CALIFORNIA HEALTH AND HUMAN SERVICE

DEPARTMENT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES (X1) PROVlDERlSUPPLIERlCLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY

AND PLAN OF CORREC TI ON IDENTIFICATION NUMBER COMPLETED

A BUILDING

050152 B.~NG 0112412011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, Sl ATE. ZIP CODE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES I

" I

PROVIDER'S PLAN OF CORRECTI ON , PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFI X (EACH CORRECTIVE ACTION SHOULD BE CRO SS·

"G REGULATORY OR LSC IDENTIFYING INFORMATION) " G REFERENCED TO THE APPROPRIATE DEFICIENCY)

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

T22 DIV CH1 ART3-70223(b)(2)

Complaint Intake Number: SURGICAL SERVICE GENERAL

CA00254601 - Substantiated REQUIREMENTS

I Immediate Corrective Action: Representing the Department of Public Health: ,

Surveyor ID # 23107, HFEN The hospital policy, "Prevention of

I The inspection was limited to the speCific facility

Retained Surgical Items" (see allachmentlabeled 'Appendix 14') was reviewed and revised to include

event investigated and does not represent the procedures addressing the following:

findings of a full inspection of the facility. • Separating and sorting sponges

Section after removal from the kick bucket

Health and Safety Code 1280.1(c): Fo' prior to placing in the sponge purposes of this section "immediate jeopardy" holder. means a situation in which the licensee's i • Requirement for annual , noncompliance with one 0' more requirements of I I competency review ! I licensure has caused, or is likely to cause , serious

i I injury or death to the patient. i All staff were provided one-an-one

I I training regarding the Sponge

T22 DIV CH1 ART3-70223Ib)(21 Surgical Service Accounting process and the

General Requirements requirement to separate and sort all sponges .

(bl A committee of the medical staff shall be assigned responsibility for: The Surgical Services Staffing

121 Development, maintenance and implementation Guidelines, were revised to include

of written policies and procedures in consultation language addressing the assignment

with other appropriate health professionals and of non-employee personnel (see attachment labeled 'Appendix 15').

administration. Policies shall be approved by the governing body, Procedures shall be approved by Employees responsible for making the administration and medical staff where such is staffing assignments were provided

i appropriate. education via one-an-one I (Continue to page 2) This regulation was not met as evidenced by:

Event ID:1GDJ11 4/12/2012 2:08:06PM

R REPRESENTATIVE·S SIGNATURE TITLE

1-\ 'PI Aoy stalement e~di ng with an asteriSk (0) denotes a deficiency which the inst ifu(ion may be excused from correctln9 pro~ld ing It is determined

Ihal other s eguards provide sufficient protection 10 the pal,enls. Except for nurSing homes, (he findings aoove are disclosable 90 days followln9 the date

of survey whether or not a plan of correction is provided. For nursmg homes. the above fi ndmgs and plans of correc1 ion are disclosable 14 days fol lOWing

the dale Ihese documents are made available to the fac il 'ty If deficiencies are cited. an approved plan of correchon IS requlsile to conl inued program

(X5)

COMPLETE

DATE

02/03/11

, , ,

i I

01/20/10

02/03/11

! 01/12/11

,

I

panlclpalion. l\ l L 1

511.11';:-2-"-'- -- ______ ._. _____ _ _ __ _ .Uh-~JL~====~--~~~.--------.---------- .. -----1 of 13

CALIFORNIA HEALTH AND HUMAN SERVICEf ,NCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUM8ER:

(x.) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

A. BUILDING

050152 B. WING 0112412011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE

SAI NT FRA NCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 941 09-4806 SAN FRANCISCO COUNTY

(X4) 10

PREFI X

"G

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

Continued From page 1

Based on intelView and record review, the facil ity failed to develop and implement a surgical count policy and procedure that specified that the circulating nurse separate out each sponge to determine the size, type and number of sponges present after removing it from the kick bucket and before placing in the sponge holder, failed to include the count process in Ihe operating room staff annual competency. fa iled 10 conduct audits to I ensure compliance with the count process and failed to develop a policy that addressed the issue , of two non-employee personnel wor\(ing together on a complicated case. This resulted in a surgical sponge being left in Patient 1 who had to undergo a second surgery to remove the retained surgical item.

Findings:

Patient 1 was admitted to the hospital on " 10 for lumbar three (L3) to lumbar four (L4) extreme : lateral inter-body fusion and lumbar three to lumbar !

! five laminectomy and fusion with screws. (Th is was i I a two part procedure in which Ihe patient was i , placed in two different positions, The patient was first placed in the right lateral position for an extreme lateral disk approach, complete L3-4 diskectomy and an interior decompression of the spine at L3-4, partial vertebrectomy/diskectomy and L3-4 fusion with cage using nelVe monitoring and NuVasive Retractor system. Patient 1 was then placed in the prone position on a Jackson table for placement of posterior pedicle screws at i L3 and L5, laminectomy at L3-4 and L4-5, and I

i posterior fusion with local and allograft bone from !

'" PREFIX

'"

PROVIDER'S PLAN OF CORRECTION (EACH CORRE CTIVE ACTION SHOULD BE CROSS­

REFERENCED TO THE APPROPRIATE DEFICIENCY)

T22 DIV CH1 ART3-70223(b)(2) SURGICAL SERVICE GENERAL REQUIREMENTS

conversation regarding staffing guideline revisions .

The revisions to the policy, "Prevention of Surgical Items," and

i , i

the Surgical Services Staffing Guidelines were approved by the 1

Surgical Care Evaluation Committee I (SCEC), Medical Executive Committee (MEC) and Board of Trustees. respectively.

Systemic Changes to Prevent Recurrence: All policy revisions are based on the 2010 guidelines established by the Association of Perioperative Registered Nurses (AORN) and Dr. Verna Gibbs, "No Thing Left Behind."

Annual competencies include Sponge Accounting . Validation of competencies is assessed by the successful completion of a written exam and return demonstration (see attachmenl labeled 'Appendix 7').

Review of staff assignment records ' (Continue to page 3)

Event IO:1GDJ11 4/1212012 2.08.06PM

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

Any deficiency statement ending with an asteriSK {OJ denotes a deficiency which the institutIon may be excused from corre cting provIding It is determlfled

that other safeguards provide suffIcient protection to the pati ents, Except for nursing homes, the fmdmgs above are disclosable 90 days fol lowing the date

of survey whether or not a plan of correction is provided. For nursmg homes, the above findings and plans of correctIOn are disclosable 14 days fo ll OWIng

the date these documents are made available to the facility . If defic iencies are cited. an approved plan of correction is requisite 10 continued program

participation

State·2567

(X51

COMPLE TE

DATE

01/12/11 0 1/20/11 02/03111

(X6) OATE

2 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE

DEPARTME NT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES (X l ) PROVIOER/SUPPlIER/CUA (X2) MUL TlI>LE CONS1HUCTION (X3) OATE SURVE\' ANO PLA"I OF CORRECTION IOENTIFICATION NUMBER COMPLETEO

A. BUILDING

050152 ,WNG 01 /24/20 11

NAME OF PRO\llO£R OR SUPPLIER STREET AOORESS. cny. STATE. ZIP COOE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde Sl, San Franc isco, Ca 94109-4806 SAN FRANCISCO COUNTY

(H)!D SUMMAR\' SIAIEI.lE"IT OF OEF ICIENCIES '0 PROlllDER·S PLA"I OF CORRECTION (X5) PREFIX I (EACH OCr-ICIENC\' MUST BE PRECEEO£O B\, FLILL PREFIX I ([ACft CORRECTIVE ACTION SHOLILO BE CROSS. i COMPlETE

"G REGULATOR\, OR LSC 10E"ITIFYING INFORMATION) "G REFERENCED TO THE APPROPRIATE DEFiCIENC\') I OATE

Conti nued From page 2

L3-L5). During Patient 1's routine post-op follow up

on . 11 , lumbar spine x-rays showed a possible T22 DIV CH1 ARTJ-70223(b)(2) re tained surgical sponge. Patient 1 was readmitted S URGICAL SERVICE GENERAL to the facility on _ 1 and had surgery to remove REQUIREMENTS a retained surgical sponge .

record dated I i

are conducted on a daily basis by the

00 2122111, Patient 1', intraoperative ,

D irector of Perioperative , _0 was reviewed and showed that the initial. i Services/designee to ensure that at , first and final sponge counts were documented as I least one member of the nursing , correct. There w"' '" intraoperative repon daled surgical team is a hospital employee.

1 which l isted Ih. surgical procedure a, All exceptions are approved by the

MSpinal Wound Exploration-. D irector of Perioperative Services

prior to the start of a case . Approval

Palient 1 's operative note dated .1 indicated a confirmat ion is d ocumented by the

pre and post operative diagnosis of retained sponge Director o f Perioperative Services on

after L3 (lumbar) to L5 fus ion. The description of the the staffing assignment record.

I procedure included the following" "(Name of Patient Mon itori n g : I

1) was brought to the operating room after informed 1 ,

consen!. He was put in the prone position, prepped i 10 random observations per week , and draped in the usual sterile fashion . I made a i were conducted to ensure staff

complia n ce Sponge Accounting in ; 2-inch laminectomy incision al 'h. prior scar

, acco rdance with the hospital policy I

centered over the sponge. I dissected down to the "Prevention of Retained Surgical sponge, ... Sponge w"' removed partially adherent lIems." Audits were performed until 10 surrounding structures aod dissected with blunt (six) 6 months of compliance was aod finger dissection . Fluoroscopy used 10 maintained at 100%, then quarterly to confi rm it was completely removed. It was overlying include a minimum of 40 cases . the dura on the inferior aspect of the laminectomy." Aggregate data is a standing monthly I During an interview on 2122/11 at 10:10 AM. the !

agenda item to the Quality

I Assessment and Improvement (QA&I)I

Director o f Perioperatlve Services (DPS) stated the : Committee, Medical Executive ,

circulating nurse aod scrub technician involved in : ,

Committee (MEC), and at least , , ,

Patient ", longer work al the facility . I , q uarterly to the Board o f T rustees. surgery no

