Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on December 17, 2024. DEBRA PRICE MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and laboratory consultant interview, the laboratory failed to ensure that one out of four testing personnel (TP) participated in the twice a year accuracy verification for Hematoxylin and Eosin stain interpretation testing for two out of two years reviewed. Findings included: 1- Review of FORM CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director on12/17 /2024 revealed that the Laboratory Director, Technical Supervisor, General Supervisor was the same person and that the laboratory had three TP (TP#A, TP#B, TP#C) listed in the 209. 2-Patient log review revealed that there was another TP in this period (TP#D). TP#D performed testing on 06/13/2023, 09/11/2023, 11/13/2023, 11/15/2023, 01/10/2024, 02/21/2024 and 03/13/2024. -Review of Peer Review records revealed that the laboratory failed to have records for TP#D for the years 2023 and 2024. 3-During an interview on 12/17/2024 at 12:30 PM, the laboratory consultant confirmed that the laboratory failed to ensure that TP#D participated in the accuracy verification for Hematoxylin and Eosin stain testing for TP#D during 2023 and 2024. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring 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 -- that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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, the Technical Supervisor (TS) failed to evaluate competency for one out of two testing personnel (TP) in 2023 and for two out of four TP in 2024. Findings included: 1-Review of the FORM CMS-209 signed by the Laboratory Director (LD) on 12/17/2024 revealed that LD, Clinical Consultant (CC), TS, General Supervisor (GS) was the same person, The laboratory listed three TP (TP#A, TP#B, TP#C. 2-Patient log review revealed that there was another TP in this period (TP#D). TP#D performed testing on 06/13/2023, 09/11/2023, 11/13/2023, 11/15/2023, 01/10/2024, 02/21/2024 and 03/13/2024. 3-Review of Patient log revealed that TP#C started testing on 09/04/2024 and did testing from September to December 2024. 3-Review of personnel records revealed that there were no records of competency for TP#C in 2024. and no records for TP#D for 2023 and 2024. 5-During an interview on 12/17/2024 at 12:45 PM with laboratory consultant, she confirmed that the TS failed to document the competency evaluation for TP#C and TP#D for the period listed above. -- 2 of 2 --