Positive Steps Fertility Shreveport

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted January 14, 2025 at Positive Steps Fertility Shreveport - CLIA ID # 19D2210497. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure, quality control records, patient test reports, and interview with personnel, the laboratory failed to perform and document quality control (QC) every eight (8) hours of patient testing for manual sperm counts. Findings: 1. Review of the laboratory's policy for "Quality Control" revealed "Perform Andrology QC using QC beads. All techs should perform QC if they perform a semen analysis. At least one level of QC beads must be performed and logged for every 8 hours worked". 2. Review of the laboratory's quality control (QC) and patient test records reviewed from January 2024 through December 2024 revealed the laboratory did not perform or document at least one level of QC for the following five (5) of five (5) patients reviewed: a) Patient 20403: Reported August 14, 2024 at 08:00 am (no QC documented) b) Patient 20027: Reported August 15, 202 at 09:00 am (no QC documented) c) Patient 20712: Reported August 15, 2024 at 13:30 pm (no QC documented) d) Patient 19723: Reported August 15, 2024 at 14:30 pm (no QC documented) e) Patient 20735: Reported August 16, 2024 at 13:30 pm (no QC documented) 3. In interview on January 14, 2025 at 1:10 pm, the Laboratory Director confirmed the testing personnel did not document the QC for the identified patients. D5785

Summary Statement of Deficiencies D0000 An Initial Survey was performed on July 21, 2021 at Positive Steps Fertility Shreveport, CLIA ID # 19D2210497. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on review of the laboratory's personnel records, policy and procedure manual and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant, Technical Consultant, Technical Supervisor, and General Supervisor were complete. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written, detailed policies to assess competency for the duties assigned to the positions of Clinical Consultant, Technical Consultant, Technical Supervisor, and General Supervisor and the frequency at which the assessments will be performed if needed. 2. Review of the laboratory's personnel records revealed Personnel 1 serves as the Laboratory Director, Technical Consultant, Technical Supervisor, and General Supervisor; however, Personnel 3 serves as the Clinical Consultant. 3. Further review of the Clinical Consultant's personnel records revealed a competency assessment for the duties of Clinical Consultant was not performed. 4. In interview on July 16, 2021 at 10:30 am, the Laboratory Director stated that she is serving as all of the positions except for the Clinical Consultant and was unaware that the above policies were needed. II. Based on review of the laboratory's policy and procedure manual, personnel records and interview with personnel, the laboratory failed to ensure 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 -- written, detailed policies and procedures to assess competency for Testing Personnel were complete. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Further review of the laboratory's policy and procedure manual revealed how testing personnel competency will be assessed was not included as well as the frequency that the assessments will be performed. 3. Review of the laboratory's personnel records revealed the Laboratory Director did perform an initial competency assessment for Personnel 2 in April of 2021. 4. In interview on July 16, at 10:30 am, the Laboratory Director confirmed the laboratory's policy did not include the frequency and required procedures to assess competency for Testing Personnel. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a written procedure for all aspects of testing. Findings: 1. Review of the policy and procedure manual revealed the laboratory did not have written, detailed instructions for the following: a) Proficiency Testing, to include but not all inclusive of how to test proficiency samples, who is responsible for proficiency testing reviews, and the assessment of unacceptable results, and how often proficiency testing samples are tested. b)