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LUKE'S CAMPUS HOSPITAL - California Department of … D… ·  · 2017-07-05the truth of the fact...

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLI C HEALTH STATEMENT OF DEFICIENCIES AND PlAN Of CORRECTION (Xl ) PROVIDERISuPP .. ..IERICllA IDENTIFICATION NUMBER: (X2) MULTIPLE CONSTRUCTION A.. BUILDI NG (X3) DATE SURVEY COMPlETED 050055 B. WING MAY I 6 201 NAME OF PROVIDER OR SUPPLIER CALIFORNIA PACIFIC MEDICAL CENTER - ST. LUKE'S CAMPUS HOSPITAL STREET AD DRESS, CI TY . STATE, ZIP CODE (X4) ID PREFIX TAG 3555 Cesar Chavez, San Francisco, Ca COUNTY SUMMARY STATEMENT OF DEFICIEN CIES (EACH DEFICIENCY MUST BE RPECEDED BY FULL REGUlATORY OR LSC IDENTIFYING INFOOMATION) The followi ng reflects the fi nd ings of the Department of Public Heal th during an inspection vi sit: Complaint Intake Number: CA00272808 - Substantiated Representing the Department of Public Health : Surveyor 10 # 26616 , HFEN The inspection was limited to th e specific fac ili ty event investigaled and does not rep resent th e findings of a full inspection of the fac ili ty. Health and Safety Code Section 1280.1 (c): For purposes of this section "immediate jeopa rd y" mea ns a situation in which the l ic ensee's noncompliance with one or more requirements of li censure has caused, or is like ly to cause , serious injury or death to the patient. 10 PREFIX TAG PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTI ON SHOULD BE CROSS- REFERENCED TO THE APPROPRIATE DEFICIENCY) Please Note: The following consti tutes Californ ia Pa ci fic Med ical Ce nter (CPMC) - St. Luke's Campus Hospital's credible evidence of correction of the alleged deficiencies cited by the California Department of Public health in the Statement of Deficiencies Form CMS-2567 dated 6/24/ 11 . Preparat ion and lor execution of th is credible evidence does not constitute admission of agreement by the provider of the truth of the fact alleged or the conclusions set forth in the Statement of Deficiencies . Corrective Action : 1. The central line insertion process was changed to i nc lude post-p rocedure communicat io n and documentation to 'X>I COMPLETE DATE He alth and Sa fety Cod e Section 1279 .1(b)(1 ) (0) account f or the removal of the guidewire f 7/1/ 11 (b) For pu rposes of this section, "ad verse event" includes any of th e following: (1) Surgical events, including the following: (0) Retention of a foreign object in a patient after surgery or other procedure, exclu ding objects intentiona ll y implanted as part of a planned intervention and objects present prior to surgery that are intent io nally retained. T22 0l V5 CH1 ART3-70223(b) (2) Service General Req ui rements Surgical (b) A committee of the medical staff shall be Evenl} p :6BX411 r 412012012 PROVIDER/SUPPLI ER REPRESENTATIVE'S SIGNATURE "Il l. \. I" introducer used in th e procedure. CPMC providers use a Central Line Procedure Checklist. The Chec kl ist was revised to include a space for documenti ng 7/20/11 the removal of the guidewire 1 introducer. A co py of the checklist is attached . Monitoring Process: The Centra l Li ne Insertio n Chec klist is us ed ongo ing to provi de documentation of all componen ts of the insertion procedure. A form is comp leted for every central line insertion in order to be sure that all processes related to central line placement are executed with each line placement. 10:06:46AM II (X6)OATE M. IJ A.ny deficiency sial emeni .h an (.) a defICiency which institution may excused from it is determined 0 that Olher saf eg uards provide sur/tO nl p fOt ecli on to \he patien ts . Excepl for nur.nng homes, the rlOdl rlgS aboVe are d tSClosable 90 days bllowing the dale of survey whether or not a plan ott: rredKlfi Is provided. For nursing homes. the abollB findings and pl ans of correction are disclosa ble 14 days following the date lhese documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisi te 10 continued prog ram pa rt iCipa tion, itate-256 7 1 018
Transcript

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES AND PlAN Of CORRECTION

(Xl ) PROVIDERISuPP .. ..IERICllA IDENTIFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION

A.. BUILDING

(X3) DATE SURVEY COMPlETED

050055 B. WING MAY I 6 201 06/2~/2011

NAME OF PROVIDER OR SUPPLIER

CALIFORNIA PACIFIC MEDICAL CENTER - ST.

LUKE'S CAMPUS HOSPITAL

STREET ADDRESS, CITY. STATE, ZIP CODE

(X4) ID PREFIX

TAG

3555 Cesar Chavez, San Francisco, Ca 94Si~E~¥~~~fISCO COUNTY

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

REGUlATORY OR LSC IDENTIFYING INFOOMATION)

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

Complaint Intake Number: CA00272808 - Substantiated

Representing the Department of Public Health : Surveyor 10 # 26616, HFEN

The inspection was limited to the specific facility event investigaled 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.

10 PREFIX

TAG

PROVIDER'S PlAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS­

REFERENCED TO THE APPROPRIATE DEFICIENCY)

Please Note: The following consti tutes Californ ia Pacific Medical Center (CPMC) - St. Luke's Campus Hospital's credible evidence of correction of the alleged deficiencies cited by the California Department of Public health in the Statement of Deficiencies Form CMS-2567 dated 6/24/11 . Preparation and lor execution of this credible evidence does not constitute admission of agreement by the provider of the truth of the fact alleged or the conclusions set forth in the Statement of Deficiencies.

Corrective Action :

1. The central line insertion process was changed to include post-procedure communication and documentation to

'X>I COMPLETE

DATE

Health and Safety Code Section 1279.1(b)(1 ) (0)

account for the removal of the guidewire f 7/1/11

(b) For purposes of this section, "adverse event" includes any of the following: (1) Surgical events, including the following: (0) 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 0lV5 CH1 ART3-70223(b) (2) Service General Requirements

Surgical

(b) A committee of the medical staff shall be

Evenl} p :6BX411 r 412012012

\BO~RY DIRECT~R'S{>R PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

"Il l. \. I"

introducer used in the procedure.

CPMC providers use a Central Line Procedure Checklist. The Checkl ist was revised to include a space for documenting 7/20/11 the removal of the guidewire 1 introducer. A copy of the checklist is attached.

Monitoring Process:

The Central Line Insertion Checklist is used ongoing to provide documentation of all components of the insertion procedure. A form is completed for every central line insertion in order to be sure that all processes related to central line placement are executed with each line placement.

10:06:46AM

II (X6)OATE

M. IJ JoI~ A.ny deficiency sialemeni ~ndi ng ~ .h an asteri~k (.) denote~ a defICiency which ~e institution may ~ excused from ~~!:~ Pro:~~g it is determined 0 that Olher safeguards provide sur/tO nl pfOteclion to \he patien ts. Excepl for nur.nng homes, the rlOdlrlgS aboVe are d tSClosable 90 days bllowing the dale of survey whether or not a plan ott: rredKlfi Is provided. For nursing homes. the abollB findings and plans of correction are disclosable 14 days following the date lhese documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite 10 continued program partiCipation,

i tate-2567 1018

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY r ~ DEPT OF PUBUC HEALTH DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (Xl ) PROVIDERISUPPUER/CUA (X2) MULTIPLE CONSTRUCnON (X3)OATESURVEY AND PlAN OF CORRECTION IDENTIFICATION NUMBER:

A.. BUILDING U . 1 6 1011 COMPLETED

050055 B. WING

06/2412011

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE ' l,.I ~ NCISCO ,~

CALIFORNIA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 9411 0-4403 SAN FRANCISCO COUNTY

LUKE'S CAMPUS HOSPITAL

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION PREFIX (EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS·

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE DEFICIENCY)

Continued From page 1

assigned responsibility for: Copies of all completed Central Line Insertion Checklist and Procedure Note

(2) Development, maintenance and forms are forwarded to the Quality implementation of written policies and department. The forms are reviewed to procedures in consultation with other confirm the line insertion process was appropriate health professionals and followed and the guidewire I introducer was administration. Policies shall be approved by removed. the governing body. Procedures shall be approved by the administration and medical Responsible Person: staff where such is appropriate. Director, Risk Management

This regulation was not met as evidenced by: Corrective Action :

Patient 1 was admitted to the Emergency 2. The Emergency Department is staffed by Department on _ 11 with diagnoses experienced Emergency Department including diabetic ketoacidosis (serious physicians however; the group has limited complication of diabetes that occurs when experience in placing catheters used for there's little insulin and the body breaks down dialysis access. fats producing acids called ketones) acute kidney failure, and lactic acidosis (an acid There was an in-service presentation and produced by muscle cells and red blood cells discussion at the Emergency Department that build up in the bloodstream faster than it physician meeting. Additional training on can be removed). the use of the dialysis vascular access kit

The _ 11 emergency room (ER) Admission was provided to the ED physicians.

notes indicated Patient 1 needed an Monitoring Process: emergency dialysis due to possible kidney failure and lactic acidosis. The doctor wrote , " ... Placement of a dialysis vascular assess A Hemacath (catheter used for hemodialysis) catheter is a low volume procedure for the was inserted in the f ight femoral (right groin) ... Emergency Department. Each time the A guide-wire was inserted and a dilator was procedure is performed, it will be reviewed used and the catheter was inserted with about by the ED physician group. 10 mi. of blood loss without complications. All ports were flushed after good aspiration and Responsible Person: smooth flow of blood. This was sutured in placed and dressed without complication .... The Medical Director, Emergency Department

Even110.68X411 4I20I2012 10:06:46AM

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

tvJy derlCiency statement ending with an asterisk (0) denotes a deficiency which the instijuijon may be excused from correding provid ing it is determined

tha t other safeguards provide sufficient protection to the patients. Except fO( nursing homes. the findings above are d isclosable 90 days i;)llO'Mng the date

ol sufV8y whether 0( not a plan 01 correcllon is provicled. For nursing homes. the above findings and plans of COfTectioo are disclosable 14 days following

the date these documents are made available to the facility. II deficiencies are cited, an approved plan 01 correction Is requisite to continued program oartieipation.

)tate·2567

(X5) COMPLETE

DATE

quarterly

.

6/15/11

June 2011 and ongoing

(X6) DATE

2018

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH STATEMENT OF DEFICIENCIES (Xl) PROVIDERlSUPPUERlCUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A. BUILDING

050055 B. WING

0612412011

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

CALIFORNIA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 9411 0-4403 SAN FRANCISCO COUNTY LU KE'S CAMPUS HOSPITAL

(X4)ID SUMMARY STATEMENT OF DEFICIENCIES 10 PROVIDER'S PLAN OF CORRECTION PREFIX (EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG I

REFERENCED TO THE APPROPRIATE DEFICIENCy)

Continued From page 2 ,

patient was admitted 10 Ihe ICU (Inlensive Care

I

Unit), .. . 10 have emergent dialysis ... "

The _ 11 intensive care unit (ICU) doctor History and Physical Examination notes indicated, "Bradycardic arrest (heartbeat drops below 50 beats/minute) during HD

I (hemodialysis). He responded to epinephrine (medication 10 increase heart rate) and

I bicarbonate (medicalion 10 neutralize too much I acid in the blood).~

The . 11 Pulmonary Critical Care Consultation indicated, under History of Present Illness " ... Upon arrival to the ICU, it was

I noted that he was very tachypneiC (rapid breathing), had altered mental status, had bradycardic arrest (arrhythmia or abnormally I slow heartbeat less than 50 beats per minute)

I short CPR (cardiopulmonary resuscitation), apparently difficult intubation. ..... Under section

CA DEPT OF PUBUC HEALTH Studies: ~".Chest x·ray post intubation." also noted that he had something that looked like a guide ' wire at the level of his right ventricle (right lower chamber of heart) and extending I MIY 1 6 1011 up to the superior vena cava (large vein that carries blood from the upper part of the body to the right side of the heart) and that was . L&C DiVISION confirmed twice on the chesl x-ray" Under I SAN FRANCISCO section Plan: # 10. Of note, possibility of retained wire will be addressed and patient may need inlerventional radiology procedure to ~fish it out~ ....

Review of the manufacturer's Hemo-Cath I

Event ID.6BX411 412012012 10:06:46AM

~BORATORY DIRECTOR'S OR PROvtOERlSUPPlIER REPRESENTATrJE'S SIGNATURE TITlE

.... ny derlCiency statement ending with an aslerisk (' ) denotes a deficienC)' which the Institution may be excused from correcting providing it is determined that other safeguards provide sufficient prolection lo the patienls. Excepl for nursing homes, the find ings above are dlsclosable 90 days following the date of survey whether or not a plan of c()(rection is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following Ihe dale these documents are made available 10 the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participatlon.

