State College Urologic Mnpg

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with the technical consultant (TC) ( CMS 209 personnel #2), the laboratory failed to verify the accuracy of the PT results obtained for 2 of 6 API Clinical Microscopy testing events in 2022 and 2023. Findings Include: 1. On the day of survey, 02/16/2024 at 09:40 am., review of the laboratory's CAP PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency due to non-consensus: - CM B 2022 Clinical Microscopy Transitional Epithelial CMP 14 - CM B 2023 Clinical Microscopy Erythrocyte Dysmorphic CMP 05 2. Acording to laboratory's proficiency testing policy "Ungraded results will be compared to all methods once results are returned to the laboratory." 3. The TC confirmed the findings above on 02/16/2024 at 12:30 pm. 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 review of patient test reports and interview with the technical consultant 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 -- (TC) (CMS 209 personnel #2), the laboratory failed to include pertinent reference intervals/normal values on patient test reports for 2 of 2 microscopic urinalysis and 1 of 1 semen analysis testing performed in 2022 and 2023. Findings Include: 1. On the day of the survey, 02/16/2024 at 11:50 am, review of patient reports revealed that the laboratory failed to include pertinent reference intervals/normal values on the final report for microscopic urinalysis (Red Blood Cells, White Blood Cells, Bacteria, Yeast, Trichomonas, Crystals) and semen analysis testing performed in following dates- - 11/22/2022 Microscopic Urinalysis - 07/11/2023 Microscopic Urinalysis - 07 /14/2023 Semen Analysis 2. The TC confirmed the findings above on 02/16/2024 at 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory competency assessment policy, testing personnel (TP) competency records and interview with the practice administrator, technical consultant (TC) and TP#1, the laboratory failed to follow and establish a complete competency assessment policy to assess the competency of 1 of 1 technical consultant and 5 of 10 TP performing post vasectomy semen and urine microscopic examinations from 11/13/2017 to the date of survey. Findings Include: 1. The General Laboratory Policy Manual, Subject: Competency Assessment, III. Guidelines states, "Competency assessment will be performed semiannually during the first year." 2. On the day of survey, 09/11/2019, review of TP competency assessment records revealed, the laboratory did not perform semiannually competency during the first year of employment for 5 of 10 TP (TP#3, #4, #5, #6 and #7) in 2019. 3. The laboratory's competency assessment policy did not include guidelines to assess the competency of 1 of 1 technical consultant from 11/13/2017 to 9/11/2019. 4. The practice administrator, TC and TP#1 confirmed the findings above on 09/11/2019 around 9:30 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --