Document Librar… · printed: 11/1412007 form approved fatement of-deficiencies ~o plan of...

.. PRINTED: 11/1412007

FORM APPROVED

fATEMENT OF-DEFICIENCIES ~O PLAN OF CORRECTION

(X1) PROVIDERJSUPPLIER/CLIA IDENTIFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COUPLE TED

A. BUILDING

CA220000031 B. WING ________ _

09/24/2007 ~E OF PROVIDER OR SUPPUER

CSF MEDICAL CENTER

STREET ADDRESS, CITY, STATE, ZIP CODE

505 PARNASSUS AVE SAN FRANCISCO, CA 94143

~)ID •Ri:F1)C TAG

SUMJMRY STA'TCMEMT OF Ol:FICl!;HCIE8 (EACH D~ENCY UUST BE PRECEDED ftf FUU

REGUIATORY OR LSO IOENTIFYING INFORMATION)

A 000 Initial Comments

I The fallowing reflects the findings of the Department of Public: Health during a Full

ID PREAX

T>.(}

AOOO

.Validation Survey. State California 1 COP ·L&C ! Representing the Department of Publio Health:

aceutiCal CQnsultant NOV 21 2007 f!>harmece\illGSI ~llil~r

Pharmaeeulloa.1 C~f-.,1 edlcel Coo.suttant ealth Facilities Evaluator

Health Facll~ Evaluator Nurse acilitles Evaluator Nurse leticlan

- --- - ·- - - - ·- ----- - -·· .... - -1280.1 (a} Health and Safety Code Section 1280 (a) If a licensee of a health facility &censed under

1 subdivision (a), (b), or (f} of Section 1250 I r~eive15 a notice of deficiency constituting an · lmlTll;ldiate jeopardy to the he.alth or safety of a

patient and is required to submit a plan of correction, the department may asses.s the licensee an administrative- penalty In an amount not to exceed twenly·flve thousand dollars ($25,000) per violation.

1280.1 (c) Health and Safety Code Section 1280 (c)' For purposes of this section " immediate jeopardy " means a sibJatlon 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.

Dfst. 0

A 334 CCR TITLE 22 DIV5 CH1 ART3 ·70263(c) A 334 Pharmaceutical Service General Requirements

\BOAATO~ OR PRO

TATE FORM

PROVIDER'S Pl.AH OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE

CRQSS.REFEREHCED TO TiiE APPROPRIATE DEFICIENCY)

(XS) COMPLETE

l».TE

Corrective Action (A 334-a): By midnight on September 20, 2007 UCSF Medical Center conducted a 1 OOOAi review and reconciliation with physician orders of all Medication Administration Records (MAR)/Medication Prescription Record (MPR) on every inpatient at Mount Zion and at Moffitt/Longho&pital.s. Between midnight of September 20, 2007 and the morning of September 2 l, 2007, extra l& staff were deployed throughout the Medical Center to

Qouble check all orders written over night and transcribed by the bedside nursing staff. By 9:00 am on the moming of September 21, 2007, UCSF Medical Center had deployed additional staff (''traJlsaribers") to eacb unit to partner with the Medication Safety Nurse to assist with order transcription. Beginning with the 7pm change of shift report on 912fJl61, nwses were educated about the new · process. This education continued at each change of shift for 7 days. Physicians were informed of the process on 9/20/07 via an email from the CMO, reminding them of the requirements for a complete medication order. ·

Since this time, in order to ensme ongoing accuracy of the MARs, UCSF Medical Center has begun implementation of an automated medication administration record ("aMAR"). The phased aMAR implementation began on 11/15/07.

Additionally, transcribers and Medication Safety Nurses (MSN) remain in place to assist with order transcription. TWo RNs check all orders and transcription. Additional clarification of ambiguous or incomplete orders is also provided by the phannacy staff upon review of the scanned

TITLE

HJ6K11 If

9120/07

11/15/07

:atlfOmia Oenartment of Pub le Health

TATEMENT OF DCFICIEltlCIES ND PLAN ~F C9RRECTION

(X1) P~OV1DERISUPP~ DEHllFJCATOt' NUMBER:

CA220000031

(X2) MULTIPLE CONSTRUCTION

A. BUI.DING B. WING ________ _

PRINTED: 11114/2007 FORM APPROVED

(X3) DATE SURvEY . COMPLETED

09124/2007 IAME OF PRCMDER OR SUPPLIER ·

JCSF MEDICAL CENTER

STREET ADDRESS, CITY, STATE; ZIP COOE


(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DERCIENCY MUST BE PRECEDED BY FUU.

