Fkc Bethlehem

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 36372 Based on observations, review of policies/procedures, and an interview with the Administrator, it was determined that the facility failed to provide oversight for infection control practices and failed to ensure facility staff followed established infection control policies. This CONDITION is not met as evidenced under the following standards: Findings Include: Cross Reference: 42CFR 494.30(a)(1)(i) IC-If To Station=disp/dedicate Or Disinfect (Tag 0116): Facility failed to ensure items taken into the patients (HBV+) dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before taken to a common clean area or used on a another patient. 42CFR 494.30(a)(1)(i) Ic-Hbv-Isolation-Machines/equip/supplies (Tag 0130): Facility failed to ensure any one entering the isolation area/room during the patient’s (HBV+) patient treatment must wear a protective gown. The cumulative effect of these systematic problems resulted in the ESRD’s inability to ensure the provision of quality healthcare in a safe/sanitary environment. An Immediate Jeopardy (IJ) situation was identified on November 4, 2024 at approximately 11:40 a.m. The facility was notified of the IJ on November 4, 2024 at approximately 11:40 a.m. and an IJ template was provided. The IJ template included the specific requirements that were violated with a description of the noncompliance: 494.30 Condition - Infection Control (Tag 0116, 0130). “Facility failed to ensure items taken into the isolation room were disposed of, dedicated for use on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. Facility failed to ensure anyone entering the isolation room during the patients treatment must wear a protective gown. Separate dedicated supplies/equipment must be used to provide care to a HBV+ patient.” Employee #10 - Employee #16 were identified by the facility as being at risk of serious injury, harm, impairment, or death. The first Immediate Jeopardy removal plan was submitted on November 4, 2024 at approximately 2:15 p.m. The removal plan was rejected. A second Immediate Jeopardy removal plan was submitted on November 5, 2024 at approximately 10:57 a.m. The removal plan was rejected. A third acceptable Immediate Jeopardy removal plan was submitted by the facility on November 5, 2024 at approximately 3:34 p.m. and the Immediate jeopardy was removed onsite on November 6, 2024 at approximately 11:00 a.m.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 36372 Based on review of facility policy, observations,staff interviews, and an interview with the facility Administrator, the facility failed to ensure items taken into the dialysis station were either disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient for one (1) of one (1) treatment floor observations (Observation#1). Findings include: A review was conducted of facility policy on November 4, 2024 at approximately 11:30 a.m. Policy: ‘Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)’ ’(Setting: IC, HT)’ ‘Purpose’ “The purpose of this policy is to prevent transmission of Hepatitis B.” ‘Background’ “Caring for HBsAg positive patients requires strict guidelines. ....” ‘Hand Hygiene and PPE’ “ .... Anyone entering the isolation area/room during the patients treatment must wear a separate fluid resistant gown at all times.” ‘Equipment and Supplies’ “Separate dedicated supplies and equipment, ... must be used to provide care to the HBsAg positive patient: ...” Observations conducted in the facility/patient treatment area on November 4, 2024 between approximately 9:50 a.m.-10:30 a.m. and on April 19, 2019 revealed the following: Observation #1: On 11/04/24 at approximately 9:50 a.m. employee #10 (physician assistant) was observed in the isolation room interacting with patient #10 (HBsAg positive patient). Employee #10 was working on a computer which is attached to a rolling cart. Employee #10 did not clean and disinfect the rolling cart/computer after leaving the isolation room. An interview was conducted with employee #10 on 11/04/24 at approximately 10:55 a.m. Employee #10 confirmed that the rolling cart with computer attached was not disinfected after exiting the isolation room. An interview conducted with facility Administrator on November 6, 2024 at approximately 11:00 a.m. confirmed the above findings.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 36372 Based on review of facility policy, observations, staff interviews, and an interview with the facility Administrator, the facility failed to ensure any one entering the isolation area/room during the patient’s treatment donned a protective gown for one (1) of one (1) treatment floor observations (Observation#1). Findings include: A review was conducted of facility policy on November 4, 2024 at approximately 11:30 a.m. Policy: ‘Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+)’ ’(Setting: IC, HT)’ ‘Purpose’ “The purpose of this policy is to prevent transmission of Hepatitis B.” ‘Background’ “Caring for HBsAg positive patients requires strict guidelines. ....” ‘Hand Hygiene and PPE’ “ .... Anyone entering the isolation area/room during the patients treatment must wear a separate fluid resistant gown at all times.” ‘Equipment and Supplies’ “Separate dedicated supplies and equipment, ... must be used to provide care to the HBsAg positive patient: ...” Observations conducted in the facility/patient treatment area on November 4, 2024 between approximately 9:50 a.m.