Ronald J Daigle, Md, Apmc

Summary Statement of Deficiencies D0000 A Recertification Survey was performed on September 27, 2023 at Ronald J. Daigle, M.D., CLIA ID # 19D0460740. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of twice annual verification records and the laboratory's policy and procedure manual, as well as interview with personnel, the laboratory failed to verify the accuracy of the performance of Histopathology testing at least twice annually. Findings: 1. Review of the laboratory's test menu revealed the laboratory reads Histopathology slides. 2. Review of the laboratory's policies and procedures revealed "Twice a year, 2 pathology specimens that have been interpreted by Dr. Daigle will be verified by a pathologist or a board certified dermatologist who is proficient in dermatopathology." 3. Review of the laboratory's twice annual verification documents revealed the laboratory did not have documentation of the verification of the accuracy of Histopathology testing for 2022 and the first half of 2023. 4. In interview on September 27, 2023 at 1:29 p.m., the Laboratory Director confirmed a twice annual performance verification was not performed in 2022 and the first half of 2023. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure laboratory personnel were performing the test methods as required for accurate and reliable results. Refer to D5217. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on July 31, 2019 at Ronald J. Daigle, MD, APMC, CLIA ID # 19D0460740. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 personnel, the laboratory failed to verify the accuracy of the performance of Histopathology testing at least twice annually. Findings: 1. Review of the laboratory's test menu revealed the laboratory reads Hematoxylin ad Eosin (H&E) stained Histopathology slides. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a written policy for verification of the accuracy of performance of Histopathology testing. 3. Review of the laboratory's documents revealed the laboratory did not have documentation of the verification of the accuracy of Histopathology testing for 2017 and 2018. 4. In interview on July 31, 2019 at 1:30 pm, the Laboratory Director stated he did not perform verification of the accuracy of Histopathology testing. The Laboratory Director confirmed no performance at least twice annually in 2017 and 2018. 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 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 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed it did not include the following: a) Twice a year verification of the accuracy of histopathology test performance to include frequency, acceptability criteria, and