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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH STATEMENT OF DEFICIENCIES AND PlAN OF CORRECTION (X1) PROVJOER1SUPPUER/CLIA IDENTIFICATION NUMBER (X2J MUL i iPLE CCNSTRUCTiot4 (Xl) DATE SURVEY COMPLETED 050609 ABUILDING ll. WING 10/12/2010 NAME OF PP.OVIOER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE Kaiser Foundation Hospital- Orange County • Anah!!im 3440 E La Palma Ave, Anaheim, CA 92806-2020 ORANGE COUNTY (X4) ID PREFil( TAG SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEOED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) The following reflects the findings of the Depanment of Public Health during an inspection visit: Complaint Intake Number: CA00239949 ·Substantiated I Representing tile Department of Publfc Health: I Surveyor ID # 25052, Pharmaceutical Consultant II The inspection was limited to the specific facility I event investigated and does not represent the findings of a full inspection of the facility. I Health and Safety Code Section 1280.1(c}. For purposes of this section "immediate Jeopardy" means a situation in wh ich the licensee's I noncompliance with one or more requirements of licens.ure has caused. or is likely to cause, serious I injury or death to the patient I Health and Safety Code Sect ion 12791 (c)· I The facility shall inform tile patient or the party 1 1 I responsible for the patient of the adverse event by the time the report is made. The CDPH verified that the facility had informed the I patient or party responsible for the patient of the 1 adverse event by the time the report was made. DEFICIENCY JEOPARDY CONSTITUTING Title 22, Division 5, Chapter 1 §70263. IMMEDIATE ID PRI:f.IX lAG Event ID:E6TS11 4/2/2014 l ' R PROVIDER/ SUPPLIER REPRESENTATIVE'S SIGNATURE PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS· REFERENCED TO THE APPROPRIATE DEFICIENCY\ 3 ror btginning of Action rl3ns 3:07:19PM TITLE receipl of l.he entire citation pac ket Pagefsi ·1 tl>ru .9 Any deficiency tlatemenl ending wilh an asterisk (•) der>otes a Which lhe inslitution may ba excased from oorreding it i& delermined that other safeguarc;s provide sufficient protection to the pati ents. Excepl for nursing homes. !he findings above are disclosab(e 90 days following the date of survey whether or nola plan of correction is provided. For nursing homes, the above findings and plans of correcticn are disclosable 14 days following the date t. he. se documents are made available to the facility ff deficiencies are cited. an approved plan of correction is requisite to continued program participation. Staae-2567 (X5) COMPLETE DATE Page 1 of9
Transcript
Page 1: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES

AND PlAN OF CORRECTION

(X1) PROVJOER1SUPPUER/CLIA

IDENTIFICATION NUMBER

(X2J MUL i iPLE CCNSTRUCTiot4 (Xl) DATE SURVEY

COMPLETED

050609

ABUILDING

ll. WING 10/12/2010

NAME OF PP.OVIOER OR SUPPLIER STREET ADDRESS. CITY. STATE. ZIP CODE

Kaiser Foundation Hospital- Orange County •

Anah!!im

3440 E La Palma Ave, Anaheim, CA 92806-2020 ORANGE COUNTY

(X4) ID

PREFil(

TAG

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

REGULATORY OR LSC IDENTIFYING INFORMATION)

The following reflects the findings of the Depanment

of Public Health during an inspection visit:

Complaint Intake Number: CA00239949 ·Substantiated

I Representing tile Department of Publfc Health:

I Surveyor ID # 25052, Pharmaceutical Consultant II

The inspection was limited to the specific facility

I event investigated and does not represent the

findings of a full inspection of the facility.

I Health and Safety Code Section 1280.1(c}. For purposes of this section "immediate Jeopardy"

means a situation in which the licensee's

I noncompliance with one or more requirements of licens.ure has caused. or is likely to cause, serious

I injury or death to the patient I

Health and Safety Code Section 12791 (c)·

I The facility shall inform tile patient or the party 1

1

I responsible for the patient of the adverse event by the time the report is made.

