CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PRDVIDER/SUPPUER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING

050567 8 WING 06/15/2011

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

MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Medical Center Rd, M1ss1on Viejo, CA 92691-6426 ORANGE COUNTY

(X4) ID 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 REFEREN CED TO THE APPROPRIATE DEFICIENCY) DATE

The followmg reflects the find1ngs of the Department

of Public Health dunng an 1nspect1on v1s1t

Compla1nt Intake Number a. Conective actions

CA00245251 - Substantiated

Representing the Department of Public Health • Education Department

Surveyor ID # 06793, HFEN completed focused one on
one reviews of Hospital's
The mspect1on was limited to the spec1fic fac11ity
Policy to prevent retained
event rnveshgated and does not represent the
findings of a full mspectron of the fac1l1ty
foreign bodies with all
Operating Room staff. A
Health and Safety Code Sect ron 1280 1(c) For mock surgical field was set
purposes of thrs sectron "rmmedrate Jeopardy" up and policy review and
means a srtuation 1n wh1ch the licensee's
discussion, demonstration,
noncompliance w1th one or more requirements of
licensure has caused, or rs likely to cause, senous
and repeat demonstration
Injury or death to the patrent performed. All staff signed
an attestation that they
Health and Safety Code Section 1279 1 (c) understood and will follow
The facility shall mform the patient or the party the policy that was reviewed
responsrble for the patrent of the adverse event by with them.
the trme the report IS made
• Erasable white boards are
The CDPH venfied that the fac1l1ty Informed the used in each OR suite to
patrent or the party responsible for the pat1ent of the document the presence of all
adverse event by the t1me the report was made sponges and miscellaneous
items used in a surgical case
DEFICIENCY CONSTITUTING IMMEDIATE
that are present on the sterile
JEOPARDY
surgical field.
T22 DIV 5 CH1 ART3- 70223 (b) (2) A comm1ttee
of the medical staff shall be assigned responsibility
for development, maintenance and 1mplementat1on

Event ID CEVI11 7/27/2012 1213 43PM

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

Anyvdef1c1ency statement endrng w1th an asterrsk (*)denotes a def1c1ency wh1ch the rnst1tut1on may be excused from correct1ng prov1d1ng 1t1s determined
th at other safeguards prov1de suffiCient protection to the pat1ents Except for nursrng homes, the f1nd1ngs above are d1sclosable 90 days foll owrng the date
of survey whether or not a plan of correct1on IS provided For nurs1ng homes, the above findings and plans of correct1on are d1sclosable 14 days followrng
the date these documents are made available to the fac1lrty If defic1enc1es are c1ted, an approved plan of correction 1s requ1s1te to contrnued program
part1c1pat1on 1\ · .v~
'¥ (l,t.lv? (/ -~-
8t;;te-:-25s7 u , W<l, ·y::'l"~-'lP-v·~,z) ·-- --- --- -- -
0 ~+- ,o ./ 1 of 4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING

050567 B WING 06/15/2011

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

MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Med1cal Center Rd, Miss1on VieJO, CA 92691-6426 ORANGE COUNTY

(X4) ID 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 DEFICIENCY) DATE

Continued From page 1

of wntten pol1c1es and procedures m consultatton
wtth other appropriate health professtonals and
• Clear plastic pocketed panels
adm1ntstrat1on Policies shall be approved by the
are used on all surgical cases
governmg body Procedures shall be approved by to separate and hold sponges
the adm1mstrat1on and medical staff where such 1s of any type or size to assist in
appropnate the visual verification of
items removed from the
The above regulation was NOT MET as evtdenced
sterile surgical field and to
by
aid in the performance of a
Based on med1cal record rev1ew, staff mterv1ew, and surgical count.
rev1ew of the factlity's poliCies, the facility failed to
ensure Implementation of established policies
• All surgical cases of 3 hours
in length or less are
addressing sponge counts for surg1cal procedures
completed by the same
A retatned surg1cal sponge after a major surgtcal
Perioperative staff that
8
.r-v
procedure caused ·the pat1ent to be subjected to the
nsks of a second maJor surgery and general started the case. This :D
c=
anesthesia for the removal of the retained sponge c:>
practice was put in place to
~

Fmd1ngs.
minimize the number of -..:1
Perioperative staff involved ·::o
Rev1ew of the policy "Counts Sponges, Sharps, in a surgical procedure. :3
Instruments, and Miscellaneous" showed the
d1rect1ve that sponges, sharps, and miscellaneous
• A customized Crew Resource ~
~-
Management program rv
1tems must be counted and documented pnor to -l
mc1s1on, before closure of a cavtty Within a cavtty,
presented by Safer
before wound closure begms, and at skm closure or Healthcare Inc. was
at the end of the procedure completed at both Mission
Hospital Campus Locations.
Review of Pat1ent 1's medical record showed an
The Crew Resource
Intraoperative Nursmg Record documentmg Patient
1 had undergone a coronary artery bypass surgical
Management program is an
procedure (a surg1cal procedure m which one or integrated training, process
more blocked coronary arteries are bypassed by a improvement and
blood vessel graft to restore normal blood flow to

