Michael N Rutman Do Amc

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, Glucose and BUN, 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, Sodium, as follows: 2021 Q3 2022 Q2 SODIUM 40% 20% Q2 = Second Testing Event Q3 = Third 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, Sodium. 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, Sodium, 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 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 review of the laboratory's records and the American Proficiency Institute (API) proficiency testing (PT) testing result reports, and interview with the technical consultant (TC), it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory failed to attain a score of 80% of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event b. The laboratory used Olympus AU 400 chemistry analyzer to perform routine chemistry panel including, but not limited to the following analytes: Alkaline Phosphatase (Alk P), total Bilirubin (tBi), Sodium (Na). c. The laboratory failed to attain a score of at least 80% of acceptable responses for the following analytes in the following PT testing event which were unsatisfactory analyte performance for the testing events. PT Analyte score (%) Q2 2020 Alk P 0 Q3 2020 Na 40 Q3 2021 tBi 20 Q3 2021 Na 40 d. The laboratory performed Alk P, Na and TBi in approximately 50 patient sample for each analyte monthly. e. The laboratory TC affirmed (2/15/2022 @ 10:35 am) that the laboratory failed to attain a score of at least 80 percent of acceptable responses for analyte of Alk P, Na, and TBi in various 2020 and 2021 PT testing events (item c) were unsatisfactory analyte performance for the testing event. 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 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 -- 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 laboratory's records and the American Proficiency Institute (API) proficiency testing (PT) testing result reports, and interview with the technical consultant (TC), it was determined that the laboratory failed to verify at least twice annually, the accuracy of any test or procedure it performs that is not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory used Olympus AU400 chemistry analyzer to perform chemistry testing including, but not limited to the following analytes: 25-OH Vitamin (Vit D), direct Bilirubin (dBi), CO2, Phosphorus (iP) which are not in the list of subpart I of 42 CFR part 493. b. The laboratory elected to enroll with American Proficiency Institute (API) PT program to verify the accuracy of the testing results at least twice annually. c. The laboratory failed to attain a score of at least 80% of acceptable responses for the following analytes in the following PT testing events which were unsatisfactory analyte performance for the testing events. PT Analyte score (%) Q2 2020 Vit D 0 Q2 2020 CO2 40 Q3 2020 CO2 40 Q1 2021 iP 60 Q2 2021 dBi 40 c. The laboratory performed Vit D, CO2, iP and dBi in approximately 50 patient samples for each analyte monthly. d. The laboratory TC affirmed (2/15/2022 @ 10:35 am) that the laboratory failed to attain a score of at least 80 percent of acceptable responses for analyte of Vit D, CO2, iP, and dBi in various 2020 and 2021 PT testing events (item c) were unsatisfactory analyte performance for the testing event 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 review of the laboratory's records and the American Proficiency Institute (API) proficiency testing (PT) testing result reports, and interview with the technical consultant (TC), it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required to verify the accuracy, reliability of the patient test results reports. The findings included: a. The laboratory director failed to ensure that the proficiency testing samples were tested as required to verify the accuracy, reliability of the patient test results reports b. The laboratory used Olympus AU 400 chemistry analyzer to perform routine chemistry including, but not limited to the following analytes: Alkaline Phosphatase (Alk P), total Bilirubin (tBi), Sodium (Na). c. The laboratory failed to attain a score of at least 80% of acceptable responses for the analyte identified above item (a), which were unsatisfactory analyte performance for the testing events. see D-2087 d. The laboratory used Olympus AU400 chemistry analyzer to perform chemistry testing including, but not limited to the following analytes: 25-OH Vitamin (Vit D), direct Bilirubin (dBi), CO2, Phosphorus (iP) which are not in the list of subpart I of 42 CFR part 493. e. The laboratory elected to enroll with API PT program to verify the accuracy of the testing results at least twice annually. f. The laboratory failed to attain a score of at least 80% -- 2 of 3 -- of acceptable responses for the analytes identified above item (c) were unsatisfactory analyte performance for the testing events, see D-5217 -- 3 of 3 --