Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted on 8/27/2024. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 record review and interview with staff the laboratory failed to twice annually verify the accuracy of two of two moderately complex tests in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. The laboratory was asked to provide documentation of verification of accuracy. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. 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 record review, the laboratory's procedures, and interview with staff the 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 -- laboratory failed to establish written policies and procedures for the performance of two of two moderately complex test. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. The laboratory was asked to provide written procedures for the performance of urine sediments and qualitative semen analysis. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. 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 record review, direct observations, and interview with staff the laboratory failed to establish an acceptable room temperature since 1/1/2022 to 8/27/2024. a. A review of the Daily Temperature Log revealed "Room Temperature should be between 64.4 F and 77 F".(18 degrees to 25 degrees Celsius). Room Temperature was not documented 8/1-8/13 and 8/16-8/22. b. On 8/27/2024 at 10:30 AM the surveyor observed (sampling): BD Vacutainer K2 EDTA: 1 half full pack of 100 lot number 316452, Expiration date 8/31/2024, Storage Temperature 4-25 [degrees Celsius]; 2 full packs of 100 lot number 3318816, Expiration date 3/31/2025, Storage Temperature 4-25 [degrees Celsius]. BD Vacutainer SST: 2 packs of 100 lot number 4130218, Expiration Date 4/30/2025, Storage Temperature 4-25 [degrees Celsius]; 1 pack of 11 lot number 4010734, Expiration Date 12/31/2024, Storage Temperature 4- 25 [degrees Celsius]. c. An interview with the office manager on 8/27/204 at 10:30 AM in the laboratory revealed the laboratory began documenting room temperature in August 2024. 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 record review, the laboratory's procedures, and interview with staff the laboratory failed to establish written policies and procedures for the performance of two of two moderately complex test. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and -- 2 of 3 -- qualitative semen analysis. b. The laboratory was asked to provide written procedures for the performance of urine sediments and qualitative semen analysis. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. 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: Based on record review, the laboratory's policy, and interview with staff the Technical Consultant failed to document competency of 3 of 3 testing personnel in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. A review of the laboratory's Quality Assurance Plan provided by the office manager revealed "PERSONNEL ASSESSMENT ...At least annually the laboratory director and/or technical consultant will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filed in the individual's personnel file. Opportunities will be made available to laboratory personnel for continuing education and noted in the record at the time of this review." c. The laboratory was asked to provide competency assessment for testing personnel that perform moderately complex testing. No documentation was provided. d. An interview with the office manager on 8/27/2024 at 9:41 AM in their office confirmed the laboratory did not perform competency on testing personnel that performed moderately complex testing. -- 3 of 3 --