE

Marian Regional Medlcal center 1400 E Church St Santa Marla CA 93454--5906 SANTA BARBARA COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (XS) PREFIX (eACH OEFICl~NCY MUST BE PReCEE05D SY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD ae CROSSshy COMPLETE

TM REGULATORY OR ~SC IDENTIFYING INFORMATION) TAG R~FERENCED TO THE AP)ROPRIATE DEFICIENCY) DATE

A review of Patient As Surgical Document Final Report elated 7 f15 at 11 20 am revealed the initial count (IN Count) was performed by registered nurse (RN 1) and (RN 2) at approximately 752 am There was no other documentation of any of the OUT counts (cavity closing or final)

During an interview with the r~lstered nurse (RN 1) on 32316 at 305 pmbull he reviewed the Surgical Document Final Report dated 717115 at 11 20 am to locate Patient As sponge counts RN 1 acknowledged the closing and final sponge counts were not documented on the final report Furthermore RN 1 acknowledged that If the closing and final count were not documented on the surgical final report that meant The closing and final middot sponge counts were not donebull

During an Interview with registered nurse (RN 2) on 41 16 at 900 am she explained and recalled performing the Initial sponge count during Patient As surgical procedure with RN 1 but did not acknowledge or explain any other counts during Patient As surgical procedure According to RN 2 the Ray-Tee sponge was under all the items and used to produce clotting

During an Interview with the scrub technlcl~n (SCT 1) on 32316 at 405 pm he explained he did not do any sponge counts during Patient As surgical procedure A review of the document entitled Responsibilities Circulating Nurse (RN) and Scrub Penon revised 515 sets forth under Section 111 B the following During surgery the circulating RN will be

shy

shy

Event ID4QW011 811 12017 103547AM

Stale-2567 Page 6 of9

08242017 1804 P011013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTf1ENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIOlRSUPP~ltRIC~IA (X2) MULTIPU CONSTRUCTION (X3) DATE SURVEY AND PLAbl OF CORRECTION IDENTIFICATION NUMaER COMPLETED

A ElUl~DING

0$0107 S WING 081 1Z017

NAME OF PROVIDER OR SUPPLIER smeer ADDRESS CITY STA-m ZIP CODE

Marian Reglom1l Medical c1mter 1400 E Church St Santa Maril CA 934545906 SANTA BARBARA COUNlY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES 10 - PROVIDERS PLAN OF CORRECTION (XS) PREFIX (EACH DEFICIENCY MUSI ee PRECEEOED ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TAG REGULAIORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED O THE APPROPRIATI DEFICIENCY) CATE

responsible for managing and coordinating ell aspects of patient care

In part B (1 of the policy the following is set forth The Circulating Registered Nurse (RN Is responsible for documenting allnursing care In the electronic medical record In SurgfnetPerloperatlve DocOperating Room lntraoperatlve Nursing Record

In part D of the policy the following is set forth The cfrcufatrng RN and scrub person share accountability for sponge sharp and instrument counts as well as patient safety and infection control

In section 1V A 1 0) of the policy a circulating nurse responsibilities is documented to Include the following Perform sponge sharp and instrument counts with scrub person per policy

A review of Patient As Computed Tomography CT chest (serial of X-rays dated 3416 at 455 pm revealed Small tangle of wires approximately 25 crn (centimeters) of the rnediastinum just above and anterior to the right pulmonary arteiy

The surgeon (MD 1) was inteNiewed on (41416 at 1056 am MD 1 stated the two X rays of the chest taken biifore Patient As discharge were underpenetrated and the sponge was not seen at that time_ After reviewing the GT the surgeon shared the sponge was Isolated between the graft and the patients old aorta

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Event ID4QW011 8112017 103547AM

State-2567 Pege 7 of 9

0812412017 1804 (fIJ) P0121013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEAL TH

STATEMENT ormiddotDEFICIENCIES (X1) PROVIDERSUPPLIERCtIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLA~ OF COFtRECTION IDEITTIFICATION NUMeER COMPLETED

