PRINTED: 11/10/2011 DEPARTMENT OF HEALTH AND HUMAN ... · department of health and human services...

(X1) PROVIDER/SUPPLIER/CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

11/10/2011PRINTED:

FORM APPROVED

OMB NO. 0938-0391

STATEMENT OF DEFICIENCIES

AND PLAN OF CORRECTION IDENTIFICATION NUMBER:

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NAME OF PROVIDER OR SUPPLIERSTREET ADDRESS, CITY, STATE, ZIP CODE

(X4) ID

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SUMMARY STATEMENT OF DEFICIENCIES

(EACH DEFICIENCY MUST BE PERCEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

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IDPROVIDER'S PLAN OF CORRECTION

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DEFICIENCY)

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2015 JACKSON ST

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SAINT JOHN'S HEALTH SYSTEM

00

S0000

The visit was for a licensure survey.

Facility Number: 005078

Survey Date: 10-03-11 to 10-05-11

Surveyors:

Brian Montgomery, RN

Public Health Nurse Surveyor

Linda Plummer, RN

Public Health Nurse Surveyor

Cleone Peterson, BS ASCPMT

Medical Surveyor 3

QA: claughlin 10/17/11

S0000

S0178 410 IAC 15-1.3-2(a)

(a)The license shall be conspicuously

posted on the hospital premises in an

area open to patients and public. A

copy shall be conspicuously posted in

an area open to patients and public on

the premises of each separate hospital

building of a multiple hospital

building system.

_____________________________________________________________________________________________________

Any defiencystatement ending with an asterisk (*) denotes a deficency which the institution may be excused from correcting providing it is determined that

other safegaurds 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

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE

Event ID: O37E11 Facility ID: 005078

TITLE

If continuation sheet of 29

(X6) DATE




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Based upon observation and interview,

the facility failed to post a license copy in

a common public area for each hospital

services off-site location for 7 off-sites.

Findings:

1. During a facility tour on 10-04-11, lack

of a posted license was observed in the

common public areas of the following

outpatient services located in the

Ambulatory Services Center:

a) Radiation Oncology suite at 1015

hours

b) Chemotherapy infusion suite at 1040

hours

c) Endoscopy suite at 1055 hours

d) Anticoagulation clinic suite at 1120

hours

2. During a facility tour on 10-04-11 at

1135 hours, lack of a posted license was

observed in the common public areas of

the St John's Children's Clinic.

3. During an interview on 10-04-11 at

1205 hours, staff #A7 confirmed the

locations [ 1(abcd) and 2 ] lacked a posted

license.




the Erskine Rehabilitation Center.

S0178 11/2/11 – A copy of the 2011

hospital license was posted in every

off-site listed on the Saint John’s

Health System off-site list that

accompanies the license, including

all sites identified by the surveyor in

the survey report. Annually, a copy

of the hospital license will be posted

in all off-site locations. Director;

Quality, Risk Management, and

Regulatory Readiness

11/02/2011 12:00:00AM

FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: O37E11 Facility ID: 005078 If continuation sheet of 29




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the St John's Orthopedic Surgery Center.



locations [ 4 and 5 ] lacked a posted

license.

S0322 410 IAC 15-1.4-1(c)(6)(H)

(c) The governing board is responsible

for managing the hospital. The

governing board shall do the

following:

(6) Require that the chief executive

officer develops policies and programs

for the following:

(H) Requiring all services to have

policies and procedures that are

updated as needed and reviewed at

least triennially.

Based on document review and interview,

the facility failed to follow its

policy/procedure and ensure that all

policy/procedures are reviewed at least

triennially for 2 services.

Findings:

1. The administrative Policy Statement

re: Policies (approved 10-01-82) indicated

the following: "...a Departmental Policy

S0322 11/1/11 – All Radiology and Nuclear

Medicine department policies not

reviewed and approved within the

last three years were reviewed and

updated as necessary by the

Radiology Department Director.

Including those policies specifically

identified in the survey report.

These policies are viewable online to

all Associates in the PolicyStat

software system and a hard copy

manual is now available in the

Radiology and Nuclear Medicine

11/01/2011 12:00:00AM





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Manual ... should be accessible to

employees at all times ... the department

director is the identified owner and as

such is responsible for maintaining the

Department Policy Manual. [and]

Current hard copy policies will be

accessible at all times. [and] Policies

will be scheduled for review every three

years or as required by changing

conditions."

2. On 10-03-11 at 1030 hours, staff #A1

was requested to provide departmental

policy/procedure manuals for the areas of

Radiology and Nuclear Medicine and

none were provided prior to exit.

