Tanglewood Medical Center Pa

Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form, nine of nine moderate complexity testing personnel (TP) competencies for 2024, and interview with the technical consultant (TC), the technical consultant failed to include direct observation of routine patient test performance. Findings: 1. Review of the CMS 209 revealed nine moderate complexity TP. 2. The surveyors requested 2024 TP competencies for review. The laboratory provided nine competencies. The dates of competency assessments and the dates the TC signed the competencies did not match. 3. The surveyor asked the TC if she performed direct observation of patient testing on the nine TP. The TC stated she did not perform direct observation of patient testing on any of the nine TP. 4. In interview on 4/21/25 at 11:15 a.m., the TC confirmed, the technical consultant failed to include direct observation of routine patient test performance. 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 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)