The CDPH verified that the facility had informed the I patient or party responsible for the patient of the

1

adverse event by the time the report was made.

DEFICIENCY JEOPARDY

CONSTITUTING

Title 22, Division 5, Chapter 1 §70263.

IMMEDIATE

ID PRI:f.IX

lAG

Event ID:E6TS11 4/2/2014

l

' R PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

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

REFERENCED TO THE APPROPRIATE DEFICIENCY\

""S~~ Pag~: 3 ror btginning of Action rl3ns

3:07:19PM

TITLE

~--:r.ing receipl of l.he entire citation packet Pagefsi ·1 tl>ru .9

Any deficiency tlatemenl ending wilh an asterisk (•) der>otes a deflc~ney Which lhe inslitution may ba excased from oorreding ~rovidin9 it i& delermined

that other safeguarc;s provide sufficient protection to the patients. Excepl for nursing homes. !he findings above are disclosab(e 90 days following the date

of survey whether or nola plan of correction is provided. For nursing homes, the above findings and plans of correcticn are disclosable 14 days following the date t.he.se documents are made available to the facility ff deficiencies are cited. an approved plan of correction is requisite to continued program

participation.

Staae-2567

(X5)

COMPLETE

DATE

Page 1 of9

Page 2: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIOERISUPPLIERICLIA IDENTIFICATION NUMBER:

050609

(X2) Mt.iL TIPLE CONSTRUCTION

A BUILDING

B. 'MNG

(X3) DATE SURVEY COMPLETED

10/12/2010

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

Kaiser Foundation Hospital ·Orange County •

Anaheim

3440 E La Palma Ave, Anaheim, CA 92806·2020 ORANGE COUNTY

(X4)1D PREFIX

TAG

I

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEEOE:D BY FULL REGULA TORY OR LSC IDENTIFYING INFORMATION)

Pharmaceutical Service General Requirement.

(c) A pharmacy and therapeutics committee, or a committee of equjvalent composition, shall be

I

I established. The committee shall consist of at least one physician, one pharmacist, the director of I nursing service or her representative and the administrator or his representative.

(1) The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement. storage, distribution, dispensing and use of drugs and chemicals. The I pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and

I implementations of procedures. Policies shall be approved by the governing body. Procedures shall

1 be approved by the administration and medical staff where such is appropriate.

The above regulations were NOT MET as evidenced

by:

Based on interview and medical record review, the hospital failed to follow their policy and procedure (P&P) regarding the administration of alteplase and heparin medications (two anticoagulant

I medications used to dissolve and prevent blood clots} within 4 hours and 10 minutes of each other. Patient 1 was administered bolus (whole) dose and

I continuous dose of heparin intravenous (into the vein) infusion within 4 hours and 10 minutes after the administration of alteplase. Patient 1 received two potent anticoagulant medications, alteplase

I

Event ID;E6TS11 412/2014

S~te-2567

ID PREFIX

TAG

i

PROVIDER'S PLAN OF CORRECnON (EACH CORRECTIVE: ACTION SHOULD BE CROSS­

REFERENCED TO THE APPROPRIATE DEFICIENCY)

"'*Ser PaJ!e J tor beginning of Action Plans

3:07:19PM

I· I

(X5)

COMPLETE DATE

Page 2 ol9

Page 3: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES 1\NO PlAN OF' CORRECTION

(XI) PROVIDI:RJSUPPliERICLIA IDENTIFICATION NUMBER·

050609

l)t2) 1.\UL TIPLE CONSTRUCTION

A BUILDING

B WING

1:0.3) DATE SURI/Ff COMPLETED

1011212010

NAME" OF' PROVI{)eR OR SUPPLIER STREET ADDRESS. CrrY, STATE, Zlf> COPE

Kaiser FoUJldatlon Hospital • Orang& County •

Anaheim

3440 E L;;~ Palma Avo; Anaheim, CA 92806·2020 ORANGE COUNTY

(X4}10 I P!tfFU(

SUMMARY STATEJ .. ENT OF Oo.FICIENCIES lEACH DEFICIENCY MUST BE PRECEEOED BY FULL REGUlATORY OR LSC IOENTIFYI,.G.INFORMATION) TAG

' I I and heparin (both medications enhance the risk of bleeding), resulting in intracranial (w•thin the skull) hemorrhage {bleeding) and death on - 0. two

I days after the hospital admission on - 0.