--_ ..... _----._- - -.--- ... . _-ilate-2567

(X5) COM?LETE

DATE

I

I

(X6) OATE

3018

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (Xl) PROVIDERlSUPPLIERlCLIA AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

A BUILDING

050055 B, WING

0612412011

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

CALIFORNIA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 94110-4403 SAN FRANCISCO COUNTY

LUKE'S CAMPUS HOSPITAL

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES '0 PROVIDER'S PLAN OF CORRECTION PREFIX (EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS·

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE DEFICIENCY)

Continued From page 3

Instructions for Use indicated, " ... Read instructions carefully before using this device .. .. Caution: The length of the wire inserted is determined by the size of the patient. ... Cardiac arrythmias (heart rhythm which could be abnormally rapid or abnormally slow) may result if guidewire is allowed to pass the right atrium (right upper chamber of heart)."

The Hemo-Cath guidewire was inserted from the right femoral vein in which the guide-wire could have traveled in the direction of the blood flow from femoral vein to the heart where the catheter lodged and was seen on the chest X-Ray. This occurrence had the potential to cause the bradycardic arrest (a cardiac arrythmia) when the guide-wire passed the right atrium (upper chamber of heart) going Ihru the right ventricle (right lower chamber) as the Hemo-Calh instruction for use indicated, "Caution: Cardiac arrythmias may result if guidewire is allowed to pass the right atrium." CA DEPT OF PUBLIC HEALTH The _ 11 Radiology Consultation Report indicated, "Emergency consent obtained. I was MAY 1 6 2m2 I asked by Dr .... to perform emergent guidewire

I retrieval from the vena cava. Patient I L&CDMSION transferred emergently from SI. Luke's

Hospital. Skin anesthetized with 1 % Lidocaine SAN FRANCISCO solution. Indwelling right femoral venous catheter removed and exchanged with a French sheath. Using a 15 mm (millimeter) loop snare, the indwell ing guide-wire was then , removed in its entirety with careful observation ,

I i Event ID:6BX41 1 4/20/2012 10:06:46AM

!o"BORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

tl.ny deficiency statemenl ending with an asterisk (0) denotes a deficiency which the inst itution may be excused from correcting providing ij is determined

that other saleguards provide sufficienl protection to the patients. Except lor nursing homes, the findings above are disclosable gO days bllowing Ihe date

01 survey whether or not a plan 01 correction is provided. For nursing homes. the above findings and plans 01 correction are dlsclosable 14 days loliowing

Ihe date these documents are made available to the lacility. II deficiencies are cited. an approved plan of correcUon is requisite to continued program participation.

3Iate-2567

(X5) COMPLETE

DATE

(X6) DATE

40f8

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (Xl) PROVIDER/SUPPLIER/CLIA AND PLAN OF CORRECTION IDENTIFICATION NUMBER

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

A. BUILDING

050055 B. WING

06/2412011

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

CALIFORNIA PACIFIC MEDICAL CE NTER - ST. JSSS Cesar Chavez, San Francisco, Ca 941 HI-440J SAN FRANCISCO COUNTY

LUKE'S CAMPUS HOSPITAL

(X4)ID SUMMARY STATEMENT OF DEFlCIENCIES '0 PROVIDER'S PLAN OF CORRECTION PREFIX {EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS·

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE DEFICIENCY)

Continued From page 4 of the guide-wire as it traverses the right atrium (right upper chamber of heart). Guidewire removed In its entirety. Guidewire sent for

i appropriate pathologic analysis. Indwelling

I sheath removed and replaced with vas (vascular) catheter. Vas catheter sutured In place."

