PRINTED: 12/04/2017 DEPARTMENT OF HEALTH AND …printed: 12/04/2017 form approved omb no. 0938-0391...

(X1) PROVIDER/SUPPLIER/CLIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

12/04/2017PRINTED:

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 PRECEDED BY FULL

REGULATORY OR LSC IDENTIFYING INFORMATION)

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TAG

IDPROVIDER'S PLAN OF CORRECTION

(EACH CORRECTIVE ACTION SHOULD BE

DEFICIENCY)

(X5)

COMPLETION

DATECROSS-REFERENCED TO THE APPROPRIATE

MUNCIE, IN 47304

15C0001162 06/20/2017

AMERICAN HEALTH NETWORK

3631 N MORRISON RD STE 106

00

S 0000

Bldg. 00

The visit was for a Licensure survey.

Facility Number: 004964

Survey Date: 6/19-20/17

QA: 09/22/17

IDR Committe met on 11/09/17. No

changes were made.

S 0000 This Plan of Correction (“PoC”) is

submitted for the purpose of

responding to the specific case

and citations set forth herein and

to demonstrate how American

Health Network of Indiana, LLC’s

(“AHN”) programs, policies, and

practices operate to promote its

commitment to assuring that all

patients receive services that are

of a quality that meet

professionally recognized

standards of care and that comply

with all applicable federal and

state laws. With all due respect

to ISDH and to its survey

process, the AHN’s preparation

and submission of this response

and Plan of Correction (PoC) is

not intended to be a legal

admission that the violations

existed or exist, that the

deficiencies are correct, or that

AHN has acted in a negligent or

wanton manner and is not to be

construed by a third party as an

admission against the interest of

AHN or against the interests of

its affiliates, directors, officers,

agents, employees, or other

individuals who drafted , may be

discussed in or assisted with the

preparation of this PoC. AHN is

committed to complying with its

obligations under the applicable

federal and state laws including

Indiana licensure rules for

ambulatory surgery centers and

the Medicare Conditions of

State Form

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.

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

_____________________________________________________________________________________________________Event ID: 4X3O11 Facility ID: 004964

TITLE

If continuation sheet of 48

(X6) DATE




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Participation. It has implemented

this PoC to ensure its ongoing

compliance with these obligations

and in furtherance of its

commitment to legal and

regulatory compliance with the

goal of providing clinically

superior patient care services.

410 IAC 15-2.4-1

GOVERNING BODY; POWERS AND

DUTIES

410 IAC 15-2.4-1 (a)(3)

The governing body shall do the

following:

(3) Review the bylaws at least

triennially.

S 0106

Bldg. 00

Based on document review and

interview, the Governing Body failed to

maintain documentation indicating its

Bylaws were reviewed in the past three

years.

Findings include:

1. Review of the Governing Body

documentation titled By-Laws of the

American Health Network of Indiana,

INC as Amended and Restated (effective

4-24-1997) lacked documentation

indicating a periodic review had been

performed.

2. On 6-19-17 at 0930 hours and on

6-20-17 at 1155 hours, the Patient Care

Manager, staff A1 and the Business

S 0106

Tag #S 106

This deficiency has been

corrected. Additional

actions are being taken to

prevent the risk of

recurrence that will be

completed on or before:

October 31, 2017. The

following corrective steps

are being taken:

1. The Operating

Agreement (“Company

Bylaws”) of AHN was

reviewed by the Board of

Managers of AHN (“Board”)

effective October 11,

2017.

2. To ensure this

10/31/2017 12:00:00AM

State Form Event ID: 4X3O11 Facility ID: 004964 If continuation sheet of 48




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Manager, staff A2 were requested to

provide documentation indicating the

Governing Board Bylaws were reviewed

by the Governing Body in the past 3

years and none was provided prior to

exit.

3. On 6-20-17 at 1550 hours, the Patient

Care Manager, staff A1 confirmed the

center lacked documentation indicating

the Governing Body Bylaws had been

reviewed within the past 3 years.

deficiency does not recur,

the triennial review of the

Company Bylaws has been

added as a recurring event

on the Outlook calendars of

the assistant to the

Secretary of AHN and of

the Associate General

Counsel. Outlook is the

electronic calendar system

maintained by AHN.

Training of appropriate

corporate and ASC staff is

being undertaken to prevent

the deficiency from

recurring.

3. The Associate

General Counsel for AHN is

responsible for this

Training, and it will be

completed no later than

October 31, 2017.

Attachments:

1. Copy of the

written Consent of the

Board, documenting review

of the Company Bylaws.

2. The training

materials and list of

personnel to be trained.

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1 (a)(5)

S 0110

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The governing body shall do the

following:

(5) Review, at least quarterly,

reports of management operations,

including, but not limited to, quality

assessment and improvement program,

patient services provided, results

attained, recommendations made,

actions taken, and follow-up.



conduct meetings and ensure a quarterly

review of ASC (ambulatory surgery

center) management functions including

QAPI (quality assessment and

performance improvement) program

documentation was performed for 3 of 6

quarters in 2016 and 2017 (3rd quarter

2016 and 1st and 2nd quarter 2017).

Findings include:

1. Review of the Medical Quality

Improvement Program (approved 4-17)

indicated the following: "A summary

report of each ASC Quality Management

Committee meeting will be made to the

center's Board of Managers (the

governing body)."

2. Review of 2016 and 2017 Board of

Managers meeting documentation

indicated meetings were held on 2-12-16,

4-20-16 and 12-14-16 and no meeting

documentation in 2017 was identified.

S 0110 Tag #S 110




prevent the risk of





are being taken:

1. The Board has

reviewed all six of the

Quarterly Reports of the

ASC management

operations for Q1 – Q4 of

2016 and Q1 and Q2 of

2017 as set forth on table

below:

Quarter

Documentation of Board

Review

Q1 2016

Supplement to Minutes of

the Meeting of the Board

10/31/2017 12:00:00AM





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On 6-19-17 at 1420 hours, the ASC

Patient Care Manager, staff A1, was

requested to provide Board meeting

documentation for July, August and/or

September, 2016 and all 2017 meeting

activity and no other documentation was

provided prior to exit.

3. On 6-20-17 at 0850 hours, the ASC

Patient Care Manager, staff A1, and the

Business Manager, staff A2 confirmed

the Board of Managers failed to hold

meetings in 2017 and failed to review

quarterly reports of ASC management

functions and QAPI program

documentation in a timely manner.

dated December 14, 2016

Q2 2016




Q3 2016




Q4 2016

Written Consent of the

Board of Managers,

effective February 3, 2017,

signed September 14, 2017

Q1 2017


Board of Managers,

effective May 26, 2017,

signed September 14, 2017

Q2 2017


Board of Managers,

effective September 29,

2017, signed October 5,

2017

2. Training of

appropriate corporate and

ASC staff is being

undertaken to prevent the

deficiency from recurring.

3. To ensure this


the quarterly Quality

Management Report has

been updated to include a





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graph with dates of

approvals of the ASC

management operations by

the Board of Managers.

Reporting to begin with the

Quality Improvement

Report for the third (3rd)

quarter of 2017. The

Patient Care Manager is

responsible for reporting the

status of the approval of the

ASC management

operations to the Quality

Management Committee.

Adding this as a permanent

reporting category will

enable the Patient Care

Manager to report on the


ASC management

operations by the Board of

Managers on a quarterly

basis.

4. The Associate


responsible for this

Training, and it will be


October 31, 2017.

Attachments:

1. The training



2. Written

Consents listed in the table





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above and copies of the

relevant minutes.

3. Copy of the

Quality Management

Report template.

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1 (b)(2)(A-D)

The governing body shall do the following:

(2) Ensure the following:

(A) The requests of practitioners,

for appointment or reappointment to

practice in the center are acted

upon, with the advice and

recommendation of the medical

staff.

(B) Reappointments are acted upon

at least biennially.

(C) Practitioners are granted

privileges consistent with their

individual training, experience,

and other qualifications.

(D) This process occurs within a

reasonable period of time as

specified by the medical staff

bylaws.

S 0116

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Based upon document review and

interview, the Board of Directors failed

to maintain documentation indicating its

approval or other action for all medical

staff requesting privileges at the ASC

(ambulatory surgery center) in

accordance with its Medical Staff Bylaws

for 2 of 2 credentialed medical staff files

S 0116 Tag #S 116

Deficiency has been



prevent the risk of




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reviewed (MD3 & MD4).

Findings include:

1. Review of the Bylaws of the

Physicians Medical Policy Council

(approved 5-20-08) indicated the

following: "Physicians practicing at any

Company ambulatory surgery center will

be recredentialed and privileged every

two years.... After the Credentialing

Committee reviews an application, it

shall notify the Council of its finding...

The Council may accept, reject, or

modify the Credentialing Committee's

recommendations... The Company may

accept, reject, or modify the Council's

finding or may refer the matter back to

the Council for further consideration..."

2. Review of 3-8-16 documentation

found in the credential files for Physician

MD3 and Physician MD4 indicated the

following: "The Credentials Committee

has recently reviewed your file for

re-credentialing and has approved your

participation through February 2018..."

and no additional credential file

documentation indicated a date of

approval by the Medical Policy Council

or indicated a date of approval by the

Board of Directors and/or its authorized

representative.


are being taken:

1. A review of the

minutes of the April 20,

2016 Board meetings was

completed on October 6,

2017 under the direction of

the Associate General

Counsel. The review found

that the Board did approve

the credentialing decisions

of the Credentialing

Committee with respect to

MD3 and MD4 at its April

20, 2016 meeting.

2. AHN failed to

provide the relevant minute

documents during the

survey in response to the

surveyor’s request for

documentation of Board

review of the credentialing

decisions. Two minute

documents typically are

maintained for Board

meetings: a supplement

intended to document

review of ASC-only Board

activities, and a main

document, intended to

document review of Board

activities that reach other

areas of AHN’s business.

During the survey, the ASC

supplement minute





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3. Review of the 3-18-16 Medical Policy

Council minutes indicated the 2-23-16

Credentialing Committee

recommendations for re-appointment of

the Physician MD3 and Physician MD4

were approved by unanimous vote of the

Council.

4. Review of the 4-20-16 documentation

titled Supplement to the Minutes of the

Meeting of the Board of Directors of

American Health Network, LLC (for

items related to its ambulatory surgery

center located at the Muncie, IN,

physician offices) indicated the

following: "[Board Chairman, Physician

MD10] directed [staff A8], as Secretary,

to record the minutes related to the

Muncie ASC separately to facilitate

accurate record-keeping for the ASC."

The 4-20-16 minutes lacked

documentation indicating the 3-18-16

Medical Policy Council minutes were

presented and approved without changes

and no other documentation indicated the

Board approval (or other action)

regarding the re-appointment and

privileges requested by Physician MD3

and Physician MD4.

5. On 6-20-17 at 1530 hours, the ASC

Patient Care Manager, staff A1

confirmed the credential files for MD3

and MD4 and the 4-20-16 Board of

documents were provided,

since those are the

documents that typically

contain minutes of actions

pertaining to the ASC. The

credentialing approval,

however, is documented in

the main minute document

because it impacts both

ASC and non-ASC

business.

3. To prevent this

issue from recurring, the

Executive Director and

Patient Care Manager with

responsibilities for ASC

surveys and the

Administrative Assistant to

the Secretary of AHN were

reminded in writing on

October 9, 2017 to review

both the main minutes and

supplemental minutes when

responding to requests for

information. Each

individual has been asked

to provide written

acknowledgment in

response.

4. The Associate

General Counsel for AHN

was responsible for the

written reminders and

acknowledgements.

Attachments:





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Directors minutes lacked documentation

indicating Board approval for

re-appointment as requested by the two

physicians.

6. On 6-20-17 at 1635 hours, the Chief

Medical Officer, Physician MD5

confirmed the credential files and Board

minutes lacked the indicated

documentation.

1. Copies of the

reminders and

acknowledgements.

2. A copy of the

relevant minutes.

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1 (b)(3)

The governing body shall do the following:

(3) Ensure that the medical staff has

approved bylaws and rules, and that

the bylaws and rules are reviewed and

approved at least triennially by the

governing body.

S 0122

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maintain documentation indicating it

reviewed and approved the Medical Staff

Bylaws in the past three years.

Findings include:

Review of the Bylaws of the Physicians

Medical Policy Council (approved

5-20-08) indicated the following: "The

Council shall review these Bylaws,

including the Fair Hearing Plan, no less

S 0122 Tag #S 122

Deficiency is in the process

of being corrected, and

correction will be completed

no later than October 31,

2017. The following

corrective steps are being

taken:

1. Medical Policy

Council Bylaws, including

the Fair Hearing Plan, (the

“Medical Policy Bylaws”)

have been reviewed by

counsel AHN, and review

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frequently than triennially and shall

report its recommendations for any

amendments to the Board of Managers

..." and lacked documentation ensuring

that the Board of Managers will review

and approve the Bylaws of the Physicians

Medical Policy Council at least

triennially.


6-20-17 at 1155 hours, the Surgery

Center Manager, staff A1 and the

Business Manager, staff A2 were

requested to provide documentation

indicating the Bylaws of the Physicians

Medical Policy Council were reviewed

and approved by the Board of Managers

within the past 3 years and none was





the Bylaws of the Physicians Medical

Policy Council had not been reviewed

and approved by the Board of Managers

within the past 3 years and confirmed no

other documentation was available.

by the Medical Policy

Council is on the agenda

for its October 27, 2017

Meeting. Medical Policy

Council will report their

recommendations to the

Board, and the Board will

take action to review and

approve the Medical Policy

Bylaws no later than

October 31, 2017.

2. To ensure this



Medical Policy Bylaws has

been added as a recurring

event on the Outlook

calendars of the assistant

to the Secretary of AHN

and of the Associate

General Counsel. Outlook

is the electronic calendar

system maintained by the

AHN.

3. Training of


ASC staff is being



This training will be


October 31, 2017.

4. The General

Counsel for AHN is

responsible to completion





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of the review and approval

of the Medical Policy

Bylaws. The Associate


responsible for the training.

Attachments:

1. The training



2. Form Written

Consent of the Board

Approving Medical Council

Policy Bylaws

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1 (c) (3)

(c) The governing body shall do the

following:

(3) Require the chief executive

officer or a designee to attend

meetings of the governing body and its

committees and act as its

representative at medical staff

meetings.

S 0146

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ensure that the CEO (Chief Executive

Officer) or their designee attended its

Board of Directors meetings and acted as

it's representative at Medical Staff

Meetings for 3 of 3 Board meetings in

2016, 8 of 9 Medical Staff meetings in

S 0146

Tag # S 146

Deficiency has been



prevent the risk of



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2016, and 2 of 5 Medical Staff meetings

in 2017.

Findings include:

1. Review of Board of Directors meeting

documentation dated 2-12-16, 4-20-16

and 12-14-16 failed to indicate the

Executive Director, staff A9 or their

designee attended any 2016 Board

meetings.

2. Review of Medical Policy Council

meeting minutes dated 1-27-16, 3-18-16,

5-20-16, 7-22-16, 8-26-16, 9-23-16,

10-28-16, 11-18-16 and 12-16-16

indicated the Executive Director, staff A9

attended one meeting on 11-18-16 and no

documentation indicated they or their

designee attended the remainder of

meetings in 2016.

3. Review of Medical Policy Council

meeting minutes dated 1-27-17, 2-24-17,

3-17-17, 4-21-17 and 5-19-17 indicated

the Interim Executive Director, staff A6

attended the 2-24-17, 3-17-17 and

4-21-17 meetings and no documentation

indicated they or their designee attended

the January or May meetings or were

excused.


Care Manager, staff A1, and the Business



are being taken:

1. Complete

minutes of the meetings

referenced in Tag 146 were

reviewed under the

direction of the Associate

General Counsel of AHN, to

determine whether the

Chief Executive Officer of

AHN, or the Executive

Director for the Muncie ASC

had attended the meeting.

The findings of that review

were as follows:

Meeting

Was CEO in Attendance?

If CEO not in Attendance,

did Muncie Executive

Director attend?

Board of Managers

2/12/2016 Meeting

Yes

N/A

Board of Managers

4/20/2016 Meeting

Yes

N/A

Board of Managers

12/14/2016 Meeting

Yes

N/A

Medical Policy Council

1/22/2016 Meeting





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Manager, staff A2 confirmed the meeting

documentation failed to indicate the

Executive Director, staff A9 attended the

Board of Directors meetings in 2016.


Care Manager, staff A1, confirmed the

meeting documentation failed to indicate

the Executive Director, staff A9 or the

Interim Executive Director, staff A6 had

attended the Medical Policy Council

meetings as indicated.

Yes

N/A


3/18/2016 Meeting

Yes

N/A


5/20/2016 Meeting

Yes

N/A


7/22/2016 Meeting

Yes

N/A


8/26/2016 Meeting

Yes

N/A


9/23/2016 Meeting

Yes

N/A


10/28/2016 Meeting

Yes

N/A


11/18/2016 Meeting

Yes

N/A


12/16/16 Meeting

Yes

N/A






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1/27/2017 Meeting

No

No


2/24/2017 Meeting

No

Yes


3/17/2017 Meeting

Yes

N/A


4/21/2017 Meeting

Yes

N/A


5/19/2017 Meeting

Yes

N/A

The review found that the

Chief Executive Officer

attended 3 of the 3 Board

Meetings and 12 of the 14


Meetings. Of the 2

meetings that the Chief

Executive Officer did not

himself attend, 1 was

attended by the Executive

Director of the ASC at the

time of the meeting. There

was one meeting, the

January 27, 2017 Medical

Policy Meeting that was not





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attended by either the Chief

Executive Officer or the

Executive Director

2. To prevent the

deficiency from recurring,

the Chief Executive Officer

on October 11, 2017,

named designee(s) to

attend meetings when he

does not. The Medical

Director for AHN and a

fellow member of the Board

and Medical Policy Council

has been designated to

serve as the CEO’s

designee to attend

meetings of the Board, its

committees and Medical

Policy Council in those

instances where the CEO

does not attend himself.

3. In addition,

training of appropriate

corporate and ASC staff is

being undertaken to prevent

the deficiency from

recurring. The training


personnel to be trained are

attached. This training will

be completed no later than


Associate General Counsel

for AHN is responsible for





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the training.

Attachments:

1. The training



2. Letter from the

Chief Executive Officer

designating the Medical

Director for AHN as his

designee.3. Minutes of Board of AHN

meetings and Medical Policy

Council meetings

demonstrating the Chief

Executive Officer’s attendance.

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1(e)(2)

The governing body is

responsible for services delivered in

the center whether or not they are

delivered under contracts. The

governing body shall do the following:

(2) Ensure that the services performed

under a contract are provided in a

safe and effective manner and are

included in the center's quality

assessment and improvement program.

S 0224

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Based on document review, the

governing body failed to ensure that its

contracted services were provided in a

safe and effective manner and evaluated

through its QAPI (quality

S 0224 Tag #S 224


corrected. Additional actions are

being taken to prevent the risk of

recurrence that will be completed

on or before: October 31, 2017.

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assurance/performance improvement)

program for 1 of 12 contracted services

(housekeeping).

Findings include:

1. Review of the policy/procedure

Contracted Services (approved 4-17)

indicated the following: "All contractors

providing services to the center are

expected to provide their services in a

safe and effective manner."

2. Review of a 3-13-17 list of contracted

services included in quarterly QAPI

documentation reported on 4-10-17 to the

Board of Directors failed to indicate the

service provider CS12 was providing

housekeeping services as confirmed by

1-9-17 staff training documentation.

The following corrective actions

are being taken:

1. AHN has revised its QAPI

Monitors spreadsheet to include

housekeeping services. This is

the spreadsheet it uses to

monitor and report on its

contractors’ compliance with

AHN’s QAPI policies and

procedures. The Patient Care

Manager will complete the

revised spreadsheet with

information collected from

random audits of the

housekeeping staff while they are

performing their services and

daily reviews of the surgery

suites.

2. The Patient Care

Manager has begun conducting

random audits of the

housekeeping staff’s services.

These audits are conducted no

less than weekly using the

“Cleaning Crew Observation

Checklist” to ensure

housekeeping complies with

AHN’s applicable QAPI policies

and procedures. The Cleaning

Crew Observation Checklist was

compiled by the Patient Care

Manager using AHN’s QAPI

policies and procedures

pertaining to housekeeping.

Information from the checklists

will be used to populate the QAPI

Monitors spreadsheet.

3. In addition, each morning

a member of the ASC staff will

use the Daily Housekeeping

Checklist to survey the surgery

suites prior to any procedures





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being performed. This daily

checklist and the random

Cleaning Crew Observation

Checklists will be used by the

Patient Care Manager, along with

other observations and

information, to complete the

housekeeping category on the

QAPI Monitors spreadsheet.

4. The Quality Improvement

Quarterly Report template has

been revised to include

housekeeping. The Patient Care

Manager is now using this revised

template in conjunction with the

QAPI Monitors spreadsheet to

track and report on housekeeping

compliance to the Quality


5. In addition, the Patient

Care Manager will report

housekeeping’s QAPI compliance

to the Executive Director prior to

the quarterly Quality Management

Committee meetings. The QAPI

Monitors spreadsheet is reviewed

on a quarterly basis by the Quality

Management Committee, which

then reports on its review of the

QAPI Monitor spreadsheet to the

Medical Policy Council, which will

then report to the Board.

6. To ensure this deficiency

does not recur, the Patient Care

Manager will audit the minutes of

the Board for three consecutive

quarters to ensure that the

Quality Management Committee

is reporting on its review of the


7. Finally, training of

appropriate corporate and ASC





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staff is being undertaken to

prevent the deficiency from

recurring. The training will be

completed by October 31, 2017.

The training materials and list of


attached.

8. The Patient Care

Manager of the ASC is

responsible for the training. The

Patient Care Manager was

responsible for updating the QAPI

Monitor Spreadsheet and the

Quality Management Report and

will be responsible for ensuring

that the QAPI Monitors

spreadsheet is reviewed on a

quarterly basis by the Quality


then reports its review to Medical

Policy Council, followed by the

Board. The Associate General

Counsel for AHN will verify that

training has been completed.

Attachments:

1. A copy of the QAPI


2. Quality Improvement

Quarterly Report template.

3. Cleaning Crew

Observation Checklist.

4. Daily Housekeeping

Checklist.

5. Training Certification

Form.

410 IAC 15-2.4-1


DUTIES

410 IAC 15-2.4-1(e)(3)

The governing body is

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responsible for services delivered in

the center whether or not they are

delivered under contracts. The

governing body shall do the following:

(3) Ensure that the center maintains a

list of all contracted services,

including the scope and nature of the

services provided.


interview, the facility failed to maintain

its list of all contracted services,

including the scope and nature of services

provided, for 8 of 12 contracted services

at the center.

Findings include:

1. Review of the list of contracted

services dated 06-02-17 lacked

documentation indicating a service

provider for biomedical engineering,

heating and air conditioning, medical

physics, medical records review,

pharmacist services, radiology equipment

service, or a radiation badge monitoring

service.

2. Review of center documentation

indicated biomedical engineering services

were provided by CS10, heating and air

conditioning services were provided by

CS11, housekeeping services were being

provided by CS12, medical physics was

provided by CS13, medical records

reviewing by CS14, pest control services

S 0226 Tag #S 226







are being taken:

1. AHN maintains its

list of current contracted service

providers on its QAPI Monitors

spreadsheet. The AHN QAPI

Monitors spreadsheet was

revised by the Patient Care

Manager to include an updated

list of all contracted services.

2. The Quality

Management Quarterly Report

template has been revised to

include the updated list of

contractor categories and

contractors. The Patient Care

Manager is now using this revised

template in conjunction with the

QAPI Monitors spreadsheet to

track and report on the listed

categories of contractors to the

Quality Management Committee.

3. To ensure that

deficiency will not recur, the QAPI

Monitors spreadsheet is reviewed

on a quarterly basis by the Quality


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were being provided by CS15,

pharmacist services were provided by

CS16, radiology equipment (C-arm)

service was provided by CS17, and

radiation badge monitoring service was

provided by CS18.


Care Manager, staff A1, confirmed that

the list of contracted services had not

been maintained.

then reports on its review of the

QAPI Monitor spreadsheet to the

Medical Policy Council, which

then reports to the Board. The

Patient Care Manager will audit

the minutes of the Board for three

(3) consecutive quarters to

ensure that the Quality

Management Committee is

reporting on its review of the


4. On a quarterly basis the

Patient Care Manager will request

a list of third party vendors who

have been paid by the AHN

business unit operating at 3631

N. Morrison Road, Suite 106 in

Muncie, Indiana from the AHN

accounts payable department.

The Patient Care Manager will

compare that vendor list to the

contractors listed on the QAPI

Monitors spreadsheet and Quality

Improvement Quarterly Report

and update the spreadsheet as

necessary. This crosscheck will

ensure that the QAPI Monitors

spreadsheet and the Quality

Improvement Quarterly Report

are up to date and capture the

contractors that are furnishing

services to AHN.

5. Finally, training of

appropriate corporate and ASC

staff is being undertaken to

prevent the deficiency from

recurring. The training will be


The training materials and list of


attached.

6. The Patient Care





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Manager for the ASC is

responsible for the training. The

Patient Care Manager was

responsible for updating the QAPI

Monitor Spreadsheet and the

Quality Management Report and

will be responsible for ensuring

that the QAPI Monitors

Spreadsheet is reviewed on a



then reports its review to Medical

Policy Council, followed by the

Board. The Associate General

Counsel for AHN will verify that

training has been completed.

Attachments:

1. A copy of the QAPI


2. Quality Improvement

Quarterly Report template.

3. Training Certification

Form.

410 IAC 15-2.4-2.2

QUALITY ASSESSMENT AND

IMPROVEMENT

410 IAC 15-2.4-2.2(a)(1)

Sec. 2.2. (a) The center's quality

assessment and improvement program

under section 2 of this rule shall include the

following:

(1) A process for determining the

occurrence of the following reportable

events within the center:

(A) The following surgical events:

(i) Surgery performed on the wrong body

part, defined as any surgery performed on a

body part that is not consistent with the

documented informed consent for that

patient. Excluded are emergent situations:

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(AA) that occur in the course of surgery; or

(BB) whose exigency precludes obtaining

informed consent;

or both

(ii) Surgery performed on the wrong patient,

defined as any surgery on a patient that is

not consistent with the documented

informed consent for that patient.

(iii) Wrong surgical procedure performed on

a patient, defined as any procedure

performed on a patient that is not consistent

with the documented informed consent for

that patient. Excluded are emergent

situations:

(AA) that occur in the course of surgery; or

(BB) whose exigency precludes obtaining

informed consent;

or both

(iv) Retention of a foreign object in a patient

after surgery or other invasive procedure.

The following are

excluded:

(AA) Objects intentionally implanted as part

of a planned intervention.

(BB) Objects present before surgery that

were intentionally retained.

(CC) Objects not present prior to surgery

that are intentionally left in when the risk of

removal exceeds the risk of retention, such

as microneedles or broken screws.

(v) Intraoperative or immediately

postoperative death in an ASA Class I

patient. Included are all ASA Class I patient

deaths in situations where anesthesia was

administered; the planned surgical

procedure may or may not have been

carried out.

(B) The following product or device events:

(i) Patient death or serious disability

associated with the use of contaminated

drugs, devices, or biologics provided by the

center. Included are generally detectable





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contaminants in drugs, devices, or biologics

regardless of the source of contamination or

product.

(ii) Patient death or serious disability

associated with the use or function of a

device in patient care in which the device is

used or functions other than as intended.

Included are, but not limited to, the following:

(AA) Catheters.

(BB) Drains and other specialized tubes.

(CC) Infusion pumps.

(DD) Ventilators.

(iii) Patient death or serious disability

associated with intravascular air embolism

that occurs while being cared for in the

center. Excluded are deaths or serious

disability associated with neurosurgical

procedures known to present a high risk of

intravascular air embolism.

(C) The following patient protection events:

(i) Infant discharged to the wrong person.


associated with patient elopement.

(iii) Patient suicide or attempted suicide

resulting in serious disability, while being

cared for in the center, defined as events

that result from patient actions after

admission to the center. Excluded are

deaths resulting from self inflicted injuries

that were the reason for admission to the

center.

(D) The following care management events:


associated with a medication error, for

example, errors involving the wrong:

(AA) drug;

(BB) dose;

(CC) patient;

(DD) time;

(EE) rate;

(FF) preparation; or

(GG) route of administration.





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Excluded are reasonable differences in

clinical judgment on drug selection and

dose. Includes administration of a

medication to which a patient has a known

allergy and drug=drug interactions for which

there is known potential for death or serious

disability.


associated with a hemolytic reaction due to

the administration of ABO/HLA incompatible

blood or blood products.

(iii) Maternal death or serious disability

associated with labor or delivery in a low-risk

pregnancy while being cared for in the

center. Included are events that occur within

forty-two (42) days postdelivery. Excluded

are deaths from any of the following:

(AA) Pulmonary or amniotic fluid embolism.

(BB) Acute fatty liver of pregnancy.

(CC) Cardiomyopathy.

(iv) Patient death or serious disability

associated with hypoglycemia, the onset of

which occurs while the patient is being cared

for in the center.

(v) Death or serious disability (kernicterus)

associated with the failure to identify and

treat hyperbilirubinemia in neonates.

(vi) Stage 3 or 4 pressure ulcers acquired

after admission to the center. Excluded is

progression from Stage 2 or Stage 3 if the

Stage 2 or Stage 3 pressure ulcer was

recognized upon admission or unstageable

because of the presence of eschar.

(vii) Patient death or serious disability

resulting from joint movement therapy

performed in the center.

(viii) Artificial insemination with the wrong

donor sperm or wrong egg.

(E) The following environmental events:


associated with an electric shock while being

cared for in the center.





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Excluded are events involving planned

treatment, such as electrical countershock

or elective cardioversion.

(ii) Any incident in which a line designated

for oxygen or other gas to be delivered to a

patient:

(AA) contains the wrong gas; or

(BB) is contaminated by toxic substances.

(iii) Patient death or serious disability

associated with a burn incurred from any

source while being cared for in the center.

(iv) Patient death or serious disability

associated with a fall while being cared for in

the center.

(v) Patient death or serious disability

associated with the use of restraints or

bedrails while being cared for in the center.

(F) The following criminal events:

(i) Any instance of care ordered by or

provided by someone impersonating a

physician, nurse, pharmacist, or other

licensed healthcare provider.

(ii) Abduction of a patient of any age.

(iii) Sexual assault on a patient within or on

the grounds of the center.

(iv) Death or significant injury of a patient or

staff member resulting from a physical

assault (i.e., battery) that occurs within or on

the grounds of the center.


interview, the center failed to ensure its

QAPI (quality assurance & performance

improvement) program included a

process to determine the occurrence of all

reportable events at the facility.

Findings include:

1. Review of QAPI program

documentation and policy/procedures

S 0332 Tag #S 332







are being taken:

1. AHN has revised its QAPI

policy entitled: “Quality Monitor

Report/Adverse Incidents” to

include a list of reportable events

consistent with 410 IAC

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failed to indicate a process for

determining and reporting serious

adverse events to the State agency. On

6-20-17 at 1330 hours, the Patient Care

Manager, staff A1 was requested to

provide documentation indicating the

adverse events required to be reported to

the ISDH (Indiana State Department of

Health) and none was provided prior to

exit.


Care Manager, staff A1 confirmed no

documentation indicating a list of adverse

events to be reported to the ISDH or the

process for reporting was available.

15-2.4-2.2(a)(1). At the time of

the survey AHN had, and will

continue to maintain, discrete

policies on reportable events,

including policies on medication

errors, deaths, medical device

reporting, and adverse

reactions/incident report. By also

listing the adverse events in the

Quality Monitor Report/Adverse

Incidents policy, employees will

have a consolidated list of the

various adverse event types.

2. Training of the ASC staff on

this revised policy is being

undertaken by the Patient Care

Manager of the ASC, and will be

completed no later than October

31, 2017.

Attachments:

1. Revised Quality Monitor

Report/Adverse Incidents Policy

2. Additional Policies:

Medication Error, Protocol and

Remediation: Deaths; Reporting

of Communicable Diseases;

Medical Device Reporting;

Adverse Reaction/Incident

Reports

3. Occurrence Report Form

4. Confidential Report of

Communicable Diseases

5. Employee Training

Certification Form that will be


410 IAC 15-2.5-1

INFECTION CONTROL PROGRAM

410 IAC 15-2.5-1(a)

(a) The center shall provide a safe

and healthful environment that

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minimizes infection exposure and risk

to patients, health care workers, and

visitors.


interview, the facility failed to follow

policy Tuberculosis Screening for

Employees, by not providing a two-step

TB test to 1 of 9 personnel records

reviewed (N9).

1. Review of policy Tuberculosis

Screening for Employees, last reviewed

in 2014, indicates under PROCEDURE:

All New Employees, 2. "If PPD is

negative, then repeat PPD in one to two

weeks to establish with certainty that the

baseline is indeed negative....this is a

two-step procedure".

2. Review of personnel record for N9,

registered nurse hired 04/03/17, had

results on one PPD in record.

3. Interview with P50, Patient Care

Manager on 06/20/17 at 9:30 am

confirmed that N9, registered nurse,

lacked a 2nd PPD.

S 0400 Tag #S 400


corrected. Completion date:

October 4, 2017. The following

corrective actions have been

taken:

1. The Patient Care

Manager reviewed the

Tuberculosis Screening for

Employees policy on June 21,

2017.

2. The Employee

Health Files checklist was revised

by the Patient Care Manager to

reflect that the tuberculosis

screening is a two-step process

to be completed within two

weeks, per the Tuberculosis

Screening for Employees policy.

The date of each step will be

recorded on the checklist by the

Patient Care Manager or

appropriate clinical personal

performing the TB skin test. This

checklist will be used for all new

employees of the ASC and

reviewed by the Patient Care

Manager to confirm that both

steps are completed for the ASC.

3. The staff member

listed in the survey report as N9

received the second TB skin test

on October 2, 2017. That test

was read on October 4, 2017.

4. The Patient Care

Manager and the Infection

Control Officer were re-educated

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on the Tuberculosis Screening for

Employees policy and the revised

Employee Health Files checklist

on September 28, 2017.

5. Going forward all

ASC new hire employee files will

be audited every two weeks by

the Patient Care Manager until

TB two step compliance is

achieved.

6. The Infection

Control Officer will be notified of

all ASC new hires prior to their

start date to assist with the TB

two step compliance.

7. The Patient Care

Manager of the ASC is

responsible for the corrective

actions identified above.

Attachments:

1. The revised

Employee Health Files checklist.

2. Staff member N9’s

TB skin test results.

3. The Tuberculosis

Screening for Employees policy

and the written statement

executed by the Patient Care


Control Officer attesting that they

have been re-educated on the

policy.

410 IAC 15-2.5-1

INFECTION CONTROL PROGRAM

410 IAC 15-2.5-1(f)(2)(E)(i)

The infection control committee

responsibilities must include, but are

not limited to:

(E) Reviewing and recommending

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changes in procedures, policies, and

programs which are pertinent to

infection control. These include, but

are not limited to, the following:

(i) Sanitation.

Based on document review, observation

and interview, the Infection Control

committee failed to ensure its surgical

environment and patient care areas were

maintained in a safe and sanitary manner

for 2 of 2 operating rooms (ORs) and the

pre and post-op areas of the center.

Findings include:


Care Manager, staff A5 was requested to

provide documentation indicating that the

contracted housekeeping service policies

and procedures were reviewed and

approved by the hospital infection control

committee and none was provided prior

to exit.

2. Review of the housekeeping service's

policy/procedure titled Operating Room

Cleaning Policy (no date of approval)

indicated the following: "Follow EPA

(Environmental Protection Agency)

approved contact time as directed by the

disinfectant manufacturer."

3. During a tour of the surgery area on

6-19-17 at 1318 hours, in the company of

S 0428 Tag #S 428





on or before October 31, 2017.


are being taken:

1. The list of approved

cleaning agents has been

reviewed by the Infection Control

Officer and has been updated to

include OcyCide daily disinfectant

cleaner and to remove Diversey

Alpha HP 52.

2. The Infection

Control Officer will continue to

review the list of approved

cleaning agents on a quarterly

basis and will monitor the use of

cleaning agents at the ASC to

ensure that only approved

cleaning agents are used, that all

cleaning agents are properly

labeled, and that all cleaning

agents are being used in

accordance with all requirements

regarding contact time.

3. The Infection

Control Officer discarded all

bottles of Diversey Alpha HP 52

from the ASC.

4. The Infection

Control Officer is responsible for

quarterly reports of infection

control issues to the Quality

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the Patient Care Manager, staff A1 and

the Business Manager, staff A2 a 32 oz.

spray bottle of Virex II 256 was observed

on the shelf of cleaning supplies and a

concentrated cleaning product called

Diversey Alpha HP 52 (item # 3350743)

was observed with a mixing manifold for

filling mop buckets in the housekeeping

closet of the surgery area. Review of the

product label failed to indicate:

A. an EPA (Environmental Protection

Agency) registration number

B. the product was a hospital-grade

disinfectant cleaner

C. a minimum wet contact time for

disinfecting surfaces

D. effectiveness against any specific

microorganisms


Care Manager, staff A1 and the Business

Manager, staff A2 confirmed the cleaning

product lacked an EPA registration

number, failed to indicate a minimum

wet contact time for disinfecting surfaces,

and failed to indicate it was effective

against any human pathogens frequently

associated with endoscopy center

services.

5. Review of the list titled Chemicals

used by Contracted Cleaning Staff

(revised 1/2017) indicated the following:

"Diversey: Virex II One Step Disinfectant

Management Committee,

including supervision and review

of the approved cleaning agents

list and monitoring to ensure that

only approved cleaning agents

are used at the ASC and that

such agents are properly labeled

and used in compliance with all

requirements.

5. The Quality



include the review of the

approved cleaning agents list.

The Infection Control Officer is

now using this revised template in

conjunction with the approved

cleaning agents list to track and

report on infection control

compliance to the Quality


6. In addition, the

Infection Control Officer will report

on the review of the approved

cleaning agents list and whether

only approved cleaning agents

are being used at the ambulatory

ASC to the Executive Director

prior to the quarterly Quality

Management Committee

meetings. The approved cleaning

agents list is reviewed on a


Management Committee, as are

the use of approved cleaning

agents at the ASC, which then

reports on its review to the

Medical Policy Council, followed

by the Board.

7. The Cleaning and

Sanitation Policy and the Medical

Quality Improvement Program





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Cleaner and Deodorant... Dry Time

(minimum wet contact time for

disinfecting surfaces)... 5 minutes ..."

6. Review of the Diversey 2012 product

information and recommendations for

Virex II 256 One-Step Disinfectant

Cleaner and Deodorant indicated the

following: "To disinfect, all surfaces

must remain wet for 10 minutes."


Care Manager, staff A1 confirmed the list

of approved cleaning products indicated

wet contact time of 5 minutes for Virex II

was less than the manufacturer's

recommendations, confirmed the

Diversey Alpha HP 52 lacked

documentation of disinfecting

effectiveness against any

microorganisms, and confirmed that the

center currently lacked a disinfectant

product that was effective against

Clostridium difficile if diagnosed by

direct observation during colonoscopy.

Policy have been approved by the

Quality Management Committee,

Medical Policy Board and the

Board , as reflected in the April

2015 Minutes of the Meeting of

the Board. To ensure this

deficiency does not recur, the



consecutive quarters to ensure

that the Quality Management

Committee is reporting on its

review of the approved cleaning

agents list and the use of

approved cleaning agents at the

ASC.

8. The Patient Care


Control Officer will be trained on

the Cleaning and Sanitation policy

and the Medical Quality

Improvement Program policy on

or before October 31, 2017.

9. The Patient Care

Manager of the ASC and the

Infection Control Officer of the

ASC were responsible for

updating the Approved Cleaning

Agents List and the Quality

Management Report and will be

responsible for ensuring that the

Approved Cleaning Agents List is

reviewed on a quarterly basis by

the Quality Management

Committee, which then reports its

review to Medical Policy Council,

followed by the Board.

Attachments:

1. Updated Approved

Cleaning Agents List.

2. Medical Quality

Improvement Program Policy.





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3. Cleaning and

Sanitation Policy.

4. Minutes of the

Meeting of the Board

demonstrating review and

approval of the Cleaning and



Policy by the Quality Management

Committee, the Medical Policy

Board and the Board.


Certification executed by Patient

Care Manager.


Certification Form (to be

completed by Infection Control

Officer).

410 IAC 15-2.5-4

MEDICAL STAFF; ANESTHESIA AND

SURGICAL

410 IAC 15-2.5-4(b)(2)

These bylaws

and rules must be as follows:

(2) Be reviewed at least triennially.

S 0732

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Based upon document review and

interview, the Medical Staff failed to

follow its Bylaws and ensure its Bylaws,

Rules and Regulations were reviewed at

least triennially.

Findings include:

1. Review of the Bylaws of the

Physicians Medical Policy Council

(approved 5-20-08) indicated the

S 0732 Tag #S 732

This deficiency is in the

process of being corrected,

and correction will be




are being taken:

1. Medical Policy

Council Bylaws, including

the Fair Hearing Plan, (the

“Medical Policy Bylaws”)

10/31/2017 12:00:00AM





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following: "The Council shall review

these Bylaws, including the Fair Hearing

Plan, no less frequently than

triennially..."


6-20-17 at 1155 hours, the Surgery

Center Manager, staff A1 and the

Business Manager, staff A2 were

requested to provide documentation

indicating the Bylaws of the Physicians

Medical Policy Council were reviewed

by the Physicians Medical Policy Council

within the past 3 years and none was





the Bylaws of the Physicians Medical

Policy Council had not been reviewed by

the Physicians Medical Policy Council

within the past 3 years and confirmed no

other documentation was available.

have been reviewed by

counsel for Company, and

review by the Medical

Policy Council is on the

agenda for its October 27,

2017 Meeting. Medical

Policy Council will report

their recommendations to

the Board, and the Board

will take action to review

and approve the Medical

Policy Bylaws no later than

October 31, 2017.

2. Training of


ASC staff is being



This training will be


October 31, 2017.

3. To ensure this


the quarterly Quality

Management Report has

been updated to include a

graph with dates of

approvals of the bylaws by

the Medical Policy Council.

Reporting to begin with the

Quality Improvement

Report for the third (3rd)

quarter of 2017. The







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bylaws to the Quality



reporting category will

enable the Patient Care

Manager to report on the


bylaws by the Medical

Policy Council on a

quarterly basis.

4. To ensure this



Medical Policy Bylaws by

the Medical Policy Council

has been added as a

recurring event on the

Outlook calendars of the

assistant to the Secretary of

AHN and of the Associate

General Counsel. Outlook

is the electronic calendar

system maintained by the

AHN.

5. The General

Counsel for AHN is

responsible for completion

of the review and approval

of the Medical Policy

Bylaws. The Associate


responsible for the training.

Attachments:

1. Proposed





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Resolutions for review of

the Medical Policy Council

bylaws, under consideration

by Medical Policy Council

for their October 27, 2017

meeting.

2. The training



410 IAC 15-2.5-5

PATIENT CARE SERVICES

410 IAC 15-2.5-5(a)

(a) All patient care services must

meet the needs of the patient, within

the scope of the service offered, in

accordance with acceptable standards

of practice. Patient care services

must be under the direction of a

qualified person or persons. Patient

care services must require the

following:

S 0900

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and interview the facility failed to follow

policy Glucose Testing, last reviewed

2014, by not adhering to the User's Guide

when opening and dating a bottle of new

test strips.

1. Review of policy Glucose Testing, last

reviewed in 2014, lacked documentation

of expiration dates for the glucose sticks

used in testing. It did indicate "...for

additional information regarding the

Asensia Contour (blood sugar machine),

S 0900 Tag #S 900

This deficiency is in the process

of being corrected. Completion

date: December 8, 2017. The

following corrective steps have

been taken:

1. Use of New Meter: AHN has

begun using a new Contour Meter

and has discarded the Ascensia

Meter which was in use at the

time of the survey.

2. User Guide Review: The

Patient Care Manager has

reviewed the current Contour

Blood Glucose

Monitoring System User Guide,

11/27/2017 12:00:00AM





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refer to the User Guide."

2. Review of reference guide indicated

"Always use test strips within 6 months

after opening bottle. Don't forget to write

the 'discard date' in the space provided on

the bottle label".

3. During tour of unit with P50, Patient

Care Manager and P54, staff registered

nurse on 06/20/17 at 12 noon, a bottle of

test strips were found without a date.

4. Interview with P50, Patient Care

Manager and P54, staff registered nurse

on 06/20/17 at 12:15pm, confirmed that

there was no date on bottle of test strips

which sets forth the proper

procedure for the use of the

Contour Meter that AHN is

currently using. According to the

User Guide, test strips are to be

used prior to the manufacturer’s

expiration date that is printed on

the test strip bottle or outside

carton. This current User Guide,

which governs the Blood Glucose

Monitoring System AHN is now

using, does not require AHN to

write the discard date on test strip

bottles. Because AHN no longer

uses the Ascensia Meter which

was in use at the time of the

survey, the manufacturer’s

guidelines which required AHN to

write a discard date of the test

strip bottles are no longer

applicable.

3. Package Insert Review:

The Patient Care Manager

reviewed the package insert for

the Contour blood glucose test

strips, which AHN is currently

using and was using at the time

of the survey. The package insert

provides as follows: “Do not use

the test strips after the expiration

date. The expiration date is

printed on the bottle label and on

the outside carton”. The Patient

Care Manager then reviewed the

package insert for the Contour

control solution. The instructions

on the package insert for the

control solution follows the

language in the User Guide.

4. Manufacturer Confirmation:

The Patient Care Manager has

contacted the manufacturer’s





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help line to ensure that she

understood the instructions set

out in the User Guide and on the

package inserts for the Contour

blood glucose monitoring system.

The manufacturer representative

confirmed that the Patient Care

Manager correctly understood the

User Guide and package insert

instructions.

5. The glucose test strip bottle

observed by the inspector on the

survey date was discarded that

day in sight of the inspector as

requested.

6. The following additional

corrective steps are being taken:

a. The ASC’s Glucose

Testing policy was revised to

reflect AHN’s practice of verifying

that expiration dates are printed

on test strip containers and

discarding test strip containers on

the expiration date, in accordance

with the manufacturer’s current

guidelines.

b. To ensure that this


Patient Care Manager will be

conducting weekly audits of the

test strip containers each week

for a period of four weeks to

ensure that each test strip

container has a pre-printed

expiration date and that expired

test strip containers are

discarded.

c. Additionally, the Patient

Care Manager will review the

manufacturer’s User Guide and

package inserts to ensure that

the most up to date User Guide





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and package inserts are being

followed on a monthly basis.

d. In addition, to ensure that

this deficiency does not recur, the

Patient Care Manager will

undertake training of all ASC staff

on the revised Glucose Testing

policy, the Contour Meter User

Guide, the Glucose Test Strip

Package Insert and the Glucose

Solution Package Insert. This

training will be completed no later

than December 8, 2017.

The Patient Care Manager of the

ASC was responsible for the

corrective actions described

above.

Attachments:

1. Updated ASC

Glucose Testing Policy

2. Contour Meter User

Guide

3. Glucose Test Strip

Package Insert

4. The training

materials and list of personnel to

be trained

410 IAC 15-2.5-7

PHYSICAL PLANT, EQUIPMENT

MAINTENANCE,

410 IAC 15-2.5-7(b)(5)

(b) The condition of the physical

plant and the overall center

environment must be developed and

maintained in such a manner that the

safety and well-being of patients are

assured as follows:

(5) The building or buildings, including

fixtures, walls, floors, ceiling, and

S 1172

Bldg. 00





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furnishings throughout, must be kept

clean and orderly in accordance with

current standards of practice, including the

following:


and interview, the contracted

housekeeping service provider failed to

maintain the facility in a clean and

sanitary condition for the patient care and

surgical services areas observed on tour.

Findings include:


Care Manager, staff A5 was requested to

provide documentation indicating that the

contracted housekeeping service policies

and procedures were approved by the

hospital infection control committee and

none was provided prior to exit.

2. Review of the housekeeping service's

policy/procedure titled Operating Room

Cleaning Policy (no date of approval)

indicated the following: "Follow EPA

(Environmental Protection Agency)

approved contact time as directed by the

disinfectant manufacturer... Use a damp

high dusting tool with cleaner

disinfectant solution... to clean fixed and

ceiling-mounted equipment, as well as

surgical lights... Perform other high

dusting with a clean damp microfiber

high duster with cleaner disinfectant...

Pay special attention to air exhaust and

S 1172 Tag #S 1172





on or before October 31, 2017.


are being taken:

1. The ASC was

thoroughly cleaned on June 19,

2017, following the surveyors’

departure.

2. The Patient Care

Manager and the ASC staff have

been regularly inspecting the ASC

since the survey to ensure that

the cleaning company is

adequately cleaning the ASC, as

provided in the attached policies

and procedures.

3. The Patient Care

Manager reviewed the Cleaning

and Sanitation Policy and the

Medical Quality Improvement

Program Policy with the cleaning

company staff and the Manager

of the cleaning company to

ensure that the cleaning company

staff understands the full scope of

the cleaning services to be

provided. The cleaning company

staff acknowledged and agreed

that they must provide cleaning

services in compliance with the

policies and procedures.

4. The Cleaning and



10/31/2017 12:00:00AM





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intake vents, as they must be kept free of

lint and dust..."

3. During a tour of the pre and post-op

area on 6-19-17 at 1300 hours, in the

company of the Patient Care Manager,

staff A1 and the Business Manager, staff

A2 the presence of dust was observed on

the horizontal surfaces of the wall cabinet

and the cardiac monitor in recovery room

#3.

4. During a tour of the pre and post-op

area on 6-19-17 at 1305 hours, in the

company of the Patient Care Manager,

staff A1 and the Business Manager, staff

A2 the presence of dust was observed on

the 12" x 12" ceiling return air grille in

the nursing station.




the Business Manager, staff A2 the

presence of dust was observed on the

horizontal surfaces of the electric door

opener over the entrance to the restricted

surgical area.





presence of dust was observed on the 12"

Policy have previously being

approved by the Quality

Management Committee, Medical

Policy Council and Board , as

reflected in the April 2015

Minutes of the Meeting of the

Board of AHN.

5. The Patient Care

Manager and the Executive

Director created the attached

Cleaning Staff Observation

Checklist and Daily

Housekeeping Checklist to be

utilized by the Patient Care

Manager and the ASC staff.

6. The Quality



include the review of the

completion of the Cleaning Staff

Observation Checklist and Daily

Housekeeping Checklist.

7. The ASC staff will

complete the Daily Housekeeping

Checklist before the first

procedure of the day, every day

that the ASC is open for

procedures. If the ASC staff

discovers that the surgery suites

have not been properly cleaned

during completion of the Daily

Housekeeping Checklist, the ASC

staff will ensure that the surgery

suites are adequately cleaned

and will inform the Patient Care


Director of the issue.

8. The Patient Care

Manager will conduct audits of

the existing cleaning company

using the Cleaning Staff

Observation Checklist at least





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x 12" ceiling return air grille in the soiled

instrument reprocessing room.





presence of dust was observed on the

tops of lockers in the staff locker room.

8. During a tour of the surgery center on




presence of dust was observed in the OR

(operating room) "B" on the overhead

boom light, on the tops of wall cabinets,

and on the 12" x 24" wall return air grille.


Care Manager, staff A1 and the Business

Manager, staff A2 confirmed the

observations of dust in the OR, patient,

and staff areas of the center.

twice a week until the new

cleaning company begins

cleaning the ASC, as explained

below. The Patient Care Manager

will inform the Executive Director

if the cleaning company is not

cleaning the ASC in compliance

with the applicable policies and

procedures. The Patient Care


Director will then notify the

cleaning company of any issues

and ensure that they are

corrected immediately.

9. In addition, the

Patient Care Manager will report

on the completion of the Cleaning

Staff Observation Checklist and

the Daily Housekeeping Checklist

to the Executive Director prior to

the quarterly Quality Management

Committee meetings. The Patient

Care Manager is now using this

revised template to track and

report on cleaning compliance to

the Quality Management

Committee.

10. Once the new

cleaning company has begun

cleaning the ASC, the Patient

Care Manager will conduct audits

using the Cleaning Staff

Observation Checklist at least

once a week for the first month

the new cleaning company cleans

the ASC. Going forward after the

first month the new cleaning

company has cleaned the ASC,

the Patient Care Manager will

conduct audits using the Cleaning

Staff Observation Checklist at

least weekly. The Patient Care





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Manager will inform the Executive

Director if the cleaning company

is not cleaning the ASC in

compliance with the applicable

policies and procedures. The

Patient Care Manager and the

Executive Director will then notify

the cleaning company of any

issues and ensure that they are

corrected immediately.

11. To ensure that this


Patient Care Manager will be

conducting random audits of the

cleaning company staff, as

described above, where she will

observe the cleaning staff’s

compliance with the Cleaning and

Sanitation Policy and the ASC

staff will be completing Daily

Housekeeping Checklists to

ensure that the ASC has been

cleaned properly every day.

12. Additionally, the



consecutive quarters to ensure

that the Quality Management

Committee is reporting on its

review of the completion of the

Cleaning Staff Observation

Checklist and the Daily

Housekeeping Checklists by the

Patient Care Manager and the

ASC staff.

13. In addition, to ensure

that this deficiency does not

recur, the Patient Care Manager

and the Executive Director have

begun interviewing new cleaning

companies that provide cleaning

services to ambulatory surgery





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centers in and around Muncie.

The ASC received quotes from

three of these cleaning

companies on October 11, 2017.

Because the ASC’s lease

provides for the building owner to

contract with any cleaning

companies, the building owner

will evaluate the quotes from the

cleaning companies and, with

input provided from the Patient

Care Manager and Executive

Director regarding the quality of

services provided by the cleaning

companies. The building owner,

Patient Care Manager and

Executive Director are working

toward the goal of having the new

cleaning company begin providing

cleaning services at the ASC by

November 15, 2017. The new

cleaning company will receive

training from the Patient Care

Manager regarding the Cleaning

and Sanitation Policy.

14. The ASC staff

received education on completing

the checklists and the cleaning

policies and procedures.

15. The Associate


responsible for the education.


ASC will be responsible for

ensuring that the Cleaning Staff

Observation Checklist and the

Daily Housekeeping Checklist are

completed as set forth in this PoC

and that the new cleaning

company receives appropriate

training and is compliant with the

Cleaning and Sanitation Policy.





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Attachments:

1. Cleaning Staff

Observation Checklist.

2. Daily Housekeeping

Checklist.

3. Minutes of the

Meeting of the Board of AHN

demonstrating review and

approval of the Cleaning and



Policy by the Quality Management

Committee, the Medical Policy

Council and the Board.

4. Surgery Center

Staff Training Certification

5. Quality Management

Committee Report.

410 IAC 15-2.5-7

PHYSICAL PLANT, EQUIPMENT

MAINTENANCE,

410 IAc 15-2.5-7(c)(5)

(c) A safety management program must

include, but not be limited to, the

following:

(5) Maintenance of written evidence

of regular inspection and approval by

state or local fire control agencies

in accordance with center policy and

state and local regulations.

S 1196

Bldg. 00


interview, the center failed to ensure that

periodic fire inspections were performed

in 2016 and 2017.

Findings include:

S 1196 Tag #S 1196


corrected. Completion Date: July

11, 2017. Corrective action: the

fire inspection was completed on

July 11, 2017 by the Muncie Fire

Department, Fire Prevention

Bureau. In addition, the Patient

07/11/2017 12:00:00AM





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1. Review of center documentation

indicated the most recent fire safety

inspection was performed on 7-30-15 by

the local fire department.

2. On 6-19-17 at 1225 hours, the

Property Maintenance Manager, staff A4

confirmed that the center failed to ensure

that a fire inspection was performed in

2016 or 2017 by State or local officials

and confirmed no documentation

indicating a recent request for an

inspection from fire officials was

available.

Care Manager has taken the

following corrective actions:

1. A rule has been added to

the Patient Care Manager’s

Outlook calendar to automatically

create an appointment for the first

week of June each year, notifying

the Patient Care Manager to

schedule the fire inspection. The

Outlook calendar is the electronic

calendar system maintained by

AHN for its employees.

2. A similar yearly reminder

has also been added to the

ASC’s Executive Manager’s

Outlook calendar.

3. To ensure this deficiency

does not recur, the fire inspection

has been added as a permanent

category to the quarterly Quality

Management Report. Reporting

to begin with the Quality

Improvement Report for the

fourth (4th) quarter of 2017. The



status of the fire inspection to the

Quality Management Committee.


reporting category will enable the

Patient Care Manager to report

on the status of the fire inspection

on a quarterly basis.


ASC was responsible for the

corrective actions described

above.

Attachments:

1. A copy of the fire

inspection report.

2. A copy of the quality

Improvement Committee





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quarterly report template.

3. A copy of the outlook

calendar with the reminder.


PRINTED: 12/04/2017 DEPARTMENT OF HEALTH AND …printed: 12/04/2017 form approved omb no. 0938-0391...

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