Associated Physicians, Llp

Summary Statement of Deficiencies 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 surveyor review of competence evaluation policy and records and interview with the Laboratory Supervisor (Staff A), the laboratory did not ensure they followed their competence evaluation policies. The laboratory did not document annual competence evaluations for three of four laboratory testing personnel and five of five physicians performing provider performed microscopy (PPM) testing. Findings include: 1. Review of the 'Lab Staff Orientation, Training, and Assessment' policy showed the policy stated, "Each employee will be given an evaluation for competency at six months from hire and annually thereafter. 2. Review of competence evaluation records showed: Staff A: no annual competence evaluation after June 2022. Staff D: no annual competence evaluation in 2023. Staff E: Start date May 15, 2023, initial and six-month competence documented, no annual competence evaluation. Staff F: Start date July 15, 2024, initial competence documented, six-month evaluation in process. No records of competence evaluation for the five physician testing personnel that perform PPM testing were available. 3. Interview with Staff A on March 24, 2025, at 1:50 PM confirmed the laboratory did not document competence evaluations annually as required by the laboratory's policy and as specified in the personnel requirements in subpart M. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration 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 -- the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the submitted Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form Centers for Medicare and Medicaid Services Form 116 (CMS-116) and laboratory records and interview with the laboratory manager (Staff A), the laboratory director did not ensure notification requirements were met as required at 493.51. Findings include: 1. Review of the CMS- 116 submitted for this survey showed the submission included a change of the laboratory director. 2. Review of an email from Staff B to Staff A dated March 6, 2024 at 12:32 PM showed Staff C assumed the role of Laboratory Director and Staff B would function as the Assistant Laboratory Director, effective immediately. 3. Interview with Staff A on March 24, 2025, at 9:20 AM confirmed the laboratory director responsibilities were transferred from Staff B to Staff C on March 6, 2024 but the director did not ensure the laboratory notified Health and Human Services (HHS) or its designee within thirty days of the director change as required at 493.51 (c). -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory supervisor's office, review of the manufacturer's requirements and temperature logs, and interview with the laboratory supervisor, staff A, the laboratory did not define an acceptable temperature range that was consistent with the manufacturer's acceptable range for the Cepheid 4-plex Xpress and Chlamydia trachomatis/Neisseria gonorrheae (CT/NG) reagents stored in the laboratory office. Findings include: 1. Observation of the laboratory supervisor's office April 12, 2023, at 9:32 AM showed Cepheid Gene Xpert 4-plex and CT/NG cartridges were being stored in the office. Further observation showed the manufacturer's required storage at 2-28 degrees Celsius (C). 2. Review of temperature logs showed a no established room temperature range or documentation of temperatures for the laboratory supervisor's office. 3. Interview with the staff A on April 12, 2023, at 11:55 AM confirmed the laboratory had not defined an acceptable range for the laboratory office and did not document temperatures in the area the reagents were stored. D5781

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 surveyor review of laboratory procedures and interview with the technical consultant, the laboratory did not have a procedure for performing white blood cell differentials. Findings include: 1. Review of laboratory procedures showed no evidence of a written procedure for performing white blood cell differentials. 2. Interview with the technical consultant on June 9, 2021 at 1:24 PM confirmed the laboratory performs white blood cell differentials and confirmed the laboratory does not have a written procedure for this test. This is a repeat deficiency previously cited on January 23, 2013 and April 13, 2011. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of Rheumatoid Factor (RF) control and patient records and interview with the technical consultant, the laboratory performs RF tests producing titered results when the patient test is positive but does not test a control material with titered reactivity. Findings include: 1. Review of RF Control records for the Rhuemajet RF- Biokit showed the laboratory tests a negative and positive control each day of patient testing. No evidence of a titered control is present. 2. Review of patient records showed the laboratory reported titered results for patient samples when the RF result for the undiluted specimen was positive. 3. Interview with the technical consultant on June 9, 2021 at 11:15 AM confirmed the laboratory did not include a control material with titered reactivity when testing titered patient samples. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory quality control records and interview with the technical consultant, the laboratory does not use an elevated serum bilirubin control for monitoring the abnormal high range of neonatal bilirubin testing. Findings include: 1. Review of chemistry quality control (QC) records for the bilirubin test show that two levels of QC are performed each day of testing, and that an elevated bilirubin control for monitoring the abnormal high range of neonatal bilirubin's is not performed when neonatal bilirubin tests are performed. 2. Interview with the technical consultant on March 20, 2019 at 1:00 PM confirmed that the laboratory does not use an elevated serum bilirubin control for monitoring the abnormal high range of neonatal bilirubin testing. 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 --