-10:30 a.m. and on April 19, 2019 revealed the following: Observation #1: On 11/04/24 at approximately 9:50 a.m. employee #10 (physician assistant) was observed in the isolation room interacting with patient #10 (HBsAg positive patient). Employee #10 was working on a computer which is attached to a rolling cart. The patient in the isolation room (patient #10) was sitting in the treatment chair and employee #10 was faced towards patient #10. Employee #10 was not wearing a gown. An interview was conducted with employee #10 on 11/04/24 at approximately 10:55 a.m. Employee #10 confirmed that a gown was not worn, when first observed, while in the isolation room. An interview conducted with facility Administrator on November 6, 2024 at approximately 11:00 a.m. confirmed the above findings.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 36372 Based on a review of facility policy/procedures, observations, and an interview with the facility Administrator, the facility failed to ensure the facility/water treatment area was secured against unauthorized individuals (tag 0400); The facility failed to ensure the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment (Tag 407). Cross Reference: 42 CFR 484.60 Pe-Safe/functional/comfortable Environment (Tag 401): The facility failed to ensure the facility/water treatment area was secured against unauthorized individuals. 42 CFR 494.60(a) Pe-Hd Pts In View During Treatments (Tag 407): The facility failed to ensure the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment. The cumulative effect of these systematic problems resulted in the ESRD’s inability to ensure the provision of quality healthcare in a safe/sanitary environment.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. 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 facility Administrator, the facility failed to ensure patients were provided with quarterly emergency training for three (3) of five (5) in-center patient medical records (MR) reviewed (MR#2, MR#3, MR#4). Findings: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy: ‘Clinical Services’ ‘Fire Drill’ (Setting: IC, HT) ‘Fire Drills’ “Quarterly, all FKC facilities shall perform a fire drill for each shift of patients and staff.....” ‘Documentation’ “Document patient participation in fire and disaster drills on the ‘Patient Participation in Fire and Disaster Drills’ form.” A review of patient medical records conducted on September 20, 2024 between approximately 9:00 a.m. - 2:30 p.m. revealed the following: MR#2 Date of admission 01/16/23: No quarterly emergency training documentation provided for the 3rd and 4th quarter of 2023. MR#3 Date of admission 07/26/18: No quarterly emergency training documentation provided for the 4th quarter of 2023. MR#4 Date of admission 02/22/23: No quarterly emergency training documentation provided for the 2nd, 3rd, and 4th quarters of 2023. An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) 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. 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, the facility failed to ensure routine testing for the Hepatitis B Virus of all patients based on their Hepatitis B testing results, for one (1) of five (5) in-center patient medical records (MR) reviewed (MR#4). Findings: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy: ‘Clinical Services’ ‘Patient Hepatitis B Testing Requirements’ (Setting: IC. HT) “HBV Patient Testing’ “..... ‘Susceptible’ ‘HBsAg’ (Hepatitis B Surface Antigen)”Monthly testing.” A review of patient medical records conducted on September 20, 2024 between approximately 9:00 a.m. - 2:30 p.m. revealed the following: MR#4 Date of admission 02/22/23: Per the facility Administrator and laboratory results obtained on 02/23/23 (Anti-Hepatitis B Surface Antibodies less than 10 mIU/mL), this patient is susceptible for the Hepatitis B virus. No documentation povided of HBsAg monthly testing from 02/22/23 - 08/24/23. HBsAg monthly testing began on 08/24/24. An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. 