Infinity Health

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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the specialty, hematology and the analytes: white blood cell count, white blood cell automated differential, red blood cell count, hematocrit, hemoglobin and platelet count for two out of three consecutive testing events: 2021 event 3 and 2022 event 1 (refer to D2130 and D2131). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 review of proficiency testing (PT) reports and records, the laboratory failed to achieve satisfactory performance for the analytes: white blood cell count, white blood cell automated differential, red blood cell count, hematocrit, hemoglobin, and platelet count, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2021 testing event 3 and 2022 testing event 2. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for the specialty, hematology. The laboratory received unsatisfactory performance scores of zero for 2021 testing event 3 and 2022 testing event 2. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8:30 am on 5 /11/2022, the laboratory failed to retain proficiency testing records for two out of four testing events from 1/1/2021 - 5/18/2022. The findings include: 1. For 2021 event 2, the laboratory failed to retain the signed PT attestation forms and the forms submitted to the PT company. 2. For 2022 event 1, the laboratory failed to retain the signed PT attestation forms and the forms submitted to the PT company. 3. At the time of the survey, the laboratory did not have the above PT forms. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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)