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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED


CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 000 INITIAL COMMENTS A 000

The following reflects the findings of the


California Department of Public Health during a
Complaint Validation survey.

Complaint Number: 510008

Representing the Department:


27137, HFEN
38305, HFEN
21905, HFES
22710, Medical Consultant
35653, Medical Consultant

The census was 38, and the sample size was 6.

During the survey, an Immediate Jeopardy (IJ)


was called on 11/9/16, at 2:50 PM, regarding
surgical services. One surgeon (Medical Doctor
[MD]) 6, performed high risk (e.g., patients with
life threatening conditions, whose surgery posed
a risk for life threatening complications) and
lengthy (taking between two and eight hours)
surgical cases without a surgical assistant after
hours; despite existing policy and procedure
criteria. The hospital had only one Operating
Room on-call team to cover all emergency
surgeries and emergent Caesarean-section (also
known as C-Sections, a procedure where a baby
is surgically delivered via a series of incisions
into the mother's abdomen) deliveries between 5
PM and 7 AM. The hospital had no plan to
enforce existing surgical policy and procedures;
no criteria to discern different level of surgical
classifications; no plan on how to develop a
second Operating Room team; no plan on how to
incorporate obstetrics into surgical procedures
policy and procedures; no plan on how to ensure
LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

01/26/2017
Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that
other safeguards provide sufficient protection to the patients. (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days
following 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. If deficiencies are cited, an approved plan of correction is requisite to continued
program participation.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 1 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 000 Continued From page 1 A 000


a surgical assistant was available per the
standard of surgical practice [Refer to A-940 and
A-941].

After accepting the hospital's Plan of Correction,


the IJ was abated on 11/14/16, at 2:30 PM.
A 043 482.12 GOVERNING BODY A 043 1/31/17

There must be an effective governing body that is


legally responsible for the conduct of the hospital.
If a hospital does not have an organized
governing body, the persons legally responsible
for the conduct of the hospital must carry out the
functions specified in this part that pertain to the
governing body ...

This CONDITION is not met as evidenced by:


Based on interviews and document reviews, the
hospital failed to effectively govern the activities
and conduct of the hospital's operations to
provide safe and quality health care in
accordance with the Governing Body (GB)
bylaws, as evidenced by:

1. The GB failed to provide appropriate


resources and support for surgical services to
ensure safe and timely care for approximately 45
surgical patients per month, or approximately 500
surgical patients per year. Lengthy (taking
between 2 and 8 hours), high-risk (e.g., patients
with life threatening conditions, whose surgery
posed a risk for life threatening complications),
urgent and emergent surgeries were routinely
performed during periods when the limited
operating room resources (a single on-call
surgical team) were needed to care for multiple
surgeries at the same time. This failure resulted
in delays for assessments and surgical

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 2 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 043 Continued From page 2 A 043


operations and/or alterations in the surgical plan.
These delays/alterations contributed to
deterioration of patient conditions, medical
complications, and/or death for three of six
patient records reviewed (A, B, and C).

2. The failure to ensure that the Medical Staff


was accountable for the quality of care provided
to surgical patients when a shortage of operating
room resources caused delays in treating high
risk surgical cases. The medical staff failed to
implement alternative procedures, or formally
request solutions from the Governing Body in a
timely manner. The delays put patients at risk for
complications and contributed to deterioration
and/or alteration in the surgical plan for three of
six patient records reviewed (A, B, and C) [Refer
to A-49].

3. The failure to ensure that surgical services


were organized and provided in accordance with
hospital policies and acceptable standards of
practice, to ensure safe surgical care to all
patients when:

a. Lengthy, high-risk, urgent and emergent


surgeries were routinely performed during
periods when the limited operating room
resources (a single on-call surgical team) were
needed to care for multiple surgeries at the same
time [Refer to A-941].

b. High risk surgeries were performed without


an assistant surgeon [Refer to A-941].

c. The hospital had only one Operating Room


on-call surgical team to cover all emergency
surgeries and emergent Caesarean sections

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 3 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 043 Continued From page 3 A 043


(also known as a C-section, a surgical procedure
used to deliver a baby through incisions in the
mother's abdomen) between 5 PM, and 7 AM.
The hospital had no plan to enforce their existing
policy and procedures regarding surgical
services; no criteria to discern different levels of
surgical classifications; no plan on how to
develop a second Operating Room surgical
team; no plan on how to incorporate obstetrics
into surgery policies and procedures [Refer to
A-941].

These failures resulted in delays for assessments


and surgical operations and/or alterations in the
surgical plan. These delays/alterations put all
surgical patients at risk, and contributed to
deterioration of patient conditions, medical
complications, and/or death for three of six
patient records reviewed (A, B, and C).

Findings:

Review of the 5/22/13 Governing Body bylaws


documented under Article I, Section 3-a Mission,
"To provide safe, efficient, technologically
advanced healthcare with respect for the
diversity of our region." Section 3-c Values
documented, "Quality: To provide high-quality
care, based on the best practices and in
collaboration with Medical Staff that exceeds
patient expectations."

The GB bylaws Article III, Section 2-c, noted that


the GB "shall determine the policies and
procedures and shall have control of and be
responsible for the overall operations and affairs
of the district and its facilities, according to the
best interests of the communities served by the

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 4 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 043 Continued From page 4 A 043


District." Article VII, Section 5-a documented that
the GB "shall assure that there is an efficient,
effective, comprehensive and integrated solution
focused Quality of Care/Patient Safety and
Performance Improvement Program." Article VII,
Section 5-c directed the medical staff and district
staff to "implement and report on the activities
and mechanisms for monitoring and evaluating
the quality of patient care, for identifying and
resolving patient care problems, and for
identifying opportunities to improve patient care."

The cumulative effect of these systemic problems


resulted in the hospital's inability to comply with
the statutorily-mandated Condition of
Participation for Governing Body.
A 049 482.12(a)(5) MEDICAL STAFF - A 049 1/31/17
ACCOUNTABILITY

[The governing body must] ensure that the


medical staff is accountable to the governing
body for the quality of care provided to patients.

This STANDARD is not met as evidenced by:


Based on interviews and document reviews, the
Governing Body (GB) failed to ensure the
Medical Staff was accountable for the quality of
care provided to surgical patients when a
shortage of operating room resources caused
delays in treating high risk (e.g., patients with life
threatening conditions, whose surgery posed a
risk for life threatening complications) surgical
cases; the Medical Staff failed to implement
alternative procedures or formally request
solutions from the GB in a timely manner, in
accordance with Medical Staff bylaws and
policies. The delays put patients at risk for
complications and contributed to deterioration

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 5 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 5 A 049


and/or alteration in the surgical plan for three of
six patient records reviewed (A, B, and C).

Findings:

Review of the 5/16/16 Medical Staff Bylaws


under Preamble section, documented that the
Bylaws provided a framework for organization for
the Medical Staff "to discharge its responsibilities
in matters involving the quality of medical care, to
govern the orderly resolution of issues and the
conduct of the Medical Staff functions supportive
of those purposes, and to account to the
Governing Body for the effective performance of
Medical Staff responsibilities. The Medical Staff
acknowledges that the Governing Body must act,
directly or through its Manager, to protect the
quality of medical care provided and the
competency of the Medical Staff, and to ensure
the responsible governance of the Hospital."

Medical Staff responsibilities listed in Section


1.4.2 included:

"(d) To establish and enforce, subject to the


Governing Body approval, professional standards
related to the delivery of health care within the
Hospital.
(e) To account to the Governing Body for the
quality of patient care through regular reports and
recommendations concerning the
implementation, operation, and results of the
quality review and evaluation activities.
(f) To initiate and pursue corrective action with
respect to members where warranted."

Section 10 described the organization of clinical


services (which would include a surgery service)

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 6 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 6 A 049


to be led by a service chief. Section 10.5.5 listed
the roles and responsibilities for each service
chief including:

"(h) Coordination and integration of interservice


and intraservice services;
(i) Development and implementation of policies
and procedures that guide and support the
provision of care, treatment, and services;
(j) Recommendations for a sufficient number of
qualified and competent persons to provide care,
treatment, and services;
(l) Continuous assessment and improvement of
the quality of care, treatment and services;
(m) Maintenance of quality control programs, as
appropriate."

Concurrent review of Medical Staff Peer Review


Committee (MSQRC) meeting minutes on
11/8/16 at 9:30 AM, with the Quality Manager
(QM) indicated that incidents for three patients
(A, B, and C) that occurred in 8/2016 and 9/2016,
were referred for an outside peer review on
10/27/16. The QM stated that two of the
incidents involved delays in performing surgeries
and both patients died (A and B). A third incident
involved the retention of a foreign object following
surgery, for which additional surgery was
performed (Patient C).

Review of patient records indicated that Patient A


needed urgent surgery to control suspected
bleeding from the lower bowel (intestines), but
the surgery on 8/22/16 was delayed by about 12
hours for other urgent/emergent cases. Patient
B's urgent/emergent surgery for a bowel
obstruction with infection and strangulation (the
stoppage of blood flow) of the bowel on 9/16/16

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 7 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 7 A 049


was delayed by more than 9 hours due to other
emergent cases. Patient B's surgery was also
interrupted and the surgical plan altered when
the operating room team was needed for another
emergent surgery. Patient C's complex surgery
to reconnect portions of bowel on 9/29/16 was
lengthy and required additional operating room
staff to position the patient.

Per interviews on 10/26/16, beginning at 2 PM,


with Medical Doctor (MD) 6, the Operating Room
Director (ORD) and Surgical Technician (ST) 1,
who was present at Patient C's surgery, toward
the end of Patient C's case, operating room staff
was called away to help with another emergent
surgery case, thereby causing distraction for the
instrument count and compromising the
positioning which contributed to retention of a
surgical device into Patient C's wound.

In an interview on 11/8/16, at 9:30 AM, the QM


stated that she created a root cause analysis to
evaluate various decision points by all providers
who had a hand in Patient B's care. However, no
procedures to formally guide the decisions when
surgical emergencies were lined up and delayed,
to either transfer patients to another hospital or
have second on-call teams immediately
available, had been implemented. Regarding
Patient C's incident, the QM indicated that the
short-staffing aspect of the incident was not
discussed by medical staff or the quality
committees. No referrals to other departments
and/or groups to evaluate the impact of surgical
staff shortages on patient safety resulted from
this opportunity. In a review of the Performance
Improvement (PI) Committee materials (tracking
of quality indicators and data), the QM

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 8 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 8 A 049


acknowledged that formal tracking of the delays
for surgical emergencies, shortage of OR
(Operating Room) team support, transfers of
surgical patients due to insufficient resources, or
provider practice patterns were not captured by
the PI program.

In an interview on 11/8/16 beginning at 11:15 AM,


the interim Operating Room Director (ORD)
stated that for two years he had concerns for
patient safety from lengthy complex surgical
cases backing up emergent cases, mostly when
one particular surgeon was on-call (MD 6). The
hospital was a non-trauma, community hospital
with only one on-call OR team (one
anesthesiologist, one registered nurse, and one
surgical technician) available afterhours (5 PM to
7 AM weekdays and all weekend hours). The
strain on OR resources was frequently discussed
at the ORD's internal weekly or monthly steering
committee meetings. The ORD also expressed
these concerns at Surgery and Anesthesia
Department meetings in 2015. Since January of
2016, the medical staff was restructured and the
ORD asked the current Surgery Committee Chair
to address the concerns and bring the issue
forward for solutions. However, formal meetings
between the steering committee and the Surgery
Committee and/or the Surgery Committee Chair
were often canceled and had not yet occurred.
The ORD prepared a log to show patterns and
causes of delays for surgeries from 1/2016 to
9/2016. The ORD provided the log to the
hospital Chief Executive Officer in an appeal for
more resources. The ORD indicated that
solutions had not been implemented, the same
problems continued, and surgeries for urgent and
emergent patients were still at times delayed. In

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 9 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 9 A 049


some cases, errors were made and patient
outcomes suffered. The Surgery Committee
Chair was the same surgeon (MD 6) who drove
many of the incidents about which the ORD was
concerned.

In an interview on 11/1/16 at 2:30 PM, MD 9, an


anesthesiologist and past Surgery Committee
Chair prior to 1/2016, indicated that concerns
about strains on the on-call operating room
resources and delays in surgeries were
discussed by the Surgery Committee in 2015.
MD 9 stated that he requested the hospital
administration to address how the surgical
resources were utilized, but no solutions were
enacted. MD 9 stated that he observed a
preference for MD 6 to perform surgeries late in
the day and at night, including cases that could
be scheduled early in the day when three OR
teams were available. To date, no efforts had
changed MD 6's practice pattern of arranging for
surgeries late in the day when resources were
stretched thin.

Review of the OR Delay Log from 1/14/16 to


9/21/16 indicated that more than most other
surgeons, surgical patients assigned to MD 6
experienced frequent delays of 2-4 hours, with
comments that MD 6 had worked the previous
night and was too tired to start cases at several
scheduled times prior to 1 PM. MD 6 was also
delayed from car problems and health issues.
After hours cases done by MD 6 occurred on
1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16,
4/13/16, 4/15/16 (which included a 6 hour delay),
4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16
(which included Patient A's 12 hour delay),
8/24/16 (which included a 7 hour delay), and

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 10 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 10 A 049


9/16/16 (which included Patient B's 9 hour delay).
MD 6 also rescheduled cases to a Saturday
(when only one on-call OR team was available)
on two occasions, 3/25/16 and 7/8/16.

Review of Medical Executive Committee (MEC,


the highest level of Medical Staff leadership)
minutes, dated 11/5/15, documented under
Obstetric (the branch of medicine and surgery
concerned with childbirth and the care of women
giving birth) Committee Report, "There needs to
be full back-up coverage for emergency cases
after hours. Currently after 4:30 p.m. no cases
can be scheduled and should a patient come in
that needs to have an emergency c-section [also
known as a Caesarean section - a surgical
procedure used to deliver a baby through
incisions into the mother's abdomen] there can
be a three or four hour wait to arrange for a
back-up surgical team to be available. However,
it has been noted that there are non-emergent
cases that are being allowed to take place
afterhours and on weekends." The MEC
recommended that Administration assure full
coverage for emergency cases afterhours and on
weekends. "Currently there is only a skeleton
crew for emergency cases, which puts patients at
risk."

Review of the hospital's GB meeting minutes


dated 1/26/16 documented a motion to terminate
the hospital's relationship with its Medical Staff
and adopt an arrangement with a new medical
staff association comprised of virtually identical
members but with different leadership designees.

Review of the monthly MEC minutes from the


new leadership starting 1/2016 showed no

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 11 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 11 A 049


documented discussion of delays in surgeries,
impact on staff and patients, and over-utilization
of the single on-call OR team until the 9/14/16
meeting. "Have been discussing with
administration regarding having 2 surgeries
simultaneously." "Great safety issue with not
being able to provide two surgical crews at the
same time (Referring to Emergency Cases)."
The MEC minutes noted considerations for hiring
additional surgical technicians, anesthesia
providers, and a trained surgical assistant; but no
discussion for evaluating the procedures for
accepting surgical cases late in the day and
afterhours, recruiting additional surgeons to
share call, when to transfer surgical patients, or
how to address the practice patterns of a
surgeon who was largely driving the incidents
behind these concerns (MD 6). No formal
Recommendations or Actions were documented
from the discussion. Minutes from the 10/12/16
MEC meeting noted approval of the 8/17/16
Surgery Committee and 9/12/16 Obstetric
Committee reports; but no further discussions or
solutions related to delays in surgeries or the
competing needs of afterhours surgical patients
were declared.

Similarly, no discussions or solutions related to


delays in surgeries or the competing needs of
afterhours surgical patients were documented in
the GB minutes in all of 2015 and 2016 (through
10/11/16). Review of Medical Staff policies and
procedures (P&Ps), effective since 1/26/16,
showed no P&P to revise the organization of
surgical services and provision of resources to
meet the identified needs of surgical patients.

Review of Medical Staff policies, rules and

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 12 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 049 Continued From page 12 A 049


bylaws showed no formal listing of the surgical
procedures that required a surgical assistant. No
policies set expectations for surgical practices to
conform with nationally recognized organizational
standards (e.g., procedures requiring a surgical
assistant).

In an interview on 11/8/16 at 11:30 AM, the ORD


stated that sometime in the past such a list
existed but that he and anesthesia staff were
unable to locate it.
A 263 482.21 QAPI A 263 1/31/17

The hospital must develop, implement and


maintain an effective, ongoing, hospital-wide,
data-driven quality assessment and performance
improvement program.

The hospital's governing body must ensure that


the program reflects the complexity of the
hospital's organization and services; involves all
hospital departments and services (including
those services furnished under contract or
arrangement); and focuses on indicators related
to improved health outcomes and the prevention
and reduction of medical errors.

The hospital must maintain and demonstrate


evidence of its QAPI program for review by CMS.

This CONDITION is not met as evidenced by:


Based on staff interview and record review, the
hospital failed to ensure an effective Quality
Assurance and Performance Improvement
(QAPI) program in place to protect the safety of
its patients when:

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 13 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 263 Continued From page 13 A 263


1. The hospital's Governing Body (GB) did not
specify the detail and frequency of data collection
for its QAPI program [Refer to A-273].

2. The hospital failed to correct the long-standing


issues on Operating Room (OR) coverage which
contributed to serious complications and patient
deaths; failed to implement corrective actions
and mechanisms after tracking and analyzing
adverse patient events, and continued to put its
patients' at risk for untoward outcomes [Refer to
A-286].

3. The hospital failed to document the reasons


why certain quality improvement projects are
being conducted, and the measurable progress
achieved on the projects [Refer to A-297].

4. The hospital's GB, Medical Staff, and


administrative officials failed to ensure that
patient safety were not compromised, when
issues of OR coverage and faulty physician
practice pattern were identified but not corrected;
and the hospital did not provide evidence of
approval of the GB on its formal QAPI programs,
to have clearly written policy and procedures and
budgeted resources -- approved by the GB after
input from the Chief Executive Officer and
medical staff leadership [Refer to A-309].

