Dialyze Direct Pa

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 37972 Based on review of facility policies, documentation of missed and shortened treatments, hemodialysis (HD) treatment records and an interview with the Regional Manager, the facility staff failed to follow the prescribed plan of treatment and document the reason why treatments were terminated prior to the time prescribed by the physician for five (5) of sixteen (16) shortened treatments. Findings: A review of facility policy #DDCS9992 titled “Initiation/Monitoring/Termination of HD Treatment Using the Fresenius 2008 Series or Baxter Phoenix Dialysis Machines” on July 1, 2025, at approximately 10:30 A.M. states, “Monitoring: Termination: 1. Unless there are extenuating circumstances, the dialysis treatment is not ended until the prescribed treatment goals have been reached... 4. Document discontinuation of treatment and vital signs in EMR... 11. “Record all post treatment patient information in the patient medical record (EMR)...” Review of missed and shortened treatments from March 1, 2025, through June 26, 2025, on July 1, 2025, at approximately 8:15 A.M. revealed the following: There were three (3) dates that treatments were rescheduled due to staffing issues, March 31, 2025, May 2, 2025, and May 30, 2025. All patients affected by the closings were given the opportunity to reschedule. Review of treatment records and missed visits conducted on July 1, 2025, at approximately 9:30 A.M. and July 3, 2025, at approximately revealed the following: Clinical record #1 contained a ‘Dialysis Prescription’ dated March 10, 2025, listed the modality as Hemodialysis - NxStage, Dialysis Frequency 5 (5x per week), treatment duration 2.84 hrs - 12hrs 50 min. Review of the treatment summary from March 3, 2025, through June 20, 2025, revealed there were 80 scheduled treatments. CR #1 completed 74 treatments. Treatments were refused on March 27, 2025, April 2, 2025, April 5, 2025, April 17, 2025, May 3, 2025, and May 15, 2025. Five (5) of sixteen (16) shortened treatments did not contain documentation of a reason for the shortened treatment. March 14, 2025, regular start time, ended 20 minutes early, no reason documented March 24, 2025, ended 51 minutes early, no reason documented April 1, 2025, treatment started late, ended 20 minutes early, no reason documented April 25, 2025, no documentation of reason why treatment ended 11 minutes early June 2, 2025, late start due to staffing, treatment ended 18 minutes early, no reason documented. Email communication with the Regional Manager on July 3, 2025, confirmed the above findings.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 37972 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 followed infection control protocols during the initiation of dialysis with a CVC (central venous catheter) for one (1) of three(3) OBS (OBS #19 at SNF #22); during the discontinuation of dialysis with a CVC for four (4) of four (4) OBS (OBS #1 at SNF #14, #16, 17, and 18 at SNF #22); and during discontinuation of dialysis with an AV fistula or graft for one (1) of four (4) OBS (OBS #9 at SNF #14). Findings included: Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens: SNF #12, Maybrook Hills Rehabilitation and Healthcare Center, 301 Valley View Blvd., Altoona, PA 16602 SNF #14, Providence Rehabilitation and Nursing Center, 600 S. Wycombe Avenue, Yeadon, PA 19050 SNF #16, Roosevelt Rehabilitation Center, 7800 Bustleton Avenue, Philadelphia, PA 19152 SNF #22, Valley Manor Health and Rehabilitation, 7650 PA-309, Coopersburg, PA 18036 Review of Policy # DDCS0319 titled “Gloves Policy” on August 16, 2024, at approximately 1:45 P.M. stated, “Policy: Gloves shall be changed: When soiled (i.e., with blood, dialysate or other body fluids). When going from a “dirty” area or task to a “clean” area or task... When moving from a contaminated body site to a clean body site of the same patient... After touching one patient or his/her machine and before arriving to care for another patient or touch another patient’s machine...” Review of Policy # DDCS0419 titled “Infection Prevention and Control Policies and Practices” on August 16, 2024, at appro”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) 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. This Standard is not met as evidenced by: 37972 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-four (24) OBS during the provision of care in the dialysis clinical area. (OBS #22 and 24) Findings included: Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens: SNF #12, Maybrook Hills Rehabilitation and Healthcare Center, 301 Valley View Blvd., Altoona, PA 16602 SNF #14, Providence Rehabilitation and Nursing Center, 600 S. Wycombe Avenue, Yeadon, PA 19050 SNF #16, Roosevelt Rehabilitation Center, 7800 Bustleton Avenue, Philadelphia, PA 19152 SNF #22, Valley Manor Health and Rehabilitation, 7650 PA-309, Coopersburg, PA 18036 Review of facility policy #DDCS0419 titled “Infection Prevention and Control Policy and Practices” on August 16, 2024, at approximately 1:50 P.