Event ID CEVI11 7/27/2012 12 13 43PM

TITLE (X6) DATE

Any diificlency state nt ending With an astensk (') denotes a defiCiency Whl '
the mslilUllon may be excused from correcting providing 1l1s delerm1ned
that other safeguards provide suff1c1ent protection to the patients Except for nurs1ng homes, the findings above are d1sclosable 90 days following the dale
of survey whether or not a plan of correction IS provided For nursing homes, the above findings and plans of correction are d1sclosable 14 days followmg
the date these documents are made available to the facility If defic1enc1es are Cited, an approved plan of correct1on IS requ1s1te to conl1nued program
participation

State-2567 2 of 4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1) PROVIDER!SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING

050567 B WING 06/15/2011

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

MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Med1cal Center Rd, Mission V1ejo, CA 92691-6426 ORANGE COUNTY

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

PREFIX (EACH DEFICIENCY MUST BE PRECEEDED BY FULL PREFIX (EACH CORRECTIVE AC TION SHOULD BE CROSS- COMPLETE
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG REFERENCED TO THE APPROPRIATE DEFICIENCY) DATE

Continued From page 2

management system that uses
the heart) on - 1 0 On the Intraoperative Nursmg all available resources
Record, the nurse documented the "1n1t1al,"
including people, process and
"add1t1onal," and "final" sponge counts as correct
technology to enhance safety
In the Discharge Summary, the phys1c1an and operational efficiency.
documented that at the end of the coronary artery All levels of staff including

-0,
bypass surgical procedure the sponge, needle, and
mstrument counts were correct However, on
a chest x-ray performed on Pat1ent 1
showed "opacJtles" (an area that the x-ray light
cannot pass through) and a Computed Tomography •
Physicians and
Anesthesiologists were
required to attend.
Crew Resource Management
(CT) scan (a medical 1mag1ng procedure that (CRM) implementation then
utilizes computer-processed x-rays) confirmed a entered Phase II where on
fore1gn object
site coaching of the CRM
Patient 1 and Pallen! 1's family member were skill set and a train the trainer
mformed of the reta1ned fore1gn obJect on . 1 0 program began the week of
July 5-8, 2011.
Dunng mterview on 6/15/11, the Clinical Coordmator
• All lap sponges and raytec (4
of Cardiovascular Surgery disclosed that possibly
after the last count the surgeon had taken a sponge
x 4) sponges used in the
off the mstrument table and Inadvertently left the Operating Room have been
sponge 1n the cav1ty The Cllmcal Coordmator replaced with radio frequency
stated the operat1ng room staff had felt "pressured" tagged sponges provided by
because the next case was due and the final count
RF Surgical Inc. All custom ::n
was done prematurely before the cav1ty was closed ::3
case packs have the RF
On-10, Pat1ent 1 was returned to the facility for product in place. A special
the second surgery under general anesthesia A mat is in place on all
thoracotomy (a surgical JncJsJon made 1n the chest Operating Room tables that
wall) was performed. A surg1cal sponge was found
works in conjunction with a
Jn the pencard1al cav1ty (a hollow space between
the outer llmng of the heart and the heart) and was
scanning "wand" to detect the
removed Pat1ent 1 was discharged on - 0 , 111 presence of any RF tagged
stable condJ!Jon to cont1nue treatment at a

Event ID CEV111 7/27/2012 12 13 43PM

TITLE (X6) DATE

Any d f1 1ency slale ent endmg w1th an aslensk (') denotes a def1c1ency wh1ch t e mstJtut1on may be excused from correctmg proVIding 11 1s determmed
that other safeguards prov1de suffiCient protection to the pat1ents Except for nursmg homes, lhe fmdmgs above are d1sclosable 90 days followmg lhe date
of survey whether or not a plan or correction 1s prov1ded For nurs1ng homes, the above findmgs and plans or correcl1on are disclosable 14 days follow1ng
the date these documents are made available to lhe facility If defic1enc1es are Cited, an approved plan of correction IS requ1s1te to continued program
participation

State-2567 3 of 4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH

STATEMENT OF DEFICIENCIES (X1} PROVIDERJSUPPLIERICLIA (X2} MULTIPLE CONSTRUCTION (X3} DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING

050567 B WING 06/15/2011

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

MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Medical Center Rd, M1ss1on VIeJo, CA 92691-6426 ORANGE COUNTY

