Planned Parenthood Ames Health Center

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (CMS-116 form), the laboratory procedure manual, and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 07/12/2023, the laboratory director failed to approve, sign and date all laboratory procedures. The findings include: 1. The Iowa State Agency received a CLIA Application for Certification (CMS-116 form) on 07/29 /2022 requesting a change to a new laboratory director. 2. At the time of the survey, the new laboratory director did not approve, sign or date any of the laboratory procedures. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: 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 -- Based on review of the Daily and Weekly Maintenance and Cleaning Checklist and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 10:45 am on 07/12/2023, the laboratory failed to perform and document daily microscope maintenance for two out of two days of testing reviewed from March 2023. The findings include: 1. The laboratory's Daily and Weekly Maintenance and Cleaning Checklist stated the following for daily microscope maintenance: *Clean Microscope: wipe down control knobs and stage [NA if not used] 2. Patient identifier E had a wet mount examination performed on 03 /15/2023. 3. Patient identifier F had a wet mount examination performed on 03/21 /2023. 4. Review of the laboratory's Daily and Weekly Maintenance and Cleaning Checklist from March 2023 showed "NA" written on the log for daily microscope maintenance from 03/15/2023 and 03/21/2023. 5. At the time of the survey, personnel identifier #9 confirmed the laboratory did not have documented microscope maintenance for 03/15/2023 and 03/21/2023. 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 records, the IUC Visit Quick Guide, and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 10:15 am on 07/12/2023, the laboratory failed to include the identity of testing personnel for four out of four patients reviewed who had Rh typing performed in March 2023. The findings include: 1. Patient identifier A had Rh typing performed on 03/01/2023. 2. Patient identifier B had Rh typing performed on 03/02/2023. 3. Patient identifier C had Rh typing performed on 03/16/2023. 4. Patient identifier D had Rh typing performed on 03/24/2023. 5. The IUC Visit Quick Guide showed that when testing personnel enter patient test results in the Lab Module of the electronic health record (EHR), they are to enter their first initial, last name, and credentials into the result comment field. 6. At the time of the survey, the laboratory did not have records documenting the identity of the testing personnel for the patients listed above. -- 2 of 2 --

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 records and reports, the laboratory fails to successfully participate in a proficiency testing program for the subspecialty, ABO group and D (Rho) typing, and analytes, ABO group and D(Rho) typing, for two consecutive proficiency testing events: 2022 testing events 2 and 3 (refer to D2162 and D2163). D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) 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 -- Failure to achieve satisfactory performance for the same analyte 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 reports and records, the laboratory fails to achieve satisfactory performance for the analytes, ABO group and D(Rho) typing, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2022 testing event 2 and 80% for 2022 testing event 3. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory 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 review of proficiency testing reports and records, the laboratory fails to achieve an overall testing event score of satisfactory performance for two consecutive testing events for the subspecialty, ABO group and D (Rho) typing. The laboratory received unsatisfactory performance scores of zero for 2022 testing event 2 and 80% for 2022 testing event 3 for the subspecialty, ABO group and D (Rho) typing. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 Laboratory Personnel Report, Form CMS-209, proficiency testing (PT) records, and confirmed by laboratory personnel identifier #9 (refer to the Laboratory Personnel Report) at approximately 9:50 am on 09/30/2021, the laboratory failed to rotate proficiency testing samples among all testing personnel for five out of five PT events and six out of eight testing personnel in 2020 and 2021. The findings include: 1. The Laboratory Personnel Report, Form CMS-209 listed personnel identifiers #2- #9 as testing personnel. 2. PT result records revealed that personnel identifier #8 performed the following PT testing events: 2020 event 3 and 2021 event 2. 3. PT result records revealed that personnel identifier #9 performed the following PT testing events: 2020 events 1 and 2, and 2021 event 1. 4. At the time of the survey, personnel identifier #9 confirmed that personnel identifiers #2- #7 performed patient testing but did not participate in proficiency testing in 2020 and 2021. 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 --