REGULATORY OR LSC IDENTIFYING INFORMATION)

A 334 Continued From Page 1 ' . committee of equivalent composition, shaU be establlshed. The committee shan consist of at least one physician, one pharmacist, the director of nursing service or her representative and the administrator or his representative. (1) The commtttee shall de._;e1op wrttten policies and procedures· for. establishment of safe and effective sys~ms for procurement, stQrage, distribution, dlspr;msing and use of drugs and r.hemlcals. The pharmacist in conaultetloll with other appropriate health professlona!J and administration shall be responsible for the development and Implementations of · proced1:fre5. Pollclet shall be approved by the govemlng body. Procedures shall be approved by the admlnlsttetlon and medlcal staff Where such is aj)proprlate. ·tat-The 6Qmmlttee s"8U be responSibla.fQr..t!a de.velopment and m.etntenanoe of a formulary Of druge ror use tAroughout the hospital.

The above regulations a~e not met as evidenced by:

Based on cHnfcal record review of three patients (Patient 1, 2 and 3), document review, and Interview of hospltal staff, the hospital failed to enaure that policies and procedures were developed and/or implemented tO ensure accurate administration of medications to Patient 21 and mlnlmlze advenie medlcatton outcomes for Patient 1 and 3 as evidenced by the fonowtng:

a. Patient 2 ' s medication admlnlstraUon record (MAR: used by nurilng staff·io guide the administration of medications to their patients) . did not accurately ·reflect the physician orders which potentially exposed Patlel'.'lt 2 to the excessive effect$ of medications or deprived the patient of the benefit of medications therapy for those medications which did not appear on tJ:le

TATE FORM 11211•

ID PREFIX

TAG

A334

PRO\'l>ER'S PlAN OF COR~CTION tEACH CORRECTIVE ACTTON SHOULD BE .

CftOss..REFERENCED to THE APPftOPRIATE - DEFICIENCY)

order, as necessary. In addition, a multidisciplinary Transcription Clarification and Standardization Workgroup (composed of Phannacy, Nursing and Medical Staff representation) was formed on 10/4/07 to standardize transcription throughout the inpatient units.

The Nursing Education Department has developed-a Transcriptfon Training Competency. All nurses are required to undergo re-education of transcription guidelines in conjllllction with the aMAR implementation on their units.

Monitoring: To ensure accuracy of the MARs matching the MD orders, effective August of2007, UCSF Medical Center is auditing and reconciling approximately 230 ~~Rs w.eekly. Audit results are reviewed bY Pharmacy -aiia ihe Patient Care Managers. Direct feedback is provided to staff and opportwtities for improvement are identified. Audit results are reviewed on a monthly basis at the Medication Safety Committee, Nursing Perfonnance Improvement Executive Committee (NPIEC), and on a quarterly schedule at the Quality Improvement Executive Committee (QIEC), until the aMar is implemented. Once the aMar is implemented the staffing and monitoring plan will be reviewed and revised as needed.

Responsible Party: ChiefNursing Officer, ChiefMedical Officer, Director of Pharmacy

(XS) COMP,tETE

DATE

Corrective Action (A 334-b): Beginning the 9/20/07 I evening of September 20, 2007, the Worx station system instructions have included a flag on any fentanyl patch dose increase that occurs more frequently than every 3 days after the initial dose or more frequently than

HJ6K11

~llfomia Oeoartment of Pub le Heatlh

iTATEMENT OF CEFICIENCIES IND Pl.AN OF COARECTION

(X1) PROVIDER/SUPPUERICLI" IDENTIFICATION NUMBER:

CA220000031


A. BUILDING B. WING ________ _

PRINTED: 11/14/2007 FORM APPROVED

(X3) DATE 'SURVEY COMPLETED

09/2412007 -IAME OF PROVIDER OR SUPPLIER

JCSF MEPICAL CENTER

mEET ADDRESS, CITY, STATE, ZIP CODE

505 PARNASSUS AVS SANfRA.NCISCO, CA 94143

(X4)1D PR19'1X

TAG

SUUMARV STATalENl' OF DEFICll!HClES ~CH DfFIClENCY MUST Bli PRECEDED BY FUU.

R1$UlATOR'I' OR LSC IDENTIFYING INFORMATION)

A 334 Continued From Page 2

MAR.

b. Patient 1 received dose increases in fentanyl p~ (a potent syntnetlc opiate narcotic manufacrured ln patch form that releases the medication In a controlled fashion and ls indjcated for the management of chronic pain r. ni:lrootic tolerant patients whose paln has not been manageable by o.'thet means) that Mre not In accordanoe with the 1Tl$n¢Elcturer's dosing guidelines and as a result requlred treatment

1 with a reversal agent, naloxone.

i c. Review of Patient 3 ' s clinical record on ! S11ptember 22, 2007 at 11 :47 a.m. revealed the

hospital faJ~d to ensure that a possible adVerse reaction to ondansetron (Zofran: used to treat

• ..,""" hAAn ~ onto tha ohvslOlan order sheets by a physician and had been - - -documented on the cover of Patient 3 • s clinical record, as required by a hOIJpltal policy and procedure, so that subsequent physicians and other staff such as pharmacl$t$ would b.e alerted to this reaction. All the reaction was not documented on the cover of the clinical record, a second physician prescribed ondansetron six -days later potentially exposing Patient 3 to the drug a second time.

Findings:

1. On 9120/07 at 11 :38 a.m., a review of Patient 2 ' s cnnlcal medical record revealed l!atlent · was status post heart transplant In 2007 and diagnosed to be lmmunosuppress (suppression of the immune system by drug use in order to prevent the rejection of grafts or transplants).

A review of Patient 2 ' s Medication Administration Record (MAR) against the current

TATE FORM ~,.

ID PREJ=IX

TAG

A334

PROlll)ER'S PlAM O'F CORRECTION WACH CORRECTIVE ACTION SHOULD BE

CR~REF!RENCa> TO THE APPROPRIATE DeFICIEMCY)

every 6 days thereafter, as recommended by the product insert. The flag prompts the p~cist to contact the ordering physician to confer and discuss treatment alternatives. On 9/20/07, a one time review of all fentanyl patch orders was conducted by a pharmacist. Physicians were informed by email on September 20, 2007 that fentanyl patch increases more frequent than those recommended on the product insert will result in a consultation with a pharmacist.

Monitoring: All fentanyl patch dose increases are reviewed by a pharmacist for compliance with manufacturer r~endations.

Responsible Party: Director of Pharmacy - --!------.-- .. - ·

Corrective Action (A 334-<:): On September 22, 2007, UCSF Medical Center conducted a 100% review of each patient's orders to ascertain the allergy status of each patient at Moffitt/Long and Mowit Zion campus. Nursing checked the MAR, armband and allergy sticker on the front of the chart to ensure conformance to policy. Any discrepancies identified were clarified with the physician, as appropriate, and documented according to policy. .

By 0800 September 23, 2007 nursing provided to pharmacy a list of all patients with allergit'3. On September 23, 2007 pharmacy updated the phannacy profile for patients with allergies as needed. Beginning September 24, 2007, nursing and physician staff were reeducated to policy and procedure related to allergies.

I 9122101 I

' II

HJ6K11 II contlnuallon lhMI 3 DI 11

;alifomla De artment of Publ Health

iTATEMENT OF DEFICIENCIES ,ND PLAN OF CORRECTION

(X1} PROVIDERISUPPUERICLiA IDENTIFlCATION NUMBER:

CA2lQ000031


A. BUILDING

B. WING-----.,----

PRINTED: 1111412007 FORM APPROVED

{X3) DA TE SURVEY COMPLETED

09/2412007 olAME OF PROVIDER OR SUPPLIER

JCSF MEDICAL CENTER

STREET ADDRESS, CITY, STATE. ZIP. CODE


!X<ll ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIEHCY MUST BE PrteCEDEO BY FUlL

REGul.ATORY OR LSC IDEm1FYING lto!FORMATIOH)

ID PREFIX

TAG

A 334 Continued From Page 3 A 334

physician orders revealed 9 medication order discrepancies out of a total of 30 medications. The following were the 9 dlscrepancles found .. along With the medication order as Written:

a. Valgancyclovl1 (antlfUngal medication)- patient rec.elvec:t 450mg twice a day as documented on the MAR. The current order In the chart was for 450mg daily. The patient received double the dose whfch could lead to adverse drug consequences.

b. Magnesium Oxide (magnes.lum supplement) -patient ree\Wed eo0mg twice a dl!ly as documented on the MAR. The current order In the chart was for 800mg daily. The patient received double the dose which could lead to adve e dru conse uences..:. . _ . _ _ _ •. _

c. Robaxin 500rng .every 6 hours as needed for · muscle spasm- this medication was listed on the ·I MAR. There was no current order in the chart

for the patient to receive this medication.

d. Vicodin 1-2 tablets evlH)' 6 hours as needed ~ered for the patient on ...._2007. This medication wa_s not list~ on the MAR so the nursing staff would not know the patient had an order for this medication when needed to treat his pain.

e. Zofran 4mg IV every 6 hours as needed for nausea and vomiting was documented on the MAR. There was no current order In the chart for the patient to receive this medlca1jon.

f. Bisaoodyl suppositories 10mg rectally every 12 d for constipation was ordered on 2007. This medication was not

listed on the MAR .so the nursing staff would not .know the patient had an order for this medication

TATE FORM

cJ:f=:~~ln~:O~eE CROSs-REFERENCED TO THE APPROPRIATE

. DEFICIENCY)

The Adverse Drug Reaction (ADR)

(X6) COMPlrn

DA"TE

Identification, Reporting and 11114/07 Documentation Policy, (6.09.01) (see Attachment 1), was revised and approved by the P&T Committee on 11/14/07. The policy stipulates that ADRs requiring specific intervention, increased monitoring, which are potentially lire-threatening or cause permanent damage or that are associated wilh a medkation that should not be re-administered are treated in the same manner as allergies (Policy 6.07.18 Allergy /denJlficalion and DocumentationXsee Attachment 2). This requires docwnentation in the medical record through a physician order which is scanned to pharmacy so that the infonnation is entered into the pharmacy system and the patient's phannacy profile .. C~mcomitant allergy alerts are implemented (alert sticker QD 'the C:li8it; anetgy aii:iiliiiia, MAR/flowsheet notations). The policy also stipulates a newly created ADR hotline with the aim to increase the reporting of ADRs by staff. Nurses, physicians and phannacists were educated regarding the policy change,, beginning 11/16/07.

