O Goussis, Md Pc

Summary Statement of Deficiencies D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of API PT summary reports, the laboratory failed to participate successfully in proficiency testing for the test analytes Estradiol, Parathyroid Hormone, FSH, and BNP. Finding: Following scores were assigned: 2021 first event = 50% 2022 first event = 50% 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) summary reports and an interview with the technical consultant, the laboratory failed to review and evaluate the obtained PT results. FINDINGS: 1. 2021 second and third event summary report were not signed by the laboratory director. 2. Confirmed on an interview technical consultant on 4/22/2022 2:00pm D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the QC and calibration records for the test analytes Testosterone, BNP, Vitamin D and controls for the Allergen testing and interview with the technical consultant, the laboratory performed QC and calibrations using expired materials. FINDINGS: 1. Testosterone Level Low, Med, High a. Lot#902930489 Exp 12/14 /2020 used on 12/23/2020 and 1/21/2021. b. Lot#902936830 Exp 12/1/21 used on 12/2 /21. c. Lot#902936838 Exp 10/10/21 used on 10/13/21. d. Approximately 20 patients were tested at above dates. 2. Testosterone Calibrator Lot#902931804 Exp 4/30/21 used on 5/19/21 3. BNP Level 1,2,3 Lot# 44K08421 Exp 11/1/2021 used on 11/11 /2021 and 1/19/2022. Approximately 20 patients were tested at above dates. 4. Immuno MCC Level 1,2,3 Lot#32908190 Exp 11/30/202 used on 12/1/21, 12/22/21, 1 /19/22. Approximately 10 patients were tested at above date. Approximately 10 patients were tested at above dates. 5. Vitamin D calibrator Lot#18328U100 Exp 9/20 /21 used on 10/13/2021. 6. Confirmed on an interview with technical consultant on 4 /27/22 about 1:00pm D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's QC policy and QC records for calendar year 2020 through survey date and an interview with the technical consultant, the laboratory failed to establish and follow a QC procedure to include the number, type, frequency controls are performed and the criteria for acceptability. FINDINGS 1. The December 2021 QC records for Vitamin 12 that the testing person accepted 2 out of 3 levels of controls as an acceptable criterion for QC prior to testing patient specimen. 2. The laboratory failed to establish the criteria for QC acceptability. 3. Technical consultant confirmed on an interview on 4/27/2022 about 1:30pm. D5783

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 a surveyor review of proficiency testing (PT) records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the following analyte: Parathyroid Hormone (PTH): 2016 third event = 0% 2017 first event = 0% 2017 second event = 0% Vitamin B12 2017 first event = 67% 2017 second event = 0% 2017 third event = no participation 2018 first event = 100% Vitamin D 2017 first event = 0% 2017 second event = no participation 2018 first event = 0% Refer to : D2107 and 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 9 -- 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 a review of American Proficiency Institute (API) Proficiency Testing (PT) test reports, the laboratory failed to successfully participate in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the test the following analytes: The following scores were assigned: Vitamin B12 2017 first event = 67% 2017 second event = 0% 2017 third event = no participation 2018 first event = 100% Vitamin D 2017 first event = 0% 2017 second event = no participation 2018 first event = 0% This is considered repeatedly unsuccessful PT performance. 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 a review of American Proficiency Institute (API) Proficiency Testing (PT) test reports, the laboratory failed to successfully participate in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the test the following analytes: The following scores were assigned: Parathyroid Hormone: 2016 third event = 0% 2017 first event = 0% 2017 second event = 0% 2017 third event = No participation 2018 first event = Not graded This is considered repeatedly unsuccessful PT performance. 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) Proficiency Testing (PT) reports and an interview with the technical consultant, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2017 first event: Estrodial = 67% 2017 second event: Testosterone = 0% Leuteinizing Hormone (LH) = 33% 2017 third event: Cortisol = 20% Total Triiodothyronine (TT3) = 40% D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic -- 2 of 9 -- 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. This CONDITION is not met as evidenced by: Based on surveyor's review of records and an interview with the technical consultant, the laboratory failed to: 1. Ensure that a comprehensive procedure manual is available for all aspect of the testing process. Refer to D5403; 2. Ensure that the laboratory follows laboratory's temperature policy. Refer to D5413; 3. Ensure that the laboratory discontinued the use of expired QC and calibrator materials. Refer to D5417; 4. Ensure that the Validation study was performed and documented. Refer to D5421; 5. Perform and document calibration for endocrinology and chemistry. Refer to D5437; 6. Perform and document QC for Immunology. Refer to D5449; 7. Perform and document calibration verification for analytes with less than 3 point calibrators. Refer to D5439; 8. Ensure that chemistry and endocrinology QC test results were within acceptable range prior to testing patient specimens. Refer to D5481; 9. Ensure that