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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY

DEPARTMENT OF PUBLIC HEALTH


STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PRDVIDER/SUPPUER/CLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
050567
A BUILDING
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
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TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
The followmg reflects the find1ngs of the Department
of Public Health dunng an 1nspect1on v1s1t
Compla1nt Intake Number
CA00245251 - Substantiated
Representing the Department of Public Health
Surveyor ID # 06793, HFEN
The mspect1on was limited to the spec1fic fac11ity
event rnveshgated and does not represent the
findings of a full mspectron of the fac1l1ty
Health and Safety Code Sect ron 1280 1 (c) For
purposes of thrs sectron "rmmedrate Jeopardy"
means a srtuation 1n wh1ch the licensee's
noncompliance w1th one or more requirements of
licensure has caused, or rs likely to cause, senous
Injury or death to the patrent
Health and Safety Code Section 1279 1 (c)
The facility shall mform the patient or the party
responsrble for the patrent of the adverse event by
the trme the report IS made
The CDPH venfied that the fac1l1ty Informed the
patrent or the party responsible for the pat1ent of the
adverse event by the t1me the report was made
DEFICIENCY
JEOPARDY
CONSTITUTING IMMEDIATE
T22 DIV 5 CH1 ART3- 70223 (b) (2) A comm1ttee
of the medical staff shall be assigned responsibility
for development, maintenance and 1mplementat1on
ID
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PROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE CROSS-
REFERENCED TO THE APPROPRIATE DEFICIENCY)
a. Conective actions
Education Department
completed focused one on
one reviews of Hospital's
Policy to prevent retained
foreign bodies with all
Operating Room staff. A
mock surgical field was set
up and policy review and
discussion, demonstration,
and repeat demonstration
performed. All staff signed
an attestation that they
understood and will follow
the policy that was reviewed
with them.
Erasable white boards are
used in each OR suite to
document the presence of all
sponges and miscellaneous
items used in a surgical case
that are present on the sterile
surgical field.
Event ID CEVI11 7/27/2012 1213 43PM
'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE
Anyvdef1c1ency statement endrng w1th an asterrsk (*)denotes a def1c1ency wh1ch the rnst1tut1on may be excused from correct1ng prov1d1ng 1t1s determined
that 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
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(X5)
COMPLETE
DATE
(X6) DATE
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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDERISUPPLIERICLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
050567
A BUILDING
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
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
Continued From page 1
of wntten pol1c1es and procedures m consultatton
wtth other appropriate health professtonals and
adm1ntstrat1on Policies shall be approved by the
governmg body Procedures shall be approved by
the adm1mstrat1on and medical staff where such 1s
appropnate
The above regulation was NOT MET as evtdenced
by
Based on med1cal record rev1ew, staff mterv1ew, and
rev1ew of the factlity's poliCies, the facility failed to
ensure Implementation of established policies
addressing sponge counts for surg1cal procedures
A retatned surg1cal sponge after a major surgtcal
procedure caused the pat1ent to be subjected to the
nsks of a second maJor surgery and general
anesthesia for the removal of the retained sponge
Fmd1ngs.
Rev1ew of the policy "Counts Sponges, Sharps,
Instruments, and Miscellaneous" showed the
d1rect1ve that sponges, sharps, and miscellaneous
1tems must be counted and documented pnor to
mc1s1on, before closure of a cavtty Within a cavtty,
before wound closure begms, and at skm closure or
at the end of the procedure
Review of Pat1ent 1's medical record showed an
Intraoperative Nursmg Record documentmg Patient
1 had undergone a coronary artery bypass surgical
procedure (a surg1cal procedure m which one or
more blocked coronary arteries are bypassed by a
blood vessel graft to restore normal blood flow to
Event ID CEVI11
7/27/2012
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ID
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PROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE CROSS-
REFERENCED TO THE APPROPRIATE DEFICIENCY)
Clear plastic pocketed panels
are used on all surgical cases
to separate and hold sponges
of any type or size to assist in
the visual verification of
items removed from the
sterile surgical field and to
aid in the performance of a
surgical count.
All surgical cases of 3 hours
in length or less are
completed by the same
Perioperati ve staff that
started the case. This
practice was put in place to
minimize the number of
Perioperative staff involved
in a surgical procedure.
A customized Crew Resource
Management program
presented by Safer
Healthcare Inc. was
completed at both Mission
Hospital Campus Locations.
The Crew Resource
Management program is an
integrated training, process
improvement and
12 13 43PM
TITLE
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
(X5)
COMPLETE
DATE
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2 of 4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER!SUPPLIER/CLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
050567
A BUILDING
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
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
Continued From page 2
the heart) on -10 On the Intraoperative Nursmg
Record, the nurse documented the "1n1t1al,"
"add1t1onal," and "final" sponge counts as correct
In the Discharge Summary, the phys1c1an
documented that at the end of the coronary artery
bypass surgical procedure the sponge, needle, and
mstrument counts were correct However, on
-0, a chest x-ray performed on Pat1ent 1
showed "opacJtles" (an area that the x-ray light
cannot pass through) and a Computed Tomography
(CT) scan (a medical 1mag1ng procedure that
utilizes computer-processed x-rays) confirmed a
fore1gn object
Patient 1 and Pallen! 1 's family member were
mformed of the reta1ned fore1gn obJect on .1 0
Dunng mterview on 6/15/11, the Clinical Coordmator
of Cardiovascular Surgery disclosed that possibly
after the last count the surgeon had taken a sponge
off the mstrument table and Inadvertently left the
sponge 1n the cav1ty The Cllmcal Coordmator
stated the operat1ng room staff had felt "pressured"
because the next case was due and the final count
was done prematurely before the cav1ty was closed
On-10, Pat1ent 1 was returned to the facility for
the second surgery under general anesthesia A
thoracotomy (a surgical JncJsJon made 1n the chest
wall) was performed. A surg1cal sponge was found
Jn the pencard1al cav1ty (a hollow space between
the outer llmng of the heart and the heart) and was
removed Pat1ent 1 was discharged on -0, 111
stable condJ!Jon to cont1nue treatment at a
Event ID CEV111 7/27/2012
ID
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PROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE CROSS-
REFERENCED TO THE APPROPRIATE DEFICIENCY)
management system that uses
all available resources
including people, process and
technology to enhance safety
and operational efficiency.
All levels of staff including
Physicians and
Anesthesiologists were
required to attend.
Crew Resource Management
(CRM) implementation then
entered Phase II where on
site coaching of the CRM
skill set and a train the trainer
program began the week of
July 5-8, 2011.
All lap sponges and raytec ( 4
x 4) sponges used in the
Operating Room have been
replaced with radio frequency
tagged sponges provided by
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
12 13 43PM
TITLE
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
(X5)
COMPLETE
DATE
::n
::3
(X6) DATE
3 of 4
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1} PROVIDERJSUPPLIERICLIA
IDENTIFICATION NUMBER
050567
(X2} MULTIPLE CONSTRUCTION
A BUILDING
B WING
(X3} DATE SURVEY
COMPLETED
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
ID PROVIDER'S PLAN OF CORRECTION (X5} (X4}1D
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
PREFIX (EACH CORRECTIVE ACTION SHOULD BE CROSS COMPLETE
TAG REFERENCED TO THE APPROPRIATE DEFICIENCY)
Continued From page 3
Rehab1htat1on Umt
This fac1l1ty failed to prevent the defic1ency(1es) as
descnbed above that caused, or IS likely to cause,
senous InJUry or death to the patient, and therefore
constitutes an 1mmed1ate Jeopardy Within the
meamng of Health and Safety Code Sect1on
1280 1(c)
Event ID CEVI11 7/27/2012
OR PROVI DER/SUPPLIER REPRESENTATIVE'S SIGNATURE

b.
c.

12 13 43PM
sponge. All staffwere in-
serviced on the use of the
product and the scanning is
done on all surgical cases
where sponges of any type
are used.
The Surgery Department and
the Leadership, Education,
and Practice councils worked
together to develop and
implement standard work
practices surrounding
surgical case set up,
communication, hand-off and
the performance of surgical
counts.
Director, Surgical Services
Monitoring processes
Random audits ofthe
counting practice are
conducted daily along with
the surgical time out and any
observed deviation is
corrected on the spot. The
audits from July-October
2011 demonstrated
TITLE
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
DATE
I
I
(X6) DATE
4 of4
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CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDERISUPPLIERICLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
050567
A BUILDING
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
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
Continued From page 3
Rehabtlitatton Umt
Thts facility failed to prevent the defictericy(tes) as
descnbed above that caused, or ts ltkely to cause,
senous InjUry or death to the patten!, and therefore
constt!u!es an tmmedta!e jeopardy Within the
meantng of Health and Safety Code Sectton
12801(c)
ID
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TAG


PROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE CROSS
REFERENCED TO THE APPROPRIATE DEFICIENCY)
compliance just below 100%.
These audits continue as part
of the Standard Work of the
OR.
Erasable white boards used in
each OR suite to document
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
L) It ~ c 7c). '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
(X5)
COMPLETE
DATE
(X6) DATE
~ 1 4
s-
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY
DEPARTMENT OF PUBLIC HEALTH
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDERISUPPLIERICLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
050567
A BUILDING
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
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
Continued From page 3
RehabJiitatJOn Umt
This fac111ty failed to prevent the defic1ericy(1es) as
descnbed above that caused, or JS likely to cause,
senous InjUry or death to the patient, and therefore
constitutes an 1mmed1ate jeopardy Within the
meanmg of Health and Safety Code SectJon
1280 1 (c)
7/27/2012
ID
PREFIX
TAG
PROVIDER'S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE CROSS-
REFERENCED TO THE APPROPRIATE DEFICIENCY)
monitoring for retained
foreign bodies (specifically
sponges), and is now part of
the Standard Work of the OR.
d. July 14, 2011
12 13 43PM
TITLE
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
(XS)
COMPLETE
DATE
7/14/11
(X6) DATE