Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/27/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with testing person #1 at the conclusion of the survey. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to ensure patient test reports included a unique identifier for four of four patient Urine Microscopic and Wet Prep analysis reports reviewed. Findings include: (1) On 07/27/2023 at 09:35 am, testing person #1 stated the laboratory performed the following: (a) Urine Microscopic testing; (b) Wet Prep Analysis testing (2) A review of four patient reports for the above testing identified that although the following reports included the patient name, they did not include a unique identifier: (a) Urine Microscopic testing performed on 01/19/2023; (b) Urine Microscopic and Wet Prep Analysis testing performed on 02/17/2023; (c) Urine Microscopic testing performed on 03/20/2023; (d) Wet Prep Analysis testing performed on 04/06/2023. (3) The findings were reviewed with testing person #1 who stated on 07/27/2023 at 02:50 pm, the patient reports did not include a unique identifier. 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 -- D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient reports and interview with testing person #1, the laboratory failed to provide normal reference intervals for four of four Urine Microscopic and Wet Prep analysis reports reviewed. Findings include: (1) On 07/27 /2023 at 09:35 am, testing person #1 stated the laboratory performed the following: (a) Urine Microscopic testing; (b) Wet Prep Analysis testing (2) A review of four patient reports for the above testing identified the following reports did not include normal reference ranges: (a) Urine Microscopic testing performed on 01/19/2023; (b) Urine Microscopic and Wet Prep Analysis testing performed on 02/17/2023; (c) Urine Microscopic testing performed on 03/20/2023; (d) Wet Prep Analysis testing performed on 04/06/2023. (3) The reports were reviewed with testing person #1 who stated on 07/27/2023 at 02:40 pm, the patient reports did not include normal reference ranges. 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: Based on a review of records and interview with testing person #1, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of six persons during the review period from 9 /22/2020 to 07/15/2023. Findings include: (1) A review of personnel records for six persons performing moderate complexity testing during the review period of 9/22 /2020 through 07/15/2023 identified no evidence an annual competency evaluation had been performed for one of six testing person as follows: (a) Testing Person #2 - No annual competency evaluation between 09/22/2020 and 07/15/2022; (2) The records were reviewed with testing person #1 who stated on 07/27/2023 at 02:50 pm, the annual evaluation had not been performed. -- 2 of 2 --