Pattner & Grodstein Md Pa

Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM), patient work records and interview with the Technical Consultant (TC), the laboratory failed to follow their PM policy for "Act Diff #2 Flags and Codes" for Hematology tests ran on the Beckman Coulter AcT diff 2 from 1/7/21 to the date of survey. The finding includes: 1) The PM stated "X flag indicates that one of the multiple Alert criteria was not met. 1. Thoroughly mix and rerun the sample. 2. If the flag does not repeat report result. 3. If flag repeats, clean the aperture as instructed in zapping the aperture. 4. If after cleaning, problem persists contact your Beckman Coulter Representative". a) Patient number 25071 run on 1/7/21 with "X" flagged results was not rerun. b) Patient number 111350 run on 4/6/21 with "X" flagged results was not rerun. c) Patient number 52458 run on 4/6/21 with "X" flagged results was not rerun. d) Patient number 23951 run on 4/30/21 with "X" flagged results was not rerun. e) Patient number 50062 run on 3/18/21 with "X" flagged results was not rerun. f) Patient number 331369 run on 3/31/21 with "X" flagged results was not rerun. 2) The TC confirmed on 5/11/21 at 2:05 pm the above mentioned procedure was not followed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification 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 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration Verification (CV) records and interview with the Technical Consultant (TC), the laboratory failed to perform and document CV procedures at least once every six months for Hematology Testing on the Beckman Coulter AcT diff 2 analyzer in the calendar years 2019 and 2020. The finding includes: 1. The laboratory last performed CV 8/21/18, but there was no documented evidence CV was after that. 2. The TC confirmed on 5/11/21 at 2:30 am CV was not performed every six months. 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 review of Quality Control (QC) records, Manufacturers Package Insert (MPI) and interview with the Technical Consultant (TC), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Hematology testing performed on the Beckman Coulter AcT Diff 2 analyzer from 12 /11/18 to the date of survey. The TC confirmed on 5/11/21 at 1:45 pm that the assayed values of QC materials were not verified before putting in use. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of Quality Control (QC) records, Manufactures Package Insert (MPI) and interview with the Technical Consultant (TC), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Hematology testing performed on the AcT Diff 2 analyzer from on the date of survey. The finding includes: 1. One (Normal level) out of three control levels was being run for QC verification before new QC material was being put into use. 2. The results of normal level QC material was not verified with MPI values. 3. The laboratory did not verify all QC materials used in 2017 and 2018. 4. The TC confirmed on 12/11/18 at 12:00 pm that the assayed values of QC materials were not verified before putting in use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for White Blood Cell tests with Oneworld Accuracy. 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. 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 -- This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for White Blood Cell tests. The finding includes: The laboratory scored 60% in 3-17 and 20% in 2-18 events with Oneworld Accuracy. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and in compliance with the CLIA regulations are maintained. -- 2 of 2 --