3. Radiation safety documents indicated

that many department policy'procedures

had not been reviewed by the director for

more than 3 years [Safety (revised

09-08), Patients with Previous Contrast

Reaction (revised 11-04), MRI Safety

(revised 03-02), MRI Patient Pregnancy

(revised 02-05), Safety Rules for

Working with Radioactive Material

(reviewed 04-05), Safety Monitoring

(revised 04-05), Safety Handling

Radioisotopes (revised 04-05)].


1250 hours, staff #A6 confirmed that the

Radiology and Nuclear Medicine

departments lacked a hard copy of their

departments. A Policy

Administrator has been assigned for

Radiology and Nuclear Medicine.

This Administrator has been granted

system access to routinely receive

alerts from the PolicyStat system

notifying the department of all

policies due for review within the

next 90 days. This ongoing

compliance tool was not available

prior to PolicyStat implementation

in September 2011. Director;

Radiology.





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policies and procedures and that many of

the policy/procedures had not been

reviewed or revised within the past 3

years.

S0406 410 IAC 15-1.4-2(a)(1)

(a) The hospital shall have an

effective, organized, hospital-wide,

comprehensive quality assessment and

improvement program in which all areas

of the hospital participate. The

program shall be ongoing and have a

written plan of implementation that

evaluates, but is not limited to, the

following:

(1) All services, including services

furnished by a contractor.


the facility failed to include 5 direct

services and 3 contracted service in its

Quality Assessment and Improvement

(QA&I) program.

Findings:

1. Department QA report cards failed to

indicate ongoing monitoring for the direct

services of cardiac catheterization,

radiation therapy, and tissue

transplantation, lacked data for the direct

services of central sterile and oncology,

and lacked monitoring for the contracted

services of hemodialysis, housekeeping

S0406 10/31/11 – Cardiac

Catheterization completed a

quarterly complication review of

all Catheterization cases

occurring during the months of

July, August and September. This

metric has been added to their

department Scorecard which

incorporates it into the facility QI

program. Director; Quality, Risk

Management, Regulatory

Readiness.11/1/11 – Oncology

services which includes Radiation

Therapy have historically

monitored diagnostic and

outcome measures for selected

patient groups and reported this

data to the Cancer Committee of

the Medical Staff. Effective

11/1/11 this quarterly data will be

forwarded to the Quality Analyst

and added to their department

11/01/2011 12:00:00AM





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services for one off-site, and a mobile

radiology service.


1630, staff #A1 confirmed the 5 direct

services lacked effective monitoring and

the 3 contracted services would be added

to the QA&I program.

Scorecard which incorporates it

into the facility QI



Readiness. 11/1/1- Tissue

Transplantation metrics currently

being collected but not integrated

into the facility QI program were

added to the Surgical Services

department Scorecard. Metrics

include: tissue received

unsuitable for use, temperature

monitor for tissue freezer,

infection review of 100% of

patients with implanted tissues

developing post-operative

infections. Director; Quality, Risk


Readiness.11/1/11- Central

Supply leadership identified the

following metrics for their

department Scorecard: % Code

Carts inspected for outdated

supplies, % of PAR areas

inspected for outdated supplies,

% of storerooms inspected for

outdated supplies. Data

collection had been collected and

analyzed within the department

for these metrics. Inclusion in the

department Scorecard now

incorporates it into the facility QI



Readiness. (Three contracted

Services – Env. Services,

Hemodialysis, and Mobile

Radiology Services) 10/20/11 –

Hemodialysis - Meeting with

Hemodialysis provider and

hospital leadership to agree on

appropriate Quality Metrics in





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accordance with contract. Water

sample compliance and

preventive maintenance data for

the period July, August,

September 2011 was reviewed

and found to be satisfactory.

Agreed to conduct quarterly

Quality meetings to review these

Quality Metrics and identify other

opportunities for improvement.

Next meeting to be held in

January 2012 and quarterly

thereafter. Quality reviews of all

contracted services are

completed in January annually.

This summary of review is

incorporated in the facility QI



Readiness. 10/21/11 –

Environmental Services - Clarified

contractual relationship with

outside cleaning service that

cleans Ambulatory Services

Center and Roby Building. Saint

John’s is a tenant within this

building and does not own the

building. The Cleaning Service is

contracted by the Landlord to

provide cleaning services and is

not contracted by Saint John’s.

All feedback and concerns

regarding quality of cleaning are

forwarded to the Landowner to

address. To date all feedback

and issues have been

satisfactorily resolved. Director;

Quality, Risk Management,

Regulatory Readiness. 10/21/11

- Mobile Radiology Services –

Patient satisfaction and complaint

documentation is currently being





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collected and analyzed at the

department level. Appropriate

Quality Metrics are currently

under consideration for inclusion

effective 12/1/12. Director;

Radiology

S0570 410 IAC 15-1.5-2 (f)(1)(A)(b)(C)(D)(E)

(f) The hospital shall establish an

infection control committee to monitor

and guide the infection control

program in the facility as follows:

(1) The infection control committee

shall be a hospital or medical staff

committee that meets at least

quarterly, with membership that

includes, but is not limited to, the

following:

(A) The person directly responsible

for management of the infection

surveillance, prevention and control

program.

(B) A representative from the medical

staff.

(C) A representative from nursing

service.

(D) A representative from

administration.

(E) Consultants from other appropriate

services within the hospital, as

needed.

Based on review of the facility's infection

control plan, review of the 2011 meeting

minutes, and staff interview, the facility

failed to ensure that the pharmacist

attended the infection control meetings, as

required, and failed to ensure that a

physician and administrator were included

in the committee makeup.

S0570 11/10/11 – 2012 Infection Control

Plan will be submitted to the

Pharmacy and Therapeutics

Committee for approval. This plan

includes a recommendation that

effective January 2012 the Pharmacy

and Therapeutics Committee will

formally be assigned the Infection

Control Committee oversight duties.

At present all Infection Control

reporting, policy changes, problem

11/10/2011 12:00:00AM





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Findings:

1. at 4:05 PM on 10/3/11, review of the

Infection Control Plan, signed 11/10,

indicated:

a. on page 10 under section "E.

Infection Control Committee The

Infection Control Committee shall be a

standing committee and consist of a

chairperson or chairpersons and members

representing the following

departments/services: Infection Control,

Associate Health Services, Emergency

Department, Pharmacy,..."

2. at 9:30 AM on 10/4/11, review of the

2011 "Infection Control Committee"

meeting minutes indicated:

a. there was no attendance by a

physician or administrator at any of the 8

meetings held so far in 2011

b. the pharmacist did not attend the

following meetings: 3/9/11; 4/13/11;

5/11/11; (no meeting held in June);

7/13/11; 8/10/11 and 9/14/11

3. interview with staff member NK at

3:10 PM on 10/4/11 indicated:

a. currently, there is no physician or

administration inclusion/attendance at the

infection control committee meetings

b. pharmacy representation has been

absent for 5 meetings so far in 2011

identification and issue resolution is

presented to Pharmacy and

Therapeutics Committee for review

and final approval. The membership

of the Pharmacy and Therapeutics

Committee includes representation

by Pharmacy, Medical Staff, Nursing

and Administration as required.

The committee previously identified

as the Infection Control Committee

did not complete these functions

and is now renamed the Workfoce

Infection Control Team. Infection

Control Practitioner.





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S0606 410 IAC 15-1.5-2(f)(3)(D)(viii)

(f) The hospital shall establish an

infection control committee to monitor

and guide the infection control

program in the facility as follows:

(3) The infection control committee

responsibilities shall include, but

not be limited to, the following:

(D) Reviewing and recommending changes

in procedures, policies, and programs

which are pertinent to infection

control. These include, but are not

limited to, the following:

(viii) An employee health program to

determine the communicable disease

history of new personnel as required

by state and federal agencies.

Based on policy and procedure review,

product manufacturer insert review,

employee health file review, and staff

interview, the facility failed to implement

its policy related to communicable disease

status for 1 of 3 agency RNs (registered

nurses), P2, and for 1 of 1 MTTs

(multiple task technicians), P8.

Findings:


policy and procedure "Post Offer Physical

Assessment" - AH-05, indicated:

a. in the section "Pre Admissions will"',

it reads in item 9.: "Fax Lab Requisition

for all associates referred to Saint John's

lab...for out patient lab work."

b. in the section "Associate Health

S0606 10/7/11 – Actual time and date of all

TB testing and reading implemented

by Associate Health Nurse.

10/31/11 – Post Offer Physical

Assessment Policy – AH -5 revised to

specifically state all TB tests will be

read within 48 – 72 hours in

accordance with package insert.

Also revised to state annual TB

testing is not required based on the

organizations low risk assessment.

Associate Health Nurse.

10/31/11 – Verified with CNO that

the three agency files reviewed

during survey are nurses no longer

assigned to Saint John’s, and that all

other contract files contained

required documentation. Director;

Quality, Risk, Regulatory Readiness.

10/31/2011 12:00:00AM





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will:", it reads in item 7.: "Complete job

specific baseline screening, second TB

test, vaccinations..."

c. on the "New Associate Onboarding

Lab Testing Requisition" form, it

indicated that Varicella Zoster IgG

Antibody was required as part of the

employee new hire process


policy and procedure "Associate Health

Service" HR-306, indicated:

a. under "Action Steps", it reads: "A

two step TB skin test is required of all

new associates and then annually

thereafter..."


Tubersol brand package insert for PPD

(purified protein derivative) for TB

(tuberculosis) testing indicated:

a. in the area "Interpretation of Test", it

reads: "The skin test should be read...48

to 72 hours after administration of

Tubersol..."

