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(F P.0041007 OF PUBLIC H~l · The "Surgical Documents Final Report/dated . 12/19/14, noted the...

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17:39 QUALITY MANAGEMENT (FA}:)8059887136 P.0041007 ,,_.,,, .. ,, '···'""'"''""" HSJ\L.iH AMO HUMAN SERVICES AGENCY OF PUBLIC H~l. TH BTAili.MENr ore Dliii-lCIENCleS (X1) PAOVIDERtSUPPUER/OLIA {X2.} MULTIPLE CONSTRUOTION (XS) DATE. SURVEY COMPLEITSO 08/09/2018 AND f'tAN Of! COF\Ht:CilON IDENTIFIOATlON NUMBER: A.BUILDING B.WING 050082 Nt\l\?iF. OF PROVIDER OR SIJPP!.11:H STRE!iff ADDRESS, CITY, STATE, ZIP CODE ~ff JOHN$ Ft!::~IONAL. .MJ:DSCAL CENTi=~ 1$00 NRo10 Av&, Oxnard. OA 930304122 Vf!N'J'URA COUNTY 8UMMARV STAT!::MENT OFDEFICIENCIES PROVIOt~•s PLAN OF OOAAEatlON (eAO.H DflFICll::N~Y MUST BE PREOEEDEO BY FULL (1:ACH CORRt:Ol'~ A(HlON $HOl)l.0 ea CR()$$- ~GULAfORY 014 LSC IDENTIFYING INrORMAilON) F\eFl5R5NCEO TO THEAPPROPRIATE DliFIOl~NCY) The t1,uow111g reflects the flndlnga of the Department . of Publlc He~lth durtng an fnspaotlon vJstt: Cmnp!a!nt Inteka Number: GA00450055 - Subitanllated Reprt3£Hmtlng the Department of Public Health: Surveyor ID# 1896 1 HFEN The inspection W81s limited to the specific facility ov@nt Investigated and does not represent the flrwJlrig!S. of a full rnspeQtlon of the faoJUty, H,sftdth ~mi Safety Code Section 1280.S(g): For purpo!iles of thla section "Immediate Jeopardylf m~ahs a $ltustfon In which the lh:::ensae 1 s noncompUanca with one ot mora requirements of Hoent1t.1ra han caused, or Js l!kely to cause, serious lnJtJry or de~th to_ the patient A health fac!Uty Ucensed purnuant to subcllvislon (a), (b) j or (f) of Seo.tlon 1250. shall report sn AdVtrtr$A eventto the-department no later than five days after th~ .adverse event has been detected. or, If that event !s ~·1, ongoing urgent or emergent threat to the ww!f~re, heatth1 or eafety of patianh~1 parsormel,. or visllors 1 not later than 24 hours after the adverse event n~e b~n detected. Dlaolosure of lndlvlduany ld$ntl'ttable patient information $hall be ronsfstent 1Nlth appllr.able law. He~!th ::md Safety Code Section 1279,1 (b) {1) (0) .. .,...,...____ For p1..n-poae9 of this seotlon, "adverse event'' Event f[J:30V9i 1 81.14/.2018 10!37:59AM R PROVlOER/SQPPLIER REPRESENTATIVE'S SIGNATURE (X6)0ATE Any d@fldiancy atatom&nt Griding wlth en a1terlsk (*) demotes a deficiency which the lnutttuUon may be ex<iused from correcting providing lt Is determined tl-J,\i!t otn~r si.ifegu1;1rd$ pn,v!d~ truffi¢i&.nt protooUon to the patlentl!i. Except for nursing hom~s. the findings above tra dlacloubte 90 days followlng the data of ti\,lfVt'Y wneth~r or not a plan Qf CQrrectlon ie pn;iv/ctijQ. For riurolng rn:irnlli$, ths $®V(;l tin~1ng11 and plat'lu of C(Jl'Motion are dliltlOt1$bla 1'4 daya 1ollowlng th$ dat~ thGs<S< doeum0ntt ara made avallabl& lo tho faclllty. If deflcfenclea Dfti cited, a.n 1tpproved plan of aorroctlon le requisite to oontlnuetJ program
Transcript
Page 1: (F P.0041007 OF PUBLIC H~l · The "Surgical Documents Final Report/dated . 12/19/14, noted the surgical count was . 11. correct. 11 . PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE

17:39 QUALITY MANAGEMENT (FA:)8059887136 P.0041007

,,_.,,, •.. ,, '···'""'"''""" HSJ\L.iH AMO HUMAN SERVICES AGENCY OF PUBLIC H~l.TH

BTAili.MENr ore Dliii-lCIENCleS (X1) PAOVIDERtSUPPUER/OLIA X2. MULTIPLE CONSTRUOTION (XS) DATE. SURVEY COMPLEITSO

08/09/2018

AND f'tAN Of! COF\Ht:CilON IDENTIFIOATlON NUMBER: A.BUILDING B.WING050082

Nt\l\?iF. OF PROVIDER OR SIJPP!.11:H STRE!iff ADDRESS, CITY, STATE, ZIP CODE

~ff JOHN$ Ft!::~IONAL. .MJ:DSCAL CENTi=~ 1$00 NRo10 Av&, Oxnard. OA 930304122 Vf!N'J'URA COUNTY

8UMMARV STAT!::MENT OFDEFICIENCIES PROVIOt~•s PLAN OF OOAAEatlON (eAO.H DflFICll::N~Y MUST BE PREOEEDEO BY FULL (1:ACH CORRt:Ol'~ A(HlON $HOl)l.0 ea CR()$$­~GULAfORY 014 LSC IDENTIFYING INrORMAilON) F\eFl5R5NCEO TO THEAPPROPRIATE DliFIOl~NCY)

The t1,uow111g reflects the flndlnga of the Department . of Publlc He~lth durtng an fnspaotlon vJstt:

Cmnp!a!nt Inteka Number: GA00450055 - Subitanllated

Reprt3£Hmtlng the Department of Public Health: Surveyor ID# 18961 HFEN

The inspection W81s limited to the specific facility ov@nt Investigated and does not represent the flrwJlrig!S. of a full rnspeQtlon of the faoJUty,

H,sftdth ~mi Safety Code Section 1280.S(g): For purpo!iles of thla section "ImmediateJeopardylf m~ahs a $ltustfon In which the lh:::ensae1s noncompUanca with one ot mora requirements of Hoent1t.1ra han caused, or Js l!kely to cause, serious lnJtJry or de~th to_ the patient

A health fac!Uty Ucensed purnuant to subcllvislon (a), (b) j or (f) of Seo.tlon 1250. shall report sn AdVtrtr$A

eventto the-department no later than five days after th~ .adverse event has been detected. or, If that event !s ~·1, ongoing urgent or emergent threat to the ww!f~re, heatth1 or eafety of patianh~1 parsormel,. or visllors1 not later than 24 hours after the adverse event n~e b~n detected. Dlaolosure of lndlvlduany ld$ntl'ttable patient information $hall be ronsfstent 1Nlth appllr.able law.

He~!th ::md Safety Code Section 1279,1 (b) 1) (0)

...,...,...____For p1..n-poae9 of this seotlon, "adverse event''

Event f[J:30V9i 1 81.14/.2018 10!37:59AM

RPROVlOER/SQPPLIER REPRESENTATIVE'S SIGNATURE (X6)0ATE

Any d@fldiancy atatom&nt Griding wlth en a1terlsk (*) demotes a deficiency which the lnutttuUon may be ex<iused from correcting providing lt Is determined tl-J,\i!t otn~r si.ifegu1;1rd$ pn,v!d~ truffi¢i&.nt protooUon to the patlentl!i. Except for nursing hom~s. the findings above tra dlacloubte 90 days followlng the data of ti\,lfVt'Y wneth~r or not aplan Qf CQrrectlon ie pn;iv/ctijQ. For riurolng rn:irnlli$, ths $®V(;l tin~1ng11 and plat'lu of C(Jl'Motion are dliltlOt1$bla 1'4 daya 1ollowlng th$ dat~ thGs<S< doeum0ntt ara made avallabl& lo tho faclllty. Ifdeflcfenclea Dfti cited, a.n 1tpproved plan of aorroctlon le requisite to oontlnuetJ program

Page 2: (F P.0041007 OF PUBLIC H~l · The "Surgical Documents Final Report/dated . 12/19/14, noted the surgical count was . 11. correct. 11 . PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY .DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF OEF[C!ENCIES (X1) PROVIDER/SUPPUER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY ANO PLAN· OF CORRECTION IDENTIF.ICATION NUMBER: COMPLETED

A.8UILOING

050082 B.WlNG 08/09/2018

STREET ADDRESS, CITY, STATE, ZIP CODENA.ME OF PROVIDER OR SUPPLIER

1600 N Rose Ave, Oxnard1 CA 93030w3722 VENTURA COUNTYST JOHNS REGIONAL MEDICAL CENTER

(X4)10 SUMMARY STATEMENT OF DEFICIENCIES 10 PROVIDER'S PLAN OF CORRECTION (XS) PREFIX (EACH DEFICIENCY MUST ae PRECEEDEO BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE. CROSS. COMPLETE

TAG REGULATORY OR LSC IDENTIFYING INFORMATION TAG REFERI!NCEO TO THE APPROPRIATE DEFICIENCY) DATE

to surgery that are intentionally retained.

Health and Safety Code Section 1280.3 (g):

For purposes of this section, 11 immedlate jeopardy11 means a situation In which the licensee's noncompllance with.one or tnore requirements of licensure has caused, or is likely to cause, serious Injury or death to the patient ·

This RULE: is not met as evidenced by:

Title 22, California Code of Regulatlons, Division 5, Chapter 1, Article 3, Section 70223 (b)(2), Surgical Service General Requirements:

(b) A committee of the medical staff shall be assigned responsibtllty for:

_ (2) Development, maintenance and Implementation 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 approved by the administration and medical staff where such is appropriate.

This RULE: is not met as evidenced by:

Based on interview and record review, the facility failed to ensure the surgical team members followed the facilities' policies and pr9cedures. This failure resulted In the

Event ID:30V911 8/9/2018 11:43:54AM

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMEN.TOF DEFICIENCIES (X1) PR.0VJOER/SUPPLIER/Cl1A X2) MULTIPLE CONSTRUCTION X3) OATE $URVEY ANO PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A.BUILDING

050082 B,WING 08/09/2018

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODI::

ST.JOHNS REGIONAL MEDICAL CENTER 1fi00 N Rose Ave, Oxnard, CA 93030•3722 VENTURA COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5) PREFIX EACH DEFICIENCY MUST BE PRECEEDED av FULL PREFIX EACH CORRECl;IVE ACTION SHOULD BE CROSS. COMPLETE

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG R~FERENCEO TO: THE APPROPRIATE DEFICIENCY) OATE

retention of a surgical straight suture pacing wir-e needle inside one patiant (Patient A), following open-heart surgery.

A review ofthe fE1cility's policy and procedure entitled., ''Acaounting­Sponges/Needles/Sharps/Misc. Small Items/Instruments," dated 4/14, setforth the

__ ...,.""··- ,, purpppas ,pfJhe PPUPY asfollows:.. ... •

"(1) Account for sponges! sharps, mfscellaneous small items and instruments used In operative/invasive proceduresj

(2) To safegua;rd the surgical patient from retained foreign bodies; and

3) To define surgical materials to be counted. the times counts are done and the documentation required."

The policy further set forth the following: "Counts are performed for all sponges, sharps, and miscellaneous small Items and Instruments to account for all items used during all invasive procedures to ensure that the patient Is not harmed by a retained foreign body. Instrument counts are performed on all procedures In which the likelihood exists that an Instrument could be retained. with the following exception: open hearts, spines and emergency traumas. Two~view post-operative x-rays anterior..posterior AP (to visualize through the front and back aspect of the chest) and Oblique (to visualize the ribs, sternum and chest at a 45

Event ID:30V911 8/9/2018 11:43:54AM

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CALIFORNIA HEALT.H AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC Hl=ALTH

srATEMENT OF DEFICIENCIES (X1) PROVlDE.R/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A.BUILDING

050082 a.WING 08/09/2018

STREET ADDRESS, CITY, STATE, ZIP CODENAME.OF PROVIDER OR SUPPLIER

1600 N Rose Ave,Oxnard, CA $3030•3722 VENTURA COUNTYST JOHNS REGlONAL MEDICAL CENTER

(X4)1D SUMMARY STATEMENT OF OEFIGIENClES ID PROVIDER'S PLAN OF CORRECTION (X5) PREFIX (EACH DEFICIENC,Y MUST BE PRECEEOEO BY FULL PREFIX (EACH CORRE.Cl'.IVE ACTION SHOULD SE CROSS, COMPLETE

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED tq THE APPROPRIATE DEFICIENCY) DATE.

degree angle) will be taken In the OR (operating room) 1nHeu of an instrument count for these procedures.11 The policy also set forth the following: 0Any rnember of tha surgical team may initiate a count, but It (is) the responsibility of the RN to ensure the countis peformed at designated times:" "Sponges, sharps and miscellaneous items wm be counted before the

