Allied Physicians Group Pllc

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's Quality Assessment (QA) polices /procedures and an interview with the office manager and laboratory director, the laboratory failed to establish the a written QA policy, to include a monthly and annual QA review for the refrigerator temperature log. refer D6021 Findings: 1.Office manager and laboratory director confirmed on November 30, 2021 at aproximately 10am, the surveyors finding monthly refigerator temperature logs were not reviewed for the the calendar years of 2019, 2020, and through October of 2021. 2.The surveyor reviewed annual QA forms, for the above dates, and found it did not include refrigerator temerature log reviews. 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. 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: Based on the surveyor's review of the laboratory's QA polices/procedures and an interview with the office manager and laboratory director, the laboratory failed to ensure a written QA policy was established and maintained for the caldenar years 2019, 2020, and upto October 2021. Refer to: D5291 -- 2 of 2 --

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 a review of competency procedures, records and an interview with the laboratory director and office manager, the laboratory failed to have a complete policy /procedure to assess employees competency. Finding Include: At approximately 2:00 pm on January 31, 2019, it was confirmed by the laboratory director and office manager that the laboratory failed to include in their competency procedure direct observation of routine patient test performance (including patient preparation, if applicable, specimen handling, processing, and testing); and the performance of instrument maintenance and function checks. 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 --