Sunflower Medical Group Pa

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: An on-site revisit was conducted 5/22/25. Based on the review of the CMS 209 personnel form and interview with TC #1, the TC failed to evaluate competency for one of five moderate complexity testing personnel (TP). Findings: 1. Review of the CMS 209 personnel form for the validation survey conducted 12/3/24 revealed five moderate complexity TP. 2. Interview with TC #1 revealed that TP #4 and TP #5 were no longer employeed at this laboratory. 3. The surveyor requested competency documentation for TP #2 and TP #3. No documentation for TP #2 competency was provided at the time of survey. 4. Interview with TC #1 on 5/22/25 at 10:45 a.m. confirmed, the TC failed to evaluate competency for one of five moderate complexity TP.. 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 validation survey was completed December 3, 2024. Sunflower Medical Group PA- Mission Office laboratory was found not in compliance with the following CONDITIONAL LEVEL DEFICIENCIES: D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant Moderate Complexity 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)