Hilman Family Clinic, Pa

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Review of laboratory policies and procedures, observations made during a tour of the laboratory, and interviews with staff, determined the laboratory failed to follow procedures to ensure positive identification of blood specimens. Survey findings include: A) Laboratory policies and procedures for "Specimen Collection" stated "correct and timely labeling is crucial, specimens are to be labeled with the patient's name and chart number" B) During a tour of the laboratory, at 11:00 a.m. on 9/12/24, the surveyor observed 2 of 13 blood specimens for complete blood cell counts and 2 of 7 blood specimens for chemistry analysis labeled with the patient's name only C) In an interview, at 11:00 a.m. on 9/12/24, laboratory employee #2 (as listed on the form CMS-209) confirmed the four specimens identified above lacked chart numbers as required by laboratory policy and procedure. . D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, 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 postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Review of personnel files for two testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize one of two testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for two testing personnel listed on form CMS-209 (Personnel #'s 2, 3) the surveyor determined employee number 3 (as listed on the form CMS-209), with a date of hire of July 2024, failed to have written authorization, from the laboratory director, to perform moderate complexity testing without direct supervision. B) In an interview, at 9:30 a.m.. on 9/12/24, laboratory employee #2 (as listed on the form CMS-209) confirmed the lack of written authorizations to test for employee # 3 (on form CMS 209) and confirmed the employee is performing and reporting moderately complex complete blood cell procedures. -- 2 of 2 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: No deficiency details available. 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 D0000 Hilman Family Clinic laboratory is in compliance with the applicable Standards and Conditions of 42 CFR Part 493, Laboratory Requirements. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview the laboratory failed to report SARS-CoV-2 test results as required for 223 of 223 days reviewed from February 7, 2022 through December 31, 2022. Findings include: A. SARS-CoV-2 testing documentation (patient results) were reviewed from February 7, 2022 through December 31, 2022. B. SARS-CoV-2 test result reporting documentation (fax records) were reviewed from February 7, 2022 through December 31, 2022. C. Documentation revealed that SARS- CoV-2 test results were not reported as required for 6 days in February 2022, 23 days in March 2022, 21 days in April 2022, 22 days in May of 2022, 22 days in June of 2022, 20 days in July of 2022, 22 days in August of 2022, 22 days in September of 2022, 21 days in October of 2022, 22 days in November of 2022, and 22 days in December 2022. D. 87 test results were not reported as required during the period of 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 -- review. E. The laboratory performed 297 SARS-CoV-2 tests during the period of review. F. The laboratory director (individual #1 on CMS 209) confirmed the findings on 2/13/23 at 2:22 pm. -- 2 of 2 --

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: Through a review of the AAB Non-Chemistry proficiency test attestation records for 2019 and 2020, and interview with laboratory staff, it was determined the testing personnel failed to attest to the routine integration of proficiency test samples in the patient workload for five of six surveys reviewed. Survey findings follow: A) Review of the six attestation statements for AAB Non-Chemistry proficiency test attestation statements revealed that there were no signatures for testing personnel on the attestation statements for 2019 2nd Quarter event, 2019 3rd Quarter event, and 1st, 2nd, and 3rd Quarter events in 2020. B) In an interview, at approximately 11:10 on 1 /28/21, the laboratory staff member, identified as number two on the CMS-209 form, stated that it was assumed that since testing personnel names are printed on the attestation statements when proficiency testing results are submitted on-line, that signatures were not required and that the testing personnel had not signed the attestations statements for the quarterly events identified above. 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 D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Through a review of proficiency records for 2018 and 2017, lack of documentation, as well as interview with staff, it was determined the laboratory failed to retain proficiency testing documentation for at least 2 years. A. Upon request the laboratory failed to have completed submission forms, signed attestation statements, instrument printouts or graded reports for the second, and third proficiency testing events of 2017 (2 of 3 proficiency testing events). B. In an interview on 5/23/2018 at 10:30, the technical consultant (as listed on form CMS 209) confirmed the lack of documentation and that the laboratory had not retained the records for the second and third proficiency testing events of 2017. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through observations made during a tour of the laboratory, lack of documentation, and interviews with staff, it was determined the laboratory failed to assign a unique identifier ( patient date of birth or account number) to twenty-three of twenty-three patient's specimens observed. As evidenced by: A. During a tour of the laboratory on 7 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 -- /13/2018 at 1130, the surveyor observed eleven of eleven red top vacutainer tubes and twelve of twelve purple top vacutainer tubes with the patient's first and last name only with no unique patient identifier (patient's date of birth or account number). B. In an interview at 1145 on 7/13/2018, laboratory personnel #3 (as listed on form CMS 209) confirmed the laboratory does not use a unique identifier to label patient samples. -- 2 of 2 --