She said Ih. staff were ~travelers~ and their I (Con t i n u e t o p age 4) contracts had expired . She said at the time of I Patient " s surgery, the circulating nurse had I ,

I

Event lD:1GDJ11 4112/2012 2.08.06PM

LABORATORY DIRECTOR·S OR PROVlDERlSUPPLIER REPRESENTATIVE'S S(GNATURE TITLE (X6) DATE

My defIciency statement ending WIth an asterisk rl denotes a defiClenc~ whICh the instltutlOl1 ma~ be excused from corroctmg providIng ~ is determll1·ed Ihat other safeguards pro~lde suffICient prolection to the pallents. Except for nurSIng homes. the findIngs above are dlsdosable 90 da~s follOWing the dale of su ... ey whether or not a plan of correclion is prO~l ded For nursmg homes. the above findings and plans of correction an! disdosable 14 days fo llowing the date Ihese documenlS are made available 10 the facility If deficienCIes are cited. an approvoo plan of corrnct ion IS requlsile to continued prOgram partlcipallon

.. -.---.--.. ---------~----------- .. ------ -- .. ------S18te·2567 3 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE~ "NCY DEPARTM ENT OF PUBLIC HEALTH

STATEMEN f OF DEFICIENCIES AND PLAN OF CORRECTION

IX 1) PROVIDER/SUPPliER/ellA IDENTIFICATION NUMBER

(X2) MULTiPlE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

050152

A BUllDiNC

B . ...... NG 0112412011

NAME OF PROVIDER OR SUPPliER STREET ADDRESS. CITY. STATE. liP CODE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde 5 1, San Francisco, Col 94109-4806 SAN FRANCISCO COUNTY

(X4) 10

PREFI X ,.0

SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCV MUST BE PRECEEDED BY FULL

REGUlATORV OR lSC IDENTIFYING INFORMATION)

\ Continued From page 3

I

worked at the faCility for 10 months and the surgical. technician for three weeks. When asked if she I

I thought having two non~employee personnel working together on a complicated surgery had I contributed to the sponge being left in Patient 1, she responded "I don't think it contributed, everyone did what Ihey were supposed to." She stated the facility conducted an RCA (root cause analysis) to determine the cause of the retained sponge but 'W e didn't come up with a definitive answer. ~

The Director of Perioperative Services (DPS) was asked if the RCA explained how the staff followed the facility's policy on sponge counts and a sponge I was still left in Patient 1. She said then RCA didn't I come up with an answer but one explanation was I

there was an extra sponge in the room that was put i in the sponge holder so the count was correct. She said the extra sponge may have been left in the operating room from a previous case or that "another person" came into the room during the case and left a sponge there. When asked if there was a flaw in the facility'S policy that allowed a sponge to be left in Patient 1, she responded "II's

'0 PREFIX

"G

! I

PROVIOER·S PLAN OF CORRECTION

(EACti COHR£ CTIVE ACTION SHOULD BE CROSS­

REFERENCED 10 THE APPROPRIATE DEFICIENCY)

T22 DIV CH1 ART3-70223(b)(2) SURGICAL SERVICE GENERAL REQUIREMENTS

Responsible Ro le: Director of Perioperative Services

IX51 COMPlETE

OME

I an excellent policy, we've taken it one step further 10 make sure everything is in the sponge holders" i CA DEPT OF PUBLIC HEA~TH

I The DPS was unable 10 explain how a surgical t

I sponge was left in Patient 1 during his surgery . I , The DPS said the facility used sponge holders to ensure Ihat all sponges are accounted for at the end of a case. She said the circulating nurse removes sponges from the kick bucket throughout the case, stretches them out to verify the type and size of the sponge, rolls them up and places them

Event tD· t GOJll 411212012

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

208.06PM

APR 2 0 2012

l&C ClVlS!CN SA:. FP.A,~C:SCO

n TLE

Any denciency statement eno.r.g Wllh an asteriSk (oJ denotes a de~coency whd! the Insti tullon may be excused from correc1ong prov.,jlng ,t IS determIned

thai other safeguard s provide suffICient protection to the paliems Except for nursing homes, lhe firldlngs abov(l are dl$Closatlle 90 days follOWing the date

01 survey whether or nol a plan of correcllon 1$ provided For nursing homes, the above r,ndlngs arld plans of cor rectIon are dlsclosatl1e 14 days following

the date these documents are made avalla tllc to the facility II deficienCIes are Cited, an approved plan of corroctioo is reqUISite to continued program

panlClpatoon.

(X6) DATE

~------- ---------------~----.-----

Slate·2567 4 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE DEPARTME NT OF PUBLIC HEALTH

'ENCY

STATEMENT OF DEFICIENCIES (X 1j PROVIDER/SUPPLIER/CLIA rX2 j MULTIPLE CONSTRUCTION IX)) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED

A. BUILDING

050152 8 IMNG 01124/2011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE

SAINT FRAN CIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES m PROVIDER'S PLAN OF CORRECTION (X5)

PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS· COMPLETE ''0 REGULATORY OR LSC IDENTIFYING INFORMATION) ''0 REFERENCED TO THE APPROPRIATe DEFICIENCY)

! , Continued From page 4 I ,

I I in the sponge holders with the blue radiopaque tag i I

I visible. She stated It was important that surg ical ,

I sponges were placed In the holders with the blue radiographic tag visible as this prevented dressing

sponges being counted as surgical sponges. She

said at he "closing count" which occurs before wound closure, the circulating nurse and operating

room technician count all the sponges. she stated , the "Final count" occurs after the incision is closed ! and all sponges are off the surgical field and in the sponge holders. At that point. two people (usually

the cirGulating nurse and the surgeon) verify that the number of sponges in the sponge holders is the same as written on the white board.

A review of the facility's Count, Sponges. Needles

and Instruments six page policy and procedure (revised 6/12/09) indicated the following:

Purpose:

Counts are performed to account for all items and to lessen the potential for injury to the patient as a I result of a retained foreign body. , ,

i

Procedure:

4. Use of plastic hanging sponge-holders and a dry CA DEPT OF PUBLIC HEALTr erase board: This process involves the ose of plastic hanging

I blue-backed sponge-holders which each contain 5 APR 2 0 2012 pouches. Each pouch has a thin center-divider I which separates each pouch into 2 pockets. One I I sponge should be placed in each pocket. One I L&.C D!V1SiON sponge per pocket. 2 pockets per pouch and 5 SAr'~ FRANC1SCO

I pouches holder means that each holder can : , Event ID:1GDJ1 1 4/1212012 2.0B.06PM

LABORATORY DIRECTOR'S OR PROVIDERISUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

Any defic iency statement ending with an aSlerisk (oJ denotes a deficiency which the institution may be excused from correctmg prOViding It is determined

(hat other safeguards provide sufficient protection to the patients. Except for nursing homes. the findings above are disclosable 90 days following Ihe dale

of survey whether or nol a plan of correction is provid~ . For nursing homes, the above rmdings and plans of correct ion are disclosable 14 days following

the date Ihese documentS are made availab le to Ihe facl)ity If defiCienCies are c,ted, an approv~ plan of correchon is reqUisite 10 continued program

pan'clpa(K,n

DATE

, , , , I

I

I I i

•

(X6) DATE

5 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE' OEPARTMENT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES IX I) PROVIDER/SUPPLIER/CLIA (X2) MUlTIPLE CONS TRUCTION (X 3) DATE SURVEY

AND PLAN OF CORRECTION IDENTIFICATION NUMBER. COMPLETED

A BUILDING

050152 B. WNG 01124120 11

NAME OF PROVIDER OR SUPPliER STREET ADDRES S, CITY. STATE,. IIP CODE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES " PROVIOER'S PLAN OF CORRECTION

I (X51

PREFIX (EACH OEFICIENCY MUST BE PRECEEOED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS· COMPI.ETE

" G REGULATORY OR LSC IDENTIFYING INFORMATION) "G REFERENCED TO THE APPR OPRIATE DEFICIENCY) DAlE

Continued From page 5 !

Each holder will I accommodate 10 sponges , ' always be sel up to hold 10 sponges regardless of

I type of sponge. Different types of sponges cannot I , b, mixed within on, holder. A wall -mounted dey ,

I erase board will b, used to record operative

information including counts. Th, process will b" all operating rooms I ,

standardized for use throughout , to provide consistency in all types of operative i i cases. I

Th, policy did not specify that the circulating nurse wa, responsible for removing the sponges from the

kick bucket throughout th, case oc that each sponge was to be stretched out to it's lull length to

verify the type and size of the sponge. rolled up and

I placed in the holder with the blue radiographic tag

I visible to ensure that only surgical sponges were placed in the sponge holders . This had the potential i ; to increase the risk of an incorrect sponge count as I

could b, in th, holder ,

a I I dressing placed sponge ,

CA DEPT OF PUBUC HtTH

'which would result in a correct count even though a sponge remained in the patient.

The policy did not include any information regarding competency validation. The policy did not specify if the count process was part of the operating room staff annual competency or if observational audits of APR 2 0 2012 staff were done to ensure compliance with th, count policy . The policy did not show how new staff i or non-employee personnel (travelers) would be ! ! L&C DIVISION

i oriented to the facility count pol icy, the facility had !

I SAN FRANCISCO ,

no process in place to determine the competency i of the operating room staff in count procedures.

I During a follow up interview on 2122/11 at 2:05 PM, I

Event ID:1GDJll 4/1212012 2:08:06PM

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

Any deficiency slatement ending with an aSlerisk n denotes a deficiency which the instltul ion may be excused from correcting provid Ing It is delermlned

Ihat other safeguard s provide sufficient protection to Ihe patients. Except for nursing homes. the fInd ings above are dlsclosable 90 days follOWIng the date

of survey whelher or not a plan of correctIon is proVIded. For nurs ing homes. the above find Ings and plans of correcti on are dlsd osable 14 days follow,ng

