Allegiance Specialty Hospital of Greenville

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 44086 Based on observation of facility medication room, interview with staff member, and facility policy and procedure review the facility failed ensure the facility’s medical staff approved policies and procedures for clear and consistent direction based on accepted standards of practice for the safe preparation and administration of drugs and biologicals in multiuse medication vials with appropriate labeling and beyond-use-date (BUD) for three (3) of eight (8) open multidose vials stored in the medication refrigerator. Findings Include: Observation in the medication room during a tour of the long-term acute care unit (LTAC) on 02/19/2025 from 11:05 a.m. to 11:50 a.m. with Nurse #1 revealed three (3) open multidose vials of medication in the medication room refrigerator with multidose red and white labels covering the vial and no open date or beyond use date documented on the vial label. Interview with Nurse #1 on 02/19/2025 at 11:05 a.m. to 11:50 a.m. confirms three open multidose vials with no open date or beyond use date documented. Nurse #1 further confirms the facility practice is to document the open date and a use by date on the multidose label. Review of the facility policy and procedures titled, “Care of Patients - Medication ...Subject: Medication Administration”, with date of last review 08/2023; “Care of Patients - Medication ...Subject: Medication Error”, dated 08/2023; and the facility policy and procedure titled, “Care of patient-Medication ...Subject: Medication Documentation,” dated 08/2023 do not address the use of or appropriate labeling of multidose vials based on standard of practice for medication safety (i.e., for “Safe Injection Practices,” dated March 26, 2024, from the United States Center for disease Control and Prevention). During exit conference on 02/20/2025 at 6:30 p.m. the survey findings were discussed with the Chief Operating Officer, Chief Executive Officer and the Director of Nursing with no additional documentation submitted.”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 44086 Based on observation in the facility’s medication room, interview with staff member, and review of facility policy and procedures, the facility failed to ensure patient safety with preparation and administration of multiuse vial medication as evidence by outdated, unlabeled, or otherwise unusable drugs and biologicals present in the medication refrigerator for patient use on four (4) of eight (8) multidose vials observed. Findings Include: Observation in the medication room during tour of the long-term acute care unit (LTAC) on 02/19/2025 from 11:05 a.m. to 11:50 a.m. with Nurse #1 revealed three (3) open multidose vials in the medication room refrigerator with multidose vial labels attached and no open date or beyond use date recorded and one (1) unopened multidose vial past a manufacture expiration date. Interview with Nurse #1 on 02/19/2025 at 11:05 a.m. to 11:50 a.m. confirmed three (3) open multidose vials with no open date or beyond use date recorded and further confirmed the facility’s practice is to document the open date and a use by date on the multidose vial label. Nurse #1 also confirmed one (1) unopened multidose vial in the medication room refrigerator with a past manufacturer expiration date of 10/31/2024 and additionally confirmed the pharmacy department monitors expiration dates of medications during stocking management. Review of the facility policy and procedures titled, “Care of Patients - Medication ...Subject: Medication Administration”, with date of last review 08/2023; “Care of Patients - Medication ...Subject: Medication Error”, dated 08/2023; and the facility policy and procedure titled, “Care of patient-Medication ...Subject: Medication Documentation,” dated 08/2023 do not address use of or labeling of multidose vials or management of medication expiration dates as required based on standards of practice for medication safety (i.e., “Safe Injection Practices,” dated March 26, 2024, from the United States Center for disease Control and Prevention). During the exit conference on 02/20/2025 at 6:30 p.m. the survey findings were discussed with the Chief Operating Officer, Chief Executive Officer and the Director of Nursing with no additional documentation submitted.”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 44086 Based on observation of the facility medical supply storage, interview with facility staff members, and review of facility policy and procedures, the facility failed to ensure an acceptable level of safety and quality of care as evidence by supplies available for patient use with expired dates on two (2) of two (2) foley catheter insertion trays, two (2) of two (2) water seal trays, and two (2) of two (2) central line kits. Findings Include: Observation of the medical supply storage room during the facility tour of the long-term acute care unit (LTAC) on 02/19/2025 from 11:05 a.m. to 11:50 a.m. with Nurse #1 revealed two (2) of two (2) foley catheter insertion trays with an expiration date of 11/30/2024, two (2) of two (2) water seal kits with an expiration date of 01/18/2025, and two (2) of two (2) central line kits with an expiration date of 09/19/2024, available in supply storage room for patient use. Interview with Nurse #1 on 02/19/2025 from 11:05 a.m. to 11:50 a.m. confirmed the six (6) expired supply kits and further revealed that the Materials Manager is responsible for re-stocking medical supplies and checking expiration dates. An interview with the CEO on 02/19/2025 at 12:25 a.m. confirmed that the Director of Material Management is responsible for managing the supply storage room stock and expiration dates. Review of the facility policy and procedure titled “Material Management ...Duties of Materials Manager,” dated with last revision date of 02/2022, revealed on page 2 of 2, the director of material management is responsible for “ ...Policy: ... 10. Manage product expiration by manually monitoring and rotating items by hand during stocking. Ensure close-dated items are placed in front of shelves so they are selected first when used, if any outdated product is found it is removed. Periodic storage checks are done to ensure used, if any outdated product is found it is removed. Periodic storage checks are done to ensure oldest products are clearly positioned in front and there are not any expired items.” Review of the facility Policy and Procedure titled “Material Management...Adjustments to Inventory” dated with last revision 07/2018, revealed, “ ...B. Obsolete Materials 1. Dispose of inventory items that are obsolete ...a. Expiration of sterile shelf life (fluids, catheters, etc.) ...”. During the exit conference on 02/20/2025 at 6:30 p.m. the survey findings were discussed with the Chief Operating Officer, Chief Executive Officer and the Director of Nursing with no additional documentation submitted.”