Valley Women's Health

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, direct observation, and interview with Testing Personnel 3 (TP3), the laboratory failed to establish and follow written procedures to ensure positive identification of the patient's specimen through all phases of testing for laboratory microscope slides. The laboratory performs approximately 1000 microbiology tests a year. Findings include: 1. Review of the policy and procedure manual revealed a lack instruction to ensure positive identification of the patient's specimen throughout the testing process. 2. Direct observation of micro urinalysis testing on 01/23/2025 at 12:20 PM found a microscope slide was not labeled with any unique patient identification. 3. Interview with the TP3 on 01/23/2025 at approximately 12:22 PM confirmed the microscope slide was not labeled with any unique patient identification. 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: 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 -- Based on lack of documentation and interview with Testing Personnel 1 (TP1), the laboratory failed to establish and follow written policies that assess employee competency for 31 of 31 testing personnel for microbiology and serum HCG testing that followed the six requirements in subpart M since the last survey was performed on 02/09/2021. The laboratory performs approximately 1117 tests a year. Findings include: 1. Record review revealed the laboratory failed to establish, follow, and document competency assessment for 31 of 31 TP performing microscopic and serum pregnancy testing following the six requirements in subpart M. 2. In an interview on 01/23/2025 at approximately 10:45 AM, TP1 confirmed that the laboratory failed to establish, document, and perform competency assessment that follows the six required components in subpart M. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of competency evaluation documentation and an interview with Testing Personnel 1 (TP 1), the laboratory failed to perform and document semi- annual competency evaluations for 22 of 22 Testing Personnel during their first year of performing for microbiology and serum HCG testing since the last survey was performed on 02/09/2021. The laboratory performs approximately 1117 tests a year. Findings include: 1. A review of competency evaluation records on 01/23/25 revealed that 22 of 22 TP did not have documentation of a semi-annual competency assessment during their first year of performing microbiology and serum HCG testing. 2. An interview with the TP1 at approximately 11:42 AM on 01/23/25 confirmed that 22 of 22 TP reviewed since the last survey on 02/09/2021 did not have documentation of a semi-annual competency assessment during their first year of performing microbiology and serum HCG testing. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review of employee qualification and training documentation and interview with Testing Personnel 1 (TP1), the laboratory failed to provide documentation of laboratory training prior to analyzing patient specimens for 19 of 19 employees who qualify as TP by earning a high school diploma or equivalent since the last survey on 02/09/2021. The laboratory performs approximately 117 serum HCG tests a year. Findings include: 1. Document review of employee qualification and training documentation failed to produce documentation that appropriate laboratory training was performed prior to analyzing patient specimens for 19 of 19 employees who qualify as TP by earning a high school diploma or equivalent since the last survey on 02/09/2021. 2. Interview with the TP1 on 01/23/2025 at approximately 11:00 AM confirmed TP did not have documentation of appropriate laboratory training prior to analyzing patient specimens. -- 3 of 3 --

Summary Statement of Deficiencies 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 direct observation, patient records review, and confirmation by staff, the laboratory failed to ensure potassium hydroxide (KOH) reagent was not used past the expiration date of 2020-05-31. The laboratory performed approximately 113 KOH preparations per year. Findings include: 1. Direct observation on 02/09/2021 at approximately 11:05 A.M. KOH reagent lot number B01A333M expired on 2020-05- 31. 2. Patient test records review included documentation KOH reagent was used on 11/04/2020 for patient 137143. 3. In an interview conducted on 02/09/2021 at approximately 11:10 A.M. staff confirmed the reagent expired on 2020/05/31 and was used past the expiration date. 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 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) 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. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory director failed to attest proficiency specimens were tested in the same manner as patient specimens for 5 of 6 Wisconsin State Laboratory of Hygiene (WSLH)proficiency testing events reviewed. Findings include: 1. Proficiency testing attestation statements reviewed failed to include the signature of the laboratory director for WSLH events 1 and 3 of 2017 and events 1, 2, and 3 of 2018. 2. In an interview on 01/09/2019, the laboratory manager confirmed the laboratory director had not signed the attestation statements and that the laboratory did not have a director's delegation of duty authorization to a qualified technical consultant. 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 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 -- activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on quality control records review, lack of documentation, and interview with staff, the laboratory failed to document and retain the lot numbers and expiration dates for serum pregnancy tests in use from January 2017 to January 2019. Findings include: 1. Quality control records review failed to include the serum pregnancy test kit's lot numbers, expiration dates, and the dates the reagents were placed in use by the laboratory. 2. In an interview with the laboratory manager on 01/09/2019 at approximately 5:10 P.M., the laboratory manager stated the lab did not retain the serum pregnancy test kit lot numbers and the kit expiration dates. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation and confirmation by the laboratory manager, the laboratory failed to use control materials of the same matrix as patient samples for serum human chorionic gonadotrophin (pregnancy) testing. The time period the laboratory used control materials of a different matrix was not determined. The laboratory tested approximately one serum pregnancy test per day. Findings include: 1. Direct observation of the laboratory test refrigerated storage space failed to include pregnancy controls that were made from the same serum matrix. The pregnancy controls were made from urine. 2. The laboratory manager confirmed, in an interview conducted on 01/09/2019 at approximately 5:00 P.M., the controls were not of the same matrix as patient serum pregnancy specimens. -- 2 of 2 --