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 the facility/water treatment area was secured against unauthorized individuals for two (2) of two (2) observations (Observation #1, Observation #2). Findings: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy ‘Clinical Services’ ‘Physical Security and Facility Access’ (Setting: IC, HT) ‘Physical Security’ states “.... All secondary external entrances (employee entrance doors, delivery doors) to the facility are to be kept closed and locked when not in use ....” ‘Water treatment Area Security’ “Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. This is accomplished by .....Locking all doors that allow access to the water treatment equipment. No exterior building door will be left unlocked unless under the continual supervision of a facility staff member.” Observations conducted in the patient treatment area/facility on September 18, 2024 between approximately 8:35 a.m. and 12:50 p.m. revealed the following: Observation #1: On 09/18/24 at approximately 8:35 a.m., the two (2) doors exiting the treatment area (with access to the staff area, the supply area, and the water treatment area) were observed to not have locking mechanisms to prevent unauthorized entry from the patient treatment area. Direct access from unauthorized individuals to these areas was possible. Observation #2: On 09/18/24 at approximately 3:15 p.m., the exterior garage type sliding door exit (which provides access to the general storage area and the water treatment area room) was observed unlatched/unlocked. (There is a sliding type latch on the door and the door could be opened from the exterior of the building). No facility staff was observed in the area. The facility Clinical Nurse Manager (employee #1) was made aware. Employee #1 observed and opened the unlocked door. Per the Clinical Nurse Manager, the facility Bio-Medical Technician (employee #21) was not in the facility at the time. An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). 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 the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment for one (1) of one (1) treatment floor observations (Observation #1) Findings include: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. ‘Clinical Services ‘Patient Assessment and Monitoring’ ‘General Observation/Mental Status’ ‘Access’ “Observe connections are secure and visible. .....Ensure access remains uncovered throughout the treatment.” Observations conducted in the patient treatment area on September 18, 2024 between approximately 8:35 a.m. and 12:50 p.m. revealed the following: Observation #1: During treatment floor observations on 09/18/24 at approximately 8:55 a.m., patient #8, at station #10; The patients AV Fistula access site was covered by a green blanket from approximately 8:55 a.m. - 9:25 a.m. ( approximately 30 minutes). An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. 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, the facility failed to ensure a home visit was conducted at the initiation of home therapy, per policy, for one (1) of two (2) home therapy patient medical records (MR) reviewed (MR#6). Findings: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy: ‘Clinical Services’ ‘Home Visits for Home Dialysis Patients’ ‘Policy’ “A home visit must be conducted at the initiation of home hemodialysis and peritoneal dialysis to assess the home environment and verify adaptation to home therapy. ... This visit must be conducted in person ... utilizing the ‘RN home Visit Initial Skills and Validation’ and the ‘Patient Home Environment Evaluation’. A review of patient medical records conducted on September 20, 2024 between approximately 9:00 a.m. - 2:30 p.m. revealed the following: MR#6 Date of admission 09/26/22: No documentation provided of an initial home visit being conducted utilizing the facility ‘RN home Visit Initial Skills and Validation’ and the ‘Patient Home Environment Evaluation’ forms. Documentation provided of a ‘Clinical Notes Report’ dated 09/29/22 “Training note: Patient completed exchange in home, ....Patient is well organized with great set up to complete exchanges in ... bedroom. No eminent issues noted.” Documentation provided of a home visit conducted on 11/11/22 and on 10/10/23. An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.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 facility water logs, a review of patient medical records, a review of facility employee files, and an interview with the Administrator, it was determined the facility failed to ensure facility water logs were completed per policy/procedure, for two (2) of two (2) water logs reviewed (Log Review #1, Log Review #2), failed to ensure TB (tuberculosis) screening and color blind testing was conducted according to facility policy for two (2) of three (3) employee files (EF) reviewed (EF#4, EF#16), failed to ensure staff reported patient hypotension to the registered nurse for one (1) of five (5) in-center patient medical records (MR) reviewed (MR#2), and failed to label patient bio-hazard waste, according to facility policy, for one (1) of one (1) Bio-Hazard Waste Room observations (Observation #1). Findings include: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy ‘Carbon Filtration Monitoring for Incenter Central Water Systems Policy’ (Setting: IC) ‘Clinical