Ivf-Pgt Lab Tinley Park

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory records, and interview with the technical consultant (TC); the laboratory failed to have proficiency testing (PT) samples tested by two of three testing personnel (TP) who routinely performed endocrinology testing for three PT events in 2025. Findings include: 1. Review of CMS-209 (Laboratory Personnel Report) Form and laboratory competency documents revealed three TP (TP #1, TP #2, and TP #3) authorized to perform endocrinology testing on the Tosoh AIA 360 analyzer (Serial Number: 2A492112). 2. Review of American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) PT records revealed TP #1 performed three of three endocrinology PT events in 2025. Event: TP: 2025, Event 1 1 2025, Event 2 1 2025, Event 3 1 3. Interview with the TC on 01/14/2026, at 1:23 pm, confirmed the laboratory failed to have PT samples tested by two of three TP who routinely performed endocrinology testing for three of three events in 2025. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to ensure attestation statement were completed for three of six PT events for five endocrinology regulated analytes on the Tosoh AIA analyzer (Serial Number: 2A492112) in 2024 and 2025. Findings include: 1. Review of American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) PT records for 2024 and 2025 revealed a lack of attestation statements for three of six endocrinology events in 2024 and 2025. PT Event: Attestation Completed: 2024, Event 1 No 2024, Event 3 No 2025, Event 3 No 2. Interview with the TC on 01/14/2026, at 1:23 pm, confirmed the laboratory failed to ensure attestation statement were completed for three of six PT events for five endocrinology regulated analytes on the Tosoh AIA analyzer in 2024 and 2025. 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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to retain logs of ambient temperature and humidity of the laboratory as well as storage temperature for endocrinology reagents to ensure accurate and reliable operation of the Tosoh AIA 360 analyzer (Serial Number: 2A492112) for five of six patient testing dates reviewed in 2024 and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled "Quality Management Plan", which stated, under "DC.02.04.01", "The laboratory retains records as required by law and regulation .... At least 2 years ...." 2. Review of laboratory records for endocrinology testing on the Tosoh AIA 360 analyzer found no documentation of the ambient temperature and humidity of the laboratory as well as storage temperature for endocrinology reagents for five of six dates of patient testing reviewed. Accession #: Date of testing: L118807 03/19/2024 L129905 05/28/2024 L180824 10/09/2024 L227770 01/30/2025 L243000 06/12/2025 3. Interview with TP #2 on 01/14/2026, at 12:01 pm, confirmed the laboratory failed to retain logs of ambient temperature and humidity of the laboratory as well as storage temperature for endocrinology reagents to ensure accurate and reliable operation of the Tosoh AIA 360 analyzer for five of six patient testing dates reviewed in 2024 and 2025. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interviews with the technical consultant and testing personnel #2; -- 2 of 7 -- the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory system for two of two years reviewed (see D5291), failed to evaluate quality control results as stated in the laboratory's standard operating procedure for six of six patient testing dates reviewed (see D5445), and failed to ensure results of quality control (QC) materials met the laboratory's defined acceptability prior to reporting patient test results on five of six patient testing dates reviewed (see D5481). D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #2; the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory system for two of two years reviewed (2024 and 2025) in the subspecialty of endocrinology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Quality Management Plan", which stated, under "3. Quality Report", "Tinley Park Director must review the status of the [In Vitro Fertilization-Preimplantation Genetic Testing] IVF-PGT Lab's [Quality Management System] QMS at least on a quarterly basis, to summarize internal and external assessment data .... An annual Quality Report should include performance data and information in a way that highlights gaps between The IVF-PGT Lab's established QMS and its stated goals and objectives; international, national, accreditation, local, and organization requirements; and customer expectations." 2. Review of laboratory records revealed a lack of documentation of quarterly and annual quality assurance reviews performed in the laboratory for the previous two years, 2024 and 2025. 3. Interview with TP #2 on 01/14/2026, at 12:19 pm, confirmed the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the general laboratory system for two of two years reviewed (2024 and 2025) in the subspecialty of endocrinology. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, manufacturer's quality control (QC) value assignment sheets, laboratory quality control records, and interview with testing personnel (TP) #2; the laboratory failed to evaluate quality control results as stated in the laboratory's standard operating procedure for six of six patient testing dates reviewed from the beginning of testing, 03/19/2024, through the date of survey, 01/14/2026, in the subspecialty of endocrinology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Automated Immunoassays using the Tosoh AIA 360", which stated, under "Controls", "A control value of >2 [standard deviations] SD from the mean of the control data of either Controls I, II, or III required the run to be rejected. Controls must be re-run and patient results cannot be accepted until the Controls are within acceptable limits." 