Galen Medical Group Laboratory Pc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory's procedures and environmental logs, and interview with the laboratory manager, determined the laboratory failed to follow their own written procedure for performing and documenting

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ================================== Based on review of patient test audit for 10/5/2021 for ABO Type and Antibody Screen (Type and Screen), review of ABO Rh Blood Grouping MTS Gel Method policy, Antibody Screen/Indirect Antiglobulin Test (IAT): Ortho MTS-IgG Gel System policy and interview with the technical consultant, determined the laboratory failed to meet acceptable quality control guidelines prior to testing a total of 10 patients. The findings include: 1. A patient test audit for Type and Screen results on 10/5/2021 revealed lack of two levels of acceptable control materials prior to testing patients. 2. A review of the laboratory's ABO RH Blood Grouping MTS Gel Method policy stated, "Quality Control: Reagents are checked each day of use for expected positive and negative reactions using appropriate test cells." 3. A review of the laboratory's Antibody Screen/Indirect Antiglobulin Test (IAT): Ortho MTS-IgG Gel System policy stated, "Quality Control: To recognize reagent deterioration and to confirm reagent specificity/reactivity, reagents must be inspected and tested daily with appropriate controls and recorded in the computer." 4. An interview at approximately 12:30 p.m. April 18, 2022 with the technical consultant confirmed that no Type and Screen control materials were documented on 10/5/2021 with 10 patient Type and Screens tested and reported that day. ================================== 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 D0000 A revisit survey was conducted on Galen Medical Laboratory for all previous deficiencies cited on January 23, 2019. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations surveyed. 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 a review of 2018 precision results and an interview with the laboratory supervisor, the laboratory failed to confirm the precision for Vitamin B 12, Prolactin, and Human Chorionic Gonadotrophin (HCG) testing. Findings include: 1. A review of Vitamin B 12, Prolactin and HCG precision testing for 2018 yielded an "imprecise" response from the testing company preparing the results for Linearity 8 A and Linearity 8 B. 2. An interview with the laboratory supervisor at 1:30 PM on January 23, 2019 confirmed Vitamin B 12, Prolactin and HCG precision testing for 2018 yielded an "imprecise" response from the testing company preparing the results for Linearity 8 A and Linearity 8 B. 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 --