Oral & Maxillofacial Path Diag & Consultative Serv

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 18, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: A review of the procedure manual, training and competency assessment documents including staff interview (TP#3 CMS 209), the laboratory director failed to perform Competency Assessments for his staff in the specialty of Histopathology in 2020 to 2022. Findings include: 1.) Testing Personnel (TP) records review revealed competency assessments were not performed on (TPs # 2 and 3 CMS 209) in 2020, 2021 and 2022. 2.) An interview with the laboratory lead (TP#3 CMS 209) at approximately 11:30 AM on 07/18/2022 in the lab room confirmed the findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 laboratory records review and staff interview, the laboratory failed to establish adequate quality assessment plan (QA) to monitor, assess, and correct problems in the laboratory as they occur. The laboratory did not have a written quality assessment policy that covers Pre-Analytic, Analytic and Post Analytic technical and non-technical functions of the lab. 1. The laboratory failed to have a QA policy to assess specimen identification and integrity, complaint investigations and personnel competency. 2. The laboratory does not have a written QA checklist for 2020, 2021 and 2022 at the time of survey. 3. An interview with lab lead (TP #3 CMS 209) on 07 /18/2022 at approximately 12:45 PM in the lab room confirmed that the laboratory did not have a written and established QA policy for the laboratory. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Quality Assurance(QA) documents review and staff interview, the Lab Director(LD) failed to ensure that proper QA guidelines were established and followed to identify and fix problems in the laboratory as required by Clinical Laboratory Improvement Amendments (CLIA). Findings include: 1. (QA) documents review revealed the laboratory director did not establish adequqte guidelines to identify and correct problems in the laboratory as they occur in 2020 thru date of survey 07/18/2022. 2. An interview with the lab lead (TP#3 CMS209) in the lab room on 07/18/2022, at approximately 12:00 PM, confirmed the LD did not have the aformentioned (QA) policy in 2020 thru the date of survey 07/18/2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 14, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Based on maintenance log review and staff interview and staff interview, the laboratory failed to monitor and document humidity as required by the manufacturer. Findings include: 1. Maintenance log review revealed the laboratory failed to monitor humidity in the microscope room and the histology room as recommended by the microscope manufacturer and the fume hood manufacturer for 2018 (March through December), 2019, and 2020 thus far. 2. An interview with the histotech in the microscope room at approximately 3:30 p.m. on 1/14/2020 confirmed the lack of humidity monitoring and documentation for the aforementioned dates. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance document review and staff interview, the laboratory failed to document and perform maintenance as defined by the manufacturer and with the frequency specified by the manufacturer as required. Findings include: 1. Maintenance document review revealed the Olympus microscope in the microscope room was not professionally calibrated in 2018. 2. An interview with the laboratory director in the microscope room on 1/14/2020 at approximately 2:45 p.m. confirmed the lack of Olympus microscope professional calibration in 2018. . -- 2 of 2 --