Findings:

The hospital"s P&P titled Inpatient Anticoagulant Protocol, revised as of 10108. showed for non·hemorrhagic stroke (disruption of blood flow to an area of the brain due to obstruction or bleeding) patients who have received alteplase, heparin IS

I

I contraindicated tn the ftrst 24 hours after the I administration of alteplase, and not to give heparin in the first 24 hours after the administration of

alteplase.

The manufacturer's guidelines for alteplase showed

the most common complication encountered during alteplase therapy is serious intracran1al and gastrointestinal (mtes"linal} bleeding wh1ch could result in significant disability or death. The concomitant use of hepann and alteplase may contribute to serious bleeding problems.

According to Lexi-Comp's pharmacology website.

thrombolytic (to dissolve blood clots) drugs such as alteplase may enhance the anticoagulant effec1 of fleparin in increasing the -rlsk of bleeding

Pahent 1's medical record rev•ew was conducted on 10/12/10

The HistOry and Physical report dated showed the patient was admitted to the lrv1ne

Eveni1D:E6TS11 4/2{2014

State-2567

10

PfiEI'Il\ TAG

P'<OVIOER"S PLAN OF CORRE.CT!OH (EACH CORRECTI11E.ACTION SHOUlD BE CROSS·

REFE..'lEIJCEOTO THE .-.PPROPRIAlt; Of~ICIENCY)

1. Action Plan: Policy ··Jnpatknt Anticn:tgulalinn Protocor· was r~vised to includ.:: F<.lr TIA ancJ Struke patients: t-on-Hemorrhagic Stwkc Patient:. who have r<'ccive.d Alll:pluse (!PA)·

··Jio.:parin is contr-aindicated in the lirst 24 h<lurs after the end ol"thc infusion MAiteplase (If' 1\J. Do not give. any llqmrin 111 the llrst .:!4 hours:· l'hannucy staff re-educated on Pol icy ··1 n patient Anticoagulation Pmttlt.:ol . •·

I Person Responsible: Inpatient Pharmacy Dir.:cltm.

Date Completed: 10/2010: Pharmacy staffrc-cJucalcd

II 0/ J 5/20 lu: Policy was apprn\•cd by the Pharmacy an~ Tho:rapcutics Committee: 10122{2010: Policy \\US :tpprovcd b~ 1hc Exccutiv.e Committe.-:

3:07:19PM

(XS)

COMPI.ET'E IJATE

I Oi2(H 0 10/ 15/j ()

10/12· ICI

Page3of9

Page 4: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY

D!:PARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES ANO Pl)l)'l 0 1" CORRECTION

!X IJ PRO\IIDERISVPPt,.IERICliA tDENTIFICATION NUMBER-

050609

;K2) MUl TIPL.:: CONSTRUCTION

A BUILDING

a IMNG

(1(3) DATE SURiiEY CO~PLETED

10112/2010

NAM!Z OF PROVID~R OR SUPPLIER STREET ADDRESS, CI TY, STATE. ZIP CODE

Kaiser Foundation Hospital- Orange County·

Anaheim

3440 E La Palma Av&, Anaheim, CA 92800-2020 ORANGE COUNTY

I SUIIIMAAY STATEMENT OF DEFICIENCIES

(EACI-I DEfiCIENCY MUST 6E PRECEEDEO 9"' fULL

REGULATORY OR LSC tDENT .FYING INFOfiMAlJON)

I campus of' the hospital o~O, due to syncope I (temporary loss of consciousness and posture). The patient was fully alert and able to recount what medications he was ta~ing.

The. CT sc;:an (Computed Tomography scan is an I imaging metbod that uses x-rays to create pictures of cross-sections of the body) of the head dated .0. showed no evidence of Intracranial hemorrhage (bleeding).