4. at 3:30 PM on 10/3/11, review of 3

agency RN (registered nurse) files

indicated staff member P2:

a. had a first date worked as 7/1/11

b. had documentation of a self reported

history of Varicella

c. had a TB test dated as given on

5/20/11 and read on 5/23/11, but was





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lacking a time given and a time read to be

able to determine that the reading

occurred between 48 and 72 hours, as

required per manufacturer

d. lacked documentation of a second

step TB test

5. at 4:15 PM on 10/4/11, review of

personnel files P4 through P9 indicated

staff member P8:

a. had returned to employment within

60 days on 8/15/11, and had a return TB

test on 7/27/11 that was read on 7/29/11,

but was lacking a time given and a time

read to be able to determine that the

reading occurred between 48 and 72

hours, as required per manufacturer

b. had documentation by associate

health that the employee "Did not return

to have skin test read within 72 hours"

c. also had documentation signed

7/31/11 by an RN that appeared to have

had the TB test read on that day, which

was outside the 72 hour time limit (and

conflicts with the 7/29/11 date that was

also written on the form as the date the

TB test was read)

6. interview with staff member NA at

11:20 AM on 10/5/11 indicated:

a. in the fall of 2010, it was determined

that new employees would no longer be

able to self report Varicella history of

disease





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b. it is unclear why/how agency staff

member P2 was not found by associate

health staff to be lacking a Varicella titer

c. the Associate Health Service policy

(listed in 2. above) needs to be updated, as

the facility no longer performs annual TB

testing based on determination of being a

low risk geographical area

S0726 410 IAC 15-1.5-4 (c)(7)(A)(B)

(c) An adequate medical record shall

be maintained with documentation of

service rendered for each individual

who is evaluated or treated as

follows:

(7) The hospital shall ensure the

confidentiality of patient records

which includes, but is not limited to,

the following:

(A) A procedure for releasing

information from or copies of records

only to authorized individuals in

accordance with federal and state

laws.

(B) A procedure that ensures that

unauthorized individuals cannot gain

access to patient records.

Based upon document review, observation

and interview, the facility failed follow

S0726 10/31/11 – Meeting with

Department Directors of areas

identified in survey and HIPAA

Compliance Officer to review

11/03/2011 12:00:00AM





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their policy/procedure ensuring that

medical records (MR) were not accessible

to unauthorized individuals.

Findings:

1. Review of the policy/procedure

Security of Medical Records (revised

08-11) indicated the following:

Confidentiality will be maintained by

limiting access to authorized personnel.

2. During an off-site tour of the radiation

oncology department on 10-04-11 at 1030

hours, MR were observed on open shelves

in a nursing station room with a locking

door. Staff #A7 indicated that

housekeeping provided cleaning services

in the area when unit staff were not

present.

3. During an off-site tour of the

anticoagulation clinic on 10-04-11 at 1120

hours, MR were observed in an open-top,

wheeled chart rack stored in a small room

without a locking door. Staff #A7

confirmed the room was accessible to

patients and unauthorized staff.

4. During an off-site tour of the children's

clinic on 10-04-11 at 1135 hours, MR

were observed on open shelving in the

registration area. Staff #A7 confirmed

that the records were accessible to

unauthorized staff.

security measures and

enhancements. HIPAA

Compliance Officer confirmed

that Saint John’s Environmental

Services Associates complete

annual HIPAA training and

execute Confidentiailty

Agreements upon hire. This is the

same degree of education and

documentation of all other Saint

John’s Associates which does

authorize them to clean in the

presence of patient records

unattended. Health System

leadership concurs with this

practice. In addition, A Business

Associate agreement has been

executed by the Landlord of

off-site locations cleaned by

outside cleaning service.

However, the following security

and access enhancements have

been made to the areas noted in

survey.11/3/11 Medical Records

– The door to the storage area

noted is now kept locked at all

times and the area is cleaned by

a Saint John’s Associate during

open hours while observed by

Medical Records staff. Director;

HIM10/7/11 Coagulation Clinic –

Patient Records in this area were

relocated to a locking storage

cabinet kept secure at all times.

Director; Pharmacy11/3/11

Children’s Clinic – The area is

now cleaned by a Saint John’s

Associate during open hours

while observed by Children’s

Clinic staff. Children's Clinic

Charge Nurse.11/3/11 Day

Surgery – Overnight charts are





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5. During a tour of the day surgery on

10-04-11 at 1520 hours, MR were

observed in an open-top, wheeled chart

rack located partway under the nursing

station counter. Department staff #A17

indicated that the rack containing patient

records for the next day procedures was

stored overnight under the counter and

housekeeping staff cleaned the unit during

the evening/night hours when unit staff

were not present.

6. During a tour of the medical records

department on 10-04-11 at 1525 hours,

open wall shelving containing incomplete

patient charts were observed in the chart

completion room. Staff #A4 confirmed

that housekeeping services were provided

in the area when department staff were

not present.

7. During a off-site rehabilitation

department tour on 10-05-2011 at 0855

hours, a large under-counter cabinet

containing current medical records was

observed in the front office area of the

department. Department coordinator

#A14 indicated the staff were not locking

the cabinet overnight when housekeeping

provided cleaning services and was failed

to provide a working key for the cabinet

when requested at the time of the tour.

now kept in a locked cabinet.

Director; Surgical

Services 11/3/11 Rehabilitation –

Keys were obtained to lock the

cabinet observed to be kept

unlocked during survey. It is now

kept locked when not in use.

Director; Rehabilitation11/1/11

The HIPAA Compliance Officer

developed a unit tour checklist to

be implemented this month in all

areas storing patient records to

further assess and enhance

security of records. Results of

these tours will be forwarded to

the Unit Manager and reviewed

by the HIPAA oversight team for

improvement opportunities.

HIPAA Compliance Officer.





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S0912 410 IAC 15-15-6 (a)(2)(B)(i)(ii)

(iii)(iv)(v)

(a) The hospital shall have an

organized nursing service that

provides twenty-four (24) hour nursing

service furnished or supervised by a

registered nurse. The service shall

have the following:

(2) A nurse executive who is:

(B) responsible for the following:

(i) The operation of the services,

including, but not limited to,

determining the types and numbers of

nursing personnel and staff necessary

to provide care for all patient care

areas of the hospital.

(ii) Maintaining a current nursing

service organization chart.

(iii) Maintaining current job

descriptions with reporting

responsibilities for all nursing staff

positions.

(iv) Ensuring that all nursing

personnel meet annual in-service

requirements as established by

hospital and medical staff policy and

procedure, and federal and state

requirements.

(v) Establishing the standards of

nursing care and practice in all

settings in which nursing care is

provided in the hospital.

Based on pediatric medical record review,

review of the "Standard Patient Care

Protocol", and staff interview, the chief

nursing officer failed to develop a

standard for pediatric admission

assessment and care.

S0912 10/27/11 – Director; Maternal Child

Services worked with Information

Technology to add head

circumference to the online

Pediatric Admission Assessment for

all pediatric admissions. All nurses

responsible for completion of

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Findings:

1. at 1:35 PM on 10/5/11, review of

pediatric records N17, N18, and N19,

indicated:

a. pt. N17 was a 6 week old infant

admitted without a head circumference

being done by nursing staff

b. pt. N18 was a 3 month old infant



c. pt. N19 was a 12 month old child



2. interview with staff member NI at 1:50

PM on 10/5/11 indicated:

a. a child's head circumference is only

done on admission "depending on

admitting diagnosis or physician's order"

(the specific diagnoses that would indicate

when nursing would do a head

circumference were not provided to the

surveyor)


form titled "Standard Patient Care

Protocol Medical/Surgical Units Care

Coordination Unit, Joint Replacement

Unit 3 South, 5 South & 6 South"

indicated:

a. the one page document does not

address the facility's pediatric patients

b. only adult patients are addressed in the

Pediatric assessments were notified

of this change to be effective

10/31/11. Director; Maternal Child

Services

10/31/11 – Revised online admission

assessment implemented. Director;

Maternal Child Services

11/1/11 – New Pediatric Standard of

Care developed to define ongoing

required Pediatric Assessment and

Care. All nurses responsible for

completion of Pediatric assessments

were notified of this planned

implementation. CNO

11/11/11- New Pediatric Standard

of Care to be fully implemented.

CNO

11/1/11 – The Quality Nurses began

assessing compliance with Standard

of Care documentation as part of

their existing ongoing record

review. The results of this review

will be reported to the Nursing

Manager s for follow-up. The

monthly review will continue until 3

months of 100% compliance is

achieved. Manager; Quality and Risk

Management.





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protocol

4. at 2:55 PM on 10/5/11, interview with

staff member NA indicated:

a. the facility "standard of care" does not

include measuring a head circumference

for pediatric patients, which is a standard

of practice for patients less than 24

months old

b. there is no pediatric "standard of

care" for nursing to follow, even though

the facility cares for pediatric patients

c. pediatric patients are cared for on the

3 South medical unit (but will be moving

to the 5 South unit this month)--there is

no specific pediatric unit

S1118 410 IAC 15-1.5-8 (b)(2)

(b) The condition of the physical

plant and the overall hospital

environment shall be developed and

maintained in such a manner that the

safety and well-being of patients are

assured as follows:

(2) No condition shall be created or

maintained which may result in a

hazard to patients, public, or

employees.


manufacturer's recommendation,

observation, and staff interview, the

facility failed to ensure that no condition

was created that may cause a hazard to

S1118 GLUCOMETER TEST STRIPS

10/7/11 – All hospital departments

completing glucometer testing were

notified to immediately verify the

date control solutions were opened

was documented on the bottle. All

11/01/2011 12:00:00AM





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patients in relation to the possible

incorrect results of glucometer and coag

testing in two areas toured; failed to

ensure the cleanliness of four refrigerators

and failed to monitor the refrigerator

temperature for one staff refrigerator.

Findings:


policy and procedure "Refrigerator

Monitoring" -ADMIN-191, indicated:

a. under "Definition", it reads: "...7.

ensuring that a system is in place to

guarantee cleanliness/temperature of the

refrigerator is the responsibility of the

Manager..."

2. at 2:30 PM on 10/3/11, while on tour

of the CCU (coronary care unit) pantry

area in the company of

staff member NF it was observed that:

a. the patient refrigerator emitted a foul

odor indicating something had spilled at

an earlier time and had not been

appropriately cleaned

b. the staff refrigerator was dirty and

had evidence of spillage and debris


of the Rehab unit in the company of staff

members NB and NG it was observed

that:

a. the pantry refrigerator was dirty and

had evidence of spillage and debris

undated controls were discarded.

Director; Quality, Risk Management,


10/7/11 – Confirmed with Waived

Testing Coordinator that a policy did

exist for glucometer use and did

address dating of controls. The staff

members interviewed during survey

were unaware of this existing policy

even though they had successfully

completed glucometer competency

training which includes review of

this policy. Effective immediately all

glucometer competency training will

include increased focus of this policy

and specifically the dating of

controls. A copy of the policy will be

posted at each glucometer location.


Regulatory Readiness and Waived

Testing Coordinator.

11/1/11 – The ongoing quality

assurance monitoring conducted by

the Waived Testing Coordinator will

monitor compliance with the dating

control bottles. Results of this

monitoring will be forwarded to the

appropriate Unit Managers for

follow-up. Waived Testing

Coordinator.

COAG CONTROL TEST STRIPS

10/7/11 – Director of Pharmacy

counseled Associates of the

Coagulation Clinic regarding proper

verification of expiration date prior

to conducting tests. Associates were

aware of the importance of this step

but failed to consistently verify with

every use. Director; Pharmacy.





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4. at 11:25 AM on 10/4/11, while on tour

of the off site Coag Clinic in the company

of staff members NH and NI, it was

observed that:

a. in one testing room, the co ag control

test solutions (package with 2 bottles) had

expired 8/11

b. in the medical records/staff lounge

room, it was observed that:

I. the half full pot of coffee had a layer

of green mold floating on the cold coffee

II. the staff refrigerator was grossly dirty

with evidence of spillage and debris

III. there were dirty dishes piled and

filling the small sink (included silverware,

cups, bowls and plates)

IV. the trash receptacle under the sink

was overflowing with paper towels and

trash with several pieces of trash (>3) on

the floor around the trash receptacle

V. the temperature of the employee

refrigerator was only logged on January,

February, March and May in 2011

5. interview with staff member NA at

10:00 AM on 10/5/11 indicated:

a. nursing staff are responsible for

maintaining the cleanliness of patient and

staff refrigerators

b. the Refrigerator Temperature policy

indicates that staff refrigerators are

exempt from the policy, but in fact,

temperatures are monitored on the

REFRIGERATOR MONITORING

10/7/11 – Infection Control

Practitioner notified of refrigerator

findings and general lack of

appropriate cleanliness observed in

four areas during survey. Director;

Quality, Risk Management,


10/7/11 – Department Managers of

the specific refrigerators observed

during survey were notified to

immediately clean the identified

refrigerator. All were completed.


Regulatory Compliance.

10/7/11 – Director; Pharmacy

notified of all issues observed in

Coag Clinic at the time of survey.


Regulatory Readiness.

10/7/11 – Coag Clinic thoroughly

cleaned and all noted areas of

noncompliance resolved. Director;

Pharmacy.

10/7/11 – Coag Clinic Associates

counseled about routine daily

cleaning of department, logging of

refrigerator temperature and overall

basic sanitation. Director;

Pharmacy.

11/1/11 – Infection Control

Practitioner added cleanliness of

refrigerator inspection to the

monthly unit Infection Control

designee inspection checklist. These

checklists are submitted to the ICP

for review. Results of these

inspections will be forwarded to the

Unit Mangers, who are responsible





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employee refrigerators

c. there is no nursing procedure/nursing

unit schedule for cleaning refrigerators,

and other appliances, utilized by staff, but

nursing unit managers are responsible for

seeing that this is accomplished on a

routine basis


Roche brand package insert for the

Accu-Chek control solutions indicated:

a. under "How Do I Run a Quality

Control Test?", it reads: "Be sure to write

the date on the label when you open a new

bottle of control solution. A bottle is

good for three months after opening..."

b. under "What do I need to Know about

my Glucose Control Solutions?", it reads:

"...the glucose control solutions are stable

for three months after first opening the

bottles..."