(X4}1D 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 DEFICIENCY) DATE

Continued From page 3

sponge. All staffwere in-
Rehab1htat1on Umt
serviced on the use of the
This fac1l1ty failed to prevent the defic1ency(1es) as product and the scanning is
descnbed above that caused, or IS likely to cause, done on all surgical cases
senous InJUry or death to the patient, and therefore
constitutes an 1mmed1ate Jeopardy Within the
where sponges of any type
meamng of Health and Safety Code Sect1on are used.
1280 1(c) • The Surgery Department and
the Leadership, Education,
and Practice councils worked
together to develop and
implement standard work
practices surrounding
I
surgical case set up,
communication, hand-off and
the perfo rmance of surgical
counts.
b. Director, Surgical Services ~

=
,__.
~

:n
c=
c. Monitoring processes GJ
~
-:1
• Random audits ofthe
counting practice are ::0
::3
conducted daily along with ~
the surgical time out and any 1--'

observed deviation is ~
-:1
corrected on the spot. The
audits from July-October
2011 demonstrated
I
Event ID CEVI11 7/27/2012 12 13 43PM
OR PROVI DER/SU PP LIE R REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

Any d c1ency state ent ending With an astensk (')denotes a defiCiency Which t e mslitut1on may be excused from correcting prov1dmg 1t 1s determined
that other safeguards provide suff1c1ent protection to the pat1ents Except for nursing homes, the findings above are disclosable 90 days following the date
of survey whether or not a plan of correction IS provided For nurs1ng homes, the above findings and plans of correction are disclosable 14 days following
the date these documents are made available to the facility If deficiencies are c1ted, an approved plan of correction 1s requ1s1te to contmued program
participation

State-2567 4 of4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING

050567 B WING 06/15/2011

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

MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Medical Center Rd, MISSIOn VIejo, CA 92691-6426 ORANGE COUNTY

(X4) ID 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 DEFICIENCY) DATE

Continued From page 3

Rehabtlitatton Umt
compliance just below 100%.
These audits continue as part
Thts facility failed to prevent the defictericy(tes) as of the Standard Work of the
descnbed above that caused, or ts ltkely to cause, OR.
senous InjUry or death to the patten!, and therefore
• Erasable white boards used in
constt!u!es an tmmedta!e jeopardy Within the
meantng of Health and Safety Code Sectton
each OR suite to document
12801(c) the presence of all sponges
and miscellaneous items
provide real time auditing of
every case for prevention of
retained foreign bodies. This
has become part of the
Standard Work ofthe OR.
• All lap sponges and raytec (4
x 4) sponges used in the
Operating Room were
replaced with radio frequency
tagged sponges (RF Surgical
Inc). All custom case packs
have the RF product in place.
A special mat is in place on
all Operating Room tables
that works in conjunction
with a scanning "wand" to
detect the presence of any RF
tagged sponge. This scanning
serves as another real time

Event ID CEVI11 7/27/2012 12 13 43PM

R PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

L) It ~c7c).£ 'L --e::? o?cJ :;:;.___

Any d ~ c1ency statem nt ending With an astensk (') denotes a defiCiency Which the mst1tut!on may be excused from correctmg providing 1t IS determmed
that other safeguards provide sufficient protection to the patients Except for nursmg homes, the findings above are d1sclosable 90 days followmg the date
of survey whether or not a plan of correc!lon IS prov1ded For nurs1ng homes, the above findings and plans of correction are d!sclosable 14 days followmg
the date these documents are made available to the facility If defic1enc1es are c1ted, an approved plan of correc!lon IS requiSite to continued program
part1c1pat1on

State-2567 ~ 14
s-
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER COMPLETED
A BUILDING
050567 B WING 06/15/2011
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
MISSION HOSPITAL REGIONAL MEDICAL CENTER 27700 Medical Center Rd, M1ss1on VIejo, CA 92691-6426 ORANGE COUNTY

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)

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 DEFICIENCY) DATE

Continued From page 3

RehabJiitatJOn Umt monitoring for retained
foreign bodies (specifically
This fac111ty failed to prevent the defic1ericy(1es) as sponges), and is now part of
descnbed above that caused, or JS likely to cause,
senous InjUry or death to the patient, and therefore
the Standard Work of the OR.
constitutes an 1mmed1ate jeopardy Within the
meanmg of Health and Safety Code SectJon
1280 1(c) d. July 14, 2011

7/14/11

7/27/2012 12 13 43PM

TITLE (X6) DATE

Any def!!i>l ncy statement ending With an astensk (') denotes a def1c1ency which the mst1tUt1on may be excused from correctmg providing 1! 1s determmed
that other safeguards provide sufficient protection to the pat1ents Except for nursmg homes, the findings above are d1sclosable 90 days followmg the date
of survey whether or not a plan of correction 1s provided For nurs1ng homes, the above findings and plans of correction are disclosable 14 days following
the date these documents are made avmlable to the facility If deficiencies are c1ted, an approved plan of correction Js requisite to contmued program
participation

State-2567