Apollo Medical

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Through a review of the laboratory test menu, a review of CASPER 155 reports for 2023, lack of documentation, and interviews with laboratory personnel, it was observed the laboratory failed to enroll in proficiency testing for CBC (complete blood count). Survey findings include: A. A review of the laboratory's test menu revealed the laboratory performed CBCs on the Sysmex XN-430. B. No proficiency test results for the facility were shown for 2023 in the CASPER 155 reports. C. In an interview, at 12:32 on 1/3/24, testing person #1 (as listed on the form CMS-209) confirmed the laboratory was not enrolled in proficiency testing for CBC. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through a review of the personnel records, patient testing logs, lack of documentation as well as interviews with staff, it was determined the laboratory failed to meet the general laboratory systems requirements and to monitor and evaluate the overall quality of the general laboratory systems as cited at: D5203: The laboratory failed to follow written policies for positive identification of blood samples D5291: The laboratory failed to to follow written Quality Assessment policies and procedures to monitor, assess and correct problems identified in the laboratory 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 a review of the laboratory Policy and Procedure Manual, observations made during a tour of the laboratory, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to follow written policies for positive identification of blood samples. As evidenced by: A. A review of the laboratory policy section for specimen collection and handling revealed "Label the tube with the patient's name and date of birth." B. During a tour of the laboratory, at 13:34 on 01/03/24, seven blood tubes were observed on the lab countertop. Seven of seven blood samples were labeled with the patients last name only. C. In an interview at 13:34 on 01/03/24, testing person #1 confirmed the urine containers were labeled with only the patient's last name. 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 laboratory's policy and procedure manual, lack of documentation, and interviews, it was determined the laboratory failed to follow written Quality Assessment (QA) policies and procedures to monitor, assess and correct problems identified in the laboratory. Findings Follow: A. The laboratory policy and procedure manual states "All quality assessment activities including problems identified and

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Through a review of new instrument validation documentation for the Sysmex XN- 400 Hematology analyzer, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to demonstrate that the Sysmex XN-400 Hematology analyzer could obtain the reportable range established by the manufacturer for their patient's population. Survey findings follow: A. A review of the validation documentation revealed the laboratory installed the new Sysmex XN-400 Hematology analyzer on 01/30/2021 and performed the accuracy and precision at the time of install. B. The surveyor requested validation documentation for verification of the reportable range for the Sysmex XN-400 Hematology analyzer. None was provided. C. In an interview on 02/09/2021 at 11:00, laboratory personnel #1(as listed on CMS form 209) confirmed the laboratory failed to verify the reportable range of the Sysmex XN-400 Hematology analyzer. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Through a review of personnel records, lack of documentation, and interviews with staff, it was determined the laboratory director failed to ensure testing personnel received appropriate training prior to testing patient specimens. Survey findings follow: A. A review of personnel records for testing personnel #1 (as listed on the form CMS-209) revealed there was no documentation that testing personnel #1 had received appropriate training or demonstrated that they could perform all testing operations reliably prior to testing patient specimens. B. In an interview at 10:45 on 02 /09/2021, testing personnel #1 stated that she started working in the laboratory in July of 2019. She confirmed there was no documentation of on-site training prior to testing patients. 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, 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: . Through a review of CMS form 209, personnel records for one of one testing personnel, and interviews with laboratory staff, it was determined the laboratory director failed to specify, in writing, which examinations and procedures each individual was authorized to perform and whether supervision was required. Survey findings follow: A. A review of CMS form 209 revealed the name of laboratory testing personnel performing moderate complexity testing. B. A review of personnel record, revealed there was no signed authorization to perform moderate complexity testing for test personnel #1 as listed on the form CMS-209. C. Upon request, the laboratory could not provide signed authorization for testing personnel listed on CMS form 209 to perform moderate complexity testing. D. In an interview at 10; 00 a.m. on 02/09/2021, the clinic manager confirmed there was no written authorization from the laboratory director stating which tests the testing personnel #1 (on the CMS form 209) are authorized to perform. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) -- 2 of 3 -- (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Through review of the CMS form 209, personnel records, lack of documentation, and interview, it was determined that the technical consultant failed to document personnel competency on an annual basis for one of one testing personnel identified on the CMS form 209. Survey findings follow: A. A review of personnel records revealed no competency evaluations for 2019 and 2020 were performed for moderate complexity testing personnel identified as number 1 on form CMS 209. B. Upon request, the laboratory could not provide competency evaluations for the personnel identified above. C. In an interview on 02/09/2021 at 10:30 a.m., the clinical manager confirmed that competency evaluations had not been performed on testing personnel #1(as listed on form CMS 209). -- 3 of 3 --

Summary Statement of Deficiencies D0000 . This is the CLIA recertification survey of the Laboratory conducted on 5/24/2018. At the time of recertification survey the laboratory was not in compliance with the following conditions: 42 CFR 493.803(a)(b)(c): Successful Participation 42 CFR 493.807: Reinstatement of Nonwaived Laboratories 42 CFR 493.1215: Hematology 42 CFR 493.1403: Moderate Complexity- Laboratory Director 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 a review of the 2017 and 2018 CMS Casper Reports 153D, 155D and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory had unsuccessful performance in proficiency testing for the tests of White Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Blood Cell (WBC DIFF) Differential, Granulocytes (GRANS), Lymphocytes (LYMPHS), and Monocytes (MONO) as evidenced by: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: . Based on review of 2017 and 2018 CMS Casper Reports 155D, 153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory had a subsequent unsuccessful performance for the test White Blood Cell Differential, Granulocytes, and Monocytes as cited at 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: . A. Based on review of the 2017 and 2018 CMS Casper Reports 155D and 153D, and the American Proficiency Institute proficiency testing results, it was determined the laboratory failed two out of three proficiency testing for the tests of Lymphocytes (LYMPHS) as evidenced by: 1. The laboratory received a score of 40% for the test of LYMPHS in the second proficiency testing event of 2017. 2. The laboratory received a score of 0% for the test of LYMPHS in the first proficiency testing event of 2018. B. Based on the review of the 2017 and 2018 CMS Casper Reports, it was determined the laboratory had three out of three consecutive failures which constitutes unsuccessful performance for the test White Blood Cell Differential (WBC DIFF), Granulocytes (GRANS), and Monocytes (MONO) as evidenced by: 1. The laboratory received a score of 73% for the test of WBC DIFF, 60% for the test of GRANS, and 60% for the test of MONO in the first proficiency testing event of 2017. 2. The laboratory received a score of 33% for the test of WBC DIFF, 20% for the test of GRANS, and 40% for the test of MONO in the second proficiency testing event of -- 2 of 6 -- 2017. 3. The laboratory received a score of 0% for the test of WBC DIFF, 0% for the test of GRANS, and 0% for the test of MONO in the first proficiency testing event of 2018. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Through a review of proficiency testing records for 2017 and 2018, manufacturer's instruction, temperature records for 2017 and 2018, observations made during a tour of laboratory, Quality Controls records, laboratory policy and procedure manual, patient medical records, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to meet requirements for Hematology. As evidenced by: D5291: the laboratory failed to prevent recurrence of proficiency testing failures in the general laboratory systems. D5417: laboratory had supplies available for use when they had exceeded their expiration date. D5447: laboratory failed to perform quality control at least once per day when patient specimens were analyzed. D5783: the laboratory failed to document