Beverly Lab Associates

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 proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (Cl), as follows: 2019 Q2 2019 Q1 Cl 60% 40% Q1 = First testing event Q2 = Second testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Cl. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Cl, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the second quarter (Q2-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Complement C3 analyte. The findings included: a. Q2-2017, API reported 0% proficiency testing score for Complement C3 analyte. b. For four (4) out of four (4) random patient sampling test results reviewed covering period from 1/22/2016 to 5/15/2018, the laboratory analyzed and reported Complement C3 analyte during the time the laboratory received an unsatisfactory proficiency testing score. c. The technical consultant confirmed (1/24 /2019, 1300), that the laboratory received the above unsatisfactory proficiency test score. 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 the first quarter (Q1-2017) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- score of at least 80 percent of acceptable responses for Prothrombin Time (PT) analyte. The findings included: a. API reported the following unsatisfactory proficiency testing score. Analyte: Score: Event/Year PT 60% Q1-2017 b. For four (4) out of sixteen (16) random patient sampling test results reviewed covering period from 3/15017 to 4/3/2017, the laboratory analyzed and reported PT analyte during the time the laboratory received an unsatisfactory proficiency testing scores. c. The technical consultant confirmed (1/24019, 1300) that the laboratory received the above unsatisfactory proficiency test score. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the third quarter (Q3-2017), second quarter (Q1-2018), third quarter (Q3-2018) of the American Proficiency Institute (API) proficiency testing records, random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to attain at least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I. The findings included: a. API reported the following unsatisfactory proficiency testing scores. Analyte: Score: Event/Year UIBC 20% Q3- 2017 Sed Rate 50% Q3-2017 PTH 67% Q2-2018 CRP 50% Q3-2018 b. For fourteen (14) out of fourteen (14) random patient sampling test results reviewed covering period from 1/22/2016 to 12/13/2018, the laboratory analyzed and reported CRP analyte. For two (2) out of two (2) random patient sampling test results reviewed from 5/25/2018 and 5/29/2018, the laboratory analyzed and reported PTH analyte. For two (2) out of two (2) random patient test results reviewed from 8/24/2018 and 9/19/2018, laboratory analyzed and reported UIBC, and For sixteen (16) of out sixteen (16) random patient test results reviewed covering period from 1/22/2016 to 12/1/2018, the laboratory analyzed and reported Sed Rate during the time the laboratory received the above unsatisfactory proficiency testing scores. c. The technical consultant confirmed (1/24/2018, 1300), that the laboratory received the above unsatisfactory proficiency test scores. 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 direct observation, request for an International Sensitivity Index (ISI) value, Normal Prothrombin Time (PT) mean values entered into the instrument (Dade Behring BTTll2 model), random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory director failed to meet the qualification requirements of 493.1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. See D 6007 -- 2 of 4 -- D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on direct observation, request for an International Sensitivity Index (ISI) value, Mean Normal Prothrombin Time (PT) value entered into the instrument (Dade Behring BTTll2 model), random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory director failed to ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. a. Based on the laboratory's Mean Normal PT documented on the laboratory's data sheet performed and accepted on 2/5/2018, the Geometric PT mean was (10.5), Innovin Lot # 549706, Exp Date 9/20/2020. b. The mean Normal PT value entered on the instrument was 11.5 while mean Normal PT calculated based on normal patient samples performed by the laboratory was 10.5. c. The following are random selected patient sampling test results reviewed. Date Patient: PT: INR: Analyzed: Results: 2/28 /18 02111065 8.3 0.70 3/7/18 00211480 71.1 0.84 3/9/18 00211693 9.2 0.79 3/9/18 00211694 31.3 3.91 3/14/18 00211980 28.8 2.88 3/15/18 00212047 9.0 0.85 3/15/18 00212048 59.1 5.77 4/2/18 00212857 17.4 1.64 4/5/18 00213105 24.1 2.37 4/23/18 00214023 31.4 3.21 5/1/18 00214567 47.1 5.08 5/31/18 00216134 24.9 2.46 6/28/18 00217484 49.0 5.33 7/5/18 00217863 22.7 2.21 12/6/18 00226384 19.7 1.88 d. The laboratory analyzed and reported approximately 125 PT tests covering period from 2 /28/2018 to 1/4/2019. There were 25 patients with an abnormal PT results, that the INR results cannot be assured. e. The technical consultant confirmed (1/24/2019, 1300) that the laboratory failed to ensure that the correct mean Normal PT value was entered into the instrument. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on direct observation, request for the laboratory's current International Sensitivity Index (ISI) value, Normal Prothrombin Time (PT) mean value entered into the instrument (Dade Behring BTTll2 model), random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory to meet the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. See D 6036. -- 3 of 4 -- D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on direct observation, request for the laboratory's current International Sensitivity Index (ISI) value, Normal Prothrombin Time (PT) mean value entered into the instrument (Dade Behring BTTll2 model), random patient sampling test results, and interview with the technical consultant, it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings included: a. Based on the laboratory's Mean Normal PT documented on the laboratory's data sheet performed and accepted on 2/5/2018, the Geometric PT mean was (10.5), Innovin Lot # 549706, Exp Date 9/20/2020. b. The mean Normal PT value entered on the instrument was 11.5 while mean Normal PT calculated based on normal patient samples performed by the laboratory was 10.5. c. The following are random selected patient sampling test results reviewed. Date Patient: PT: INR: Analyzed: Results: 2/28/18 02111065 8.3 0.70 3/7/18 00211480 71.1 0.84 3/9/18 00211693 9.2 0.79 3/9/18 00211694 31.3 3.91 3/14/18 00211980 28.8 2.88 3/15/18 00212047 9.0 0.85 3/15/18 00212048 59.1 5.77 4/2/18 00212857 17.4 1.64 4/5/18 00213105 24.1 2.37 4/23/18 00214023 31.4 3.21 5/1/18 00214567 47.1 5.08 5/31/18 00216134 24.9 2.46 6/28/18 00217484 49.0 5.33 7/5/18 00217863 22.7 2.21 12/6/18 00226384 19.7 1.88 d. The laboratory analyzed and reported approximately 125 PT tests covering period from 2/28/2018 to 1/4/2019. There were 25 patients with an abnormal PT results, that the INR results cannot be assured. e. The technical consultant confirmed (1/24/2019, 1300) that the laboratory failed to ensure that the correct mean Normal PT value was entered into the instrument. -- 4 of 4 --