North Hudson Ivf Center For

Summary Statement of Deficiencies D2098 ENDOCRINOLOGY CFR(s): 493.843(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 surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboraotry failed to attain a score of at least 80 percent for all Sex Hormones analytes performed on the Tosoh AIA for PT events provided by the College of American Pathologists (CAP) in calendar year 2023. The findings include: 1. The laboratory failed to achieve an 80 percent for the analyte Progesterone in PT event Y-B-2023. 2. The laboratory failed to achieve an 80 percent for the analyte Follicle Stimulating Hormone in PT event Y-A-2023. 3. The LD confirmed on 1/30/24 at 11:30am the laboratory failed to acheive an 80 percent for all analytes for Endocrinology testing. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to retain copies of all PT records for testing performed with the College of American Pathologists (CAP) for Sex Hormones event Y-B-2022. The findings include: 1. The laboratory failed to retain work records and the attestation page for PT event Y-B-2022. 2. The LD confirmed on 1/30/24 at 11:30 am that PT records were not retained. 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 -- 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: A) Based on surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to evaluate coded results obtained from the College of American Pathologists (CAP) for Sperm Morphology & Motility events A and B in 2022 and 2023. The finding includes: 1. The laboratory failed to evaluate Code 26 (Educational Challenge) response from CAP for Sperm Morphology & Motility in events A and B of 2022 and 2023. 2. The LD confirmed on 1/30/24 at 11:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. B) Based on surveyor review of PT records and interview with the LD, the laboratory failed to evaluate coded results obtained from the CAP for Sex Hormones for event Y-A-2022 in calendar year 2022. The finding includes: 1. The laboratory failed to evaluate Code 22 (Result is outside the method/instrument reportable range) response from CAP for Estradiol for event Y-A-2022. 2. The LD confirmed on 1/30 /24 at 11:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. Note: The laboratory was previously cited for this deficiency on previous surveys on 6/17/21, 9/24/18, and 4/6/17. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to record discontinuance dates for all applicable procedures for the Siemens Immulite analyzer from 6/17/21 to 1/30/24. The finding includes: 1. The LD stated the Siemens Immulite analyzer is no longer in use and the Tosoh AIA analyzer is currently in use for Endocrinology testing. 2. The LD confirmed on 1/30/24 at 11:45 am that discontinuance dates for all applicable procedures for the Siemens Immulite analyzer were not documented. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Maintenance Records (MR) and interview with the Laboratory Director (LD), the laboratory failed to document function checks for the pipettes used in Endocrinology and Hematology testing from 6/17/21 to 1/30/24. The -- 2 of 4 -- finding includes: 1. The laboratory failed to have documented evidence for performing the procedure "accuracy checks for pipettors" on 3 out of 3 pipettors. 2. The LD confirmed on 1/30/24 at 11:45 am that the function checks on the pipettors were not performed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Reports (TR) and interview with the Laboratory Director (LD) the laboratory failed to ensure that the TR for Semen Analysis included all the required information from 9/24/18 to 1/30/24 . The finding include: 1. A review of ten TR revealed that a different physican was listed as the LD on the TR and not the current LD. 2. The LD confirmed on 1/30/24 at 10:45 am that the TR for semen analysis did not have the current LD listed as the LD of the laboratory. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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: a) Based on surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to evaluate coded results obtained from the College of American Pathologists (CAP) for Sperm Morphology & Motility event A and B in 2020. The finding includes: 1. The laboratory did not evaluate Code 26 (Educational Challenge) response from CAP for Sperm Morphology & Motility Non WHO %, Forward Progression No in events A and B 2020. 2. The LD confirmed on 6/17/21 at 10:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. b) Based on surveyor review of PT records and interview with the LD, the laboratory failed to evaluate coded results obtained from the CAP for Ligand-General for events A, B and C in 2019. The finding includes: 1. The laboratory did not evaluate Code 20 (No appropriate target/response could not be graded) response from CAP for Thyroid Stimulating Hormone for events C and B 2019. 1. The laboratory did not evaluate Code 20 (No appropriate target/response could not be graded) response from CAP for Human Chorionic Gonadotropin (hCG) in event B 2019. 2. The LD confirmed on 6/17/21 at 10:00 am that the laboratory failed to evaluate coded results for Sperm Morphology & Motility. Note: This was previously cited on 9/24/18, and 4/6/17 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results 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 -- within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM), Quality Control Records (QCR) and interview with Laboratory Director (LD), the laboratory failed to follow the OM for the Tosoh AIA-360 analyzer used for Endocrinology testing in March 2021. The findings include: 1) The OM states the Calibration Void (CV) flag is as follows "Calibration Void. Cause: 1. Valid calibration periods of 30 or 60 days expired 2. This flag will appear for 60 days after the curve has expired, Resolution: Recalibrate, accept curve, and then recalculate results in result review" 2) Follicle- stimulating hormone (FSH), and Prolactin (PRL) had CV flags on 3/1/21, 3/8/21, 3/15 /21 and 3/29/21. 3) No documented evidence to show FSH and PRL were recalibrated before running patient samples. 4) The LD confirmed on 6/17/21 at 12:00 pm that the laboratory failed to follow the OM. 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) 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 surveyor review of the Performance Specification (PS) records and interview with the Laboratory Director (LD), the laboratory failed to ensure that all PS procedures were performed for endocrinology testing on the Tosoh AIA-360 analyzer from October 2020 to the date of survey. The finding includes: 1. The laboratory did not verify Patient Normal Range. 2. The LD confirmed on 6/17/21 at 11:15 am that not all PS were performed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on surveyor review of Calibration Records (CR), Quality Control Records (QCR) and interview with the Laboratory Director (LD), the laboratory failed to perform and document Calibration procedures for Endocringoly Tests performed on the Tosoh AIA-360 analyzer from 3/1/21 to 3/29/21. The finding includes: 1) QCR revealed that Follicle-stimulating hormone (FSH), and Prolactin (PRL) where not calibrated in March of 2021 2) The LD confirmed on 6/17/2021 at 11:30 am that the Calibration was not performed on the above analytes in March of 2021. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with Laboratory Director (LD), the laboratory failed to perform and document two levels of external controls on each day of patient testing for Endocrinology test performed on the Tosoh AIA-360 analyzer from 1/6/21 to 1/30/21. The findings include: 1. The laboratory reported Follicle-stimulating hormone (FSH), Thyroid Stimulating Hormone (TSH), Prolactin (PRL), Luteinising Hormone (LH), Estradiol (E2) and Human Chorionic Gonadotropin (hCG) results but there was no documented evidence that QC was performed every day of patient testing. 2. The laboratory ran and reported 36 patients. 3. The LD confirmed on 6/17/21 at 11:20 am that two levels of QC were not run each of patient testing. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 surveyor review of the Performance Specification (PS) records and interview with the Laboratory Director (LD), the LD failed to ensure that PS procedures performed on the Tosoh AIA-3670 analyzer were adequate from October 2020 to the date of survey. The findings include: 1. The LD did not review and sign the PS results. 2. The LD did not verify Patient Normal Range. 6. The LD confimed on 6/17/2021 at 10:20 am that PS records were not adequate. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to retain copies of all PT records for testing performed with the College of American Pathologists (CAP) in the calendar year 2017. The findings include: 1. The laboratory did not have graded PT results for event A2017 - Sperm Morphology and Motility. 2. The laboratory did not have the attestation statement for event A2017 - Sperm Morphology and Motility. 3. The LD confirmed on 9/24/18 at 10:10 am that PT records were not retained. 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 surveyor review of Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to evaluate coded results obtained from the College of American Pathologists (CAP) for Ligand Assay in 2017 and 2018. The finding includes: 1. The laboratory did not evaluate Code 20 (No appropriate target/response cannot be graded) response from CAP for Thyroid Stimulating Hormone in event K - B 2017 and K - A and B 2018. 2. The LD confirmed on 9/24/18 at 10:00 am that the laboratory failed to evaluate coded results for Ligand Assay. 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 -- 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 surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of Semen Morphology test twice in the calendar year 2017. The LD confirmed on 9/24/18 at 10: 30 am the laboratory did not verify Semen Morphology twice annually in 2017. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Temperature Log (TL) and interview with Laboratory Director (LD), the laboratory failed to define an acceptable range for Room Temperature (RT) where Endocrinology and Semen Analysis testing was performed from 4/6/17 to the date of survey. The LD confirmed on 9/24/18 at 11: 40 am that the laboratory did not define a RT range. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) 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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with Laboratory Director (LD), the laboratory failed to perform and document two level of controls on each day of patient testing for Semen analysis tests performed on the CASA System analyzer from 4/6/17 to the date of the survey. The LD confirmed on 9 /24/17 at 11:20 am that QC was not run on each of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 4 -- 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 surveyor review of the Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for Semen counts from 4/6/17 to the date of survey. The LD confirmed on 9/24/2018 at 11:40 am that the laboratory did not verify QC materials before use. D5781