Parochial Medical Center Lab

Summary Statement of Deficiencies D0000 A CLIA validation survey was conducted by the Pennsylvania Department of Health at the Parochial Medical Center Lab, that was concluded on June 17, 2025. Conditions cited under 42 CFR part 493 CLIA Regulation: D6033 -42 CFR. 493.1409 Technical Consultant-Moderate Complexity. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A. Based on observation in the laboratory, review of laboratory temperature records, and interview with Testing Personnel (TP) #1, the laboratory failed to monitor room temperatures to ensure proper storage of reagents and operating conditions of the laboratory were met for 238 of 731 days from 6/17/2023 to 6/17/2025. Findings include: 1. On the day of survey, 6/17/2025, at 11:00 am, during the tour of the laboratory, the surveyor observed the following supplies stored in the laboratory: - Various Vacutainer Collection Supplies Storage requirements 39.2F to 77F. - Abbott Cell-Dyn Emerald Instrument Reagents. Storage requirements 39.2F to 95F. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document room temperatures for 238 of 731 days from 6/17/2023 to 6/17 /2025 when the laboratory was closed. 3. TP #1 confirmed the findings above on 6/17 /2025 at 11:30 am. B. Based on observation in the laboratory, lack of documentation, 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 -- and interview with Testing Personnel (TP) #1, the laboratory failed to monitor refrigerature temperature to ensure reagent stability and proper operating conditions of the supplies used for hematology testing stored there for 731 of 731 days from 6/17 /2023 to 6/17/2025. Findings include: 1. On the day of survey, 6/17/2025, at 11:00 am, during the tour of the laboratory, the surveyor observed the following hematology reagents stored in the laboratory refrigerator: - Cell-Dyn Emerald Quality Control. Storage requirements 35.6F to 46.4F. 2. The laboratory could not provide documentation of temperature monitoring for the refrigerator where Cell-Dyn Emerald Quality Control was stored for 731 of 731days from 6/17/2023 to 6/17/2025. 3. TP #1 confirmed the findings above on 6/17/2025 at 11:30 am. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager (LM), the Laboratory failed to have a policy to assess the competency of 9 of 9 Testing Personnel (TP) that performed the Complete Blood Count test from 2017 to date of survey, 04/25/19. Findings Include: 1. Competency assessment in 2018 was not performed on 9 of 9 TP. 2. During time of survey, LM could not produce a competency assessment policy on 04/25/19 at 12:00 pm. 3. LM confirmed findings on 04/25/19 at 12:00 pm. 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 record review and interview with the Laboratory Manager (LM), the Technical Consultant (TC) failed to conduct competency assessment on 9 of 9 Testing Personnel (TP) from 2017 to the date of survey, 04/25/2019. Findings Include: 1. Laboratory Director (LD) was listed as the TC on the Laboratory Personnel Report (CLIA) Form, CMS-209. 2. During the survey, surveyor identified TP #3 and TP #7 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 -- conducted the 2019 competency assessments. a. TP #3 conducted competency assessments on 7 of 9 TP. b. TP #7 conducted competency assessments on 2 of 9 TP. 3. Record review showed TP #3 was awarded a high school diploma and did not meet the TC qualifications. 4. Record review showed TP #7 was awarded an associate in science, major in nursing and did not meet the TC qualifications. 5. LM confirmed findings on 04/25/19 at 12:00 pm. -- 2 of 2 --