Ihe date these documents are made avaI lab le to the faCility If defiCIencies are CIted, an approved plan of correction IS requIs ite to continued program

participation

~- - ------------ ----- ----~--

State·2S67

,

(X6) DATE

60113

CALIFORNIA HEALTH AND HUMAN SERVICE

DEPARTMENT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION

(XI) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

A. BUILDING

050152 B. WING 011241201 1

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE

SAINT FRANCIS MEMORIAL HOSPITA L 900 Hyde St, San Franc isco, Ca 94 109-4806 SAN FRANCISCO COUNTY

(X4) 10

PREFIX

" G

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUSr BE PRECEEOED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

Continued From page 6 I

the DPS was asked to explain the difference I between what she said was the facility's policy on I counting sponges and what the actual policy I

! showed, She said that the facility's count policy

I was "revised" in January 2011 after the RCA regarding Patient 1. She showed the surveyor a 28

'I page document (Version 5 December 2010) which had a subject of "Prevention of retained Surgical Items Policy". She said this was a corporate administrative policy and procedure. When asked if this policy had been approved by the facili ty 's governing body, she responded approved but it is our policy ,"

"It has not been

, . . i

She stated a new count process which Included the I

use of sponge holders was "rolled out" In 2009 i shortly after she started working at the facility, She II

said she took information from the corporate policy

regarding the use of the sponge holders and I "tailored it to fit our facility. " She acknowledged that

the policy in effect when the surgical sponge was left in Patient 1 did not specify that circulating nurse was responsible for removing the sponges from the kick bucket throughout the case or that each sponge was to be stretched out to it's fu ll length to verify the type and size of the sponge , rolied up and placed in the holder with the blue radiographic tag visible to ensure that only surg ical I sponges were placed in the sponge holders.

, In the morning of 2123/11 , the DPS was interviewed regarding staff training on the new count process that was implemented in 2009. She stated all staff received tra ining in the new process and audits

I were conducted "for a while" to ensure compliance.

Event ID:1GDJ 1 t 4!t 2l20 12

m PREFIX

"G

PROVIDER'S PLAN OF CORRECTION

lEACH CORRECTIVE ACTION SHOULO BE CROSS­

REFERENCED TO THE APPROPRIATE DEFICIENCY)

2,08,06PM

LABORATORY DIRECT O R'S OR PROVIDER/SUPPLIER REPRESENTATI VE 'S SIG NATURE T ITLE

Any defiCiency statement endmg WIth an astensk n denotes a defIciency wh ich the in~lIlut lon may be excused from correctIng providIng illS determIned

that olher safeguards proVIde sufficient proleclion lo Ihe pal ients Excepl for nursIng homes. the find ings above all.! dlsclosable 90 days following the dale

of survey whelher or not a plan of correction is provided, For nursing homes. Ihe above fInd ings and plans of co rreclion are disclosable 14 days following

the date Ihese documents are made available to Ihe fac ilIty. If de ficiencies are ciled. an approved plan of correct ion is requ iSIte to conl inued program

participa lion

Sla te·2567

(X5)

COMPLETE

DATE

(X6) DATE

7 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE DEPARTME NT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES ~X') PROVIDER/SUPPLIER/CUA ~X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY

AND PLAN OF CORRECTION IDENTIFICATION NUMBER' COMPLETED

A, BUILDING

050152 B,WNG 01124/2011

NAME OF PROVIDER OR SUPPLIER STREET AOORESS, CITY. STATE, ZIP CODE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

~X4) 10 SUMMARY STATEMENT OF DEFICIENCIES

I " I PROVIDER'S PLAN OF CORRE CTION

PREFIX (EACH DEFICIENCY MUST BE PRECEEOED BY FULL PREFIX lEACH CORRECTIVE AC TION SHOUlD BE CROSS-

"G REGULATORY OR LSC IDENTIFYING INFORMATION) , "G REFERENCED TO THE APPR OPRIATE DEFICIENCYI I I I

i Continued From page 7 I i I Wheo asked if the count process w", part of the

operating room staff annual competency, 'he replied "I 'll have have to look to see if it's included in

Ihe annual competency, I don't think we did." 'he also slated there were 00 audits done '0 2010 to

ensure staff compliance with the count process.

During ao interview '0 Ihe operating room 00

12123/11 at 1010AM Circulating RN 1 was asked i would place

, I to explain how he used surgical I I

'0 Ihe holder. He said he would I ,

sponges sponge remove the sponges from Ihe kick bucket , start at

Ihe bottom of the holder, go from left to right and

place Ihe sponges '0 Ihe holder with Ihe blue lag "out" Circulating RN 1 did 001 ,ay that he would

open up each sponge to it's full length to verify the size aod type of sponge prior to placing it '0 Ihe holder.

The Association of periOperative Registered

Nurses , or AORN, is an organization with input and

. liaisons including CDC (Centers fo' Disease ' I

, Control) , Association fo' Professionals " Infection : , Control aod Epidemiology, American College of i Surgeon. American Society of Anesthesiologists

iand Ihe American Association 01 Ambulatory

Surgery Center. The AORN position papers,

standard aod recommended practices a'e widely

used 001 only '0 Ihe perioperative clinical setting

bul a, ao authoritative guide 10 clarify regulatory requirements.

According 10 2011 AORN Perioperative Standards I aod Recommended Practice, pg 207 , "Retained , , objects are considered a preventable occurrence , I :

, ,

EventID:1GDJ11 411212012 208.06PM

LABORATORY D IRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

Any defICiency slatement er'lding with an astensk. (0) denotes a defic iency which the instituliOr'l may 00 excused from correcting providing it is determined

Ihat other safeguards provide sufficient protection to the palienls, Except for nursing homes. the f<ndings above are d,sc losable 90 days following the date

of survey whether or nOI a plan of correction is provided For nursing homeS, the above fi ndings and plans of correction are disciosable 14 days following

the date these documents are made avai lab le to Ihe facIlity If deficiencies are Cited, an approved plan of correctoon IS requisite to cont inued prOgram

p<I"icipation.

------ -- - - --- -- ------Stale-2567

I IX5)

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DATE

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8 of 13

CALI FORNIA HEALTH AND HUMAN SERVICE DEPARTMENT OF PUBLIC HEALTH

'ENCY

STATEMEN T OF DEFICIENCIES (X 1) PRDVIDER/SUPPLIER/CLIA

AND PLAN OF CORRECTION IDENTIFICATION NUMBER

(X21 MULTIPLE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

A, BUILDING

050152 B,WNG 01 /2 412011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE, ZIP CODE

SAI NT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES

I " i PROVIDER'S PLAN OF CORRECTION

PREFI X (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE AC TION SHOULD BE CRO SS-

''0 REGULATORY OR LSC IDENTIFYING INFORMATION) '" ,

REFERENCED TO THE APPROPRIATE DEFICIENCYI I I I Continued From page B

aod careful counting and documentation can significanlly reduce , if not eliminate , these incidents."

Recommended Practices fo, Sponge , Sharp, and I

Instrument Counts. , I

Recommendation I (pg. 207 & 208) . Sponges I

! should be counted on all procedures in which the I possibil ity exists that a sponge could be retained. ,

I

3, Accurately accounting fo' sponges throughout a I

surgical procedure should be a priority of the

surgical team to minimize the risks of a retained

sponge.

8. Sponge counts should be conducted in the same

sequence each time as defined by the facility. The

counting sequence should be In a logical I progression (e.g, from large to small 01 from

proximal to distal) . A standardized count ,

procedure, following the same sequence, assists in achieving accuracy, efficiency , and continuity among perioperative team members. Studies In human error have shown that all errors involve some kind of deviation from routine practice.

Recommendation VI (pg . 213 & 214). Policies and

procedures fo' sponge, sharp, and instrument counts should be developed, reviewed periodically,

I revised as necessary, and readily available In the i

practice setting. , I

,

l ' These policies and procedures should include. I I but not limited to, items to be counted, I for pertorming counts (e.g . sequence, item

directions

I Event lD:1GDJ11 411212012 2.0S.0SPM

LABORATORY DIRECTOR'S OR PROV1DERISUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

Any de ficiency sta tement ending With an aSlensk (") denotes a deficiency wh ich the Institution may be e~cused from correcting providing it is determined

1hat other safeguards provide sufficient protection to the pa tients Except for nurs ing homes. the fIndings above are disclosable 90 days follOWIng the da1e

of survey whether or not a plan of correction is provided For nursing homes, the above findings and plans of correction are disclosab le 14 days follOWIng

the date these documents are made availab le 10 the facl l11y If def,c,enCies are cited, an approved plan of correctIon IS requIsite to continued program

participati on

! (X51

COMPLETE

I DATE

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(XS) DATE

9 of 13

CALIFORNIA HEALTH AND HUMAN SERVICE DEPARTMENT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES (Xl) PROVIDER/SUPPLIER/CLI A

AND PLAN OF CORRECTION IDENTIFICAT ION NUMBER:

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

A BUILDING

050152 B WING 0112412011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS. CITY, STATE, ZIP CODE

SAINT FRANCIS MEM ORIA L HOSPITA L 900 Hyde St , Sao Franc isco, Ca 94109-4806 SAN FRA NCISCO COUNTY

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES

I " I

PROVIDERS PLAN OF CORRECTION

I (X5)

PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS, COMPLETE

"G REGULATORY OR LSC IDENTIFYING INFORMATION) ," REFERENCED TO THE APPROPRIATE DEFICIENCY) i DAlE

I , Continued From page 9 I

, , !

,

I grouping, .,competency validation .

I : ,

Policies a"d procedures establish authority, , responsibility. a"d accountability a"d serve a, operational guidelines, Policies a"d procedures

also assist '" the development of patient safety ,

quality assessment, a"d quality improvement

activities, Nurses should collaborate wilh all members of the healthcare team to develop policies

that address surgical counts.

I 3. Practices. policies and procedu res are subject to ,

change with advent of new technologies , , , !

14 A" introduction a"d review of policies and i I procedures should be included '" orientation and I

ongoing education of perioperative personnel to

assist them '" obtaining knowledge a"d developing skins and attitudes that affecl patient outcomes.

0" 2/23111 at 11:50AM, the surveyors called the

AORN to verify the facility 's process fm removing

CA DEPT OF PUBLIC HE. ,LTH used surgical sponges from the kick bucket and I placing them '" the sponge holders, The

I I Perioperative Nursing Ispecialist stated he wou ld

I I discuss the issue with his colleagues a"d respond , APR 2 0 2011

110 the surveyors via 1·maiL On 22511 , the surveyor I , , I received the following response from the AORN :

I I Peri operative Nursing Specia list: I L&C DIVISION ,

: "You described a situation '" which the circulator SAN FRANCISCO took the sponges from the kick bucket and placed them in the count bag. The consensus of our group I, that '" the situation described the circulator

should open the sponges to confirm the type, size. and number of sponges present. there could be a ! ,

, ,

Event IO:1GOJ11 4/12/2012 2.08:06PM

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

Any deficiency statement ending with an asterisk 1") denotes a deficiency whIch the Instllutlon may be excused from corrccllng prOVIding It IS delermlned

that other safeguards provide suffic ient protectIon to the palienls. Except for nursing homes, the find ings above are disclosable 90 days following the date

of survey whether or nol a plan of correction IS provided. For nursIng homes. Ihe above fi ndings and plans of correction are disclosabfe 14 days followmg

the date Ihese documents are made available to the facility If defic iencies are cited. an approved plan of correct ion is r-equlslte 10 continued program

partlcLpa1l0n

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State-2567

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(XS) DATE

10 of 13

CALIFORNIA HEALTH AND HUMAN SERVICF DEPARTMENT OF PUBLIC HEALTH

;ENCY

STATEMENT OF OEFICIENCIES (XI) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (XJ) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED

A BUILDING

050152 8. WING 0112412011

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

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 941 09-4806 SAN FRANCISCO COUNTY

• (X4) 10 SUMMARY STATEMENT OF DEFIC IENCIES m

I PROVIDER'S PLAN OF CORRECTION

PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-

'" REGULATORY OR lSC IDENTIFYING INFORMATION) ''0 REFERENCED TO THE APPROPRIATE DEFICIENCY)

I I Continued From page 10 , ,

I situation in which more than one sponge is present I and there may be various sizes of sponges stuck l and hidden with the typical ball of sponge material • I present"

•

! The facility's count policy did not meet the AOR N's

acceptable standard of practice when II failed to require the circulating nurse to open each sponge to confirm the type , size ,nd number of sponges present after removing them from the kick bucket and before placing them in the sponge holder.

On 2124f11 at 10:10 AM , the CNO (chief nursing officer) wa, interviewed ,nd stated Ihe facility h,d

determined that the sponge w" left In Patient 1 during the last 15 minutes of his surgery, He said an x-ray taken 15 minutes before the end of the

I surgery showed no evidence of , sponge. """en asked how a sponge was left in Patient 1, he I i

! responded "One of the sponge in the sponge holder , ,

could have been , 4, 4 because the sponge I , ,

retained was a 4 X 8. I ,

I The CNO stated the facility's policy no longer allowed two travelers to work together in the same operating room unless approved by the director of perioperative services. He said , "II wasn't , deliberate thought to put two travelers in the room

I during the surgery (Patient l's) but we were I concerned it might have contributed to the retained I ,

! sponge ." He stated that he wasn't sure If the ,

i updated policy h,d been written yet but that "the 1 !

practice h" changed even If the document hasn't ,

changed yet." I I

Event ID:1GDJ11 411212012 2:08:06PM

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

Any deficiency statemenl endrng with an asterisk (') denotes 11 derlciency which the insti tutIon may be excuseu from correcting prOVIding it is delermmed

Ihat other sa feguards prOVide suffIc ient protection \0 the patients Except for nursing homes, the findings above are dlsc losable 90 days follow'ng the dale

of sUNey whether Or nOI 11 plan of correction IS provided For nursing homes. Ihe above fi ndings and plans of correCI,on are d,sclosable 14 days fo llowmg

Ihe date these documents are made avai lable to the facility, If dofLc;encles are cited, an approved plan of correct ion is requ isite 10 continued program

partic ipation ,

State-2567

i (X5)

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I I of 13

CALIFORNIA HEALTH AND HUMAN SERVICE DEPARTMENT OF PUBLIC HEALTH

ENCY

STATEMENT OF DEFICIENCIES (Xl) PROVIDER/SUPPLIER/CLI A

AND PLAN OF CORRECTION IDENTIFICATION NUMBER.

(X2) MULTIPLE CONSTRUCTION IX3) DATE SURVEY

COMPLE1ED

A. BUILDING

050152 B WING 01124/2011

NAM E OF PROVIDER OR SUPPLI ER STREET ADD RES S. CIH. STATE. ZIP CODE

SAINT FRANCIS MEMORIAL HOSPITAL 900 Hydc St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X4) 10 I SUMMARY STATEMENT OF DEFICIENCIES ! m I PROVIDER'S PLAN OF CORRECTION

PREFIX

I lEACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFI X lEACH CORRECTIVE AC TION SHOULD BE CRO SS. ,

" G REGULATORY OR LSC IDENTIFYING INFORMATI ON) i " G REFERENCED TO THE APPROPRIATE DEFICIENCY)

I Continued From page 11

A review of the facility's undated Surgical Services Staffing Guidelines policy indicated the following :

, I

Purpose:

I I To provide appropriate levels 0 1 competent nurses , ! I and technical staff 10 deliver competency based ' ,

perioperative care. I

Staffing : C Provision 01 Staffing Doe To Unexpected

Increase in Needs Utilization 01 employees' on -call, pel diem, 01

qualified registry personnel ale used when there ale I

add it ional staffing needs . When possible,

I non-employee personnel with less than 6 months! (name of facility) experience will not be assigned as

I Ihe primary circulator aod primary scrub 101 Ihe same case. Staffing assignments ale made with consideration 101 patient need aod acuity . complexity of procedure , and case mix.