These failures resulted in the hospital's inability


to ensure the provision of quality health care in a
safe environment, due to lack of optimal and
timely surgical care.

The cumulative effect of these systemic failures


resulted in the inability of the hospital to comply
with the statutorily-mandated Conditions of

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PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 263 Continued From page 14 A 263


Participation for QAPI.
A 273 482.21(a), (b)(1),(b)(2)(i), (b)(3) DATA A 273 1/31/17
COLLECTION & ANALYSIS

(a) Program Scope


(1) The program must include, but not be limited
to, an ongoing program that shows measurable
improvement in indicators for which there is
evidence that it will improve health outcomes ...
(2) The hospital must measure, analyze, and
track quality indicators ... and other aspects of
performance that assess processes of care,
hospital service and operations.

(b)Program Data
(1) The program must incorporate quality
indicator data including patient care data, and
other relevant data, for example, information
submitted to, or received from, the hospital's
Quality Improvement Organization.
(2) The hospital must use the data collected to--
(i) Monitor the effectiveness and safety of
services and quality of care; and ....
(3) The frequency and detail of data collection
must be specified by the hospital's governing
body.

This STANDARD is not met as evidenced by:


Based on staff interview and document review,
the hospital's Governing Body (GB) failed to
specify the detail and frequency of data collection
for its Quality Assurance and Performance
Improvement (QAPI) programs, in accordance
with GB Bylaws. This had the potential to not

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 15 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 273 Continued From page 15 A 273


enable the GB to provide a clear overview and
oversight for its QAPI programs.

Findings:

1. A concurrent staff interview and document


review was conducted with the Quality Manager
(QM) on 11/10/16, between 10:45 AM and 1:35
PM. The Quality improvement project binders,
quality committee meeting minutes, board
meeting minutes, GB Bylaws, hospital's policy on
serious clinical adverse event and internal audit
policy were reviewed. The QM showed multiple
quality indicators that were tracked by various
departments. When the surveyor asked to see
the GB's approval for these projects with
specifications of instruction on data collection,
the QM was not able to provide such evidence.
When asked, "Do you have formal approval of
your projects by Governing Body?" QM replied,
"No."

Subsequent review of the quality management


system review meeting minutes, dated in
10/2016, indicated that the hospital plan was to
reduce the departmental quality objectives from
five to three, and set specific goals for each
project. However, there were no specifics about
how often each project will collect data and
details for the data collection.

2. A concurrent staff interview and document


review was conducted with the Chief Nursing
Officer (CNO) on 11/10/16, between 1:35 PM and
3 PM. The CNO was able to demonstrate a
poster on a QAPI project that was completed in
2015, called the "Provider in Triage" project. The
project carried out a baseline study which

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 16 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 273 Continued From page 16 A 273


showed that the rate of patient "Left without being
seen (LWBS)" in the Emergency Department
(ED) was 12-14%, and it decreased to 4% during
the intervention period when a second Physician
Assistant was added to the provider in the ED for
5 days a week. When asked, "Have your
Governing Body approved this project?" The
CNO replied, "Not formally." When asked
whether there was any written evidence that this
project was discussed at a board meeting, the
CNO stated, "No."

Review of the hospital's GB Bylaws, adopted


5/2013, indicated in Article V, Section 4, "Hospital
Committees", that Performance Improvement
Committee's primary purpose "is to provide
oversight of the [hospital]'s performance
improvement activities, and to establish a
consistent, systematic approach to improving
organization wide improvement. A summary of
Performance Improvement activities is to be
submitted to the Board on periodic basis, but not
less than semi-annually."
A 286 482.21(a), (c)(2), (e)(3) PATIENT SAFETY A 286 1/31/17

(a) Standard: Program Scope


(1) The program must include, but not be limited
to, an ongoing program that shows measurable
improvement in indicators for which there is
evidence that it will ... identify and reduce
medical errors.
(2) The hospital must measure, analyze, and
track ...adverse patient events ...

(c) Program Activities .....


(2) Performance improvement activities must
track medical errors and adverse patient events,
analyze their causes, and implement preventive

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 17 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 17 A 286


actions and mechanisms that include feedback
and learning throughout the hospital.

(e) Executive Responsibilities, The hospital's


governing body (or organized group or individual
who assumes full legal authority and
responsibility for operations of the hospital),
medical staff, and administrative officials are
responsible and accountable for ensuring the
following: ...
(3) That clear expectations for safety are
established.

This STANDARD is not met as evidenced by:


Based on interviews and document reviews, the
hospital failed to implement corrective actions
and mechanisms after tracking and analyzing
patient adverse events; failed to correct the
issues on Operating Room (OR) coverage which
contributed to several serious complications,
including patient deaths, in three of six patient
records reviewed (A, B, and C) [refer to A-940,
A-941], and continued to put its patients at risk
for untoward medical outcomes.

These failures contributed to several serious


complications, including patient deaths, and
continued to put its patients' at risk for untoward
medical outcomes.

Findings:

Concurrent review of medical staff peer review


committee (MSQRC) meeting minutes on
11/8/16, at 9:30 AM, with the Quality Manager

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PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 18 A 286


(QM) indicated that incidents for three patients
(A, B, and C) that occurred in August and
September of 2016, were referred for an outside
peer review on 10/27/16. The QM stated that
two of the incidents involved delays in performing
surgeries and both patients died (A and B). A
third incident involved the retention of a foreign
object following surgery, for which additional
surgery was performed (Patient C).

Review of patient records indicated that Patient A


needed urgent surgery to control suspected
bleeding from the lower bowel (intestines), but
the surgery on 8/22/16 was delayed by about 12
hours for other urgent/emergent cases. Patient
B's urgent/emergent surgery for a bowel
obstruction with infection and strangulation
(stoppage of blood flow) of the bowel on 9/16/16
was delayed by more than 9 hours due to other
emergent cases. Patient B's surgery was also
interrupted and the surgical plan altered when
the operating room team was needed for another
emergent surgery. Patient C's complex surgery
to reconnect portions of bowel on 9/29/16 was
lengthy and required additional operating room
staff to position the patient. Per interviews on
10/26/16 at 2 PM, with Medical Doctor (MD) 6,
the Operating Room Director (ORD) and Surgical
Technician (ST) 1 who was present at Patient C's
surgery, toward the end of Patient C's case,
operating room staff was called away to help with
another emergent surgery case, thereby causing
distraction for the instrument count and
compromising the positioning which contributed
to retention of a surgical device into Patient C's
wound.

In an interview on 11/8/16 at 9:30 AM, the QM

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 19 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 19 A 286


stated that she created a root cause analysis to
evaluate various decision points by all providers
who had a hand in Patient B's care. However, no
procedures to formally guide the decisions when
surgical emergencies were lined up and delayed,
to either transfer patients to another hospital or
have second on-call teams immediately
available, had been implemented. Regarding
Patient C's incident, the QM indicated that the
short-staffing aspect of the incident was not
discussed by medical staff or quality committees.
No referrals to other departments and/or groups
to evaluate the impact of surgical staff shortages
on patient safety resulted from this opportunity.
In a review of the Performance Improvement (PI)
Committee materials (tracking of quality
indicators and data), the QM acknowledged that
formal tracking of the delays for surgical
emergencies, shortage of OR team support,
transfers of surgical patients due to insufficient
resources, or provider practice patterns were not
captured by the PI program.

In an interview on 11/8/16 beginning at 11:15 AM,


the interim Operating Room Director (ORD)
stated that for two years he had concerns for
patient safety from lengthy complex surgical
cases backing up emergent cases, mostly when
one particular surgeon was on-call (MD 6). The
hospital was a non-trauma, community hospital
with only one on-call OR team (one
anesthesiologist, one registered nurse, and one
surgical technician) available afterhours (5 PM to
7 AM weekdays and all weekend hours). The
strain on OR resources was frequently discussed
at the ORD's internal weekly or monthly steering
committee meetings. The ORD also expressed
these concerns at Surgery and Anesthesia

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PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 20 A 286


Department meetings in 2015. Since January of
2016, the medical staff was restructured and the
ORD asked the current Surgery Committee Chair
to address the concerns and bring the issue
forward for solutions. However, the ORD stated
that the formal meetings between the steering
committee and the Surgery Committee and/or the
Surgery Committee Chair were often canceled
and had not yet occurred. The ORD prepared a
log to show patterns and causes of delays for
surgeries from 1/2016 to 9/2016. The ORD
provided the log to the hospital Chief Executive
Officer in an appeal for more resources. The
ORD indicated that solutions had not been
implemented, the same problems continued, and
surgeries for urgent and emergent patients were
still at times delayed. In some cases, errors were
made and patient outcomes suffered. The
Surgery Committee Chair was the same surgeon
(MD 6) who drove many of the incidents about
which the ORD was concerned.