Oversight’ states “The Clinical Manager (CM) or the nurse in charge is responsible for oversight of daily testing and documentation of total chlorine testing. The CM or the nurse in charge must do the following: “..... Complete from the TM’S clinical application the “TC CM Weekly Review Log”.....” A review of the facility water logs conducted on September 19, 2024 at approximately 9:00 a.m. revealed the following: Log Review #1: The ‘TC-CM Weekly Review Log - 58397’ was reviewed for the months of June/July 2024. Documentation of a review on June 10, 2024. Documentation of a review on June 24, 2024. No review documented for June 17, 2024 (between June 11, 2024 - June 24, 2024). Documentation of a review on July 1, 2024. Documentation of a review on July 29, 2024. No review documented for June 8, 2024, July 15, 2024, nor July 22, 2024 (between July 2, 2024 - July 29, 2024). Policy ‘Biomedical Support Services’ ‘Lionization (DI) Installation Operation and Maintenance Policy’ ‘DI System Monitoring’ ‘Following installation of the DI System .... DI system will be closely monitored... ‘Frequency’ “Following installation of the system, Each morning prior to use of the DI System ...Every four hours ....Every hour if the first resistivity monitor indicates water resistivity of ...” Log Review #2: The ‘DI Resistivity Monitoring (4 Hours) - 54668’ log was reviewed for the months of June 2022 and July 2022. Time frames below on the logs are in military time. Documentation of the first reading on 06/02/22 conducted at 0345. The second reading was conducted at 0848 (greater than 4 hours). The third reading was conducted 0345 (a data entry/system error), the fourth reading was conducted at 1530. Documentation of the first reading on 06/04/22 conducted at 0500. The second reading was conducted at 0304 (a data entry/system error), the third reading was conducted 1210. the fourth reading was conducted at 1530. Documentation of the first reading on 06/09/22 conducted at 0340. The second reading was conducted at 0840 (greater than 4 hours). The third reading was conducted 1230. The fourth reading was conducted at 1517. Documentation of the first reading on 06/15/22 conducted at 0339. The second reading was conducted at 0850 (greater than 4 hours). The third reading was conducted 0340 (a data entry/system error). The fourth reading was conducted at 1546. Documentation of the first reading on 06/16/22 conducted at 0340. The second reading was conducted at 0845 (greater than 4 hours). The third reading was conducted 1239. The fourth reading was conducted at 1530. Documentation of the first reading on 07/01/22 conducted at 0507. The second reading was conducted at 0830. The third reading was conducted 0340 (a data entry/system error). The third reading was conducted 0340 (a data entry/system error). The fourth reading was conducted 0340 (a data entry/system error). Documentation of the first reading on 07/06/22 conducted at 0340. The second reading was conducted at 0330 (a data entry/system error). The third reading was conducted 1203. The fourth reading was conducted at 1437. Policy ‘Clinical Services’ ‘Employee Tuberculosis Testing’ (Setting:IC, HT, IPPS) ‘New Hire Screening Policy’ states “ TB testing using the two step tuberculin skin test (TST) method is required upon hire. .........” Policy ‘Clinical Services’ Color Blindness Testing’ ‘Policy’ “New hire, rehire, or transfer staff working in direct patient care or biomedical position are required to take the Sharma Test for Color Blindness to .....” A review of employee files was completed on September 19, 2024 at approximately 1:45 p.m. Employees date of hire is listed below. EF#4 Date of hire 06/27/22: Documentation provided of a two-step TST administered late on 08/22/24 and 08/26/24. Documentation provided of a color blindness test conducted late on 08/22/24. EF#16 Date of hire 11/13/23: Documentation provided of a two-step TST administered late on 08/22/24 and 09/03/24. Documentation provided of a color blindness test conducted late on 08/22/24. Policy ‘Clinical Services’ Intradialytic Hypotension’ (Setting: IC, HT) ‘Treating Hypotension on Hemodialysis” ’.... ‘Step #3’ “Notify the nurse in charge.” ‘Hypotension’ (Setting: IPPS) ‘Definition’ “Intradialytic hypotension is defined as a decrease in systolic blood pressure of 20 mmHg or more or a decrease in mean arterial pressure of 10 mmHg. ...” A review of patient medical records conducted on September 20, 2024 between approximately 9:00 a.m. - 2:30 p.m. revealed the following: MR #2, Date of admission 01/16/23: Treatment flowsheet dated 09/12/24 reviewed. Treatment initiated at 6:16 a.m. Blood pressure (BP) was “115/58” (entered by Employee #15, patient care technician). At 6:56 a.m. blood pressure (BP) was “98/52” (entered by Employee #16, patient care technician). At 7:27 a.m. blood pressure (BP) was “88/52” (entered by Employee #15, patient care technician). At 7:57 a.m. blood pressure (BP) was “86/40” (entered by Employee #16, patient care technician). At 8:31 a.m. blood pressure (BP) was “85/53” (entered by Employee #16, patient care technician). At 8:58 a.m. blood pressure (BP) was “104/51” (entered by Employee #15, patient care technician). At 9:24 a.m. blood pressure (BP) was “85/40” (entered by Employee #15, patient care technician). At 9:53 a.m. blood pressure (BP) was “88/42” (entered by Employee #15, patient care technician). No documentation provided of the patient care technician notifying the registered nurse of the patients low blood pressure readings during treatment. Policy ‘Clinical Services’ ‘Dialyzing patients with Positive Hepatitis B Antigen (HBsAg+)’ ‘Equipment and Supplies’ “....All disposable items, including the patients dialyzer, shall be considered infectious, and shall be red-bagged, labeled as “Infectious Waste”, and removed from the HBsAg positive patient care room/area each day using Standard Precautions.” Observation #1: During an observation of the facility bio-hazard waste room on September 19, 2024 at approximately 2:45 p.m., approximately eight (8) bio-waste containers (containing bio-hazard waste) contained the same label which included but not limited to the facility name (“Generator”), address, the Bio-hazard waste transportation company (“Carrier”), and a bar code. None of the containers included ‘Infectious Waste’ on the label. There are currently two (2) Hepatitis B+ patients on census (MR#9, most recent treatment date 09/18/24 and MR#10, most recent treatment date 09/19/24). An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”

“MR-CENTRALIZE ALL INFO;IDT HAS ACCESS CFR(s): 494.170(b)(2) (2) All clinical information pertaining to a patient must be centralized in the patient’s record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient’s condition and prescribed treatment. This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, medical records, and an interview with facility Administrator, it was determined the facility failed to ensure documentation of conductivity of dialysate solution prior to patient treatment for two (2) of five (5) incenter hemodialysis patient medical records (MR) reviewed (MR#3, MR#4). Findings include: A review was conducted of facility policy on September 20, 2024 at approximately 1:30 p.m. Policy ‘Checking Conductivity and pH of Final Dialysate’ ‘Purpose’ “The purpose of this policy is to provide guidelines to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required.” ‘Test Verification Prior to Treatment’ .”..... Note: If BlueStar software is enabled for independent conductivity and pH readings, an external meter is not a requirement to measure pre-treatment conductivity and pH. This is only allowed on Bluestar machines with a bibag system.” ..... Documentation’ “Record conductivity and pH readings in the FKC treatment record.” Policy ‘Regulatory Guidance for Using the 2008 Independent Conductivity and pH’ (Setting: TSB) ‘Documentation’ ‘Documentation of the Machines Independent Conductivity and pH Verification’ “As was outlined in a Clinical Services ....communication, documentation of the independent conductivity and pH in chairside will be done as follows ....” (Note: This policy is not reflective of the Department of Health May 09, 2024 notice to providers “....From a patient safety aspect, the Department of Health surveyors will be ensuring that documentation that the TCD (theoretical conductivity value) and alarm limits is verified on the treatment sheets when conducting Medicare recertification surveys. (Example: TCD and actual conductivity within normal limits to start treatment.”) A review of patient medical records conducted on September 20, 2024 between approximately 9:00 a.m. - 2:30 p.m. revealed the following: MR#3, date of admit 07/26/18: This patient was treated on a ‘2008T BlueStar Hemodialysis Machine’ which utilizes bibags (bicarbonate bags). Patient treatment flowsheet dated 09/11/24 was reviewed. No documentation (flow sheet or elsewhere) of the theoretical conductivity value (TCD) and actual conductivity being within normal limits, prior to the start of treatment. Patient treatment flowsheet dated 09/16/24 was reviewed. No documentation (flow sheet or elsewhere) of the theoretical conductivity value (TCD) and actual conductivity being within normal limits, prior to the start of treatment. MR#4, date of admit 02/22/23: This patient is treated on a ‘2008T BlueStar Hemodialysis Machine’ which utilizes bibags (bicarbonate bags). Patient treatment flowsheet dated 09/16/24 was reviewed. No documentation (flow sheet or elsewhere) of the theoretical conductivity value (TCD) and actual conductivity being within normal limits, prior to the start of treatment. An interview with the facility Administrator on September 20, 2024 at approximately 2:15 p.m. and email correspondence with the facility Administrator on September 23, 2024 at approximately 4:10 p.m. confirmed the above findings.”