Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 6/04/2026 at Penn Highlands Mon Valley/Resp by the Pennsylvania State Agency. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on review of competency records and interview with Testing Personnel (TP) #2, the technical consultant (TC) failed to evaluate performance of instrument maintenance and function checks through direct observation for 12 of 15 testing personnel (TP) who performed blood gas examinations in 2024 and 2025. Findings Include: 1. On the day of survey, 6/04/2026 at 11:00am, review of competency records revealed the TC failed to evaluate performance of instrument maintenance and function checks through direct observation for the following TP who performed blood gas analysis in 2024 and 2025: - 2024:12 of 15 TP (CMS 209, TP #2, 3, 4, 5, 6, 7, 8, 9, 11, 13,14 and 15, dated 6/04/2026) - 2025: 12 of 15 TP (CMS 209, TP #1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, dated 6/04/2026) 2. The laboratory performed 1,500 blood gas examinations in 2025 (CMS total estimated annual test volume, dated 6/04/2026). 3. TP #2 confirmed the above findings on 06/04/2026 at 12:00pm. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and 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 -- This STANDARD is not met as evidenced by: Based on review of competency records and interview with Testing Personnel (TP) #2, the technical consultant (TC) failed to evaluate problem solving skills for 14 of 15 laboratory testing personnel (TP) in 2024 and 15 of 15 TP in 2025, who performed blood gas examinations. Findings Include: 1. On the day of survey, 6/04/2026 at 11: 00am, review of competency records revealed the TC failed to evaluate problem solving skills for the following TP who performed blood gas analysis in 2024 and 2025: -2024: 14 of 15 TP (CMS 209, TP #2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, dated 6/04/2026) -2025: 15 of 15 TP (CMS 209, TP #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,13, 14, 15, dated 6/04/2026) 2. The laboratory performed 1,500 blood gas examinations in 2025 (CMS total estimated annual test volume, dated 6/04/2026). 3. TP #2 confirmed the above findings on 06/04/2026 at 12:00pm. -- 2 of 2 --