Charles Hanson Md

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 08/06/2026,the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records 2026-1 and 2026-2, the laboratory failed to 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 -- successfully participate in a proficiency testing program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the Throat Culture ID test resulting in unsuccessful performances. See D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2026-1 and 2026-2) for the Throat Culture ID test (Specialty Microbiology): The finding include: Throat Culture ID 0% - 2026 first testing event; Throat Culture ID 40% - 2026 second testing event. A review of the 2026 scores from the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records for 2026-1 and 2026-2 events, the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful participation of the proficiency testing. See D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records for 2026-1 and 2026-2 events, the laboratory director failed to ensure successful proficiency testing participation as required in this subpart. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) evaluation documentation and an interview with the testing personnel (TP), it was determined that the laboratory failed to obtain an overall testing event score of at least 80 percent (%) in Bacteriology for the third event of 2023 (Q3-2023). The findings include: 1. The laboratory was enrolled in AAB-MLE PT program and received an overall unsatisfactory score of 0% for the Bacteriology subspecialty in the Q3-2023 event. 2. The TP affirmed by an interview on March 3, 2026 at approximately 9:15 a.m. that the laboratory obtained the unsatisfactory score as mentioned in statement #1. The quality and accuracy of patient testing results cannot be assured. 3. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported approximately 80 patient samples for Bacteriology including the time the laboratory obtained the unsatisfactory scores for proficiency testing. . D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, five patient 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 -- records, preventive maintenance (PM) records, an interview with the testing personnel (TP) on March 3, 2026, it was determined that the laboratory failed to retain the quality system assessment records for at least two years. The findings include: 1. The laboratory's policy and documentation indicated that the preventive maintenance for the microscope was performed annually by Western Scientific Company, Inc. 2. The surveyor reviewed the PM records and found that the laboratory had the 2025 service record but was unable to retrieve the 2023 and 2024 documentation potentially affecting at least all five patient records reviewed. 3. The TP stated in an interview on March 3, 2026, at approximately 9:45 a.m. that the PM service records for the microscope for the years 2023 and 2024 were not located. 4. According to the laboratory testing declaration form (Lab-144) submitted on March 3, 2026, the laboratory performed and reported approximately 107 patient samples annually including the time when quality system assessment records were not properly retained for 2023 and 2024. . 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 the surveyor's review of the laboratory's policy and procedure, ten randomly chosen patient records, lack of personnel competency documentation, and an interview with the testing personnel (TP) on March 3, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform the personnel competency assessment prior to patient testing. The findings include: 1. The laboratory had no written and approved policy for personnel competency assessment as defined in this subpart with elements specified under 493. 1413 regulation. 2. The surveyor reviewed five patient records wherein the tests were performed by the TP. The laboratory lacked competency assessment records for the years 2023, 2024, and 2025 and that no