I The MRI (Magnetic Resonance lmagtng is a test I

I that uses a magnetic field and pulses of radio wave energy to make pictures or organs and structures inside the body) of the brain dated .10 at 1245 1 hours. showed evidence of a large area of infarct

I [an area of tissue that undergoes necrosis (narrowing) as a result of obstruc1ion of local blood supply] Aga1n, no evidence of intracranial

I hemorrhage was noted.

The Multi-Disciplinary Note dated - 0 at 1332

I hours, showed the patient was assessed to have weakness to the left upper and lower extremities.

I

s. lurred speech, and right facial drooping. The patient stated he could not feel when the nurse touched his right hand. I

I The blood test result dated .10 at 1535 hours, showed the patient's APTI (activated partial thromboplastin time; a blood test used to detec1

I

abnormalities in blood clottmg and monitor the effect of anticoagulants such as heparin to determine the blood's thinness) was 28 seconds (reference range: 25-35 seconds).

EventiD:E6TS11 4/212014

State-2~7

10 I p~;~~ '

I

Pf!OV!OER"S PLAN OF CORRECTION \E.lCH CORRECTIVE ACTION SHOV..O SE CROSS·

REF ERE>ICEO TO TI-'E APPROPRIA lE Ol:F 'CIENCY)

2. Ac:tion Plan: Dir~ctive "Heparin Dosing and Monitoring Protoo.:ol: lntcrvcntional Imaging" was d..:wloped to inclu<k

·Guideline~ lhr do!>ing ofll~parin during lntcrvcnt ionu I Radio log) procedures

Radtology statl' educat.:d t1n Uirecttv~

"Heparin Dosing. IIJld 1\·iunitoring. Prutm:ul: Intcr,•entional Imaging"

Person Responsible: Radiol<lgy Dcpurtmcnt 1\dminl::.trator

Datt Completed: I 0/2010: Radiology stall' eJucatcd <In the Directive 10/2010: Directive wa~ approv(d by Chtef of RaJillfog.> 10/ 1512010: Dil'l:ctiw was ;tpprlwo:d b) tho:

1 Phamlacy and lllcr.tpcutk s Committee 112812011: Directi\oc was ;rppro\cd b) the F:..ecutive Committee

3;07;19PM

(XS)

COMPLETE DATE

I Q/2()10

lfl/2010

10115/2010

I !2Rr1!ll I

Page4o19

Page 5: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HeALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBliC HEALTH

STATEilE#f OF OEFClENCIES ANO PI.Mf 01' CC.R~ECTlOII

lll1) 1'1~0\'ICEAJSUPI>LIERK:LIA I{)E'OtF'<:"TIOIII NUUBER

050609

~2) MllliiPLE CO"lSTRuCTtO" (X31 OA -e SURViOY

COioiPLETEC

1011212010

NAME OF I'AOVIOER OR SUPI'UEF STREET AOORESS. Cfr'V, STATE lJPCOOE

K.lliser Foundation Hospi~l· Orenge County· Anaheim

3440 E La Palma Ave. Anahoim. CA 92806·2020 ORANGE COUNTY

tX<I)I()

PAEfl,l( TAG

I

I

SJIIIIMRY ST.ATEUfNT Of OEFICI£HCIES EACHO€FICIENCY t.4UST B!l Pf'IECEECEO ev FUU ~EGUI.ATOAt OR lSC IOENTIFYIHG INFORW.TO'II)

The Medication Admimstration Record (MAR) showed the patient rece1ved alteplase 56.94 mg (milligram) intravenously on -0 from 1615 hours

to 1735 hours. as ordered.

The CT scan of head dated .10 at 1925 hours showed no ev1dence of entracran~at hemorrhage _ Diffuse atrophy (narroweng) and chronic small

vessel (blood vessels) 1schom•c (blockage) diSease

was noted

The Mult•·DISOlphne Progress Note dated . o at 1925 hours,. showed the patient was transferred to

the Anahe1m campur. or lhe hosp'ltal for a cerebral 1

(bratn) ang1ogram (a fturoscopic test to take pictures of the blood flow •n an artery or a vein) procedure At 2129 hours. the patient had a cerebral ang•ogram procedure with blood Clot retrieval procedure that was completed at 2152 hours The cerebral angiogram report showed the

patient had occlusion (blockage} of the right Internal

c.arohd artery (ma1or paired artery. one .on each side of the head and neck}.

