Boris Ratiner Md Inc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 the survey on September 19, 2024, a review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the technical consultant (TC), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for alanine aminotransferase (ALT) analyte in 2023. The findings include: 1. Based on review of PT records for the first event of 2023 (Q1-2023), API reported an unsatisfactory score report as follows: ALT PT Q1-2023 Overall score: 60% Specimen Reported Expected CHM-01 *26 13 - 21 CHM-02 *27 10 - 17 CHM-03 247 199 - 300 CHM-04 93 69 - 104 CHM-05 182 144 - 218 2. The TC affirmed by interview on September 19, 2024, at approximately 10:30 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 15,470 Routine Chemistry test samples, including ALT analyte, during the time the laboratory had unsatisfactory proficiency testing results. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) 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 -- Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the lack of the laboratory's verification of performance documentation for moderate complexity testing for Cell Blood Count (CBC), interviews with the technical consultant (TC) and testing personnel (TP), and review of nine (9) randomly selected patient test records, the laboratory failed to demonstrate that it established performance specifications comparable to those established by the manufacturer. The findings include: 1. Based on the review of laboratory records on September 19, 2024, the laboratory had no documentation to show for the verification of performance for CBC using the Cell-dyn instrument when it was acquired in 2022. The laboratory must be able to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics and those to be approved by the laboratory director before starting testing patients' samples: (A) Accuracy (B) Precision (C) Reportable range (D) Reference Range 2. Based on the interviews with the TC and TP, no method correlation was performed for Horiba, the old Hematology instrument, as it was unusable. The facility acquired Cell-dyn as a replacement in 2022 but was unable to find the documentation during the survey. 3. Based on the review of two out of nine patient test records, the CBC results reported couldn't be assured due to the missing documentation for the verification of performance for the Hematology analyzer, Cell-dyn. 4. The TC and TP affirmed at the time of the survey on September 19, 2024, at approximately 10:45 a.m. that no binder or documents could be retrieved to show that performance specifications were performed prior to reporting patient test results when the laboratory went live testing and reporting CBC tests. 5. Based on the laboratory testing declaration submitted at the time of the survey, the laboratory performed and reported approximately 14,200 CBC tests. Thus, the precision and accuracy of the reported test results could not be assured. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on survey findings on September 19, 2024, review of proficiency testing records, and interview with the technical consultant, the laboratory director is herein cited for the deficient practice in providing overall technical oversight for ALT testing. See D2087. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on the deficiency cited (D5421), the laboratory director is herein cited for deficient practice in ensuring test system verification procedures were compliant with the regulations at 493.1253(b)(1) before the laboratory personnel was allowed to test patients' samples without confirming the manufacturer's performance specifications. -- 3 of 3 --

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, Sodium (Na), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Na, as follows: 2020 Q2 2021 Q1 Na 20% 60% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Na. 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, Na, 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 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 third quarter (Q3-2017) American Proficiency Institute (API)) proficiency testing records and interview with the technical consultant, it was determined that the laboratory failed attain a score of at least 80 percent of acceptable responses for Red Blood Cell (RBC) count. The findings included: a. Q3-2017, API reported an unsatisfactory score of 60% for RBC analyte. b. For fourteen (14) out of fourteen (14) random patient test results reviewed covering period from 12/15/2016 to 8/15/2018 the laboratory analyzed and reported these patients for Complete Blood Count (CBC) tests during the approximate time the laboratory received an unsatisfactory proficiency testing score for RBC. c. The testing personnel confirmed (1 /14/2019, 1300) that the laboratory received the above unsatisfactory proficiency testing 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 American Proficiency Institute (API) proficiency testing records and interview with the technical consultant, it was determined that the laboratory failed to at least twice annually, the laboratory must verify the accuracy of 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 -- any test or procedure it performs that is not included in subpart I of this part. The findings included: a. API reported the following unsatisfactory scores. Analyte: Score: Event/Year: CRP Quant 0% Q3-2016 CRP Quant 50% Q2-2017 CRP Quant 0% Q3- 2017 PTH 0 Q2-2017 25 OH Vit D 0% Q2-2017 b. For thirteen (13) out of fourteen (14) random patient test results reviewed covering period from 12/15/2016 to 8/15 /2018, the laboratory analyzed and reported these patients for C-Reactive Protein (CRP) tests during the approximate time the laboratory received an unsatisfactory proficiency testing scores for CRP. For six (6) out of fourteen (14) random patient test results reviewed covering period from 12/15/2016 to 8/15/2018, the laboratory analyzed and reported these patients for Parathyroid Hormone (PTH) tests during the approximate time the laboratory received an unsatisfactory proficiency testing score for PTH. For five (5) out of fourteen (14) random patient test results reviewed covering period from 12/15/2016 to 8/15/2018, the laboratory analyzed and reported these patients for 25-Hydroxy Vitamin D tests during the approximate time the laboratory received an unsatisfactory proficiency testing score for 25-Hydroxy Vitamin D. c. The technical consultant confirmed (1/14/2019, 1300) that the laboratory received the above unsatisfactory proficiency testing scores. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of random patient 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 postanalytic systems specified in 493. 1291. The findings incuded: a. Based on review of the following random patient test results: Patient #1 EL-ANA Screen (Collection Date: 11/16/2017 18:22, Status: Final) Results entered four (4) times. EL-ANA9C Elisa Method, IgG (Collection Date: 11/16 /2017 18; 22, Status: Final) Results entered three (3) times. Patient #2 Rheumatoid Factor /3 IgM IgG, IgA (Collection date 6/8/2018, Status: Final) Results were entered two (2) times. 25-Hydroxy Vitamin D (Collection Date: 6/8/2018, Status: Final) Results were entered two (2) times. Patient #3 Quantiferon-TB Gold IT (Collection Date: 6/13/2018 09:22, Status: Final) Results were entered two (2) times. Patient #4 Cyclic Citrullinated Peptide-4P (Collection Date: 8/15/2018 09:30, Status: Final) Results entered three (3) times. Patient #5 Cyclic Citrullinated Peptide-4P (Collection Date: 8/15/2018 09:30, Status: Final) Results entered three (3) times. b. The technical consultant confirmed (1/14/2019, 1300) that the above patient test results are entered on the final test reports multiple times. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved