QA Investigation Results

Pennsylvania Department of Health
BMA OF HAZLETON
Health Inspection Results
BMA OF HAZLETON
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted September 10 through September 13, 2019, BMA of Hazleton was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.






Plan of Correction:




Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted September 10 through September 13, 2019, BMA of Hazleton was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.







Plan of Correction:




494.60(a) STANDARD
PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY

Name - Component - 00
The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public.



Observations:

Based on review of facility policies/procedures and documentation, observation, and interview with the social worker (SW), clinic manager (CM), area technical operations manager (ATOM), the medical director (MD) and the administrator, the facility failed to ensure the in-center hemodialysis supplies were secured from unauthorized access.

Findings include:

On September 13, 2019 at approximately 2:30 PM, review of the facility policy titled "Storage of Supplies" revealed the following under "Background": "Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not contaminated or damaged."

Between September 10, 2019 at approximately 1:30 PM and September 13, 2019 at approximately 12:40 PM, review of the "Patient List Form" revealed facility's current in-center hemodialysis census was 32 patients.

On September 11, 2019 at approximately 1:05 PM, review of the "Sublease Agreement" dated September 1, 2019 revealed the following as related to the formal lease agreement between the hemodialysis clinic/facility (Sublessor) and a hospital-based outpatient provider (Sublessee):
"This Sublease Agreement...is entered into as of Sept 1 2019 (the "Effective Date")...2. Subleased Premises: Sublessor, in consideration of the rents and covenants hereinafter set forth, does hereby demise (layman's term for transfer), let and lease to the Sublessee, and Sublessee does hereby hire, take and lease from the Sublessor...approximately 393 square feet of space situated on the Premises, together with the use of the common areas and facilities consisting of common staff lounge, waiting rooms, restrooms and others as may be designated from time to time by Sublessor...
4. Usage of Subleased Premises: The Subleased Premises may be used by the Sublessee during the following times: Space may be used 8 hours per month, one Wednesday per month, or on another day mutually agreed upon by the parties but in no the event more than eight (8) hours per month. Sublessor shall permit Sublessee, during the Sublessee's scheduled use of the Subleased Premises, exclusive use of the Subleased Premises and to peacefully hold and enjoy the Subleased Premises.
5. Rent: During the Term of this Sublease, Sublessee shall pay the Sublessor as Rent the sum of 1,814.40 per year, payable, at Sublessee's option, annually, with the first payment due on or before the Effective Date, and each subsequent payment due on or before the anniversary of the Effective Date, or in equal monthly installments of $151.20 per month..."

During observational tour on Wednesday, September 11, 2019 at approximately 11:15 AM, which was conducted during the in-center hemodialysis shift turnover, an unknown person knocked on the hemodialysis treatment room door. An in-center hemodialysis staff member informed the person that the person was in the incorrect area of the facility and directed the person to another area of the facility.
During interview on September 11, 2019 at approximately 11:15 PM, the SW reported that an outpatient clinic was being conducted in an area in the facility which was leased to a hospital-based outpatient provider.

On September 11, 2019 at approximately 11:20 AM, the CM reported that the peritoneal/home hemodialysis training room had been leased to a hospital-based outpatient provider. The CM reported that it was the CM's understanding that the hospital-based outpatient provider was only to tour the space which was to be leased, but instead the hospital-based outpatient provider was conducting an outpatient clinic in the facility's home dialysis training room on September 11, 2019. The CM reported the facility's in-center hemodialysis patients will no longer have to drive significant distances for access for transplant related services since the hospital-based outpatient provider will be conducting the outpatient clinic in the hemodialysis facility.

On September 11, 2019 at approximately 12:40 PM, an unknown person knocked on the door of the conference room in which the surveyor was working and informed the surveyor that the person was there for the hospital-based outpatient clinic.
During observational tour on September 11, 2019 conducted between approximately 12:40 PM and 1:20 PM, the unknown person was observed entering the facility's home dialysis training room which is located across the hall from the in-center hemodialysis supply storage room. The in-center hemodialysis storage room door was propped open and the in-center hemodialysis supplies stored in the room included, but were not limited to, the following: hemodialyzers, bags of intravenous (IV) saline, bottles of bleach, and laboratory supplies. An unlocked door in the supply room provided access to a small room which contained the facility's ventilation unit. An unknown staff member was observed working at the desk a separate room in the hallway located around the corner from the facility's home dialysis training room. The wall placard indicated that the room was the office of the facility's medical director. The staff member reported that she was an employee of the hospital-based outpatient provider.

