Centennial Medical Group

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) procedure and instrument results and interview with the technical supervisor (TS), the laboratory failed to test PT samples the same number of times it tested patient specimens for the 2023 3rd PT event for the molecular Influenza A (Flu A) assay. Findings: 1. The "Proficiency Testing" procedure stated that "PT samples are run the same number of times as routine patient testing." 2. Instrument results were reviewed for Flu A PT sample 11 from the 2023 3rd event. 3. Flu A sample 11 was tested in triplicate. 4. During the survey on 06/18 /2024 at 12:30 PM, the TS confirmed that Flu A PT sample 11 was tested in triplicate and that patient samples were routinely tested once, not in triplicate. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to fully document the investigations and failed to address the potential impact on patient results when chemistry PT results were graded as unacceptable (see D5211 for findings); failed to have procedures to monitor, assess, and correct problems identified during the accessioning of patient specimens for chemistry (see D5391 for findings); failed to define criteria for temperature conditions for proper storage of reagents and specimens, accurate and reliable test system operation (see D5413 for findings); failed to ensure that the preventive maintenance information recorded on the chemistry records was complete (see D5429 cite I for findings); failed to have control procedures that monitored the accuracy and precision of the complete analytic process, detect and monitor quality control over time (see D5441 cites I, II, III, and IV for findings); failed to ensure that one or both Levels of the chemistry control reagent were tested each day of patient testing (see D5445 for findings); failed to establish or verify the criteria for acceptability of control materials providing quantitative results, statistical parameters (see D5469 for findings); failed to take

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review and interview with the general supervisor (GS), the laboratory did not have a detailed QA procedure to monitor, assess, and, when indicated, correct problems identified in the general laboratory system. Findings: 1. The procedure, "Quality Assessment Policy" was reviewed. The procedure was preceded by 2 pages of "Quality Assessment Monitors" which listed QA activities in the left column and dates in the right column. The QA activities were listed under the headings, "General Phase of Testing/Focus Studies," "Pre-Analytical Phase of Testing," "Analytical Phase of Testing," and "Post- Analytical Phase of Testing." 2. Review of the "Quality Assessment Policy" showed that there were no instructions for how to perform the QA duties listed under "Quality Assessment Monitors." 3. During an interview on 08/03/2022 at 2:45 PM, the GS confirmed that the laboratory's QA policy did not include instructions on how to perform the QA activities. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the standard operating procedure manual (SOPM) and interview with the general supervisor (GS), the laboratory's SOPM failed to define the specimen rejection criteria for each assay based on age of specimen. Findings: 1. The laboratory performed polymerase chain reaction (PCR) testing for multiple panels: 1) severe acute respiratory syndrome coronavirus 2, influenza, and respiratory syncytial virus; 2) sexually transmitted infections; and 3) urinary tract microbiota and antibiotic resistance markers. 2. Each PCR panel's procedure in the SOPM included a "Sample Rejection Criteria" section that stated that specimens would be rejected if "integrity is compromised (too old or damaged)" but did not specify what age was "too old" for each panel. 3. The procedure titled "Laboratory Specimen Collection and Rejection Guidelines" was not specific to the testing performed at the laboratory that was surveyed and did not include sample rejection criteria for the PCR testing panels. 4. During the survey on 08/08/2022 at 2:45 PM, the GS confirmed that the laboratory's SOPM did not define the rejection criteria for age of specimen for each PCR panel. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory procedure manual and record review and interview with the laboratory staff and the general supervisor (GS), the laboratory did not ensure that the procedure for maintaining the laboratory refrigerator thermometers accurately reflected the current practice in the laboratory. Findings: 1. During an interview on 08 /08/2022 at 1:00 PM the laboratory staff stated that monthly each laboratory refrigerator thermometer is checked against a NIST (National Institute of Standards and Technology) certified thermometer in order to verify their calibration. 2. Record review showed that there was no documentation that monthly thermometer calibrations had been performed. This was confirmed by the laboratory staff at 1:00 PM. 3. The procedure, "Equipment Maintenance and Remedial Plan" states that "Thermometers are certified upon receipt by the vendor to ensure their accuracy and consistency" but the procedure did not give instructions on how to perform the monthly thermometer checks. 4. During an interview on 08/08/2022 at 2:45 PM, the GS confirmed that the written procedure manual did not accurately reflect the actual practice of the laboratory. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with the general supervisor (GS), the GS failed to evaluate and document the performance of all testing personnel (TP). Findings: 1. The laboratory currently has 3 TP listed on the "Laboratory Personnel Report" (CMS- 209). 2. A review of competency assessment records from 2021 to 2022 showed that initial training documents for 1 of 3 TP were not present at the time of the survey. 3. During an interview on 08/03/2022 at 3:00 PM, the GS confirmed that the training records could not be located. -- 3 of 3 --