Galen Medical Group

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, direct observation, and interview with the laboratory's technical consultant, determined the laboratory failed to provide specimen labeling instructions for Complete Blood Count (CBC) specimen collection from 2020 to February 23, 2023. The findings include: 1. Review of the laboratory's CBC procedure manual failed to provide specimen labeling instructions for CBC specimen collection. 2. Direct observation of one CBC fingerstick specimen on 2.23.2023 at approximately 10:00 a.m. revealed the specimen was not labeled with any patient identifier. 3. Interview with the laboratory's technical consultant on 2.23.2023 at 11:00 a.m. confirmed the laboratory failed to provide specimen labeling instructions for Complete Blood Count (CBC) specimen collection from 2020 to February 23, 2023. 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 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 -- 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 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. This STANDARD is not met as evidenced by: Based on review of 14 of 14 testing personnel (TP) competency documents for performing Complete Blood Counts (CBC) and upon interview with the lead lab tech, determined the technical consultants failed to ensure documented/signed initial, semi- annual, and annual competency evaluations for 2017-2019. The findings include: 1. There were no competency evaluations documented/signed for 14 of 14 testing personnel in 2017-2018 for performance of CBC testing. 2. Upon interview with the lead lab tech at approximately 9:30am, on March 19, 2019, confirmed the technical consultants failed to document/sign competency assessments for 14 of 14 TPs in 2017- 2018 for CBC testing. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a lack of testing person's (TP) initial and six months competencies for 2018- 2019 and an interview with the lead lab tech, the technical consultants failed to document the required initial and six months competencies for 2 of 5 TPs in 2018-19. 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 -- Findings include: 1. There were no completed initial and six months competencies for 2 of 5 TPs (TP#9 & TP#14) for 2018-19 available for review. 2. In an interview, approximately 9:35am, on March 19, 2019, the lead lab tech confirmed the technical consultants failed to complete the required initial and six months competencies for 2 of 5 TPs in 2018-19. -- 2 of 2 --