Initial Comments:
Based on the findings of an on-site unannounced Medicare recertification survey conducted on August 4, 2025, through August 5, 2025, and August 7, 2025, and concluded off-site on August 14, 2025, Dialyze Direct PA LLC was found not 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:
494.62(d)(3) STANDARD
ESRD Patient Orientation Training
Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.
Observations:
Based on review of dialysis facility policy, medical records (MR), and interview with the dialysis facility Area Manager, the dialysis facility staff failed to document that patients received initial and/or quarterly fire safety/emergency evacuation training per policy for six (6) of fifteen (15) MR reviewed. (MR # 6, 10, 11, 13, 14, and 15)
Findings include:
A request was made for a dialysis facility policy for patient emergency drill on August 7, 2025, at approximately 4:00 P.M. Policy #DD-EP-0902 titled "Emergency and Disaster Plan for the Dialysis Facility Creation and Implementation Policy" was provided on August 13, 2025, at approximately 5:23 P.M. The policy, which was reviewed on August 14, 2025, at approximately 8:15 A.M., stated, "Preparedness During Normal Operations: Quarterly: 1. Conduct fire drills per policy. a. One drill for each shift of patients b. Include patient emergency takeoff and evacuation procedures c. Document training for both employees and patients."
Review of MR conducted on August 4, 2025, from approximately 3:00 P.M. to 4:00 P.M., August 5, 2025, from approximately 9:00 A.M. to 4:00 P.M., and August 7, 2025, from approximately 2:00 P.M. to 4:00 P.M., revealed the following:
MR #6, start of treatment at Skilled Nursing Facility #15: Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468, on October 27, 2023, contained documentation of a quarterly fire drill on April 25, 2025. There was no documentation provided of intitial emergency training and quarterly fire drills.
MR #10, start of treatment at Skilled Nursing Facility #10: Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136 on March 6, 2025, contained no documentation of a quarterly fire drills for the second quarter of 2025.
MR #11, start of treatment at Skilled Nursing Facility #11: Liberty Pointe Rehabilitation & Healthcare Center: 252 Belmont Avenue, Doylestown, PA 18901 on March 12, 2025, contained no documentation of initial emergency training.
MR #13, start of treatment at Skilled Nursing Facility #17: Restore Health At University City: 3609 Chestnut Street, Philadelphia, PA on December 22, 2023, contained no documentation of a fire drill on July 31, 2025. There was no documentation of initial emergency training and quarterly fire drills.
MR #14, start of treatment at Skilled Nursing Facility #18: St. Francis Center for Rehabilitation and Healthcare: 1412 Lansdowne Avenue, Darby, PA 19023 on April 6, 2023, contained documentation of a fire drill on August 1, 2025. There was no documentation of initial emergency training and quarterly fire drills.
MR #15, start of treatment at Skilled Nursing Facility #8: Greenery Center for Rehab and Nursing: 2200 Hill Church-Houston Road, Canonsburg, PA 15317 on December 20, 2024, contained documentation of a fire drill on July 25, 2025. There was no documentation of an initial emergency training or quarterly fire drills.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings,
Plan of Correction:Beginning the week of 9/1/25 Regional Director (RD) or designee will conduct staff education on the document entitled #DD-EP-0902 titled "Emergency and Disaster Plan for the Dialysis Facility Creation and Implementation Policy. Staff will be educated on the need to complete this upon admission and then Quarterly moving forward. The RD or designee will conduct an audit on 100% of current patients using the Medical Records audit tool to ensure that they have this education completed and the documentation is up to date.
Going forward, all newly admitted patients records will be monitored monthly by the Regional Director or designee using the Medical Records audit tool to ensure all have received their initial patient emergency drill instruction and it has been appropriately documented. Moving forward we will also monitor all patients quarterly fire drills by utilizing the Medical Records audit tool to audit 10% of all patient records at each location to ensure that a quarterly fire drill was appropriately documented.
Results of the audits will be presented to the QAPI committee for review and determination for the frequency of observation going forward to prevent reoccurrence.
Initial Comments:
Based on the findings of an on-site unannounced Medicare recertification survey conducted on August 4, 2025, through August 5, 2025, and August 7, 2025, and concluded off-site on August 14, 2025, Dialyze Direct PA LLC 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on review of facility policy, observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens, and interview with the Area Manager, the facility failed to ensure facility staff members maintained a clean treatment area for two (2) of four(4) OBS. (OBS # 1 and 2)
Findings include:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
Policy regarding cleaning of medication refrigerator was request on August 4, 2025, at approximately 2:00 P.M. The Area Manager stated that there is no policy for cleaning the medication refrigerators.
OBS #1 at SNF #15 on August 4, 2025, at approximately 12:00 P.M., the medication refrigerator was observed to have stains, debris and dust in the door and on the bottom of the refrigerator.
OBS #2 at SNF #7 on August 4, 2025, at approximately 11:00 A.M. revealed thirty-one (31) BD Safety Glide 21 G x 1 1/2 TW needles that expired on April 30, 2025, two (2) 28 G x 1/2 inch Tuberculin syringes that expired May 7, 2025, eight (8) 10 ml bottles of sterile water for injection that expired May 1, 2025, and seventeen (17) 10 ml bottles of sterile water for injection that expired on January 1, 2025.
An interview with the facility Area Manger and the Chief Nursing Officer on August 7, 2025 at approximately 4:30 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/1/2025 the Regional Director or designee will provide education to all staff on policy DDCS0511 MEDICATION PREPARATION AND ADMINISTRATION POLICY. This will highlight the importance of conducting the monthly inspections and discarding expired medications and supplies, as well as the importance of keeping medication refrigerators clean of stains and dust.
To ensure the effectiveness of the education, the nurse manager or designee will perform Infection Control observation audits weekly x 2 or until 100% compliance is maintained. Audits will continue on a monthly basis thereafter to ensure ongoing compliance.
Audit findings will be reviewed with the QAPI committee to determine if the plan requires revision or additional staff education and monitoring.
494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on review of facility policy, observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens, and staff interviews, the facility failed to ensure staff members wore the required personal protective equipment (PPE) to protect themselves when performing procedures during which spurting and spattering of blood might occur for two (2) of twenty-three (23) OBS during the provision of care in the dialysis clinical area. (OBS #19 and 21)
Findings include:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
Review of facility policy #DD-IC-10643 titled "Infection Prevention and Control Policy and Practices" on August 14, 2025, at approximately 8:00 A.M. stated, "Policy: Staff shall wear gowns, face shield, eye wear or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur..."
OBS at facility #10 on August 5, 2025, revealed the following:
OBS #19, at 10:00 A.M., EMP #1 (RN) was observed attending to patients at stations #1, 2, 3, and 4 without wearing the required PPE (gown).
OBS #21, at 10:50 A.M., EMP #2 (PCT) was observed entering station #4 without the required PPD (gown). EMP #2 was reminded by EMP #1 to don a gown.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/1/25 Regional Director or designee will conduct Staff education on DD-CS-0085 "Personal Protective Equipment PPE Policy".
To monitor compliance and prevent recurrence, the Regional Director or designee will complete Infection Control observation audits at each SNF location weekly x 2 weeks or until 100% compliance is achieved, then biweekly. Once compliance is achieved, infection control audits will be conducted monthly thereafter to prevent recurrence.
Results of the audits will be presented to the QAPI committee for review to determine if additional monitoring or corrective actions are required.
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on review of facility policy, observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens, and staff interviews, the facility failed to ensure the staff follow infection control protocols for cleaning and disinfecting dialysis equipment between patients for three (3) of twenty-three (23) OBS. (OBS #9 at SNF #7, OBS #16 and 17 at SNF #12)
Findings include:
OBS were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
Review of facility policy #DD-IC-0071 titled " Cleaning and Disinfection of Medical Devices and Equipment Policy " on August 14, 2025, at approximately 8:45 A.M. stated, " Policy: Medical devices and equipment used for patient care shall be cleaned and disinfected after each patient use and at the end of the day.
Environmental surfaces to be clean and disinfected include:
Patient chair: chair should be fully reclined, and if equipped, the sides are to be opened in order to clean all potentially contaminated surfaces of the chair.
