(X2) MUL TIPL£ CONSTRUCTI3t L COMPLETED l&COMSION

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVlDER/SUPPLIERICLIA IDENTIFICATION NUMBER:

CA DEPT OF PUBUC HEALTH

(X2) MUL TIPL£ CONSTRUCTI3t tJ L f l UI£ (X3) DATE SURVEY

COMPLETED

A. BUILDING

050454 B. WING l&COMSION ..... ,l

06/~0/2011

NAME OF PROVIDER OR SUPPLIER

UCSF MEDICAL CENTER

STREI'T ADDRESS, CITY, STATE, ZIP CODE

505 Pamassus Ave, San Francisco, Ca 94143-2204 SAN FRANCISCO COUNTY

(X4) 1D PREFIX

TAG

LA

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEOED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

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

Complaint Intake Number: CA002731 12 - Substantiated

Representing the Department of Public Health: Surveyor ID # 26616, HFEN

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

Health and Safety Code Section 1279.1(b)(1)(0) Retention of foreign object in a patient (b) For purposes of this section, "adverse event" includes any of the following: (1) Surgical events, Including the following: (D) Retention of a foreign object in a patient after surgery or other procedure, excluding objects Intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained.

T22 DIV5 CH1 ART3 - 70223(b)(2) (b) A committee of the medical staff shall -be a;5signed responsibility for: (2) Development, maintenance and implementation

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS· REFE~ENCED TO THE APPROPRIATE DEFICIENCY)

Tbe UCSF Medical Center Patient Sal:ety Committe·e (PSc) ·

conducted a comprehensive, multidisciplinary review of the event that occurred on June 9, 2011, referenced in the findings. F~llowing review of the event, the PSC dev~loped and directed an action plan to be i~lemented in periope rative s~r.vice sites (Parnassus/ Moffitt .Long OR, Parn.assus ASC, Mount Zion ~R, Orthopedic Institute, and Labor and Deli very) . At the direction of PSC, the Direc~or of Perioperative Seryices implemented improved education, communication, auditing and monitoring ~easure~ to better

I addre.ss consistent .application I of the surgical sponge count

policy and proeedu~e in t he department and reported on the status of these adtivities to

PSC on June 22, 2?11 and again

j on -July 20, 2 011. . Additionallr, beginn~ng october 4, 2011, the Director of Perioperative Services provided monthly status reports regarding continued

21612012 4:50:48PM

PRESENTAfl.~'S SIGNATURE 1?. j.)rr.e~

An d clency statement ending with an asterisk (•) den es a deficiency which the institution may be excused from correctin9 providing Ills determined ·

that other safeguards provide sufficient protection to the patients. Except for nursing homes, the findings above are dlsclosable 90 days following the date

of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plarts of correction are dlsclosable 14 days following

the date these documents are made available to the facility. If deficiencle$ are cited, an approved plan of correction Is requisite to continued program

participation.

State-2567

I

(XS) COMPLETE

DATE

6/15/li

! 6/;22/11

7/20/11 ongoing 10/4/11

1 of 16

CALIFORNIA HEAL 11-t AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH


()(1) PROVIDERISUPPUERICLIA IDENTFICATION NUMBER:

050454

(X2) MULTIPLE CONSTRUCTION

A. BUILI>ING

B,WING

STREET ADDRESS. CrTY, STAT!:. ZIP CODE

()(3) DATE SURVEY COMPLETED

06/3012011


UCSF MEDICAL CENTER 505 PARNASSUS AVENUE, SAN FRANCISCO, CA 94143 SAN FRANCISCO COUNTY

(X4)10 PREFIX

TAG

SUI.!IMRV STATEMENT OF DEFICIENCIES (EACH DEF1CIENCY MUST BE PRE((EEDEO BY FUll REGUlATORY OR LSC IDENTIFYING lNFORW.TlON)

Continued From page 1

of written policies and procedures in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be app_roved by the administration and medical staff where such is appropriate.

These regulations were not met as evidenced by:

Based on interview and record review, the hospital falled to ensure that its surgical services were delivered using acceptable standards of practice, maintaining compliance with applicable regulations and guidelines governing surgical services, when two operating room nurses failed to perform a sponge count according to the facility's policy. This failure directly resulted In the retention of a laparotomy sponge in the abdominal cavity of Patient 1, who had to undergo a second surgery and anesthetic to remove it.

• RN 2 documented the counts as correct on the electronic record before all the sponges had been reconciled with the scanner. • They ignored the request of ORT 1 to reconcile a sponge count discrepancy, a fact he announced •more than once". • They neglected to call for additional assistance from the charge nurse during a disputed sponge counl • RN 2 failed to scan out the laps from the ring stand and place them in the counter bags. Instead, she ''visuaily"counted them directly from the ring stand and delayed scanning them while she counted instruments.

Event ID:V65C11 1/12/2012

ID PREAX

TAG

PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE AcnON SHOULD BE CllOS$

REFERENCEO TO TilE APPAOPiliATE OEflCIENCYl

implementation of the action p l an and monitoring and auditing activities to Quali~y Improvement Executive Committee (QIEC) for additional review and oversight, to continue unti l the QIEC determines an alternative reporting period for such matters. The PSC report s to QIEC. QI EC reports to the Executive Medical Board (EMB ) which in turn reports to the Governance Advisory Council (GAC) , the designated Governing Body.

Regarding RN 1 and RN 2, they were interviewed, delivered a notice of intent t o terminate,

and termina ted for noncompliance with the surgical sponge count policy and procedure.

On June 14 , 201~, the Obstetrics, Gynecology , a nd Reproductive Sciences Department's Mortality and Morbidity Commit t ee reviewed and discussed the incident.

2:20:54PM

lABORATORY DIRECTOR'S OR PROVIOERISUPPI. IER REPRESENTATIVE'S SIGNATURE TITLE

Any dellclency atalemenl ending wllh an asleri&k (') doootu a deliciency which the institution may be excused from cone<:1lng providing it ia delerrnlned

thal olher safeguards provide SUffiCfenl protec1lon to the patients. Except for nursing homes. lhe findings ~~f..Of" Jli.!f!DH~IFf'\? 1P' [£!~~ 'qltJate ot aurvey wholher 0( not a plan of correction Is prov1ded. For nursing homes, lhe above findings ar{d'.n\~c\!9f'aif ~~ f.il !feP\ooY..\ng

tho date lheso documenls are made avaHabfe to lhe facility. If detlclenc:ies are clled, an appro110d ~~ ~ correcti011 is requisile lo CXlnlinued program

particlpaUon.

Slale-2567 +-if E-HB--16---·tffit,_ __

L&C DIVISION SAN FRANCISCO

(X5)

COMPlffE OAI"E

6/17/11

7/13/ 11

8/18 / 11

8 / 22/ 11

6/14/11

(XG) DATE

2of 16


STATEMENT OF DEFICIENCIES liND PlAN OF CORRECT10N

()(1) PROVIOERISUPPUERICLIA IDENTIFICATION NUMBER:

050454


A. BUILOING

B. W1NG

(X3) DATE SURVEY COMPI.ETEO

06/30/2011

NAME OF PROVIDER OR SUPPUER

UCSF MEDICAL CENTER

STREET 1\00RESS, Cll'Y, STATE, ZIP CODE

505 PARNASSUS AVENUE, SAN FRANCISCO, CA 94143 SAN FRANCISCO COUNTY

()(4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDEO BY FUI.l REGULATORY OR LSC IDENTIFYING INFORMATION)

ID PREfiX

TAG

PROVIDER'S PLAN OF CORRECTION (EAC~t CORRECTIVE 1\CTION SHOULD BE CROS5-REfEJlENCED TO THE APPROPRII\ TE DEFICIENCY)

(XS)

COMPLETF. OJ\TE


• They failed to maintain the sterility of the field and the room before conflrmatlon that tlie wound was clear of sponges. They knew a lap sponge was missing, and assumed it "had to be in the trash". ·

Beginning June 15, 2011, a forma 6115111

retraining of perioperative

* They failed to notify the surgeon that a sponge could not be found. She had no knowledge that the count was In dispute and had no reason to do a manual sweep of the operative site before the skin was closed. * RN 1 failed to call for a STAT x-ray to rule out foreign body retention.

Findings:

Patient 1 was an 85 year old admitted to the medical center on - 1 with advanced stage high-grade ovarian cancer who underwent an exploratory laparotomy (abdominal operation), tumor debulking (removal a part) including supracervical hysterectomy( removal of uterus), transverse colectomy (excision of colon) and omentectomy on the same day. On - 11, after Patient 1 had been stabilized In the ICU, she was returned to the operating room on - 11 to remove a retained laparotomy sponge, discovered by the surgeon between the edge of her liver and right diaphragm. A 6/28/11 review of the patient's

11 Intraoperative record indicated that the final counts were "correctn.

In the afternoon of 6/29111, a series of interviews were conducted at the MZ campus with staff involved In the first case (surgery) on - 11 , when the laparotomy sponge (18" x 18") had been retained.

'EveniiD:V65C11 1/1l'J2012

LABORATORY DIRECTOR'S OR PROVIOERISUPPUER REPRESENTATIVE'S SIGNATURE

nursing and operating room surgical technologist staff regarding the surgical sponge count competency was implemented in intensive, individual or smal group (3- 4 staff members) sessions, with each session requiring ·G0-90 minutes of detailed interactive education. The purpose of such sessions was to permit the evaluator to revie and assess each individual's competency with the surgical sponge count policy and procedure , identify any individual deficiencies unique t the staff member, and permit

immediate corrective action for each staff member, as needed. The detailed and intensive interactive surgical sponge coun

competency assessments enabled UCSF Medical Center to implement a process to assess and establis system-wide adherence within the perioperative department staff t the surgical sponge count policy and procedure . By September 1,

2011, all active perioperative department nursing and operating

2:20:54PM

TITI.E

Any deficiency stalemenl ending will! an aslerisk (•) dunolea a defiCiency whiclllho lnslilution may be exoused from corrocllng provldJng It is determined tnal olher safeguards provide sufficlenl protection 1o 1/le patients. Except for nun~ing homes. lhe fondlngs abo\ICI arc disclosable 90 days follOwing lhe dale of survey whelher or not a plan of COITecllon Is provided. For nursing homes, the above rmdlngs and plans of com!CUon are disclosable 14 day1 fallowing

:ert~:==e documents are mado available to lho faclily. If deficiencies are cited, an approYe<l plan of corrC1\0E'f''f,.~CJrJae"ft t..nLl jj

9/1/11

(X6)0ATE

- - --·- .. ·--- -Stalo-25&7

FEB 6 2012 3 ol16



(X1) PROVIOER/SUPPLIER/CLIA IOENTIFICA TIOH NUMBER: .

050454

(X2) MULTIPLE COI'IS1'l1UCTIOH

/\. BUILDING

B. WING

(X3) OA rE: SURVGY COMPLETED

06/30/2011


UCSF MEDICAL CENTER

SlREET ADDRESS, CllY, STATE, ZIP COOE


()(4) 10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY t.IUST BE PRECEEOEO BY FULL REGUlATORY OR LSC IDEHTIFYlNG INFORMATION)


10 PREFIX

TAG

PROVIOER'S PlAN OF CORRECTlON (EACH CORRI!CTIVE ACllON SHOUlD UE CROSS· REFEliENCED TOniE APPROPRIATE DefiCIENCY)

r oom surgical t e chnologist s ta ff r eceived surgical sponge count

(X5)

COMf'L!Ol E DATE

At 12:05 p.m. RN 3 said she was woli<ing the 11 a.m. to 9 p.m. shift on that day. She brought Patient 1 to the operating room from the pre-op unil "RN 4 (Cha1'9e Nurse) was helping set up the room and doing the (initial counts) until I got into the room (to resume the lunch · break for RN 1 ). I stayed until the permanent people returned. I left at 1:15 p.m. The patient was still not asleep when I left".

competenc y review. For s t a ff on Ongoing leave of absence and new hires, each staff member receives a s urgical sponge count competency training and assessment following r eturn _to work or prior to beginning work as a new employee. Formal assessment of ongoing sur gical sponge count competencies is now included as part of the annua l competency review of per i operative department staff .

On 6129/11 at 12:40 p.m. the - 11 RN 4 told surveyors that he had also worked the 11 a.m. to 9 p.m. shift that day. He said he was helping during a 30 minute lunch break for RN 1, who was the circulating nurse on the case. "The patient was not in the room yet. I got the room set up, did the Initial count (instruments, sponges, and needles) with Operating Room Technician 1 (ORT 1). I scanned in all the sponges with ORT 1. When I left, the patient was still not In the room•.

As part of the PSC r eview and 6/15/ 11

On the same day at 12:48 p.m. RN 2 was interviewed. She told surveyors she was out in the substerile room gathering supplies for another case when she met RN 1 who looked tired, and asked her if she had lime to give her a 15 minute afternoon break. She checked with the charge nurse (RN 4) and went into the room to give RN 1 a break. "They were just about to start the first count; they were closing the peritoneum. We counted the Bookwalter retractor pieces (a large self retaining abdominal retractor which Is attached to the OR table by the surgeon and the circulating nurse). Some of the sponges were in the (sponge counter)

EventiD:V65C11 1/1212012

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

action plan1 6 key r eminders were i dentified to be s t ressed with ~erioperative nursing and operating room s urgical

technologist s taff f or increased awareness and retention of t he surgical sponge count policy and procedure. Colle c t ively, t he 6

key element s were referred to as apause for the Gauze Reminders " and distributed t o peri operative nursing and operating room sur gical t echnologi st staff as a handout or l anyard card to be a t t ached to i den t ification badges for purposes of conti nuing

2:20:54PM

TITLE

A ny deficiency statement ending with an asterisk (' ) do notes a deficiency which tho instl tu6on may be excused from correcting providing Ills determined

that other safeguards provide aufflclent protection to the patients. Except for. nursing homes, the rmdings ebov~aro dis o~'IJI: iQflMt'~i"W~I!!.IM111J!H of survey whether or not a plan of cormclion is provided. For nursing homes. the llbove Rndlngs and plarfS\:A• a~~U\wyfl~'"d the date these docwnenis ant made avaaable to the faclity. If dellclencies are ciled. an apprwed plan oh!J~ Is requlslle lo conllnued program

par1icipation.

(X6) DATE

Stale-2567 - - F E-w-B _...,6·- 2H-h0lt,.__ _ _ ---·

~ ol 16

L&C DIVISION SAN FHANCISCO

CALIFORNIA HEAl,.. TH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

srAlEMEHT OF OEJ'ICIENCIES AND PLAN OF CORRECTION

~l)PRO~~S~~~~

fDEmlFICAllON NUMBER:

050454

(X2) MUlTIPLE CONsTRUCTION

A. BUILDING

B. WING

~3) 0/ITE SUllVEY COMPlETED

06/30/201 1


UCSF ri!EOICAL CENTER

STREET 1\0DRESS. CITY, STIITE. ZIP COOE


(X4)1D

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEJ:lEO OY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)


bags and about 5 or 6 were still in the ring stand".

ID PREFIX

TAG

PROVIDI!Il'S PIAN OF CORRECTION (EJ\Cii CORREC1 IVE IICTION SHOULD BF. CROSS·

REFERENCED TO THE APPHOPRIATE DEFICIENCY)

education and' retention of critical points in the surgical sponge count policy and

JX 5) COMPLETE

011'1'1:

RN 2 further stated "I grabbed them in my hand, they were very wet, and counted manually with ORT 2 so he could see them. I'm not sure if he saw what was in the ring stand. I dropped them in the bucket so he could see them. ORT 2 counted what he had on the field and the back table. I didn't scan them at that time. Too much time. They were still closing. I put them back in the bags to scan later. I finished counting the small items, needles, instruments. Very busy case, a Jot of changes. At the end of the instrument count, ORT 1 returned from his break and counted a 12 item GYN specialty sel ORT 2 was now leaving. The surgeons were finishing closing. lhey were putting in the (skin) staples. We counted sponges, needles and the small items {e.g. Bovie tips, knife blades, etc.) The policy says there should only be 2 sponges (one wet and one dry) left at the end of the case for patient cleanup, but thafs not the reality . There were at least 10 sponges left on the field".

procedure. By July 22, 2011 , all 7/22/1

active operating room registered nursing staff confirmed review and receipt of the "Pause for th Gauze Reminders" in wri ting. Fo operating r oom registered nursin staff on leave of absence, each staff member receives the "Pause for t he Gauze Remi nders '' handout or lanyard a nd confirms review and receipt in writing prior to scheduled operat ing room case assignment . As part of the new Ongoing

hire orientation for operating room registered nurs ing staff, each new hire receives the "Paus

for the Gauze Reminders" handout or lanyard and wil l confirm review and receipt in writing. "RN 1 came back from her break. I (RN 2) told her

everything was ok as far as the manual count, but we still hadn't scanned the sponges on the field. The surgeons were taking lhe drapes off. ORT 1 scanned the sponges on the field. He armounced, "I'm missing a sponge".

For operating room surgical Ongoing

"RN 1 and I (RN 2) searched everywhere. It was 'fuzzy' as far as the time Physician 1 left the room to talk to the family. The resident and the fellow were stapling. I was comfortable that we actually had seen all the sponges. The anesthesia attending

Event ID:V65C11 1/12/2012

lABORATORY DIRECTOR'S OR PROVIDER/SUPPUER REPRESENTATIVE'S SIGNATURE

technologist staff on leave and

new hires, each staff member wil receive the "Pause for the Gauze Reminders" handout or lanyard fo purposes of continuing education and retention of the surgical sponge count pOlicy and procedurE following return to work

2:20:54PM

TITLE

Any defiCiency statomenl ending wilh an aalorlsk (") deootO$ a doficlency which !he Institution may be excused from correctlno providing ills determined

thai olher safeguards provide sufficient protection to the patients. Except lor nursing homes, the llndlnga above are disclosable 90 days following the date

of J;urvey whclher> or nola plan of cOITection Ia provldo<f. For nursing homes, the abovo findinQ$ and plana or c:orrecUon are dlsdosable. l'-'d,y~. · 1 the date these documents are made available to the rae~lay. u dellclencies are cllad. an approved plan e~EPlneF~UQl~ ~~ n participation. n

(X6) DATE

- ---- - - --- - - - - - --·------ -------- - - ··-- ---·-- - - - - - ·· --State-2567

FEB 6 2012

L&C DIVISION SAN FHANCISCO

5 ol16

CALIFORNIA HEAllli AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAL 1li

STATEMENT OF DEFICIENCIES ANO PLAN OF CORRECTION

(X1) PROVIOER/SUPPUERICLIII IDENTIFICATION NUMBER:

(X2) MUI.TIPLE CONSTRUCTION \)(3) DATE SURVE'I' COMPLE'J'EO

050454

II. BUILDING

B. WING 06/30/2011

STREET I\OORESS. crrv, STATE, ZIP COOE NAME Of PROVIDER OR SUPPLIER

UCSF ME,DICAL CENTER 505 PARNASSUS AVENUE, SAN FRANCISCO, CA 94143 SAN FRANCISCO COUNTY

(X4) 10 PREFIX

TAG

SUM,..ARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST B€ PRECEEDED BY FUU REGULATORY OR LSC IDENTIFYING INFORMATION)


who came in to help the anesthesia provider doing the case asked, 'What do we have to do (regarding the missing sponge)?' I told RN 1 to take care of that I went through all the bags, and wasn't privy to what went on between them (anesthesia and RN 1). All of a sudden, we're on our way to ICU. The patient wasn't crashing, but she was hemodynamically unstable":

RN 2 told surveyors that apparently there ware 2 sponges packed behind the liver that she was unaware of. "They took one out. RN 1 wrote it on the white board but didn't tell me about it. An x-ray was done in ICU which was negative, but we continued to look everywhere in the room. We thought the likelihood of a sponge being in there (the patient) was so small". Surveyors asked RN 2 if Physician 1 (surgeon) was the type of surgeon who would be uncooperative with the count process. She answered, ''They were all tired. It was a long case, but I think if at any point we had said something to her about the possibility of a missing sponge, she (Physician 1) would have gone back to check". She added, 'We have been so good, we got too comfortable. We thought, 'it can't be in there (the patient)".

RN 2 said that around 8 p.m., the team searching for the sponge in the empty operating room told Physician 2 that they were unsuccessful in locating 11. Physician 2 (surgical fellow)informed them that the x-ray had been negative. Surveyors asked RN 2 when they notifioo the charge nurse about the missing sponge. She said she wasn't aware of that. She said when RN 4 was finally notified, he called

II)

PREFIX TAG

PROVIDER'S PLAN OF CORRECTION lEACH CORRECTIVE ACTION SHOULD DE CROSS·

REFERENCED TO THE APPROPRIATE DEFICIENCY)

or prior to beginning work as a new employee. On September 29,

2011, t he Director of Perioperative Services distributed additiona l education via email to perioperative nursing and operating room surgical technologis t staff reinforcing the "Pause for the Gauze Remindersn and

r edistributed lanyard cards to all perioperative sites mentioned above.

On June 22, 201L, and June 29 ,

2011, at Mount Zion 'OR and Parnassus/Moffitt Long OR, respectively, staff in-service education sessions were conducted t hat reviewed the

surgical sponge count policy and procedure as well as a detailed discussion of t he incident. The presentation focused on communication techniques and

improvements i n the operating room regarding the surgical sponge count policy and

procedure, the policy points that were not met during the ~ncident that resulted in a retained l ap sponge, and the ~xpectation of . mandatory

· EveniiD:V65C11 1/12/2012 2:20:54PM

\ABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

Any dellclenoy statement ending with an aslcrisk (") denotoa a dof~eiency wl\lcn the institution may be e~'id ~'flttV<:Ji\V~~1~ it is detennined

11\al othor sa1eguards provido oufficienl proteelion to the patients. Except f()( ou~ing homns. \he fildings \!)IPfel,;tf§<fo~ ~ \!JIU l~G~H !;At~ of survey whether or not a plan of correction ia provided. for nursing homes, tho above r10dings and plans of corrocUon are disclosable 14 days r~fiig the data these documents aro made available 10 \he fac~ity . II deflclencioa oro cited. an approved plan of corrucUon Is requisile lo continued program

partjclpaijon.

State-2567

FEB 6 20JL_

l&C DIVISION SAN FRANCISCO

IX5) COMPLETE

DATE

1/29/11

6/2 2 / 11

6/29 /11

(X6) DATE

6of16

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBliC HEAL 1H

STA TEMEHT OF DEFICIENCIES ANO PLAN OF CORRECTION

~1)PROVD~UPPUE~~

IDENTlfiCATION NUMBER:

050454

DQ) MULTIPlE CONSTRUCTION

A. BUILDING

B. WING

{)(3) DATE SUilVEY

COMPLETED

06/30/2011


UCSF MEDICAL CENTER

STREET ADDRESS, CITY, STATE. ZIP CODE


()(4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDED BY FULL REGUlATORY OR LSC IDENTIFYING INFORMATION)


ID PREFIX

TAG

PROVIDER'S PLAN OF COHilECTION (EACH CORRECTIVE AC110N SHOULD BE CROSS


compliance with the surgical

sponge count policy and

procedure .

()(5)

COMPLETE DATE

the Periop Manager and put her on the phone to talk to her about it. Finally, surveyors asked why she hadn't called for some help when she found herself having to deal with the multiple counts and scrub personnel changes on a case she hadn't been in on from the start. She answered, "II felt doable. I felt it was under control at the time." She also added that she was the nurse who charted that the counts were correct, because "the manual counts were correct•.

On June 30, 2011, the incident 6/30/ 11

was revi ewed and discussed at

Following this interview, RN 1 was interviewed at 1:40 p.m. She told surveyors that she took over from RN 3 after she returned from a lunch break at

1:05 p.m. She said RN 4 did the initial count and spoke with the patient When she arrived back in the room the patient was still on a gurney and RN 3 was helping the anesthesia provider with the epidural. She said she just "jumped in there" and took over. She said It was a very busy start, with having to get positioning aids, extra sucl.ion cannisters to handle the patienrs ascites (Ouid in abdomen), blood tubes sent to the lab for blood transfusions, and getting a· headlight on Physidan 1, which was unexpected since "she usually doesn't wear one." She also had to open a number of instrument trays, including 2 bariatric Bookwalter retractors (self retaining abdominal retractor which attaches to the OR table, adjusted by the circulating nurse under the sterile drapes), and had numerous specimens to process. She said the patient was ''bleeding like heck, anesthesia was giving her FFP (fresh frozen plasma) and I was giving ORT 1 len laps at a time."

Event ID:V65C11 1/12/2012


the Anesthesia Resident

Conference, providing education

regarding the rol e and

responsibilities of the

anesthesiologist as part of the

surgical team in the surgical

sponge count policy and

procedure. This educati on

i nc luded communicat ion on t he

imp ortance of supporting the

nurses in the surgical sponge

,count process.

On July 6, 2011 , the incident

was reviewed and discussed at

t he Department of Anesthesi a Qual ity Improvement Conference

wi th anesthesia f acultY, and

residents and included education

regarding the need for

physicians to support the

consistent application of the

surgical sponge count policy and

procedure.

On July 8, 2011, the Medical

Director of Perioperative

Services presented to the

Operating Room Committee

2:20:54PM

llTLE

Any deficiency atetomont ending with on asteli~k (') denotes a defiCiency which the inst"ulion may be excused from correcting providing it is determined that other safeguards provide suflicionl protootion lo the paUenl&. Except tor nursing homes. the tindlno~ above are dlsclosablo 90 days following lhe dale

7/6/11

7/8/11

(X6)0ATE

or surwy whether or not a plan ol oarrucllon is provided·. For nuralng home$, the abovo findings and plana of ~n ~¥\II-' 1t'\1lff'J to'l?"'i'li1EALJH the dele those documents are made available to the facility. If donclencies ate cited, an approved plan of corroc:1icW~fii i> Wii'n~ieU!iijgj~ f I participa6on.

Slato-2567 ·--- - -=-::=-- ·-- ---

FEB 6 2012


7 ol16


STATEMENT OF1lEFICIENCIES AND PLAN OF CORRECTlON

(XI) PROVIOERISUPPUERICliA IDENTIFlCA TION NUMBER:

050454

(X2) MUL TlPLE CONSTRUCTION

A. BUILDING

B. WING

STREET ADDRESS, CITY. STATE, ZJP CODE

()(3) DATE SURVEY COMPlEl UD

06/30/2011


UCSF MEDICAL CENTER 5D5 PARNASSUS AVENUE, SAN FRANCIS90, CA 94143 SAN FRANCISCO COUNTY

(X4)1D

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEOED BY FUll. REGULATORY OR LSC IOENT\FYING INFOR!t'ATION)


She (RN 1 ) said, "I usually initial the sponge ·bags with my initials and the initials of the scrub, but not this time, I was just too busy. At 5 p.m. RN 2 came in the room. I asked her, 'Are you here for my p.m. break?' She sa.id, 'No, but I will find out.' Then ORT 2 came in to relieve ORT 1. He (ORT 2) was already scrubbed in and ORT 1 had just left when RN 2 came in to relieve me. I ·came back from my break at about 5:20p.m. and saw the patient undraped, with the dressing gauze on the abdomen. l helped Physician 2 (surgical fellow) put the Elastoplast on (pressure dressing tape). I saw ORT 1 looking in the trash for a lap sponge. I don'i remember if Physician 1 was in the room at the time. I turned to RN 2 and ORT 1 and said, 'Do both of you swear you visualized your laps?' They told me the counts were fine but we're missing a lap, which is probably in the trash. We really didn't believe it was in the patient''. Surveyors asked RN 1 whether she told anyone about the packed sponges. She answered, "I did write on the board that there were 2 sponges packed under the liver but I didn't tell RN 2 when she relieved me".

Vv'hen surveyors asked RN 1 how the count could be correct if they hadn't all been scanned, she replied, "Only recently has it become policy that the count is only correct when the manual firyal count, the written (on the white board) count and the · electronic (Surglcount scanner) counts are identical. The scanner was a supplemental counting measure until a few months ago". She continued. 'We told Physician 2 and anesthesia (anesthesia care providers) we are supposed to get an x-ray because we are missing a lap sponge, but

Event ID:V65C11 111212012

ID · PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOUlD SE CROSs

REFERENCED TO THE A:PPROPrliA TE DEFICIENCY)

a review of the inc ident, a historical overvi ew and discussion of past issues with retained sponges, the continued need to review and consistently implement the surgical sponge count policy and procedure, and the importance of facil itating and responding to communication regarding additional time for surgical sp?nge counts and any concerns related to surgical sponge count variances. The OR Committee membership i ncludes surgeons from various surgical services and anesthesiologists from the Department of Anesthesia who share the

i nformation with their

respective surgery and anesthesiology colleagues. On July 13, 14, and 20, 2011, thE Director of Risk Management presented education and training regarding the importance of the role of the nurse in the operat ing room and expected

professional accountability for compliance wi t h operating room policies, including, but not limited to, the surgical sponge count policy and procedure. This

2:20:54PM

(X5)

COMPtJ:.TE · · DATE

7/13/11

7/14/11

7/20/11

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

Ally defiCiency slolomont ending wll!l an asterisk (•) denoles o dellclency which the lnsUMion may be excusedl'\lJ\1 ~"''t!!li!!JNf'ReW"''If.llt-ALJH that other safeguards proll1de suHicienl proteelion to the paUonts. Except for nursing homes, the tlridlrigs abov~tlis'~fa!Ae Wldafs W.~lU:i/\ of survey wllel!lor or not a plan of correction Is provided. For nursing homes, the obove findings and plans or correction are dlsclosable 1A days rollowlr>g the dale these documents are made available 1o the racJity. II deficlenciell are cited, an approved plan of correction Is roquulllo lo continued program

participation. FEB 6 2012 - - - ---- --

Slate·2567

l&C DIVISION SAN FRANCISCO

Sol 16

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAL TI-l

STATE.IENT Of OEFICIEHCIES AND PlAH OF CORRECTION

(X1) PROVIOERISU'PUERICU\

DEHTlACATION NUMBER:

050454

(X2)MULTIPI.E CONSTRUCTION

A. BU-.DING

B. WING

0(3) DATE SURVEY

COI.IPL£TED

06/30/2011

NAME Of PROVIDER OR stJPPIJER

UCSF MEDICAL CENTER

STREET ADORESS, CITY, STATE. ZIP CODE


(X~) 10

PREFIX

lAG

SUMMARY STATEMEHT OF DEI'ICIEHCES

(EACH DEFICIENCY MUST BE PRECEEDED BY FlJll REGULA TORY OR LSC IOENT1FY1NG INFOAMATION)


10 PREFOt

TAG

PROVIDER'S PLAN OF CORRECllON (EACH CORrlECTI\IF. ACTION SHOULD BE CROss

REFERENCED TO THE APPHOPRIATE DEFICIENCY)

education was recorded and is available for future training, as needed.

On August 17, 2011, the Anesthesia Department's Mortalit\ and Morbidity Committee r eviewed and discussed t he i ncident.

(XS)

COio!Pl£11.

DA le

B/17/11

we highly doubt it's actually in the patient. They (Physician 2 and anesthesia staff) said, 'What do you want us to do?' They were keeping the patient Intubated, had to call the ICU for a vent (ventilator). I

didn't know who was still looking at U1is point because I was focused on the patient. I was looking at all the possibflities. The room was already contaminated. The sponge can't be in the patient. Thinking the count was correct, and 99% of the time (a missing sponge) is found in the trash, I went with the patient to ICU. It was dose to 6 p.m. when I told Physician 2 they couldn't find the sponge after searching everyWhere. I called x-ray told them we had a possible retained surgical sponge. I left at the end of my shift, because I didn't know what else I could do".

On August 23, 2011, EMB reviewed B/23/11

Physician 2 (surgical fellow) was interviewed next, at 2:55 p.m. on the same afternoon. She told surveyors that the nurses told her that the past two counts were correct. "They didn't specify that the scanner count wasn't done or complete. They said they were looking for a sponge but gave me the impression that they were going to find it in the room·.

and approved reports from PSC discussing the incident, issues identified following review of the incident, and risk reduction strategies.

On September 27, 2011, EMB reviewed and discussed the incident and had a follow-up d iscussion at the October 2011 meeting to review details of the status of implemented educat i on,

communication, monitoring and auditing measures to address consistent compl iance with the surgical sponge count policy and procedure.

9/23/11

10/25/1

The final interview on 6/29/11 was at 3 p.m., with ORT 2. He told surveyors that around 5 p.m. on ~1 . he camo in to Patient 1's room to give a scrub brea~ to ORT 1 for 15-20 minutes. He said, "RN 2 came In after me. ORT 1 didn't mention there were sponges under the liver. He and I counted needles and small supplies, what I could see on the (sterile) field. 5 minutes after I came in we started to close. I told RN 2 we need to start

On Sept ember 29, 2011, the Chief 9/29/11

Event IO:V65C11 1/12/2012

Medical Officer distributed edu~ation to anesthesiology and surgery faculty and residents highlighting the "Pause for the Gauze Reminders,• key elements o the surgical sponge count policy and procedure, the i mportance of

2:20:54PM

lABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTAllVE'S SIGNATURE nn e (X6) DATE

Atrt dcfodoncy statement ending with an asterisk(' ) denotes a deliciency whiclllhe instituclon may be excused from cortOCiing p10vlding it is deierminod

\hal othel salegwml11 ptovide auftlc:leot ptOtec;tion lo the patients. ExcepliOf nursing hom ... the llldings ebow are diados.ble 90 d~ foi~Vfo\'1"\ ~lit j r: A 1 "JH or survey whether or not a plan of oomtclTon Is provided. For nursing homea, the above lindings 1111<1 piMI or correc:(ll'lrA,a~~1·~~ ~~ni:J'\1.. the dolo those documenla are mado avallabla lo tho rac~ity. II clefociencies are cited, an approved plan of correction ~~lrfslm to continued program

partlclpalion.

Stato-2587 FEB 6 2012


9of 18


STATEMENT Of DEFICIENCIES ANO PLAN Of CORRECTION

(X1) PROVIDERISUPPUER/CUA IOENTlFlCATION NUMBER:

(Xi) MU!. TIPLE CONSTRUCTION (X3) OATESURVSY COMPLETED

050454

A. BUlLDING

fl. WING 06/3012011

STREET ADDRESS. CITY, STArE, 2!P CODE NAME Of PROVIDER OR SUPPLIER


(X4) 10 PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)


ID PREFIX

TAG

PROIIIOER'S PlAN OF CORRECTION (EACH CORRECTIVE AcnON SHOUlD BE CROSS·

REFERENCED TO THE Al'PROPRIATE DEFICIENCY)

facil itating and responding to

surgical sponge count concerns,

and the need t o allow sufficient

time f or perioperative staff to

complete surgical sponge counts

in accordance with the policy

and procedure.

(X5) COMPt£11:

DATE

counting. We were getting the laps out (of the abdomen), and I threw them in the kick bucket and started the first count, starting with the field, the Mayo stand, and then the back table. RN 2 showed me the sponges, hung on the side of the ring stand. 1 was able to count (lap) sponges, needles, small things. I didn't count the last instrument set (12 pieces). ORT 1 came back in the room. I assume he counted it with RN 2. I know there were still sponges to count. They (physicians) continued to close. I wasn't there for the final count. but when I left we were not scanning anything in."

