Family Reproductive Health, Inc

Summary Statement of Deficiencies 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper Reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 9/28/20, the laboratory failed to successfully participate in proficiency testing for D(Rho) type. See deficiency cited at D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 9/28/20, the laboratory failed to achieve satisfactory performance for D (Rho) type on two consecutive proficiency testing events, resulting in unsuccessful participation. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the 2020 1st Immunology /Immunohematology test event. 2. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the 2020 2nd Immunology /Immunohematology test event. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 9/28/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. 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; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API(American Proficiency Institute) proficiency testing results 9/28/20, the laboratory director failed to ensure successful participation as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the 2020 1st Immunology /Immunohematology test event. 2. Desk review of CMS Casper report 155D and 2020 -- 2 of 3 -- API Proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the 2020 2nd Immunology /Immunohematology test event. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of 2016, 2017, and 2018 API (American Proficiency Institute) proficiency testing records and review of 2016, 2017, and 2018 patient Rh(D) logs 4 /12/18, the laboratory failed to test proficiency samples in the same manner that patient specimens are routinely tested. Review of 2016, 2017, and 2018 API proficiency testing records and review of daily patient logs revealed proficiency samples were not documented on the daily patient Rh(D) testing logs in the same manner as patients for the the following test events: 1. 2017 1st, 2nd, and 3rd test events; 2. 2018 1st test event. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed 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 -- by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of 2016, 2017, and 2018 API (American Proficiency Institute) proficiency testing records and interview with the owner 4/12/18, the laboratory failed to maintain a copy of all proficiency testing records for at least two years. Findings: Review of 2016, 2017, and 2018 API proficiency testing records revealed the laboratory failed to maintain copies of signed attestation statements for the following proficiency testing events: a. 2016 2nd and 3rd events; b. 2017 2nd and 3rd events. During interview at approximately 11:40 a.m., the owner stated that she was unsure where the attestation statements might be if they were not in the manual. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)