New York Fertility Institute

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 a surveyor's observation and confirmation by the clinical consultant/testing person and the laboratory director, at the time of this survey, the laboratory failed to discontinue the use of expired testing materials for patient testing. FINDINGS: The surveyor observed the following bottles of reagents, calibrators and audit calibrators in the laboratory refrigerator: 1. 1 bottle each of Audit Calibration/verification material for T3 Uptake #06523 expiration date 2/19/17; Beta-hcg lot# GYO3590 expiration date 10/31/17. 2. 1 bottle each of Calibration material for Beta-hcg lot# J633530 expiration date 5/31/20; T3 Uptake lot# A134427 expiration date 12/31/20; Estradiol lot# JZ32992 expiration date 11/30/20 and Progesterone lot# 1-6Y3C323 expiration date 10/31/19. 3. 1 bottle each of Diluents Beta-hcg lot# GY53519 expiration date 10/31/17 and 2 bottles of AIA Pack Diluents Concentrate lot# 1380076 expiration date 2/29/20 & Lot#1880065 expiration date 7/31/19. 4. TSH Reagent packs lot # JZ17297 expiration date 11/30/20 (Cup# 97) a. 8 patients samples were tested with the expired reagent cups from 12/4/20 through 1/4/21 5. Total of 3 reagent packs for T3 Uptake lot# JY12073 (Cup#73) expiration date 10/31/20 a. 2 patient samples were tested with the reagent cups from 12/4/20 through 1/4/21 b. 2 reagent packs for the same lot number and expiration date were not open D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- laboratory must do the following: Perform and document calibration verification 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 surveyor's review of the calibration verification records and an interview with the clinical consultant/testing person and the laboratory director, the laboratory failed to perform calibration verification at least once every six months for FSH and Beta- hcg endocrinology tests performed on the TOSOH AIA 360 from 1/14/2020 through 3 /20/20 and again from 5/3/20 through survey date. FINDINGS: 1. At approximately 11:30 AM on January 14, 2021, the clinical consultant/testing person and the laboratory director confirmed that the laboratory had not performed calibration verification on the TOSOH AIA 360 from 1/14/2020 through 3/20/20 and again from 5 /3/20 through survey date. a. FSH and Beta-hcg have a 2 point-calibrator and required calibration verification b. The laboratory closed from 3/20/20 through 5/13/20 due to Covid shutdown and reopened on 5/13/20. c. The last recorded calibration verification was 7/14/2019, it was due on 1/14/2020 d. TOSOH AIA 360 analyzer was therefore out of calibration from 1/14/2020 through 3/20/20 and again from 5/3/20 through survey date. 2. Approximately 120 patients were tested during this time period. 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 surveyor's findings and an interview with the clinical consultant/testing person and laboratory director, the laboratory director failed to provide overall management of the laboratory. Refer to D6024 D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: Based on the surveyor's observation and review of calibration/verification records and confirmed in an interview with the clinical consultant/testing person and the laboratory director, the laboratory director failed to ensure that remedial action was taken and documented when problems were identified. Refer to D5417 and D5439 -- 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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Association of Bioanalysis (AAB) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Total Thyroxine (TT4). The following scores were assigned: 2017 second event = 40% 2017 third event = 100% 2018 first event = 60% 2018 second event = 60% This is considered repeatedly unsuccessful PT performance. Refer to D2107. D2107 ENDOCRINOLOGY 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 -- 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 PT desk review of the CMS PT reports and PT records from the AAB PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Total Thyroxine (TT4). The following scores were assigned: 2017 second event = 40% 2017 third event = 100% 2018 first event = 60% 2018 second event = 60% This is considered repeatedly 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. This CONDITION is not met as evidenced by: Based on PT desk review of the CMS PT and AAB 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 analyte TT4. 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 AAB 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 analyte TT4. The following scores were assigned: 2017 second event = 40% 2017 third event = 100% 2018 first event = 60% 2018 second event = 60% This is considered repeatedly unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 a lack of quality control (QC) records, assay range sheets and patient test reports and an interview with the laboratory director, the laboratory failed to retain copies of QC records, manufacturers assay sheets and patient test reports from August 2016 through the date of this survey. FINDINGS: The laboratory director confirmed on January 24, 2018 at approximately 1:45 pm that the laboratory failed to retain the manufacturer's assay sheets, QC and patient test records for the Tosoh AIA 360 endocrinology analyzer for a period of at least two years. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, patient worksheets and an interview with the laboratory director, the laboratory failed to test and document the Accubeads QC material. Findings Include: 1. It was confirmed with the laboratory director on January 24, 2018 at approximately 1:00 pm, that the laboratory failed to 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 -- test the QC material each day of patient testing as required by the manufacturer. The laboratory director stated, "Accubeads are performed once a month." 2. Approximately 100 patient specimens were tested and results released during this time period. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's QC procedures and records and confirmed in an interview with the laboratory director at the time of the survey, the laboratory director failed to ensure that the QC program was maintained for hematology testing. Refer to: D5543 -- 2 of 2 --