Davita Lehighton Dialysis

“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: 36372 Based on review of facility policy/procedures, observations, and an interview with the facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, performing hand hygiene/donning clean gloves, for one (1) of two (2) ‘Access of AV Fistula or Graft for Initiation of Dialysis’ observations (Observation #1) and two (2) of three (3) ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ observations (Observation #2, Observation #3). Findings include: A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m. Procedure #1-04-01E ‘AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose’ ‘Procedure’ (1) states “Have patient wash access site with appropriate antibacterial soap, if able. If patient is unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent.” (2) Perform hand hygiene. Put on PPE.” ...... (11) “While maintaining aseptic technique, cleanse the site by applying skin antiseptic ....” Observations conducted in patient treatment area on September 19, 2025 between approximately 9:20 a.m. - 1:45 p.m. revealed the following: Observation #1: During observation #1 of 2 ‘Access of AV Fistula or Graft for Initiation of Dialysis’ on 09/19/25 at approximately 10:35 a.m., of patient #5 at station #2; Employee #6 washed skin over access site and did not remove gloves/perform hand hygiene before applying antiseptic over cannulation site. Procedure: 1-03-121 ‘Termination of Dialysis Utilizing B Braun Dialog+ Dialysis Delivery Systems with all Single Use Dialyzer Types and Streamline Bloodlines’ ‘Procedure’ (7) “... Aseptically disconnect arterial blood line from arterial access connection. ...(14) “Disconnect venous blood line from the venous access. (15): Discard gloves, perform hand hygiene and put on new gloves.” (16) “Perform post dialysis access care per procedure.” Observation #2: During observation #2 of 3 ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ on 09/19/25 at approximately 9:25 a.m., of patient #7 at station #6; Employee #7 did not perform hand hygiene after disconnecting the bloodlines and prior to before removing the first needle. Observation #3: During observation #3 of 3 ‘Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft’ on 09/19/25 at approximately 10:25 a.m., of patient #8 at station #7; Employee #7 did not perform hand hygiene after disconnecting the bloodlines and prior to before removing the first needle. An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, water log review, and an interview with the facility Administrator, it was determined the facility failed to ensure staff followed facility policy/procedure and/or manufacturers directions for use for dialysis machine cleaning/disinfection procedures for one (1) of one (1) ‘B. Braun Dialysis Delivery System Clean and Disinfect Log’ reviewed (Machine Log #1); failed to ensure the water purification machine annual preventive maintenance was conducted for one (1) of one (1) ‘CWP Preventive Maintenance Checklist’ reviewed (Maintenance Checklist #1); and failed to ensure the CWP water purification machine was disinfected weekly for one (1) of one (1) ‘Daily Water Treatment Log’ reviewed (Water Treatment Log #1). Findings include: A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m. Policy ‘B Braun Dialog Dialysis Delivery System Cleaning and Disinfection Policy’ ‘Purpose’ “To promote patient safety by cleaning and disinfection of B Braun dialysis delivery Systems.” (4) ‘Examples of Cleaning. Disinfection Procedures and Intervals’ ‘Procedure’ ‘Thermal Disinfection’ “Each Treatment Day” (if delivery system has not come in contact with bicarb concentrate, thermal disinfection is acceptable). ‘50 % Citric Acid/Thermal Disinfection’ “Each Treatment Day” (after patient use, end of day).’Paracetic Acid End to End Disinfection’ “Monthly” (Integrated Heat Program). (6) “Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log ..... Cleaning and disinfection of dialysis delivery systems will be documented on this log.” Facility water/machine maintenance logs were reviewed on September 22, 2025 at approximately 10:00 a.m. Machine Log #1: A review of the ‘B Braun Dialysis Delivery System Clean and Disinfect Log’ (Date range from 02/12/24 - 11/09/24) revealed the following: The ‘Descale’, ‘Disinfect Type’ ‘Initials PM’ columns were either blank with no entries and/or partial entries on the following dates: 02/13/24, 02/16/24, 02/24/24, 05/07/24, 10/23/24, 10/29/24, and 11/06/24. Facility policy/procedure for the water purification machine was requested on September 22, 2025 at approximately 11:00 a.m. Per the facility Administrator on 09/23/25 at approximately 1:20 p.m., there is no Davita policy related to the water purification machine maintenance, the manufacturers directions for use are utilized. ‘PM Schedule Matrix’ was provided. It included but was not limited to ‘Evoqua Water Technologies’ ‘Model Number’ “CWP 100’ series ‘Equipment Sub Type Code’ “Primary Water Treatment’ ‘Annual’ “Yes.” ‘Marcor Purification CWP 100, Model H/S Service Manual’ excerpts were provided. (3) Maintenance’ ‘Components’ ‘Number’ included Numbers “1, 33, 34, 36, 41, 62, 102, 103, 105, 106, 125, and 154” ‘Inspection Intervals’ “Every Year.” Maintenance Checklist #1: Documentation provided of a ‘CWP Preventive Maintenance Checklist’ ‘Service Date’ 10/26/23 ‘Work Order’ “1 year annual maintenance” and ‘CWP Preventive Maintenance Checklist’ conducted late with a ‘Service Date’ 02/03/25. Policy ‘Title: CWP RO Chemical Disinfect’ ‘Purpose’ “To disinfect the CWP Internal components. .... This procedure will be performed on a weekly basis.” Manufacturers directions for use ‘CWP 100, Model WRO H/S’ (3.6.1) ‘Frequency’ “..... As a guideline, MCP recommends a minimum weekly chemical disinfection to ensure consistent product water microbiological quality.” Water Treatment Log #1: A review of the ‘Daily Water Treatment Log’ (Date range from 06/17/24 - 01/25/25) revealed the following: ‘CWP RO Unit Chemical Disinfection’ Line #37 ‘Chemical Disinfection Initiated’ ‘Time of Day/Initials’ or Line #38 ‘Test for Chemical Residual after Disinfection’ ‘Yes or No/Initials’ or Line #39 ‘Chemical Consumed and Jug marked with Date and Initials?’ ‘Yes or No/Initials’ was blank with no entries on the following dates: 06/19/24 (line #38, #39), 07/30/24 (line #37), 11/12/24 (line #37), 11/19/24 (line #37), 01/02/25 (line #38, #39, facility closed 01/01/25, test for chemical residual should have been conducted prior to treatment the next operating day), 01/22/25 (line #38, #39). An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, a review of patient medical records, and an interview with the facility Administrator, it was determined the facility failed to ensure the home hemodialysis patient completed blood pressure results in the patient treatment flowsheet for one (1) of one (1) home hemodialysis patient medical records (MR) reviewed (MR#4). Findings include: A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m. Policy ‘3-02-24 ‘Home Hemodialysis/Peritoneal Dialysis Daily/Monthly Reconciliation, Audit and Close Process’ ‘Definitions’ (1) “Home treatment Records (flowsheets)- The record submitted by the patient or care partner of applicable treatment data including, but not limited to, date, vital signs, ....” (2) Reconcile - Review Home Treatment Records (flowsheets) for accuracy and completeness of documentation in the Clinical System.” A review was conducted of patient medical records on September 23, 2025 at approximately 12:00 p.m. MR#4 Date of admission 08/14/23: A review of patient treatment flowsheets dated May 1, 2025 - July 28, 2025 revealed the following: ‘Pre-Sys/Dia (mmHg) column several dates were marked “Skipped”, with no blood pressure entry. The dates with no entries were 05/03/25 - 05/18/25, 05/27/25 - 05/31/25, 06/02/25 - 06/10/25, 06/13/25 - 06/15/25, 06/23/25 - 6/24/25, 06/26/25 - 06/28/25, 07/03/25 - 07/05/25. Documentation provided of the patient treatment flowsheets being reviewed by the registered nurse. No documentation of the registered nurse providing education to the patient related to the importance of treatment flowsheet entry completeness. An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) 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; This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, a review of patient medical records, a review of air testing logs,and an interview with the facility Administrator, it was determined the facility failed to ensure medications were administered as ordered for one (1) of three (3) in-center hemodialysis patient medical records (MR) reviewed (MR#2) and failed to ensure air testing for one (1) of one (1) air testing logs reviewed (Air Testing Log #1). Findings include: A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m. Policy ‘3-02-03’ ‘Physician Orders for Patient Care’ ‘Purpose’ To verify that orders are properly documented, transcribed, verified, and implemented ......” A review was conducted of patient medical records on September 23, 2025 at approximately 12:00 p.m. MR#2 Date of admission 07/01/24: ‘Treatment time:’ 3 hours, 15 minutes. Initial Heparin order with a ‘Start Date’ of 10/05/24, ‘Total Heparin Units’ 1,900 units. Patient treatment flowsheet dated 09/12/25 was reviewed. ‘Treatment Duration’ 197 minutes. ‘Heparin Pork’ ‘600 units/hour, intravenous; Infusion, ‘Stop Time for hourly dose before end of treatment: 0 minutes.’ ‘Given’ 1,300 units. Medication dosage not administered as ordered by the physician. Policy 1-22-04 ‘Air Testing Policy’ ‘Purpose’ “To provide guidance for air testing.” ‘Policy’ (3) “Quarterly, after successful baseline testing .....” Facility general testing logs were reviewed on September 22, 2025 at approximately 10:00 a.m. Air Testing Log #1): Documentation provided of ‘Baseline Acetic Acid in Air Testing Logs’ for 2022 and 2024. No documentation provided of quarterly air testing in 2023. An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) 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. This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure patient medical records were secure against unauthorized individuals for one (1) of one (1) observations (Observation #1). Findings: A review was completed of facility policy/procedure on September 24, 2025 at approximately 9:15 a.m. Policy ‘Medical Records Custodian and Maintenance’ ‘Policy’ “Safeguards the confidentiality of the medical record in accordance with established policy and legal requirements. ..... Verifies that all medical records are stored in a safe manner to protect against loss, destruction, or unauthorized use.” Observations conducted in patient treatment area on September 19, 2025 between approximately 9:20 a.m. - 1:45 p.m. revealed the following: Observation #1: On 09/19/25 at approximately 10:15 a.m., the door exiting the treatment area to the staff hallway with access to the front office (adjacent to the patient waiting room) was observed to not have a locking mechanism. The door leading into the front office did not have a locking mechanism to prevent unauthorized entry. The front office contained patient medical records (inactive/active) in three (3) unlocked metal storage racks. Direct access from unauthorized individuals from the patient treatment area was possible. An interview with the facility Administrator on September 23, 2025 at approximately 2:45 p.m. and email correspondence with the facility Administrator on September 24, 2025 at approximately 9:00 a.m. confirmed the above findings.”