Unity Health Mcafee Medical Clinic

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 observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 3/9/26 at 1:17 pm, one (of three) box containing ten kits of Para-Pak ZN- PVA/Formalin, lot# 538000T, expiration date 3/7/26, REF 301012, Meridian Bioscience Inc, was observed in the laboratory, available for use beyond the expiration date. B) In an interview on 3/7/26 at 1:17 pm testing person #1 (as listed on the CMS 209 form) confirmed that the items, identified above, had exceeded their expiration date and were available for use in the laboratory. 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 D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Through review of personnel competency records for three testing personnel listed on the CMS 209 form, authorizations to perform tests, and interview, it was determined that the laboratory did not assess the competency of one of three testing personnel semi-annually during the first year of employment. Findings follow: A) Review of personnel records of testing personnel (number 8 on the CMS 209 form) indicated that the employee was hired in November 2021 and authorized by the laboratory director to perform moderately complex testing without direct supervision. B) Upon review of personnel records of testing personnel (number 2 on the CMS 209 form) Initial competency evaluation were dated as performed on July 5, 2023, and no further document competencies performed semi-annually during the first year of employment which should have occurred January of 2024 for this personnel. C) In an interview on 3/15/2024 at 1:10 p.m., the testing personnel (number 1 on the CMS 209 form) verified that competency evaluations were not performed semi-annually during the first year of employment for the testing personnel (number 3 on the CMS 209 form). 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label four of five specimen collection containers with patient name or unique patient identifier. Findings follow: A) During a tour of the laboratory on 5/26/22 at 12:45 pm five urine specimens containers were observed in the testing area three with patient's first and last initial only, and one labeled with the patient's first name and last initial only. B) Review of the laboratory policy and procedure revealed that specimen containers are to be labeled with the patient's first and last names and the patient's date of birth. C) In an interview on 5/26 /22 at 01:02 pm , the laboratory staff member, identified as number four on the CMS 209 form, confirmed that the specimens identified above lacked proper patient identification on the containers as required by policy and procedure. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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: Through review of the "All Samples Summary Report" for July 2021, November 2021 and March 2022 and interview with laboratory staff it was determined that the laboratory reported patient results for complete blood cell counts (CBC) prior to confirming quality control (QC) results met the criteria for acceptability in occurrences found in three of the three months reviewed. Findings follow: A) Review of the All Samples summary report revealed that on 7/6/21 patient 573816 had CBC results reported at 10:38 am prior to QC being performed at 11:05 am, the previous QC was reported on 7/2/21 at 11:01 am; on 7/21/21 patient 574123 was reported at 10: 32 am prior to QC results being performed at 12:21 pm the previous QC was performed on 7/20/21 at 11:32 am; on 7/28/21 patient 574259 was reported at 11:43 am prior to QC being performed at 11:55 am, the previous QC was performed on 7/27 /21 at 12:24 pm. B) Review of the All Samples summary report revealed that on 11/10 /21 patient 576386 had CBC results reported at 11:52 am prior to QC being performed at 01:33 pm, the previous QC was reported on 11/9/21 at 12:00 pm. C) Review of the All Samples summary report revealed that on 3/28/22 patient 579010 had CBC results reported at 10:35 am prior to QC being performed at 12:49 pm, the previous QC was reported on 3/25/22 at 12:19 pm. D) In an interview on 5/26/22 at 11:00 am the laboratory staff member, identified as number four on the CMS 209 form, confirmed that on the occasions identified above patient results were reported prior to QC being perfomed and found acceptable. -- 2 of 2 --