The MAR showed the patient recetved the heparin I bolus (whole) dose of 7.000 units on -0 at 2145 hours. as ordered. during the cerebral angiogram

procedure, which was 4 nours and 10 minutes after the oatient had received the alteptase medication.

Tl'le MAR also showed the patient rece1ved

continuous heparin Intravenous Infusion 25.000 un\ts at li' ml (mlllthtt!r } per how from -Oat

2334 nours till-10 at 0030 hours, as ordered.

Event ID E6TS11 41212014

St!lt&-2567

10 <>REFIX

TAG I PROVIDE II S Pl,>,N OF ::ORR£C11014

IEJICH C:JWlfCTIVE AC liON SHOUlD BE CROSS­Rf.fEREHCI:U TO Ttii: APPiiO!'f!IATE. OEFICIEI\C1l

l. ,\ction Pl~tn: 'I he Electronic Medii.:<~ I Record \\<h cnhanct!d 1\l h:lVc a. !>')'Stcmic phllrllllll!cutkal !lag l()r a 24 hm1r look back for tP /\ !tdmini~lr:ltion to alert l'ractitiono.:rs and Stair (II" heparin is ordered there'' ill be a look had: ll1r 24 hours to see if

1 tPA ha~ hcen ordered 1111d M hanging-\\ hich ''ill thc:n trigger th.: II(' aim I PhJmmc.:utica.l lla!_!.}

hlh:ncnttunal RmJtol<lg,) Phy~ictan staff 1.\lnltiiUlliCOJtiull un c:kctrolll' nu:JI\<tl r.Xotd

I enhanced''' hav.: a ~)~h?nlic pharmaceutical llag li1r 2 .t htlllr l<!ul. hack li.1r II' A ndmin ls1ra1 iun.

I Person Rtsponsiblr: Rcg.ional Phanna9 t linic.tl Content Team

Date Completed: llr.!UIO

3:07' 19PM

(l(5)

C~lETi

OATE

11'2010

Pages ol9

Page 6: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CAliFORNIA HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAlTH

STf•TEMENl OfOEACIENCIES AND PlAN OF CORRECT10N

(l<.l J PRO\IIDfR/SUPPliERICVA IOENIIFICAT10N NUMBER;

050609

(X2J hiUl TlPLE COfo!ST~UCTIO!i

A BUILDING

G. WINC

(X31 DATE SURYEY COMPlETED

1011212010

NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CI'TY, STATE, ZlP COOE

Kaistr Foundation Hospital - Orango County ­

Anaheim

3440 E La Palma Ave, Anahoim, CA 92806·2020 ORANGE COUNTY

(X4) (0

PREF~

TAG

SUMMARY STATEMENi OF DEFICIENCIES (EACH DEFICIENCY MU$1 BE i>RECEEDEO BY FULL REGULATORY OR lSC IDEm II'YI"'G INFORMATION)

The Multi-Discipline Progress Note dated . 0. showed at "0000' hours, the patient had coffee-gr,ound emesis {vomitus) and blood spurting from his right groin {the depresston or fold where the legs join the abdomen) where there was an arterial (blood vessel) puncture from the earlier cerebral angiogram procedure At 0030 hours. the continuous heparin infusron was discontinued. The patient was assessed to be nonresponsive walh pupils unequal and sluggashly reacted to hght. measunng 4 mm (mtlltmeter) on the right pupil and 2 mm on the left pupil (normal :. pupils equal.

I round, reactive to light). The right groin bfeeding had stopped after 40 minutes of direct pressure applied. At 0400 hours. the patient had massive bleeding from the ·right groin again,

I

The CT scan of head dated - 0 at 0356 hours. showed large hemorrhage areas were found in the right temporal (right S1de of the braan). right parietal

{behind the frontal lobes of the brain), and right I frontal lobes (behind the Forehead, front side of the brain).

