Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and (re)certification is recommended. Standard level 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: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of a competency assessment for one of one general supervisor and one of one technical supervisor in 2023 and 2024. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 1 general supervisor and 1 technical supervisor. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of a competency assessment for the general supervisor and technical supervisor in 2023 and 2024. 3. In an interview on 2/6/25 at 11:30 a.m. in the laboratory, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, the laboratory's records, and staff interview, the laboratory failed to have documentation of verifying the accuracy of two of two test kits used by the laboratory for patient testing at least twice annually in 2024. Findings include: 1. A review of the laboratory's test menu revealed the laboratory performed the following testing: - determination of peroxidase-positive white blood cells using the FertiPro LeucoScreen Plus kit - detection of fructose in seminal plasma using the AlphaTec FructoScreen kit. 2. A review of the laboratory's records from 2024 revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for the two test kits- FertiPro LeucoScreen Plus and AlphaTec FructoScreen. 3. Further review of the laboratory's records from 2024 revealed the laboratory performed 14 patient tests using the LeucoScreen Plus kit and 6 patient tests using the FructoScreen kit. 4. In an interview on 2/6/25 at 11:30 a.m. in the laboratory, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and staff interview, the technical supervisor failed to ensure one of one competency assessment performed on testing personnel in 2024 evaluated patient preparation, specimen handling, processing, and testing. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed 2 testing personnel performing high complexity testing. 2. A review of the laboratory's personnel files revealed the following testing personnel's competency assessments performed in 2024 did not include an assessment of patient preparation, specimen handling, processing, and testing: - Testing person #1 - performed in October 2024 3. In an interview on 2/6/25 at 11:30 a.m. in the laboratory, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) (b)(8)(ii) Monitoring the recording and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and staff interview, the technical supervisor failed to ensure one of one competency assessment performed on testing personnel in 2024 monitored the recording and reporting of test results. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed 2 testing personnel performing high complexity testing. 2. A review of the laboratory's personnel files revealed the following testing personnel's competency assessments performed in 2024 did not include an assessment of monitoring the recording and reporting of test results: - Testing person #1 - performed in October 2024 3. In an -- 2 of 3 -- interview on 2/6/25 at 11:30 a.m. in the laboratory, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and staff interview, the technical supervisor failed to ensure one of one competency assessment performed on testing personnel in 2024 included an assessment of test performance through testing previous specimens, blind test samples, or external proficiency test samples. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed 2 testing personnel performing high complexity testing. 2. A review of the laboratory's personnel files revealed the following testing personnel's competency assessments performed in 2024 did not include an assessment of test performance through testing previous specimens, blind test samples, or external proficiency test samples: - Testing person #1 - performed in October 2024 3. In an interview on 2/6/25 at 11:30 a.m. in the laboratory, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. -- 3 of 3 --