Gunnar H Gibson Md

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the Care of the Microscope procedure manual, lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to twice a year maintenance as specified by the Laboratory: A. A review of the Care of the Microscope procedure manual revealed the maintenance policy states on step 12 "Have the microscope cleaned twice a year by professional microscope service person". B. Reviewing the Daily Cleaning Schedule Microscope Log for 2022 revealed no date was recorded of the Semi-annual Professional Cleaning was performed. No records/receipts of professional service of the cleaning. C. Reviewing the Daily Cleaning Schedule Microscope Log for 2023 revealed no date was recorded of the Semi-annual Professional Cleaning was performed. No records/receipts of professional service of the cleaning. D. In an interview on 06/07/2024 at 12:10, Office Manager confirmed the Laboratory failed to document the microscope maintenance in accordance with Care of the Microscope procedure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Through interviews with staff, review of Consultation Reports, and review of competency assessments, it was determined competency assessments were not documented by the technical consultant listed on the CMS 209. Findings include: D6046 - competency assessments were documented by personnel not listed as technical consultant on the CMS 209 and direct observation competency assessments were documented by personnel who was not present on the date of the assessment. 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: . Through interviews with staff, review of Consultation Reports, and review of competency assessments, it was determined competency assessments were documented by personnel not listed as technical consultant on the CMS 209 and documented by personnel who were not present on the date of the assessment. Survey findings follow: A. Laboratory employee #3, who was present for the survey was not 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 -- listed on the form CMS-209 and stated in an interview (8:40 on 9/25/2020) that she was not the technical consultant for the laboratory but is called by the laboratory and only comes in when the laboratory is having a CLIA inspection (3/16/18 and 3/11 /2020). B. In a review of the Employee Competency Assessments dated 12/26/2018, 3 /22/2019, and 9/9/2019 it was observed the handwriting that documented the direct observation competency assessment matched the handwriting of laboratory employee #3 as listed on the Employee Identification Worksheet. In an interview at 8:46 on 9/25 /2020, employee #3 confirmed it was her handwriting that documented direct observation competency assessments on dates when she was not at the facility and could not directly observe competency. C. In an interview at 8:50 on 9/25/2020, employee #3 (as listed on the Employee Identification Worksheet), stated again that she only comes to the laboratory when the laboratory contacts her prior to their CLIA surveys. She confirmed the only dates she had been to the laboratory prior to the current survey were 3/16/2018 and 3/11/2020 (not the dates of the competency assessments which were in her handwriting). D. The surveyor requested documentation of consultation by employee #3 and was presented with Consultation Reports dated 3/16/2018 and 3/11/2020. Employee #3 confirmed (8:50 on 9/25/2020) no other documentation of consultation visits was available. There were discrepancies in the dates employee #3 reported she was in the laboratory and the documented dates of direct observation competencies. -- 2 of 2 --