B Pediatrics

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on March 11, 2021, 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 D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing non-waived testing 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Institute proficiency testing records, the facility failed to achieve successful performance in three out of four consecutive testing events for the specialty of Hematology, resulting in unsuccessful performance in the specialty of Hematology. Refer to D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve successful performance in three out of four consecutive testing events for the analyte specialty of Hematology, resulting in a non-initial proficiency testing failure in the specialty of Hematology. The findings included: 1. The laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the specialty of Hematology in three of four consecutive testing events in 2019 and 2020. 2019 API 3rd event - Hematology Score: 0 2020 API 2nd event - Hematology Score: 0 2020 API 3rd event - Hematology Score: 0 2. For the 3rd event of 2019, the facility failed to participate for the specialty of hematology, including the following analytes: 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON- WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 2nd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 3rd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program -- 2 of 5 -- within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to participate in three out of four consecutive testing events for the specialty of Hematology, resulting in unsuccessful performance in the specialty of Hematology. The findings included: 1. Based on review of the American Proficiency Institute (API) proficiency evaluation reports, the laboratory failed to participate in the following events between 2019 and 2020: For the 3rd event of 2019, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY FAILED TO PARTICIPATE 0765 CELL I.D. OR WBC DIFF FAILED TO PARTICIPATE 0785 HCT (NON-WAIVED) FAILED TO PARTICIPATE 0795 HGB (NON-WAIVED) FAILED TO PARTICIPATE 0805 WBC FAILED TO PARTICIPATE 0815 PLATELETS FAILED TO PARTICIPATE For the 2nd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY FAILED TO PARTICIPATE 0765 CELL I.D. OR WBC DIFF FAILED TO PARTICIPATE 0785 HCT (NON-WAIVED) FAILED TO PARTICIPATE 0795 HGB (NON-WAIVED) FAILED TO PARTICIPATE 0805 WBC FAILED TO PARTICIPATE 0815 PLATELETS FAILED TO PARTICIPATE For the 3rd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY FAILED TO PARTICIPATE 0765 CELL I.D. OR WBC DIFF FAILED TO PARTICIPATE 0785 HCT (NON-WAIVED) FAILED TO PARTICIPATE 0795 HGB (NON-WAIVED) FAILED TO PARTICIPATE 0805 WBC FAILED TO PARTICIPATE 0815 PLATELETS FAILED TO PARTICIPATE 2. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, the laboratory received a score of 0 percent for each event the laboratory failed to participate: For the 3rd event of 2019, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 2nd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 3rd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve satisfactory performance in three out of four consecutive testing events for the analytes CELL I.D. OR WBC DIFF, HCT (NON-WAIVED), HGB (NON-WAIVED), WBC, PLATELETS , resulting in unsuccessful performance in the specialty of Hematology. The findings included: 1. Based on review of the American Proficiency Institute (API) proficiency evaluation reports, the laboratory failed to participate in the following events between 2019 and 2020, resulting in a score of 0 percent: For the 3rd event of 2019, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 2nd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 For the 3rd event of 2020, the facility failed to participate for the specialty of hematology, including the following analytes: 0760 HEMATOLOGY Score: 0 0765 CELL I.D. OR WBC DIFF Score: 0 0785 HCT (NON-WAIVED) Score: 0 0795 HGB (NON-WAIVED) Score: 0 0805 WBC Score: 0 0815 PLATELETS Score: 0 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve successful performance in three out of four consecutive testing events for the analyte specialty of Hematology, resulting in a non-initial proficiency testing failure in the specialty of Hematology. The findings included: 1. The laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the specialty of Hematology in three of four consecutive testing events in 2019 and 2020. 2019 API 3rd event - Hematology 0% 2020 API 2nd event - Hematology 0% 2020 API 3rd event - Hematology 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: -- 4 of 5 -- Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory director failed to ensure successful participation in a 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: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for specialty of Hematology. Refer to D2130. -- 5 of 5 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2016 and 2017 and staff interview, the laboratory director failed to attest to the integration of PT samples into the patient workload using the laboratory's routine methods. Findings: 1. API PT documentation for 2016, 2017 and 2018 was reviewed. Attestation forms stating: "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens" were included. Forms for the 3rd event 2016 and 1st, 2nd and 3rd events 2017 were signed by testing person 1 (CMS form 209) as the person performing the tests. The forms were not signed by the laboratory director. In an interview at the site on 08-23-18, testing person 1 confirmed that the laboratory director had failed to sign the attestation forms. . 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 API PT documentation for hematology testing using the QBC Autoread analyzer in the second event 2018, confirmed by staff interview, the 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 -- laboratory failed to attain satisfactory scores in 4 of 6 analytes tested in the specialty of hematology. Findings: 1. API PT documentation for the second testing event of 2018 were reviewed. The following analytes received scores below 80%. Hematocrit (%) Sample Reported Expected Grade QBC-06 28 31-36 Unacceptable QBC-07 34 33-38 Acceptable QBC-08 23 21-25 Acceptable QBC-09 32 31-36 Acceptable QBC- 10 32 26-30 Unacceptable Cumulative score: 60% Hemoglobin (g/dL) Sample Reported Expected Grade QBC-06 9.7 10.6-12.3 Unacceptable QBC-07 12.4 11.4- 13.2 Acceptable QBC-08 7.9 7.3-8.6 Acceptable QBC-09 11.3 10.7-12.4 Acceptable QBC-10 11.4 9.1-10.6 Unacceptable Cumulative score: 60% Platelet Count (X10^9 /L) Sample Reported Expected Grade QBC-06 322 76-128 Unacceptable QBC-07 169 80-135 Unacceptable QBC-08 614 426-712 Acceptable QBC-09 129 76-127 Acceptable QBC-10 142 201-336 Unacceptable Cumulative score: 40% White Cell Count (X10^9/L) Sample Reported Expected Grade QBC-06 6.5 9.7-13.3 Unacceptable QBC-07 11.3 12.7-17.2 Unacceptable QBC-08 6.1 4.9-6.8 Acceptable QBC-09 11.3 9.8-13.4 Acceptable QBC-10 11.0 5.3-7.3 Unacceptable Cumulative score:40% 2. In an interview at the site on 08-23-2018, testing person 1 stated she had verified that the values obtained in testing had been entered correctly and was in the process of investigating the issue. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on review of daily logs for hematology testing using the QBC Autoread analyzer from 2016, 2017 and 2018, confirmed by staff interview, the laboratory failed to perform system checks according to manufacturer's instructions. Findings: 1. The operator's manual for the QBC Autoread hematology analyzer states: "The Calibration Check Rod should be tested daily following the startup self-check procedures." (QBC Autoread Operator's Manual, Rev. A, p. 4-7, 4.5.1) 2. Review of daily logs for hematology revealed that, since the time of the previous survey, the calibration check had been performed on the following dates: 07-13-2016 08-16-2016 09-09-2016 03-09-2017 06-22-2018 3. In an interview at the site on 08-23-2018, testing person 1 stated that calibration checks were not routinely performed, and that the dates shown on the log were representative of the laboratory's performance of the procedure. -- 2 of 2 --