Surfaces of dialysis equipment ... "
OBS in the SNF dialysis treatment dens revealed the following:
OBS # 9 at SNF #7 on August 4, 2025, at 10:00 A.M., patient was discharged from the dialysis treatment area on the dialysis chair. There was no evidence or documentation that the chair was properly cleaned after patient use.
OBS # 16 at SNF #12 on August 4, 2025, at approximately 10:00 A.M. PCT #1 did not empty and disinfect the prime waste container after the patient was discharged.
OBS # 17, at SNF #12 on August 4, 2025, at approximately 10:15 A.M., patient was discharged from the dialysis treatment area on the dialysis chair. There was no evidence or documentation that the chair was properly cleaned after patient use.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 09/01/25 Regional Director or designee will conduct Staff education on policy DD-CS-047 Cleaning and Disinfection of Medical Devices and Equipment Policy. The SNF staff will be educated on disinfecting the dialysis chair and provided with a disinfection cloth to use after each patient. The dialysis staff will be educated on DD-IC-0071 titled " Cleaning and Disinfection of Medical Devices and Equipment Policy for proper disinfection of the machine side bucket.
To monitor compliance and prevent recurrence, the Regional Director or designee will complete Infection Control observation audits at each SNF location weekly x 2 weeks or until 100% compliance is achieved, then biweekly x 1 month. Once compliance is achieved, infection control audits will be continued monthly thereafter to prevent recurrence.
Results of the audits will be presented to the QAPI committee for review to determine if additional monitoring or corrective actions are required.
494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE
Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children
I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.
II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.
Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.
VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].
Observations:
Based on review of facility policy, observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens, and interview with the Area Manager, the facility failed to ensure staff disinfected the catheter hubs for the appropriate amount of time (15 seconds or longer) while initiating and discontinuing treatment for one (1) of four (4) OBS of initiation and/or discontinuation of treatment with a CVC. (OBS #2)
Findings include:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
Review of policy: #DD-CS-10121-CENTRAL VENOUS CATHETER CARE POLICY, PROCEDURE on August 14, 2025, at approximately 8:50 A.M. stated, "Treatment Termination/Post Treatment: Procedure: Procedure: 2. Prior the end of treatment, Soak two 4x4 gauze pads in Alcavis. Scrub each catheter/line connection separately for 1 minute. Pads are then wrapped around the connection ports and allowed to soak for 3-5 minutes."
OBS #2 at SNF #15, on August 4, 2025, at 10:45 A.M., Station #2 by the door, RN #1 was observed discontinuing dialysis with the CVC catheter and did not scrub the line connections for one (1) minute, in accordance with facility policy.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/1/2025 Regional Director or designee will conduct Staff education on DD-CS-10121-CENTRAL VENOUS CATHETER CARE POLICY, PROCEDURE.
To monitor compliance and prevent recurrence, the Regional Director or designee will complete the Infection Control monthly observation audit at each SNF location weekly x 2, every 2 weeks x 2, monthly x 2. The Infection Control monthly observation audits will continue monthly thereafter.
Results of the audits will be presented to the QAPI committee for review to determine if additional monitoring or corrective actions are required.
494.40(a) STANDARD
RO-MEETS AAMI/MONITORED, RECORDED ON LOG
Name - Component - 00
5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log
Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2.
5.2.7 Reverse osmosis
Users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters.
6.2.7 Reverse osmosis
All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review.