,~·= =-= ,=. ,. QJosur~rnfa,cavitlwtthln !i£fil1!y11st count•.. -·- _ ,,.= . , • __ .. ""···- _ ,, , ·····--·"· ___

before wound closure begins (2nd count). at skin closure or the end of procedure (3rd or Final count);" and lfMisceHaneous Items will be counted before procedure is concluded ensuring only the device intended far implant was left in the patient." Finally, the following: 1ithe surgeon will account for all p.arts of sharps broken during the surgical procedure;'' "Members of the surgical team will account for instruments broken or dlsassembled during the surgical procedure;" and, "Immediately prior to the end of the procedure the physician wlll verify aU of the components not meant to be retained in the patient are accounted tor:' The pollcy defines "counts'' as "audibly and visually" counted.

A review of Patient A's medical recor.d Indicated that Patient A was admitted on 12/19/14 for open heart surgery to replace the mltral valve the valve between the two chambers of the left heart preventing blood from flowing back into the top chamber) and the aortic valve (a valve In the heart that prevents the blood from flowing back into the aorta when the heart pumps).

Event ID:3DV911 8/9/2018 11:43:54AM

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

(X1) PROVIOER/SUPPLIER/CLIA (X3) DATE SURVEY(X2) MULTIPle CONSTRUCTIONSTATEMENT OF DEflCIENCIES COMPLETEDIDENTIFICATION NUMBER;AND PLAN OF CORRECTION

A.BUILDING 08/09/20188,WING050082

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

ST JOHNS REGIONAL MEDICAL qeNTER 1600N Rose Ave. Oxnard, CA 93031.l-3722 VENTURA COUNTY

(X4)I0 SUMMARY STATEMENT OF DEFICIENCIES ID PRl=f=IX

TAG PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BV FULL

REGULATORY OR LSC IDENTIFYING INFORMATION TAO

An operative report dated 12/19/14, set forth that Patient A's physician and surgeon, MD 1, placed pacer wires (wires use to improve blood flow In the presence of irregular or abnormal heart beats) to pace the heart externally.

During an Interview with MD 1, on 7/28/15 at 12 p.m.1 he stated that during Patient A's surgery;

. _ ™K-- •. '.'.Qm,~pac~k~-~~-brok.!imt;.:\MD,.._.___ * ,=··•/ .."" ....,·"··

1 explained that a pacer-wire is a tong needle that consists ofJwo parts, a breakaway needle and a pacer wire. The breakaway needle section Is meant to exlt the skin, only the wire section stays Inside the chest attached to the heart in,orderto be able to pace the heart from the outside of the body; MD 1 stated; lione of the pacer wire needles broke off, the needle got lost inside the patient's abdominal tissue* I attempted to retrieve the needle, but I couldn't retrieve it." During the same Interview, MD 1 stated; 11 1forgot about the needle completelyt I didn't remember anything about the pacer-wire needle until recently when Quality contacted me to let me know there was a needle Inside the patient. At that time, I remembered the Incident again:'

On 7/27/15, at 11:30a.m., Patient A's clinical record was reviewed and there was no documentation In the patlent*s clinical record to reflectthe broken needle or that it was left inside Patient A.

The "Surgical Documents Final Report/dated 12/19/14, noted the surgical count was 11correct11

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

REFERENCED TO Jt!E APPROPRIATE DEFICIENCY)

(XS) COMPLETE

DATE

Event ID:30V911 8/9/2018 11:43:54AM

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OFPUBUC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTlPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A. BUILDING

050082 a.WING 08/09/2018

NAME OF PROVIDER OR SUPPUER STREETADDRESS, CITY, STATE, ZIP CODE

Si JOHNS REGIONAL MEDICAL CENTER 1600 N Rose Ave, Oxnard, CA 93030-3722 VENTURA COUNTY

(X4)10 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5) PREFIX (EACH DEFICIENCY MUST BE PRECEEOE BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS· COMPLETE

TAG REGULATORY OR LSC meNTIFYING INFORMATION TAG ReFERENCEO TO THE APPROPRIATE DEFICIENCY) DATE

for all three counts during Patient A's surgical procedure. Further review of the same document revealed that no AP and Oblique X-rays were taken on Patient A post operatively (end of surgery) in the OR as required by the facility's policy and procedure for open heart surgery.

. = - =

. . __ On 7/28/15 atJ~50_p.m., license- nurse (LN 2) ..... = ~-- - was Interviewed. LN2 confirmed durl.ngfue -•··

w··, -, ___ " _ -·= ............. " ""'" ·'" -~ ,__,, _, ....,....... ···-·· _

interview sh~ was presentand performed the final surgical Instruments count during Patient A's surgery, and that she was aware of one needle (pacer-wire needle) being inside the patient at the time· that she performed the final procedure count. LN2 stated, 111asked the scrub tech, where'.s the needle? The scrub tech (S$CT1) pointed to the patient. We both knew where the needle was (in the patient), that's why we accounted for the needle as number 1." LN 2 acknowledged during interview that counting withoutvisualizing the needles was not right nor correct. LN 2 further explained and confirmed that X--rays were not completed for Patient at the end of surgery.

On 7/30/15, at9:35 a.m., the senior scrub tech (SSCT 1) was interviewed. SSCT 1 confirmed she was present and performed the final surgical· Instruments count during Patient A's surgery. SSCT 1 stated the following during the interview: 11When we counted, I mentioned there was a needle inside the patient. Everyone knew one needle was still Inside the patient. We started counting by saying, 11 0ne needle in the

Event ID:30V911 8/9/2018 i1:43:54AM

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER; COMPLETED

A. BUILDING

050082 B.WING 08/09/2018

STREET ADDRESS, CITY, STATE, 21P CODENAME OF PROVIDE:R OR SUPPLIER

1600 N Rose Ave, Ol<nard, CA 93030-3722 VENTURA COUNTYST JOHNS REGIONAL MEDICAL CENTER

(X4)10 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5) PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS, COMPLETE

TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE O~FlCIENCY . DATE

patient/* that was needle number 1, then we continued counting the rest of the needles, the ones outside on the table. 11 SSCT 1 explained during Interview that she knew the needle was in the patient's abdomen and that other staff present at the surgery knew the needle was inside the patient. SSCT 1 stated that she did not know why the counts were documented as

·===-= '"", _c~cljf..l!,.nee.dle..waastilLinALdeJhe.. P,~W:mt... SSCT 1 confirmed that x-rays were not completed for Patient A at the end of the surgery..

During an Interview with.MD 1 on 7/2.8/15, at 12 p.m., he explained that the nurses told him the counts were correct, that Is why there was no need to have x~rays taken on Patient A. MD 1 confirmed X-rays were not taken on Patient A In the OR.

!

An interview on 7/28/15 at 11 :50 a.rn.• was conducted with LN 1. LN 1 confirmed she was present and performed the final surgical instruments count documentation during Patient A's surgery. LN 1 explained she was charting (documenting the events) on Patient A1s open-heart surgical procedure of 12/19/14. However, she wa.s far away and could not see wha.t was going on or hear the surgical team members.

A review of the medical record entitled, "Emergency Department (ED) Physician Notes," dated 7/6/15, revealed Patient A returned to the hospital's emergency room complaining of

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF OEFICIENCIES ANO PLAN Or CORRECTION

(XI) PROVIDER/SUPPLIER/CLIA IDENTIFICAilON NUMBER:

(X2) MULTIPLE CONSTRUCTION (X:l DATE SURVEY COMPLETED

A.BUILDING

050082 8,WING 08/09/2018

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

ST JOHNS REGIONAL MEDICAL CENTER 1600 N Rose Ave, Oxnard, CA 93030•3722 VENTURA COUNTY

(X41D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF COF.IRECTION (X5) PREFIX (EACH OE.F!C!ENCV MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS· COMPLETE

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

abdominal pain. The ED Physician notes indicated the following: "The patient presents with epigastrium (top of stomach) burning for past 15 days, tonight pt. (patient) states she notioed a sharp object protruding from her abdomen when she bent forward, pt. with a hx (history) of heart surgery in December. After obtaining .CT (computerized tomography), the 21?J~,PtWMI§D.!9-V§..~J:IJ..i.t.!9,&cal anesth_etlc,. ,,,.. ···­without compllcatlon. The object appeared-to be a surgical stralghtsuture needle."

According to the· CT scan report there was a "7 cm (2.75 inches) long metallic wire within the upperabdominal wall subcutaneous tissues is stable and probably represents a remnant epicardial (heart) pacing lead. The end of the wire appears to tent if not protrude beyond the skin surface. Correlation with clinical findings and the surgical history rec:ommertded."

A review of the ''Surgical Pathology Report/' dated7/6/15, further revealed a llSllvet.;.Uke object 7 centimeter (cm) in length, and approximately 1 · millimeter (mm In dlameter was the foreign object removed from Patient Ms abdomen.11

The failure of the surgeon and the OR staff to follow the facility's policies and procedures, as it pertained to performing two-view post-operative x-rays while in the OR on patients who had an open heart procedure, accounting for any and all items entering the patient and ensuring the Items came back out of the patient, during a

Event 1D:30V911 8/9/2018 11:43:54AM

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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

(XJ) DATE SURVEYSTAiEMENTOF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION ANO PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED

A.BU!LDING

050082 B,WING 08/09/2018

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

ST JOHNS REGIONAL Ml:OICAL CENTER 1600 N Rose Ave, Oxnard, CA 93030·3122 ·VENTURA COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5) PREFIX EACH DEFICIENCY MUST ae PREC.EEOED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS· COMPLETE

rAG RE.GULATORY OR LSC IDENTIFYING INFORMATION) TAG ReFERENCE;O TO THE APPROPRIATE Dl:FICIE:NCV) DATE

surgical procedure, resulted In the retention of a 2,75 Inch pacing wire needle in Patient A, and the necessity of an emergency room visit, a CT scan, and a second surgical procedure under local anesthesia to remove the retained needle.

The facility's failure to lmplement pollcles and procedures for surgical care and services is an Immediate jeopardy Inwhich the facility's noncompliance with one or mor,e requirements of Jlcensure has caused, or is likely to cause, serious Injury or death to the patient as defined under Health and Safety Code Section.1280.3 (g).

Event ID:30V911 8/9/2018 11:43:54AM

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17:40 QUALITY MANAGEMENT · f AX)8059887136 P.0051007

:A 00450055

immediate Correcttve Action: tt Case reviewed by departments of surgery and radiology, 5/18/15 e Reviewed prqcedure for red tag tracking damaged items in.the OR and Sterile Processing

Clf:partment, (6/12/15) e Dt;partment of Surgery informal rounds were conducted by the Risk Manager reminding staff of

the hospital gMerar high risk event reportrng, and reporting spedflcally related to retained svrgfcal items. 6/15/15)

* Ci1t~e presented to the Quality Improvement committee by Manager of Quality, 6/17/1S

!iiystemath: Corrective Action: ® Broken/Malfunctloning Instrument Policy was created and approved by the Medical Executive

Committee. (10/5/16 $ Dignity Health Prevention of Retained Surgical Items was approved by Medical Executive

Committee. 10/5/16) lit Communication from the Chief of Staff to all physicians on the importance of confirming the

final count as outlined In the approved poHcy. 10/10/16 * Daily intraoperative staff huddles rncludereinforcement of preventionof retained items

requirements. (l0/10/16) "' Daily staff huddles in procedural departments Include reinforcement of prevention of retained

surgical item requirements. (10/10/16) * Education session conducted with procedural departmental leaders to review the revised

Broken/Malfunctioning Instrument Policy andPreventlon of Retalned,surgical Items policies and st~ff huddles. (10/14/16)

® written communication disseminated to all procedurat departmental leaders by the Interim iv1anager Perioperative Services to review new 13roken/Malfunctfon Instrument pollcy and procedure and implementation ofbroken instrument log. (10/14/16)

1.1 Expert Safety Consultant from Dignity Health ls scheduled to conduct education and training to surgeons on the Prevention .of Retained Surgical Items. (10/21/16)

9 Formal education was rotled .out to aH operative/procedure cUnlcal staff on 10/10/16 using tools, post-tests1 and observation evaluations as directed by Dignity Health based on the Prevention of Retained Surgical Items Policy" (10/27/16)

t Competency ·assessment for retained surgfcal Items was revised and initiated on 10/03/16 by the Clinical Supervisor for operative/procedural staff with full completion by 10/27 /16 or prior to next scheduled shift 10/27/16) _

w Competency assessment was created t;1nd initiated on 10/10/16 by the Clinical Supervisor for Broken Equipment through direct observation or verbal response for operative/procedural staff with full completJon by 10/27/16 or prior to next scheduled shift. (10/27/16

Moriitor: 20 observation rounds conducted monthly to verify perioperative staff complete all requirements retat~d to the prevention of retained surgical items. Results reported to surgery Committee, Hospital Quality Committee, Medical Executive Committee (MEC), Quality.Improvement Committee (Q!C), and Governing Board untH 100% compliance sustained for 4 months. (10/10/16)

~1ii!sponsible P~rson(s: Manager Perioperative Services


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