Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on document review and interview with the Laboratory director (LD), the LD failed to be present for a reasonable period of each working day in each laboratory for which they were director from 08/12/2020 to the day of survey as required by Pennsylvania (PA) state regulations. Findings include: 1.The PA State regulation 5.22 (g) states: "A director shall be present for a reasonable period of each working day in each laboratory for which he is director." 2.On day of survey 09/05/2024, review of the PA Application for Approval to Direct more than Two Clinical Laboratories (Exception to 5.22) form, revealed the LD currently oversees 4 accredited laboratories, with 3 of the 4 laboratories located out of the state of PA. 3. Penn Fertility Care personnel policy states " The Laboratory Director will provide approximately thirty (30) hours of service per month. It is anticipated that visits will take place a minimum of four (4) times per year." 4. Further review of the laboratory's Quality Assessment Site Visit Logs revealed the LD was on site once a quarter. 5. The LD confirmed the findings above on 09/05/2024 at 11:45 am 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. 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 assessment records and interview with the Laboratory Director (LD), the laboratory failed to establish a competency assessment procedure to assess 1 of 2 Technical Supervisors (TS) and 1 of 1 General supervisor (GS) for their supervisory responsibilities from 11/10/2020 to the day of survey. Findings Include: 1. On the day of survey, 09/05/2024 at 9:25 am, the laboratory failed to provide a competency assessment procedure to assess the competency of 1 of 2 TS (CMS 209 personnel #4) and 1 of 1 GS (CMS 209 personnel #5) for their supervisory responsibilities from 11/10/2020 to 09/05/2024. 2. The laboratory failed to provide competency assessment documentation for 1 of 1 GS (CMS 209 personnel #5) from 11 /10/2020 to 09/05/2024. 3. The LD confirmed the findings above on 09/05/2024 at 11: 40 am -- 2 of 2 --