15C0001131 04/05/2017 NAME OF PROVIDER OR SUPPLIER

[Pages:19]DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 000 INITIAL COMMENTS

The visit was for a re-certification survey.

Facility Number: 003903

Survey Date: 4/3-5/17

QA: 4/21/17 LH Q 100 416.44 ENVIRONMENT

The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.

This CONDITION is not met as evidenced by: A Life Safety Code Recertification Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 416.44(b).

Survey Date: 04/11/17

Facility Number: 003903 Provider Number: 15C0001131 AIM Number: 200263270A

At this Life Safety Code survey, Elkhart Clinic Endoscopy and Surgery Center LLC was found not in compliance with Requirements for Participation in Medicare/Medicaid, 42 CFR Subpart 416.44(b), Life Safety from Fire and the 2012 edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC), Chapter 21, Existing Ambulatory Health Care Occupancies.

This facility located on the south side of a one story building with a basement was determined to

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

Q 000 Q 100

TITLE

(X6) DATE

Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation.

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Facility ID: 003903

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 100 Continued From page 1

be of Type II (000) construction and was fully sprinklered. The facility has a fire alarm system with smoke detection in the corridors and most rooms.

Based on observation and interview and record review, the facility failed to ensure the penetration in 2 of 2 fire barrier walls was maintained to ensure the fire resistance of the barrier. LSC 6.1.14.4.2 requires occupancy separations to meet the requirements of Chapter 8. LSC 8.3.5.1 requires penetrations for cables, cable trays, conduits, pipes, tubes, combustion vents and exhaust vents, wires, and similar items to accommodate electrical, mechanical, plumbing, and communications systems that pass through a wall, floor, or floor/ceiling assembly constructed as a fire barrier shall be protected by a firestop system or device. The firestop system or device shall be tested in accordance with ASTM E 814, Standard Test Method for Fire Tests of Through Penetration Fire Stops, or ANSI/UL 1479, Standard for Fire Tests of Through-Penetration Fire Stops. This deficient practice could affect all occupants (see tag K131), and the facility failed to ensure 1 of 2 egress stairwells were in accordance with Chapter 7. LSC 7.1.10.2.1 requires no furnishings, decorations, or other objects shall obstruct exits or their access thereto, egress therefrom, or visibility thereof. This deficient practice could affect staff only (see tag K211), and the facility failed to maintain 1 of 1 FM 200 system in accordance with LSC 9.7.3.1. LSC 9.7.3.1 requires in any occupancy where the character of the fuel for fire is such that extinguishment or control of fire is accomplished by a type of automatic extinguishing system in lieu of an automatic sprinkler system, such system shall be installed in accordance with the

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Q 100

Facility ID: 003903

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

Q 100 Continued From page 2 appropriate standard, as determined in accordance with Table 9.7.3.1. NFPA 2001, Standard on Clean Agent Fire Extinguishing System, 7.1.1 at least annually, all systems shall be thoroughly inspected and tested for proper orientation by personnel qualified in the installation and testing of clean agent extinguishment systems. 7.1.3 at least semiannually, the agent quantity and pressure of refillable containers shall be checked. This deficient practice could affect staff only (see tag K351).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure it had implemented a systemic plan of correction to prevent recurrence, therefore failing to ensure the provision of quality health care in a safe environment. Q 101 416.44(a)(1) PHYSICIAL ENVIRONMENT

The ASC must provide a functional and sanitary environment for the provision of surgical services. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.

This STANDARD is not met as evidenced by: Based on observation, the facility failed to ensure 1 of 2 egress stairwells were in accordance with Chapter 7. LSC 7.1.10.2.1 requires no furnishings, decorations, or other objects shall obstruct exits or their access thereto, egress therefrom, or visibility thereof. This deficient practice could affect staff only.

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 100

Q 101

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Facility ID: 003903

If continuation sheet Page 3 of 19

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 101 Continued From page 3

Findings include:

Based on observation with the Director of Environmental Services and the Director of Regulatory and Compliance on 04/11/17 at 12:38 p.m., the stairwell near the Business office contained six cardboard boxes, two racks of folding chairs, nine pieces of wooden boards were stored at the bottom of the stairwell. Based on interview at the time of observation, the Director of Environmental Services and the Director of Regulatory and Compliance acknowledged the aforementioned. Q 104 416.44(b) SAFETY FROM FIRE

(1) Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory Health Care Centers of the 2000 edition of the Life Safety Code of the National Fire Protection Association, regardless of the number of patients served. The Director of the Office of the Federal Register has approved the NFPA 101? 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to ederal-regulations/ibr_locations.html. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS

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Event ID: XHYI11

Q 101 Q 104

Facility ID: 003903

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 104 Continued From page 4 will publish notice in the Federal Register to announce the changes.

(2) In consideration of a recommendation by the State survey agency, CMS may waive, for periods deemed appropriate, specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients.

(3) The provisions of the Life Safety Code do not apply in a State if CMS finds that a fire and safety code imposed by State law adequately protects patients in an ASC.

(4) An ASC must be in compliance with Chapter 21.2.9.1, Emergency Lighting, beginning on March 13, 2006.

