Summary:
Summary Statement of Deficiencies 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 surveyor review of Histopathology Laboratory Department Policies and Procedures Manual, case reports and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of the microscopic examination of 35 of 35 frozen section specimens from 2022-2023 as required . Findings Include: 1) On the day of survey 06/15/23 at 8:55am, the laboratory could not provide a procedure manual for the verification of accuracy of frozen section performed in the laboratory. 2. At the time of survey, the laboratory could not provide documentation of verfication activities performed. 3.The LD confirmed the findings above on 06/15 /2023 around 10:00 am. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring 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 review of the Reading Hospital Laboratory Department Policies 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 -- Procedures Manual, interview with the Laboratory Operations Manager (LOM) and Laboratory Director (LD), the technical supervisor (is also laboratory director) failed to ensure the competency of 2 of 2 testing personnel (TP), (listed on CMS-209 form,) who performed frozen sections from 2021 through the date of survey. Findings Include: 1. The Reading Hospital Laboratory Department Policies and Procedures Manual (Procedure D) reviewed at the time of survey, states competency assessments will be performed during initial training and again after each 6 months during the first year of an individual's employment. Thereafter, competency assessment will be performed at least annually. 2. On the day of survey, 06/15/2023, the LD and LOM could not provide documentation of competency assessments performed for 2 of 2 TP who performed frozen sections from 2021 through the date of survey. 3. The LD and LOM confirmed the findings above on 06/15/2023 around 10:00 am. -- 2 of 2 --