In an interview on 11/1/16 at 2:30 PM, MD 9, an


anesthesiologist and past Surgery Committee
Chair prior to 1/2016, indicated that concerns
about strains on the on-call operating room
resources and delays in surgeries were
discussed by the Surgery Committee in 2015.
MD 9 stated that he requested the hospital
administration to address how the surgical
resources were utilized, but no solutions were
enacted. MD 9 stated that he observed a
preference for MD 6 to perform surgeries late in
the day and at night, including cases that could
be scheduled early in the day when three OR
teams were available. To date, no efforts had
changed MD 6's practice pattern of arranging for
surgeries late in the day when resources were

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 21 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 21 A 286


stretched thin.

Review of the OR Delay Log from 1/14/16 to


9/21/16, indicated that more than most other
surgeons, surgical patients assigned to MD 6
experienced frequent delays of 2-4 hours, with
comments that MD 6 had worked the previous
night and was too tired to start cases at several
scheduled times prior to 1 PM. MD 6 was also
delayed from car problems and health issues.
After hours cases done by MD 6 occurred on
1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16,
4/13/16, 4/15/16 (which included a 6 hour delay),
4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16
(which included Patient A's 12 hour delay),
8/24/16 (which included a 7 hour delay), and
9/16/16 (which included Patient B's 9 hour delay).
MD 6 also rescheduled cases to a Saturday
(when only one on-call OR team was available)
on two occasions, 3/25/16 and 7/8/16.

Review of the Medical Executive Committee


(MEC, the highest level of medical staff
leadership) minutes dated 11/5/15, documented
under Obstetric (the branch of medicine and
surgery concerned with childbirth and the care of
women giving birth) Committee Report, "There
needs to be full back-up coverage for emergency
cases after hours. Currently after 4:30 PM no
cases can be scheduled and should a patient
come in that needs to have an emergency
Cesarean section [also known as a C-section, a
surgical procedure used to deliver a baby
through incisions in the mother's abdomen] there
it can be a three or four hour wait to arrange for
back-up surgical team to be available. However,
it has been noted that there are non-emergent
cases that are being allowed to take place

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 22 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 22 A 286


afterhours and on weekends." The MEC
recommended that Administration assure full
coverage for emergency cases afterhours and on
weekends. "Currently there is only a skeleton
crew for emergency cases, which puts patients at
risk. "

Review of the hospital's Governing Body (GB)


meeting minutes dated 1/26/16 documented a
motion to terminate the hospital's relationship
with its Medical Staff and adopt an arrangement
with a new Medical Staff association comprised
of virtually identical members but with different
leadership designees.

Review of the monthly MEC minutes from the


new leadership starting 1/2016, showed no
documented discussion of delays in surgeries,
impact on staff and patients, and over-utilization
of the single on-call OR team until the 9/14/16
meeting. "Have been discussing with
administration regarding having 2 surgeries
simultaneously." "Great safety issue with not
being able to provide two surgical crews at the
same time (Referring to Emergency Cases)."

The MEC minutes noted considerations for hiring


additional surgical technicians, anesthesia
providers, and a trained surgical assistant; but no
discussion for evaluating the procedures for
accepting surgical cases late in the day and
afterhours, recruiting additional surgeons to
share call, when to transfer surgical patients, or
how to address the practice patterns of a
surgeon who was largely driving the incidents
behind these concerns (MD 6). No formal
Recommendations or Actions were documented
from the discussion. Minutes from the 10/12/16

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 23 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 286 Continued From page 23 A 286


MEC meeting noted approval of the 8/17/16
Surgery Committee and 9/12/16 Obstetric
Committee reports; but no further discussions or
solutions related to delays in surgeries or the
competing needs of afterhours surgical patients
were declared.

Similarly, no discussions or solutions related to


delays in surgeries or the competing needs of
afterhours surgical patients were documented in
the GB minutes in all of 2015 and 2016 (through
10/11/16). Review of medical staff policies and
procedures (P&Ps) effective since 1/26/16
showed no P&Ps to revise the organization of
surgical services and provision of resources to
meet the identified needs of surgical patients.
A 297 482.21(d) QAPI PERFORMANCE A 297 2/1/17
IMPROVEMENT PROJECTS

As part of its quality assessment and


performance improvement program, the hospital
must conduct performance improvement projects.

(1) The number and scope of distinct


improvement projects conducted annually must
be proportional to the scope and complexity of
the hospital's services and operations.
(2) A hospital may, as one of its projects, develop
and implement an information technology system
explicitly designed to improve patient safety and
quality of care. This project, in its initial stage of
development, does not need to demonstrate
measurable improvement in indicators related to
health outcomes.
(3) The hospital must document what quality
improvement projects are being conducted, the
reasons for conducting these projects, and the
measurable progress achieved on these projects.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 24 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 297 Continued From page 24 A 297


(4) A hospital is not required to participate in a
QIO cooperative project, but its own projects are
required to be of comparable effort.

This STANDARD is not met as evidenced by:


Based on staff interview and document review,
the hospital failed to document the reasons why
certain quality improvement projects are being
conducted and the measurable progress
achieved on the projects. This failure had the
potential to not enable the hospital to clearly
recognize the impact of the Quality Assurance
and Performance Improvement (QAPI) project on
health care quality and effectively monitor its
progress.

Findings:

A concurrent staff interview and document review


was conducted with the Chief Nursing Officer
(CNO) on 11/10/16, between 1:35 PM and 3 PM.
The CNO was able to demonstrate a poster
about a QAPI project that was completed in
2015, the "Provider in Triage" project. The
project carried out a baseline study which
showed that the rate of patient "Left without being
seen (LWBS)" in Emergency Department (ED)
was 12-14%, and it decreased to 4% during the
intervention period when a second Physician
Assistant was added to the provider in the ED for
5 days in a week. The CNO stated that in her
presentation to the leadership team for the
hospital, the leadership was aware that
decreasing the rate of LWBS was beneficial for
the quality of health care. When asked whether
she can provide formal documentation of the

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 25 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 297 Continued From page 25 A 297


reasons why this project was chosen, and what
the goal and expectations were, the CNO stated
"There were no written explanation of the
project". The CNO further stated that these
questions were not formally addressed.
A 309 482.21(e)(1), (e)(2), (e)(5) QAPI EXECUTIVE A 309 2/28/17
RESPONSIBILITIES

The hospital's governing body (or organized


group or individual who assumes full legal
authority and responsibility for operations of the
hospital), medical staff, and administrative
officials are responsible and accountable for
ensuring the following:

1) That an ongoing program for quality


improvement and patient safety, including the
reduction of medical errors, is defined,
implemented, and maintained .
(2) That the hospital-wide quality assessment
and performance improvement efforts address
priorities for improved quality of care and patient
safety and that all improvement actions are
evaluated.
(5) That the determination of the number of
distinct improvement projects is conducted
annually.

This STANDARD is not met as evidenced by:


Based on staff interview and document review,
the hospital's Governing Body (GB), medical
staff, and administrative officials failed to ensure,
in accordance with GB bylaws, that patient safety
were not compromised, after issues of Operating
Room (OR) coverage and faulty physician
practice pattern were identified; and the hospital

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 26 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 26 A 309


did not provide evidence of approval of the GB
on its formal Quality Assurance and Performance
Improvement (QAPI) programs; to have clearly
written policy and procedures, budgeted
resources, and clearly identified responsible
staff-approved by the GB after input from the
Chief Executive Officer (CEO) and medical staff
leadership.

These failures contributed to the occurrences of


several serious complications, including patient
deaths; continued to put patients at risk for
untoward health care outcome; and had the
potential to not enable the hospital carry out its
QAPI program with adequate planning and
resources to ensure the success of the programs
and the quality of health care provided by the
hospital.

Findings:

1. Concurrent review of medical staff peer review


committee (MSQRC) meeting minutes on
11/8/16, at 9:30 AM, with the Quality Manager
(QM) indicated that incidents for three patients
(A, B, and C) that occurred in 8/2016 and 9/2016
were referred for an outside peer review on
10/27/16. The QM stated that two of the
incidents involved delays in performing surgeries
and both patients died (A and B). A third incident
involved the retention of a foreign object following
surgery, for which additional surgery was
performed (Patient C).

Review of patient records indicated that Patient A


needed urgent surgery to control suspected
bleeding from the lower bowel (intestine), but the
surgery on 8/22/16 was delayed by about 12

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 27 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 27 A 309


hours for other urgent/emergent cases. Patient
B's urgent/emergent surgery for a bowel
obstruction with infection and strangulation
(stoppage of blood flow) of the bowel on 9/16/16
was delayed by more than 9 hours due to other
emergent cases. Patient B's surgery was also
interrupted and the surgical plan altered when
the operating room team was needed for another
emergent surgery. Patient C's complex surgery
to reconnect portions of bowel on 9/29/16 was
lengthy and required additional operating room
staff to position the patient.

Per interviews on 10/26/16, at 2 PM, with Medical


Doctor (MD) 6, the Operating Room Director
(ORD) and Surgical Technician (ST) 1 who was
present at Patient C's surgery, toward the end of
Patient C's case, operating room staff was called
away to help with another emergent surgery
case, thereby causing distraction for the
instrument count and compromising the
positioning which contributed to retention of a
surgical device into Patient C's wound.

