Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. 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 surveyor observation, a review of the laboratory's temperature logs, a review of the laboratory's records, and staff interview, it was revealed that the laboratory failed to ensure BioFire RP2.1/RP1.2 plus Control Panels were stored at temperatures required by the manufacturer for 31 of 61 days reviewed from July 1, 2022 to August 31, 2022. Findings include: 1. Surveyor observation of the laboratory on 6/28/23 at 12: 00 p.m. revealed 2 boxes of BioFire RP2.1/RP2.1 plus Control Panel (lot: Q11Jan23 expiration: 1/31/24) stored in the laboratory's freezer. 2. Further observation of the boxes of control material revealed the storage requirement of -25C - -15C. 3. A review of the laboratory's Temperature logs from July 1, 2022 to August 31, 2022 revealed the following 31 days when the temperature was recorded as outside of the acceptable storage requirement: 7/1/22 -25.9C 7/2/22 -25.8C 7/3/22 -25.8C 7/4/22 -25.8C 7/5/22 -25.6C 7/6/22 -25.5C 7/7/22 -25.6C 7/8/22 -25.8C 7/9/22 -26.0C 7/10 /22 -26.1C 7/11/22 -25.4C 7/12/22 -25.2C 7/13/22 -25.4C 7/14/22 -25.7C 7/15/22 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 -- -25.7C 7/16/22 -26.0C 7/17/22 -25.8C 7/18/22 -25.7C 7/19/22 -25.7C 7/20/22 -25.8C 7/21/22 -25.8C 7/22/22 -25.7C 7/23/22 -25.6C 7/24/22 -25.7C 7/25/22 -25.6C 7/26/22 -25.7C 7/29/22 -25.7C 7/30/22 -25.9C 7/31/22 -25.7C 8/1/22 -26.1C 8/2/22 -26.1C 4. A review of the laboratory's records revealed the laboratory estimated performing 9000 tests annually on the BioFire Torch analyzer. 5. An interview with the director of lab services on 6/28/23 at 12:00 p.m. in the office, after review of the records, confirmed the above findings. Key: C = degrees Celsius D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of the technical consultant performing a competency assessment, at least semiannually during the first year of testing, for two of twelve testing personnel in 2021 and 2022 for all moderate complexity testing performed in the laboratory. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 12 testing person performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed the following testing personnel, their hire date, and date(s) a competency assessment was performed by the technical consultant: a) Testing person #3 Hire date: September 2021 Competency assessment: January 2022 Based on the hire date, testing person #3 should have had at least 2 competency assessments performed prior to September 2022. b) Testing person #4 Hire date: August 2020 Competency assessment: February 2021 Based on the hire date, testing person #4 should have had at least 2 competency assessments performed prior to August 2021. 3. An interview with the director of lab services on 6/28/23 at 10:20 a.m. in the office, after review of the records, confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: I. Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel files, and staff interview, it was revealed that the technical consultant failed to perform a competency assessment on three of twelve testing personnel in 2021. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 12 testing personnel performing moderate complexity testing. 2. A review of the laboratory's personnel records revealed no documentation of the technical consultant performing a competency assessment in 2021 for the following: - Testing person #7 - Testing person #8 - Testing person #10 3. An interview with the director of lab services on 6/28/23 at 9:45 a.m. in the office, after review of the -- 2 of 3 -- records, confirmed the above findings. II. Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel files, and staff interview, it was revealed that the technical consultant failed to perform a competency assessment for the BioFire Torch analyzer on three of twelve testing personnel in 2021 and one of twelve testing personnel in 2022. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 12 testing personnel performing moderate complexity testing on the BioFire Torch analyzer. 2. A review of the laboratory's personnel records revealed no documentation of the technical consultant performing a competency assessment for the BioFire Torch analyzer for the following: 2021: - Testing person #5 - Testing person #11 - Testing person #12 2022: - Testing person #3 3. An interview with the director of lab services on 6/28/23 at 9:50 a.m. in the office, after review of the records, confirmed the above findings. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, it was revealed that two of twelve testing personnel failed to have documentation of training prior to performing patient testing on the Medonic M Series hematology analyzer. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 12 testing personnel who performed moderate complexity testing. 2. A review of the laboratory's personnel records revealed that testing person #10 and testing person #11 failed to have documentation of training on the Medonic M Series hematology analyzer. 3. An interview with the director of lab services on 6/28/23 at 10:30 a.m. in the office, after review of the records, confirmed the above findings. -- 3 of 3 --