CALIFORNIA HEALTH ANa HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES AND PlNI OF CORRECTION

()(1) PRO\IIOERISUPPUERICUI. IDEJrnACATION NUM8ER!

A. BUILDfNG

B.WlNG

()(3) IMTE SURVEY COMPLETED

04111/2008

NAME OF PROVIDER OR SUPPLIER

UCSF MEDICAL CENTER STREET ADDRESS. CITY. STATE. ZIP COIlE

()(4)1O

PREAX TAG

1108 PARNASSUS AVENUE, SAN FRANCISCO, CA 94122-0210 SAN FRANCISCO COUNTY

~MARY STATEIENT OF DEFICIENCIES (EACH OEFICENCY MUST BE PRECEEDED BY FLU REGUlATORY OR I.lIC IDErmFYlNG INFORMATION)

The following reflects the findings of the Califomia Department of Public HeaHh during the Inveallgation of an entity reported incident. Entity reported inddent: CAOO145949.

Inspection W88 limited to the specific entity reponed incident and does not represent the findings of a full Inspection of the hospital.

Representing the Callfomia Department of Public HeaHh Phannaceutlcal Consultant

Title 22

70214(8)(2) Nursing Staff Development (a) There shalt be a written, organized in-service education program for all patient care personnel, Including temporary staff as described In subsection 70217(m). The program shall include, bui shall not be IImtted to, orientation and the proo,aa of competency validation 88 described In subsection 70213(c).

(2) All patient care personnel, including temporary staff as described in subsection 70217(m), ahall be subject to the pr()()Q8 or competency validation for their aasigned patient care unit or units. Prior to the completion of validation of the <XImpetency standards for a patient care unit, patient care 888lgnmenls shall be subject to the following restrictions:

70214(a)(A) Nursing Staff Development (a) There shall be a written, orgarized in-service education progrem for all patlant care persomel, Including temporary staff as described in

ID PAEFIX

TAG

PROVIDER'S PLAN OF CORRecnON (EACH CORRECTIVE ACTION SHOULO BE CROSS­

REFERENCED TO THe APPROPRIATE DEFICIENCY)

Corrective Action Fiolan was addec to the UCSF Medical Center's list of high risk medications, and the policy, Medication Administration: High Risk Drugs ~ revised accordingly, reviewed and approved by the Phannacyand Therapeutics CommjttE~

()(5)

COMPLETE DATE

on May 14,2008. 5/14/08

In the days following this incident, UCSF Medical Center began an expedited transition from use of the Alaris IV Pump to the CADD pump for all patients on Flolan or Remodulin. en April 9, 2008, CADD pumps were 4/9/08 received and staff training began. All staff that routinely cared for patients receiving Flolan were trained on the use of the CADD pump, including rate and concentration calculations. This included staff in the 10 ICC and the 1OCVT. Staff training in these areas was completed by April 11, 2008. 4/11/08 Patients on Fiolan are only admitted te 10 ICC or 10 CVT. On April 10, 2008, a 4/10/08 memo was distributed to the entire nursing staff describing the process related to Flolan management and specifying the requirement that only competent, trained nurses care for patients on Flalan.