According to 2011 AORN Guidance Statement: Perioperative Staffing. P9 609, Perioperative clinical

staffing guidelines should be based 00 individual patient needs, patient acuity , technological demands, staff member competency, skill mix,

practice standards, health care regulations, aod accreditation requirement. . The perioperative staffing policy should state Ihe minimum number 01 nursing personnel that will be provided 101 various types 01 surgical procedures Complexity of the procedure may require more than

the minimum number 01 nursing personnel

identified .

i Event ID:1GDJ11 411212012 2.08.06PM

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

Any de fiCIency statement ending with an asteriSk n denotes a def,c,ency whIch Ihe Inslltu llon may be excused from correctmg p rO~Idlng It is determIned

that other safeguards p ro~idc sufflClenl prOlectlon to tho patients Except for nursing homes. the findIngs above are disclosable 90 days following the date

01 survey whether or not a plan of correctIon is provi ded. For nurSing homes. the above fi ndings and plans 01 correction are disclosablc 14 days lollowong

Ihe datc these documents are made avai lable to the fac ility II defICIenCIes are ciled. an approved plan 01 correctIOn IS reqUIsite 10 conllnued program

partlCipalion.

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5ta le·2567

I 1:<. 5) COMPLETE

DATE

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{X5) DATE

12 0113

CALIFORNIA HEALTH AND HUMAN SERVICf

DEPARTMENT OF PUBLIC HEALTH

,ENCY

STATEMENT OF DE~ICI ENCI ES (Xl) PROVIDER/SUPPLIER/CLIA

AND PLAN OF CORRECTI ON IDENTIF ICATION NUMBER;

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY

COMPLETED

A BUILDING

050152 B. WNG 01/24/2011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY. STATE, liP CODE

SAI NT FRANCIS MEMORIAL HOSPITAL 900 Hyde St, San Francisco, Ca 94109-4806 SAN FRANCISCO COUNTY

(X~) 10

I

SUMMARY STA TEMENT OF DEF ICIENCIES ,

'" PROVIDER'S PLAN OF CORRECTION

1 (~ 5)

PRE FI~ {EACH DEFICIENCY MUST BE PRECEEDEO BY FULL I PREF I ~ lEACH CORRECTIVE ACTION SHOULD BE CROSS_ COMPLETE

"G REGULATORY OR l SC IDENTif YING INFORMATI ON)

I "G REFERENCED TO THE APPROPRIATE DEFICIENCY)

, DAfE

I I Contin ued From page 12 i The facility failed to develop and implement a count i , aod procedure that specified that the circulating I nurse separate out each sponge to determine the I size, type ,nd number of sponges present after I removing it from the kick bucket and before placing

it In the sponge holder, to include the count . process In the operating room staff annual

competency. ,nd to conduct audits to ensure compl iance with the count process, The facility

also fa iled to develop , policy ,nd guidelines foe operating room staffing that addressed the issue of traveling or registry personnel working together on a complicated case. (In this case , the scrub I i technician had only worked in the faci lity operating I room foc 3 weeks before she w"' assigned to , I complicated spinal procedure with another I

non-employee circulating nurse).

These fai lures resulted in a surgical sponge being

left In Patient 1 who h,d to undergo , second

I surgery to remove the retained surgical item, and is , deficiency that has caused serious injury to the

patient. ,nd therefore constitutes immediate I ,n , I

i , jeopardy within the meaning 'f Health ,nd Safety CA DEPT OF PUBliC HEAlJTH Code section 1280.1.

I I

This facility failed to prevent the deficiency(ies) as APR 20 1DI2 described above that caused, or is likely to cause,

serious injury or death to the patient, and therefore

I constitutes ao immediate jeopardy wi thin the L&C DIVISION meaning of Health ,nd 1280.1(c).

Safety Code Section S,~N FRANCISCO

I !

Event ID:1GDJ11 4/12/2012 208'06PM

LABORATORY DIRECTOR'S OR PROVI DER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

Any defiCiency stalement ending wllh an asterisk (") denotes 11 deficiency wh ich the institution may be excused from correcting providing it is determined

that other safeguards prOVide suffiCient protection to the pat ien ts Except for nursing homes. the findings above are dlsciosable 90 days following the date

of survey whether or not a plan of correction is provided For nursing homes. the above findings and plans of co rrect ion are disclosable f4 days follOWing

the date these documents are made avai lable to the facility . If def,ciencies are Cited , an approved plan of correct ion is requISite to continued program

partiCipation

State-2S67

I I

(X6) DAT E

13 of 13