South Henry Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of two of two Patient Care Technicians (PCT) (PCT AA and PCT BB) and two of two Licensed Practical Nurses (LPN) (LPN BB and LPN AA) observed, to correctly verify the hemodialysis (HD) machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU. This deficient practice had the potential to negatively affect the health and safety of 14 of 14 patients seated at Station (S) 2, S3, S4, S5, S7, S8, S9, S10, S11, S12, S13, S14, S15, and S16, who were undergoing hemodialysis treatment at the time of this observation. The facility census was 34. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that all staff followed the manufacturer’s DFU in verifying the machine’s final dialysate pH and conductivity prior to the initiation of HD treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, staff interviews, a review of the manufacturer’s Directions for Use (DFU), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 34 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity) and conductivity (ability of the dialysate to conduct electricity) according to the Manufacturer’s DFU prior to the initiation of each patient treatment.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 50523 Based on observation, staff interview, and a review of the Food and Drug Administration (FDA) recommendations, it was determined that the facility failed to ensure that expired medications in one of one medication cabinet and one of one medication refrigerator were removed and not made available for use and expired laboratory (lab) supplies found in the lab supply cabinet were not made available for use. This deficient practice had the potential to negatively affect the health and safety of 34 in-center hemodialysis patients who were under the care of this facility. During a tour with the Clinical Manager (CM) in the Patient Treatment Room on 1/6/25 from 10:15 a.m. though 11:01 a.m., the following medications and supplies had expired, thus these were not suitable for use. Findings include: In the In-Center Medication Cabinet: - There were five vials of Vancomycin Hydrochloride Injection (antibiotic) 500 milligrams (mg) each for injection that expired 11/2024. - There were 10 vials of Vancomycin Hydrochloride Injection (antibiotic) 1 gram (g) each for injection that expired 11/2024. In the Medication Refrigerator: - There were 15 Pneumococcal Vaccine Polyvalent (vaccine that helps protect against serious infection such as meningitis, bacteria in the blood due to certain bacteria Streptococcus pneumoniae) 0.5 Milliliter (mL) injectable solution that expired 11/22/24. In the Laboratory Cabinet: - There were 100 gold top laboratory tubes that expired 12/5/24. On 1/6/25 the CM acknowledged these findings at 10:45 a.m. According to FDA recommendations dated 2/8/21, drug and supplies’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 50523 Based on observation, review of records, staff interview, and a review of the Centers for Disease Control and Prevention (CDC) guidelines, it was determined that the infection control committee failed to ensure that one of one Licensed Practical Nurse (LPN) (LPN AA) who cared for Hepatitis B Surface Antigen positive (HBsAg+) patient, did not care for Hepatitis B Virus (HBV) susceptible patients at the same time. This failure increased the risk for cross-contamination through transmission of HBV by contact, to three of three susceptible patients (P) (P#1, P#3, and P#4) who were assigned to stations nearest to Isolation Room (Station [S] 2, S3, and S4). Findings include: A review of the “Daily Patient Schedule” from November 2024 through January 2025 revealed the following: On 11/29/24: - LPN AA was assigned to care for patients in Isolation Room (S 1), S2, S3 and S4 on the first shift. - P#2 who dialyzed in Isolation Room had a positive HBsAg. - P#1 was assigned to dialyze in S4. - A review of P#1’s medical records showed P#1 had a Hepatitis B Surface Antibody (HBsAb) of < (less than) 4 mIU/ml, who was considered susceptible to HBV. On 12/2/24: - LPN AA was assigned to care for both P#2 and P#3 on the first shift. - A review of P#3’s medical records revealed that P#3 was susceptible to HBV with HBsAb of <4 mIU/ml. On 12/4/24: - LPN AA was assigned to care for both P#2 and P#4 on the first shift. - A review of P#4’s medical records revealed that P#4’s HBsAb was <4 mIU/ml which indicated susceptibility to HBV. - On 12/13/24, 12/16/24, 12/18/24, 12/20/24, 12/27/24, 12/30/24, 1/1/25, 1/3/25, and on 1/6/25, LPN AA was assigned to care for both P#1 and P#2 on the first shift. During an interview on 1/7/25 at 11:15 a.m., LPN AA stated she is usually the one assigned to care for patients in Pod 1 which included the Isolation Room. LPN AA stated she is immune to hepatitis B therefore; she took care of P#2 who is HBsAg positive. Stated she was unaware of P#1’s immunity status. According to CDC guidelines, when treating a Hepatitis B positive dialysis patient alongside a susceptible patient, the key practice is to strictly isolate the HBsAg positive patient by assigning a separate dialysis machine, room, and dedicated supplies to prevent cross-contamination; this includes ensuring staff assigned to the positive patient do not work with susceptible patients during the same shift... If HBsAb was <10 mIU/mL, a patient or staff member is considered susceptible to hepatitis B virus. A review of facility records lacked policies and procedures for the prevention of the spread of hepatitis B per CDC guidelines. On 1/7/25 at 11: 23 a.m., the Clinical Manager was notified and acknowledged the above findings.”