In the emergency department and procedural areas, select staff were

Ewnt ID;L'TVWv'11 11212009 11;28;12AM

Y DIRE OR'S OR PROVIDERlSuPPUER REPRESEffTATIVE'S SIGNATURE

~~~~~~~~~~ 2>'f~~ deIIc'-nc:y ....... 1II1ding with .... • (1 denoteIa ~ Whith the Inlllllutioo mey be IIXI:UIed fIvm CQrTtICIi"" pnwidlng M ia dNnniled

h\ oIhef' ufeguents ~ wIIiciItn\ pnMdion to the palierI\a. EJICept fur ncnlng hamill. the fincIlngIabow are <*CIosebIII 90 &Jyl foIowIng the date of SUNeY whelhM or not a plan ofCOfYllClion is~. For nursing ho!nM.1he abow ftndlnga and planS ofCOrtedIon ere disao-ble 14 daya~~ C<:!I; .~ . ~~ the date these documents n made a'lllllbla to the Wity. If deficiencies ~ cited, an approved plan of c:orrocIIon is requialle to eonIinuad ~D"'H.l. iSc G participation.

Stele-2i567 JAN 2 0 7AA§

1 of 12

')]IV ~Hv Djst. Ci'.'::

CALIFORNIA HEAlTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAlTH

STATEJAEfIIT' OF DEFICIENCIES two PlAN OF COiR:CTlON

~')PR~E~PUE~ IDENTIFICATION NUMBER:

(liZ) w.:npl..E CONSTRUCTION (X3) Do\ TE SURVEY COMPlETED

050454

A. BUILDING

B.WlNG 04111/2008

tI"".E OF PRO'lllDER OR S~p\'IER

UCSF MEDICAL CENTER

STREET ADDREss. CITY, STAlE, VP CODE

505 PARNASSUS AVENUE, SAN FRANCISCO, CA 94122-0210 SAN FRANCISCO COUNTY

SUMMARY STATEMENT' OF DEFlCIENCIQ (EAaf DEFICIENCY MUST BE PRECEEOED 8Y F\A.L RWUlAlOR't OR LSC IllEHIlFYING JNR)RlilATlON)

Continued from page 1

subsection 70211(m). The program shall include, bUt shall not be limited to, orientation and the process of competency validation as described In subsection 70213(c).

(A) ASsignments shall include only those dulles and responsibilities for which competency has been validated

10263(c)(1} . Pharmaceutical Service General Requirements (c) A pharmacy and therapeulics commiHee. or a committee of equtvalent composition, shaH be established. The committee shall consISt of at least one physician, one phaJmscist. the director of nursing service or her representative and the administrator or his representative,

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distnbution. dispensing and use of drugs and Chemicals. The pharmacist in consuHation with other appropriate heaHh professionals and administration shall be responsible for the development and implementatlons of procedures. Policies shaD be approved by the governing body. Procedures ahall be approved by the administration and medical staff where such is appropriate.

Based on observaOOn, staff interview and record review, the facility's Pharmacy and Therapeutics (P&T) committee failed to establish a safe and effective system for the administration of a high risk

Evenl lO:L lWW11 1t212OO9

10 PREFIX

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PROVIDER'S PI..AH OF CORRECTION (EACH CORRECl1\IE ACllON SHOULD BE CROSS­

REFERENCED TO lliE APPROPRIATE DEFICIENCY)

trained to be Flolan competent and designated as a resource to be used should that department receive a patient on Flolan. This training was completed by April 28, 2008. If a patient on Flolan presents to an area outside of 10 ICC, 10 CVT, the emergency department or the procedural areas, the 10 ICC charge nurse is paged to come and evall.!,ate the patient and assist with all care related to monitOring and administratic n of Flolan.

CLARIFICATION SUBMmED FEBRUARY 26. 2009

The P&T Committee will reView ISMP guidelines for updates on high risk medications on an annual basis. Recommendations for revisions to the UCSF Medical Center policy. Medication Management: High Risk Drugs will be made in accordance wit the P& T Comm ittee's review of the ISMP guidelines.

Monitoring: On April 10, 2008, a memo was distributed to the entire nursing staff describing the process related to Aolan management and specifying the requirement that only competent. trained nurses care for patients on Flolan. Beginning on Apri

11:28:12AM

(X5) COMPlErE

DATE

4/28108

2126/09

5/30/08

ORY OIREC"~ YlDER1S\JPPl.'~ REPRESENTAlM'S SIGNATURE (/

)fJ- L D:re. c:.:7rN'i )\' , / (X8) DATE

3/-¥o deficIcIrIey sIIIl8ment arD1g with In a deficiency which the inalltutiOn may be eICCIII8d from corrIICIing providfng It ill dlllelminod

that other seteguarcb provide aullk:ient protection to t/Ie patiefU. &!lap\. for I¥.II'WlsJ Ilome$, \he tindlnga above arelhdllsllbla iO diy, foIlO'Mng the dII~ ~

of survey Whether or not a plan of c:omIdIon hi pnMdad. For nurailg hom ... the abcMt &!dings and plans of c:onecIian ara disdoIallie 14 days folloWIng \ 0 -, the datu these docUmlllP are made aVili1ab1e to the fIIcIlty. If dalicianc:iea are ciIad, an app1OY8d plan of COffiICIion ~ reql.lilli\8 to IlOIIIlnued PlClgram , y.... - \fj \ pe.rtIc1patlon. V~ .~

Stal&-2567 20f12

CALIFORNIA HEALTH AND HUMo\N SERVICES AGeNCY DEPARTMENT OF PUBlIC HEALTH

STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION

(Xt) PROVIDERlSUpp~IERlCLIA IDeNTIFICATION NUMBER:

(X2) MUL TJPLE CONSmUCTlOH (X3) D.\TE S\JRIIEY COMPLETED

A. BUlI.OING

B.WlNG 04I1112OOB

S'm£ET AIlORESS, CITY, STATE, liP CODE NAME OF PROVIDER OR SUPPLIER

UCSF MEDICAl CENTER !solS PARNASSUS AVENUE. SAN FRANCISCO, CA 94122-0210 SAN FRANCISCO icOUNlY

(lC4) 10 PREFIX

TAG

SUMMARY STATEMENt' OF OEF\ClENCIEtI (EACH OERCIENCY MUST BE PRECEEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

Continued From page 2

medication, Flo/an (a drug with a short half-life that opens up blood vessels In the lungs and throughout the body), which tesulted in Patient 1 receiving 23

the prescribed close of the medication on The infusion device that was used for the

administration of Fiolan did not meet the manufacturer's specification requirements for the delivery of the medication. In addHlon, during the california Department of Public Health investigation on 411 0108, H was cflSCOVered that one registered nurse (RN), with no validated competency in the operation of the FIoIan Infusion device, was 86Signed to provide care to Patient 2, a patient on Flolan. Due to the short-life nature of FloI8n and the fact that any interruption of Flo/an infusion can be life-threatening, the f8cirrty's failure to ensure the safe administration of Fiolan by competent staff was likely to place other patients requiring the drug, FloIan, in the sitUation of immediate jeopardy wHh the potential to cause serious Injury or death.

On 4110108 at 2:10 p.m., an Immediate Jeopardy (IJ) situation was declared pertaining to the unsafe administration of Fiolan, a high risk medication, in the presence of the Director of Regulatory Affairs and the Ucensing and Certlficetion Coordinator of the facility.

The IJ was abated at 5:33pm on 4110108 when an immediate corredive action plan was submhted by the facility and accepted by the Carlfomia Department of Public Health.

Findings:

Evant IO:L lVY\N11 1I2l2009

ID PREFIX

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PROVIDER'S PlAN OF CORAECTION (EACH CORfa:CTJ\IE ACTION 5HOULD BE CROSS­

REFERENCED TO THE IJ'PROPRIATE D'EfiClatCY>

10, 2008, the Nursing Supervisor monitored staff aSSignment to Flolan patients until May 30,2008. The Nursing Supervisor confirmed that an~ staff caring for a Flolan patient had a completed and signed competency or file.

Responsible Party: Chief Nursing Officer

":28:12AM

LABORATORY DIRECTOR'S OR PROVIDERJSUPPI..IER REPRESENTATIVE'S SIGNATURE (X8)DATE

Any dllfidency ~t ending with an asterisk r) denotes 8 deficiency whk:h lhe institution may be m:uMd !rom IlOI1'KtIno prowldlnQ 1\1$ d8\wrnlnMI thel other aa1eguarde provide IlUfticiant PfOI8dIort to the pallon1& e.:.pt for IIUnJIng homes. the Incllngl ,bow are disdoIabie 90 day' funowing tile dste of survey whether or not. pa, of 0DmICII0n Is provided. For nurtllng hOmes, the above IInd1ngs end plan. of ~ ara d~bIe 14 days foIk7Mng the d~ ,!*,e doc;umenta lite made IMriIllbla 10 the facility. If dIIIcIenc:iaI81'11 cited, an approved plan of IlDIT8diDn i. requisn to continued program \ 0 ~ ~. ~'~~1

CALIFORNIA HEALm AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAL m STATEMENT Of DEfICIENCIES NfD PlAN OF CORRECTION

(X1) PROVIOERI&A'I.IERICUA OENTlFlCAl1ON Nl.WIIER:

(X2l MULllPt.E CONSTRUCTION (X!\) DAlE S~Y COMP\£fED

A. BVII.DING

B.WNG O4It112008

f\lAME OF PROVIDER OR SUPPUER

UCSF MEDICAL CENTER

SllIEfT IIDORESS. CITY. STATE.l1P CODE

OC")IO PREFIX

TAG

&05 PARNASSUS AveNUE. SAN FRANCISCO, CA 94122-0210 SAN FRANCISCO COUNTY

SUMMAAY STATEMENT OF DeFICIENCIES (EACH DeFICIENCY MUST BE PRECEEOED BY FULL REGlAATORY OR LSC IDENTIFYING 1NF0000TlON)

Contfnued From page 3

An investigaUon was initiated on 41912008 as a result of an Incident reported by the facility Involving the accidental overdose of Flolan 10 a patient who suffered a cardiac arrest and expired 45 minutes after the medication administration error.

During an intervieW at approximately 10:25 a.m. on 419/08, the facility Ucenslng and Certification Coordinator provided a summary of the incident as follow: On~, Pa\lent 1 was receiving Flolan, dobutamine (a heart medication), and normal saline through intravenous therapy controlled by the same electronic Infusion device, the Aleria infusion system. At approximately 7;10 p.m., RN 1 was preparing to start Patient 1 on potassium chloride by secondary infusion (piggybacking) through the normal saline infusion line at the rate of 100 mlJhr (millifiter per hour). However, RN 1 made an error and adjusted Patient 1's Flolan Infusion rate from 4.2 mlfhr to 100 mlJhour. Immediately after the error was made, Patient 1 complained to RN 1 of feeling extremely tired while sitting in bed and collapsed into the bed and became unresponsive immediately after. The hospHaI Code Blue Team was called at once. A registered nurse responded to the code blue call noticed the mistake In the Fiolan infusion rate a-.d reset the Infusion rate to 4.2 mln1r approximately 5 minutes after the error was made. Cardiopulmonary resuscitation started at approximately 7:15 p.m. and continued until Patient 1 was pronounced dead at 7;58 p.m. on the same day.

A review of Patient 1's clinical record showed that Patient 1 was admitted to the facility with

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PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOIA.D BE CROS~

Re=EREHCED TO tHE APPROPRA11: DEFICIENCy)

Evant ID:L lWIN11 112/2009 11:28:12AM

()(5)

COMPlETE DAn:

lABORATORY DIRECTOR'S OR PROVIDER/SUPPlIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

Any deftcienGy 8111temllllt ending with IIIIlISteriak r) denotes II deficIenCY which the inItiIuIIon may be excused I'ronI COI'IlICIIng proWling it Is detBfmlned that oIher saf8gUanjs provide a.dIcIenl protection 10 the patient.. Except fOr nursing homes, the trnelings lbove 1m! diSdoubie go dayS CoIcMin; \he date of swvey whether or not I plan of COIT8Ctian is proYidecI. For nursing homa, the IIIIcM findings end pllllII of conedion 118 dildoaable 14 dll)lS following the date theae documents era made available to the 18cl11ty. If de1k:ienciea Ire cited. IIIIIPPfO\'ed plan of corredion is requisila to continued program partiCipatJon.

State-2567 40f 12

CAliFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAlTH

STATEUE/'lrOf DeFICENCIES AND ~ Of CORRECTION

(XI) PROVIOERISUPPlIER.lCLLA IOElmFlCATtON NUMBER:

()(al MULTIPlECOMSTRUCltON

050454

A. BUILDING

B.IIWIO 04111/2008

NANE OF PROVIDER OR SUPflUER

UCSFMEDlCAlCENTER

smEET ADDRESS. CITY. STATE. ZIP CODE

505 PARNASSUS AVENUE, SAN FRANCISCO, CA 14122.0210 SAN FRANCISCO COUNTY

0(4)10

PREFIX TAG

SWMAAY STATEMENT OF DEFICIENCIES (EACH DERCIENCY MUST BE PRECEElED BY FlAL REGUlATORY OR lSC IOENTtF'fING INFORMATION)

Continued From page ..

pulmonary hypertension on~. Fiolan therepy was initiated on ~8. On -..us, Patient 1 was on a stable dose of Fiolan 20 nanograms(ng) per idiogram per minute (2Ong1kgfmln) at the infusion rate of 4.2 ml/tlr in the 10 South Unit of the facility. The Fiolan pump event log indicated that the infusion rate of FlOIan was adjusted from 4.2mllhr to 100mllhr at 19:16 (7:16 p.m.) on ~ and was later on re-adjusted to 4.2mllhr at 19:21 on the same day. An event note time-stamped at 1:32 p.m. on ~ by an unknown provider slated, • I have reviewed the events surrolJ'ldlng this patienfs death. 'MIhin one to two minutes before his cardiopulmonary arrest and the subsequent death, there was a mlsadministralion of Flolan that resulted in the patient receiving a substantially higher dose than was ordered. In addition, he had received IV Zofran for nausea and emesis. It is very likely that 'he FIoIan mlsadmlnlstratlon was causal given it. temporal relationship to the patlenfs arrest. We are awaiting resullt> of the medical 8lCarniner's evaluation to exclude other less Ifttely potential causes, such as large pulmonary emboli or aspiration pneumonitis.·

10 PRERX

TAG

PROVIDER'S PlAN OF CORRECTION (EACH CORRECTlIIEACTIOH SHOULO BE CROSS. REFERENCED TO THe APPROPRIATE OEFICIENCY)

>t ... ·'V: (I.C(Cr;1 -::.

Gui-'H -l. 01 C

(X5)

COMPlETE DATE

At approximately 11:35 a.m. on 419108, a team consisted of nursing managers, Director of Pharmacy (OOP) , Patient Care Director, nurse specialists and Director of Regulatory Affairs demonstrated the infusion pump set-up as in Patient 1's room at the time of the incident. The Alaris Medley Medication Safety System with Point-of-Care Unit 8000 series and Pump Module 8100 Series, Version 7 was used in the incident. RN 3 explained that each Infusion system

JAN 2 0 7nnq

"l"lv ~if'll O,'st Of.': !"',' ~ -' ' .. t, .... 1, .'

Event ID:llWW11 11212009 11:28:12AM

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

Any defic:iency tIelement ending with an asterisk r) denOles e def1ciency which ItIe inlllituUOn may be 6lCQI8ed frOm correcIing proyk1lre H iI detvlIIllned thaI o\her a8laguards provida eutrlClenl proleclion to th8 pIIl,nc.. Except for nunsing homes, tho findfngo ebova 1H8 disdtll8bIB 80 deya ftJIIowing the date of IWNay I!IheItler or not • plan of canaction Is provldad. For nUlSfng homes. lila eboVe findings end pIanI of COfI'8Clion are dtac:losable 14 days foIc7.I,fng the dale these daoumentlere msde aVllllable to the facl"lty. 1f daftclencies are dbId. en approved plan of COIT8CtiOn is requisite 10 continued program participation.

5181&-2567

(X6) DATE

50f12

CALIFORNIA HEAL. TI-f AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEI\l..lH

STATEMENT OF DEFlCIEHCIeS AND PlNI OF CORRECllOH

IX1) PROlllDER1SUPPLIERIC~ IDENTIA~TIOH NUMBER:

(X2) MUI. TIPLE CONSTRUCTION (l(3) DATE SURVEY COMPlETED

060454

A. IIUIUlING

B. IMNG 0411112008

fWotE OF PROVIDER OR S\FP\.4ER

UCSF MEDICAL CENTER

STlIa:T AOORESS. CITY. STATe. ZIP CODE

(l(4)10 PREf'I)(

TAG

505 PARNASSUS AVENUE, SAN FRANCISCO, CA 14122-0210 SAN FRANCISCO COUNTY

SUMMARY STATEMENT OF DEFIClENCIES (EACH DEAClEHCY MUST BE PRECEEDEP BY FULL REGUlATORY OR LSC IDENTIFYING ItIFORMATlON)

Continued From page 5

