Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 10, 2025, Pocono Home Center was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 10, 2025, Pocono Home Center 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 of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(a)(1)(i) STANDARD
IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT
Name - Component - 00
Routine Testing for Hepatitis B
The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit.
Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results.
Observations:
Based on a review of facility policy, a review of medical records, and an interview with the facility Administrator, facility failed to ensure that patient Hepatitis B status was known before admission and prior to first treatment for two (2) out of six (6) medical records (MR) reviewed (MR#1, MR#6).
Findings:
A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 1-05-02 'Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance' 'Policy' (1) "HBV serological status ...... of all patients should be known before admission to the hemodialysis facility." (2) "If hepatitis B surface antigen ... is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for hepatitis B infection. ..."
A review of patient medical records was completed on July 9, 2025 at approximately 3:00 p.m. Patients date of admit is included below.
MR#1 Date of Admission 08/08/22: Patient's first treatment date at the facility was 08/08/22 ('Start Time: 10:10, Stop Time: 12:45'). No documentation provided of the patients hepatitis B status before admission to the facility and prior to the first treatment.
Documentation provided of the facility hepatitis B testing on 08/08/22.
MR#6 Date of Admission 03/31/25: Patient's first treatment date at the facility was 03/31/25. No documentation provided of the patients hepatitis B status before admission to the facility and prior to the first treatment.
Patient was treated four (4) days at the facility with hepatitis B status unknown (last treatment day, prior to facility receiving hepatitis B lab results, was 04/03/25).
According to documentation provided of a facility adverse event report, the treatment room was utilized by other patients during this time period. The Medical Director and Davita management team was notified on 04/03/25. The treatment room was terminally cleaned on 04/04/25.
Documentation provided of 'Hepatitis B DNA, Quantitative PCR' test ordered on 04/04/25 with results (negative/non-reactive) obtained on 04/07/25.
An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.
Plan of Correction:
V0124
A Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 7/10/25. The Governing Body directed the Facility Administrator or his/her designee to review all perspective admission's documentation prior to the patient receiving treatment in the facility to verify hepatitis serology has been received and reviewed to disposition each patient appropriately.
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting 07/16/25. Surveyor observations were reviewed. Education included a review of Policy 5-06-04 Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance emphasizing 1) HBV serological status ...... of all patients should be known before admission to the hemodialysis facility. 2) If hepatitis B surface antigen ... is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for hepatitis B infection. Verification of attendance at in-service is evidenced by teammate signature on sign-in sheet. The Facility Administrator or designee will review all admission's documentation prior to the patient receiving their first treatment in the facility to verify hepatitis serology has been received, reviewed and dispositioned appropriately monthly for three (3) months. Instances of non-compliance will be addressed immediately. The Facility Administrator or designee will review results of the audits with the Medical Director during monthly Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes.
494.100(a)(3) STANDARD
H-TRAIN CONTENT INCLUDES ER PREP HOME PTS
Name - Component - 00
The training must-
(3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas:
(i) The nature and management of ESRD.
(ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient's plan of care.
(iii) How to detect, report, and manage potential dialysis complications, including water treatment problems.
(iv) Availability of support resources and how to access and use resources.
(v) How to self-monitor health status and record and report health status information.
(vi) How to handle medical and non-medical emergencies.
(vii) Infection control precautions.
(viii) Proper waste storage and disposal procedures.
Observations:
Based on a review of facility policy, patient interviews, and an interview with the facility Administrator, facility failed to ensure home dialysis patients have access to resources and assistance 24 hours/day, 7 days/week, for one (1) out of two (2) patient interviews conducted (Interview #1).
Findings:
A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 5-01-04 'Services Provided' 'Policy' section (4) "The facility will provide ongoing services, including, but not limited to: .......Identify 24 hour coverage. ...." (5) The facility will provide the patient/care partner with the facility's normal operating hours and contact information. In addition, the patient/caregiver will be provided with contact information for after hours and emergency issues."
Patient interviews were conducted at the facility on July 7, 2025 between approximately 10:15 a.m. and 11:00 a.m.