2. Review of manufacturer's quality control value assignment sheets for Bio-Rad Liquichek Immunoassay Plus Control (Levels 1, 2, and 3) utilized for endocrinology testing on the Tosoh AIA 360 analyzer (Serial Number: 2A492112) revealed the manufacturer's assigned ranges represented 3 SD from the manufacturer's assigned mean of the control. 3. Review of laboratory quality control records revealed acceptability ranges for quality control results obtained prior to six of six patient testing dates were evaluated based on manufacturer's 3 SD from the mean value assignment sheets for Bio-Rad Liquichek Immunoassay Plus Control (Levels 1, 2, and 3), not the calculated 2 SD from the mean as stated in the laboratory's standard operating procedure. Patient: Date of Testing: QC Lot: 33383298 03/19/2024 85350 24710 05/28/2024 85350 33381253 10/09/2024 85350 33356336 01/30/2025 85370 33416693 06/12/2025 1003900 33460168 12/03/2025 1003940 4. Interview with TP #2 on 01/14/2026, at 1:23 pm, confirmed the laboratory failed to evaluate quality control results as stated in the laboratory's standard operating procedure for six of six patient testing dates reviewed from the beginning of testing, 03/19/2024, through the date of survey, 01/14/2026, in the subspecialty of endocrinology. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, and interview with the technical consultant (TC); the laboratory failed to ensure results of quality control (QC) materials met the laboratory's defined acceptability prior to reporting patient test results on five of six patient testing dates reviewed from the beginning of testing, 03/19/2024, through the date of survey, 01/14/2026. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled "Automated Immunoassays using the Tosoh AIA 360", which stated, under "Controls", "A control value of >2 [standard deviations] SD from the mean of the control data of either Controls I, II, or III required the run to be rejected. Controls must be re-run and patient results cannot be accepted until the Controls are within acceptable limits." 2. Review of QC records for endocrinology testing on the Tosoh AIA 360 analyzer (Serial Number: 2A492112) revealed five of six patient testing dates had at least one level of QC out of the laboratory's defined >2 SD [from the mean] range. Date: Analyte(s): Levels Out of Range: 03/19/2024 LH* I, II 10/09/2024 Estradiol I, III 01/30/2025 Progesterone I 06/12/2025 Progesterone I 12/03/2025 -- 4 of 7 -- Progesterone I *LH = Luteinizing Hormone 3. Interview with the TC on 01/14/2026, at 1:23 pm, confirmed the laboratory failed to ensure results of QC materials met the laboratory's defined acceptability prior to reporting patient test results on five of six patient testing dates reviewed from the beginning of testing, 03/19/2024, through the date of survey, 01/14/2026. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory director (LD) failed to perform and document one of two required on-site visits in the second half of 2025. Findings include: 1. Review of laboratory records revealed three on-site visits from the acting LD in the first half of 2025, documented on proficiency testing review documents on the following dates. 02/21/2025 04/30/2025 05/29/2025 2. Interview with the TC on 01/14/2026, at 9:31 am, confirmed the laboratory director (LD) failed to perform and document one of two required on-site visits in the second half of 2025. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have at least two years of documented training or experience in the subspecialty of endocrinology on file for one of one TC (see D6035). D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory -- 5 of 7 -- training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory failed to have at least two years of documented training or experience in the subspecialty of endocrinology on file for one of one TC. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed one individual serving as TC. 2. Review of the laboratory personnel records for one of one TC revealed the laboratory lacked documentation of at least two years of documented training or experience in the subspecialty of endocrinology. 3. Interview with the TC on 01/14/2026, at 1:23 pm, confirmed the laboratory failed to have at least two years of documented training or experience in the subspecialty of endocrinology on file for one of one TC. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: -- 6 of 7 -- Based on review of the CMS-209 (Laboratory Personnel Report) Form, laboratory policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the TC failed evaluate and document the performance of one of two new testing personnel (TP) at least semiannually during the first year the TP tested patient specimens in the subspecialty of endocrinology from their Date of Hire (DoH) through the date of survey, 01/14/2026. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed two new TP (TP #2 and TP #3). 2. Review of laboratory policies and procedures revealed the policy titled "Quality Management Plan", which stated, under "4. Assessment of Competence", "To determine if employees possesses and continues to demonstrate the skill in which they were trained, an individual's competence is assessed at the following times: "-After initial training and before working independently -Every 6 months during the first year of employment and once a year throughout employment". 3. Review of employee competency records revealed one of two new TP failed to have their competency evaluated and documented at least semiannually during the first year the TP tested patient specimens. TP: DoH: 6-month: 1st Annual: TP #2 04/25 /2024 9/10/2024 12/31/2025 4. Interview with the TC on 01/14/2026, at 9:31 am, confirmed the TC failed evaluate and document the performance of one of two new TP at least semiannually during the first year the TP tested patient specimens in the subspecialty of endocrinology from their DoH through the date of survey, 01/14/2026. -- 7 of 7 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)