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 #12 on August 9, 2024, revealed the following: OBS #22, at 10:59 A.M., at station #5, EMP #1 (RN) was observed attending to patient #2’s dialysis access without wearing the required PPE (face shield). EMP #2 (PCT) was observed attending to patient #2’s dialysis access wearing regular glasses with a half shield attached. OBS #24, at 1:20 P.M., at”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 37972 Based on observations (OBS) at four (4) skilled nursing facility (SNF) dialysis dens and staff interviews, the facility failed to ensure clean areas were separated from contaminated areas, and that unused supplies and patient care items were stored in a clean area for one (1) of four (4) OBS. (OBS #3) Findings included: Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens: SNF #12, Maybrook Hills Rehabilitation and Healthcare Center, 301 Valley View Blvd., Altoona, PA 16602 SNF #14, Providence Rehabilitation and Nursing Center, 600 S. Wycombe Avenue, Yeadon, PA 19050 SNF #16, Roosevelt Rehabilitation Center, 7800 Bustleton Avenue, Philadelphia, PA 19152 SNF #22, Valley Manor Health and Rehabilitation, 7650 PA-309, Coopersburg, PA 18036 OBS #3 on August 7, 2024, at 9:20 A.M. in SNF #22, Dialysis Den #1, revealed an area on the right side of the Dialysis Den that appeared to be a closet with no doors or coverings. The area contained stacked boxes of supplies that were directly on the floor. A patient was receiving a dialysis treatment directly next to the closet area. The patient was lying in the dialysis chair with their face less than one (1) foot from the stack of boxes. The patient was not wearing a face mask at the time of the observation. An interview with the Nephrology Clinical Specialist on August 7, 2024, at 9:30 A.M. revealed that skids were ordered for the supply areas. The skids had arrived but had not been placed in all of the supply areas. An interview with the Administrator, on August 14, 2024 at approximately 3:00 P.M. and a follow-up telephone call with the Administrator on August 15, 2”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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. This Standard is not met as evidenced by: 37972 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 six(6) of twenty-four (24) OBS. (OBS #2, 4, and 11 at SNF #14, OBS #14 at SNF #16, and OBS #16 and 17 at SNF #22) Findings Include: Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens: SNF #12, Maybrook Hills Rehabilitation and Healthcare Center, 301 Valley View Blvd., Altoona, PA 16602 SNF #14, Providence Rehabilitation and Nursing Center, 600 S. Wycombe Avenue, Yeadon, PA 19050 SNF #16, Roosevelt Rehabilitation Center, 7800 Bustleton Avenue, Philadelphia, PA 19152 SNF #22, Valley Manor Health and Rehabilitation, 7650 PA-309, Coopersburg, PA 18036 A review facility policy #DDCS047 titled, ‘Cleaning and Disinfection of Medical Devices and Equipment Policy” on August 16, 2024, at approximately 2:00 P.M. stated, “Policy: Environmental surfaces 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, surfaces of dialysis equipment, adjacent tables and work surfaces...” Observations in the SNF dialysis treatment dens revealed the following: OBS #2 at SNF #14 on August 5, 2024, at 9:55 A.M., Room 115, Bed #2. PCT #2 did not disinfect the blood pressure cuff, cuff tubing or bed remote. OBS # 4 at SNF #14 on August 5, 2024, at 10:50 A.M., Room 115, Bed #1. PCT #2 did not disinfect the blood pressure cuff, cuff tubing or bed”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 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. This Standard is not met as evidenced by: 37972 Based upon review of R.O. (reverse osmosis) water logs and staff interviews, the dialysis facility failed to show action taken for documented readings outside of acceptable parameters for seven (7) of thirteen (13) Skilled Nursing Facility (SNF) dialysis dens with R.O. water systems. (SNF #3 Care Pavilion Nursing and Rehab, 6212 Walnut Street, Philadelphia, PA 19139, SNF #4 Caring Heart Rehabilitation and Nursing Center, 6445 Germantown Avenue, Philadelphia, PA 19119, SNF #5 Chestnut