Oncology Association Pa

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 21, 2022 for The Oncology Association, PA. The Oncology Association, PA is not in compliance with the Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2022, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Refer to D2131. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of 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 3 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 21, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff) for two consecutive testing events 2022. 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Findings include: On September 21, 2022 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff), as shown below. Event #1, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% Event #2, 2022 WBC-0% RBC-0% HGB- 0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score in proficiency testing for analytes found in the specialty of hematology. Findings include: On September 21, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2131. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for analyte(s) found in the specialty of hematolo. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 21, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events for the analytes shown below. Event #1, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% Event #2, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% -- 3 of 3 --

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 Proficiency Institute (API) proficiency testing results and interview with the Laboratory Director, the laboratory failed to score at least 80% for White Blood Cell (WBC) Differential in 1 out of 7 (1st testing event 2017 through 1st testing event in 2018) testing events reviewed in the specialty of Hematology. Findings Included: Review of API proficiency testing results in the 1st testing event in 2017 revealed a score of 67% for WBC Differential. Interview on 08/24/2018 at 11:00 AM the Laboratory Director confirmed the proficiency testing failure. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) Hematology proficiency testing results and interview with the Laboratory Director, the laboratory failed to submit the laboratory's proficiency testing results in the specificied timeframe for the 1st Hematology Event in 2016, resulting in a score of 0% for all Hematology analytes. Findings included: Review of the API Hematology proficiency testing results revealed that the laboratory had obtained a score of 0% for 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 -- Hematology, Cell Identification or White Blood Differential, Red Blood Cell, Hematocrit, Hemoglobin, and Platelets for the 1st Hematology Event of 2016. Interview on 08/24/2018 at 11:50 AM, the Laboratory Director stated that they forgot to send in the API proficiency test results for the 1st Hematology Event in 2016. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and interview with the Laboratory Director, the Laboratory Director failed to review and evaluate the proficiency testing results for 6 out of 7 Hematology testing events reviewed. Findings Included: Review of API Hematology proficiency testing results revealed that the Laboratory Director did not review and evaluate the results in the 1st, 2nd and 3rd Hematology testing events in 2016, 2nd and 3rd Hematology Event in 2017, and 1st Event in 2018. The 1st Hematology API proficiency testing results were not submitted in time, but the laboratory did test the samples. The Laboratory Director did not perform a self grade of the results. During an interview on 08/24 /2018 at 11:50 AM the Laboratory Director confirmed there was no documentation that the Laboratory Director reviewed and did not know that the laboratory needed to perform a self grade on proficiency testing results not submitted. 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)