During a concurrent observation and interview on 6/24/11 al 4:45 PM, Dr. A stated Patient 1 was seen by another doctor in the ER and he recommended a Hemacath so the patient could have an emergency dialysis. He said that he had placed dialysis access before but when he looked at the Hemo-Cath kit in the ER, he said, "I wasn't fam iliar of the Hemo-Cath kit because it was not the usual kit that I used but when I opened the kit and saw that the only difference was the Vascu-Sheath (type of dilator with sheath or covering), I thought I knew how to use it" When he was asked if he had read the Hemo-Cath instructions for use, he said, ''The kit does nol come with instructions but Ihe CA DEPT OF PUBLIC HEALTH insertion procedure and techn ique would be the same for all catheters, so I really thought I could use the Hemo-Cath ." He was asked to

MAY 1 6 2012 describe and demonstrate the procedure he used on how he inserted the Hemo-Cath to Patient 1. He opened the Hemo-Cath kit and L&C DIVISION using the contents of the kit, he described and SAN FRANCISCO demonstrated the procedure as follows:

1 . He prepped, draped and anesthetized the I site on the right groin, he inserted the introducer needle to the site, thread the

Event ID.6BX4 11 4/2012012 10:06:46AM

"'BORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

t..ny deficiency statement ending with an asterisk (") denotes a deficiency which the institution may be excused from correcting providing it is delermined

Ihat other safeguards provide sufficient protection to the patients. Except for nursin9 homes, lhe findings above are disclosable 90 days tlilowing the date

of survey whether or not a plan of COfrection is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days 10Howing

the date these documents are made available to Ihe facil ity. II deficiencies are cited, an approved plan of correction is requisite to cooUnued program participation.

------ -- - -----' late·2567

(X5) COMPLETE

DATE

i

I

,

(X6) DATE

5018

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAL T H STATEMENT OF DEFICIENCIES (Xl ) PRQVIDERlSUPPlIERJCLlA (Xl ) MULTIPLE CONSTRUCTION (Xl) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

A. BUILDING COMPLETED

050055 B. WING

0612412011

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

CALIFORN IA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 94110-4403 SAN FRANCISCO COUNTY

LUKE'S CAMPUS HOSPITAL

(X4) 10 SUMMARY STATEMENT OF DEFICIENCIES 10 PROVIDER'S PlAN OF CORRECTION PREFIX (EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-

TAG REGUlATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCeO TO THE APPROPRlATE DEFICIENCy)

Continued From page 5

guide-wire in to the needle and advanced the guidewire (27.5 inches length) about 1/2 to

, 2/3's of the length of the wire then removed the introducer needle wh ile securely holding the guidewire on his left hand.

I 2. He took the scalpel, made a slit in to the skin I site and thread the 12F Dilator and the 13F

Vascu·sheath into the guidewire and dilated I the vein.

3. He removed the 12F Dilator and left the 13F Vascu·Sheath and <he guidewire inside <he vein.

4. He took the double lumen catheter, thread it into the guide-wire and the 13F Vascu·Sheath. I During the observation on 6124/11, as soon as Dr. A finished threading the double lumen catheter into the guide·wire and the 13F Vascu-Sheath, he let go of the guide-wire, and

I CA DEPT OF PUBLIC HEALTH the guide·wire was no longer visible. The only

th ing he was holding securely was the catheter. At this point, he was stopped in continuing his demonstration and was asked if he could see MI' 1 6 1011 how he let go of the guidewire and losl sight of it during (he procedure. He said, "YesM

• He added that at the time of the procedure, he did L&C o;VISION not realize that the guidewire was inside the SAN FRANCISCO catheter and 13F Vascu-Sheath, because he was focused on the Vascu-Sheath being left in place with the catheter. He said he realized the catheter won't work with the Vascu·Sheath in and after realizing thaI, he said he had no

Event ID:6BX411 4f2012012 10:06:46AM

,,-BORATORY DIRECTOR'S OR PROVIOERfSUPPLIER REPRESENTATIVE'S SIGNATURE Tnl.'

l\rIy defiCiency statement ending with an asterisk (0) denotes a defICiency Yotlich the institution may be eJ:cused from correcting providing it is determined Ihat other safeguards provide sufficient prolection 10 the patients. Except for nursing homes, the findings above are disclosable 90 days following the date

of survey whether or not a plan of corredion is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date Ihese documents are made available to the facil ity. If deficiencies are ciled. an approved plan of correction is requis~e 10 continued program participation.

:;tate-2567

(><5) COIIPLETE

DATE

,

I (X6) DATE

• ,,18

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH STATEMENT OF DEFICIENCIES (Xl) PRDVIDER/SUPPLIER/CLIA AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED

A. BUILDING

050055 B. WING

06f2412011

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

CALIFORNIA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 9411 0-4403 SAN FRANCISCO COUNTY

L.UKE'S CAMPUS HOSPITAL

(X4) 10 i SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION PREFIX , {EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS-

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) , TAG REFERENCED TO THE APPROPRIATE DEFICIENCY) I

Continued From page 6 I other option but to remove the catheter and place a new one. He opened another vascular kit (a different kit from Hemo-Cath) and inserted another guidewire into the site. He was asked if he checked where was the first guidewire he used, he said, "I looked for it but I thought I dropped it on the floor when I removed the 13F Vascu-Sheath and the double lumen catheter. I did not think it was inside the patient until they told me that the guidewire was seen on the X-ray."

Review of the manufacturer's Hemo-Cath Instruction For Use indicated, " ... Read instructions carefully before using this device .. .. Caution: .. . The guidewire should be held securely during this procedure ... . Once proper placement is confirmed, remove

! guidewire and stylet and close the clamp .... ~

An article from Nothing Left Behind: A National I CA DEPT OF PUBLIC HEALTH Surgical Patient-Project to Prevent Retained Surgical Items (an educational site intended for use by the healthcare organization to prevent MA 6 2012 retained surgical item at http://nothingleflbehind.org/lnstruments.html titled retained Surgical Instruments and Other L&C DiVISION Items, indicated " ... Guidewires inserted as part

I SAN FRANCISCO

of the central line placements have not uncommonly been lost in vessels and require interventional radiographic retrieval. A recommendation for the guidewires is to place a clamp on the end of the guidewire before inserting so it cannot slip away and replace the clamp as soon as possible after the catheter

Event ID.68X411 412012012 10.06A6AM

~BORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TillE

A.ny deficiency statement ending with an asterisk (0) denotes a deficiency which the institution may be excused Irom correcting providing it is determined

[hat other safeguards provide sufficient protection to the patients. Except for nursing homes, the findings above are disclosable 90 days bllowing the date

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

the date these documenls are made available to the lacility. II deficiencies are cited, an approved plan of correction is requisite to continued program participation.

>tale-2567

(X5) COMPLETE

, DATE

(X6) DATE

7 of a

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (XI ) PROVIDERlSUPPLIER/CLIA AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

(X2) MULTIPLE CONSTRUCTION (Xl) DATE SURVEY COMPLETED

A. BUILDING

050055 B. WING

06/24/2011

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

CALIFORNIA PACIFIC MEDICAL CENTER - ST. 3555 Cesar Chavez, San Francisco, Ca 94110-4403 SAN FRANCISCO COUNTY

LUKE' S CAMPUS HOSPITAL

, (X4)ID SUMMARY STATEMENT OF DEFICIENCIES 1 ID PROVIDER'S PlAN OF CORRECTION PREFIX (EACH DEFICIENCY MUST BE RPECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS·

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE DEFICIENCY)

Continued From page 7

has been slipped over the guidewire to prevent ,

the wire from being lost in the vessel as the catheter advanced .. . "

'.

Review of the _ 11 Universal Protocol Pre-Procedural Safety Checklist form did not include the guidewire as one of the items to be accounted for and checked before and after vascular catheter insertion procedure, to ensure that any members of the team disposed the guidewire appropriately after the insertion of the catheter, and not left in the patient's body.

In an interview on 6/24/11 at 5:30 PM, the Director of Risk Management stated that Ihe facility did not have policy and procedure for vascular catheter insertion because the procedure was done by a phys ician. She further stated that although vascular catheter insertion is an invasive procedure, there was no policy to include the counting of guidewire in CA DEPT OF PUBLIC HEALTH

, the Pre-Procedural Safely Checklist form .

I The facility's failure to prevent the retention of M: 6 2011 a guidewire during catheter insertion is a deficiency that has caused, or is likely to cause, serious injury or death to the patient, L&C DiVISION and therefore constitutes an immediate SAN FRANCISCO jeopardy within the meaning of Health and I Safety Code Section 1280.1.

i , I ,

I i I

Event ID.68X411 412012012 10.06.46AM

"BORATORY DIRECTOR·S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE

o,ny deficiency statement ending with an asterisk (') denotes a deficiency which the institution may be excused from correcting providing II is determined

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

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

the date these documents are made available to the faCility . Jf deficiencies are cited, an approved plan of correction is requisite to continued program participation.

- _ ... _---

,\ate-2567

(X5) COMPLETE

DATE

,

(X6) DATE

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