Bloom Reproductive Institute, Pllc

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on August 23, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and AAB-Medical Laboratory Evaluation, the laboratory failed to successfully participate in three of three consecutive testing events in the subspecialty of 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 -- Endocrinology for the regulated analyte Thyroid Stimulating Hormone (TSH) in 2023 and 2024, resulting in non-initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the third event of 2023 as indicated below: - TSH - 0% 2. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - TSH - 40% 3. The laboratory's PT performance was unsatisfactory for the second event of 2024 as indicated below: - TSH - 60% 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 review of the CASPER 155 report and AAB-Medical Laboratory Evaluation. PT records from 2023 and 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for three of three consecutive testing events in the subspecialty of Endocrinology for the regulated analyte Thyroid Stimulating Hormone (TSH). Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2023 event 3, TSH 0% 2024 event 1, TSH 40% 2024 event 2, TSH 60% 2. A review of the proficiency testing scores from AAB- Medical Laboratory Evaluation. (2023 and 2024) confirmed the above findings. 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and AAB-Medical Laboratory Evaluation 2023 and 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. 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 a proficiency testing desk review of the CASPER-0155 and AAB-Medical -- 2 of 3 -- Laboratory Evaluation 2023-3, 2024-1, and 2024-2 evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 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 review of Proficiency Testing (PT) reports for 2023 and 2024 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the subspecialty of Endocrinology and for the regulated analyte, Thyroid-stimulating hormone (TSH). Findings include: 1. The laboratory's PT performance was unsatisfactory for the third event of 2023 as indicated below: - Subspecialty of Endocrinology - 0% - TSH - 0% 2. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - Subspecialty of Endocrinology - 70% - TSH - 40% 3. Unsatisfactory participation in the third event of 2023 and the first event of 2024 (two consecutive testing events) for the regulated 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 -- analyte, TSH, constitutes unsuccessful PT performance. 4. Unsatisfactory participation in the third event of 2023 and the first event of 2024 (two consecutive testing events) for the subspecialty of Endocrinology constitutes unsuccessful PT performance. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on information the Proficiency Testing (PT) provider furnishes to the State Agency for 2023 and 2024, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failures for the subspecialty of Endocrinology and for the regulated analyte, Thyroid- stimulating hormone (TSH). See D2016 for findings. 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 review of Proficiency Testing (PT) reports for 2023 and 2024 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Thyroid-stimulating hormone (TSH), for the third event of 2023 and the first event of 2024 resulting in unsuccessful PT performance. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the subspecialty of Endocrinology for the third event of 2023 and the first event of 2024, resulting in unsuccessful PT performance. See D2016 for findings. -- 2 of 3 -- 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the subspecialty of Endocrinology, and for the regulated analyte, Thyroid-stimulating hormone (TSH), for the third event of 2023 and the first event of 2024. See D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the manufacturer's specified environmental conditions listed in the instrument user manual, lack of humidity logs presented for review and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity reading where the Tosoh AIA900 instrument is utilized for patient testing under the sub-specialties of Endocrinology. Findings include: 1. The laboratory performs patient testing on the Tosoh AIA900 analyzer, with an approximate annual test volume of 14,382. 2. The instrument user manual indicates a relative ambient humidity range of 40-80% is required while the instrument is in operational mode. 3. No documentation was presented for review during the survey to indicate the laboratory was monitoring and documenting the humidity of the laboratory where the instrument is used for patient testing. 4. The facility personnel confirmed that the humidity of the laboratory was not monitored and documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --