Medscan Laboratory, Inc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of 32 of 136 non-regulated analytes (Hydroxyethylflurazepam, 3-hydroxy-LSD, 25I-NBOMe, Fluorophenmetrazine, 3- Methylhistidine, AB-Pinaca, Atomoxetine, Baclofen, Buspirone, Chlorpromazine, Desmethylvenlafaxine, Dibutylone, Fluvoxamine, Hydroxyrisperidone, Lacosamide, MDPV (Methylenedioxypyrovalerone), Methocarbamol, Methylone, N- Ethylpentylone, Naltrexone, Norcocaine, Normetanephrine, Orphenadrine, Pentazocine, Ramelteon, Risperidone, Ritalinic Acid, Rizatriptan, Sufentanil, Sumatriptan, Tianeptine, Zolpidem COOH) in 2024. The laboratory performed approximately 60,000 to 90,000 of each of these analytes for patient testing in 2024. Findings include: 1. Reviewed at 9:00 a.m. on 06/03/25, the laboratory's test menu listed Hydroxyethylflurazepam, 3-hydroxy-LSD, 25I-NBOMe, Fluorophenmetrazine, 3-Methylhistidine, AB-Pinaca, Atomoxetine, Baclofen, Buspirone, Chlorpromazine, Desmethylvenlafaxine, Dibutylone, Fluvoxamine, Hydroxyrisperidone, Lacosamide, MDPV (Methylenedioxypyrovalerone), Methocarbamol, Methylone, N- Ethylpentylone, Naltrexone, Norcocaine, Normetanephrine, Orphenadrine, Pentazocine, Ramelteon, Risperidone, Ritalinic Acid, Rizatriptan, Sufentanil, Sumatriptan, Tianeptine, and Zolpidem COOH tests available for patient testing. 2. Reviewed at 9:30 a.m. on 06/03/25, the 2024 proficiency testing records indicated the laboratory did not participate in proficiency testing for Hydroxyethylflurazepam, 3- hydroxy-LSD, 25I-NBOMe, Fluorophenmetrazine, 3-Methylhistidine, AB-Pinaca, Atomoxetine, Baclofen, Buspirone, Chlorpromazine, Desmethylvenlafaxine, Dibutylone, Fluvoxamine, Hydroxyrisperidone, Lacosamide, MDPV Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (Methylenedioxypyrovalerone), Methocarbamol, Methylone, N-Ethylpentylone, Naltrexone, Norcocaine, Normetanephrine, Orphenadrine, Pentazocine, Ramelteon, Risperidone, Ritalinic Acid, Rizatriptan, Sufentanil, Sumatriptan, Tianeptine, and Zolpidem COOH analytes. 3. Upon request, the laboratory failed to provide evidence of a twice annual accuracy verification in 2024 for the above 32 toxicology analytes. 4. During interview at 1:36 p.m. on 06/03/25, an administrative staff member (#1) confirmed the laboratory performed patient testing on the above 32 analytes in 2024 and did not verify the accuracy of these tests in 2024. 5. Upon request, the laboratory failed to provide a policy related to twice annual accuracy verification of non- regulated analytes. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, staff interview, and procedure review, the laboratory failed to label 4 of 4 hematology staining containers (Fixative, Solution I, Solution II, and deionized water) observed. Findings include: 1. Observation at 11:40 a.m. on 06/08 /23 showed four filled containers in a sink at the hematology bench with no identifying information. 2. During interview at 11:40 a.m. on 06/08/23, a technical consultant (#1) stated the containers in the hematology sink contained hematology staining solutions and deionized water used for patient testing and confirmed the laboratory had not labeled these containers. 3. Reviewed on 06/08/23, the policy "Peripheral Blood Smear Staining using Hema 3 Staining Solution," dated 01/12/23, stated, ". . . Required Materials: Hema 3 fixative solution Hema 3 Solution I Hema 3 Solution II 4 Coplin Jars . . . Deionized Water . . . Procedure 1. Transfer each solution to a coplin jar . . ." The procedure failed to include a requirement to label the Coplin jars when filling with staining solutions and deionized water. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the technical consultant failed to include the TOSOH chemistry and Sysmex hematology analyzers in the 2022 annual competency evaluations for 2 of 2 testing personnel's (Testing Personnel #1 and #2) annual evaluations completed in 2022. Findings include: 1. Reviewed at 3:15 p.m. on 06/07/23, the 2022 annual competency evaluations for Testing Personnel #1 and #2 lacked evidence of completed competency evaluations for the TOSOH chemistry analyzer and Sysmex Hematology analyzer. 2. Upon request, the laboratory failed to provide evidence of TOSOH chemistry analyzer and Sysmex Hematology analyzer 2022 competency evaluations for Testing Personnel #1 and #2. 3. During interview at 11:15 a.m. on 06/08/23, a technical consultant (#1) confirmed the 2022 competency evaluations for Testing Personnel #1 and #2 did not include the TOSOH chemistry analyzer and Sysmex Hematology analyzer. 4. Reviewed on 06/08/23, the policy "Training and Competency," revised 04/30/19, stated, ". . . competencies will be determined yearly . . . See appendix A for competency sheets. . . ." The competency sheets in appendix A included: XN1000 (Sysmex hematology analyzer) and TOSOH G8 (TOSOH chemistry analyzer). -- 2 of 2 --

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to monitor the analytic system for four of five specialties/sub-specialties (general immunology, routine chemistry, endocrinology, and hematology) for the year 2020. Findings include: 1. Reviewed at 3:25 p.m. on 09/29/21, the 2020 quality assessment records lacked evidence of analytic system monitoring for the specialties/sub- specialties of general immunology, routine chemistry, endocrinology, and hematology. 2. During interview at 4:25 p.m. on 09/29/21, a technical supervisor (#1) confirmed the laboratory had not performed analytic monitoring for the specialties /sub-specialties of general immunology, routine chemistry, endocrinology, and hematology in 2020. 3. Reviewed on 09/29/21, the policy "Blood Quality Assurance," updated 01/08/20, stated, ". . . Analytical Lot to Lot Comparisons - Perform quarterly. Random test analyte selection. Run 20 samples on the old lot and the same 20 samples on the new lot. Compare the results; should be within 20% of each other. Reviewed quarterly by the laboratory supervisor. . . ." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --