I Document...Based on interview, observation and record review tne facility failed to develop policies and procedures for the safe use of the portable ECMO (Extra Corporeal membrane

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STAll;MEiN10f rlEr-ICIENCIES

AND PLAN OF COARECllON

(X,) PROVIDER/SUPPLIERICLIA

IDENTI FICATION NUMBER:

(X2) MULTIPLF. CONS'fRUCTION IX3) DATE SURVEY

COMPLETEO

050457

A eUILDING

B WING 0612812010

STR!<ET ADDRESS. CITY. STATE. ZIP CODE NAME OF PROVIf.lf; I~ 011 SUPPLIER

ST. MARY'S MEDICAL CENTER 450 STANYAN STREET, SAN FRANCISCO, CA 94117 SAN FRANCISCO COUNTY

(X4) 10

PReFIX

TAG

SUMMARY STATEMENI Of DEFICIENCIES

(EACH DEfiCIENCY MUST BE PRECEF.OED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATIONI

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

Complaint Intake Number: CA00232109 • Substantiated

Representing the Department of Public Health: Surveyor ID # 25732, HFEN

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

Health and Safety Code Section 1280.1(c): For purposes of this section "immediate jeopardy" meanS a situation in which the licensee's noncompliance with one or more requirements of licensure has caused, or is likely to cause, serious injury or death to the patient.

Title 22

70433(8) (4) Cardiovascular Surgery Sel\lice General Requirement

10 PREFIX

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(a) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate. These policies if /I ~/Il and procedures shall include provision for at least t1

EvenIIO:ZZ2C11 4/4/2011 3:37:19PM

PROVIDER'S PLAN OF CORRECTION

(EA.CH CORRECTIVE ACTION SHOULD Be CROSS·

REFERENCED TO TH~ APPROPRIATE DEFICIENCY)

C.O. P. ri -

L&C D Y DALY CIT'"

LA~O~~~R~IRECTO 'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE ' -L

~ tV J }l--u .r~·fM5()-v r Any dehciency statement ending with astorisk (' ) donotes a deficiency which the Institution may be excused from cO(TC)cUn providing II Is do 'nl1d

Ihal olher safeguards prOVide sufficienl protection to Ihe pallents. Except for nursinll homes. the findings above sre disclosable 90 days following Ihe dale

Of survey whether or not a plan of correction is provided For nursing homes. the above findings and plans ,,' _rection are disctosable 14 days following

Ihe date these documents are made available to the facilily. If deficiencies ale ~jJ.ef , an approved plan of correction Is requisile 10 continued program

pal1icipa tion. j-" OC ~~-;t.c:y

Stato-2567

(X5)

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1 of 10

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFIClfNCI" S

AND PLAN OF CORRECTION

(X1) PROVIDER/SuPPliER/eLlA

IDENTIFICATION NUMBER

050457

(X2) MUL TIPLE CON5TRI)CTION

C.D.P.H.

APR t B ZOl1 , r- (X3j DATE SURVEY

L&b D~4PLETED A BUILDING

B WING -----bl-JDAL-{ C lTV

06/28/2010

N4ME or PROVIDER DR SUPPI.IER

ST. MARY'S MEDICAL CENTER

STREn ADDRt:SS CITY, STATE. ZIP CODE

450 STANYAN STREET, SAN FRANCISCO, CA 94117 SAN FRANCISCO COUNTY

j X4 1 1tJ

PI .. ?F:HX

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SUMMARY STATEMEN T Of DEFICIENCIES

(tAOI DEFICIENCY MUST 8E PRECEEDEO 8 '1' FUll

REGIJ!.ATORV OR LSC IOENTIFYING INFORMATIONi

ID

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(EACH CORRECTIVE AC nON SHOULD BE CROSS ·

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Continued From page 1

(4) Recommendations regarding equipment used, procedures performed and staffing patterns in the catheterization laboratory and cardiovascular surgery units.

These regulations were not met as evidenced by:

Based on interview, observation and record review tne facility failed to develop policies and procedures for the safe use of the portable ECMO (Extra Corporeal membrane

Title 22 §70433(a) (4) The statute is not met as evidenced by: Based on interview, observation and record review, the facility failed to develop policies and procedures for the safe use of the portable ECMO bypass machine for intra-facility transport to prevent sudden disconnection of the tubing.

How the correction will be accomplished. both ~PQrarily and permanently.

1. ECMO tubing packs borrowed from 6/10/10 Oxygenation device-a portable heart lung machine) bypass macnine for intra-facility transport to prevent the sudden disconnection of tubing on the oxygenator venous blood inlet of the ECMO.The tubing was stretched and came off of the oxygenator inlet when Patient l's gurney was being lifted into the ambulance at the facifity's ambulance loading dock on . 10 at 8:20 P.M. The facility failed to follow the oxygenator manufacturer's recommendation to connect and band all blood lines. This failed practice resulted in the disconnection of the blood tubing from the oxygenator venous inlet and was the direct cause of the death of Patient 1.

Findings:

According to Facility A's Transfer Summary dated ~O, it indicated that Patienl 1 had hypertension (high blood pressure), presenting with acute onset of continuous chest pain at rest and was found to be in new atrial

Evenl ID:ZZ2C 11 41412011 3:37:19PM

UCSF while waiting custom tubing packs created for S1. Mary's Medical Center by vendor.

2. Custom ECMO tubing pack configured for St. Mary's Medical Center. Purchased 3 packs to be available at all times. (Attachment A)

3. ECMO Transport policy developed for surgical services. (Attached B)

4. Transfer/ discharge to a higher level of care policy developed for medical center. Includes responsibilities and process. (Attached C). Policy approved by Medical Executive Committee and Community Board.

5. Table Top teaching exercise for patient evacuation on EeMO bypass for OR staff.

6. Purchased BioMedieus PBS cart (portable bypass cart) to facilitate efficient transport. (Attachment D)

I

7130110

6120/10

6120/10

)012111 1114/10

9117110 4/15(\ ) & quarter)

9130110

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

Any deficiency sialemenlltnding wilh an aSlerisk (oJ denoles a defiCiency which Ihe instlluhon may be excused from correcting providing il is delermined

(hal olher safeguards provide suffiCIent proteclio" to Ihe patienls . Excepllor nursing homes. Ihe findings above are disclosable 90 days following the dale

01 survey whether or not a plan o( correclion IS provided. For nursing home • • the above findings and plans of correction are disctosable 14 day.lollowing

1M date these document. are made ,"·allable to the facility. II detiCi enCle~ Qre ciled. an approved plan 01 correction is ,equi.lte 10 continued program

partiCIpation

State-2567 20110

0

y

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY


S'I A rEMENl OF DEFICIENC IES

AND PIAN 0, CORRECTION

IX1) PROVloER/SUPPLIER/CLIA

IO[NlIFICA n ON NUI,lBER IX2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

050457

A 8UILDING

O WIN G 0612812010

NAtoi'!' or PROVIDER OR SUPPUER S1REET ADDReSS. crIY. STATE. 2.11' CODE

ST, MARY'S MEDICAL CENTER 450 STANYAN STREET, SAN FRANCISCO, CA 94117 SAN FRANCISCO COUNTY

PROVIDER'S PLAN Of CORRECTION (X5) IX 4110 PREFIX

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SUMMARY STATEMENT OF DEFICIENCIES

lEACH DEFICIENCY MUST BE PRECEEOED 8Y FULL

REGULATORY OR LSC IDENTIFYING iNFORMf;TION)

10

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(EACH CORRECTIVE ACTION SHOULD BE CROSS·

REFERENCED TO THE' APPROPRIATE DEFICIENCY)

COMPLETE


fibrillation (Irregular and often rapid heart rate that commonly causes poor blood flow to the body) with EKG (electrocardiogram a graphic representation of the electrical activity of the heart) notable for ST depression (an irregular pallern on an EKG). Patient 1 was transferred to the facility on .,0 for evaluation for coronary bypass surgery (surgery where veins are taken from other parts of the body and grafted to the heart to by pass diseased coronary arteries).

Review of Patient 1 's operative record. dated ~ 0, indicated she was taken to the operating room on _ ,0 and underwent triple coronary artery bypass surgery. During surgery, Patient 1 was placed on a cardiopulmonary bypass machine (machine that takes over the function of heart and lung during heart surgery). Following the surgery, several attempts were made to wean (switch from heart-lung machine to person's own heart and lung) Patient 1 from the cardiopulmonary bypass machine. An intra-aortic balloon pump (balloon placed in aorta to help heart pump more easily) was placed in Patient 1's descending aorta. Another attempt was made to wean Patient 1 off the bypass pump without success The decision was made to transfer Patient 1 to Facility 8's Intensive Care Unit so she could be placed on a long term left ventricular assist device (LVAD-device that helps maintain pumping ability of heart) to rest the heart. Surgeon 1 decided to place Palien! 1 on an exlracorporeal membrane oxygenation

EvenIID :ZZ2C 11 4/4/2011

Description of Monitoring process to prevent reculTence of the deficiency.

1. Monitoring of expiration date and package integrity of tubing packs on monthly basis.

2. Bypass machine, BioConsole 560 on preventive maintenance schedule every 6 months.

3. Table Top teaching exercise for patient evacuation on ECMO bypass.

Responsible parties: Director of Surgical Services Perfusionistl Circulatory Support Manager of Biomedical Engineering

C.O.P.H .

3:37:19PM

DATE

417111 & ongo; ng

)17111 & ongo; ng

9117/1 0 4115/1 1 & quarte rly

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

Any delielency sIatement ending wllh an .slensk n denoles a deliciency w~ich the institution may be excvsed 'rom correcting providing il i. determined

Ihal other safeguardS prOVIde suffiCIent protec~on 10 the patients Except lor nurSing homss, the finding' above ale disclo.sble 90 days following the dale

01 survey whether or nol a plan 01 correction 15 provided For nursing homes. the above findings and pl.~s of correction are disclosabl~ 14 days following

the dale the.e documents are made avalleble 10 the '.cdily. II defidoncies ate ciled , an approved plan 01 correction is requisite to continued program

partic'pailon

Stale -2S6? J of 10


STA r~MENT OF DEFICIENCI(,S

AND PLAN OF CORREe nON (X 1) PllOVIOERISUPPl!(fl/CllA

IOENTIFICATION NUMBER

(X2) MUL TlP~~ CONSTRUCTION (X3) DATE SURVEY

COMPLETED

050457

A BUiLDING

B WING 06/28/2010

STREET ADDRESS. CITY. STATE, ZIP CODE NAM( OF PROVIDER OR SUPPl IE'R


IX4) If)

PRl'FIX

TI\G

SUMMARY STATEMENT OF DEFICIENCIES

tEACH DEFICIENCY MUST BE PRECEEDED BY FULL

REGULflTORY OR I.SC IDENTIFYING INFORMATION)


assist device (ECMO-a portable heart lung machine) in preparation for a crilical care ambulance transfer, Patient 1 was taken from the operating room on an ambulance gurney 10 the facility's emergency room loading area so Patient 1 could be loaded inlo the ambulance Patient 1 was accompanied by Surgeon 1, the anesthesiologist. Circulatory Support Perfusionist 1(CSP-1-a lechnician who operates and sets up heart/lung bypass and ECMO equipment under the direction of the surgeon), a Critical Care Transport Regislered Nurse and two Emergency Medical Technicians. During movement of the ECMO equipment inlo the ambulance, the ECMO tubing became disconnected and the tubing could not be reconnected.. Patient 1 expired

Ihis transfer into the ambulance Dn o at 8:20 P.M,

Record review of Patient 1 's Anesthesia Record note written _ 10 indicated: "Unable tD wean off Cardia Pulmonary Bypass( CPS) despite high dose pressors and inotrope (drugs to make the heart beal better), JABP(lntra-aortic balloon pump-balloon placed in aorta to help heart pump more easily), Plan to transfer to Facility 8's Intensive Care Unit upon transfer into ambulance at 2020 (6:20 PM); portable cardio pulmonary bypass disconnected (the ECMO), not possible to reestablish CPS patient expired thereafter, brought back to OR."

Record review of Patient 1's Discharge

Event ID.ZZ2C 11 4/4/2011

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LABORATORY OIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE


(EACH CORRECTIVE ACTION SHOULD BE CRDSS

REFERENCED TO THE APPROPRIATE DEFICIENCY)

C D.P.

, [l!C D!V L;F\L:{ \..,.~ \ '(

TITLE

Any deficiency stalemenl ending with an Jlsterisk (') denotes a deliClency wh ich the institution may be excused from correcting providing il is determined

Ihal other safeguQrds provide ~ufflcienl protection to the patients Except lor nursing homes, the findings above are disdosablo 90 days following the dale

01 survey whether or not e pion of correction is provided. For nursing homes, the above findings and plans'" correcUon are disclosable 14 days following

the date these documents are made 8vDiiabie to the facility. II defiCiencies aro cited, an npprovetf ptan or correction is requisile to conVnued program

participation.

Stata-2567

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51A rEMENT OF DEFICIENCIE.S AND P~I\N OF CORRECTION

(X,) PROVIDER/SUPPLIER/ellA IO£N1IFICATION NUMBER:

(X21 MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

050457

A BUILDING

eWING 06/28/2010

STREET ADDRESS. CllY, STATE, ZIP COOE NAMe OF PROVIDER OR SUPPLIER


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SUMMARY STATEMENT or PEflCIENCIES (EACH DEFICIENCY MUST BE PRf.CEEDED BY FULL HEGUl.ATORY OR LSC IDENTIFYING INFORMATION)


Summary note dictated on _ 10 indicated: "Patient was taken to the operating room. Surgery consisted of internal mammary left anterior descending, saphenous (large vein in leg) vein graft (use another vein to create a conduit so blood can flow around the heart) to the obtuse marginal right coronary. This was complicated by inability to come off pump as well as inability to place intra-aortic balloon pump via the grain Ultimately, intra-aortic balloon pump was placed via the ascending aorta (major artery thai carries blood away from the heart); however, patient could not come off the pump, and arrangements were to transfer the patient to the university medical center after placement of ECMO support. ECMO was placed, and patient was transferred out of the operating room and was being loaded on the ambulance when the ECMO circuit became disconnected and patient expired."

In an interview on 6/25/10 at 1:15 PM, the Hospital Risk Manager (RM-1) was asked if there were any facility policies or procedures for setting up the portable ECMO bypass system for intra-facility transport. RM-1 said, "No, we are working on writing them up now."

In the same interview RM-1 was asked if there were any performance standards for the Circulatory Support Periusionist job description that addressed the set up of an ECMO bypass system for intra-facility transport. RM-1 said, "No, there are none."

Event ID:ZZ2C11 414/2011

10

PREfiX TAG

3:37:19PM

l.ABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

PROVIDER'S P~N OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE! CROSS·


? " > [ .) P- I J '1\....;.. . • II . .. j- f !'#

APR 18 1011

L-1?i (.~ f) I V bJ.\LV CITY

TiTlE

Any deficiency slalemenl ending wi1l1 an asterisk (.) denoles a deficie~cy which the Inslilulion may be excused lrom correcting providing It Is determined

lhal olhe( safeguards provide sufficient protection 10 Ihe patients. Except ror nUf$ing homes. the findings above are disclosable 90 days following Ihe dale

01 swrvey whelher or not a plan 01 correction ii provided, For nurSing homes, the above findings and plans of correclion ar ... dlsclosabla 14 days loll<>wlng

Ihe dato Ihesa dacumenl. are made available 10 Iha lacilily. II deficiencies are cited, an approved plsn 01 correclion Is roquisile to conlinued program

participation

51ate·2567

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DATE

(X6) DATE

5 or 10

CALIFORNIA HEAL TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAL TH

STATEMEN r Of'DEfICIENCIES

AND PLAN OF CORRECTION

IX 1) PROVIDER/SuPPLIER/CLIA

IDENTIFICATION NUMBER

(XI) MUL TiPLg CONSTRUCTION (X3) DATE SURVEY

COMPLETED

050457

A 8UILDlI'IG

B WING 06/28/2010

STREET ADDRESS. CITY. STATE. ZIP CODE NANU: OF PROVIDER OR SUPPLIER


(X4) 10

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SUMMARY STATEMENT OF OEFICIENCIES

lEACH DEFICIENCY MUST BE PRECEEDEO BY FULL

REGULATORY OR LSC IDENTifYING INFORMATION)


tn an inlerview on 6/28/10 at 10: 11 AM, Circulatory Support Perfusionist 1(CSP-1) said, "We could not get Patient 1 off of the bypass machine in the OR (operating room)... the surgeon decided to put the patient on an ECMO pump to rest the heart and lung,,, this was so the patient could be transported to a different location . there was a lot of confusion when we were setting il up, this system was a little different than the normal ECMO .. . actually there was a lot of confusion going on. We had several pieces of tubing shoved together and when we were trying 10 load the patient in the ambulance the tubing became disconnected . The lower tubing connected to the oxygenator (reselVoir where blood from the body enters 10 be re-oxygenated) became disconnected."

In the same intelView CSP·1 was asked why he thought the tubing became disconnected. CSP·1 said, 'We were trying to get the ECMO equipment on the IV pole (metal pole with wheels where ECMO equipment is attached) into the ambulance before the patient... . I was trying to angle the IV pole under the door of the ambulance while we were lifting the patient up the tubing became stretched and disconnected... that was it... when the tubing becomes disconnected there is nothing else you can do, the tubing just pulled off ... Surgeon 1 called it then (declared the patient had expired) and said I guess it is over now ... we returned the patient to the OR."

Ellent ID.ZZ2C 11 4/4/2011

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LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE


(EACH CORRECTIVE ACTION SHOULD BE CROSS·


". '. p. -.0 7"" .. {\

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f!~C • V. DA'L'{ t; -(

TITLE

A ny deficiency ,Ielement ending wilh an asterisK ('J denotes a deficiency whiCh the ins~tulion may be excused from correcting providIng it is determined

Ihat olhe r safeguards provide suttlei.nl proteclion to the palients. Except for nursing homes, tho findings above oro disclosable 90 days following the dale

of survey whether or not a plan of correcfion is provided. For nursing homes, the above findings and plans of comrcflon are djsclosab4e 14 days fof lowing

Ihe date these documents are mude available to Ihe lacility. " deficiencies are cited , an approved plan 0/ corroction is requisile to continued progr~m

partiCipation

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STATEMEN'r O~ 1>t;:fICIENCIES AND PlA'j Of CORRECTION

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IDENTIFICATiON NUMBER (X2) MULTIPLE CONSTRUCTION jX3) DATE SURVEY

COMPLETUD

050457

A BUILDING

B WING 06/2812010

StR~F.T ADDRESS. CITY. STATE. ZIP CODE NAMe Of PROVIDER OR SUPPLIER

ST. MARY'S MEDICAL CENTER 450 STANYAN STREET, SAN FRANCISCO, CA 94117 SAN fRANCISCO COUNTY

tX"} 10 PREFiX

TAG

SUMMARY STATEMENT Of DEFICIENCIES

{EACH DEfiCIENCY MUST BE PRECEEDED BY FULL

REGULATORY OR LSC IDENTifYING INFORMATION}


In a concurrent interview CSP-1 was asked if there was some kind of band that is applied to secure the tubing to the oxygenator. CSP-1 said. "Well on this case we did not have a band, no tie band (plastic tie band that secures the tubing to an outlet). This was the first time we have done this type of transport out of the OR into an ambulance. We had a lot of tUbing" . not the length that we needed. just for the transfer there could have been a little extra"

CSP-1 was asked for a copy of any manufacturer's recommendations to follow when assembling the tubing to the oxygenator. CSP-1 said, "No, the only things that have warnings are about the pressure alarms on the machine."

In the same interview CSP-1 was asked, "When was the last time thai you set up the ECMO oxygenator for this type of transport?" CSP-1 said, "The last time was a couple of years ago; actually it was a different kind of situation."

In an interview on 6/28/10 at 11:00 AM, Surgeon 1 said, "Patient 1 came from another hospital for coronary artery bypass surgery , During the surgery things were going relatively uneventfully until it was time to come off the Cardiac Bypass machine... we could not wean the patient off the pump so we put in a balloon (rASP) to rest the heart... the balloon was still not enough to get her off the bypass machine so the decision was made to put her on a

Event ID:ZZ2C 11 4f4/2011

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LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATI,IRE

PROVIDER'S PLAN or CORRECTION

lEACH CORRECTIVE ACTION SHOULO BE CROSS


APR 1 8 2tln

L&C P1V DALY CITY

TITLE

Any deficiency statement ending with an asterisk (') denotes 8 deficiency which the institullon may be excused from correcting providing It is determined

Ihat otller safeguard. provide suffiCient protection to the patients Except for nursing homes. the findings above are disclosable 90 days following the date

or survey whether or nol a plan 0/ correction is provided. For nu"ing homes, the abovB findings and plans of correction are disclosablo 14 \lay. following

thO dAte these documents are made available to lile facility . If deficiencies are ciled, an approved plan of correction is requisile to continued program

participalion

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STATEM!':NT OF DEFICIENCIES

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IDENTIFICA T/ON NI)MBER.

(X21 MULTIPLE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

050457

A, BUILDING

B, WING 06128/2010

STREET ADDRESS, CITY, STA TE, ZIP CODE NAME OF PROVIDER OR SUPPLIER

ST, MARY'S MEDICAL CENTER 450 STANYAN STREET, SAN FRANCISCO, CA 94117 SAN FRANCISCO COUNTY

tX4} 10

!'RHIX

rAG

SUMMARY S rA lEMENT OF Dt:flCIENCIES lEAC H DEFICIENCY MUST BE PR ECEEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)


ECMO portable circuit 10 rest her heart and lungs, . the ECMO is a more portable unit We don't have a long term ECMO pump here so I arranged to transfer Patient 1 to the Facility B's ICU, II is just a set of tubes we switch from the big machine to the portable system .. , we switch the tubes to the oxygenator, ,, two hoses in and oul... basically we change hoses 10 the portable." she got transported over to the gurney for the ambulance." we are lifting up the patient to the rear of the ambulance then the tubing got disconnected,"

During the same interview, Surgeon-1 was asked which tube became disconnected, Surgeon-1 said, "I can't remember, basically there are only two tubes, it is a complete circuit... it is like a continuous column of water. , If a tube becomes disconnecled, it can not be reconnected , air gets in."

Surgeon 1 was asked, "If disconnected from the results?" Surgeon 1 said, "Yes,"

the tubing oxygenator

gets death

In an observation in the facility's Operating Room No, 12 on 6/28110 at 11:30 AM, a portable ECMO bypass system thaI was set up by CSP-1 was inspected, The unit consisted of an IV pole, por1able blood pump, two sets of 6' clear tubing and a while colored Medtronic Affinily NT CBS11 Oxygenator, One of the clear tubes was connected to the oxygenator bottom plastic inlet. This is known as the Venous Blood Inlet. The tubing had a plastic tie band around

EvsnIID:ZZ2C 11 414/2011

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LABORATORY DIRECTOR' S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

PROVIDER'S Pl.AN OF CORr.EcTION

(EACH CORRECTIVE AC nON SHOUlD BE CROSS,

REFERENCED TO THE APPROPR IA1E DEFICIENCYI

r . ? H. \,..1 - •

~PR , ~ 1\}"

• Q C D\V l)(~t. y Ci' T"{

TITLE

Any defiCiency Slalemenl ending with an aSlorisk (") denotes a derociency which Ihe institution may be eKcused from correcting providing ij Is determined

t~al olher saleguards provide sufficient prolecfion to the paUents. Except lor nu"lng homes, lhe findings above are disdosablc 90 days following tile date

01 survey whether or nol a plan of correction is provided, For nursing homes, the above findi~s and plans 01 correction are disclosable 14 days following

the dale Ihese documents are made available 10 the facilny, II deficienCies are ciled, an approved plan of correction is requisite 10 coobnuad program

partiCipation

Slalo-2567

IX5}

COMPLETE DATE

(X6) DATE

BoliO

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC ~iEAL TH

SlMEME;NT OF llE~ICI£NCIES

'IND P~',N Of CORREC1IOI>I (X 1 J PROVIDER/SupPliER/ellA

IDEN1IFJCA TION NUMBER

050457

(X2l MUL TIPtE CONSTRUCTION

A BUILDING

B WiNG

STREET ADDRESS. CITY. STATE. ZIP CODE

(X3j DATE SURVEY COMPLETED

06/2~/2010

NAMe Of PROVIOER OR SUPPLIER


(X~I'D

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SUMMAHY STATEMENT OF DEFICIENCIES (EliCH DEFICIENCY MUST BE PRECEEOEO BY FULL REGULATORY OR L5C IDENTIFYING INFORMATION)


it.