Observations:
Based upon review of dialysis facility monitoring logs and interview with the Area Manager, the dialysis facility failed to show action taken for documented readings outside of acceptable parameters for twelve (12) of twelve (12) Skilled Nursing Facility (SNF) dialysis dens with R.O. (reverse osmosis) water systems. (SNF #3, 4, 6, 8, 9, 11, 12, 14, 15, 16, 19, and 21)
Findings include:
RO monitoring logs were reviewed for the following SNF dialysis dens on August 7, 2025, from approximately 11:00 A.M. to 2:00 P.M.:
SNF #3, Brighton Rehabilitation and Wellness Center, 246 Friendship Circle #9704, Beaver, PA 15009
SNF #4, Care Pavilion Nursing and Rehab, 6212 Walnut Street, Philadelphia, PA 19139
SNF #6, Chestnut Hill Lodge, 8833 Stenton Avenue, Wyndmoor, PA 19038
SNF #8, Greenery Center for Rehab and Nursing, 2200 Hill Church-Houston Road, Canonsburg, PA 15317
SNF #9, Harborview Rehabilitation and Care Center at Doylestown, 432 Maple Avenue, Doylestown, PA 18901
SNF #11, Liberty Pointe Rehabilitation & Healthcare Center, 252 Belmont Avenue, Doylestown, PA 18901
SNF #12, Markley Rehabilitation & Healthcare Center, 550 East Fornance Street, Norristown, PA 19401
SNF #14, Oxford Rehabilitation & Healthcare Center, 300 E Winchester Avenue, Langhorne, PA 19047
SNF #15, Parkhouse Nursing & Rehabilitation Center, 1600 Black Rock Road, Royersford, PA 19468
SNF #16, Providence Rehabilitation and Nursing Center, 600 South Wycombe Avenue, Yeadon, PA 19050
SNF #19, Statesman Health and Rehab, 2629 Trenton Road, Levittown, PA 19056
SNF #21, Valley Manor Health and Rehabilitation, 7650 Route 309, Coopersburg, PA 18036)
SNF #3, logs dated June 2, 2025, through August 1, 2025, did not contain a treatment end time for any of the dates in the time period. Without a treatment end time documented, compliance with the frequency of chlorine testing cannot be determined.
SNF #4, logs dated June 2, 2025, through August 1, 2025, only contained documentation of a treatment end time on June 6, 2025. The remainder of the dates in the time period did not contain a treatment end time. Without a treatment end time documented, compliance with the frequency of chlorine testing cannot be determined.
SNF #6, logs dated June 2, through August 2, 2025, for RO #1 did not contained documentation of treatment end times on June 11, 2025, and August 2, 2025. Logs for RO #2 dated June 30, through July 18, 2025, and July 28, through August 1, 2025, did not contain treatment end times on July 1, July 3, July 7, July 18, and August 1, 2025. Logs for RO #3 from June 16, 2025, through August 1, 2025, did not contain treatment end times on July 4, July 25, and August 1, 2025. There was no documentation of feed conductivity June 23, through June 27, 2025. There was no rejection percentage documented June 16, through June 27, and July 9, through July 18, 2025.
SNF #8, logs dated June 2, 2025, through July 30, 2025, for RO #1 contained the following readings outside the identified parameters for all of the dates in the time period:
Filter Inlet Pressure (20-40 psi) readings 46 to 54 psi, Filter Outlet Pressure (10-40 psi) readings 46 to 52 psi, Pump Outlet Pressure (90-150 psi) readings 200 to 210 psi, Product Outlet Pressure (0-70 psi) readings 92 to 96 psi.
RO #1 contained the following readings outside the identified parameters for all of the dates in the time period:
Filter Inlet Pressure (20-40 psi) readings 50 to 54 psi, Filter Outlet Pressure (10-40 psi) readings 46 to 52 psi, Pump Outlet Pressure (90-150 psi) readings 170 psi, Product Outlet Pressure (0-70 psi) readings 80 to 84 psi.
RO #1 contained the following readings outside the identified parameters for all of the dates in the time period:
Filter Inlet Pressure (20-40 psi) readings 54 to 60 psi, Filter Outlet Pressure (10-40 psi) readings 48 to 58 psi, Product Outlet Pressure (0-70 psi) readings 82 to 92 psi.
Chlorine testing was only conducted at 8:25 A.M. on July 13, 2025. There was no documentation that the dialysis den closed early.
SNF #9, review of logs dated June 2, through August 1, 2025, for RO #2 contained no chlorine testing after 10:00 A.M. on June 11, 2025. There is no documentation of treatment ending time.
SNF #11, review of logs dated June 2, through August 1, 2025, contained no treatment end times on June 23, through June 27, 2025. The end time on July 4, 2025 is illegible and there was no chlorine testing completed after 1:35 P.M. The treatment end time was documented as 6:00 P.M. on July 14, 2025. There was no chlorine testing documented after 1:35 P.M. The treatment end time was documented as 6:00 P.M. on July 25, 2025. There was no chlorine testing documented after 1:35 P.M.
SNF #12, review of logs dated June 2, through August 1, 2025, contained no documentation of treatment end times for RO #1 on June 4, June 18, June 20, June 27, and July 2, 2025. There was no documentation of chlorine testing on RO #1 after 10:00 A.M. on June 4, 2025. The treatment end time was documented as 11:00 A.M. on June 6, 2025, with the last chlorine testing documented at 6:00 A.M. The treatment end time was documented as 12:00 P.M. on June 6, 2025, with the last chlorine testing documented at 6:00 A.M.
There was no documentation of treatment end times for RO #2 on June 2, through June 6, 2025. Only one log was identified as RO #2. There were six (6) additional logs that did not identify the RO number. One (1) log for RO #3 dated July 28, 2025 listed a start time of 5:30 A.M. with no chlorine testing documented until 11:00 A.M. There was no treatment end time listed. There were multiple missing end times and only initial chlorine testing documented on the logs that do not identify the RO machine.
SNF #14, review of logs dated June 2, 2025, through August 1, 2025, contained no documentation of treatment end times for RO #1 on June 23, through July 2, 2025. There was no documentation of treatment end times for RO #2 on June 23, through June 30, 2025. There was no documentation of chlorine testing on July 25, 2025, prior to 11:00 A.M. The testing start time was documented as 7:45 A.M.
SNF #15, review of logs dated June 2, 2025, through August 1, 2025, contained no documentation of staff initials for chlorine testing conducted at 2:40 P.M. on July 20, 2025, on RO #1. There was no documentation of staff initials for chlorine testing on June 9, 2025, at 6:45 P.M. and June 11, 2025, at 4:40 P.M. and July 28, 2025, at 2:40 P.M. on RO #2. There was no chlorine testing documented after 2:40 P.M. on July 28, 2025, with a treatment end time documented as 5:30 P.M. and on July 30, 2025, after 10:45 A.M. with a treatment end time documented as 4:20 P.M. There was no documentation of staff initials for chlorine testing on July 28, 2025, at 2:40 P.M.
SNF #16, review of logs dated June 2, 2025, through August 1, 2025, contained no documentation of staff initials for chlorine testing on June 2, 2025, at 5:30 P.M. There was no chlorine testing documented after 12:00 P.M. on June 30, 2025. Treatment end time was documented at 4:30 P.M. No treatment end time was documented on June 23, 2025. No RO machine number was documented.
SNF #19, review of logs dated June 2, 2025, through August 1, 2025, contained documentation of a rejection percentage of 72 percent. The maximum allowable rejection percentage in 90 percent. There is no documentation of reporting of the abnormal reading.
SNF #21, review of logs dated June 2, 2025, through August 1, 2025, contained no documentation of treatment end times for RO #3 from June 9, through June 20, and June 27, through July 25, 2025. Chlorine testing results for RO #3 was not documented on June 16, 2025, at 6:00 P.M., June 18, 2025, at 3:30 P.M., June 20, 2025, at 5:30 P.M., June 23, 2025, at 6:00 P.M., June 25, 2025, at 4:30 P.M., July 7, 2025, at 5:50 P.M., July 9, 2025, at 6:00 P.M., July 11, 2025, at 6:00 P.M., July 14, 2025, at 6:00 P.M., July 16, 2025, at 6:34 P.M., July 18, 2025, at 6:00 P.M., and July 21, 2025, at 6:00 P.M.
Treatment end times were not documented for RO #4 on June 9, through June 20, June 27, July 2, and July 7, through July 18, 2025. There was no documentation of chlorine testing completed on June 13, 2025, after 6:00 A.M., July 1, 2025, at 5:50 P.M., July 11, 2025, at 6:00 P.M., July 14, July 16, and July 18, 2025, at 6:00 P.M., July 21, 2025, at 6:00 P.M. No staff initials were documented on July 23, and July 25, 2025, at 6:00 P.M.
None of the abnormal findings listed were documented as reported to the administrative staff or the biomedical company. There was no documentation of the abnormal findings in the monthly QAPI meeting minutes.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/01/2025 the Regional Director or designee will provide an in-service to all staff on proper completion of the RO log. This will also include reeducation on the proper procedure to follow if any readings are found to be outside of the normal limits.
To monitor compliance and prevent recurrence the Regional Director or designee will audit the daily RO logs weekly x 4 weeks or until 100% compliance is achieved. The audits will then be completed monthly as long as 100% compliance is maintained. The daily RO logs will be scanned or faxed to the Regional Director or designee weekly for review and will be retained electronically for permanent record.
All audit results will be reviewed by the QAPI committee monthly to determine if additional monitoring or corrective actions are required
494.60(c)(1) STANDARD
PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE
Name - Component - 00
The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff.
Observations:
Based on observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens and an interview with the Area Manager, it was determined the facility failed to ensure adequate space for provision of care for two (2) of four (4) OBS. (OBS #1 and 4)
Findings include:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
OBS #1 at SNF #15 on August 4, 2025, at approximately 9:30 A.M. revealed inadequate space between dialysis treatment chairs to allow for caregivers to provide emergency treatment, including but not limited to, CPR, use of emergency equipment, stretchers, and EMS personnel.
Observation #4 at SNF #10 on August 5, 2025, at approximately 10:48 A.M. PCT #1 placed an office chair in front of the fire exit. At 11:00 A.M. the chair was moved back out from the desk and was blocking the fire exit.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/1/2025 staff will be educated to maintain the proper amount of space in between dialysis chairs to allow caregivers to provide emergency treatment, including but not limited to, CPR, use of emergency equipment, stretchers, and EMS personnel. The machines will remain next to the R.O.'s and the chairs on the outside to provide this room. Staff will also be educated to move any furniture away from the exit doors to block any fire exits.
To monitor compliance and prevent recurrence, the Regional Director or designee will complete the Physical Environmental Monthly observation audit at each SNF location weekly x 2, every 2 weeks x 2, monthly x 2. The Infection Control monthly observation audits will continue monthly thereafter.
Results of the audits will be presented to the QAPI committee for review to determine if additional monitoring or corrective actions are required.
494.60(c)(4) STANDARD
PE-HD PTS IN VIEW DURING TREATMENTS
Name - Component - 00
Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement).
Observations:
Based on a review of facility policy, observations at four (4) skilled nursing facility (SNF) dialysis dens, and an interview with the Area Manager, the facility failed to ensure the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment for three (3) of four (4) OBS (OBS #1, 2, and 3)
Findings include:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
Review of faciltiy policy #DD-CS-0153 titled 'Intradialytic Assessment and Monitoring Procedure' on August 7, 2025, at approximately 2:00 P.M. stated, "Procedure: The steps in this procedure shall be completed every half hour, unless more frequent monitoring is required due to the condition of the patient. The following machine parameters shall be checked: ... Visual check of patient's access (needles are visible and secure)..."
OBS #1 at SNF #15 on August 4, 2025, at approximately 10:35 A.M., station #2, the patient's access was covered with a blanket and not visible.
OBS #2 at SNF #7 on August 4, 2025, at approximately 9:30 A.M., station #1, 2, and 3, the patient's access was covered with a blanket and not visible.
OBS #3 at SNF #12 on August 4, 2025, at approximately 9:25 A.M., station #1 and 3 the patient's access was covered with a blanket and not visible.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/1/2025, the Regional Director or designee will conduct Staff education on Policy DD-CS-0153 Intradialytic Assessment and Monitoring Procedure.
To ensure compliance, the Area Manager or designee will perform Patient Safety audits weekly for 2 weeks. If 100% compliance is achieved, the audits will be complete biweekly x 2. If 100% compliance is maintained, audits will be completed monthly going forward.
Audit findings will be reviewed with the QAPI committee to determine if additional staff training or increased frequency of monitoring is indicated.
494.70 STANDARD
PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX
Name - Component - 00
The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights.
Observations:
Based on review of medical records (MR) and interview with Area Manager, the facility failed to obtain written consent for treatment from the patient for two (2) of fifteen (15) MR reviewed. (MR #7 and 9)
Findings include:
Review of MR conducted on August 4, 2025, from approximately 3:00 P.M. to 4:00 P.M., August 5, 2025, from approximately 9:00 A.M. to 4:00 P.M., and August 7, 2025, from approximately 2:00 P.M. to 4:00 P.M., revealed the following:
MR #7, start of treatment April 14, 2025, contained a 'Patient Informed Consent for Hemodialysis' documenting "Pt is unable to sign, [patient] agreed verbally. Pt is oriented x 3". The document contains a signature of a witness that is not legible, and is dated 4/14/25. The document is signed by the nephrologist with no date noted. A 'Refusal of Care Against Medical Advice' notes that the "pt. is unable to sign" and is witnessed by the same person, dated 4/14/25. Additional documents are only noted as "pt is unable to sign" with no witness documented. The documents are 'Acknowledgement of Receipt of Notice of Privacy Practices', 'Patient Acknowledgement of Receipt of Notice of Patient Rights and Responsibilities', 'Acknowledgement of Receipt of Patient Welcome Packet', and 'Assignment of Benefits'.
MR #9, start of treatment May 14, 2025, contained a 'Patient Informed Consent for Hemodialysis' documenting "phone consent from spouse." There is no documentation in the MR that the spouse is the patient's power of attorney.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:On or before 9/25/2025, the Informed Consent policy will be reviewed and revised as deemed necessary by Dialyze Direct corporate legal counsel. The revised policy will be adopted by the Governing Body, and education regarding the revised policy and procedure will be provided by the Regional Director or designee to all attending nephrologists and direct patient care personnel by 9/30/2025.
All newly admitted patient's records will be monitored by the Regional Director or designee using the Medical Records audit tool to ensure all have met the standards of the revised Informed Consent Policy. Moving forward we will monitor all patient admission records by utilizing the Medical Records audit tool to audit 10% of all patient records at each location to ensure that the admission consent documentation was appropriately documented.
Results of the audits will be presented to the QAPI committee for review and determination for the frequency of observation going forward to prevent reoccurrence.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on reivew of policy/procedure, medical records and interview with clinical staff the clinic failed to ensure the nurse was notified of weight gains greater than 2.5 kg prior to initiation of treatment for five (5) of fifteen (15) records reviewed. MR #10, 11, 12, 14 & 15.
Findings include:
Review of policy; #DD-CS-1123, "Clinical Parameters for notification of the Registered Nurse policy, procedure., section: Policy: 5. "patient data reportable to the licensed registered nurse prior to initiation of treatment may include the following: Weight > or equal to 2.5 kg weight gain from previous treatment".
Review of MR conducted on August 4, 2025, from approximately 3:00 P.M. to 4:00 P.M., August 5, 2025, from approximately 9:00 A.M. to 4:00 P.M., and August 7, 2025, from approximately 2:00 P.M. to 4:00 P.M., revealed the following:
MR # 10, admit date: 3/6/25, Physician ordered Estimated dry weight EDW: 80kg; Treatment record dated 7/22/25 shows a pre-wt. of 94kg a gain of 5 kg from the previous treatment and a gain of 14 kg from the EDW. Documentation reads, "Nurse reviewed goal, cycler settings verified, Tx stated without complication".
Treatment record dated: 7/25/25 shows a pre-wt. of 93.3 kg a gain of 1 kg from the previous treatment and a gain of 13.3 kg from the EDW. Documentation reads, "Nurse reviewed goal, cycler settings verified, Tx stated without complication".
MR #11, admit date: 3/12/25, Physician ordered EDW: 64 kg;
Treatment record dated 8/1/25 showed a pre-wt of 66.4 kg a gain of 1 kg from the previous treatment and a gain of 6.4 kg from the EDW. Documentation reads, "Nurse reviewed goal, cycler settings verified, Tx stated without complication".
MR#12, admit date: 11/21/2024, Physician ordered EDW: 63.5 kg.
Treatment record dated 7/21/25 showed a pre-wt. of 84.6 kg a gain of 20.3 kg from the previous treatment date. Documentation read, "Treatment parameters confirmed Tx started without complication,".
Treatment record dated 7/32/25 showed a pre-wt of 71.6 kg a loss of 11.8 kg from the previous treatment date. Documentation read, "Treatment parameters confirmed Tx started without complication,".
MR #14, admit date: 4/6/2023 Physician ordered EDW: 149.5 kg.
Treatment record dated 7/21/25 showed a pre-wt. of 143.1 kg a loss of 8.4 kg from the previous treatment. No documentation of nurse being notified prior to start of treatment. Documentation read,"Tx started without complication".
Treatment record dated 7/22/25 showed a pre-wt of 154.2 kg a gain of 12.1 kg from the previous treatment. Documentation read,"Tx started without complication".
MR #15, admit date: 12/20/2004 Physician ordered EDW: 88 kg.
Treatment record dated 7/21/25 showed a pre-wt of 94.7 kg a gain of 3.5 kg from the previous treatment. Documentation read,"Tx started without complication."
Treatment record dated 7/25/25 showed a pre-wt of 94.2 kg a gain of 4.8 kg from the previous treatment. Documentation read,"Tx started without complication."
Plan of Correction:Beginning the week of 9/1/25, the Regional Director or designee will provide in-service education to the clinical staff to review DD-CS-1123, Clinical Parameters for Notification of the Registered Nurse.
To monitor compliance and prevent recurrence a medical records audit of 10% or a minimum of 5 of all weekly treatment records will be reviewed to ensure adherence to these policies. Audits will be conducted weekly x4 or until 100% compliance is achieved and then 10% or a minimum of 5 of records will be reviewed monthly x2 utilizing a medical records audit tool. To ensure ongoing compliance, an audit of 10% of randomly selected current patient medical records will be conducted quarterly for a period of 1 year.
.
Audit findings will be presented to the QAPI committee for review and to determine if additional monitoring or corrective actions are required.
494.180(b)(1) STANDARD
GOV-STAFF # & RATIO MEET PT NEEDS
Name - Component - 00
The governing body or designated person responsible must ensure that-
(1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients;
Observations:
Based on observation at skilled nursing facility (SNF) dialysis dens, and interview with the Area Manger, the facility failed to ensure an adequate number of qualified personnel available to meets the needs of patients one (1) of four (4) SNF dialysis den OBS. (OBS #1)
Findings included:
Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens:
SNF #7, Garden Spring Center: 1113 Easton Road, Willow Grove, PA 19341
SNF #10, Immaculate Mary Center for Rehabilitation & Healthcare: 2990 Holme Avenue, Philadelphia, PA 19136
SNF #12, Markley Rehabilitation & Healthcare Center: 550 East Fornance Street, Norristown, PA 19401
SNF #15, Parkhouse Nursing & Rehabilitation Center: 1600 Black Rock Road, Royersford, PA 19468
OBS #1 at SNF #15 on August 4, 2025, at approximately 9:30 A.M. to 12:00 P.M. revealed three (3) patient rooms with two (2) dialysis stations in each room. Two (2) of the rooms are connected by a bathroom accessible from both sides. The third room is separate. There was one (1) registered nurse and two (2) patient care technicians covering the three (3) rooms, which did not allow for the registered nurse to visualize all patients at all times. The medication room and laboratory area is located in another hallway, which requires staff to leave patients unattended.
An interview with the dialysis facility Area Manger and the Chief Nursing Officer on August 7, 2025, at approximately 4:45 P.M. confirmed the above findings.
Plan of Correction:Beginning the week of 9/8/2025 the staffing ratio will increase to include 1 PCT for each room patients are being dialyzed in. This will allow for an adequate number of qualified personnel to be present whenever patients are undergoing dialysis. This will allow qualified personnel to visualize all patients at all times.
To ensure compliance, the Area Manager or designee will perform Patient Safety audits weekly for 2 weeks. If 100% compliance is achieved, the audits will be complete biweekly x 2. If 100% compliance is maintained, audits will be completed monthly going forward.
Audit findings will be reviewed with the QAPI committee to determine if additional staff training or increased frequency of monitoring is indicated.
|