The APTT result dated - 0 at 0407 hours, showed the patient's APTI was greater than 150 seconds (reference range was 23-35 seconds). Elevated APTT showed the patient had prolonged bleecllng.

On -0 at 0415 hours. the patient was given protamine (antidote) 25 mg intravenously to reverse the anticoagulation effects of heparin and

I

cryoprecipitate ( anhdote) 4 urltts to reverse the I

Event ID:E6TS 11 4/2/2014

SLBle-2567

10 PREFIX

TAG I I

I

P~OVIOER"S "LAN Of CORRECTION (EAC>i CORRECTIVE ACTIO-"' SHOU~O BE CROSS· litEFEREt~EO TO TI1E APPROPR"' TE O€f"ICIENCY)

4. Action Plan: Warm Handotf Algnrithm/( 'heck I bt during IPA administration Jcveh)pcd lu int.:luJ~; • Pharmacist will Jispcn~c <md deliver

Ahep!asc tPA to tho: Nursl! caring lor thr.: patient along with the ·lft l Protocol Chet'i LiM. NO II£1'.4.FU.V l!rgn a11d green t.lrmb:md lab.?led ··oo NOT GfVE

I· HEPARIN'' Pharmacist and nursing. wgcthcr at the bedside. \\ill idcntil) the patil:m using two identili~rs p<lr pulle-y I

• Phannacist will apply lhl! green armband lu t!Jt: patient on the $11ntc ill'lll thai the patient's admission armband has b.:en plac.cd

• The armband !ahd \\ill Stiltl!; ··oo NOT GIVE HEPARIN''

• Nursing will compktc. in the pre,sence of Pharmaci,1. 1hc "Nn Heparin" sign and \\ill place the sign uhu' c the patiem·._ head of bed

• The ~ignagc will incluJ.: the stan date and time ofthe tPl\ inru~iun

• Wh~:n compkl~d. buth nur~ing aml Phannacisl will sign nfl' on th\!tPA

I

Protocol Check List

Plmrmacy staff .:ducmcd on Warm l-landotl' Algorithm during tr> A admirlistration Nursing staff educated on Warm I IandolT Algorithm during tr>A administration Radiology Nursing Stall' ..:ducm.:d on Warm !-IandolT Algorithm .during tP.'\ <Hhninlstration Radiolog) Physician staff educated on Worm 1-l:lndoff Algori1l11n during tPA adrnirllstration Neurology Physician staff educated on Warm Handoff Algorithm during ti>A mhuiuistration

3:07:19PM

I

'

I

(XSJ COI.IPLETE

DATE

Page 6-of9

Page 7: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CAliFORNIA HEAlTH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH

SrATEMENI OFDEFICIENCtES

AND PI.AN CF CORRECTION l iOI PROVIOER/SUPPLIERICL!A

IOENiiFICA T!ON NUMBER.

050609

1~21 MUlTIPlE CONSTRUCTION

A 6UI~OII\IG

8 WING

IX3) DATE SURVEY

COMPLETED

10/12/2010

NAME ($ PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE:, Z IP CODE

Kaiser F oundetion Hospital • Orango County •

Anah~im

3440 E la Palma Ave, Anaheim, CA 92806-.2020 ORANG.E COUNTY

(X41t0

PREfllt

TAG I I

SUMMARY STATEMENT OF DEfiCIENCIES

iEACH DEFICIENCY ~ST BE PRECEEOEO B'Y FUl~

REGULATORY OR LSC 10ENJIHING1NFORIIIIATt0N)

anticoagulation effects from the alteplase. At 0440 hours, the patient received one unit of platelets (small blood components) to help with blood clotting p.rocess and two units or red blood cells (blood component that contains hemoglobin) to supplement blood loss. At 1253 hours, the

I

I I_

I

1 patient's heart rate had decreased quickly to asystole (a state of no cardiac electrical activity)

I and blood pressure was not detected. The physician pronounced the patient's death at lh1s

I time

The hospital's Death Summ-ary (Discharge I

I Summary) report dated - 0 at 1514 hours, showed Patient 1 was admitted for stroke, received alteplase, was transferred from the Irvine campus to the Anaheim campus for the ang1ogram procedure, had prior CT scan of the head showing no •ntracran1al hemorrhage, receiVed heparin bolus and continuous infusion dunng and post the angiogram procedure, was found wilh a large volume of blood loss from the right groin, was given antidotes to I reverse the anticoagulation effects of heparin and alteplase, was transfused with 2 units of blood, became comatose wilh pupils fixed and dilated. and had a stat (immediate) CT scan of the head show1ng extensive right hemispheric (half of the I brain) hemorrhage w1th the extension in to the ventncular system (a set of structures conla1mng cerebrospinal fluid an the brain) with compression or the brainstem (!he postenor pan of the bra1n).

The Certificate of Death showed the patient expired I on ., 0 at 125:3 hours, due to the immediate cause of spontaneous cerebral hemorrhage.

Event IO:E6TS11 4/212014

Stete-2567

10

PREfllt

iAG

PROVIDER'S PlAN OF CORRECTION

tfACH CORR£CT1Vl' ACTION SHOUlD BE CROSS·

REfERENCED 'TO THE ... PPRCPR~TE DEFICIENCY)

,-\ction Plan 11-4 Continued:

Person Responsible.: Inpatient Pharmac.y Dir.:.<\tor.o;, Chi~f Nurse Exc::cutives, Physician Chief or Neurology. Radioing~ D<'partment AdministmLOr

Date Completed: 1012010

Measure of Succ~s~: • I 00% checklist uudit of all patients

receiving. tPA (according to the Warm !:-IandolT Algori thm) completed hy Pharmacy X 4months to achieve I()()% co!nplitmco:.

3:07·19PM

(X!\) COUPLETE

DATE

Page 7 of 9

Page 8: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEAl TH

STATEMEN'T 0 1' OEF1CIENCIES AND PLMI OF CORRECnoN

(X1) PROVIOERlSUPPllfR!Clll\ IOf.NTIFICAn ON NUIABER.

050609

!X2) .1<1Ul TIPLE CONSlRUCTION

A Bl/1LOING

ll WING

(..C3J OATE SURVEY COMPLETED

1011212010

N/.1..1~ OF PROVIDER OR Sl)PPLIER STREET 1\0 DRE:S.S, CITY, S1'ATE. ZIP CODE

Kaiser Foundation Hospital -Orange County • Anaheim

3440 E La Palma Ave, AnaiJeim, CA 92806-2020 ORANGE COUNTY

()(~)10 I PREFJX

TAG

SUMMARY STATELIENT Of OEHCIENCIES (EACH OEfiCIENCV MUST BE PRECEEDEO BY FULL

RE.GUI.J'TORV OR LSC IOEN hfYING INFORM"TIONJ

On 10/12/10 at 0947 hours. tn an interview with the DOP (Director of Pharmacy}, he stated Patient 1 was admitted to the hospital on • 0 at 2118 hours, with symptoms of stroke. Tl'le patient had received al!eplase intravenously on - 0 at 1735 hours. The patient's symptoms did not improve after the alteplase adm1mstrat1on The patient had a cerebral angiogram procedure and underwent a procedvre to remove the clots. During the cerebral angiogram procedure in the lntervent1onal Radiology (a med1cal sub-specialty of radiology which utilizes m1n1mally-invasive image-gu.ided pmcedures to

I diagnose and treat diseases in nearly every organ system) on .0, MD 1 (radiologist) nad ordered to administar heparin 7.000 units as a bolus dose

1 to Patient 1 at 2145 hours, after the patient had 1 received the alteplase med1cation 4 hours and 10 mtnutes earlier Then MD 1 ordered to administer continuous hepann inlravenous 1nfusion from -0 at 2334 hours til- 0 at 0030 h,ours

On 10/12/10 at 1135 hours, dunng an interv1ew, RN 1 stated Patient 1 received alteplase on - 0 at 1735 hours, and then received bolus dose of heparin 7,000 units at 2145 hours. Heparin was administered 4 hours and 10 minutes after the administration of alteplase.