In an interview on 11/8/16, at 9:30 AM, the QM


stated that she created a root cause analysis to
evaluate various decision points by all providers
who had a hand in Patient B's care. However, no
procedures to formally guide the decisions when
surgical emergencies were lined up and delayed,
to either transfer patients to another hospital or
have second on-call teams immediately
available, had been implemented. Regarding
Patient C's incident, the QM indicated that the
short-staffing aspect of the incident was not
discussed by medical staff or quality committees.
No referrals to other departments and/or groups
to evaluate the impact of surgical staff shortages

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 28 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 28 A 309


on patient safety resulted from this opportunity.
In a review of the Performance Improvement (PI)
Committee materials (tracking of quality
indicators and data), the QM acknowledged that
formal tracking of the delays for surgical
emergencies, shortage of OR team support,
transfers of surgical patients due to insufficient
resources, or provider practice patterns were not
captured by the PI program.

During an interview on 11/8/16, beginning at


11:15 AM, the interim Operating Room Director
(ORD) stated that for two years he had concerns
for patient safety from lengthy complex surgical
cases backing up emergent cases, mostly when
one particular surgeon was on-call (MD 6). The
hospital was a non-trauma, community hospital
with only one on-call OR team (one
anesthesiologist, one registered nurse, and one
surgical technician) available afterhours (5 PM to
7 AM weekdays and all weekend hours). The
strain on OR resources was frequently discussed
at the ORD's internal weekly or monthly steering
committee meetings. The ORD also expressed
these concerns at Surgery and Anesthesia
Department meetings in 2015. Since January of
2016, the medical staff was restructured and the
ORD asked the current Surgery Committee Chair
to address the concerns and bring the issue
forward for solutions. However, the ORD stated
that formal meetings between the steering
committee and the Surgery Committee and/or the
Surgery Committee Chair were often canceled
and had not yet occurred. The ORD prepared a
log to show patterns and causes of delays for
surgeries from 1/2016 to 9/2016. The ORD
provided the log to the hospital CEO in an appeal
for more resources. The ORD indicated that

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 29 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 29 A 309


solutions had not been implemented, the same
problems continued, and surgeries for urgent and
emergent patients were still at times delayed. In
some cases, errors were made and patient
outcomes suffered. The Surgery Committee
Chair was the same surgeon (MD 6) who drove
many of the incidents about which the ORD was
concerned.

In an interview on 11/1/16, at 2:30 PM, MD 9, an


anesthesiologist and past Surgery Committee
Chair prior to 1/2016, indicated that concerns
about strains on the on-call operating room
resources and delays in surgeries were
discussed by the Surgery Committee in 2015.
MD 9 stated that he requested the hospital
administration to address how the surgical
resources were utilized, but no solutions were
enacted. MD 9 stated that he observed a
preference for MD 6 to perform surgeries late in
the day and at night, including cases that could
be scheduled early in the day when three OR
teams were available. To date, no efforts had
changed MD 6's practice pattern of arranging for
surgeries late in the day when resources were
stretched thin.

Review of the OR Delay Log from 1/14/16 to


9/21/16, indicated that more than most other
surgeons, surgical patients assigned to MD 6
experienced frequent delays of 2-4 hours, with
comments that MD 6 had worked the previous
night and was too tired to start cases at several
scheduled times prior to 1 PM. MD 6 was also
delayed from car problems and health issues.
After hours cases done by MD 6 occurred on
1/19/16, 1/20/16, 2/23/16, 3/18/16, 3/29/16,
4/13/16, 4/15/16 (which included a 6 hour delay),

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 30 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 30 A 309


4/18/16, 4/22/16, 4/25/16, 5/2/16, 7/8/16, 8/22/16
(which included Patient A's 12 hour delay),
8/24/16 (which included a 7 hour delay), and
9/16/16 (which included Patient B's 9 hour delay).
MD 6 also rescheduled cases to a Saturday
(when only one on-call OR team was available)
on two occasions, 3/25/16 and 7/8/16.

Review of the Medical Executive Committee


(MEC, the highest level of medical staff
leadership) minutes dated 11/5/15, documented
under Obstetric (the branch of medicine and
surgery concerned with childbirth and the care of
women giving birth) Committee Report, "There
needs to be full back-up coverage for emergency
cases after hours. Currently after 4:30 p.m. no
cases can be scheduled and should a patient
come in that needs to have an emergency
Cesarean section [also known as C-section, a
procedure where a baby is surgically removed by
a series of incisions into the mother's abdomen]
there it can be a three or four hour wait to
arrange for back-up surgical team to be
available. However, it has been noted that there
are non-emergent cases that are being allowed
to take place afterhours and on weekends." The
MEC recommended that Administration assure
full coverage for emergency cases afterhours
and on weekends. "Currently there is only a
skeleton crew for emergency cases, which puts
patients at risk."

Review of the hospital's GB meeting minutes


dated 1/26/16 documented a motion to terminate
the hospital's relationship with its Medical Staff
and adopt an arrangement with a new Medical
Staff association comprised of virtually identical
members but with different leadership designees.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 31 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 31 A 309

Review of the monthly MEC minutes from the


new leadership starting 1/2016 showed no
documented discussion of delays in surgeries,
impact on staff and patients, and over-utilization
of the single on-call OR team until the 9/14/16
meeting. "Have been discussing with
administration regarding having 2 surgeries
simultaneously." "Great safety issue with not
being able to provide two surgical crews at the
same time (Referring to Emergency Cases)."

The MEC minutes noted considerations for hiring


additional surgical technicians, anesthesia
providers, and a trained surgical assistant; but
no discussion for evaluating the procedures for
accepting surgical cases late in the day and
afterhours, recruiting additional surgeons to
share call, when to transfer surgical patients, or
how to address the practice patterns of a
surgeon who was largely driving the incidents
behind these concerns (MD 6). No formal
Recommendations or Actions were documented
from the discussion. Minutes from the 10/12/16
MEC meeting noted approval of the 8/17/16
Surgery Committee and 9/12/16 Obstetric
Committee reports; but no further discussions or
solutions related to delays in surgeries or the
competing needs of afterhours surgical patients
were declared.

Similarly, no discussions or solutions related to


delays in surgeries or the competing needs of
afterhours surgical patients were documented in
the GB minutes in all of 2015 and 2016 (through
10/11/16). Review of medical staff policies and
procedures (P&Ps) effective since 1/26/16
showed no P&P to revise the organization of

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 32 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 32 A 309


surgical services and provision of resources to
meet the identified needs of surgical patients.

2. A concurrent staff interview and document


review was conducted with the QM on 11/10/16
between 10:45 AM and 1:35 PM. Quality
improvement project binders, quality committee
meeting minutes, board meeting minutes, GB
Bylaws, hospital's policy on serious clinical
adverse event and internal audit policy were
reviewed. The QM showed multiple quality
indicators that were tracked by various
departments. When the surveyor asked to see
the GB's approval for these projects with
specifications of instruction on data collection,
the QM was not able to provide such evidence.
When asked, "Do you have formal approval of
your projects by governing body?" QM replied,
"No."

The QM stated she was working on setting up


Crisis Management Team to evaluate and
address serious clinical adverse events (clinical
event with untoward impact of harm or death on
a patient). When asked whether she reported
this plan to the board meeting or MEC meeting,
she replied, "Not yet. The meetings are coming
up ... ". QM further stated that the hospital's
senior leadership team was working on
increasing OR after hour coverage. When asked
who the senior leadership team included, she
replied, "They are the COO (Chief Operating
Officer), CFO (Chief Financial Officer), CEO, and
[name of the CNO, the Chief Nursing Officer]".
When asked whether Medical Staff, such as
Chief of Staff, Chief of Surgery, were involved,
the QM replied, "No."

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 33 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 33 A 309


3. A concurrent staff interview and document
review was conducted with CNO on 11/10/16
between 1:35 PM and 3 PM. The CNO was able
to demonstrate a poster on a QAPI project that
was completed in 2015, the "Provider in Triage"
project. The project carried out a baseline study
which showed that the rate of patient "Left
without being seen (LWBS)" in Emergency
Department (ED) was 12-14%, and it decreased
to 4% during the intervention period when a
second Physician Assistant was added to the
provider in the ED for 5 days a week. When
asked, "Have your Governing Body approved this
project?" the CNO replied, "Not formally." When
asked whether there was any written evidence
that this project was discussed at a board
meeting to specify the procedures and budgeted
resources, the CNO stated, "No."

Review of the hospital's GB Bylaws, adopted


05/2013, Article I, indicated that the hospital's
mission is "To provide safe, efficient,
technologically advanced healthcare with respect
for the diversity of our region." It further indicated
in Article VII, Section 5, "Quality of Care/Patient
Safety and Performance Improvement Program",
that "a. The Board of Directors shall assure that
there is an efficient, effective, comprehensive and
integrated solution focused Quality of
Care/Patient Safety and Performance
Improvement Program. b. The Board of
Directors delegates the authority and
responsibility for carrying out the Quality of
Care/Patient Safety and Performance
Improvement Program to the Active Medical Staff
and CEO, who in turn, shall demonstrate to the
Board the effectiveness of such program for
quality assurance ... c. The Medical Staff and

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 34 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 309 Continued From page 34 A 309


District [referring the hospital] staff will implement
and report on the activities and mechanisms for
monitoring and evaluating the quality of patient
care, for identifying and resolving patient care
problems, and for identifying opportunities to
improve patient care within the District."
A 940 482.51 SURGICAL SERVICES A 940 12/19/16

If the hospital provides surgical services, the


services must be well organized and provided in
accordance with acceptable standards of
practice. If outpatient surgical services are
offered the services must be consistent in quality
with inpatient care in accordance with the
complexity of services offered.