A SUILOING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STAiE ZIP CODE

Marian Roglonal Medical Centar 1400 E Chur~h St Sant Marla CA 93454-5906 SANTA SARBARA COUNTY

(X4) ID SUMMMY SlAlEMENl OF OElICIENCIES 10 PROVIDERS PLAN OF CORRECTION (X5) PREFIX (EACH DEiICIENCY MUSf ee PRECEeoeo BY FJtl PREltFIX (EACH COAAEClNE ACTION SHOULD BE CROSSmiddot COMPl5T6

TAG REGUATORY OR ~SC IOENTIFYING INFORMATION TAG REFERENCED ro THE APPROPFUATE DEFICIENCY) DATE

During an Interview with the admlnistrator(Adrn 1 ) on 32316 at 205 pm she explained that when Patient A was bleeding the Ray-Tee sponge was used to apply pressure to the bleeding site Adm 1 stated the Ray-Tee sponge Is reactive and cannot be left Inside the patients [Patient AJ chest as it may causa an Inflammatory response an abscess (pus within the tissue) andormiddot a fistula (abnormal connection between two hollow spaces such eg blood vessels) According to Adm 1 these types of sponges are not meant to be retained inside the patients body Furthermore Adm 1 explained that during (Patient A) incident it was concluded that the surgical staff did not follow the [Prevention of Retained Surgical Items] policy and the SAS whioti were In place at the time of [Patient A] Incident to account for the sponge counting

During an interview with the surgeon (MD 1) on 41416 at 1056 am he shared he fell Patient A would probably not survive the surgery to remove the sponge and stated the surgery would be too risky According to MD 1 the patient was going to be evaluated for a heart transplant and at that point they could remove the spongeThe fai lure of the surgeon and the OR staff to follow the facilitys policies and procedures as it pertained to counting any and all Items entering the patient and ensuring the items came back out of the patient d11ring a surgical procedure resulted in the retention of a Ray-Tee surgical sponge In Patient A The facllltys failure to itnplement surgical care and serViCes in compliance with section 70223 (b) (2) for Patient A with a retained 1oreign object is a deficient practice that has caused or is likely to cause serious injurymiddot

- -gt-~middot ~middot = zC -__ -ampshyctrj JI J~~ c

D cott_ r~~

~c GJ CJ C N__ r

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o(=i er 11middot-

middot-cmiddot ~rrt _ lJ rr-1 middott

Zt-= ~-i~ ~

-n1 f- - P Ono

-~

P

Event ID4QW011 6112017 103547AM

State-2567 Page 8 of g

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

middotmiddoti2~7JC4-middot middot-c 7 rn J G Cbull -middot r-- -)---r-i __-middot~~

Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9

--

_ __1shygt

rnimiddot) -gt - rl

- gt cltJmiddot gt i~1 J-~ c~ en ormiddot N -~ amp-(f middot--- r shyo -ua - JC --1 middot~middot

(jlcgt (-)_ -i~ Nmiddot-- -ICJO-11

-~bullJ

cc f2gt -middotmiddotaJ rn -r-middot r middot~-~ middot-middotgtiC) ~-q

~middot-

08242017 1804 P010013

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) fROVIOERSUPPUERCLIA (X2) MULTIPLE CONSTRUCTION (X3) DAtE SURVEY

ANO PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED

A ElU ILOING

0~0107 B WING 08112017

NAME Of PROVIDER OR SUPPLIER STREET AODRESS crrY STATE ZIP CODE

Marian Regional Medlcal center 1400 E Church St Santa Marla CA 93454--5906 SANTA BARBARA COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDERS PLAN OF CORRECTION (XS) PREFIX (eACH OEFICl~NCY MUST BE PReCEE05D SY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD ae CROSSshy COMPLETE

TM REGULATORY OR ~SC IDENTIFYING INFORMATION) TAG R~FERENCED TO THE AP)ROPRIATE DEFICIENCY) DATE

A review of Patient As Surgical Document Final Report elated 7 f15 at 11 20 am revealed the initial count (IN Count) was performed by registered nurse (RN 1) and (RN 2) at approximately 752 am There was no other documentation of any of the OUT counts (cavity closing or final)

During an interview with the r~lstered nurse (RN 1) on 32316 at 305 pmbull he reviewed the Surgical Document Final Report dated 717115 at 11 20 am to locate Patient As sponge counts RN 1 acknowledged the closing and final sponge counts were not documented on the final report Furthermore RN 1 acknowledged that If the closing and final count were not documented on the surgical final report that meant The closing and final middot sponge counts were not donebull

During an Interview with registered nurse (RN 2) on 41 16 at 900 am she explained and recalled performing the Initial sponge count during Patient As surgical procedure with RN 1 but did not acknowledge or explain any other counts during Patient As surgical procedure According to RN 2 the Ray-Tee sponge was under all the items and used to produce clotting

During an Interview with the scrub technlcl~n (SCT 1) on 32316 at 405 pm he explained he did not do any sponge counts during Patient As surgical procedure A review of the document entitled Responsibilities Circulating Nurse (RN) and Scrub Penon revised 515 sets forth under Section 111 B the following During surgery the circulating RN will be

shy

shy

Event ID4QW011 811 12017 103547AM

Stale-2567 Page 6 of9

08242017 1804 P011013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTf1ENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIOlRSUPP~ltRIC~IA (X2) MULTIPU CONSTRUCTION (X3) DATE SURVEY AND PLAbl OF CORRECTION IDENTIFICATION NUMaER COMPLETED

A ElUl~DING

0$0107 S WING 081 1Z017

NAME OF PROVIDER OR SUPPLIER smeer ADDRESS CITY STA-m ZIP CODE

Marian Reglom1l Medical c1mter 1400 E Church St Santa Maril CA 934545906 SANTA BARBARA COUNlY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES 10 - PROVIDERS PLAN OF CORRECTION (XS) PREFIX (EACH DEFICIENCY MUSI ee PRECEEOED ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TAG REGULAIORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED O THE APPROPRIATI DEFICIENCY) CATE

responsible for managing and coordinating ell aspects of patient care

In part B (1 of the policy the following is set forth The Circulating Registered Nurse (RN Is responsible for documenting allnursing care In the electronic medical record In SurgfnetPerloperatlve DocOperating Room lntraoperatlve Nursing Record

In part D of the policy the following is set forth The cfrcufatrng RN and scrub person share accountability for sponge sharp and instrument counts as well as patient safety and infection control

In section 1V A 1 0) of the policy a circulating nurse responsibilities is documented to Include the following Perform sponge sharp and instrument counts with scrub person per policy

A review of Patient As Computed Tomography CT chest (serial of X-rays dated 3416 at 455 pm revealed Small tangle of wires approximately 25 crn (centimeters) of the rnediastinum just above and anterior to the right pulmonary arteiy

The surgeon (MD 1) was inteNiewed on (41416 at 1056 am MD 1 stated the two X rays of the chest taken biifore Patient As discharge were underpenetrated and the sponge was not seen at that time_ After reviewing the GT the surgeon shared the sponge was Isolated between the graft and the patients old aorta

lt C --gtmlt1 c~zrT --_ cu --l - -~J~ c gt~~~ G CJ ttbull - N (I)( +shy4 r- U zi- -0 o _ J- middot-rt

O o GI middot

~ N CJQ rn

~ --()

=degJgt )~ --middot middot- ~middot -r-~ ~

~ __) -- shy~ bull-ri--1 r

shyshy

shy

shy

Event ID4QW011 8112017 103547AM

State-2567 Pege 7 of 9

0812412017 1804 (fIJ) P0121013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEAL TH

STATEMENT ormiddotDEFICIENCIES (X1) PROVIDERSUPPLIERCtIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLA~ OF COFtRECTION IDEITTIFICATION NUMeER COMPLETED

