Compass Health Network

Summary Statement of Deficiencies 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 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: Based on review of the performance evaluations and interview with testing personnel (TP) #1, the director failed to ensure one of one testing personnel had received appropriate training and demonstrated competency for moderate complexity testing prior to testing patient samples. Findings: 1. Review of the performance evaluations revealed no documentation to show one of one testing personnel received appropriate initial training prior to testing patient samples. 2. Interview with TP #1 on August 23, 2023 at 10:30 AM confirmed the director failed to ensure testing personnel received appropriate initial training for performing moderate complexity testing. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 review of the performance evaluations and interview with testing personnel (TP) #1, the technical consultant (whom is also the laboratory director) failed to evaluate and document performance evaluations at least semiannually during the first year for one of one testing personnel. Findings: 1. Review of performance evaluations showed no semiannual performance evaluation was documented for TP #1. 2. Interview with TP #1 on August 23, 2023 at 10:30 AM confirmed the technical consultant did not evaluate and document the semiannual performance evaluation for TP #1. -- 2 of 2 --

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 2018, 2019 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and interview with the laboratory director, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in two consecutive Sodium (Na) PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 chemistry proficiency testing (PT) results for 2018, 2019 and interview with the laboratory director, the laboratory failed to achieve satisfactory performance for sodium testing in two consecutive PT events. Findings: 1. Review of the chemistry PT results for the third event of 2018 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, sodium. 2. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 60 percent for the analyte, sodium. 3. Interview with the laboratory director on July 2, 2019 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for sodium testing in two consecutive events for 2018, 2019. 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)