An observational tour and interview were conducted with the ATOM on September 11, 2019 at approximately 1:20 PM. The ATOM confirmed that the in-center hemodialysis supply room was unlocked during the observational tour. The ATOM reported that notification was received on September 10, 2019 that space in the hemodialysis facility had been leased to the hospital-based outpatient provider.

On September 12, 2019 at approximately 8:10 AM, review of an email which was received from the facility administrator revealed the hospital-based outpatient provide would be conducting a monthly clinic for "transplant patients".

During telephone interview on September 13, 2019 at approximately 12:49 PM, the MD reported that approximately one (1) year ago he received notification that an area in the facility would be leased to a hospital-based outpatient provider.

During interview on September 13, 2019 at approximately 1:15 PM, the administrator confirmed the in-center hemodialysis supplies stored in the room across from the home dialysis training room were not secured from unauthorized access when the hospital-based outpatient provider was conducting the outpatient clinic on September 11, 2019.



















Plan of Correction:

For immediate compliance, a key lock was placed on the supply room door to secure supplies from unauthorized access. An electronic keypad with a digital code access has been ordered and will be installed on the supply room door upon delivery to the facility.
For two weeks, the CM/designee will review and reinforce with all staff at daily huddles the following policy:
- FMS-CS-IC-II-120-005A "Storage of Supplies"

With emphasis on:
- Storing supplies in a safe, secure/locked area to prevent unauthorized access to ensure supplies are not contaminated or damaged

Beginning 9/20/19, the CM and/or designee, will conduct daily audits on the locked supply room door for two weeks or until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.
Education records will be on file in the facility.
Staff found to be non-compliant will be re-educated and/or counseled.
For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review

Completion date: 9/20/19




494.90(a) STANDARD
POC-IDT DEVELOPS PLAN OF CARE

Name - Component - 00
The interdisciplinary team must develop a plan of care for each patient.


Observations:

Based on review of facility policies/procedures and medical records, and based on interview with the medical director (MD) and the administrator, the facility failed to ensure documentation was maintained in the medical record which provided evidence that the attending physician (medical director) participated in the interdisciplinary team (IDT) care plan conference for three (3) of five (5) in-center hemodialysis patients. (Patients #1, #2 and #4)

Findings include:

On September 13, 2019 at approximately 2:25 PM, review of the facility policy titled "Comprehensive Interdisciplinary Assessment and Plan of Care" revealed the following:
"Responsibility...Interdisciplinary Care Team...Attending physician and physician extenders as applicable...
General Policy for Patient Assessment and Plan of Care... The Plan of Care signed at the time of the interdisciplinary team meeting for those attending in person or if attending remotely within 30 days of the interdisciplinary team meeting..."

Patient #1: On September 12, 2019 at approximately 12:30 PM, review of the combined medical record (paper and electronic) revealed the first date of dialysis at the facility was September 25, 2014 and that the medical director was the attending physician.
Comprehensive assessment documentation revealed a physician extender (Certified Registered Nurse Practitioner-CRNP) completed the physician's portion of the IDT comprehensive assessment on September 11, 2018.
"Plan of Care" documentation revealed a physician extender (CRNP) attended the IDT care plan conference conducted on September 11, 2018 but there was no evidence that the attending physician participated in the care plan conference as a physician signature was not documented in the section titled "Team Approval Signatures".

Patient #2: On September 12, 2019 at approximately 1:29 PM, review of the combined medical record revealed the first date of dialysis at the facility was July 17, 2019 for acute dialysis, that chronic hemodialysis was initiated on August 8, 2019 and that the medical director was the attending physician.
Comprehensive assessment documentation revealed a physician extender (CRNP) completed the physician's portion of the IDT comprehensive assessment on September 3, 2019.
"Plan of Care" documentation revealed a physician extender (CRNP) attended the care plan conference conducted on September 3, 2019, which was the first care plan meeting conference after the initiation of chronic hemodialysis, but there was no evidence that the attending physician participated in the care plan conference as there was physician attendance was not documented in the section titled "Team Approval Signatures".

Patient #4: On September 13, 2019 at approximately 10:51 AM, review of the combined medical record revealed the first date of dialysis at the facility was July 15, 2018, that the patient had a total of four (4) hospitalizations been March 9 and August 10, 2019, one of which exceeded 15 days, and that the medical director was the attending physician.
Review of patient stability status revealed the patient had been deemed unstable based on the IDT care plan conferences conducted on July 23 and August 20, 2019.
Comprehensive assessment documentation revealed a physician extender (CRNP) completed the physician's portion of the IDT comprehensive assessment on August 29, 2019.
"Plan of Care" documentation revealed a physician extender (CRNP) attended the unstable care plan conference conducted on September 3, 2019 but there was no evidence that the attending physician participated in the IDT care plan conference as a physician signature was not documented in the section titled "Team Approval Signatures".

During interview on September 13, 2019 at approximately 12:49 PM, the medical director (attending physician) reported that he is unable to attend all of the IDT care plan conferences since the care plans are scheduled to be completed on a specific date instead of in the specific month. The medical director reported that he is unable to attend certain IDT care plan conferences due to conflicts with office hours and hospital rounds.

During interview on September 13, 2019 at approximately 1:15 PM, the administrator confirmed there was no documentation in the medical records which provided evidence that the attending physician (medical director) participated in the interdisciplinary team (IDT) care plan conferences for the above identified patients on the above referenced dates.



















Plan of Correction:


By 9/27/19, the Clinical Manager and/or designee, will review and re-educate the Medical Staff and Interdisciplinary Team (IDT) members on policy:
- FMS-CS-IC-I-110-125A, "Comprehensive Interdisciplinary Assessment and Plan of Care"
With emphasis on:
- Ensuring that the IDT members participate in the development of the patient's comprehensive assessment upon which the plan of care will be developed.
- The meeting will also reinforce that the plan of care must be signed at the time of the IDT meeting for those attending in person or within 30 days if attending remotely, including the physician.
- The care plan with the physician's signature indicating their oversight will be maintained in the patient's medical record.


Beginning 10/4/19, the CM and/or designee, will conduct weekly audits on physician signatures on patient comprehensive care plans for two months or until 100% compliance is observed. When 100% compliance is achieved, audits will continue monthly per QAI clinical audit checks.
Education records will be on file in the facility.
Non-compliance will result in re-education and/or counseling. Repeat non-compliance will be referred to the Governing Body for further guidance.
For ongoing compliance, the CM will present audit results at monthly QAI meetings for committee review

Completion date: 10/4/19




494.170(a) STANDARD
MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL

Name - Component - 00
The dialysis facility must-
(1)Safeguard patient records against loss, destruction, or unauthorized use; and
(2) Keep confidential all information contained in the patient's record, except when release is authorized pursuant to one of the following:
(i) The transfer of the patient to another facility.
(ii) Certain exceptions provided for in the law.
(iii) Provisions allowed under third party payment contracts.
(iv) Approval by the patient.
(v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program.



Observations:

Based on review of facility policies/procedures and documentation, observation, and based on interview with the social worker (SW), clinic manager (CM), area technical operations manager (ATOM), the medical director (MD) and the administrator, the facility failed to ensure in-center hemodialysis patient medical records were secured from unauthorized access.

Findings include:

On September 13, 2019 at approximately 2:37 PM, review of the facility policy titled "Medical Record Guidelines" revealed the following:
"Background...Every facility that creates medical record documentation must have formalized systems in place for the maintenance...and safety of medical records...
Safeguarding the Medical Record...Each facility must safeguard patient medical records against loss, destruction or unauthorized use..."

Between September 10, 2019 at approximately 1:30 PM and September 13, 2019 at approximately 12:40 PM, review of the "Patient List Form" revealed facility's current in-center hemodialysis census was 32 patients.

On September 11, 2019 at approximately 1:05 PM, review of the "Sublease Agreement" dated September 1, 2019 revealed the following as related to the formal lease agreement between the hemodialysis clinic/facility (Sublessor) and a hospital-based outpatient provider (Sublessee):
"This Sublease Agreement...is entered into as of Sept 1 2019 (the "Effective Date")...2. Subleased Premises: Sublessor, in consideration of the rents and covenants hereinafter set forth, does hereby demise (layman's term for transfer), let and lease to the Sublessee, and Sublessee does hereby hire, take and lease from the Sublessor...approximately 393 square feet of space situated on the Premises, together with the use of the common areas and facilities consisting of common staff lounge, waiting rooms, restrooms and others as may be designated from time to time by Sublessor...
4. Usage of Subleased Premises: The Subleased Premises may be used by the Sublessee during the following times: Space may be used 8 hours per month, one Wednesday per month, or on another day mutually agreed upon by the parties but in no the event more than eight (8) hours per month. Sublessor shall permit Sublessee, during the Sublessee's scheduled use of the Subleased Premises, exclusive use of the Subleased Premises and to peacefully hold and enjoy the Subleased Premises.
5. Rent: During the Term of this Sublease, Sublessee shall pay the Sublessor as Rent the sum of 1,814.40 per year, payable, at Sublessee's option, annually, with the first payment due on or before the Effective Date, and each subsequent payment due on or before the anniversary of the Effective Date, or in equal monthly installments of $151.20 per month..."

During observational tour on Wednesday, September 11, 2019 at approximately 11:15 AM, which was conducted during the in-center hemodialysis shift turnover, an unknown person knocked on the hemodialysis treatment room door. An in-center hemodialysis staff member informed the person that the person was in the incorrect area of the facility and directed the person to another area of the facility.
During interview on September 11, 2019 at approximately 11:15 PM, the SW reported that an outpatient clinic was being conducted in an area in the facility which was leased to a hospital-based outpatient provider.

On September 11, 2019 at approximately 11:20 AM, the CM reported that the peritoneal/home hemodialysis training room had been leased to a hospital-based outpatient provider. The CM reported that it was the CM's understanding that the hospital-based outpatient provider was only to tour the space which was to be leased, but instead the hospital-based outpatient provider was conducting an outpatient clinic in the facility's home dialysis training room on September 11, 2019. The CM reported the facility's in-center hemodialysis patients will no longer have to drive significant distances for access for transplant related services since the hospital-based outpatient provider will be conducting the outpatient clinic in the hemodialysis facility.

On September 12, 2019 at approximately 8:10 AM, review of an email which was received from the facility administrator revealed the hospital-based outpatient provide would be conducting a monthly clinic for "transplant patients".

On September 11, 2019 at approximately 12:40 PM, an unknown person knocked on the door of the conference room in which the surveyor was working and informed the surveyor that the person was there for the hospital-based outpatient clinic. During observational tour on September 11, 2019 conducted between approximately 12:40 PM and 1:20 PM, the unknown person was observed entering the facility's home dialysis training room. An unknown staff member was observed working at the desk a separate room in the hallway located around the corner from the facility's home dialysis training room. The wall placard indicated that the room was the office of the facility's medical director. The staff member reported that she was an employee of the hospital-based outpatient provider.
On September 11, 2019 at approximately 1:50 PM, review of documentation maintained in the file-folder rack, which was located on the top of the desk in the facility's medical director's office, revealed unsecured medical record documentation was present in the file-folder rack for 29 of the 32 in-center hemodialysis patients. The unsecured medical record documentation maintained in the facility's medical director's office included, but was not limited to, the following: medical record numbers, hemodialysis orders and treatment times, dialysis treatment attendance information, hospitalization dates, medication information, laboratory results including hepatitis results, date of birth, address, telephone number and/or clinical notes.

During telephone interview on September 13, 2019 at approximately 12:49 PM, the MD reported that approximately one (1) year ago he received notification that an area in the facility would be leased to a hospital-based outpatient provider.

During interview on September 13, 2019 at approximately 1:15 PM, the administrator confirmed in-center hemodialysis patient medical records were not secured from unauthorized access when the hospital-based outpatient provider was conducting the outpatient clinic on September 11, 2019.


















Plan of Correction:

By 9/30/19, the Clinical Manager and/or designee, will review and re-educate all facility personnel members on the following policies:
- FMS-CS-IC-II-035A "Employee and Medical Professionals' Access to Medical Records"
- FMS-CS-IC-II-037A "Medical Record Guidelines"
With emphasis on:
- Maintaining and safeguarding patient medical records against loss, defacement, tampering or use and/or access by unauthorized persons
- Compliance with applicable Physical Security, Information Security, Privacy and Record Management policies and procedure
- Rooms containing medical records not locked in file drawers or cabinets are to be locked and secured at all times when authorized personnel are not present
- Physical access to rooms containing patient medical records will be limited to Clinical Manager, RN's, LPN's, Dietitians, Social Workers, Physicians, and clerical staff who maintain the medical records
Beginning 10/1/19, the CM and/or designee, will conduct daily audits on securing medical records for one month or until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.
Education records will be on file in the facility.
Non-compliance will result in re-education and/or counseling
For ongoing compliance the CM will present audit results at monthly QAI meetings
Completion date: 10/1/19



494.180 STANDARD
GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS

Name - Component - 00
The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ' personal and property rights, and to the general operation of the facility.


Observations:

Based on review of facility policies/procedures and documentation, observation, and interview with the social worker (SW), clinic manager (CM), area technical operations manager (ATOM), the medical director (MD) and the administrator, the governing body failed to ensure governing body approval was obtained prior to leasing of facility space to a hospital-based outpatient provider.

Findings include:

On September 13, 2019 at approximately 2:33 PM, review of the facility policy titled "Governing Body Instructions" revealed the following:
"Introduction...A facility's Governing Body is directly responsible to the ongoing governance and day to day operations of the dialysis facility...
General Responsibilities...The Conditions for Coverage require that an identifiable Governing Body of designated persons with full legal authority and responsibilities...is ultimately responsible for the facility's management and oversight of the day to day operations and for ensuring the delivery of safe treatments and patient satisfaction..."

Between September 10, 2019 at approximately 1:30 PM and September 13, 2019 at approximately 12:40 PM, review of the "Patient List Form" revealed facility's current in-center hemodialysis census was 32 patients.

On September 11, 2019 at approximately 1:05 PM, review of the "Sublease Agreement" dated September 1, 2019 revealed the following as related to the formal lease agreement between the hemodialysis clinic/facility (Sublessor) and a hospital-based outpatient provider (Sublessee):
"This Sublease Agreement...is entered into as of Sept 1 2019 (the "Effective Date")...2. Subleased Premises: Sublessor, in consideration of the rents and covenants hereinafter set forth, does hereby demise (layman's term for transfer), let and lease to the Sublessee, and Sublessee does hereby hire, take and lease from the Sublessor...approximately 393 square feet of space situated on the Premises, together with the use of the common areas and facilities consisting of common staff lounge, waiting rooms, restrooms and others as may be designated from time to time by Sublessor...
4. Usage of Subleased Premises: The Subleased Premises may be used by the Sublessee during the following times: Space may be used 8 hours per month, one Wednesday per month, or on another day mutually agreed upon by the parties but in no the event more than eight (8) hours per month. Sublessor shall permit Sublessee, during the Sublessee's scheduled use of the Subleased Premises, exclusive use of the Subleased Premises and to peacefully hold and enjoy the Subleased Premises.
5. Rent: During the Term of this Sublease, Sublessee shall pay the Sublessor as Rent the sum of 1,814.40 per year, payable, at Sublessee's option, annually, with the first payment due on or before the Effective Date, and each subsequent payment due on or before the anniversary of the Effective Date, or in equal monthly installments of $151.20 per month..."

During observational tour on Wednesday, September 11, 2019 at approximately 11:15 AM, which was conducted during the in-center hemodialysis shift turnover, an unknown person knocked on the hemodialysis treatment room door. An in-center hemodialysis staff member informed the person that the person was in the incorrect area of the facility and directed the person to another area of the facility.
During interview on September 11, 2019 at approximately 11:15 PM, the SW reported that an outpatient clinic was being conducted in an area in the facility which was leased to a hospital-based outpatient provider.

On September 11, 2019 at approximately 11:20 AM, the CM reported that the peritoneal/home hemodialysis training room had been leased to a hospital-based outpatient provider. The CM reported that it was the CM's understanding that the hospital-based outpatient provider was only to tour the space which was to be leased, but instead the hospital-based outpatient provider was conducting an outpatient clinic in the facility's home dialysis training room on September 11, 2019. The CM reported the facility's in-center hemodialysis patients will no longer have to drive significant distances for access for transplant related services since the hospital-based outpatient provider will be conducting the outpatient clinic in the hemodialysis facility.

On September 11, 2019 at approximately 12:40 PM, an unknown person knocked on the door of the conference room in which the surveyor was working and informed the surveyor that the person was there for the hospital-based outpatient clinic.
During observational tour on September 11, 2019 conducted between approximately 12:40 PM and 1:20 PM, the unknown person was observed entering the facility's home dialysis training room which is located across the hall from the in-center hemodialysis supply storage room. The in-center hemodialysis storage room door was propped open and the in-center hemodialysis supplies stored in the room included, but were not limited to, the following: hemodialyzers, bags of intravenous (IV) saline, bottles of bleach, and laboratory supplies. An unlocked door in the supply room provided access to a small room which contained the facility's ventilation unit. An unknown staff member was observed working at the desk a separate room in the hallway located around the corner from the facility's home dialysis training room. The wall placard indicated that the room was the office of the facility's medical director. The staff member reported that she was an employee of the hospital-based outpatient provider.

An observational tour and interview were conducted with the ATOM on September 11, 2019 at approximately 1:20 PM. The ATOM confirmed that the in-center hemodialysis supply room was unlocked during the observational tour. The ATOM reported that notification was received on September 10, 2019 that space in the hemodialysis facility had been leased to the hospital-based outpatient provider.

On September 11, 2019 at approximately 1:50 PM, review of documentation maintained in the file-folder rack, which was located on the top of the desk in the facility's medical director's office, revealed unsecured medical record documentation was present in the file-folder rack for 29 of the 32 in-center hemodialysis patients. The unsecured medical record documentation maintained in the facility's medical director's office included, but was not limited to, the following: medical record numbers, hemodialysis orders and treatment times, dialysis treatment attendance information, hospitalization dates, medication information, laboratory results including hepatitis results, date of birth, address, telephone number and/or clinical notes.

On September 12, 2019 at approximately 8:10 AM, review of an email which was received from the facility administrator revealed the hospital-based outpatient provide would be conducting a monthly clinic for "transplant patients".

During telephone interview on September 13, 2019 at approximately 12:49 PM, the MD reported that approximately one (1) year ago he received notification that an area in the facility would be leased to a hospital-based outpatient provider but was unsure if the governing body had provided approval to lease the aforementioned hemodialysis facility space prior to September 1, 2019.

On September 13, 2019 at approximately 11:45 AM, review of the facility's governing body meeting minutes dated January 11, March 13, April 18, May 28 and June 25, 2019 failed to reveal that the governing body approved the lease of "approximately 393 square feet of space situated on the Premises" (hemodialysis facility) which included, but were not limited to, the following areas: the home dialysis training room together with the use of the common areas and facilities consisting of common staff lounge, waiting rooms, restrooms and others as may be designated from time to time by Sublessor (hemodialysis facility).

During interview on September 13, 2019 at approximately 1:15 PM, the administrator confirmed there was no documentation which provided evidence that the governing body approved the lease of "approximately 393 square feet of space situated on the Premises" (hemodialysis facility) which included, but were not limited to, the following areas: the home dialysis training room together with the use of the common areas and facilities consisting of common staff lounge, waiting rooms, restrooms and others as may be designated from time to time by Sublessor (hemodialysis facility) prior to September 11, 2019.














Plan of Correction:

The Governing Body of the Hazelton facility acknowledges its responsibility to ensure that this dialysis facility adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients' personal and property rights and to the general operation of the facility as required by the Conditions for Coverage.

On 9/17/19, an ad hoc Governing Body meeting was held to discuss the subleasing of 393 sq. ft. of facility space to a hospital-based outpatient provider. The terms of the existing sublease agreement entered into on September 1st, 2019, was reviewed and approved by the Governing Body members.
Also discussed was areas of the facility to be secured, including supply storage room and medical director's office currently housing patient medical records to prevent access by unauthorized personnel as identified in V 402 and V 727.
For ongoing compliance, the Clinical Manager will monitor to ensure only areas identified in the sublease agreement are utilized by the Subtenant and will report monitor results to the QAI committee monthly and Governing Body quarterly.
Minutes of the GB meeting are on file at the facility
Completion date: 9/17/19