Monitoring: Beginning September 22, 2007, proper documentation of allergies and ADRs, as described above, was monitored by UCSF Medical Center for a period of seven weeks. On 9/22107, Medication Safety Nurses perfonned a 100% review of all patients with documented allergies to ensure conformance to policy. All patients with known allergies and/or serious ADRs were reviewed for proper documentation in the medical record, MAR and presence of an allergy annband. Review showed an increase in compliance from a baseline of

:arifomia Decartment of Public Health

TATEMEHT OF DEFICIENCIES .ND Pt.AN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CUA IDEN11F1CA.TION NUMBER:

CA:220000031


A BUILDING B.WING ________ _

PRINTED: 11/14/2007 FORM APPROVED

(X3) DATE SURVEY COMPLETED

09124/2007 IAME OF Pl'tOW>ER OR SUPPLIER

JCSF MEDICAL CENT!R

SlREET ADORE.SS, CITY, BTAlE. ZIP CODE

505 PARNASSUS AV.E .SAN FRANCISCO, CA 94143

()(4) ID PREFIX

TAG

S\MMARY STATEMENT OF OEroENCIES (f.ACH DEFICIENCY MUST ee PRECEDED BY FULl

REGULATORY OR LSC JDENTtFYNl INFORtM.TION)


when needed for constipation.

g. Clonldlne (blood pressure med~ three times a day was ordered on.__ 2007 with the follawing blood presMire monitoring paramet81$., I.e. hold If systolic blood pressure less than 80, pulse less then 55. These parameters were not transcrtbed on the ¥AR end the pa11eht might receive thla medication when It shourd have been held.

h. Amtodiplna (blood-sure medication) 10mg dally was ordered o 007 with the following monltonng param rs, i.e. hold if systolic blood pressure less than 80. This parameter was written on the ·MAR as hold. if systolic blood pressure less than 90. This !Acor:rect parameter could prevent a needed . . dose from being given.

I. Tylenol 650mg every 4 hours as needed for temperature greatet than 38,5 or mild pain. According to the facflltles plah of~m a prevto.us surve~ on..._ 2007 and dated--2007, Tylenol orders should have a maximum dally dose included with each order. The MAR which should have reflected the complete physician order including parameters and maximum doses did not have

! this maximum dally dose documented. 1

; 2. On September 1a, 2007 re~t 1 's I cllnical record revealed that on--2007,

ID PREFIX

TAG

A334

PRO'tllaER'S PlAN OF CORRECTION (f.ACH CORRECTIVE ACTJOH miOUU> BE

CRDSS-REF!:RENcED TO THE APPROPRIATE DEFICIENCY)

94% up to 99% with each alert element of the policy.

Responsible Party: Director of Pharmacy and Chief Nursing Officer

Corrective Action (A 334-1): By midnight on September 20, 2007 UCSF Medical Center conducted a I 00% review and reconciliation with physician orders of all Medication Administration Records (MAR)IMedication Prescription Record (MPR) on every inpatient at Mount Zion and at Moffrtt/Long hospitals. Between midnight of September 20, 2007 and the morning of September 21, 2007, extra RN staff were deployed throughout the medical center to double check all orders written over night and tramcribed by the bedside

. ,_ J!msin_utaff:. By 9:.00 am on the momin_t. of September 21, 2007, UCSF Medical Center had deployed additional staff (''transcribers") to each unit to partner with the Medication Safety Nurse to assist with order transcription. Beginning w.ith the 7pm change of shift report on 9/20/07, nurses were educated about the new process. This education continued at each change of shift for 7 days. Physicians were informed of the process on 9/20/07 via an email from the CMO, reminding them of . the requirements for a complete medication order.

Since this time, in order to ensure ongoing

(X5) COMPLETE

DAT!

9/20/07

. -- -

a physician ordered that a 25 micrograms per hour (mcg/hr) fentanyl patch be applled to Patient 1. Fentanyl Is a potent synthetic opJate narcotic. One available dosage form is a patch that releases the medication at a controlled rate measured in mog/hr. It is lr:idicated for the treatment of chronic pain that l~y controlled by other means. O~e

accuracy of the MARs, UCSF Medical Center has begun implementation of an I 11/IS/07

automated inedieation administration record ("aMAR"). The phased aMAR implementation began on 11/IS/07.

iTATE FORM CIZ1111 HJ6K11 I ~•llon sh1111t 5 of 11

I

:

r

I '

I

I l

\TATBM!.NT OF DEFICIENCIES >NO PLAN Of CORRECTION

(X1) PROVIDERISUPPUER/CLIA IDE:NTFICATION NUMBER:

CA220000031

(X2) MULTIPLE .CONSTRUCTION

A. BUILDING B. WING _______ _

PRINTED: 11/14'2007 FORM APPROVED


0912412007 U>.ME OF PROVIDER OR SUPPLIER

JCSF MEDICAL CENTER

STREET AODR!SS, CITY, STATE, ZP CODE

505 PARNASSUS AVE SAN FRANCISCO, CA .94143

(X4) I> PAEFIX

T,t.G

SLJMMAR'i' STATaielT OF DEFICIEHCIES (EACH DEFICIENCY litUST BE PRECEDED 8Y FULL

REGUlATORY OR LSC IDENTIFYING INFORMATION)

ID PREFlX

TAG


-

sedto a 50 mcg/hr patch. On 007 the dose was 1ncreased to a

p . On-007the •• ~_ .r: I sed to a 100 mcglhr patch. On

..: t 07 lhe d ed k> a t50 mcg/hr patch and on he dose I was reduced to a 75 mcglhr patch.

! Review of a physician ' s progress note In the ! electronic clinleal record on se-mber 18 2007 · at 4:21 p.m. revealed ttiat on 1

1

2007 at 11:32 a.m. a physician no t at the . fentanyt patch had been "lnoreased · considerably " yesterday-based on Jarge amount

cif PRN {as needM) Rexanot (a lfquid morphlne preparillion} Qse .. Wh11e wrttln0 note, n~rse . contacted me that RR {respiratory ra~: nocmal mte: for an.adult.. per the Medllne Plus Medical Encyclopedia, Is 8 to 16 b~aths per minute) 7-8 (breaths per minute). Wfn gtve Narcan 0.1mg IV X1 (one 0.1 mg dose of \ha narcotic raversal agent Nercan), hold all PRN po (oraO Roxanol

, thla affamoQn and change fentanyl patch bacl\ to

I 75 mcg TD (tranadelTllal: in other words via the patch) q72 (every 72 hours). Wiil af$O check RR q1 H (every one hour) throughout the afternoon-dose given yest&rday around 4 p.m. "

On September 18, 2007 at 4:05 p.m. review of the manufacturer • s package labeling for the fentanyl patch in the Ml Zion Campus pharmacy revealed the manufacturer document~ that (1) each patch could be worn for 72 hours (2) that

, the Initial patch dose could be increased after three daYfi based on supplemental doses of narcotics administered during the three day i period. The prpdud label\ng documented that

I after inweasing the fentanyl patch dose it may take up to six days to reach a new equihbrium on this new dose and, therefOre, patients should wear the new higher dose through two

TATE FORM DZ11M

Additionally, transcribers and Medication Safety Nurses (MSN) remain in place to assist with order transcription. Two RNs check all orders and transcription. Additional clarification of ambiguous or incomplete orders a also provided by the pharmacy staff upon review of the scanned order, as neussaey. In addition, a multidisciplinary Tramcription Clarification and Standardization Wor.kgroup (composed of Pharmacy, Nursing and Medical Staff representation) was formed on 10/4/07 to standardize transcription throughout the inpatient units. The Nursing Education Department has developed a Transcription Training Competency. All nurses are required to midergo r~ucation of transcription guidelines in conjunction with the a.MAR implementation on their units.

Monito.rin1: Toensureaccuracy ol'the- -MARs matching the MD orders, effective August of2007, UCSF Medical Center is auditing and reconciling approximately 230 MARs/MPRs weekly. Audit results are reviewed by Pharmacy and the Patient Care Managers. Direct feedback: is provided to staff and opportunities for improvement are identified. Audit results are reviewed on a monthly basis at the Medication Safety Committee, Nursing Performance Improvement Exeeutivc Committee (NPIEC), and on a quarterly schedule at the Quality Improvement Executive Committee (QIEC), until the aMar is implemented. Once the aMar is implemented the staffing and monitoring plan will be reviewed and revised as needed.