This CONDITION is not met as evidenced by:


Based on interviews and document reviews, the
hospital failed to ensure that surgical services
were organized and provided in accordance with
hospital policies and acceptable standards of
practice to ensure safe care to approximately 45
surgical patients per month, and approximately
500 surgical patients per year, when:

1. High-risk (e.g., patients with life threatening


conditions, whose surgery posed a risk for life
threatening complications), lengthy (taking
between 2 and 8 hours), urgent and emergent
surgeries, were routinely performed during
periods when the limited operating room
resources (a single on-call surgical team) were
needed to care for multiple surgeries at the same
time [Refer to A-941].

2. Hospital had no plan to ensure high risk


surgeries were performed with an assistant
surgeon per standards of surgical practice [Refer

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 35 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 940 Continued From page 35 A 940


to A-941].

3. Hospital only had one Operating Room (OR)


on-call surgical team to cover all emergency
surgeries and emergent Caesarean sections
(also known as C-Sections, a procedure where a
baby is surgically delivered via a series of
incisions into the mother's abdomen), affecting
an average of approximately 20 C-Sections per
month, between 5 PM and 7 AM [Refer to A-941].

4. Hospital had no plan to enforce their existing


policy and procedure regarding surgical services
[Refer to A-941].

5. Hospital had no criteria to discern between


different levels of surgical classifications [Refer to
A-941].

6. Hospital had no plan on how to develop a


second OR [Refer to A-941].

7. Hospital had no plan on how to incorporate


obstetrics (the branch of medicine and surgery
concerned with childbirth and the care of women
giving birth) into surgery policies and procedures
[Refer to A-941].

Because of these issues, an Immediate Jeopardy


(IJ) was called on 11/9/16, at 2:50 PM, with the
Chief Executive Officer and Chief Nursing Officer,
Quality Director, and Quality Manager, in
attendance.

After accepting the hospital's Plan of Correction,


the IJ was abated on 11/14/16, at 2:30 PM, with
the Chief Operating Officer and Chief Nursing
Officer in attendance.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 36 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 940 Continued From page 36 A 940

The cumulative effect of these systemic problems


resulted in the hospital's inability to comply with
the statutorily-mandated Condition of
Participation for Surgical Services.
A 941 482.51(a) ORGANIZATION OF SURGICAL A 941 12/19/16
SERVICES

The organization of the surgical services must be


appropriate to the scope of the services offered.

This STANDARD is not met as evidenced by:


Based on interviews and document reviews, the
hospital failed to ensure sufficient resources of
qualified staff were available to meet the needs of
approximately 45 surgical patients per month,
and approximately 500 surgical patients per year,
within the hospital's scope as a non-trauma
community hospital, as evidenced by one
surgeon (Medical Doctor [MD]) 6, performed high
risk (e.g., patients with life threatening conditions,
whose surgery posed a risk for life threatening
complications), and lengthy (lasting between 2
and 8 hours) surgical cases without a surgical
assistant after hours; despite existing hospital
policy and procedure criteria for surgical
services; the hospital had only one Operating
Room (OR) on-call surgical team to cover all
emergency surgeries and emergent Caesarean
sections (also known as C-Sections, a procedure
where a baby is surgically removed via a series
of incisions into the mother's abdomen),
(approximately 20 such cases per month),
between 5 PM and 7 AM; hospital had no plan to
enforce their existing policy and procedures
regarding surgical services; no criteria to discern
different levels of surgical classifications; no plan
on how to develop a second OR surgical team;

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 37 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 37 A 941


no plan on how to incorporate obstetrics (the
branch of medicine and surgery concerned with
childbirth and the care of women giving birth) into
surgery policies and procedures; and no plan on
how to ensure a second surgical assistant is
available per standards of surgical practice
[Refer to A-940].

Because of these issues in surgical services, an


Immediate Jeopardy (IJ) was called on 11/9/16,
at 2:50 PM, with the Chief Executive Officer,
Chief Nursing Officer, Quality Director, and
Quality Manager, in attendance. The details of
the IJ were given as above, which put
approximately 45 surgical patients per month, or
approximately 500 surgical cases per year, at
risk. Additionally, MD 6 was scheduled to be
on-call for surgery from 11/7/16 to 11/13/16.

After accepting the hospital's Plan of Correction,


the Immediate Jeopardy was abated on 11/14/16,
at 2:30 PM, with the Chief Operating Officer and
Chief Nursing Officer in attendance. The
immediacy was removed on this date and time,
and confirmed by the survey team.

These failures resulted in delays for assessments


and surgical operations and/or alterations in the
surgical plan. These delays/alterations put the
approximate 45 per month, or 500 yearly,
surgical patients at risk, and contributed to
deterioration of patients' conditions, medical
complications, and/or death for three of six
patient records reviewed (A, B, and C).

Findings:

Review of patient records indicated the following:

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 38 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 38 A 941

1. Patient A, age 68, was admitted to the hospital


on 8/9/16, for acute (of abrupt onset, often also
connotes an illness that is of short duration,
rapidly progressive, and in need of urgent care)
bleeding from the rectum. Patient A's coexisting
conditions included diabetes (unregulated sugar
in the blood), high blood pressure, breast cancer,
and a heart rhythm disorder. Medical support
treatments were provided to Patient A in the
Intensive Care Unit (ICU). Intermittent drops in
Patient A's blood count suggested continued
bleeding between 8/9/16 and 8/21/16. Patient
A's providers suspected the bleeding source was
from rectal hemorrhoids (a swollen vein or group
of veins in the area of the anus) and advised
blood transfusions and surgery to remove the
hemorrhoids. Patient A refused the advised
treatments until 8/21/16, when blood transfusions
were first given. On the morning of 8/22/16,
Patient A consented to the surgery, to be
performed by MD 6.

In a concurrent review of Medical Staff Quality


Review Committee (MSQRC) meeting minutes
with the Quality Manager (QM) on 11/18/15 at
9:30 AM, the QM indicated that concerns about
delays in surgeries were brought to her attention
since 6/2016. The QM stated that adverse
outcomes for some patients of MD 6 were
reviewed by the MSQRC and sent out for peer
review by a neutral third party on 10/27/16. The
10/12/16 MSQRC meeting minutes documented
a review of Patient A's care, "surgery was
decided at 0845 (8:45 AM). Surgery was not
performed until 2000 (8 PM). The case had to be
stopped and the patient was moved out of OR
due to an emergent c-section."

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 39 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 39 A 941

Further review of Patient A's medical record


noted in a surgeon progress note written by MD
6, dated 8/22/16 at 2000 (8 PM), that Patient A
"refused urgent hemorrhoidectomy [surgical
removal of hemorrhoids] last night, said she
would do it today... but I was already tied up with
another emergency case." "I was called by RN
[Registered Nurse] while I was still operating and
told pt [patient] was bleeding heavily, had
dropped BP [blood pressure], was tachy [high
heart rate] to 170's [normal heart rate is 60-100
beats per minute]." [Intravenous] Fluids [Normal
Saline, a salt water solution] and blood products
were ordered. "Pt had poor IV [intravenous, or
into the vein] access and ERMD [physician from
the emergency room] came up and placed right
subclavian central line [a tube placed into the
vein beneath the shoulder, for a rapid infusion of
blood]." Heart rate was now 134 and patient was
confused, cool and clammy. Large copious
amounts of blood were exiting from her rectum.
MD 6's impression was a life-threatening
exsanguination (bleeding out) that required blood
transfusion and surgery "ASAP" (as soon as
possible).

Patient A's Anesthesia (insensitivity to pain,


especially as artificially induced by the
administration of gases or the injection of drugs
before surgical operations) Record, dated
8/22/16, noted the arrival time to the operating
room was 8:37 PM. Anesthesia was immediately
begun and surgery started at 9:02 PM. No
Surgical Assistant was in attendance. Per MD
6's Operative Report, dated 9/13/16, for a
"Stapled internal hemorrhoidectomy", the
hemorrhoids were not the source of the bleeding,

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 40 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 40 A 941


but were surgically stapled shut. Another 500
milliliters (1/2 liter) of blood from higher in the
colon (large intestine) was seen during surgery.
The surgical plan was to call in a
gastroenterologist (MD 3, a Medical Doctor that
specializes in diseases of the stomach and
intestines) to inspect the colon by way of a
viewing device that was inserted into the rectum
(colonoscopy), search for a bleeding source,
repair it if possible, and be ready to open the
abdomen to emergently excise (remove) the
entire colon (abdominal colectomy) to control
bleeding if needed.

However, as MD 6 was completing the initial


hemorrhoidectomy and brief visualization of the
rectum with a sigmoidoscope device (long hose
with camera) at 9:37 PM, the OR and staff were
immediately needed to perform an emergency
Cesarean section (STAT C-section) to rescue a
fetus (unborn baby) in distress from an obstetric
patient in labor. MD 6 altered the surgical plan
for Patient A by moving Patient A (still
unconscious and under the effects of anesthesia
with a breathing tube inserted into her lungs) out
of the Operating Room and back to the ICU for
MD 3 to perform the colonoscopy there at the
bedside.

The Procedural Moderate Sedation Record for


Colonoscopy documented that on 8/22/16,
between 10:10 AM and 10:21 PM, MD 3
attempted the colonoscopy portion of the surgical
plan, unsuccessfully due to "excessive blood
clots" extending "35-40 cm (centimeters) from the
anal verge." Patient A's sedation scale scores
were above the optimal level (more sedated)
despite no sedation administered throughout the

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 41 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 41 A 941


procedure. MD 3 was unable to see a bleeding
source, active bleeding continued, and Patient
A's blood pressure dropped to a level below
normal. At 10:53 PM, Patient A was brought
back to the operating room (c-section was over)
for an emergency total abdominal colectomy.
Surgery time was recorded as 10:56 PM to 12:14
AM.

Findings from the Operative Report, dated


9/13/16, for a "Emergency total abdominal
colectomy", documented that a tumor (a swelling
of a part of the body caused by an abnormal
growth of tissue) had invaded the colon and large
pelvic blood vessels, as the likely source of the
bleeding. Intraoperative blood loss was
estimated at 2 liters. Despite transfusions of 8
units of blood and other fluids, Patient A's
bleeding continued after return to the ICU, where
she failed to respond to rescue efforts. Patient A
died at 2:30 AM.

During an interview on 11/8/16, at 9:30 AM, the


QM acknowledged that the delay to perform
surgery on Patient A on 8/22/16, was in part due
to MD 6 being tied up all day with other surgical
cases, and that the alterations in the surgical
plan at 9:37 PM occurred because of insufficient
surgical resources and staff, and competing
needs of other surgical emergency cases. The
QM acknowledged that the disruption of Patient
A's surgical plan added 30-60 minutes of delays
to locate the bleeding source, during which time
bleeding continued and further compromised
Patient A's ability to respond to supportive and
rescue measures.

2. Patient B, age 67, presented to the hospital

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 42 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 42 A 941


Emergency Department (ED) triage on 9/16/16 at
10:50 AM, with complaints of abdominal pain for
5 days, vomiting all food and fluids, no urine
production, and a history of ventral hernia
(weakness in the stomach muscles that cause
contents of the abdominal cavity to protrude and
get pinched off) repair four years ago. ED care
included orders for laboratory tests and imaging
studies. A CT (computerized tomography, type of
imaging x-ray) of the abdomen showed possible
strangulated bowel (intestine that had had blood
flow stopped) in the ventral hernia protrusion (a
surgical emergency). The first ED nursing
assessment was documented at 1 PM, a dictated
note by an ED physician was documented at
1:17 PM, "discussed with surgeon" and "Admit to
Surgery."

However, Patient B was not moved to a surgical


inpatient bed or intensive care unit, but stayed in
the ED. Between 1:30 PM and 8:29 PM, brief
entries by ED staff recorded vital signs, pain
scores, administration of antibiotic and narcotic
(a strong and addictive type of) pain medications,
insertion of a plastic tube (catheter) into the
urinary bladder, and fluids administered into the
vein via catheter. At 2:45 PM, MD 6 (the
admitting surgeon) documented an impression of
"SBO [small bowel obstruction] with incarcerated
[where the intestine is pinched off, thereby
stopping blood flow, and a medical emergency]
ventral incision hernia [a hernia near the site of a
previous hernia], possible strangulated [stoppage
of blood flow, and a medical emergency] hernia,
severe dehydration [loss of fluid and vital
chemicals], septic [infection in the bloodstream, a
medical emergency] and hypovolemic shock [an
emergency condition in which severe blood or

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 43 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 43 A 941


fluid loss makes the heart unable to pump
enough blood to the body, and can cause many
organs to stop working], being resuscitated in
prep for OR." ED staff noted a call to the
admitting surgeon (MD 6) at 7:10 PM to report
that Patient B's blood pressure was too low. No
insertion of a tube (often a standard of practice)
to decompress Patient B's intestine (which was
obstructed by the strangulated hernia) was
documented.

At 7:45 PM, MD 6 recorded a preoperative


history and physical assessment (H&P). The
H&P, dated 9/17/16, noted that Patient B was
possibly infected and dehydrated, and in shock
but being supported in preparation for surgery.
Patient B's temperature was mildly elevated, her
abdomen was tender with redness over the
incarcerated hernia site, her skin was pale, cold
and clammy.

At 10:30 PM, a Pre-anesthesia Assessment,


dated 9/16/16, by an anesthesiologist noted
Patient B to be at high risk for surgery. The
Anesthesia start time was 11 PM. Immediately
upon administration of anesthesia medications,
and placement of a breathing tube into the lungs,
Patient B vomited bowel contents into the mouth
and lungs. Heart and lung function declined such
that a Code Blue was called at 11:15 PM to
perform advanced live-saving rescue maneuvers.
Copious bleeding from the breathing tube
occurred. The rescue attempts were
unsuccessful and Patient B died at 12:25 AM.

The Operative Report and Death Note, dated


9/17/16, documented by MD 6 noted, "we
concurrently had two separate emergencies,

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 44 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 44 A 941


which required the operating room. One of these
was an acutely bleeding patient who required
immediate surgery. This was followed by a stat
c-section. This patient was brought to the OR
after the stat c-section."

In a concurrent review of the MSQRC meeting


minutes, on 11/8/16 at 9:30 AM, the QM
acknowledged that Patient B's surgery to relieve
a life-threatening bowel obstruction was delayed
and the delay may have further compromised
Patient B's ability to respond to rescue efforts.
The MSQRC minutes addressed a complaint by
Patient B's family about why Patient B was not
transferred knowing that the surgical department
had placed other emergency cases before hers.
"Time admitted was 1345 (1:45 PM) and time to
OR (Operating Room) was 2300 [11:00 PM], this
was a total of 9 hours and 15 minutes before
surgery." The QM stated she created a root
cause analysis to evaluate various decision
points by all providers who had a hand in Patient
B's care. However, no procedures to formally
guide the decisions when surgical emergencies
were lined up and delayed, to either transfer
patients to another hospital or have second
on-call teams immediately available, had been
implemented.

3. In interviews on 10/26/16, between 2 PM and


5 PM, MD 6, the ORD, and Surgical Technician
(ST 1, who was present during Patient C's
9/29/16 surgery), were interviewed about Patient
C's surgery. The ORD and ST 1 both stated it
was determined that several operating room staff
were needed to position Patient C on the surgical
table at the beginning of the case. But at the end
of the case, staff had been called to help with

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 45 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 45 A 941


another emergency obstetric case and fewer
persons were available to position Patient C back
to a gurney. During Patient C's surgery, MD 6
did not have a surgical assistant to hold
retractors and help keep track of instrument
utilization.

MD 6 stated the retractor device that she usually


used was out of stock, and a yellow plastic
retractor device called a SurgiFish was used
instead. Patient C's abdomen was very large.
The SurgiFish device was set to one side of the
portion of a wound that was left open at the end
of the case. As Patient C was turned, no staff
noticed that the device slid into the open wound
and was not identified as missing during the
instrument counts. MD 6 stated the other
emergent case distracted members of Patient C's
surgical team during the counting of instruments.
MD 6 stated that on 10/9/16, as Patient C was
developing more abdominal pain, an x-ray
identified a suspicious image consistent with the
SurgiFish retractor inside the open wound (which
was not visible from the outside). On 10/10/16,
an additional surgery was required to remove the
Fish retractor device.

In an interview on 10/26/16, at 1:10 PM, the QM


acknowledged that the competing emergency
surgeries on 9/28/16 left Patient C's case
short-handed, and may have contributed to
distraction in counting instruments and more
difficulty in positioning, thereby allowing the
SurgiFish retractor to slide into the wound and
not be noticed.

During a record review for Patient C, the


document titled "Final Report", dated 10/29/16,

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 46 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 46 A 941


indicated she was 62 years old, and morbidly
obese with many prior abdominal surgeries that
chronically compromised her digestive function.
Patient C was admitted to the surgical unit on
9/22/16 for treatment of a chemical burn to the
skin and tissue of an ostomy port (small intestine
was temporarily diverted to open directly to the
outside through the abdominal wall while portions
of the remaining intestine were healing) that
resulted from seepage of intestinal contents onto
the surrounding abdominal skin. A reversal of
the ostomy to reconnect the bowel passage, and
to release adhesions between intestine and wall,
was planned for 9/29/16 and expected to be a
surgery lasting several hours. Per the
Anesthesia Record, dated 9/29/16, Patient C
weighed 278 pounds. Surgery started at 2:49
PM, and ended at 8:03 PM.

In a concurrent interview and record review of the


MSQRC meeting minutes on 11/8/16 at 9:30 AM,
the QM acknowledged that the retained foreign
object incident for Patient C was noted in
10/12/16 minutes and referred for outside peer
review. However, the QM stated the incident
was not discussed with the short-staffing aspect
as contributing to the incident. No referrals to
other departments and/or groups to evaluate the
impact of surgical staff shortages on patient
safety resulted from this opportunity. In a review
of the Performance Improvement (PI) Committee
materials (tracking of quality indicators and data),
the QM acknowledged that formal tracking of the
delays for surgical emergencies, shortage of the
OR team support, transfers of surgical patients
due to insufficient resources, or provider practice
patterns were not captured by the PI program.

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 47 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 47 A 941


In an interview on 11/8/16, beginning at 11:15
AM, the interim Operating Room Director (ORD)
explained that elective and urgent surgeries were
typically scheduled during the day between 8 AM
and 5 PM. The hospital was not a trauma center
and had only one on-call OR team (one
anesthesiologist, one registered nurse, one
surgical technician) available between 5 PM and
7 AM for emergent surgeries. The ORD said that
the on-call team could support Level I surgeries
(a life/limb/organ-threatened case that must start
now or bump the next available room), and some
Level II cases (case must start within two hours).
The Level classifications were defined in Surgery
and Medical Policy 12-3038.

The ORD further indicated that over the past 2


years as interim ORD, he had expressed
concerns about the stresses and impacts on his
on-call OR staff when multiple urgent and
emergent surgeries were requested
simultaneously by general surgeons and
obstetricians. Complex abdominal surgeries for
bowel obstruction or ruptured organs could take
6-8 hours. Emergency Cesarean section cases
to rescue a distressed fetus during labor routinely
occurred without warning, as the hospital had an
active obstetric service. The OR team would get
very tired and sometimes the same staff were
needed to work the next day. Of the three
general surgeons on staff, two surgeons split
their availability such that each covered call for
1-3 week blocks averaging 50% for each month.
The incidents ORD was most concerned about,
however, tended to occur mostly when one
particular surgeon (MD 6) covered for
emergencies after hours and on weekends. That
particular surgeon also performed most of the

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 48 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 48 A 941


complex surgeries "solo," without a qualified
surgical assistant. Decisions to accept complex
cases, and when to do them, were "physician
driven." The OR managers and teams had no
authority to participate in the decisions or to
recommend transfer for urgent cases to other
hospitals, even though a well-equipped trauma
center was located 15 miles away.

Review of on-call schedules for surgical services


between 6/2016 and 11/2016, confirmed that MD
6 was assigned to an average of 50% of the
days, in 1-3 week blocks. It was noted that in
7/2016, MD 6 covered 20 out of 31 days; in
8/2016, MD 6 covered 22 out of 31 days. MD 6
was scheduled to cover call from 11/7/16 to
11/13/16.

In the 11/8/16, at 11:15 AM interview, the ORD


stated that the strain on OR resources was
frequently discussed at the ORD's internal
weekly or monthly steering committee meetings.
The ORD also expressed these concerns at
Surgery and Anesthesia Department meetings in
2015. Since 1/2016, the medical staff was
restructured and the ORD asked the current
Surgery Committee Chair to address the
concerns and bring the issue forward for
solutions. However, the ORD stated that the
formal meetings between the steering committee,
the Surgery Committee, and/or the Surgery
Committee Chair were often canceled and had
not yet occurred. The ORD prepared a log to
show patterns and causes of delays for surgeries
from 1/2016 to 9/2016. The ORD provided the
log to the hospital Chief Executive Officer in an
appeal for more resources. The ORD indicated
that solutions had not been implemented, the

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 49 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 49 A 941


same problems continued, and surgeries for
Level I and Level II patients were still at times
delayed. In some cases, errors were made and
patient outcomes suffered. The Surgery
Committee Chair was the same surgeon (MD 6)
who drove many of the incidents about which the
ORD was concerned.

Review of the OR Delay Log from 1/14/16 to


9/21/16, indicated that more than most other
surgeons, surgical patients assigned to MD 6
experienced frequent delays of 2-4 hours, with
comments that MD 6 had worked the previous
night and was too tired to start cases at several
scheduled times prior to 1 PM. MD 6 was also
delayed from car problems and needing physical
therapy and knee injections. After hours cases
occurred on 1/19/16, 1/20/16, 2/23/16, 3/18/16,
3/29/16, 4/13/16, 4/15/16 (which included a 6
hour delay), 4/18/16, 4/22/16, 4/25/16, 5/2/16,
7/8/16, 8/22/16 (which included Patient A's 12
hour delay), 8/24/16 (which included a 7 hour
delay), and 9/16/16 (which included Patient B's 9
hour delay). MD 6 rescheduled cases to a
Saturday when only one on-call OR team was
available on 3/25/16 and on 7/8/16.

Review of Policy 12-3038 titled "Surgery and


Medical Procedures," approved 10/28/15, under
item IV-B-2 and 3, described the procedures for
scheduling emergency surgeries. The Level
classification was defined as the ORD stated. All
Level I and II cases were to be reviewed by the
Surgical Steering Committee. The treating
surgeon was responsible to assign the Level of
urgency. Any dispute over the Level would be
settled by the service chief (which would be the
Surgery or Obstetric Committee Chair for these

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 50 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 50 A 941


incidents). The treating surgeon was responsible
to notify the anesthesia provider and the nursing
supervisor.

However, during the interview on 11/8/16, at


11:15 AM, the ORD acknowledged that there
were no procedures for anesthesia or nursing
managers to set limits on whether the case could
be accepted, or to call in additional staff, if
operating room resources were inadequate to
manage concurrent surgeries.

In an interview on 11/1/16, at 2:30 PM, MD 9, an


anesthesiologist and past Surgery Committee
Chair prior to 1/2016, indicated that concerns
about strains on the on-call operating room
resources and delays in surgeries were
discussed by the Surgery Committee in 2015.
MD 9 stated that he requested the hospital
administration to address how the surgical
resources were utilized, but no solutions were
enacted. MD 9 stated that he observed a
preference for MD 6 to perform surgeries late in
the day and at night, including cases that could
be scheduled early in the day when three OR
teams were available. MD 9 described situations
that put patients in jeopardy. For example,
minimally invasive surgeries (e.g., laparoscopic
where a device to visualize the contents within
the abdomen through a small cut of the skin)
were done late in the day when they may have
safely been performed early the following day.
Then during the case an emergency Cesarean
section was needed and staff had to "go down
the list" of operating room personnel to get a
second OR team to come in. Delays would occur
if people could not be reached or were
unavailable. The past response from the hospital

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 51 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 51 A 941


Chief Executive Officer (CEO) was "No" for a
second on-call OR team, and no efforts had
changed MD 6's practice pattern of arranging for
surgeries late in the day when resources were
stretched thin.

In an interview on 11/3/16, beginning at 11:45


AM, the hospital CEO and Chief Operations
Officer (COO) identified more operating room
staff coverage, including anesthesia providers,
surgeons and assistant surgeons, and OR team
personnel for afterhours and weekends as a
major need for the hospital's surgical services.

Review of the current medical staff policies, rules


and bylaws showed no formal listing of the
surgical procedures that required a surgical
assistant. In an interview on 11/8/16, at 11:30
AM, the ORD stated that sometime in the past
such a list existed but that he and anesthesia
staff were unable to locate it.

In an interview on 11/8/16 at 11:15 AM, the ORD


indicated that the hospital had limited surgical
capabilities for adults and not all surgical
specialties were available. The ORD indicated
that Level I and II emergencies for children,
trauma patients, and patients needing some
surgical specialties, were routinely transferred to
appropriate hospitals that did have capability to
care for the patients. For example, women in
labor with high-risk obstetric needs were
transferred to a center with the ability to care for
newborns with special needs if delivery was not
imminent. The ORD stated that when adult
patients with general surgery conditions were
"lining up" and competing for the operating room
resources, one of the two on-call surgeons would

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 52 of 53
PRINTED: 05/17/2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING ______________________

050359 B. WING _____________________________


11/14/2016
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
869 NORTH CHERRY AVENUE
TULARE REGIONAL MEDICAL CENTER
TULARE, CA 93274
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)

A 941 Continued From page 52 A 941


transfer such patients to a hospital that had
capability. However, the ORD stated that MD 6
would commonly NOT transfer patients, and
would over-commit to take on more than the
hospital was prepared to manage.

Review of the current transfer agreements


indicated that the hospital did have active
arrangements with an ambulance transport
company, with two trauma centers located 15
and 45 miles away respectively, with a children's
hospital, and with another community hospital of
capability similar to this hospital located 20 miles
away. The hospital formally participated in an
area-wide network intended to expedite the
timely transfer of patients and records when
emergency patients and inpatients needed
specialized care for which the hospital did "not
have the capacity or capability, including
resources that are temporarily unavailable."

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 7D5P11 Facility ID: CA120001467 If continuation sheet Page 53 of 53

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