Hematology Oncology Assoc Of Brooklyn

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) Proficiency Testing (PT) summary reports, lack of CAP test result forms for test events in 2020 and 2021 and an interview with the general supervisor the laboratory failed to establish a written procedure that defines which Micros 60 analyzers is tested and reported for that specific CAP event. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. 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 -- This CONDITION is not met as evidenced by: Based on review of laboratory standard operating procedure (SOP) & QC, Calibration, Maintenance, records, direct observation of reagents in laboratory refrigerator and an interview with the general supervisor, the laboratory failed to: 1. Ensure that a SOP contain written procedures for the QC ranges when the reference limits are altered, Refer to D5401; 2 .Ensure that the laboratory's established a written procedure to back-up the Harvest LIS system, Refer to D5403; 3. Ensure that the reagent are not expired prior to use for testing, Refer to D5417; 4. Ensure that the laboratory performed the as needed and preventative maintenance for the microscope, Refer to D5431; 5. Ensure that the laboratory auxiliary maintenance is performed annually, Refer to D5435; 6. Ensure that the required calibration for the Horiba hematology analyzers are performed, Refer to D5437. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, QC records for the ABX Monitrol control assay sheets, and an interview with the general supervisor, the laboratory failed to establish written procedure for the criteria used to establish QC ranges, limits, and standard deviation of hematology Monitrol controls. FINDINGS: 1. The laboratory failed to establish a written procedure for criteria used to establish QC ranges, limits, and standard deviation for the Monitrol hematology controls. 2. The QC limits in the Harvest Orchard LIS program did not match manufacturers' control assay insert. a. The QC limits in the Harvest program for hematology Monitrol controls were much tighter by 2 SD. 3. The general supervisor confirmed on 2/1/22 at approximately 2:30 PM that the laboratory did not establish the above procedure. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor's review of 2020, 2021 College of American Pathologists (CAP) Proficiency testing (PT) attestation statements and an interview with the general supervisor/testing person, the laboratory failed to rotate the testing of PT samples among five personnel, who routinely perform hematology automated Complete Blood Count (CBC) tests. The same person performed all three events of 2020 and two 2021 events as indicated by the signed attestation statements. FINDINGS. The general supervisor/testing person confirmed on October 27, 2021 at approximately 10:00 AM, the surveyor's findings that the same testing person performed the PT hematology samples for all three events of 2020 and two 2021 events. 2. The laboratory did not rotate the testing of the PT samples for the five of six testing personnel, who routinely perform hematology CBC testing. 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 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 -- 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 surveyor's review of the third event of 2020 and second event of 2021 CAP PT summary reports, the laboratory failed to participate successfully in proficiency testing for the specialty Hematology and the test analyte's White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet and Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2020 third event = 0% (non-participation) 2021 first event = 100% 2021 second event = 0% (non-participation) This is considered unsuccessful PT performance. Refer to D2130 and D2131. 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. This STANDARD is not met as evidenced by: Based on surveyor's review of the CAP PT records for 2020 and 2021 events, the laboratory failed to participate successfully in proficiency testing for the test analyte's WBC, RBC, Hgb, Hct, Platelet and Cell I.D./WBC Diff. The following scores were assigned: 2020 third event = 0% (non-participation) 2021 first event = 100% 2021 second event = 0% (non-participation) This is considered unsuccessful PT performance. 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 surveyor's review of the CAP PT records for 2020 and 2021 events, the laboratory failed to participate successfully in proficiency testing for the specialty Hematology. The following scores were assigned: 2020 third event = 0% (non- participation) 2021 first event = 100% 2021 second event = 0% (non-participation) This is considered unsuccessful PT performance D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) -- 2 of 5 -- 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. This STANDARD is not met as evidenced by: Based on surveyor's review of Mintrol-16 Peer Review Quality Control (QC) records, current October hematology control QC records for the ABX Horiba Micros 60 instrument and an interview with the general supervisor/testing person, the laboratory failed to retain the monthly QC printouts, Levy Jennings graphs and the daily start-up printouts for the Micros 60 instrument from April 1, 2019 through September 30, 2021. FINDINGS: The general supervisor/testing person confirmed on October 27, 2021 at approximately 10:45 AM, the surveyor's findings that the laboratory failed to retain the monthly QC printouts, Levy Jennings graphs and the daily start-up printouts for the ABX Horiba Micros 60 instrument from April 1, 2019 through September 30, 2021. a. The general supervisor/testing person stated, "that he prints the 3 levels of Mintrol-16 QC monthly QC report and Levy Jennings graphs and submits them to ABX Diagnostic Peer Review Evaluation program. He then scans the Peer Review Result sheets into the Laboratory's Information System (LIS) LABDAQ and then discards the original hematology QC printouts." b. The general supervisor/testing person stated, "that he does not retain copies of the start-ups for the ABX Horiba Micros 60 instrument." c. Approximately 2,000 patient samples were tested and reported for automated CBC performed on the ABX Horiba Micros 60 from April 1, 2019 through September 30, 2021. 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 surveyor's review of competency assessment records for the five of six testing personnel, the laboratory's competency assessment policy and an interview with the general supervisor/testing person, the laboratory failed to follow their written policies for competency assessment for five of six testing personnel for the calendar year 2019 and 2020. FINDINGS: The general supervisor/testing person confirmed on October 27, 2021 at approximately 11:30 AM, the surveyor's findings that the laboratory failed to follow their written competency assessment polices for the following: a .five of six personnel who routinely perform only hematology testing failed to be evaluated for 2019 and 2020 annual competency. b. the general supervisor /testing person performs the chemistry and endocrinology testing D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policy, QA review records for the calendar year 2019, 2020, 2021 and an interview with the general supervisor/testing person, the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. FINDINGS: 1. The general supervisor/testing person confirmed on September 29, 2021 at approximately 9:15 AM, that the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. 2. The laboratory's QA policy requires an annual review of all phases of laboratory's testing and take

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Chloride. The following scores were assigned: 2020 second event = 0% 2020 third event = 40% This is considered unsuccessful PT performance. Refer to D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- 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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Bilirubin. The following scores were assigned: 2020 third event = 40% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Chloride. The following scores were assigned: 2020 second event = 0% 2020 third event = 40% This is considered unsuccessful PT performance. 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 PT desk review of the PT CMS data reports and API PT reports, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Chloride and Total Bilirubin. 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 PT desk review of the PT CMS data reports and API PT reports, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure -- 2 of 3 -- that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analyte's Chloride and Total Bilirubin. The following scores were assigned: Chloride 2020 second event = 0% 2020 third event = 40% This is considered unsuccessful PT performance. Total Bilirubin. 2020 third event = 40% This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies 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 the surveyor's review of American Proficiency Institute (API), College of American Pathologists (CAP) and Center for Medicaid and Medicare Services (CMS) Proficiency Testing (PT) reports, and an interview with the testing person at 12:00PM on 3/28/19, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2017 third event: IgA = 80% 2018 first event: Total Calcium = 80% Chloride = 80% 2018 second event: Total Calcium = 80% Chloride = 80% 2019 first event: Total Calcium = 80% ALT (SGPT) = 80% D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's procedure manual and the maintenance 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 -- records for the laboratory's instruments and interview with the testing person, the laboratory failed to establish a procedure that allows for a reduction of certain maintenance requirements for their analyzers based on their limited use. Findings: 1. During the review of maintenance sheets on the Pentra 400 Chemistry analyzer and the TOSOH Immunoassay analyzer and confirmed in an interview with the testing person at approximately 11:30 AM on March 28, 2019, the laboratory had spread out the weekly and monthly requirements based on the limited use of the analyzers. 2. The laboratory had no procedure allowing for a reduction of the maintenance schedule. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Control (QC) records for hematology, chemistry and general immunology and confirmed in a interview with the supervisor/testing person, the laboratory failed to perform a lot to lot comparison of assayed QC materials. Findings: 1. The supervisor/testing person confirmed at 12: 30 PM on 3/28/18 that the laboratory does not test new lots of control againist the current lot before using the new lot as primary QC. 2. This was noted for the Horiba controls used for general immunology, chemistry and hematology. -- 2 of 2 --