Primary Care Specialists

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the American Proficiency Institute (API) and an interview with testing personnel 1 (TP1) on 5/14/2024, the laboratory failed to sign PT attestations in 2022, 2023 and 2024. The findings include: 1. A review of PT records from API for event three in 2022 identified that the testing personnel failed to sign the attestation statement for potassium hydroxide (KOH) slide examination, wet mount slide examination and urine sediment testing. 2. A review of PT records from API for events one and three in 2023 identified that the laboratory director and testing personnel failed to sign the attestation statements for KOH slide examination,wet mount slide examination and urine sediment testing. 3. A review of PT records from API for event two in 2023 identified that the testing personnel failed to sign the attestation statement for KOH slide examination,wet mount slide examination and urine sediment testing. 4. A review of PT records from API for event one in 2024 identified that the laboratory director and testing personnel failed to sign the attestation statements for KOH slide examination,wet mount slide examination and urine sediment testing 5. An interview with TP1 on 5/14/2024 at 1:23 pm confirmed that the laboratory director and testing personnel failed to sign attestation statements for the above events. 6. The laboratory reports performing 144 KOH slide examination,wet mount slide examination and urine sediment tests annually. 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 --

Summary Statement of Deficiencies 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 patient laboratory reports and an interview with the laboratory lead on 6/22/2022, the laboratory failed to indicate the name and address of the performing laboratory for wet mount preparations and urine sediment examinations. The findings include: 1. A review of patient laboratory test reports for wet mount preparations and urine sediment examinations identified that the laboratory failed to indicate the name and address of the performing laboratory since implementing their new electronic medial record system in April 2021. 2. An interview with the laboratory lead on 6/22/2022 at 10:07 am confirmed that the name and address of the performing laboratory for wet mount preparations and urine sediment examinations are not indicated on the test report. 3. The laboratory reports performing 956 wet mount preparations and urine sediment examinations annually. 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 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 -- 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 laboratory reports and an interview with the laboratory lead on 6/22/2022, the laboratory failed to indicate the normal values for wet mount preparations and urine sediment examinations. The findings include: 1. A review of patient laboratory test reports for wet mount preparations and urine sediment examinations identified that the laboratory failed to indicate the normal values since implementing their new electronic medial record system in April 2021. 2. An interview with the laboratory lead on 6/22/2022 at 10:07 am confirmed that the normal values for wet mount preparations and urine sediment examinations are not indicated on the test report. 3. The laboratory reports performing 956 wet mount preparations and urine sediment examinations annually. -- 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 a record review of personnel competency assessments and an interview with the lead laboratory technician, the laboratory failed to establish and follow procedures to assess the competency of testing personnel since the last survey on September 7, 2016. Findings: 1. A review of personnel documents and laboratory procedures and policies, revealed the laboratory failed to establish a policy in writing and assess the competency for 3 mid-level practitioners performing potassium hydroxide/wet mounts exams and 3 testing personnel performing urine microscopic exams since the last survey. 2. An interview on April 11, 2018, at 11:15 AM, with the lead laboratory technician, confirmed the laboratory failed to establish in writing and document the competency for the practitioners and testing personnel. 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 a record review and an interview with the laboratory manager, the laboratory failed to verify the accuracy of potassium hydroxide (KOH)/wet mounts and urine microscopic exams at least twice annually since the last survey on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- September 7, 2016. Findings: 1. A record review revealed the laboratory failed to document the accuracy of KOH/wet mounts and urine microscopic, at least twice annually since the last survey. 2. An interview on April 11, 2018 at 11:40 AM, with the laboratory manager, confirmed the laboratory failed to document the accuracy of KOH/wet mounts and urine microscopic exams at least twice annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)