A SUILOING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STAiE ZIP CODE

Marian Roglonal Medical Centar 1400 E Chur~h St Sant Marla CA 93454-5906 SANTA SARBARA COUNTY

(X4) ID SUMMMY SlAlEMENl OF OElICIENCIES 10 PROVIDERS PLAN OF CORRECTION (X5) PREFIX (EACH DEiICIENCY MUSf ee PRECEeoeo BY FJtl PREltFIX (EACH COAAEClNE ACTION SHOULD BE CROSSmiddot COMPl5T6

TAG REGUATORY OR ~SC IOENTIFYING INFORMATION TAG REFERENCED ro THE APPROPFUATE DEFICIENCY) DATE

During an Interview with the admlnistrator(Adrn 1 ) on 32316 at 205 pm she explained that when Patient A was bleeding the Ray-Tee sponge was used to apply pressure to the bleeding site Adm 1 stated the Ray-Tee sponge Is reactive and cannot be left Inside the patients [Patient AJ chest as it may causa an Inflammatory response an abscess (pus within the tissue) andormiddot a fistula (abnormal connection between two hollow spaces such eg blood vessels) According to Adm 1 these types of sponges are not meant to be retained inside the patients body Furthermore Adm 1 explained that during (Patient A) incident it was concluded that the surgical staff did not follow the [Prevention of Retained Surgical Items] policy and the SAS whioti were In place at the time of [Patient A] Incident to account for the sponge counting

During an interview with the surgeon (MD 1) on 41416 at 1056 am he shared he fell Patient A would probably not survive the surgery to remove the sponge and stated the surgery would be too risky According to MD 1 the patient was going to be evaluated for a heart transplant and at that point they could remove the spongeThe fai lure of the surgeon and the OR staff to follow the facilitys policies and procedures as it pertained to counting any and all Items entering the patient and ensuring the items came back out of the patient d11ring a surgical procedure resulted in the retention of a Ray-Tee surgical sponge In Patient A The facllltys failure to itnplement surgical care and serViCes in compliance with section 70223 (b) (2) for Patient A with a retained 1oreign object is a deficient practice that has caused or is likely to cause serious injurymiddot

- -gt-~middot ~middot = zC -__ -ampshyctrj JI J~~ c

D cott_ r~~

~c GJ CJ C N__ r

imiddotmiddot0bullcmiddot --1 r1 ~l -u ltJ= i j-

o(=i er 11middot-

middot-cmiddot ~rrt _ lJ rr-1 middott

Zt-= ~-i~ ~

-n1 f- - P Ono

-~

P

Event ID4QW011 6112017 103547AM

State-2567 Page 8 of g

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

middotmiddoti2~7JC4-middot middot-c 7 rn J G Cbull -middot r-- -)---r-i __-middot~~

Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9

08242017 1804 P011013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTf1ENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIOlRSUPP~ltRIC~IA (X2) MULTIPU CONSTRUCTION (X3) DATE SURVEY AND PLAbl OF CORRECTION IDENTIFICATION NUMaER COMPLETED

A ElUl~DING

0$0107 S WING 081 1Z017

NAME OF PROVIDER OR SUPPLIER smeer ADDRESS CITY STA-m ZIP CODE

Marian Reglom1l Medical c1mter 1400 E Church St Santa Maril CA 934545906 SANTA BARBARA COUNlY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES 10 - PROVIDERS PLAN OF CORRECTION (XS) PREFIX (EACH DEFICIENCY MUSI ee PRECEEOED ev FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TAG REGULAIORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED O THE APPROPRIATI DEFICIENCY) CATE

responsible for managing and coordinating ell aspects of patient care

In part B (1 of the policy the following is set forth The Circulating Registered Nurse (RN Is responsible for documenting allnursing care In the electronic medical record In SurgfnetPerloperatlve DocOperating Room lntraoperatlve Nursing Record

In part D of the policy the following is set forth The cfrcufatrng RN and scrub person share accountability for sponge sharp and instrument counts as well as patient safety and infection control

In section 1V A 1 0) of the policy a circulating nurse responsibilities is documented to Include the following Perform sponge sharp and instrument counts with scrub person per policy

A review of Patient As Computed Tomography CT chest (serial of X-rays dated 3416 at 455 pm revealed Small tangle of wires approximately 25 crn (centimeters) of the rnediastinum just above and anterior to the right pulmonary arteiy

The surgeon (MD 1) was inteNiewed on (41416 at 1056 am MD 1 stated the two X rays of the chest taken biifore Patient As discharge were underpenetrated and the sponge was not seen at that time_ After reviewing the GT the surgeon shared the sponge was Isolated between the graft and the patients old aorta

lt C --gtmlt1 c~zrT --_ cu --l - -~J~ c gt~~~ G CJ ttbull - N (I)( +shy4 r- U zi- -0 o _ J- middot-rt

O o GI middot

~ N CJQ rn

~ --()

=degJgt )~ --middot middot- ~middot -r-~ ~

~ __) -- shy~ bull-ri--1 r

shyshy

shy

shy

Event ID4QW011 8112017 103547AM

State-2567 Pege 7 of 9

0812412017 1804 (fIJ) P0121013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEAL TH

STATEMENT ormiddotDEFICIENCIES (X1) PROVIDERSUPPLIERCtIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLA~ OF COFtRECTION IDEITTIFICATION NUMeER COMPLETED

A SUILOING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STAiE ZIP CODE

Marian Roglonal Medical Centar 1400 E Chur~h St Sant Marla CA 93454-5906 SANTA SARBARA COUNTY

(X4) ID SUMMMY SlAlEMENl OF OElICIENCIES 10 PROVIDERS PLAN OF CORRECTION (X5) PREFIX (EACH DEiICIENCY MUSf ee PRECEeoeo BY FJtl PREltFIX (EACH COAAEClNE ACTION SHOULD BE CROSSmiddot COMPl5T6

TAG REGUATORY OR ~SC IOENTIFYING INFORMATION TAG REFERENCED ro THE APPROPFUATE DEFICIENCY) DATE

During an Interview with the admlnistrator(Adrn 1 ) on 32316 at 205 pm she explained that when Patient A was bleeding the Ray-Tee sponge was used to apply pressure to the bleeding site Adm 1 stated the Ray-Tee sponge Is reactive and cannot be left Inside the patients [Patient AJ chest as it may causa an Inflammatory response an abscess (pus within the tissue) andormiddot a fistula (abnormal connection between two hollow spaces such eg blood vessels) According to Adm 1 these types of sponges are not meant to be retained inside the patients body Furthermore Adm 1 explained that during (Patient A) incident it was concluded that the surgical staff did not follow the [Prevention of Retained Surgical Items] policy and the SAS whioti were In place at the time of [Patient A] Incident to account for the sponge counting

During an interview with the surgeon (MD 1) on 41416 at 1056 am he shared he fell Patient A would probably not survive the surgery to remove the sponge and stated the surgery would be too risky According to MD 1 the patient was going to be evaluated for a heart transplant and at that point they could remove the spongeThe fai lure of the surgeon and the OR staff to follow the facilitys policies and procedures as it pertained to counting any and all Items entering the patient and ensuring the items came back out of the patient d11ring a surgical procedure resulted in the retention of a Ray-Tee surgical sponge In Patient A The facllltys failure to itnplement surgical care and serViCes in compliance with section 70223 (b) (2) for Patient A with a retained 1oreign object is a deficient practice that has caused or is likely to cause serious injurymiddot

- -gt-~middot ~middot = zC -__ -ampshyctrj JI J~~ c

D cott_ r~~

~c GJ CJ C N__ r

imiddotmiddot0bullcmiddot --1 r1 ~l -u ltJ= i j-

o(=i er 11middot-

middot-cmiddot ~rrt _ lJ rr-1 middott

Zt-= ~-i~ ~

-n1 f- - P Ono

-~

P

Event ID4QW011 6112017 103547AM

State-2567 Page 8 of g

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

middotmiddoti2~7JC4-middot middot-c 7 rn J G Cbull -middot r-- -)---r-i __-middot~~

Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9

0812412017 1804 (fIJ) P0121013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEAL TH

STATEMENT ormiddotDEFICIENCIES (X1) PROVIDERSUPPLIERCtIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLA~ OF COFtRECTION IDEITTIFICATION NUMeER COMPLETED

A SUILOING

050107 B WING 08112017

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STAiE ZIP CODE

Marian Roglonal Medical Centar 1400 E Chur~h St Sant Marla CA 93454-5906 SANTA SARBARA COUNTY

(X4) ID SUMMMY SlAlEMENl OF OElICIENCIES 10 PROVIDERS PLAN OF CORRECTION (X5) PREFIX (EACH DEiICIENCY MUSf ee PRECEeoeo BY FJtl PREltFIX (EACH COAAEClNE ACTION SHOULD BE CROSSmiddot COMPl5T6

TAG REGUATORY OR ~SC IOENTIFYING INFORMATION TAG REFERENCED ro THE APPROPFUATE DEFICIENCY) DATE

During an Interview with the admlnistrator(Adrn 1 ) on 32316 at 205 pm she explained that when Patient A was bleeding the Ray-Tee sponge was used to apply pressure to the bleeding site Adm 1 stated the Ray-Tee sponge Is reactive and cannot be left Inside the patients [Patient AJ chest as it may causa an Inflammatory response an abscess (pus within the tissue) andormiddot a fistula (abnormal connection between two hollow spaces such eg blood vessels) According to Adm 1 these types of sponges are not meant to be retained inside the patients body Furthermore Adm 1 explained that during (Patient A) incident it was concluded that the surgical staff did not follow the [Prevention of Retained Surgical Items] policy and the SAS whioti were In place at the time of [Patient A] Incident to account for the sponge counting

During an interview with the surgeon (MD 1) on 41416 at 1056 am he shared he fell Patient A would probably not survive the surgery to remove the sponge and stated the surgery would be too risky According to MD 1 the patient was going to be evaluated for a heart transplant and at that point they could remove the spongeThe fai lure of the surgeon and the OR staff to follow the facilitys policies and procedures as it pertained to counting any and all Items entering the patient and ensuring the items came back out of the patient d11ring a surgical procedure resulted in the retention of a Ray-Tee surgical sponge In Patient A The facllltys failure to itnplement surgical care and serViCes in compliance with section 70223 (b) (2) for Patient A with a retained 1oreign object is a deficient practice that has caused or is likely to cause serious injurymiddot

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Event ID4QW011 6112017 103547AM

State-2567 Page 8 of g

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

middotmiddoti2~7JC4-middot middot-c 7 rn J G Cbull -middot r-- -)---r-i __-middot~~

Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9

08242017 1804 (FAX) P013013

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATeMENT Of 0

DEFICleNCfeS (X1) PROVIOERISUPPLleRCLLA (X2) IULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLM Of CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUf(DING

050107 B WiNG 0811201 7

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS CITY STATE ZIP CODE

Marian Regional Mettlcal C11nter 1400 E Church St Santa Marla CA 93454-5906 SANTA BARBARA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES JO PROVIDEORS PLAN OF CORREClJON (XS) PREFIX (EAC-i DEFICIENCY MUST Be PRECEEOED BY FUlL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSSmiddot COMPLETE

TM REGULATORY OR LSC IDENTIFYING INFORMATION TAGgt REFERENCED TO THE APPROPRIATE OEFICIENCY) DATE

or death to the patient

This facility failed to prevent the deficlency(ies) as described above that caused or is likely to cause serious lhjury or death to the patient and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 12803(9)

middotmiddoti2~7JC4-middot middot-c 7 rn J G Cbull -middot r-- -)---r-i __-middot~~

Event ID4QW011 8112017 103547AM

S1Bte-2567 Page 9 of 9