Endocrine Associates Of Long Island Pc

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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) data and American Proficiency Institute (API) PT summary reports, the laboratory failed to successfully perform in the CMS approved PT program for the platelets test analyte. FINDINGS: The following scores were assigned: Platelets Test Analyte: 2023 First Event = 0% 2023 Second Event = 60% This is considered repeatedly unsuccessful PT performance. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 CMS PT data and API PT summary reports, the laboratory failed to achieve satisfactory performance for the platelets test analyte in two out of three consecutive testing events. FINDINGS: The following scores were assigned: Platelets Test Analyte: 2023 First Event = 0% 2023 Second Event = 60% 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 CMS PT data and API PT summary reports, the laboratory director (LD) failed to fulfill LD responsibilities and ensure that the laboratory achieved a satisfactory performance for the platelets test analyte as well as successfully participate in the CMS approved PT program. FINDINGS: The following scores were assigned: Platelets Test Analyte: 2023 First Event = 0% 2023 Second Event = 60% 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 CMS PT data and API PT summary reports, the LD failed to test the platelets test analyte as required as well as achieve a satisfactory performance in the CMS approved PT program. FINDINGS: The following scores were assigned: Platelets Test Analyte: 2023 First Event = 0% 2023 Second Event = 60% -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on the review of American Proficiency Institute (API) Proficiency Testing (PT) records for 2020 through survey date, the laboratory failed to enroll PT program for COVID-19 Spike Abs. Confirmed on an interview with testing person on 9/22/2022 about 12pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 the review of the Quality Control (QC) records, the laboratory failed to provide/maintain QC assay sheets for Abbott Cell-Dyn Emerald hematology analyzer for past two years. Confirmed in an interview with testing personnel on 9/22/2022 about 11am. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- 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 review of the laboratory's Quality Control (QC) records, the laboratory failed to perform a verification of current lot number to new lot number of the hematology analyzer Abbott Cell-Dyne Emerald. FINDINGS: 1. The new QC lot to lot validation documentations of hematology analyzer were not available upon request during the survey since the hematology analyzer implementation date to survey date. 2. The testing personnel confirmed during interview on 9/22/2022 at 11:30 am, the new lot to lot validation of QC material for hematology analyzer was not performed. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the review of laboratory's Quality Control records, and Proficiency Testing records, the laboratory director failed to maintain and assure the quality of laboratory services provided. Refer D5469, D3031, D2000 -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD 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 maintain the accuracy for the following non-regulated analyte's C-peptide, Testosterone, 25-OH-Vitamin D, Folate and Vitamin B-12. 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 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 -- 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 PT desk review of the CMS PT data reports and PT records from API PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Endocrinology and the test analyte's Free Thyroxine (FT4), Thyriod Sitmulating Hormone (TSH) and Triiodothyronine (T3). The following scores were assigned: 2021 first event = 0% [failure to participate] 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Free Thyroxine (FT4), Thyriod Sitmulating Hormone (TSH) and Triiodothyronine (T3). The following scores were assigned: 2021 first event = 0% [failure to participate] 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 PT desk review of the CMS PT data reports and PT records from API PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Endocrinology. The following scores were assigned: 2021 first event = 0% [failure to participate] 2021 second event = 0% [failure to participate] 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on PT desk review of the CMS PT and API PT program records, 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, approved by CMS, for the test speciality Endocrinology and the test analyte's Free Thyroxine (FT4), Thyriod Sitmulating Hormone (TSH) and Triiodothyronine (T3). 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 CMS PT and API PT program records, 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, approved by CMS, for the test speciality Endocrinology and the test analyte's Free Thyroxine (FT4), Thyriod Sitmulating Hormone (TSH) and Triiodothyronine (T3). The following scores were assigned: 2021 first event = 0% [failure to participate] 2021 second event = 0% [failure to participate] This is considered unsuccessful PT performance. -- 3 of 3 --