Interview #1: An interview was conducted onsite with patient #7 (home hemodialysis patient) on 07/07/25 at approximately 10:15 a.m. The patient stated that between the hours of 4:00 p.m. - 5:00 p.m. there is no patient support. Stated facility closes at 4:00 p.m. and that the on-call service does not accept calls until 5:00 p.m. Stated complaints have been entered in the past.
Discussed the patients concern with the faciltiy Administrator on 07/07/25. No complaints regarding this issue were noted in the facility complaint/incident log. Administrator completed a complaint entry on 07/08/25 at approximately 1:20 p.m. The entry included " ...nurses typically leave around 4:30 p.m. The nurse on-call hours start at 5:00 p.m. Patient reports she has been told by the on-call system that she needs to wait to resolve her issues until after 5:00 p.m." The complaint entry resolution section states "Brought to the awareness of the ROD to discuss/review a possible solution to the issue."
An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.
Plan of Correction:V0585
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting 07/16/25. Surveyor observations were reviewed. Education included a review of Policy 5-01-04 Services Provided emphasizing 1) the facility will provide ongoing services, including, but not limited to: .......Identify 24-hour coverage. .... 2) The facility will provide the patient/care partner with the facility's normal operating
hours and contact information. In addition, the patient/caregiver will be provided with contact information for after hours and emergency
issues. Verification of attendance at in-service is evidenced by teammate signature on sign-in sheet. A Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 7/10/25. Based on a review of facility policy, patient interviews, and an interview with the facility administrator, facility failed to ensure home dialysis patients have access to resources and assistance 24 hours/day, 7 days/week. On call services do not start until 5pm.The Facility has partnered with another regional facility with extended operating hours to provide on call services during the hours Pocono Home Training is not operating. The Facility Administrator or designee will provide the contact information (including the phone number) to all patients with instructions to utilize from 4-5pm in the event of an emergency and/or support is needed.
The Facility Administrator or designee will conduct audits weekly for three (3) months to monitor for adherence to the process. Instances of non-compliance will be addressed immediately. In addition, the Facility Administrator (or PCT/RN delegate) will interview each patient during monthly clinic visits with patients to confirm accessibility to support services for the month. Patient interviews will be performed for three (3) months. Any issues reported will be addressed immediately.
The Facility Administrator or designee will review results of the audits with the Medical Director during monthly Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes.
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on a review of facility policy, patient medical records, water treatment equipment records, and an interview with the facility Administrator, the facility failed to ensure a registered nurse completed an initial nursing evaluation prior to initiating treatment for two (2) of six (6) medical records (MR) reviewed (MR #1, MR #3); failed to ensure facility forms were completed per policy/procedure, for one (1) of one (1) dialysis machine maintenance logs reviewed. (Log #1); and failed to ensure physician medication orders were transcribed correctly into patients home dialysis machine for one (1) of two (2) home hemodialysis patient medical records reviewed (MR#1).
Findings:
A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 1-03-07 'Initial Patient Nursing Assessment For New Patients' section (1) "A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility." Section (4) "This initial pre-treatment evaluation will be documented in the electronic health record as the intitial Patient Nursing Assessment. In the event of system downtime, it may be documented on paper using the New Patient Pre-Treatment Initial Nurse Assessment form ...and is to be entered into CWOW when system comes back on-line."
MR#1 Date of Admission 08/08/22: Patient's first peritoneal dialysis treatment nursing note dated 08/08/22 was reviewed. The 'New PD Patient Pre-Treatment Initial Nurse Assessment' documentation was completed on 08/08/22.
No registered nurse signature/time stamp/date was included on the form. The section was left blank.
MR#3 Date of Admission 06/09/25: Patient's first peritoneal dialysis treatment nursing note dated 06/09/25 was reviewed. No documentation provided of an initial nursing assessment to determine the patients immediate needs.
Procedure: 12-13-11-A 'Home Hemodialysis Policies and Procedures' section (9) "Bleach Waste Line: The Bleach Waste Line procedure is completed at least weekly or as often as needed, when in use....." (10) "Verified by an RN: An RN will verify that maintenance log is complete."
A review of dialysis machine maintenance logs was completed on July 9, 2025 at approximately 11:00 a.m.
Log #1: The 'NxStage Maintenance Schedule Logs' dated 2023 - 2025 review revealed the following:
Cycler Serial #16691:
2023 (January - December)....'Initials of RN reviewing' section blank with no entries.
2024 (January - December)....'Initials of RN reviewing' section blank with no entries.
2025 (February - June)....'Initials of RN reviewing' section blank with no entries.
Cycler Serial #12442:
2025 (March - June)....'Initials of RN reviewing' section blank with no entries.
'Bleach Waste Line' section dates between 3/5/25 and 3/31/25 blank with no entries.
Cycler Serial #8541:
2023 (January - December)....'Initials of RN reviewing' section blank with no entries.
2024 (January - December)....'Initials of RN reviewing' section blank with no entries.
2025 (February - June)....'Initials of RN reviewing' section blank with no entries.
Cycler Serial #17512:
2024 (January - December)....'Initials of RN reviewing' section blank with no entries.
Cycler Serial #13372:
2023 (January - December)....'Initials of RN reviewing' section blank with no entries.
Policy:3-02-03 'Physician Orders For Patient Care' 'Purpose' "To verify that orders are properly documented, transcribed, verified, and implemented in a timely manner for patient care ...."
Policy: 12-01-41 'Daily Home Treatments Record (Flowsheet)' 'Policy' (3) (a) "The licensed nurse ...will review the patients data via the submitted Daily Home Treatment Records." (d) "The licensed nurse is responsible for end of month review for all Daily Home Treatment Records ...."
A review of patient medical records was completed on July 9, 2025 at approximately 3:00 p.m. Patients date of admit is included below.
MR#1, Date of admit 08/08/22: Physician 'Medication Order' (Active) "Heparin Pork (At home), Loading dose 3,000 units, every dialysis treatment, intravenous, flush." Start Date: 10/02/22. Patient treatment flowsheets were reviewed from 04/10/25 - 6/23/25. 'Prescription' section includes but is not limited to "Heparin Dose: 4,000 units." 'Medication' administration section blank with no entries.
A telephone interview was conducted on 07/09/25 at approximately 2:00 p.m. with the facility home hemodialysis registered nurse.(employee #7). Employee #7 stated the error 4,000 units of heparin listed on the treatment flowsheet was overlooked during treatment flow sheet reviews. When documentation was requested of the patient being educated on completing the 'Medication' administration section of the treatment flowsheet, no documentation was provided.
An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.
Plan of Correction:V715
A Governing Body meeting with the Medical Director, Facility Administrator, Nursing Manager and Regional Operations Director was held to review the results of the survey ending on 7/10/25. The Governing Body reviewed Policy COMP-DD-017 Medical Director Qualifications and Responsibilities. The Medical Director acknowledges that he/she is responsible to ensure the facility teammates are trained, follow policy and procedure, and deficiencies identified need to be corrected timely with the support of the facility team. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance. The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 7/16/25. Surveyor observations were reviewed. Education included a review of 1) Policy 5-02-08 Initial Patient Nursing Assessment for New Peritoneal Dialysis Patients emphasizing a registered nurse (RN) as required by federal regulation will perform an initial pretreatment evaluation of all peritoneal dialysis (PD) patients prior to the initiation of their first treatment/training at the facility. This initial pre-treatment evaluation will be documented in the electronic health record as the Initial Patient Nursing Assessment - PD. 2) Policy 12-13-11 NxStage System Maintenance Log Policy emphasizing (a) The NxStage System Maintenance Log is used by the patient to document manufacturer's recommended maintenance performed on the NxStage Cycler and Pure Flow. (b) The log is maintained by the patient and reviewed monthly by a home hemodialysis Registered Nurse. (c) The log includes i."Bleach Waste Line: The Bleach Waste Line procedure is completed at least weekly or as often as needed, when in use. ii. Verified by RN: An RN will verify that maintenance log is complete. 3) Policy 3-02-03 Physician Orders for Patient Care emphasizing to verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care. 4) Policy 12-01-41 Daily Home Treatments Record (Flowsheet) emphasizing i. The licensed nurse ...will review the patient's data via the submitted Daily Home Treatment Records. ii. The licensed nurse is responsible for end of month review for all Daily Home Treatment Records. 4) The licensed nurse will re-educate patient on ensuring all sections of the flowsheet must be completed and the education will be documented by the license nurse in the medical record.
The Facility Administrator or designee will conduct audits weekly for four (4) weeks then monthly on ten percent (10%) of the medical records during monthly medical records review to verify complete and accurate documentation is in place and nurse intervention when needed is documented. Instances of non-compliance will be addressed immediately. The review will include dialysis machine maintenance logs, and medication administration. In addition, the Facility Administrator or designee will audit all new admissions for Initials Nursing Assessment monthly for three (3) months to verify assessment are completed fully and accurately prior to the first training at the facility. Instances of non-compliance will be addressed immediately.
The Medical Director will review progress of teammate education, results of audits, and adherence to this plan of correction during monthly Quality Assessment and Performance Improvement meetings known as Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed if applicable to achieve sustained compliance. Supporting documentation will be included in the meeting minutes. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.
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 a review of facility policy, inspection of emergency evacuation kit contents, and an interview with the facility Administrator, facility failed to ensure patient records were safeguarded against unauthorized use for one (1) out of one (1) emergency evacuation kit inspections (Inspection #1).
Findings:
A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. 'Facility Emergency Management Plan (ICHD, Home)' 'Emergency Evacuation Kit' section (6) "Each evacuation kit/s should contain: (a) Copy of each patients treatment orders and medication list. FA or designee will verify patient information is updated and replaced at least monthly. (8) "Evacuation Kit will be sealed with a break away lock ..."
An inspection of the facility emergency evacuation kit on 07/09/25 at approximately 11:00 a.m. revealed the following:
Inspection #1: The emergency evacuation kit (wheeled cart) was observed next to the nursing station/treatment room area entry/exit door to the patient waiting room. The 'Patient Summary Reports' log was marked accordingly and was sitting on top of the wheeled cart, unsecured with easy access. The contents of the log (Patient Summary reports) contain confidential patient information which includes but is not limited to patient patient phone number, dialysis start dates, allergies, health diagnosis, dialysis access, and dialysis treatment orders.
The log did not contain Patient Summary reports for all facility patients. No home hemodialysis patients were in the log (seven patients, patients #1, #5, #7, #9 - #12) and two peritoneal dialysis patients (patient #3, patient #8) were not in the log.
An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.
Plan of Correction:V0727 The Facility Administrator or designee held a mandatory in-service for all clinical teammates starting 07/16/2025. Surveyor observations reviewed. Education included a review of A. Policy 4-07-01 Facility Emergency Management Plan emphasizing 1) Each facility will maintain an evacuation kit(s) with specified patient care supplies for use in case of an emergency evacuation. 2) The evacuation kit(s) will be maintained in a central location, such as the nurses' station and clearly labeled "Evacuation Kit". 3) Each evacuation kit(s) should contain: a copy of each patient's treatment orders and medication list. FA or designee will verify patient information is updated and replaced at least monthly.... Evacuation kit will be sealed with a breakaway lock and is only to be opened in the event of an emergency situation, monthly review, and/or the replacement of an outdated item. B. Policy 3-02-01 Medical Record Custodian and Maintenance emphasizing the responsibilities
of the Custodian of medical records include... Verifies that all medical records are stored in a safe manner to protect against loss, destruction or unauthorized use. Verification of attendance at in-service is evidenced by teammate signature on sign-in sheet. The Facility Administrator or designee will perform observational audits weekly for four (4) weeks then monthly for two (2) months to verify the Emergency Evacuation Kit contains a complete and accurate list of all current patient within the kit, kit is locked and in a secure area. Instances of non-compliance will be addressed immediately, The Facility Administrator or designee will review results of the audits with the Medical Director during monthly Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes.
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