7. at 2:25 PM on 10/3/11, while touring

the Birthing Center in the company of

staff member NE, it was observed that:

a. the high and low control solutions for

the Accu Chek glucometer were not dated

when opened, nor was the 90 day

expiration date written on the solution

bottles

b. it was impossible to determine when

the solutions were opened, or when they

expired, per the manufacturer's

instructions

for overall cleanliness of the

refrigerators on their unit. Infection

Control Practitioner





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8. at 9:45 AM on 10/5/11, interview with

staff member NA indicated:

a. there is no facility policy related to

the glucometer or the glucometer control

solutions

b. the control solution bottles have an

area for staff to write the "open" date and

the "exp. date" (for the 90 day expiration

of the solution as per the package insert)

S1164 410 IAC 15-1.5-8(d)(2)(B)

(d) The equipment requirements are as

follows:

(2) There shall be sufficient

equipment and space to assure the

safe, effective, and timely provision

of the available services to patients,

as follows:

(B) There shall be evidence of

preventive maintenance on all

equipment.

Based on observation and interview, the

facility failed to perform equipment

maintenance ensuring a safe working

environment for employees in one

department.

Findings:

1. During a tour of the nuclear medicine

department on 10-03-11 at 1455 hours, an

exhaust hood was observed without

evidence of routine inspection and testing

S1164 10/31/11 - The Nuclear Medicine

exhaust hood was inspected and

certified by CTG Certification

Network . A schedule was

developed to ensure annual

inspection and certification by this

company. No deficiencies in function

or safety issues were found upon

inspection. Director; Radiology

10/31/2011 12:00:00AM





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in the area where radionucleotides were

prepared for use during patient testing.

Records of preventive maintenance and

testing were requested from staff #A4 and

not provided prior to exit.



exhaust hood was not currently receiving

routine service, inspection and

certification.

S1180 410 IAC 15-1.5-8(f)(1)

(f) The safety management program

shall include, but not be limited to,

the following:

(1) An ongoing hospital-wide process

to evaluate and collect information

about hazards and safety practices to

be reviewed by the safety committee.

Based on review of the facility hazardous

materials and waste management plan,

observation, and staff interview, the

facility failed to ensure the safety of

visitors and patients in the ED (emergency

department) and failed to ensure that

hazardous waste storage areas were

appropriately labeled in two areas toured.

Findings:


Infection Control Plan and Hazardous

Materials and Waste Management Plan

S1180 10/5/11 – The appropriate

Hazardous Waste Storage signs

were installed on both ED storage

room doors noted in the survey

report. Director; Environmental

Services.11/4/11 - Additional

levels of security to mitigate risk

and decrease access to the ED

storage room were implemented.

The storage rooms are now

posted with Do Not Enter signs.

Additionally, the Hazardous

Waste tubs were retrofitted with

springloaded hinges to further

prohibit access. A risk

assessment was completed by

the Hazardous Materials Plan

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indicated:

a. under "Scope", it reads: "...The plan

will ensure that Saint John's Health

System provides an environment that

protects patients, staff and others from the

risk of exposure to hazardous materials..."


"Annual Evaluation 2010 Hazardous

Material and Waste Management Plan",

indicated:

a. under "Scope Analysis", it reads:

"...The Plan ensured that Saint John's

provided an environment that protected

patients, visitors and staff from exposure

to harmful chemical products or

potentially infectious materials or wastes."


of the ED with staff members NC and

ND, it was observed that:

a. a large red plastic hazardous waste

tub was present in two hallway storage

rooms that were unlocked, making access

by patients and visitors possible

b. the two hallway storage rooms lacked

any signage on the doors indicating that

hazardous waste materials were located

inside

4. interview with staff members NC and

ND at 1:30 PM on 10/3/11 indicated the

contents of the red tubs (with hazardous

waste emblems on the tubs) included

Owner, the Safety Officer, and

the Director; Quality, Risk


Readiness. 10/7/11 – The

appropriate Hazardous Waste

Storage sign was installed on the

Children’s Clinic storage room

noted in the survey report. All full

sharps boxes were removed from

the storage room and properly

disposed of per Environmental

Services. Also effective on this

date, the room is kept locked at

all times. Director; Environmental

Services.10/7/11 – The

Environmental Services

department did a survey of all

Hazardous Materials storage

locations to verify correct signage

was present.





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blood/body fluids that are

"soaked/dripping" and could not be placed

in the regular trash receptacles

5. at 11:40 AM on 10/4/11, while on tour

of the Children's Clinic (off site) in the

company of staff members NI and NJ, it

was observed that:

a. a red lined (over filled) box of full

sharps containers was located in the

housekeeping closet

b. the door of the housekeeping closet

lacked any signage on the doors indicating

that hazardous waste materials were

located inside

S1234 410 IAC 15-1.5-9(d)(1)

(d) A full-time, part-time, or

consulting radiologist or physician

qualified by education and experience

in the service provided as determined

by the medical staff shall do the

following:

(1) Supervise the service provided.


the medical staff failed to appoint a

radiologist or physician qualified by

education and experience to supervise the

radiology services and failed to ensure

that a qualified practitioner adequately

supervised the service.

S1234 11/30/11 – The Medical Executive

Committee will review and approve

appointment of the current

Radiology Medical Director.

Following that approval, the Medical

Director will review all Radiology

Department Policies and Procedures

and document his approval.

Director; Radiology.

11/30/2011 12:00:00AM





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Findings:


was requested to provide documentation

indicating that the radiology services

medical director was appointed by the

medical staff and none was received prior

to exit.


confirmed that the radiology services

medical director had not been appointed

by the medical staff to supervise the

radiology services for the facility.

3. The administrative Policy Statement

re: Policies (approved 10-01-82) indicated

the following: "Departmental policies are

formulated by the Division/Department

Director with appropriate input from

department managers, staff and medical

staff."

4. On 10-04-11 at 1355 hours,

documentation indicating that a qualified

practitioner had reviewed and approved

the radiology department

policy/procedures was requested from

staff #A1 and none was received prior to

exit.


confirmed that a qualified practitioner had

not reviewed and approved the





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policy/procedures for the department.

S1318 410 IAC 15-1.5-10 (e)(3)(A)(B)(C)

(D)(E)(F)

(e) To facilitate discharge as soon as

an acute level of care is no longer

required, the hospital shall have

effective, ongoing discharge planning

that:

(3) transfers or refers patients,

along with the necessary medical

information and records, to

appropriate facilities, agencies, or

outpatient services, as needed, for

follow-up or ancillary care. The

information shall include, but not be

limited to, the following:

(A) medical history;

(B) current medications;

(C) activities status;

(D) nutritional needs;

(E) outpatient service needs;

(F) follow-up care needs; and


closed patient medical record review, and

staff interview, the facility failed to

implement it's policy related patient

transfers for 3 of 3 patients. (N14, N15

and N16)

Findings:


policy and procedure "Patient Transfer"

-ADMIN-168, indicated:

a. page 5 of the policy indicated under

"b. Nursing will:...x. Complete the

S1318 10/26/11- The existing policy

“Patient Transfer – ADMIN 168” was

reviewed with the Nursing Managers

of the units responsible for the

patient transfer forms reviewed

during survey. CNO

10/28/11 – The Nursing Managers

counseled the specific nurses

responsible for completing the

transfer forms reviewed during

survey regarding the Patient

Transfer policy and form completion

requirements. Nursing Manager 3S

and Nursing Manager 6S

11/1/11 – The correct form name

11/17/2011 12:00:00AM





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Emergency Transfer Summary form..."

b. page 6 of the policy, under "When to

Utilize Specific Forms:", indicated: "1.

Emergency transfer from any patient area

of Saint John's to another acute care

facility...."

2. at 3:45 PM on 10/4/11, review of three

patient transfer records (from inpatient

status) indicated:

a. pt. N14 was lacking a patient transfer

form

b. pt. N15 lacked a signature of the

patient or family in the "Consent to

Transfer" area of the form "Physician's

Certificate of Transfer"

c. pt. N16 lacked any documentation, by

the physician, of a risk of transfer on the

"Physician's Certificate of Transfer" form

3. at 1:15 PM on 10/5/11, interview with

staff member NI indicated:

a. medical records was unable to locate

a "Physician's Certificate of Transfer"

form for pt. N14

b. the "Physician's Certificate of

Transfer" forms for patients N15 and N16

were lacking completion as stated in 2.

above

c. the forms listed in 1. a. and 2. b and c.

above are not the same title as the forms

were updated, but the policy was not

changed to reflect the title of the forms in

patients N15 and N16 medical records

was added to the existing policy

“Patient Transfer – ADMIN168”


Regulatory Readiness.

11/1/11 – The Quality Nurses will

complete a record review of all

patient transfers to ensure ongoing

compliance with the Patient Transfer

policy and documentation

requirements. The results of this

review will be reported to the

Nursing Manager s for follow-up.

The monthly review will continue

until 3 months of 100% compliance

is achieved. Manager; Quality and

Risk Management.

11/17/11 – The existing policy

“Patient Transfer – ADMIN 168” and

documentation requirements will be

reviewed with all Nursing Managers

at Nursing Operations Council. CNO





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