In an interview at the same time.CSP-1 was asked to identify the clear tubing Ihat became disconnected during the loading of Patient 1 in the ambulance on . /10 . CSP-1 pOinted to the Venous Blood Inlet of the Oxygenator and said. ''That one there came off " CSP-1 was Ihen asked if the Venous Blood Inlet during the incident with Patient 1 was tie banded like the set up described above . CSP-1 said, "No, you just don't want to tie band any inlet."

Review of the manufacturer's instruction manual for the Oxygenator ind icated: "Warnings ... all blood tubing connections should be banded for added protection against high nuid pressures. and "Connect and band all blood lines" (Medtronic Affinity NT CB511 Hollow Fiber Oxygenator, Instructions for Use manual (2006)

p. 9&p. 13.)

Review of a current textbook See: (Mongero and Beck, On Bypass: Advanced Perfusion Techniques (2008)p.S29.)) on the procedure for setting up an adult ExtracOfporeal Membrane Oxygenation (ECMO) circuit staled: "All connections must be tie banded because the coating makes the tubing slippery on the connectors ."

The facility's failure to ensure that the blood tubing was tie banded to the venous inlet of the

Event ID:ZZ2C11 4/4/2011

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( .... · ... 1 -

TITLE

Any del,ciency Slelemenl ending wim an asterisk (0) denol"s a deficiency whichlhe institution may be excused from correcting providing ills determined

that other safeguards provide sufficient protection to the patients. Except for nursing hom"s. the findings above are dlsclosable 90 days follOWing the date

01 $ulVey whelher or nol a plan of correction is provided. For nursing home5, the above findings and plans 01 correction are disdosable 14 days lollowing

the date these documents aM made available 10 the laeilily. If deficiencies are cited. an approved plan ot correction is requisite to continued program

participation.

5lale-2567

IX5) COMPLETE

DATE

(X6) DATE

9 of 10

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY


STATf:M£l'll Of !JHIC!ENCIES

AN!) PlAN OF CORRECTION

(Xl) PROVIDER/SUPPLIER/ellA

IDENTifiCATION NUMIlER (X2) MUl TIPlE CONSTRUCTION (X3) DATE SURVEy

COMPLETED

050457

A OUILDING

a. WiNG 06/28/2010

STREET ADDRESS. Cill'. STATE. ZIP CODE NAME Of PROVIDER OR SUPPl.1f:R


(X4 110

PREFIX

TAG

SUMMARY STIITEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PRECEEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)


oxygenator to Patient 1, is a deficiency that has caused or is likely to cause serious injury or death to Ihe patient and therefore constitutes an immediate jeopardy within the meaning of Heallh and Safely Code, Section 1280.1

This facility failed to prevent the deficiency (ies) as described above that caused, or is likely to cause, serious injury or death to the patient, and therefore constitutes an immediate jeopardy within the meaning of Health and Safety Code Section 1260.1 (c).

Event ID:ZZ2C11 414/2011

10

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TAG

3:37:19PM

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

PROVIDER'S PLAN o~ CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE CROSS


TITLE

Any deficiency statement ending with an asterisk (') denotes a deficiency which the institution may be excused from correctin!l proyiding it is determined

that other safeguards proyide sufficient protection to the patients. Except for nursing homes, the findings aboye are disdosable 90 days lollowing the date

01 survey whether or not a ptan of correction is proyided, For nurSing names, the above fmdings and plans 01 correction are diaclosable 14 days follOWing

lhe dale these documents are made available to \he 'acilitv. If deficiencies are cited, an approyed plan of correction is requisite to continued program

participallon

Stat~·2567

(X51

COMPLETE

DATE

(X6)OATE

100110

Documents

I Document...Based on interview, observation and record review tne facility failed to develop policies and procedures for the safe use of the portable ECMO (Extra Corporeal membrane