Livingston Clinic

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on August 30, 2023 the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) proficiency testing records, the laboratory failed to achieve 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 -- successful performance in two of two consecutive events in 2023 for the specialty of Hematology, resulting in unsuccessful performance. Refer to D2131. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) proficiency testing records, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of two consecutive testing events for the specialty of Hematology in 2023. Two out of two overall testing event scores of unsatisfactory performance result in unsuccessful proficiency testing performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for proficiency testing in 2023: 2023 Event: Specialty, Score Event 1: Hematology, 0% Event 2: Hematology, 0% 2. A proficiency desk review of AAB proficiency testing records from 2023 confirmed that the laboratory received the following scores: Nonchemistry M1 2023: Hematology, Sub- Specialty Score - 0.0% Nonchemistry M2 2023: Hematology, Sub-Specialty Score - 0.0% 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the specialty of Hematology. Refer to 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: -- 2 of 3 -- Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for two of two consecutive testing events for the specialty of Hematology in 2023. Refer to D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on review of American Association of Bioanalysts (AAB) hematology proficiency testing documentation for the first event of 2018, confirmed by staff interview, the laboratory failed to score at least 80 percent of acceptable responses for the analytes erythrocytes and hematocrit using the Coulter AcT diff 2 analyzer. Findings: 1. AAB proficiency testing documents for hematology in the first quarter 2018 showed the following unsatisfactory scores: a. Erythrocytes-60% b. Hematocrit- 0% 2. In an interview at the site on 06-19-2018, testing person 1 (CMS form 209) stated that she had examined the scores when they arrived and was aware of the unsatisfactory results. A review of instrument printouts for the testing event showed no clerical errors. . D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: . Based on review of American Association of Bioanalysts (AAB) hematology proficiency testing results for the first event of 2018, confirmed by staff interview, the laboratory failed to take