Mid Iowa Fertility, Pc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of quality control records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), the laboratory failed to retain quality control records for at least two years as specified in the standard D3031. 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 review of quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 1:40 pm on 09/19 /2023, the laboratory failed to retain endocrinology and immunology QC records for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- at least two years from 01/01/2022 to 06/20/2023. At the time of the survey, the laboratory did not have endocrinology or immunology QC records prior to 06/21 /2023. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient test reports, test requests, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 1:40 pm on 09/19 /2023, the laboratory failed to have a written or electronic test request for five out of 12 tests performed on one out of two patients (patient identifier A) reviewed having testing performed in May and September 2023. The findings include: 1. Patient identifier A had the following testing performed on 05/05/2023: ABO, Rh (D typing), anti mullerian hormone (AMH), thyroid peroxidase antibody (TPOAB), thyroid stimulating hormone (TSH), testosterone, rubella IGG, prolactin, follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and free thyroxine (FT4). 2. Patient A's associated test request included the following tests to be performed: ABO, Rh (D typing), estradiol, FSH, LH, TPOAB, and TSH. 3. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not have a written or electronic test request for the AMH, testosterone, rubella IGG, prolactin, or FT4 testing performed on 05/05/2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 review of quality control (QC) records, calibration records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report), the laboratory failed to meet the analytic systems requirements for: having control procedures that monitor the accuracy and precision of the complete analytic process as specified in the standard D5441; performing two control materials of different concentrations as specified in the standard D5447; and taking and documenting

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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10: 30 am on 10/12/21, the laboratory failed to retain the proficiency testing attestation statements for five out of five proficiency testing events from 1/1/2020 - 10/12/2021. The findings include: 1. For 2020 PT event 1, the laboratory did not have attestation statements for antimullerian hormone and thyroid microsomal antibody testing. 2. For 2020 PT event 2, the laboratory did not have the attestation statement for thyroid microsomal antibody testing. 3. For 2020 PT event 3, the laboratory did not have the attestation statement for thyroid microsomal antibody testing. 4. For 2021 PT event 1, the laboratory did not have attestation statements for antimullerian hormone and thyroid microsomal antibody testing. 5. For 2021 PT event 2, the laboratory did not have the attestation statement for thyroid microsomal antibody testing. 6. At the time of the survey, the laboratory did not have attestation statements for the above PT events. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or 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 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 10:30 am on 10/12/21, the laboratory failed to perform a self evaluation of ungraded PT scores for two out of four testing events from 1/1/2020 - 10/12/2021. The findings include: 1. The laboratory enrolled in sperm count PT testing through the American Association of Bioanalysts, and received two events per calendar year. 2. For 2020 PT event 1, the laboratory received an ungraded PT score for the analyte, sperm count - sample 2. 3. For 2021 PT event 1, the laboratory received an ungraded PT score for the analyte, sperm count - sample 2. 4. At the time of the survey, the laboratory did not perform a self evaluation for the ungraded PT scores. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient test reports and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:15 am on 10/12/21, the laboratory failed to have a record system in place to confirm the identity of the personnel performing testing on two of out four patient test reports from June 2021. The findings include: 1. On 6/3/2021, patient identifier A had thyroid stimulating hormone, testosterone, thyroid peroxidase antibody, prolactin, estradiol, anti-mullerian hormone, rubella IgG, follicle stimulating hormone, luteinizing hormone, thyroxine, progesterone, and human chorionic gonadotropin testing performed. 2. On 6/11/2021, patient identifier B had thyroid stimulating hormone, testosterone, thyroid peroxidase antibody, prolactin, estradiol, anti-mullerian hormone, rubella IgG, follicle stimulating hormone, luteinizing hormone, thyroxine, progesterone, and human chorionic gonadotropin testing performed. 3. At the time of the survey, the laboratory did not have a record system in place to confirm the identity of the personnel performing the testing on the above patients. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of patient test reports and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:15 am on 10/12/21, the laboratory test report failed to have the correct name for estradiol on two out of two patient test reports from June 2021. The findings include: 1. On 6/4/2021, patient identifier A had estradiol testing performed. 2. On 6/11/2021, patient identifier B had estradiol testing performed. 3. The test reports for patient identifiers A & B listed estradiol testing as [SNSE2]. -- 3 of 3 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2: 30 pm on 09/18/2019, the laboratory failed to perform a self evaluation when it received a score of zero for one out of three testing events (2018 event 1) in 2018 and 2019. The findings include: 1. For 2018 testing event 1, the laboratory received a score of zero for failure to submit PT results before the submission deadline for the following analytes: sperm count, sperm morphology, sperm cell identification, and sperm motility. 2. At the time of the survey, the laboratory did not have records indicating that it performed a self-evaluation for the failed PT scores. 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 review of the Laboratory Test List & Annual Volume form, lack of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 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 -- (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 09/18/2019, the laboratory failed to verify the accuracy of the analyte, thyroid peroxidase (TPO), at least twice annually for two out of two time periods from January 2018- December 2018. The findings include: 1. The laboratory listed TPO testing on the Laboratory Test List & Annual Volume form. 2. Personnel identifier #2 confirmed that the laboratory did not enroll in PT for the analyte, TPO, in 2018. 3. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not have additional records indicating the verification of accuracy for the analyte, TPO, in 2018. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the Laboratory Test List & Annual Volume form, lack of proficiency testing records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 2:30 pm on 09/18/2019, the laboratory failed to verify the accuracy of the analyte, anti mullerian hormone (AMH), at least twice annually for two out of two time periods from January 2018- December 2018. The findings include: 1. The laboratory listed AMH testing on the Laboratory Test List & Annual Volume form. 2. Personnel identifier #2 confirmed that proficiency testing samples are not available for AMH testing. 3. At the time of the survey, the laboratory did not have additional records indicating verification of accuracy for the analyte, AMH, in 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Access 2 maintenance records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3: 30 pm on 09/18/2019, the laboratory failed to perform and document weekly maintenance as defined by the manufacturer on the Access 2 instrument for four out of four weeks in March 2019. The findings include: 1. The Access 2 maintenance log indicates the following tasks are to be performed and documented weekly: *Clean Instrument Exterior *Inspect Liquid Waste Bottle *Check Waste Filter Bottle *Inspect /Clean Primary Probe *Replace/Clean Aspirate Probes *Run Daily Maintenance *Run System Check 2. The following statement is located in the weekly maintenance section of the log: "Perform the tasks listed at the left and draw a check in the accompanying box on the right. Initial the tech initials box." 3. In the weekly maintenance section of the log, the laboratory listed the beginning date of each week in March (03/04/2019, 03/11/2019, 03/18/2019, and 03/25/2019) but did not draw checks in each of the accompanying boxes to the right of each task. 4. At the time of the survey, the laboratory did not have additional documentation showing that each -- 2 of 3 -- weekly maintenance task was performed and documented for the weeks of 03/04 /2019, 03/11/2019, 03/18/2019, and 03/25/2019. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 09/18/2019, the technical consultant failed to assess and document the competency of individuals performing moderate complexity testing at least annually for three out of five testing personnel (laboratory personnel identifiers #2, #3, and #5) in 2017 and 2018. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 09/18/2019, the technical supervisor failed to assess and document the competency of individuals performing high complexity testing at least annually for one out of four testing personnel (personnel identifier #2) in 2017 and two out of four testing personnel (personnel identifiers #2 and #3) in 2018. -- 3 of 3 --