Hill Lodge, 8833 Stenton Avenue, Glenside, PA 19038, SNF #7 Greenery Center for Rehab and Nursing, 2200 Hill Church Houston Road, Canonsburg, PA 16317, SNF #11 Liberty Pointe Rehabilitation & Health Center, 252 Belmont Avenue, Doylestown, PA 18901, SNF #13 Parkhouse Nursing and Rehabilitation Center, 1600 Black Rock Road, Royersford, PA 19468, and SNF #17 Statesman Health and Rehabilitation Center, 2629 Trenton Road, Levittown, PA 19056). Findings include: Review of daily R.O. logs dated June 1, 2024, through August 2, 2024, conducted on August 9, 2024, from approximately 8:00 A.M. to 2:00 P.M. revealed the following: Skilled Nursing Facility #3 Product (permeate) Conductivity acceptable range is listed as less than 30 µS (microsiemens). Documentation on “ MRO1 Portable RO (reverse osmosis) Daily Water Log “ for RO Machine #1 June 3, 5, 7, 10, 12, 14, 17, 19, and 21, 2024, and July 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, and 31, 2024, and August 2, 2024; RO Machine #2 June 3, 5, 7, 10, 12, 14, 17, 19, 21, 24, 26, and 28, 2024, July 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, and 31, 2024, and August 2, 2024; and RO Machine #3 June 3, 5, 7, 12, 14, 17, 19, 2024, July 17, 19, 22, 24,”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 37972 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 conducted conductivity testing of the dialysate prior to initiation of dialysis for two (2) of twenty-four (24) OBS. (OBS #6 and 7) Findings include: Observations were conducted at the following skilled nursing facility (SNF) dialysis treatment dens: SNF #12, Maybrook Hills Rehabilitation and Healthcare Center, 301 Valley View Blvd., Altoona, PA 16602 SNF #14, Providence Rehabilitation and Nursing Center, 600 S. Wycombe Avenue, Yeadon, PA 19050 SNF #16, Roosevelt Rehabilitation Center, 7800 Bustleton Avenue, Philadelphia, PA 19152 SNF #22, Valley Manor Health and Rehabilitation, 7650 PA-309, Coopersburg, PA 18036 Review of Policy # DDCS9980 titled “Dialysate Conductivity Testing Using The Myron L Conductivity Meter” on August 16, 2024, at approximately 2:15 P.M. stated, “Policy: The dialysate conductivity reading from the meter must be within +/- 0.5 mS (milliSiemens) of the dialysis machine reading. Any reading outside this range requires further investigation, and treatment may not be inititiated using the suspect machine...” Observations in the SNF dialysis treatment dens revealed the following: OBS #6, at SNF #14 on August 5, 2024, at 11:10 A.M. Room 115, Bed #1, PCT #2 initiated dialysis without testing the dialysate conductivity. OBS #7, at SNF #14 on August 5, 2024, at 11:20 A.M. Room 115, Bed #2, PCT #2 initiated dialysis without testing the dialysate conductivity. An interview with the Administrator, on August 14, 2024 at approximately 3:”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) 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; This Standard is not met as evidenced by: 37972 Based on review of dialysis facility policy, medical records (MR), and an interview with the Administrator, the dialysis facility failed to address the patient not meeting the prescribed dry weight (DW) for five (5) of twenty (20) MR reviewed. (MR #3, 4, 5, 11, and 14). The dialysis facility failed to address elevated blood pressures during dialysis for three (3) of twenty (20) MR reviewed. (MR #2, 5, and 11). The dialysis facility failed to ensure facility staff followed physician ’ s prescription for dialysis treatment for three (3) of twenty (20) MR reviewed. (MR #5, 9, and 14). Findings included: Review of dialysis facility policy #DDCS9992 titled “Initiation/Monitoring/Termination of HD Treatment Using the Fresenius 2008 Series or Baxter Phoenix Dialysis Machines” on August 16, 2024, at approximately 1:30 P.M. states, “Monitoring: 6. Note significant changes B/P (blood pressure), heart rate. a. Verify blood flow rate and appropriate ultrafiltration rate (modify as needed for changes in status of patient and/or vital signs) ... 8. If necessary, dialysis trained nurse will contact Nephrologist to report complaint/symptoms and obtain orders if needed ... Termination: 1. Unless there are extenuating circumstances, the dialysis treatment is not ended until the prescribes treatment goals have been reached ... “ Review of dialysis facility policy #DDCS1123 titled “ Clinical Parameters for Notification of the Registered Nurse and/or Nephrologist or APRN Policy, Procedure “ on August 16, 2024, at approximately 2:30 P.M. states, “ Policy: 5. Post treatment findings reportable to the licensed nurse may include the following: Fluid removal: Less than”