consisted of a Point-of Care unit which worked as the 'brain" to support the delivelY of up to 4 different mellcations at the same time by detachable modules (channels). The set-up of the system showed thai the unH was supporting the infusion of Flolan and normal saline on the right side of the unit; and dobutamine and an empty channel on the left side of the unit. When asked if the system had any safeguard functions to help reduce IV medication errors, RN 3 responded flat Guardrails(r) Software was installed in each InfUSion . system which was frequently used in IV infusion therapy to alert nursing staff of dosing irregularities and provide dosing guidelines. However, the Guardrails(r) function was not utilized in the administration of Flalan in this incident. RN 3 stated that the basic infusion mode with no alert function was used in the infusion of Fiolan In the incident due 10 the inability of the Infusion system to handle Fiolan dosing in the unit of nglkglmln. When asked if Fiolan met the definition of & high risk medication according to the facility's "High Risk medications- Policy and ProcedUre, the OOP responded, "yes-. RN 3 atated that new ambulaloJY Infusion pumps, the CADD pumps, had replaced the AJaris infusion system for the admlnistTation of Flolan as of 419108.

The manufacturer's prescribing Information for Fiolan documented the following information: w

Flo/an is administered by continuous intravenous infusion Via a central venous catheter using an ambulatolY infusion pump. The ambulatolY infusion pump used to administer Fiolan should: (1) be sman and lightweight, (2) be able to adjust infusion

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PROVIDER'S PlNI OF CORREcnOH (EACH CORRECT1\IE ACTION SHOU.D BE CROS$. REFaU:NCEO TO THE Al'FROf'RIATe DEFICIENCY)

EventlD:L 'J'I.MY11 11212009 11:28:12AM

(l(5) COMPLETE

Oo\Te

LABORATORY DiRECTOR'S OR PROVIDERlSUPPlII:R REPRESENTATIVE'S SIGNATURE TiTlE (X6lDATE

Any deficiency IlIaIement ending willi an .. 18riIsk (") denotes a deficiency which the InstitUtion may be excused from correcting prcyIding it Is da1eI'rited thet oIt\er lefegllMla ~ suIIicien\ PIOtedion to \he pa\lenla. ElafIt for nlnlng hamel, lhe finclinga above are ciecIoaetIIe 90 dlI)'IlOIcIwIng the dete of survey whether or not a p8I d correction Is pnMded. For nurwing hom., !he aboYe IIndilga end plans or comtction ara dlsdoaable 14 days fDIowIng the dele thBM dOQllnenll 819 made available to the tacrlty. If defiCiencies ate cited. an approved plen of conection is I8q11iIite to QOIIIinued program participation.

Stale-2S67 6Of12

CALIFORNIA HEALTH AND HUMAN SERVlCE$AGENCY DEPARTMENT OF PUBUC HEALTH

STATEWEHT OF DEFICIENCIES AND PlAN Of CORRECTION

(Xl) PROV1DERlSlPPlERlCllA ft)ENTIFICA nON rIUMtIB'I:

0500454

(X2) MVl nPLE CONSTRUCTION

A. BUIlDING

a.WNG

(X3) /VITE SURVEY COMPlETED

0411112008

NAME Of PROVIDER OR SU>PUER

UCSF MEDICAL CE~R STREET ADORESS. CIlY. STAlE. liP CODE

(X4)ID PREFIX

TAG

505 PARNAaSUS AVENUE, SAN FRANCISCO. CA 14122-0210 SAN FRANCISCO COUNTY

SUMIoIARY STAl'£r.ENT Of DEFiCENClES (EACH DEfICIENCY MUST BE PRECEEDED fff FUll REGULATORY OR lSC IDENlFYlNG INFORMATION)

Continued From page 8

rates In 2-ng/1(gInm Increments."

The Alarls infusion system that was used in the incident was not an ambulatory pump and did not have the capability of processing Flolan dose in the unit of nglkg/min.

Flolan (epoprostenol) is a medication for the treatment of primary pulmonary hypertension. Pulmonary hypertension is a condition of progressive narrowing of the blood vessels of the lungs, causing high blood pressure in these blood vessels and eventually leading to heart failure . Flolan works by relaldng and dilating the blood vessels In the lungs, allowing Increased blood 1\ow. Flolan lasts only for 3-5 mInutes In the body and must be constantly infused intravenously directly into the bloodstream through a surgically implanted catheter inserted into the large vein teading directly into the heart by a portable, baltery-operated pump. Interruption of Flolan can be life-threatenlng, even a brief interruptIon can result In a sudden reoccurrence of symptoms. Since Flolan also dilates blood vessels throughout the body, fatal occurrences of hypoxemia (low oxygen level in blood). hypotension (low blood pressure), and respiratory arrest (ceS88tion of spontaneous breathing) have been reported following overdose of Flolan in cfinicallrials.

During an interview at approximately 4:30 p.m. on 419108, RN 4 of the 10 ICC unit stated that the incident prompted everyone in the unit to realize how error-prone the pump-sharing practice for Flolan administration was. ·RN 4 alllo stated that

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PAOVlDER'S PlNI OF CORRECTlON (EACH CORRECTlIIE ACTION SHOULD BE CROS~

REFERENCED TO THE APPROPRIATE DEFICIENCY)

EventlD:lTWW11 11212009 11:28:12AM

lABOAATOR'Y DIRECTOR'S OR PROVlOERlSUPPlIER REPRESENTAll\IE'S SIGNA1\JRE nn.E (X8) DATE

Any deficiency atetement IInding wItI\ lin UUlriIk (1 dIInoIes a deficiency 'I/IIk:t\ \he inIlI\ut!Qn mll'l be eXQlaed fnlm torTedino pnMdlng it is dMemlined Itlat oller aale!luarde prgvide suftIcIent ptVIedion \0 the pelillrU. Except for IIUf1Ing homeI. 1l1li tlnc&1ga above ,re diidosBblll 90 daye following the dale of SlIMlY whd1er or not a plan of conction Is pIVVIded. For nIning homea, the above indlnga and plana of CIIff8C:Iion are dbc:Ioaable 14 days 1bIIawing

