Planned Parenthood Of South East And North Florida

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 6/5/2024 at Planned Parenthood of South East and North Florida, a clinical laboratory in Jacksonville, Florida. Planned Parenthood of South East and North Florida was NOT in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory was not in compliance with Federal licensure requirements to perform testing for the analytes "Beta-hCG (human chorionic gonadotropin)" since testing began in December of 2023. The findings include: The Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116) obtained during survey showed the laboratory performs testing in the following specialty/subspecialties: Mycology, and ABO Group & Rh Group. The CLIA certificate provided at the time of survey confirmed the same specialties were on the license. Review of the laboratory test menu showed the laboratory performs testing for the analyte Beta-hCG on the Abbott I-stat instrument. Review of the FDA (Food and Drug Administration) web site for CLIA testing complexity showed that since 2015, the FDA has classified the testing system "Abbott i-STAT 1 Analyzer Systems" for the analyte "Beta-hCG" to be "Moderate Complexity" under the specialty of Endocrinology. The interview with Testing Person B on 6/5/2024 at 9:00 am confirmed the laboratory was not licensed for Endocrinology and approximately 180 tests had been since performed between December 2023 and June 2024. 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 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 6/16/2022 at Planned Parenthood of South East and North Florida, a clinical laboratory in Jacksonville, Florida. Planned Parenthood of South East and North Florida was NOT in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of employee competency records and interview with the Office Manager, the laboratory failed to perform competency evaluations on 1 of 12 Testing Personnel (#C) in 2021. This is a repeat deficiency from the 6/01/2020 recertification survey. The findings include : Review of employee competency records found no competency evaluations performed on Testing Person #C who performs direct wet mount testing. Testing Person #C began performing the test in March 2021. Interview with the Office Manager on 6/17/2022 confirmed that there was no documented competency evaluations for Testing Person #C. . 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to verify the accuracy of wet mounts and KOH (potassium hydroxide) testing at least twice annually for Testing Person (TP) #C in 2021. Findings Include: Review of wet mount and KOH testing showed no peer review was performed that verified the accuracy of testing for TP #C in 2021. During an interview on 6/16/22 at 1:30 PM the Office Manager confirmed that TP #C had no peer review for wet mount and KOH testing. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 record review and staff interview, the laboratory failed to document acceptable quality control for one day in May 2022. This is a repeat deficiency from the 6/1/2020 recertification survey. Findings include: The review of the quality control spreadsheet showed on 5/12/22, the negative RH (Rhesus) control was documented as positive. A total of 12 patients were testing for RH. The interview with testing person D on 6/16/22 at 1:40pm confirmed that although two people verify the quality control entry, it was documented incorrectly and was "probably a typo". -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 6/1/2020 at Planned Parenthood of South East and North Florida, a clinical laboratory in Jacksonville, Florida. Planned Parenthood of South East and North Florida was NOT in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of employee competency records and interview with the Office Manager, the laboratory failed to perform competency evaluations on 1 of 8 Testing Personnel (#F) for two of two years reviewed (2018-2019). Findings Included: Review of employee competency records found no competency evaluations performed on Testing Person #F who performs ABO/RH testing. Interview with the Office Manager on 6/1/2020 confirmed that there was no documented competency evaluations for Testing Person #F. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document acceptable quality control for one day in May 2020. Findings include: The review of the quality control spreadsheet showed on 5/28/20, the positive RH control was documented as negative. The interview with testing person A on 6/1/20 at 9:54am confirmed that although two people verify the quality control entry, it was documented incorrectly. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) attestation sheets and interview with the Director of Quality Improvement for Health Services, the Laboratory Director failed to sign the attestation sheets for six out of ten testing events reviewed for 2016-2018. Findings Included: Review of the attestation sheet for the 1st, 2nd, and 3rd Hematology/Coagulation testing event in 2017, the Immunology 3rd testing event in 2017, and the 1st event of 2018 for Hematology/Coagulation and Immunology showed that the Laboratory Director did not sign the attestation sheet that affirms to the fact that proficiency samples were treated in the same manner as patient specimens. During an interview on 5/17/18 at 11:13 AM, the Director of Quality Improvement for Health Services confirmed that the Laboratory Director failed to sign the attestation statements and stated she was never told it needed to be done. D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. 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 record review and staff interview, the facility failed to achieve a score of 100 percent for one of six American Proficiency Institute (API) proficiency testing events reviewed from 2016-2018. The findings include: The record review of the API proficiency testing scores for the first event in 2018 showed a score of 60% for D (RHo) typing. The interview with the facility administrator on 5/17/18 at 11:13am confirmed the score of 60%. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure the Eldon Cards used for patient testing were not expired for 4 days reviewed in 2017. The record review of the Eldon Card Rh control excel spread sheet for 2017 showed on 10 /6/17 and 10/20/17 for Eldon Card package with lot number 17131 expired on 4/6/17 and 3/8/17. The Eldon Cards documented on 10/27/17 and 11/3/17 with lot number 17131 expired 4/6/17. The 10:58am interview with the clinic manager on 5/17/18 confirmed the Eldon Card information was documented as expired and determined it was due to a typing error. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 record review and staff interview, the facility failed to ensure quality control was documented and in range before reporting patient results for two days in January 2018, two days in February 2018, one day in March 2018, one day in April 2018, and one day in March 2018. The findings include: The record review of the Eldon Card Rh control excel spreadsheet for 2018 showed on 1/19/18, 1/26/18, 2/2/18, 3/2/18, and 5/4/18 the positive and negative QC was not performed for each pack of Eldon Cards. The interview with testing person #1 on 5/17/18 at 10:44am confirmed that QC is performed for each packed of Eldon Cards which are labeled A and B. She confirmed the duplicate QC was missing on those dates. The record review of the Eldon Card Rh control excel spreadsheet for 2018 showed on 2/2/18 the positive control "AMR" was reported as negative. The 10:32am interview on 5/17/18 with testing person #1 confirmed the control labeled "AMR" was the positive control and had been documented as negative. The record review of the Eldon Card Rh control spreadsheet for 2018 showed on 2/16/18 the negative control "BRH1446850" is reported as positive and the positive control "EP" is reported as negative. The 10:44am interview with testing person #1 confirmed the QC had been documented incorrectly. The record review of the Eldon Card Rh control spreadsheet for 2018 showed on 4/16/18 no QC was documented. The 10:44am interview with testing person #1 confirmed no QC was documented on that date. -- 2 of 2 --