(5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, an ASC may place alcohol-based hand rub dispensers in its facility if:

(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;

(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;

(iii) The dispensers are installed in a manner that adequately protects against inappropriate access; and

(iv) The dispensers are installed in accordance with the following provisions:

(A) Where dispensers are installed in a

Q 104

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Facility ID: 003903

If continuation sheet Page 5 of 19

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

Q 104 Continued From page 5

corridor, the corridor shall have a minimum width of 6 ft (1.8m);

(B) The maximum individual dispenser fluid capacity shall be:

(1) 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors

(2) 0.5 gallons (2.0 liters) for dispensers in suites of rooms

(C) The dispensers shall have a minimum horizontal spacing of 4 feet (1.2m) from each other;

(D) Not more than an aggregate of 10 gallons (37.8 liters) of ABHR solution shall be in use in a single smoke compartment outside of a storage cabinet;

(E) Storage of quantities greater than 5 gallons (18.9 liters) in a single smoke compartment shall meet the requirements of NFPA 30, Flammable and Combustible Liquids Code;

(F) The dispensers shall not be installed over or directly adjacent to an ignition source;

(G) In locations with carpeted floor coverings, dispensers installed directly over carpeted surfaces shall be permitted only in sprinklered smoke compartments; and

(v) The dispensers are maintained in accordance with dispenser manufacturer guidelines.

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 104

This STANDARD is not met as evidenced by: Based on observation, record review and interview, the facility failed to ensure the penetration in 2 of 2 fire barrier walls was maintained to ensure the fire resistance of the

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Facility ID: 003903

If continuation sheet Page 6 of 19

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 104 Continued From page 6

barrier. LSC 6.1.14.4.2 requires occupancy separations to meet the requirements of Chapter 8. LSC 8.3.5.1 requires penetrations for cables, cable trays, conduits, pipes, tubes, combustion vents and exhaust vents, wires, and similar items to accommodate electrical, mechanical, plumbing, and communications systems that pass through a wall, floor, or floor/ceiling assembly constructed as a fire barrier shall be protected by a firestop system or device. The firestop system or device shall be tested in accordance with ASTM E 814, Standard Test Method for Fire Tests of Through Penetration Fire Stops, or ANSI/UL 1479, Standard for Fire Tests of Through-Penetration Fire Stops. This deficient practice could affect all occupants, and the facility failed to maintain 1 of 1 FM 200 system in accordance with LSC 9.7.3.1. LSC 9.7.3.1 requires in any occupancy where the character of the fuel for fire is such that extinguishment or control of fire is accomplished by a type of automatic extinguishing system in lieu of an automatic sprinkler system, such system shall be installed in accordance with the appropriate standard, as determined in accordance with Table 9.7.3.1. NFPA 2001, Standard on Clean Agent Fire Extinguishing System, 7.1.1 at least annually, all systems shall be thoroughly inspected and tested for proper orientation by personnel qualified in the installation and testing of clean agent extinguishment systems. 7.1.3 at least semiannually, the agent quantity and pressure of refillable containers shall be checked. This deficient practice could affect staff only.

Findings include:

1. Based on an observation with the Director of Environmental Services and the Director of

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Q 104

Facility ID: 003903

If continuation sheet Page 7 of 19

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR MEDICARE & MEDICAID SERVICES

STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION

(X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER:

NAME OF PROVIDER OR SUPPLIER

15C0001131

ELKHART CLINIC ENDOSCOPY AND SURGERY CENTER LLC

(X4) ID PREFIX

TAG

SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION)

(X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________

PRINTED: 05/08/2017 FORM APPROVED

OMB NO. 0938-0391

(X3) DATE SURVEY COMPLETED

B. WING _____________________________

STREET ADDRESS, CITY, STATE, ZIP CODE 2117 W LEXINGTON AVE

ELKHART, IN 46514

ID PREFIX

TAG

PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE

DEFICIENCY)

04/05/2017

(X5) COMPLETION

DATE

Q 104 Continued From page 7

Regulatory and Compliance on 04/11/17 between 1:07 p.m. and 1:39 p.m., the following unsealed penetrations were discovered: a) the ASC/ Business separation contained a six inch gap between the top of the drywall and the corrugated roof line by the visitor's bathroom b) the ASC/ Business separation contained at seventeen by seventeen inch piece of drywall removed by the "EFP Side Door" c) the OR fire wall contained a 1 inch gap between the top of the drywall and the corrugated roof line by the Doctor's Dictate Area. Additionally, a one inch penetration around a metal support and a half inch penetration inside a conduit tube. d) the OR fire wall contained four separate one inch penetrations inside conduit near the Janitor's closet Based on interview at the time of each observation, the Director of Environmental Services and the Director of Regulatory and Compliance acknowledged each aforementioned condition and provided the measurements.

2. Based on record review with the Director of Environmental Services and the Director of Regulatory and Compliance on 04/11/17 10:50 a.m., FM 200 testing was performed on 3/15/17 by Approved Fire Protection. No documentation was available for the previous semiannual check of the agent quantity and pressure of refillable containers. Based on interview at the time of record review, the Director of Environmental Services and the Director of Regulatory and Compliance confirmed no other documentation was available for review.

3. Based on observation and interview, the facility failed to provide automatic extinguishing protection for 1 of 1 Elevator Equipment rooms.

FORM CMS-2567(02-99) Previous Versions Obsolete

Event ID: XHYI11

Q 104

Facility ID: 003903

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