“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: 50523 Based on observation, staff interviews, and a review of the manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCT) (PCT AA and PCT BB) and two of two Licensed Practical Nurses (LPN) (LPN BB and LPN AA) observed, verified the hemodialysis machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU. This deficient practice had the potential to negatively affect the health and safety of 14 of 14 patients seated at Station (S) 2, S3, S4, S5, S7, S8, S9, S10, S11, S12, S13, S14, S15, and S16, who were undergoing hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced, and patient electrolyte balance could be altered. The facility census was 34. Findings include: During observation in the Patient Treatment Room on 1/6/25 between 11:02 a.m. through 1:25 p.m., the following was revealed: - PCT AA was observed testing the dialysate conductivity at S12. PCT AA poured the dialysate sample into the Myron L D-1 meter cell cup. PCT AA didn’t agitate the sample with the plunger by moving the plunger up and down three times. Then without discarding the sample, PCT AA pressed the black button and when the pointer stopped, she immediately read the conductivity and released the button. PCT AA then proceeded to check the pH of the machine by dipping the pH test strip into the test solution. PCT AA did not look at the clock and swished the pH strip (Serim Guardian BICARB pH II - pH readings at 6.5, 7.0, 7.5, 8.0 and 8.5) back and forth for eight seconds (surveyor’s time) and immediately compared to color scale. When asked at 1:03 p.m. on 1/6/25, how many times PCT AA was supposed to rinse and agitate the sample before reading the result, PCT AA stated that she just pours the sample into the cell and then checks the result. When asked how many seconds the pH testing strip was supposed to be in testing solution before comparing to color chart, PCT AA stated 10 seconds. - PCT BB was observed testing the dialysate conductivity at S15. PCT BB poured the dialysate sample into the Myron L D-1 meter cell cup twice without agitating the samples. After discarding the first sample and refilling with the second sample, PCT BB pressed the black button and when the pointer stopped, she immediately read the conductivity and released the button. When asked at 1:07 p.m. on 1/6/25, how many samples were supposed to be agitated before reading the result, PCT BB stated two samples. - LPN BB was observed testing the dialysate’s conductivity at S4. LPN BB poured the dialysate sample into the Myron L D-1 meter cell cup twice without agitating the samples. After discarding the first sample and refilling with the second sample, LPN BB pressed the black button and when the pointer stopped, she immediately read the conductivity and released the button. At 1:15 p.m. on 1/6/25, LPN BB revealed she has always performed the conductivity testing that way. - LPN AA was observed testing the pH of the machine at S4. LPN AA dipped the testing strip into the test solution. LPN AA did not look at the clock and swished the test strip back and forth for 20 seconds (surveyor’s time) and immediately compared to color scale. At 1:22 p.m. on 1/6/25, when asked how many seconds the pH testing strip was supposed to be in testing solution before comparing to color chart, LPN AA stated 30 seconds. A review of the manufacturer’s DFU on the pH Test Strip Bottle showed the following: Dip the test strip into the dialysate sample for one second. Remove strip and read immediately for warmed samples .... Test Strips have been designed to indicate the appropriate pH at an immediate read time for samples warmed to temperatures of 32-40 C (celsius). A review of the manufacturer’s DFU on the Myron L D-1 meter showed the following: 1. Fill the cell cup to just above the top electrode with a sample of the dialysate you want to test. the dipper end of the cell plunger will deliver just the right amount. be sure hands are clean and dry to avoid contamination of the sample. 2. Drop the plunger into the cell cup. Lift it about halfway out of the cell and drop it back in three or four times. Discard the sample. note: this procedure must be conscientiously performed for samples at working (body) temperature to avoid artificially low readings. 3. Repeat steps 1 and 2 at least three times. 4. Take another sample, drop in the plunger and press the black button. When the pointer stops, immediately read and release the button. 5. Repeat step 4 twice and record the last reading. 6. When you are finished with the meter, rinse the cell cup with clean water, preferably R.O., distilled, or deionized. The Clinical Manager was informed of the above findings on 1/6/25 at 3:40 p.m.”

“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: 50523 Based on observation and staff interview, it was determined that the facility failed to maintain a safe environment for patients and staff as evidenced by missing and damaged ceiling tiles; exposed and loose fill fiberglass insulation materials around the edges of the missing/damaged tiles. Fiberglass dust and particles of loose fiberglass insulation had the risk of falling from the ceiling. Skin contact with fiberglass insulation, can cause irritation and discomfort due to the tiny glass fibers that can embed themselves in the skin, leading to itching, redness, and sometimes a rash. These environmental concerns were observed in one of one Patient Treatment Room. The facility census was 34. Findings include: During a tour of the facility with the Clinical Manager on 1/6/25 from 10:15 a.m. through 11:01 a.m., the following was observed: In the Patient Treatment Room: - There was one missing ceiling tile above Station (S) 2. - There was another missing ceiling tile above S4. - There were three ceiling tiles above S4 that were damaged. One of three tiles had a hole approximately 6 x 6 inch; and two of three tiles had holes approximately 24 x 24 inch. - There were exposed fill fiberglass insulation materials and loose fiberglass insulation that dangled around the edges of the holes and missing tiles. Fiberglass dust and particles of loose fiberglass insulation had the risk of falling from the ceiling. The Biomedical Operations Manager stated on 1/6/25 at 2:30 p.m., that the facility had identified these problems during their own internal inspection and had plans and financial quotes to correct the missing and damaged ceiling tiles.”