On 10/12110 at 1201 hours, the OOP (Director of Pharmacy) stated the APTI control is 30 seconds for a clot to form When a patient is treated with neparin. the goal is 1,5-3 limes the control or 45-90 seconds. Levels above 90 seconds indicate the blood was too thm, and there was increased nsk of

Event ID:E6TS11 4/2/2014

' 10

PROVIDER'S PLAN Of CORRECTION \EACHCORRECTIIIE ACTION SHOULD BE CROSS­REFERENCED TO I);E 1\PPROPRI"' TE OEF•CIENCYt

3 07:19PM

I ()(5)

COMPI.IiTE OAlf:

Page8ol9

Page 9: CALIFORNIA HEALTH AND SERVICES OF PUBLIC HEALTH...california health and human services agency department of public health statement of deficiencies and plan of correction (x1) provjoer1suppuer/clia

CALirORNIA HEALTH AND HUMAN SE.RVICES AGENCY DEPARTMENT OF PUBLIC HEALTH

STA'!EMENT OF' OEFICIF.f'l(:IES ANO PlA~ OF COI!RECTIOIII

(X I) f'ROIIIOERISUPPLII:R!CLIA IDENTIFICATION IIIUMBER

0506~9

(X1) MULTIPlE CONSlRUCliON

A BUILDING

B'IIIINO

(X3) QATE SURVEY

COMPLETED

10!1212010

'W<'t Of PRO\IUII OR WI'PUC.A Sn:!E:T J.DnllJ~SS..crlV STATE. :ZIP COD£

Kaner Foundation Hospital • 011tnge County • Ana.heim

3440 E La Pal!l'la -.vo, Ana)leim. CA 92806-2020 ORANGE COUNTY

(K~) 11'1

PREFIX

TAG

SI/MMAR'I' STATEMENT OF DEfiCIENCIES 'EACU Ot:riCIENCY MUSt BE PRECEEDED BY flA.l REGULATORY OR LSC IOENTIF'YING INFOIUAA t iON)

bleeding. The DOP st-ated on - 0 at 0407 hours, Patient 1's APTI result be'ro:- hfs death was greater tnan 150 seconds.

On 10112/10 at 1330 hours, during ao tnterv1ew, MD 1 (rad1olog•st) stated Pat1ent 1 had total blockage af h1s right carotid artery. Present at the interv•ew

1 was the 01rector or lmagtng Services. MD 1 stated

I he had performed the cerebral angiogram procedure to remove Patient 1's clots and written the orders for 7,000 units of hepann to be given by intravenous bolus and then contmuous hepann mfus•on. MD 1 stated he did not foiiO'N the hep4lrln protocol when he ordered the heparin and wanted to be aggresstve with the hepar.n therapy to prevent the clots From nrturn1n9 He stated he was aware that Patie.nt 1 had rece1v&d tne alteplase medication 4 hours and

1

10 m1nutes earl~er, but he wanted to admimster the hepann rredtcat1on to the pat~ent anyway.

The hospital's fatlure to follow their P&P on the adminlstrahon of hepann not to be 91ven to Patient 1 within 24 hours follow1ng ihe administration ol

, alteplase has caused or ls likely to cause serious •nJury or death to the patient, and therefore constitutes an 1mmed1ate jeopardy within the

I meaning of Health and Safety Code Section 1280.1(c)

This facility fatled to prevent lhe defictency (ies) as descnbe.d above that caused or tS likely to cause. senous Injury or death to the pat.ent. and therefore constitutes an Immediate Jeopardy within the rreaning of Health and Safety Code Section 1280. 1(C)

l I

Evert ID E;6TS11 4/21'2014

S~&!e-2587

10 PR6Fl)(

TAG

FROIIIUER'S PlAN OF CORRECTION (EliCH CORRECTIVE ACTION SHOULD BE CROSS­RE.f'~Rt .. CtO TO !liE APPROPRII< IE DEFICIENCY)

3Ci719PM

(XS)

COMPL£TE

DATE


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