Jeffers, Mann & Artman Pediatrics And

Summary Statement of Deficiencies 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 records, review of patient testing logs and interviews with testing personnel (TP #3) 10/25/24, the laboratory failed to verify the performance specifications of the BR2 Total Bilirubin (TBIL) analyzer prior to performing patient testing. 8 patients were tested from September 9, 2024 until date of survey, October 25, 2024. Findings: During interview at approximately 10:00 a.m. TP#3 stated they had been having trouble with their old BR2 analyzer and had to bring one in from another facility in September of 2024. Review of performance verification records for the BR2 analyzer revealed documentation of a performance verification in 2016. There was no documentation of a verification of performance after the analyzer was moved to the new facility in September of 2024. Review of patient testing logs revealed 8 patients were tested from September 9, 2024 until October 25, 2024. Interview with TP #3 at approximately 12:30 p.m. confirmed the laboratory had not verified the performance specifications of the BR2 analyzer after it was moved to the facility. They stated they were under the impression that the verification performed in 2016 was all that was needed. They also confirmed 8 patients were tested. D6019 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of quality control (QC) records and interview with technical consultant (TC) 11/7/19, the laboratory failed to use the laboratory's established QC ranges for the bilirubin testing performed on the Advanced Instruments BR2 STAT Bilirubin analyzer as required by the manufacturer. Findings: Review of manufacturer's instructions for BIO-RAD Liquichek Pediatric quality control reagents revealed "Assignment of Values...It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of the control." Review of QC records for the BR2 STAT bilirubin analyzer revealed the laboratory had established QC ranges for the BIO-RAD Liquichek Pediatric Control Levels 1 and 2, Lot #'s 44311 and 44312, in December of 2018. Review of QC records revealed the laboratory failed to use the laboratory's established values from August 12 to October 30, 2019, a period of approximately 3 months in which the manufacturer's values were used to determine QC acceptability. Approximately 10 patients were tested from August 12 to October 30, 2019. During interview at approximately 1:00 p.m. the TC confirmed the laboratory had not used the laboratory's established values to determine QC acceptability as required from August 12 to October 30, 2019. 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 --