Summary:
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: The laboratory failed to maintain successful participation in 2 out of 2 events for the analyte red blood cell (RBC), events one and two of 2018, resulting in the first unsuccessful PT occurrence for the analyte RBC. (Refer to 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the CMS CASPER Report 0155D, phone interview with the American Association of Family Physicians (AAFP) official, and an interview with lead lab nurse, the laboratory failed to maintain satisfactory performance in two of two events for the red blood cell (RBC) analyte, events one and two of 2018, resulting in the first unsuccessful occurrence. Findings include: 1. Review of the CMS Report 0155D for Proficiency Testing (PT) scores revealed the RBC score for event one of 2018 = 60% and event two of 2018 = 40%. 2. A phone interview on October 2, 2018, at 1:30pm EST, with the AAFP PT agency official confirmed the laboratory's unsuccessful performance for the RBC score for event one of 2018 = 60% and event two of 2018 = 40%. 3. An interview on October 2, 2018, at 1:30pm EST, with the lead lab nurse confirmed the laboratory's unsuccessful performance for the RBC score for event one of 2018 = 60% and event two of 2018 = 40% and the lab received another lab's PT results for events one and two of 2018 from AAFP PT officials. 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 a lack of the proficiency testing (PT) records and an interview with the lead lab nurse, the laboratory failed to receive and retain the correct PT records from the PT agency for events one and two of 2018 for hematology complete blood count (CBC). Findings include: 1. Review of the 2018 PT book revealed the wrong laboratory's PT results located at 6918 Shallowford Road, Suite 226, Chattanooga, Tennessee. The lab missing the correct PT records from the PT agency for events one and two of 2018 for hematology complete blood count (CBC). 2. An interview on October 2, 2018, at 1:15pm, with the lead lab nurse confirmed the wrong laboratory's PT results and the lab missing the correct PT records from the PT agency for events one and two of 2018 for hematology complete blood count (CBC). D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the quality assurance (QA) plan, lack of quarterly QA meeting documents and an interview with the lead lab nurse, the laboratory failed to conduct and retain any of the required quarterly QA meeting records from 2016-2018. Findings include: 1. Review of the QA plan revealed the requirement to hold quarterly review meetings with the lab staff and the clinical consultant (CC- who is also the lab director-LD) with written minutes kept for two years. 2. Review determined a lack of any documented quarterly QA meetings or minutes for 2 years. 3. An interview on October 2, 2018, at 1:15pm, with the lead lab nurse confirmed the laboratory did not conduct and retain any of the required quarterly QA meeting records from 2016-2018. -- 2 of 6 -- 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)