Responsible Party: ChiefNursing Officer, Chief Medical Officer, Director of Pharmacy

HJ6K11 r aintlnuallon 1111• 15 Pl 11

-_ ___;;,_

'.;alitoml

ff AJEMENT OF DEFICIENCIES \ND PLAN OF CORRECTION

(X1) PROVIDER/SUPPUER/CL~ IDEMTJFICAnON NUMBER:

CA220000031

(X2)MULTIPLECONSTRUCTION

A.BUILDING B. WING _______ _

PRINTED: 11/14fl007 FORM APPROVED

(X3) °"TE SUR'llE't' COMP\.ETED

09/24/2007 o&AME OF PROYIOER OR SUPPUER

JCSF Ml:DICAL CENTER

STREET ADDRESS, crrv, STATE, ZIP CODE

505 PARNASSUS AVe. SAN FRANCISCO, CA 94143

{X~)ID PREFIX

TAG

SUMMARY STATI;MENT OF O!J'K:IENCICS {EACH OEFlClENCV MUST Bf; PRECEDS> F1Y P'UU.

REGtJLAJORY DR LSC IOOOlFYING INFQfWATION)


appUc:ations (of 72 hours each) before any further lncr~e In dosage via the patch was made.

During an Interview of S~ff Member 1 In the Mt. Zlon campus pharmacy on September 16, 2007, he could provide no evkl~noe that supported deviation from the titre.lion schedule as docum~nted 'rij the manufacturer In the product li;ibellng or that pharmacy staff had questioned the close increase as ordered. ·

·3. On September 22, 2007 at 11:47 a.m., review of Patient 3 ~ s oJlnical record at th~ Ml Zion

, Campus rev~ultAdmitlTransfer Orders dated....-2007 docWTiented

! that Patte.nt 3 had no krtown allergies. The ollnlcal record contained two pre-printud ordan;

: for pa ent cpnttol ed iilnalgea a : a ows. it ! patient to self administer.pain medteatfon Within I physic~~ establisbed pa er

nursing mpnitorln dated 7:10 a.m. and t 12:25 a.m. respectively·. Physician 2 had signed the second set of PCA Qfders. Both pre-prtntad PCA order sets also had a space in which any allergies a patient had could b& added ~y tile prescribing physician. The p~ribing physician had written " NKOA " (no known drug allergies) In the etlergy space on both PCA orders sets. Both PCA orders sets pre-printed orders for ondansetron (Zofran: t.tsed to treat naus~y to be given Intravenously everi 6 hours as ne'eded for ni;lusea. Because the orders had been checked on both order sets, the phyalcian had indicated that the patlent was to receive this drug as needed to control any nausea the atlent may have while on PCA On 007 at 1:25 p.m. PhyslcltVl 1 discon (from the first order set). On 2007, at 9:05 a.m., Physician 1 discontinued

.ATE FORM 11:111'1

ID PREFIX

TAG

A334

PROVE>EfrS PLAN OF CORREClJON (EACH CORREC'TIYE ACTION SOOULD BE

CROSS.REFERENCEt> TO THE APPROPR~TE i>EFICIEHCV)

(X5) co~ ~TE

Corrective Action (A 33+2): Beginning the evening of September 20, 2007, the Worx station system instructions have included a flag on any fentanyl patch dose increase that occurs more frequently than every 3 days after the initial dose or more frequently than every 6 days thereafter, as recommended by the product insert. The flag prompts the pharmacist to contact the ordering physician to confer and discuss treatment alternatives. Physicians were informed by email on September 20, 2007 that fentanyl patch increases more frequent than those recommended on the product insert will result in a consult.ation with a pharmacist.

On 9!20/07, a one time review of all fentanyl patch orders was conducted by a ~L OQ 9/20/07, physicians· were Informed bY email that fentanyl patch -- ~increases more frequent than those recommended on the product insert would result in a flag by the pharmacy.

Monitoring: All fentanyl patch dose increMes are reviewed by a pharmacist for

, compliance with ma.riuf.acturer recommendations.

Responsible Party: Director of Pharmacy

Corrective Action (A 334-3): On September 22, 2007, UCSF Medical Center conducted a 100% review of each patient's orders to ascertain the allergy status of each patient at Moffitt/Long and Mount Zion campus. Nursing checked the MAR, armband and allergy sticker on the front of the chart to ensure confonnance to policy. Any discrepancies identified were clarified with the physician, as appropriate, and documented according to policy.

9/20/07

9/Zl101

HJ6K11 w·conun1111Uon 1 7or11

l -- L-

:alifomia Deoartment of Pub lie Health

TATBllEHl OF DEFICIENCIES ND PLAN OF CORRECTION

(X1) PROVIDERISUPPUER/CUA JOENTIFICATION NUMBER:

CA2.20000031

(X2) MUl TIPLE. CONSTRUCTION

A. BUILOING . B. WINCJ _______ _

PRINTED: 11/14flOD7 FORM·APPROVEO


'09/2412007 IAME OF PROVIDER OR SUPPLIER

,CSF MEDICAL CENTER

S'TREET ADDRESS, CITY, STATE. ZIP CODE

505 PARNA$SUS AVE SAN FRANCISCO, CA 94143

()(4) 10 PREFIX

TAG

SUWARY STATI:MENT OF OEflCIENCIES (E>Di DEFICIENCY MUST BE PRECEDED BY FUU

REGULATORY OR l.SC IDElfl!FYING INFORMATION)

A 3~ Continued From Page 7

Zofran again {from the second order set) with instructions to· "·see ACS " (antibiotic order sheet). Review of the antibiotic order sheet . revealed that it too had a space In which the patient ' s allergies, if any, co1,11d be filled In and Zofran had been filled In the space.

Review of the medication administration record (MAR: used to docUment the date and time .a dose of medication was administered to a resk!lenJ and th~ identity of the person administering the dose) revealed that this patient ~mg dose of ondansetron on ~007 at 7 p.m. All the MARs had a space in which the patient ' s allergies, if any, CQUld be written. All the MARs In Patient 3 ' s clinical record had ~ ondansetren " written In on •i..1ft " A 11""cQi~. Other clinical .records had beer.i noted dur1ng the survey that ha<;J red bordered all~rgy s11ckel'S on the front oover of the cJlnloal record on which staff had written In the allergles for those patients but Patient 3 ' s clinical reoord had no sueh stleker on the cover.

During an interview of Patient 3 on September 22, 2007 at 12:4.5 p.m. In her room, she stated that one night she felt nauseated and r11quested

-

received one dose on. as documented above). Soon

g g , e felt numbn.ess In her feet that over a period ·of 15 to 20 minutes moved up her body until ner whole body including her face was involved. She also reported that she had difficulty breathing and that her fingers felt stiff. She reported that she had had the same . reaction. only more severe, during a car trip a couple of months prior to hM hospitalization. She stated she had that reaction after consuming two cans of a commercially available beverage, however she consumed the beverages at about 11 a.m: and later in the

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PROVIDER'S PLAN OF CORRECTION ·(EACH CORRECTM ACTIOtil SHOUl.O BE

· CROS$REFERl!NCEO TO THE Af'PROPR!AlC ~CV)

By 0800 September 23, 2007 nursing provided to pharmacy a list of all patients with allergies. On September 23, 2007 phannacy updated the pharmacy profile for patients with allergies as needed. Beginning September 24, 2007, nursing and physician staff were reeducated to policy and procedure related to allergies.

The Adverse Drug Reaction (ADR) Jderllificatlon, Reporting and Documentation Policy, (6.09.01) (see Attachment 1), was revised and approved by

(X5l COMPl.ETE

DAlC

11114101 I

the P&T Committee on 11/14/07. The policy stipulates that ADR.s requiring specific intervention, increased monitoring, which are potentially life~threatening or cause permanent damage or that are associated with 11 medication that should not be re-adminlstercd are treated in the same manner

· - - -- ' -as allergies (Policy 6.07.18 Allergy. - ~ - - ._ - - ,_I

Identification and DocumentationXsoe Attachment 2). This requires docwnentation I in the medical record through 11 physician order which is scanned to pharmacy so that the information is entered into the pharmacy system and the patient's pharmacy profile. Concomitant allergy alerts are implemented (alert sticker on the chart, allergy armband, MARJflowsheet notations). The policy also stipulates 11 newly created ADR hotline with the aim t-0 increase the reporting of ADR.s by staff. Nurses, physicians and pharmacists were educated regarding the policy changes beginning 11/16/07.

Monitoring: Beginning September 22, 2007, pro.per documentation of allergies and ADRs, as described above, was monitored by UCSF Medical Center for a period of seven weeks. On 9/2'lJ07, Medication Safety NID'Ses performed a 100% review of all

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~alifornlrt Oenartment of Public H1talth

:TATCMENT OF DEflCISICIES .NO PLAN OF CORRECTION

(X1) PROVIDERISUPPllERICLIA IDEHTIFlCATIOl!I NUMBER:

CAZ20000031


A. BUii.DiNG B. WING _ _______ _



09/2412007 w.IE OF PRoYIDER OR SUPPUER

JCSF MEDICAL C&NTER

STREil ADDRESS, ClTY, $T,t.TE, 2lP CODE


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TAG

~ STATBENT OF DEFICIEtclES (EACH DEFICIENcY MUST BE PRECEDED B'I' FULL

REGULATORY OR L.SC ID&NTIFYING INFORMATION)

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afternoon but did not have the reaction unti about 8 that evening. She had an allergy alert bracelet on her arm nsting ondansetron as a medication to which she was allergic and she reported this band had been put on her arm the day after the reaction:

On September22, 2007, at 1:15 p.m. during an interviey1 of Physician 1 on Mt. Zion Ca.mpus, he stated that he wrote '-llE. · · ntinue

-

. bcrtli and 2G07. He stated tha he had

been ca 8d beOause the resident had coniplalned of rig,ors (shaklng). Hs ws-s not sure if the patient had hed an ac:tvme reaction to ondansetron but after dlsous~ing the Issue with the nursing staff, he decided to call this an • allArnlr )I ~on. He stated that it would be prudent after a patlent has h&d a reacition soon-

, after getting a drug to dlsccntlnue It and to prevent the patient from getting fl again unless

1 the need was 60 gr~t that a tes1 dose would be I attempted to see if th~ p&"J!nl might tolB1ate the medication In qllllnotlfled by the nursing staff on 007 that ondansetron ha~ een prescn ed to the patient with a documented allergy to the medication (this was documented on the MARs) and requested that he discontinue tha medication which he aid. He stated that he depended on the presence of an allergy sticker on the front of the clinical record as well as a review of the Adult Admit/Transfer Orders to detennine a patient ' s allergy status. As lhls adverse reaction occurred after admission, caregivers would have to depend on an " allergy " sticker placed on the cover of this patient ' s cllnlcal reeord with the offending medication filled In as the first li~e of prevention for the receipt of this medication.

Review of Patient 3 ' s computerized medication I

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PROVIDERS Pl.AN Of CORREC'OON (EACH CORRECTl\IE ACTION BHPU1.D BE

CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY)

patients with documented allergies to ensure confonnance to policy. All patients with known allergies and/or serious ADRs were reviewed for proper documentation in the medical record, MAR and preSen.ce of an allergy armband. Review showed an increase in compliance from a baseline of 94% up to 99% with each alert element of the policy.

Responsible Party: Director of Pharmacy and the ChiefNursing Officer

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DATE

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~allfomia Deoa ent of PubJlc Ith

·TA'l"EMENT OF DEFICIENCIES .ND PLAN OF CORRECTION

IAME OF PROVIDER OR SUPPLIER

JCSF MEDICAL CENTER

[X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

CA220000031


A BUILDING B. 'MNG _______ _

STREET ADDRESS, CITY, STATE, ZIP CODE

605 PARNASSUS AVE SAN FRANCISCO. CA M143



. 09/2412007

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A 334 Continued From Page 9 .A 334 I . ! profile in the Ml Zion Campus phannacy reveal~ that Zofran was dsted a5 an allergy. When asked when it had been entered into the proflle data base, Staff Member 3 determined that ondansetro~tered Into the allergy field on~007, sewn days after the orlginal incident and six days after

ad been discontinued on 007.

On September 22. 2007 at 2:56 p.m. review of the policy and ~dure entitled Allergy lc.tentificatlon revealed It stipulated that if allergies are identified during the COUT39 of a patient ' s hospital stay, the physician wm document the allergy on the physician order sheet which wl!I

I. then be processed and sent. to the pnarmecy and other departments as necessary. It documented

I that nursing staff ware to aff'iic an allergy . on the clinical record rover and note the allergies . I on the sticker. On September 22; 2007at12:33 p.m. during an lnteivlew of et;aff Member 4 on Ml Zion Campus, she slated there should have been an allergy sticker on the cover of PatJent 3 ' s clinical .record (noting ondansetron as an • allergy " } and It was, In fact, not there. Other staff members who were present at the time of the lnteivfew of Staff Member 4 all agreed that while the reaction was not an allergic reaction (mediated by antibodies produced by the body after exposure to a foreign substance) it should be noted In el.lerny fields in and on the clinical record (and by extension, in the computerized pharmacy patient profile) In order to alert physician and other staff members that the patient had had such a reaction In the past

No evidence was provided that the Physician 1 had filled In this adverse reaction In the physician order sheet or that the pharmacy had been notified of this adverse reaction (until seven days

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HJ6K11 If tonllnwlion slltlel 10 of 11

;afifOmfa Deoertment of Pub le Health

TATEMENTOF DEFICIENCIES ND Pl.AN OF CORRECTION

(X1) PROVIDERISUPPL.IEWOL1A IDENllFICA'rlON NUMBER:

CA220000031

(X2) IAUL TIPLE CONSTRUCTION

A. BUILDING B. WING _______ _

PRINTED: 1111412007 FORM APPROVED

(X3) DATE SUAVEY COMPLETED

09/2412007 IME OF PROVIDER OR stJPPLrt:R

JCSF MEDICAL CENTER

STREET ADDRESS, Cl"TY, STA~. ZIP CODE

SG5 PARNASSUS AVE SAN FAANCISCO, CA 94143

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SUAAIARY STATEMEI« OF DEACIEHCIES (EACH DEFICIENCY MUST BE PRECEDEO BY fULL

REGULATORY Of!: lSC IDENTIFYING INFORMATioH)

A334 Continued From Page 10

after the index reaction) as required by the hospital policy and procedure. No allergy sticker had been placed on the cover Qf the cNnical record at the time of the reaction which could have ·subsequently alerted Physician 2 about the " allergy " so that he could nave taken that Into

11 consideration wtr~ pre-printed

. PCA order set on 007 when he ordered ondan-setron or a ent for a second time.

The violations have caused or are likely to cause serious Injury or death to the patients.

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