Anglyn Family Medical Center Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 19, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. The general laboratory procedure manual did not include a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, or how to obtain additional assistance) for staff to follow when sending specimens to reference laboratories (Quest). 2. During an interview with Testing Personnel #1(CMS 209) on May 19, 2022, at 1:00 PM, in the breakroom, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to a reference laboratories. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 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, 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: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory director (LD) failed to specify, in writing, the duties and responsibilities of each person engaged in the performance of the pre-analytic, analytic, and post-analytic phases of laboratory testing. Findings include: 1. SOP review revealed the LD failed to specify in writing the duties and responsibilities of each person engaged in the performance of all phases(Pre-analytic, analytic, and post- analytic) of laboratory testing. 2. During an interview on May 19, 2022 with Testing Personnel#1(CMS 209) at 12:25 PM, in the breakroom, confirmed the SOP did not contain the duties and responsibilities for all personnel engaged in the performance of clinical laboratory testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 7, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event of 2021 and 3rd event 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 3 -- 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Academy of Family Physicians (AAFP), the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st and 3rd events of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795. on event 1 of 2021 witha score of 60% and event 3 of 2021 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from AAFP confirms the laboratory failed Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795. on events 1 and 3 of 2021 resulting in the first unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795.. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795.. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795 on event 1 of 2021 with a score of 60% and event 3 of 2021 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from AAFP confirmed the laboratory failed Hematology # 760 including: red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795. on Events 1 and 3 of 2021, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 10, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Academy of Family Physicians (AAFP) proficiency testing (PT) documents and staff interview, the laboratory failed to review and evaluate all results obtained on PT evaluations in 2018 and 2019. Findings include: 1. Review of 2018 & 2019 PT result documents reveals the lab director (LD) did not review the PT results for 2018 events A or B; 2019 events A, B, or C. 2. Interview with staff #4 (CMS 209 form) on 12/10/19 at approximately 11:00 am in the breakroom, confirmed the LD did not review all of the PT results received. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of American Academy of Family Physicians (AAFP) proficiency testing (PT) documents and staff interview, the laboratory failed to verify the accuracy Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- of test procedures twice annually for all non-waived tests performed in 2018 and 2019. Findings include: 1. Review of 2018 & 2019 PT documents reveals the lab did not participate in PT or verify test accuracy twice annually for urine microscopics in 2018 and 2019. 2. Interview with staff #4 (CMS 209 form) on 12/10/19 at approximately 10:55 AM in the breakroom, confirmed the lab did not verify the accuracy of test procedures twice annually for all non-waived tests performed D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of American Academy of Family Physicians (AAFP) proficiency testing (PT) documents and staff interview, the laboratory failed to document

Summary Statement of Deficiencies D0000 On 1/30/2018, an off site followup review was completed. The report revealed that