Ruby A Grimm Md

Summary Statement of Deficiencies D5785

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2017 and 2018 API (American Proficiency Institute) proficiency testing records 11/29/18, the laboratory failed to test proficiency samples the same number of times that patient specimens are routinely tested. The laboratory's "Critical Values List" policy states "... Repeat any specimen with results occurring within the parameters listed below. ..." The policy specifies critical values for WBC (white blood cell count), hemoglobin, platelets, and glucose. Review of 2017 and 2018 API proficiency testing records revealed: 1. On the 2017 1st hematology test event, samples ABT #1 - ABT #5 were tested in duplicate. Review of results revealed only 2 of the 5 samples should have been repeated for critical hemoglobin values. Records did not include documentation why the testing was repeated. 2. On the 2017 2nd hematology test event, samples ABT #6 - ABT #10 were tested in duplicate. Review of results revealed 1 of the 5 samples should have been repeated for a critical hemoglobin value and another 1 of the 5 samples should have been repeated for a critical platelet value. Records did not include documentation why the testing was repeated. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of 2017 and 2018 hematology records and interview with the RN (registered nurse) 11/29/18, the laboratory failed to retain all analytic systems records for at least two years. Findings: 1. Review of 2017 and 2018 Cell-Dyn Ruby hematology records revealed the laboratory failed to retain quality control assay sheets for the following lot numbers of Streck control material: a. lot #7030, expiration 4/14/17; b. lot #7142, expiration 8/4/17; c. lot #7254, expiration 11/24/17; d. lot #7310, expiration 1/19/18; e. lot #8001, expiration 3/16/18; f. lot #8057, expiration 5/11/18; g. lot #8113, expiration 7/6/18; h. lot #8169, expiration 8/31/18; i. lot #8225, expiration 10/26/18. 2. Review of 2017 and 2018 Cell-Dyn Ruby hematology records revealed the laboratory failed to retain instrument maintenance records documenting the performance of manufacturer's specified daily, weekly, monthly, and as-needed maintenance for 2017. 3. Review of 2017 and 2018 Cell-Dyn Ruby hematology records revealed the laboratory failed to retain startup/background counts obtained during 2017 and 2018. The RN stated during interview at approximately 1:15 p.m. that the instrument hard drive crashed and the laboratory was unable to retrieve and print the data. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of job descriptions, review of personnel records, and interview with the RN (registered nurse) 11/29/18, the laboratory director failed to ensure that policies and procedures were established and followed for evaluating the competency of the TC (technical consultant) and TP (testing personnel). Findings: The "QUALITY ASSESSMENT PLAN" states "COMPETENCY EVALUATION OF LABORATORY PERSONNEL Laboratory staff performing testing will have adequate, specific training and orientation to perform the tests and demonstrate satisfactory levels of competency at least annually. ..." 1. The TC job description states "... Major Job Tasks: The responsibilities listed below are carried out in consult with and approval of (as needed) the Laboratory Director. ... 8. Evaluate the competency of all testing personnel on an on-going basis utilizing the following methods: Direct observation of test performance, maintenance, and instrument checks. Monitor the recording of test results. Review worksheets, QC records, PT results and preventive maintenance records. Testing of previously analyzed specimens, blind samples and external Proficiency Testing. Assessment of problem solving skills. ..." Review of personnel records revealed the TC used a "Competency Evaluation Summary" form to document TP competency. The form included the six methods of evaluation listed in the TC job description. The TC failed to utilize all methods for evaluation of testing personnel competency. Examples: a. In 2017, the competency evaluation for TP #1 (the RN) did not include method #2 - "Review of Recording/Reporting of Results" and did not include method #4 - "Direct Observation of Instrument Maintenance". Both methods were left blank on the form. b. In 2017, the competency evaluation for TP #6 consisted of a written test only. The test was used routinely by the TC to evaluate method #6 - "Evaluation of Problem Solving Skills" for all TP. There was no -- 2 of 7 -- documentation that TP #6 was evaluated utilizing the other 5 methods. c. In 2018, the competency evaluation for TP #6 did not include method #3 - "Review of Intermediate Test Results or Worksheets" and did not include method #4 - "Direct Observation of Instrument Maintenance". Both methods were marked "NA" on the form. 2. The quality assessment plan did not include instructions for evaluation of technical consultant competency by the laboratory director. During interview at approximately 12:20 p.m., the RN confirmed they did not have a procedure for TC competency evaluation. She stated there was no documentation of TC competency evaluation for laboratory's previous TC who recently retired, and she stated the new TC just started. 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)

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 2018 API (American Proficiency Institute) proficiency testing results 10/10/18, the laboratory failed to successfully participate in proficiency testing for the specialty of hematology in two consecutive testing events. See the deficiency cited at D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and 2018 API (American Proficiency Institute) proficiency testing results 10/10/18, the laboratory failed to achieve an overall testing event score of satisfactory performance for Hematology in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS 155D and 2018 API proficiency testing results revealed the laboratory received a score of 0% for all analytes for failure to participate, resulting in an overall score of 0% for Hematology on the 2018 1st Hematology/Coagulation test event. 2. Desk review of CMS 155D and 2018 API proficiency testing results revealed the laboratory received a score of 0% for all analytes for failure to participate, resulting in an overall score of 0% for Hematology on the 2018 2nd Hematology/Coagulation 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 2018 API (American Proficiency Institute) proficiency testing results 10/10/18, 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 2018 API (American Proficiency Institute) proficiency testing results 10/10/18, the laboratory director failed to ensure successful participation in proficiency testing as required under Subpart H. Findings: 1. Desk review of CMS 155D and 2018 API proficiency testing results revealed the laboratory received a score of 0% for all analytes for failure to participate, resulting in an overall score of 0% for Hematology on the 2018 1st Hematology/Coagulation test event. 2. Desk review of CMS 155D and 2018 API proficiency testing results revealed the -- 2 of 3 -- laboratory received a score of 0% for all analytes for failure to participate, resulting in an overall score of 0% for Hematology on the 2018 2nd Hematology/Coagulation test event. -- 3 of 3 --