Richard White Parkinson Md

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and interview with the Medical Assistant (MA), the laboratory failed to ensure that the Derrmatophyte Test Medium (DTM) was not used past the expiration date. The laboratory performs approximately 63 DTM tests annually. Findings Include: 1. Direct observation revealed the DTM, lot number 658018, had an expiration date of 11/2/2025. 2. Interview with the MA at 11:55 AM on 11/13/2025 confirmed the DTM was used for patient testing past the expiration date. 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 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 may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to have written procedures for Dermatophyte Test Medium (DTM) testing. The laboratory performs approximately 150 DTM tests annually. Findings include: 1. The laboratory failed to have a written procedure for DTM testing. 2. Medical Assistant not listed on the Laboratory Personnel Report (CMS-209) confirmed during an interview on 09/21 /2022 at approximately 2:30 p.m., the laboratory did not have a written procedure for DTM testing. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the Laboratory Director 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 -- failed to ensure a quality assessment plan was established to assure quality of laboratory services through the pre-analytical, analytical, and post-analytical phases. The laboratory performs approximately 4,900 histopathology and 150 mycology tests annually. Findings include: 1. The procedure manual failed to include a written Quality Assessment (QA) plan. 2. Medical Assistant confirmed during an interview on 09/21/2022 at approximately 2:30 p.m., the laboratory did not have a written QA plan. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on mycology proficiency testing records review, lack of documentation and interview with the office manager and laboratory staff, the laboratory failed to document a review of mycology culture proficiency test results for 4 of 5 events reviewed from the 3rd event of 2017 to the 2nd event of 2019. Findings include: 1. Proficiency testing records review failed to include a signature, initials or date that the reports were reviewed for American Proficiency Institute (API) 3rd event of 2017, the 1st and 2nd events of 2018 and the 1st and 2nd events for 2019. 2. In an interview with the office manager and laboratory staff at approximately 4:50 P.M. staff confirmed the proficiency testing reports lacked documentation they were reviewed to identify any problems with testing. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on histopathology staining records review, lack of documentation and confirmation by the office manager, the laboratory failed to document the lot numbers and expiration dates of Hematoxylin (H) and Eosin (E) Stains in use since 08/17/2017. 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 -- The laboratory stained approximately 4000 specimens per year Findings include: 1. Histopathology staining records review failed to include the lot number and expiration dates of H & E stains the laboratory used to stain histopathology specimens after the date of 08/17/2017. 2. In an interview conducted on 08/05/2019 at approximately 4:45 P. M., the office manager confirmed the histopathology staining records failed to include the lot number and expiration dates of H & E stains. -- 2 of 2 --