the date these dcIcUrnerU are mada available to the flldllty. If deficiencies are cited, an epproved plan of correction Is requl5l1ll \0 cont.nUBd ~ram participalion.

518111-2587 70112

CAUFORNIA HEAL ni AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAl ni

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

IX1) PROVID'ERlSUPPllERlCllA IOENT1FICATION NUMBER:

(X2) MUl TlPtE CONSTRUCTION IX3) DATE SURI/EY COMPlETED

050454 A. BUILDING

B.WlNG 04111/2008

NAME OF PROVIDER 00 S\JPPI.IER

UCSF MEDICAL CENTER STREET ADDRESS. CITY. STATE. ZIP CODE.

(X4) 10

PREFIX TAG

[505 PARNASSUS AVENUE. SAN FRANCISCO, CA 94122-0210 SAN FRANasCO COUNTY

SUMMARY STATEMENT OF DEFICIENCIES (EACH OEFlClENCY MUST BE PRECEEOEO BY FUll REGIAATORY OR LSC IDENTIFYING INfORMATION)

Continued From page 7

the facility had stopped the pump-sharing practice for Fiolan administration shortly after the Incident.

During a review of patient dlnlcal records and competency record of nursing staff In 10 ICC and 10 CVT (designated nursing units for patients receiving Flolan) at approximately 11:00 a.m. on 4110108, it was discovered that RN 5 did not have validated competency in the operation of the new CADD pumps but was assigned to care for Patient 2, a patient on Flolan, from 7 p.m. on 419108 to 7 a.m. on 4110108. RN 5's competency record tHled "FlolanIRemoduHn Infusion via the CADD legacy-1 Infusion Pump· dated 4191'08 showed no vandator's inlt!a\s in all 17 competency areas and the record was not signed by a vatidator (trainer). Two concentration calculations on the competency record had not been completed. A telephone interview at approxilTllltely 12:22 p.m. with Trainer 1 & 2, who were responsible fOf training and valldatil'lJ competency In 10 ICC and 10 CVT, confirmed that competency in the operation of the CADD pump would be validated when a registered nurse was able to accurately complete the calculations and demonstrate competency in all the 17 competency areas on the form as indicated by the validator's initials. Trainer 1 & 2 stated that they could not recall RN 5 being trained Dr vaMdated for competency and agreed that RN 5 did not meet the CADD pump competency requirement and should not have provided care to patients on Flolan.

During an Interview at approximately 12:50 p.m. on 4/10108, RN 1 stated that on the day of the Inc:ide~ ahe adjusted the F101an infusion rate frOm

10

PREFIX TAG

PROVIDER'S PlAN OF CORRECTION o;;ACH CORRECTIVE ACTION stIOUlO BE CROSS­

REFERENCED TO THE APPROPRIATE DEFICIENCy)

Event IO:L TWM 1 11212009 11:28:12AM

(X5) COMPL£TE

DATE

lABORATORY DIRECTOR'S OR PROVIDERlSUPPUeR REPRESENTATIVE'S SIGNATURe TIRe (X6) DATE

Any d8ficiBnc:y statement ending with an aAlIIak (*) denotea a daflciancy wI1ich the IIIsllluUon may be excused tom correctIng proyIding it II detelmlnlld that other II8feguerdl provide suIIic:Ient prat8Cllon to the patienl$. ~ for nursing hornet. \he lIndinga IIbova ere <iaclolablll 90 days follooMng the dela of tuMIY wheIh8r or not .. plen d c:orractIon is proIIided. For ~ homes. tha abcMIlndingl and piBnI 01 corredion al1l dilcloaable 14 days foIlaMng the dale these document' ere made aVlliI!lbl& to Ihe facility. If ~ are cited, an appr(MId plan of ~ Ie AlqUiaite to continued program participation.

Slste-2567 80f12

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBliC HEALTH

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

0(1) PROVlDERISUPPLIERICLJ.II loetmFlCAllON HUVl8ER:

(X2) MVl TIPlE CONSTRUCTlON

A BlJIWIPIG

B.WHO

0(3) ~Te SURVEY COMPLETED

0411112008

NIVofE OF PROIilDER OR S .... PlIER

UCSF MEDICAL CENTER

STREET ADDRESS. CITY. STATE. ZIP CODE

0(4) 10 PREFIX T~

505 PARNASSUS AVENUE, SAN FRANCISCO, CA 94122..(12tO SAN FRANCISCO COUNTY

SUWoWIY STATEMENT OF DEflCENCIES (EACH DEFICIENCY MUST BE PRECEEOED BY FU..L REGULATORY OR LSC IDENTIFYING INFORMATJOH)

Continued From page 8

".2mllhr to 100mllhr by mistake when she intended 10 adjust the rate of the normal saline module, which was located next to the Fiolan module. Both the Fiolan module and the normal salile module were attached on the right side of the infusion unit. RN 1 stated that there was no fthigh risk medication" alert sign on the infusion unit 01'

anywhere in Patient 1's room.

A review of the facility's High Risk Medications Policy and Procedure (Policy 6.09.19) dated January 2007 at approximately 1:15 p.m. on 4110108 indicated that high risk medications was defined 8S "drugs that bear a heightened risk of causing significant harm when they are used In error. Mistakes mayor may not be more common with these drugs but the consequences of an error with these medications can be harrnfuJ to the patient." The Policy also stated, "A medication can be given High Risk status If ongoing review of extemal sources, induding but not limited to the Institute for Safe Medication PractIces (ISMP) and the United States Pharmacopoeia (USP), Identify medications that should be given High Risk status. When new High Risk medications are identified, the affected department will work with the Pharmacy and Therapeutics Committee and the Medication safety SUbcommmee to review these medications and develop new process that decreases the opportunity for error. U FIoIan was not rlSted as a high risk medication In the policy.

The Institute for Safe Medication Practices (ISMP) listed Fiolen (Epoprostenol) as one of 13 high-alert specific medications. On ISMP's List of High-Alert

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REFERENCED TO THE APPROPRIATE DEFICIENCy)

E venllD:L 1WVV11 11:28:12AM

lA80AA TORY DIRECTOR'S OR PRO'vtDERISUPPLIER REPRESENTATIVE'S SIGNA lURE llTLE (XS) DATE

Any dfliciency a1atement ending with en IISteritII (oJ denolell a defic:lency which the .,1IIiIU1lon may be excused from correcting providing It II determined that oilier safegU8lUli provide suIYicienI ptOtectIOn 10 the patients. Ela:ept for I1UnIk1g homea. the findings lIbcwe are disdaIIalII8 90 ~ to!kwMg \he da\~

of Iwvey whethtr or not a plan of COI'R!CIIDn II provided. For nursing homeI,the eIxMI findings and plans oflXlfreclion are diSclOSabie 14 days fOllowing the dale \tIeae doCUmen1s are made available 10 the facIfty. If deIiciencIea are clled, an approwd plan of canectIon is IlIqIJllite to cx>ntlnuod PIOIIrIIrTI participation.

SIete-2567 901'12

CALIFORNIA HEAlTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES ",., PI.NI Of' ~RECl1ON

~1) PR~~PPUERCUA

IDENTIFICATION NUMBER: (X2ll11)lTIPlE CONSTRUCTlOH (X31 DATE SURVEY

COMPlETED

A. BUILDING

B.WlNG 0411112008

NAME OF PROVIDER OR SUPPUER

UCSF MEDICAL CENTER STREET ADDRESS. CITY. STATE. ZIP COIlE

(X411O PREFIX

TAG

505 PARNASSUS AVENUE, SAN FRANCISCO. CA ,.122-0210 SAN FRANCISCO COUNTY

SUMMARY STATeMENT OF DEFICIENCIES lEACH DEFICIENCY MUST BE PRECEEiJED BY FUll REGIJlATORV OR LSC IOEHTIFYING INFORMATION)

Continued From page 9

Medications publication. it stated: "High-alert medications are drugs that bear a heightened risk of causing Significant patient harm when they are used In error. Although mistakes may o~ may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

Contrary to the facilily's High Risk Medication Policy and Procedures. Fiolan was not identifIed as a high risk medication by the facility, and consequently was not reviewed for the development of processes to reduce oppof'lunily for error.

On 4/10108 at 2:10 p.m.. an Immediate Jeopardy (IJ) situation was declared pertaining to the unsafe administration of FloIan, a high risk medication, In the presence of the Director of Regulatory Affairs and the Licensing and Certification Coordinator of the faclily.

Due to the shoI1·life nature of Flolan and the fact that any interruption of Flolan Infusion can be life-threatening, the facility's failure to ensure the safe administration of Flolan by competent staff was likely 10 place other patients requiring the drug. Fiolan. In the situation of immediate jeopardy with the potential to cause serious injury or death.

The IJ was abated at 5:33pm on 4/10108 when an Immediate corrective action plan was submitted by the facility and accepted by the California Department of PubliC Health.

At approximately 12:40 p.m. on 4n1108,

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PRO\IIOeR'S PLAN OF CORRECTION (EACH CORRECTNE M:TlON SHOUlD BE CROSS­REFERENCE~ TO THE APPROPRIATE DEFICIENCY)

EvenIID:L 1VWV11 11212009 1t:28:12AM

1X5l COMPLETE

OAl£

lABORATORV DIRECTOR'S OR PROVIDER/SUPPUER REPRESENTATIVE'S SIGNATURE TITlE (X6) DAlE

Any de/ic:ienqI atlternent ending with en lllleriak M denoIes • deficiency wNch the fnstrtution may be exeuted from correctir1" providing it III determinll1 ttvrt otIIar ~ PRNkIe IIU!Ic:Ien\ praIBdion to lIle pa\\enla. ~ for nIII8ing nornell, the 1indlngs above ... cIItcIosabIe 90 dayv following the date o!sul'YII)' whether or not a plan 01 corredion II PfO"Ided. For nursing hom8I. the eboYe ftndlngs end plana 0' correction .re diIc:IoaabIe 14 dIIya following the date theaa documenl8 .. made evl1IabJe 10 lhe tacMy. If de1k:iencleS ere c/Ied, an.pproved plan or correction is requi&lte to conIilued prOQt8m participation.

S1ate-2567 10 of 12

CALIFORNIA HEAlTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBlIC HEAlTH

STATEMENT OF DEFICIENCIES AND PI.AN OF CORRECTION

OC I) PROIIIDERISUPPLIERICLIA IDENTIFICATION NUMBER:

OC21 MUt.lFI..E CONSTRUCTION O(3) MTe SURIIEY COMPLETED

0504s.t A. BUILDING

B.WlNG 04111/2008

NAME OF PROVIDER OR SUPPLIER

UCSF MEDICAL CENTER STRI:eT ADDRESS. CITY. STATE. ZIP CODE

(X4)ID PREFIX

TAG

505 PARNASSUS AVI'!NUE, SAN FRANCISCO, CA "122-0210 SAN FRANCISCO COUNTY

SlAIMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDEO BY FULL REGUlATORY OR LSCIOEtmI"nNG INFORMATION)

Contfnued From page 10

