Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Women's Health and Wellness, LLC, CLIA ID 19D0989149, on March 26, 2025. Women's Health and Wellness, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250: CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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's CMS 209 form, personnel records, proficiency testing (PT) records, policies, and interview with personnel, the laboratory failed to ensure that proficiency tests for Bacteriology and Parasitology were performed by personnel who routinely perform laboratory testing for four (4) of six (6) events reviewed. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel) form and personnel records revealed the Laboratory Director was listed as the laboratory's sole Testing Personnel. 2. Review of the laboratory's American Proficiency Testing (API) records for 2023 and 2024 revealed the Nurse, who was not listed as testing personnel, signed the attestation statements as personnel performing the test for the following events: 2023 Microbiology 2nd Event 2023 Microbiology 3rd Event 2024 Microbiology 2nd Event 2024 Microbiology 3rd Event 3. In interview on March 26, 2025 at 12:06 pm, the Nurse stated she was told to sign the attestation forms. The Nurse further stated that she does not test PT or patient samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the laboratory failed to maintain the attestation statements for two (2) of six (6) testing events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency records for 2023 and 2024 revealed the laboratory did not have the attestation statement forms for the 2023 Microbiology 1st Event and 2024 Microbiology 1st Event. 2. In interview on March 26, 2025 at 1:30 pm, the Compliance Personnel confirmed the laboratory did not have the attestation forms for the Microbiology 1st events for 2023 and 2024. 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 the laboratory's policies, competency assessment records, and interview with personnel, the laboratory failed to follow their established competency assessment procedures for one (1) of one (1) testing personnel reviewed for 2023 and 2024. Findings: 1. Review of the laboratory's "Proficiency Testing and Employee Competency" policy under the "Employee Competency" section revealed "Employee competency assessment will measure the following points to determine and measure the employee competency to perform the testing performed by the laboratory: The direct observation of perform each test performed by the employee {sic}, monitoring the employee's ability to report testing results, review of all QC, QA, proficiency testing, maintenance logs in ensure all proper documentation {sic}, direct observation of instrument maintenance, assessment of employee's test performance utilizing proficiency test results, and assessment of employee's problem solving skills." 2. Review of the laboratory's "Competency Assessment-Single Instrument-Testing Person" form for 2023 and 2024 revealed the following activities were included: "Direct observation of instrument maintenance: daily, monthly, six months" "Assessment of problem solving skills: Review of instrument problem log, review of QC issues, quiz or scenario" 3. Further review of the 2023 and 2024 competency assessment forms for the Laboratory Director, who served as Testing Personnel, revealed the direct observation of maintenance for daily and monthly, and the assessment of problem solving skills were not performed. 4. In interview on March 26, 2025 at 10:24 am, the Consulting Personnel confirmed the laboratory did not have documentation of performance of the identified tasks. -- 2 of 10 -- 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 observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure quality of testing within the analytic systems. Findings: 1. The laboratory failed to follow the manufacturer's instructions for unacceptable patient results for Bacteriology and Parasitology testing for three (3) of three (3) patients reviewed. Refer to D5411. 2. The laboratory failed to monitor the room temperature of one (1) of one (1) storage closets where laboratory supplies were stored. Refer to D5413. 3. The laboratory failed to test external controls every thirty days as defined in their laboratory policy for four (4) of nine (9) months reviewed. Refer to D5441. 4. The laboratory failed to perform