On September 29, 2011, UCSF 9/29/11

ORT 1 was Interviewed the following morning, 6/30/11 at 2:35 p.m. He told surveyors that he was the main scrub for Patient 1's case. "Around 4:45 p.m. ORT 2 came in and relieved me for an afternoon break. They were st1 11 working. The abdomen was open, and self retaining retractors still In place. I wasn't anticipating closing for about another hour. I came back from my break around 5 p.m. and I was surprised because they were starting to close. ORT 2 and RN 2 were doing the first count By the time I got my gown and gloves on they were just about done with the first count. They notified me everything was accounted for. They said the first count was correct; instruments, sponges, small items. I know that all sponges must be scanned once they are off the field. They were ready to start the skin closure so I requested RN 2 to start the count. The final count does not involve instruments. We started with the laps (18" x 18") or raytex {4 X 8 gauze sponges) on the field, then the Mayo, and the back table. I know I only had 3 sponge5 left; 1 next to the surgeon, and 1 wet and

EventiD:V65C1 1 1/12/2012

Medical Center ' s Governing Body

(i.e., GAC) revi ewed the initial

and recent retai ned sponge

incidents referenced in the

findings. Additionally, the .

Governing Body reviewed and

ratified the PSC's actions, the


procedure, t he " Pause for the

Gauze Reminders" education

materials and trai ning, the

revised surgical sponge count

competency evaluation tool, the

revised observational audlt tool,

and corrective action measures

that have been and will continue

to be implemented to es tablish

system-wide compl iance wi th the


procedure. At the direction of

the Governing Body, the Chief

Operating Officer and/or other

desi gnated UCSF Medical Center

representati ves will

2:20:54PM

lABORATORY DIRECTOR'S OR PROVIDERJSUPPUER REPRESENTATIVE'S SIGNATURE rme (X6)0ATE

Ally de(lclency slalement ending with an asterisk M denotes a deficiency which the Institution may be excused from correcting providing ills determined

that olher safeguards provide sufficient protection to the patien\8. Except lor nu111Jog homes. the Rndlngs above are dlsdosa.bls 90 day' following lhO date

ol survey whether 0(' not a plan or correctlon is provided. fC(' nurang homos, tho above finding• and plans or COtfii<j(io!~fFt!~ffi<R'l"Crl<\ ~ffi l~flt-"LJH 'the duto these documents are made available to tho laciHy. If dollclencles ara cited, an approved plan o1 corruc~ ~~~ td.otfiUrltr4J'Digl\gt n 1:../"\ part!clpatlon.

Stale·2667 FEB 6 2012


10ol 16



(X1) PROVIDER/SUPPUERICLIA IDENTIFICATION NUMBER:

050454


• A. BUILDING

B. WING

STREET ADDRESS, CITY, STATe, ZIP CODE

(X3) 011 TC SURVF.Y COMPLE"TED

06/30/2011



{X4}10 PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST DE PRECEEDED BY FVLL REGULATORY OR LSC IDENTIFYING INFORMATION)


1 dry on the Mayo stand for clean up".

PREFIX TAG

PROVlDER'S PLAN OF CORRECTION (EACH CORRECTIVE AC1 ION SHOULD BE CROSS. REFERENCED TO THE APPROPRtA TE DEFICIENCY)

report on the status of the action plan measures at future Governing Body .meetings.

Monitoring and Auditing:

Beginning June 15, 2011, the

volume of cases reviewe d as part of the ongoing, random

observation audits of compliance with the surgical sponge count pol i cy and procedure was increased t o 10\ of the total surgical volume for each perioperative site (Parnassus/ Moffi tt Long OR, Parnassus ASC , Mount Zion OR, Orthopedic Institute, and Labor and Delivery). Any observed deficiency in the surgical

sponge count policy and procedure i s immediately addressed and referred to management for appropriate action. The results of the random observation audits were

(XS)

COMPLETe 01\TC

6/1 5/11

ORT 1 continued to state "The ring stand had a plastic cover on it. My nurse (RN 2) had laid the sponges out on the ring stand. She pointed out the laps, but without picking each one up, from my perspective they were hard to see. (Facility policy indicated the scrub and circulator together will manually, audibly and visually count the sponges). The strings were not hanging out. The sponges in the ring stand weren't scanned yet. We verified a correct count, but the sponges weren't scanned . The patient was closed, I helped clean, and gave a cleaning sponge t_o the resident. I made sure I had my last 3 laps. When I scanned them out, I was missing one. I looked in the trash and announced to the team that I was missing a lap. I did this more than once. The patient was still on the table, intubated. I asked for some help and another ORT came in. I remember that I mentioned we can't leave the room because we need an x-ray. I don't know when the patient left Later, I was told that the x-ray they took in the ICU was negative. I couldn't accept that. AI 7:15p.m. we were still looking, checking everything and everywhere. I remember the area she (Physician 1) packed the laps in. I didn't mention it to ORT 2 when he came to relieve me, but RN 1 wrote it on the white board. I told RN 4 before I left for the evening, 'Please get another x-ray, I really think it is In the patient'.

reported to the PSC on June 22, 6/22/11

2011 and again on July 20, 2011. 7/20/11

''When I came back to work on Monday, I heard that they brought the patient back to surgery on Saturday. That lady (Patient 1) was really sick. We could have killed someone.

EvenliD:V65C1 1 1/1212012


As i ndi cated, PSC identified appropriate measures necessary to i mplement risk reduction strategies and necessary followup actions by the

2:20;54PM

TITLE

Any deficiency slatement ending with an asterisk (•) denotes • deficiency whldl the institullon may be excused from correcting providing It is determined

that other salcguards provfde sufficient protection to lhc patients. Except for nu111lng homes, tho findings abov"8f.O Rffll'l~llrn l~m-fi+lf'hb.t~'l\ LTH of survey whether or not a plan o1 correcUon Is provided. For nur.~ing homee, \he obove findings ond plans of 4!Y~~f8 ~lsWratfe ~~'!du.Yh!{f \ the date these documents aro made available to the facUlty. h' dcllclencies are elted, an approved plan ol eorrectlon is requisite lo continued program

participation.

(X6)0ATE

-----------------------------------------+~~-~20~12-------State-2567


11 of 16

CALIFORNIA HEAL lH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBUC HEALTH

STATEw:NT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDERISUPPLIERICLIA IOEtmFICATION NUMBER.

050454

(X2) MUlTIPLE CONSTRUCTION

A BUILDING

B. WING

()(3) DATE SURVEY COMPLETED

06/3012011


UCSF MEDICAL CENTER'

STREET ADDRESS, CITY, STATE, ZiP COOE


(X4)10 PREFIX

TAG

SUMtMRY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDEO BY FULL REGULATORY OR LSC IOENTIFYlNG INFORMATION)

Continued From pago 11

One thing I did not know was that they (nur~es)

have to scan the laps and raytex out before we start the count My circulator (RN 1) and I both went on a relief break at the same time; that was a factor too. The nurses do the counts differenUy. Some allow the sponges to pile up In the ringstand, and others scan them immediately and put them In the bags. The policy says everything must be scanned before we count The reason this happened is because we didn't follow the policy".

The flnal interview was conducted on 6/30/11 at 3 p.m. with Physician 1. She told surveyors that, "I was· notified that the counts were correct. I think It was RN 1 who told me at the time. I left to speak with the family and then went to the ICU to check on the patient. The fellow and the OR staff were discussing a possible retained sponge. The fellow told me; the OR staff did not communicate directly with me. I was told by the Nurse Manager Friday afternoon that there were still concerns about a relalned sponge. Discussed i1 with a radiologist and ordered a CT (computerized tomography) scan".

10 PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACl10N SHOULD BE CROSS

REFERENCED TO THE IIPPROPRIATE DEFIC[ENCY)

department to ensure systemic compliance with the surgical

sponge count policy and procedure. Additionally, beginning October 4, 2011, the Director of Perioperative Services provided monthly reports t o QIEC for additional review and oversight, until the QIEC determines an alternative reporting period for such

matters. PSC reports to QIEC. QI EC reports to EMB which in turn report s to GAC, the designated Governing Body.

Lastly , the detailed and i ntensive interactive surgical sponge count competency assessment s referenced in the

Corrective Action section above enabled UCSP Medical Center to assess and monitor system-wide adherence by the perioperative department staff to the surgical sponge count policy and

()(5)

COMPLETl' DATE

10/4/11 and Ongoing

9/1/11

A 6/28/11 review of Patient 1 's Operative Report for her second exploratory laparotomy on - 11. electronically signed by the surgeon on ~011, indicated th~ following surgeon's note: " ... This Is an 85-year-old... who underwent an exploratory laparotomy ... on - 2011 . AI the end of the procedure I was verbally told that sponge, lap, and needle counters were correct x 2. The manual sponge count was correct; however. the scanned count was 1 lap sponge short This was no! told to the supervising team until the patient had been

procedure .On July 22 , 201.1, 7/22/i1

EveniiD:V65C11 111212012

perioperative leadership devel oped and i mplemented a prototype report generated by thE SurgiCount scanner software as ar additional objective measure of

compliance with surgical sponge

Z:ZO:s'lifdMnL po.LJ.cy ana proceaure.

LABORATORY DIRECTOR'S OR PROVIOERJSUPPUER REPRESENTATIVE'S SIGNATURE TITLE (X6) OA'TE

Any def'Jcienc;y alnlement ending wllh an asterisk (i denotes a deficiency which the lnslllutioo may be excused from correcting providiog it is determined

that othet" safeguards provide sUfficient protection to the poUenlt. Except for nuralog homes, the nndlngs obuve are dlscJ.!;~.Il/..j!.D ~'P ~ft'~Rq 'r"d'I'EAlJH of survey whether or not a plan of corroctlon Is provided. For nursing homes, the a.bovo findings and plans of corrS~~~F 'f'~f29ty1rJ!II the datu these documents are mada nvofiable to the facility. If doflciencles are cited, an approved plan of correction is requisite to continued program

participation.

Slate-2567 Ff--B-6 2ffit-


12 or 16

C.o;UFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

GT ... TEt.IENT OF oeFICIEl'ICIES ANO PlAN OF CORRECTION

()(1) PROVIlERISUPPLIER/CliA IDENTIFICATION NUMBER:

050454

(X2) MlJl TIPI.E CONSmUCllON

II. BUILDING

B. WING

STREET ADDRESS, CrrY, STATE, ZIP CODE

(X3) I.MTE SURVEY COMPLETED

06/30/2011


UCSF MEDICAL CENTER 505 PARNASSUS AVENUE, SA~ FRANCISCO, CA 94143 SAN FRANCISCO COUNTY

(X4)1D PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH OEF'IClENCY MUST BE PRECEEDEO BY FULL REGULATORY OR LSC IOENTIFYINCl iNFORMATION}


transferred to the ICU. A KUB (kidney, ureters, bladder x-ray) was obtained to rule out a retained foreign body, including a laparotomy sponge. It was read as negative by 2 radiologists. They continued to search for the missing sponge and the operative team had concerns that there was potentially a retained sponge at the end of the procedure. I was notified of this find ing late on the afternoon of postoperative day number 1. At that time, the patient was in ICU and was not completely stable , She was requiring transfusion of blood products including fresh frozen plasma for a consumptive coagulopathy (blood clotting disorder) and required massive resuscitation with fluids. Given my concern as well as the ICU attenaings, it was not felt that further imaging could be done at that time. After discussion with the radiology department, the plan was for a non-contrast (dye) CT to further assess for this retained sponge once she was stable. On postoperative day number 2, the patient was noted to be stable and had been extubated. We perfonned a non-contrast CT and the reading was notable for retained sponge likely In the right upper abdomen between the liver and the diaphragm .... "

The Intraoperative Findings documented in the Operative Report dated - 11 indicated "Retained sponge between the liver edge and the right diaphragm". And, "It was also confirmed that her previous count had been incorrect by 1 lap sponge, which was found at the time of this surgery".

A 6/28/11 review of the Medical Center Counts: Instruments, Sponges, Nee<lles and Small Items policy and procedure (in effect at the time of the

Event ID:V65C11 1/12/2012

ID PREFIX

TAG .

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD DE CROSS· REFERENCED TO THE APPI'!OPRIATE DEFICIENCY)

This prococype reporc has been used i n combination wi th interview, record review, and staff counseling when a variance in procedure was identified . Subsequently, · the

prototype report has been refined and the process systematized . Beginning September 29, 2011, ongoing Surg iCount Scanner reports that identify both incomplete scanner entries and manual entries by staff are actively reviewed and monitored weekly with feedback to and counseling of staff as indicated . Beginning October 4, 2011, the Di~ector of Perioperat ive

Services provided monthly

SurgiCount Scanner reports to the OR Commi ttee and t o QIEC for addit ional r eview and oversight, until t he QIEC decermines an alternative reporting period for such matters . QIEC r eports to EMB

which in turn r eports to GAC, the designaced Governing Body .

2:20:54PM

LABORATORY DIRECTOR'S OR l>ROV1DERISUPPUER REPRESENT A TlVE'S SIGNA 11JRE TITLE

Ally dellciency atatoment ending with Ill\ asterisk (') denotea a delle Ieney which lhe Institution may be excused from corracUng providing it is delermlnod

llult other safegua~a provide sulltcient protecUon to the pallof\ta. Except for nuf311\g homes. the llndlngs abovo areJI,lljllljli~l~(l:dnt ~tl!)lltlc!P'A LTH of sutvey whether or nota plan ol correction is provided. For nursif\g homes, the above nndings and plans ol Gtfl~l!:;f'o ~~ail~~'-f61Mkr6 \

. the dale these documents are made evaUable to the facility. II dellcier~cles afll cited, on approved plan ol correction is requisito 10 continued program

parlicipa5on.

S tale-2567 6 2012 -

L&C DIV1SION SAN FRANCISCO

(XD)

COMPLETF. OIITE

9 /29/ll

10/4/ll

and

ongoing

(XG) DATE

13 of 16

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBUC HEALTH

STATEMENT OF OEFICIENCtES AND PLAN OF CORRECTION

!XI ) PROVIDERJSUPPUERICL IA IDENT!FICA TION NUMBER:

()(2) MUl TIPI.E CONSlRUC'TlON ()(3) OI.TE SURVEY COMPLETED

A. BUILDING

050454 B. WING 06/30/2011

STREET ADDRESS, CITY, STATE, ZIP CODE NAME OF PROVIDER OR SUPPUER


(X4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDEO DY FUll REGUlATORY OR LSC IDENTIFYING INFORMAl ION)


current adverse event) noted the following processes: B. General counting process:

4. The initial and final counts must agree with the numbers on the dry erase board and the SurgiCount scanner and must be documented In the electronic case record. 14. Requests of any surgical team member to reconcile discrepancy or doubt must be honored. 15. The surgeon is informed of the results of all final counts conducted once all sponges are off the sterile field, scanned out and placed In the hanging counter bags. 16. An X-Ray is mandatory prior to leaving the OR on cases where: There Is a sponge, needle, small item or instrument count discrepancy

C. Sponge Counts:

5. Scanners and hanging sponge counter bag systems are used for all cases. 6. When a sponge counter bag Is filled with 10 sponges, the scrub and circulator together will manually, audibly and visually count them. 10. Scan all sponges discarded from the sterile field ASAP, separating and scanning the data matrix tags individually. T~en place sponges in hanging counter bags. Having the data matrix tag in plain view and facing outward is suggested. 12. Do not confinn final count is correct until all sponges are off the st.erile field, scanned out and placed in hanging counter bag. 13. Confinn correct count when manual final count,

Event IO:V65C11 1/1212012

10

PREFIX TAG

PHOVIOER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTIOii SHOULD ae CROss


Responsible Party: Director , Perioperative Services; Chief Nursing Officer

2:20:54PM

LABORATORY DIRECTOR'S OR PROVIDER/SUPPUER REPRESENTATIVE'S SIGNATURE T111.E

Any deflcjency statement ending with on asterisk (1 denoles 11 dellclency which tho lnstltuUon may be excused from corractlno providing it is delermlned

that other safeguards provide aufllclont protection to tho paUonts. Except lor nursing homes. the findings above are disclosable 90 d.ays lollowino the dale

o1 survey whether or not a plan of correction Ia provided, FOf nursing homes, tho.abovo llndlngs Md plans pl.l)\>rrp<J~fl'T" jll1~t:)i!I1JM <Ih9\ ~GVitiJH the date these documents are made available to""' facllity. 11 deficiencies are cited, an opproved plan ot ~41\t;L.lla:I~;Wiio [oN!.Yd.;~g\.1"'-" participation.

- - - ·-·---·- ·-- ··. ----Slate-2&67


(XS)

COMPLETE DATE

(X6) DATE

14 of 16


STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTlON

{)(1) PROV!OERISUPPLIERICUA IDENTIFICATION NUMBER:

050454

()(2) MULTIPLE CONSTRvcnON

A. BUill>ING

B. WING

STREET ADDRESS, CrTY, STATE. ZIP CODE

(X3l DATE SURVEY COMPLETED

06/30/2011

NAME OF PROVIDER OR SUPPliER


(X4)10 PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDED BY FULL REGUlATORY OR LSC IDENTiFYING INFORMATION)

10 PREFIX

TAG

PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACY~ON SHOULD BE CROSS

REFERENCED YO l'HE APPROPRIATE DEFICIENCY)

(X&) COMPLE'I'E

0111'1:


written count and electronic count are Identical. 14: Do not count sponges from the rim of ring stand basin/kick bucket

H. Procedures for Incorrect Counts: Any count discrepancy is treated as an incorrect count. When a discrepancy is Identified the following steps are performed:

3. A visual and manual sweep of the operative site is conducted by MD to check for unintended retained items 5. The attending surgeon is notified immediately 6. It additional assistance is needed the circulating nurse notifies the charge nurse immediately. 7. In the event of the attending surgeon's departure prior to closing of the Incision, he/she shall retum to the operating room when notified of an incorrect counL 8. When a discrepancy cannot be reconciled, an x-ray Is MANDATORY before the patient leaves the operating room. 9. The sterile field will be maintained until after confirmation that the wound is clear of sponges or Instruments. References: Association of periOperative Registered Nurses (AORN) "Recommended Practices for Sponge, Sharp, and Instrument Counts-2011 Perioperative Standards and Recommended Practices"

In addition, the nurses failed to act as advocates for Patient ·1 when they "assumed the missing . lap sponge was in the trash" · and were not proactive with the surgical team to follow the protocols before

Event 1D:V65C11 1/1212012 2:20:54PM

lABORATORY DIRECTOR'S OR PROVIDERJSUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

Ally defiCiency statement ending with Pn asterisk(') denotes a doHcioncy which tho inatiluUon may be elCeused from COIT&cllng providing it is delermlnod

that other safeguards provide sufficient protection to the paUenta. Except for nursing homes, the findings above are fli~\IIO~~lf"l~'EMirJIOlejpE(JEALJH

Of survey whether or not a plan a correc1Jon Is provided. For nursing homes, tho abov~tllndlngs and plans of correclid.t\~~tW f4laJ.J le!WWJ n the date these documonta are made avabbla to the facility. If dellclencles are died, an approved plan ol correction is requlaita to continued program

participation.

Stato-2567 ----RFE;.GB ----6-2012---


15 0116

CALJFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH


()(1) PROVIDER/SUPPUERICLIA IDENTIFICATION NVMilER:

(X2) MUL TII"LE CONSTRUCTION IX3) UA TE SURVUV COMPLETED

A. BUILDII\'G

050454 B. WING 06/30/2011

STREET 1\0DRESS, Cm'. S1;o.l'E, ZIP COOE NAME OF PROVIDER OR SUPPUER


()(4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDEO BY F1Jll REGULATORY OR LSC IDENTIFYING INFORMIITION)


they allowed her to be transported to the I CU.

The facility's failure to Implement irs sponge count policy resulted in the retention of a foreign body (laparotomy sponge) in Patient 1who had to undergo a second surgery to remove the retained sponge, and is a deficiency that has caused serious Injury to the patient, and therefore constitutes an immediate jeopardy within the meaning of Health and Safety 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 1280.1(c).

EventiD:V65C11 111212012

ID PflEFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSs

REFERENCED TO THI! Af'f'ROPRIA TE DEFICIENCY)

CA DEPT OF PUBUC HEALTI

FE~ 6 2012

L&C DMSION SAN FRANCISCO

2:20:54PM

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

AnY. deficiency statement ending with an asterisk (' ) denotes a deficiency which the Institution may be excused from correcting providing it is delormlned that other safeguards provide suffiCient protection to the patients. Except for nuraing homos, tho lln<f11gs above are disdosable 90 duys following tho dale of survey whether or not a p4an of correction Is provided. For nursing homes. tho above findings and plaM or corrtlcllon are dlsclosable 14 days following the dale these documents are made available to the facility. If deficiencies aro cllcd. an approved plan of correction Is requisite to continued program

participation.

- -------··--- - ·----- - -Stale-2567

(X5]

COMPLF.TE 01\TE

(X6) DATE

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(X2) MUL TIPL£ CONSTRUCTI3t L COMPLETED l&COMSION

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