Dci Shenango Valley

“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: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to ensure staff wore a mask when performing procedures during which spurting or spattering of blood might occur for one (1) of two (2) observations of initiation of dialysis with and arteriovenous fistula (OBS# 4.1). Findings included: Review of facility policy on November 16, 2023, at 10:45 a.m. showed: “PROCEDURE NO: 301 ... Universal Precautions ... Facial Protection - Face shields provide protection for the eyes, nose and mouth. All areas of the face should be covered by whichever method is chosen. 39. Facial coverings may be either full facial shields or a mask used in conjunction with goggles.” “PROCEDURE NO: 104 ... CANNULATION OF ESTABLISHED ARTERIOVENOUS FISTULA (AVF) ... PROCEDURE ... 1. ... Put on PPE ... 9. Perform cannulation.” “PROCEDURE NO: 310 ... General Facility Infection Control ... POLICY: ... Staff members should wear gowns, face shields, eye wear, or mask to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur.” Observation (OBS#4.1) of initiation of dialysis with an AVF on November 15, 2023, at 8:50 a.m. revealed EMP10 (patient care technician) insert needles into patient’s arm and initiate dialysis but EMP10 only wore protective eyewear and no mask to cover his/her nose and mouth. Interview with EMP10 and EMP9 (charge nurse) after the observation confirmed findings.”

“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: 31759 Based on review of facility policy, manufacturer’s directions for use, observation, and staff (EMP) interview, the facility failed to ensure single use items were dedicated or disposed of for 17 of 17 patients with arteriovenous fistulas (AVF) who required the use of a tourniquet (AVF1-17). Findings included: Review of facility policy on November 16, 2023, at 10:45 a.m. showed, “PROCEDURE NO: 310 ... General Facility Infection Control ... POLICY: ... 5. 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.” Observation of a supply cart designated for clean supplies during a treatment day on November 15, 2023, a 2 p.m. revealed many orange tourniquets piled onto and hanging from the cart. Interview with EMP12 (patient care technician) and EMP14 (nurse educator) at time of observation confirmed findings. EMP12 described the facility’s process for handling the tourniquets: the tourniquets are supplied in bulk (one large bag containing quantity of 250) from a local hospital, the tourniquets are used on patients with arteriovenous fistulas during initiation of dialysis, and once dialysis is completed, the tourniquets are placed into a large container of disinfectant where they dwell for 20 minutes. The tourniquets are then placed on the supply cart for use on the next day’s patients. Review of the manufacturer’s directions for use for tourniquets used by the facility was conducted on November 16, 2023, at 10:25 a.m. with EMP2 (clinic manager). The review showed, “Tourniquets (Non-Latex) ... Single patient use [not designed to be disinfected and reused].” Retrieved from https://www.halyardhealth.com/wp-content/uploads/MediChoice-Supplier-Diversity-Catalog.pdf”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, directions for use, and staff (EMP) interview, the facility failed to ensure one (1) of one (1) medication vial of Tubersol (TB1) was discarded after opening per facility policy and manufacturer’s directions for use. Findings included: Review of facility policy on November 16, 2023, at 11 a.m. showed, “PROCEDURE NO 1115 ... Disposal of Medication Vials ... When a multi-dose vial has been opened, ... the vial should be dated, initialed, and discarded within 30 days, unless manufacturer specifies a shorter date. Refer to package insert.” A flash tour was conducted on November 14, 2023, at 8:45 a.m. with EMP2 (clinic manager). Observation of facility’s medication fridge revealed an open vial of Tubersol medication (TB1). The vial was opened and used on 10/4/2023. Interview with EMP2 at time of observation confirmed findings and that the medication was last used on 11/13/2023. Review of the medication vial’s package insert on November 14, 2023, at 9 a.m. showed, “Tubersol ... STORAGE ... A vial of Tubersol which has been entered and in use or 30 days should be discarded.””

“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: 31759 Based on review of facility policy, manufacturer’s directions for use, logs, and staff (EMP) interview, the facility failed to ensure two (2) of two (2) pHoenix meters (P01710K & P13565) were operated in accordance with manufacturer’s directions for use. Findings included: Review of facility policy and procedure on November 16, 2023, at 11:05 a.m. showed, “Phoenix Meter Disinfection, Calibration, Use and Storage PURPOSE: To assure the pHoenix Meter is properly ... calibrated ... prior to use. To assure that the dialysis machine’s conductivity, pH and temperature are accurate when compared to an independent meter. ... 2. The meter will be verified against 14.0 mS conductivity and 7.0 pH standard solutions daily prior to use, ... Conductivity should read 14 mS +/- .1; pH should read 7 +/- .1. The meter will be recalibrated when the conductivity or pH are out of range.” Review of manufacturer’s directions for use for facility’s pHoenix meters on November 16, 2023, at 11:15 a.m. showed, “Test Instrument User’s Guide For the ... pHoenix Meter ... MesaLabs ... Rev. L ... Test Instrument User’s Guide ... Checking instrument calibration ... Verify accurate calibration of the conductivity and pH functions before use.” A review of “DAILY PHOENIX METER LOG[s]” was conducted on November 14, 2023, at 1 p.m. The review showed that P01710K was out of range on 9/27/2023 with a conductivity of 13.8 (acceptable range 14.1-13.9) and no recalibration. P13565 was out of range on 8/25, and 10/4/2023 with a conductivity of 13.8 on both days with no recalibration. Interview with EMP6 (area technical manager) on November 14, 2023, at 1:42 p.m. confirmed above findings.”