Troyer Medical, Inc

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of quality control (QC) package inserts, laboratory policy, surveyor observation and testing personnel (TP)interview 03/17/25, the laboratory failed to ensure quality control (QC) reagents were labeled with the open date and new expiration date after opening. Findings: Review of package inserts for Immunalysis Tetrahydrocannabinol (THC), Oxycodone (OXY) and Buprenorphine (BUP) Urine Quality Control Sets revealed "Storage, Stability and Handling...The opened bottles are stable for 60 days or the printed expiration date, whichever comes first.". Review of laboratory policy "Quality Control and Calibrations Procedure General Laboratory Policy" revealed "When opening reagents, controls, calibrators, and supplies affected by expiration dates, the container is to be labeled with the opening date (and time if relevant), the expiration date (and time if relevant), and initials of the individual opening it.". At approximately 1:00 p.m. surveyor observed the following 6 bottles of opened and in use Immunalysis QC reagent in the refrigerator door shelf with no open date or new expiration date on the label; 2 bottles of BUP Urine Control - Lot #E54866 and Lot #E54865. 2 bottles of OXY Urine Control - Lot #E55107 and Lot #E55106. 2 bottles of THC Urine Control - Lot #E55108 and Lot #E55109. Interview with TP #1 at approximately 1:00 p.m. confirmed the 6 bottles of QC reagent were opened, in use and not labeled with the open date and new expiration date. 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 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD) 8/25/22, the laboratory failed to retain all analytic systems records for at least two years. Findings: The laboratory failed to retain Easy RA calibration and maintenance records and laboratory refrigerator and room temperature records for approximately 8 months, from September of 2021 through May of 2022. Interview with the LD at approximately 1:30 p.m. confirmed the laboratory failed to retain calibration, maintenance, and temperature records from September of 2021 through May of 2022. The LD stated they were unable to locate the documentation and it might have been taken by a previous employee. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the LD 8/25/22, the laboratory failed to discard supplies that exceeded their expiration dates. Findings: During a tour of the laboratory approximately 12:15-12:30 p.m., the surveyor observed the following items 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 -- in the laboratory's refrigerator, available for use: 1. 1 box GlucoTrol - AQ Level Low (1) and Level High (3) lot #18050010, expiration date 6/21; 2. 2 bottles Henry Schein, Inc. Urine Control Solution Level 1, lot #061033, expiration date 3/22; 3. 2 bottles Henry Schein, Inc. Urine Control Solution Level 2, lot #061034, expiration date 3/22; 4. 1 bottle Medica CREA-U CAL lot #21113, expiration date 4/23/22; 5. 1 box Verichem Urine Chemistry Standard Kit (Levels A, B, C, D, E) lot #G402206, expiration date 6/30/22. During interview at approximately 12:30 p.m., the LD stated she was unaware the expired supplies were in the laboratory's refrigerator. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of performance verification records for cocaine (COC) testing, review of analyzer performance records for the Easy RA toxicology analyzer, review of random patient test report and interview with LD 8/25/22, the laboratory test report was incorrect for the cut-off value established for COC testing. Findings: Review of performance verification records for COC revealed the laboratory had validated the testing for a cut-off value of 300 ng/mL (nanograms per milliliter). Review of analyzer performance records for the Easy RA toxicology analyzer revealed the cut- off value programmed in the analyzer to determine positive or negative results was 300 ng/mL. Review of random patient test report, patient identification number HF233283055, completed 8/12/22, revealed a cut-off value of 200 ng/mL for COC. Interview with LD at approximately 12:30 p.m. confirmed the test report had the incorrect cut-off value for COC testing and also confirmed the value should be 300 ng /mL. -- 2 of 2 --