Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed at The Neuromedical Center Clinic, CLIA ID 19D1104004, on January 24, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, temperature logs, and interview with personnel, the laboratory failed to ensure urine human chorionic gonadotropin (hCG) test kits were stored at 15 degrees Celsius to 30 degrees Celsius per the manufacturer's requirements. Findings: 1. Observation by surveyor on January 24, 2024 at 9:46 am, on the third floor in the room where urine hCG test kits were stored, revealed the laboratory utilizes SAS Ultimate hCG test kits for urine pregnancy testing. Surveyor did not observe a thermometer monitoring the room temperature. 2. Review of the manufacturer's package insert revealed the following storage requirement: "Store at 15 degrees Celsius to 30 degrees Celsius." 3. Review of the laboratory's temperature logs revealed the laboratory did not have a temperature log for the room where the urine hCG kits were stored. 4. In interview on January 24, 2024 at 1:28 pm, the Director of Clinical Systems confirmed the laboratory did not monitor the room temperature where the urine hCG kits were stored. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, patient test logs, and interview with personnel, the laboratory failed to reject five (5) of thirty- seven (37) randomly selected patient samples, from test dates January 8, 2024 through January 11, 2024, that exceeded the laboratory's 24 hours sample stability criteria. Findings: 1. Observation by surveyor in the laboratory during the tour on January 24, 2024 at 9:30 am revealed the laboratory utilized the Indiko Plus analyzer for UDS testing of the following drugs and analytes: alcohol, amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, ecstasy, hydrocodone, methadone, opiate, oxycodone, cannabinoid, pH and creatinine. 2. Review of the laboratory's "Specimen Collection, Storage & Transport" and "Specimen Rejection" policies revealed the following: a) "If the samples are not analyzed immediately, specimens may be stored refrigerated at 2-8 degrees Celsius for up to 24 hours." b) Specimen Rejection: "Specimens that do not adhere to our laboratory stability standards for storage at refrigerated temperature. Urine Stability: Refrigerated: 24 hours." 3. Review of random selection of patient test logs from test dates January 8, 2024 through January 12, 2024 revealed the following five (5) of thirty-seven (37) patients reviewed were not rejected based on the laboratory's 24 hours sample stability criteria: Patient 129121: Collected: January 2, 2024; Received: January 9, 2024 Patient 116485: Collected: January 5, 2024; Received: January 9, 2024 Patient 153253: Collected January 8, 2024; Received: January 11, 2024 Patient 134703: Collected January 8, 2024; Received: January 10, 2024 Patient 81760: Collected: January 9, 2024; Received: January 11, 2024 4. In interview on January 24, 2024 at 1:33 pm, the Testing Personnel confirmed the identified patient samples were not rejected based on the laboratory's 24 hours sample stability criteria. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to provide written instructions for specimen handling, transport, and stability to providers at satellite clinics for urine drug screen (UDS) testing. Findings: 1. In interview on January 24, 2024 at 9:27 am, the Testing Personnel stated the laboratory receives samples from their satellite clinics located in Zachary, Slidell, and Hammond. 2. Review of the laboratory's policies revealed the laboratory had written "Specimen Collection, Storage, & Transport" and "Specimen Rejection" policies. 3. In interview on January 24, 2024 at 12:53 pm, the Director of Clinical Systems, stated the satellite clinics did not have access to the written instructions for specimen -- 2 of 6 -- collection, handling, and rejection. The Director of Clinical Systems stated the laboratory has the only copy of the instructions; if satellite clinics have questions they would have to contact the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of maintenance logs, and interview with personnel, the laboratory failed to perform monthly maintenance procedures per manufacturer's requirements for one (1) of four (4) months in 2023 reviewed. Findings: 1. Observation by surveyor in the laboratory during the tour on January 24, 2024 at 9:30 am revealed the laboratory utilized the Indiko Plus analyzer for UDS testing of the following drugs and analytes: alcohol, amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, ecstasy, hydrocodone, methadone, opiate, oxycodone, cannabinoid, pH and creatinine. 2. Review of the "Indiko Plus Maintenance Checklist" logs revealed the following monthly procedures were not performed in December 2023: a) "Decontaminate all reservoirs and tubing" b) "Clean cuvette incubator" 3. In interview on January 24, 2024 at 12:04 pm, the Testing Personnel confirmed performance of the monthly maintenance procedures for December 2023 was not documented. D5783