Missouri State Public Health Lab

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Review of the manufacturer's instructions, patient test volumes, observation of one of one opened bottle of internal standard material stored in the refrigerator, and interview with the technical supervisor (TS) #2, the laboratory failed to follow the manufacturer's instructions for storage of control material for X-linked Adrenoleukodystrophy (X-ALD) Newborn Screening. Findings: 1. Review of the Perkin Elmer manufacturer's instructions stated, "to store the Lypo PC internal standard at minus 20 degrees Celsius (C)." 2. Observation of the refrigerator showed one opened bottle of Perkin Elmer Lypo PC (lot #20210222) internal standard being stored at 2-8 degrees C. 3. The laboratory performs approximately 90,000 tests annually for X-ALD. 4. Interview with TS #2 on July 18, 2022, at 10:30 a.m. confirmed the laboratory failed to store the internal standard material per manufacturer's instructions. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of three of three opened bottles of Bio-Rad quality control (QC) for blood lead testing, review of manufacturer's instructions, patient test volumes, and interview with the technical supervisor (TS) #1, the laboratory used QC material once it exceeded the expiration date. Findings: 1. Observation of the refrigerator located in the chemistry laboratory area showed three opened bottles of Bio-Rad Lyphocheck (lot #84910), QC levels 1, 2, and 3, for blood lead testing with no open date. 2. Review of Bio-Rad manufacturer's instructions confirmed, "after reconstituting and storing tightly capped at 2-8 degrees C, this product will be stable for 14 days." 3. The laboratory performs approximately 2251 tests annually. 4. Interview with TS #1 on July 18, 2022, at 9:30 a.m. confirmed the laboratory used the QC for blood lead past the expiration date of 14 days. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance verification procedures for the 17- hydroxyprogesterone (17-OHP) assay on the genetic screening processor (GSP), and interview with the technical supervisor (TS #2), the laboratory failed to ensure that the reportable range of test results for the test system was appropriate prior to reporting patient test results. Findings: 1. The laboratory uses Perkin Elmer genetic screening processors (GSP), GSP-20210150 (Oscar) and GSP-20210545 (Tony) to screen newborns for increased (17-OHP) activity. 2. Review of the verification procedures for the 17-OHP assay on the GSP-20210545 (Tony) determined that no reportable range of test results was performed. 3. The laboratory reports a 17-OHP annual test volume of 90,000. 4. Interview with TS #2 on July 20, 2022 at 9:30 a.m. confirmed that the laboratory failed to ensure that the reportable range of test results for the 17- OHP assay using GSP-20210545 (Tony) was appropriate prior to reporting patient test results. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) -- 2 of 3 -- Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of Perkin Elmer manufacturer's manual, review of the verification of performance specifications, review of patient test volumes, and interview with the technical supervisor (TS) #2, the laboratory failed to provide documentation of analytical sensitivity, analytical specificity, reportable range, and reference intervals for a non-FDA approved test system for X-linked Adrenoleukodystrophy (X-ALD) Newborn screening. 1. Review of the Perkin Elmer QSight 225 LC-MS/MS analyzer manual for X-ALD testing revealed: "not FDA approved." 2. Review of the laboratory's validation reports for performance specifications of the Perkin Elmer QSight 225 LC-MS/MS analyzer (Butters) revealed the laboratory failed to verify analytical specificity, analytical sensitivity, reoportable range, and reference intervals (normal values). 3. The laboratory performs approximately 90,000 X-ALD patient tests annually. 4. Interview with TS #2 on July 20, 2022, at 11:00 a.m. confirmed the laboratory failed to provide the performance specifications for analytical specificity, analytical sensitivity, reportable range, and reference intervals before using a non- FDA approved test system. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of four of ten proficiency testing (PT) records, review of the "Quality Systems Procedure" and interview with the laboratory director (LD), the LD failed to sign attestation statements for the specialties of virology and bacteriology performed from March 12, 2020 to December 1, 2020. Findings: 1. Review of PT attestation sheet records showed: The 1st Virology event of 2020 (VR1-A 2020), signed by TP #24. The 3rd Virology event of 2020 (VR1-C 2020), signed by TP #27. The 3rd Virology event of 2020 (VR4-C 2020); signed by TP #27 and the 3rd Bacteriology event of 2020 (HC6-C 2020); signed by laboratory staff not listed on form CMS-209. 2. Review of the "Quality Systems Procedure" stated "All proficiency tests are reviewed and signed by the Laboratory Director and CLIA Director." 3. In an interview conducted on November 19, 2020 at approximately 2:15 P.M. the LD confirmed she failed to sign the attestation statements. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel competency records, procedure manual, and staff interview, the laboratory failed to ensure 17 of 17 general supervisory (GS) and six of six technical supervisor (TS) competency assessments included specific position responsibilities listed in Subpart M. Findings: 1. Personnel competency records failed to include documentation of evaluations of specific GS and TS responsibilities besides duties related to patient testing and/or report patient test results. 2. Review of the procedure manual revealed a lack of written policies and procedures to assess employees in the position of technical and general supervisor positions. 3. In an interview conducted on 11/18/2020 at approximately 2:30 P.M. the LD confirmed that competency assessments for GS and TS failed to include specific position responsibilities. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and procedures (P&P), and confirmed during interview, two of 35 P&P were not approved, signed, and dated by the laboratory director (LD) before use. Findings: 1) Review of "Geenius HIV 1/2 Supplemental Assay" P&P revealed hand written changes on page 14 of 32 were made on November 16, 2016. 2) Review of "Geenius HIV 1/2 Supplemental Assay" P&P revealed hand written changes on page 18 of 32 were made on November 3, 2016. 3) The LD approved the "Geenius HIV 1/2 Supplemental Assay" P&P on October 13, 2016. 4) Review of "Tigris: Aptima Combo 2 Procedure" P&P revealed hand written changes on page 70 of 71 were made on November 9, 2016. 5) The LD approved the "Tigris: Aptima Combo 2 Procedure" P&P on November 4, 2016. 6) Confirmed during interview with the LD July 19, 2018 at 11 AM. 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 --