Pharmacist 1 demonstrated the operation of the Guardrails(r) editor software Version 7. The GuardraHs(r) editor software is the authoring tool that manages how rnedk:ations can be programmed on the infusion system by setting Mmils on the rates, volumes, and doses that are appropriate for a given patient care area to reduce IV medication errors. Pharmacist 1 stated that the GuardraiJs(r) safeguard functions were not used for the administration of Fiolan because Fiolan was not programmed into the Guardraila{r) library . Pharmacfst 1 explained that in order to program Flolan Into the system, it reqUired 1he manual conversion of Ftolan dosing unit from nanograms (og) to micrograms (meg) (1000ng=1mcg), which was considered an independent risk for error . Pharmacist 1 added that the facility would be upgrading the infusion pump system to a version that would be capable of processing Flolan dosing in the unit of nglkglmin in the near Mure.

At approximately 12:40 p.m. on 4111108, the fadlity Ucenslng and Certification Coordinator a'ld the DOP reported that there was no record of Flolan being discussed In any P&T or Medication safety Subcommittee meetings.

During a telephone interview at approximately 4:35 p.m. on 4/21/08, Customer Advocacy Representative 1 at Cardinal Health (the distributor of the Alarls infusion systems) stated that the AJaris infusion system used in the incident was not recommended for the administration of Fiolan due to its inability to handle Fiolan dosing in the unit of ngIkgImin. Customer Advocacy Representative 1

ID PREFIX

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PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOUlD BE CROSS­REFERENCEO TO THE APPROPRIATE DEFIc/EJojCy)

Event ID:L1VVW11 11212009 11:28:12AM

COMPLETE OATE

lABORATORY DIRECTOR'S OA PROVlOERlSUPPUI:R REPRESEN'TA1WE'S SIGNATURE TITlE (X8) DATE

Any deficiency statement ending with an aetertak rl danotee II dellcleocy which the inatiluticn may be excUSlld tom correcq proyidirlg it is deWmnlned 1het oCher 1I8feguanla p!OYIda 8II/1icient pro1ection to the patients. Exoapt tiT OOIWQ homes, the IIndInga IIbcwe ere I!lscIoseble 90 daya foltoWlng the date of 8UIV8Y whether or not a plan of corredion Is proloided. For nursing homes. the ebOWl ftndinga and plene of corredlon are diSdOSabIe 14 dey_ folloWing the dale these doCUments ere made evallable to the fllCilHy. "dllftclendlla are cled. an epproved plen of 00It8Cti0n ill ~Ie '.0 oomlnUlld program participatiOn.

S18t902587 11 DI12

CAUFORNIA HEAl. TH AND HUMAN SERViceS AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEfICIENCIES AND PlAN OF COARECTION

~1)P~D~~~ IDENTIfiCATION HUUIlER:

(lt2) MULTIPlE COKIimUCnON ~3) MTE SURVEY COMI'U:TED

AB\J!lOlNG

8.WNG 0411112008

MANE Of PROIIWJER OR SUf'PlJER

UCSF MEDICAL CENTER STREET ADORESS. CITY. STATE. ZIP COOE

(X4)1O PREFIX

TAG

fso5 PARNASSUS AVENUe. SAN FRANCISCO, CA N122..(12tO SAN FRANCISCO COUNTY

SUMIMRY STA1'E"'ENT OF DEfICIENCIES (EACH D£FICIENCY Mt.I8T Sf! PRECEEDED 8'1' F1JlL REG1JI.AlOftY OR LSC IDENTIFYING INFOR""inON)

ConUnued From page 11

also stated that the basic infUsion mode of the A1arls system. which was used In the incident, was not recommended for the infusion of Flolan or any medication due to 1he. fad that it was only a manual flow rate setting function and was not supported by the safeguard features of the system such as dosing guidelines. ratefdo&e limit aIert& and erlnical advisory.

A review of the medical examiner's report on 10117106 revealed that the cause of Patient 1's

, death was ~Complicationa of Fiolan administralion.­Due to: "Primary Pulmonary Hypertension."

The failure of the facility to follow its High Risk Medication Policy and Procedure to identify high risk medications and Implement appropriate safety measures to reduce medication errors resulted In the preventabfe fatal medication error Involving Patient 1 receiving 23 times the prescribed dose of Flolan. In addition, the falh.we of the facOIty to ensure the safe administration of Fiolan by staff with validated competency in the operation of \he infusion device had put patients receiving Rolan at risk. for fatal medication error. These Violations of licensing requirements caused, or were likely to cause, serious injury or death to the patient.

10 PRE'I'IX

TAG

PROVIJER'S PlAN OF CORRECllON (EACH CORRECIlVE ACTION SHOI.lO BE CROS$. REFERENCED TOTllE APPROPRIATE DEFICIENCY)

Event ID:L l\W\I11 11212009 11:28:12AM

(X8)

COMPl.ETe DATE

IABORAlORY DIRECTOR'S OR PROVlOERISUPPlIER REPRESENTATIVE'S SIGNATURE TI'TlE (X8)OATE

Any cterlCiency 1Ie\ement en.iIlg will an estamlt (i denote, 8 defiCiency whlctI the \n8litution rna)' be excused from COI'I8CIing proViding iI is determined that other safeguards provide suflIcitot protectiDfl to the patieI1ts. ExoepC for IlI.IrsillJl homes. tha flnd'lI!Ollbove are dIsc:IoeabIa 90 days l'oIIawing the dale of SUN8Y wheII1er or nol • plen of corrtc:lion ill prcMOed. For n&nirtg horn_ the abo'Je lIndil1gl and pllIfII of COIIlICIIon 11'8 dJacIosabJe 14 da,.. following the dl18theee documents 1118 madlllWilable to u. fac:i1ity. If defIeIencles Ire cited, an approved plan of COlI'8CtIon 18 requlelle to continued ~ partlc:ipation.

SII,&-2567 12 of t2