Women's Care Of Wisconsin

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 laboratory procedure manual and interview with technical consultant (Staff B), the laboratory director did not approve, sign, and date the individualized quality control plan (IQCP) for one of two IQCPs in use at the time of the survey. Findings include: 1. Review of the laboratory procedure manual revealed an unsigned copy of the "BD Affirm VPIII IQCP" currently in use. 2. Interview with Staff B on August 14, 2025, at 11:40 AM, confirmed that the copy of the "BD Affirm VPIII IQCP" found in the procedure manual was the version currently in use, and that the approved and signed copy of the "BD Affirm VPIII IQCP" was not available. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the procedure manual, record review, and interview with testing personnel (Staff A), the laboratory did not define the frequency of function checks in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- writing for four of four types of equipment used with the ID-MTS system for blood typing and antibody screen testing to ensure equipment performance for accurate and reliable test results. Findings include: 1. Review of procedure manual for blood typing and antibody screen with the ID-MTS system showed the procedure did not define the frequency of function checks for the equipment. 2. Interview with Staff A on August 14, 2025, at 2:00 PM, revealed that function checks for equipment used to perform blood typing and antibody screen testing are performed every six months. 3. Review of forms titled "ID-MTS Quality Control Records" revealed function checks performed more than six months apart for the most recent two years of records, as follows: 3a. The "MTS Dispenser Periodic Volume Verification Checks" form included documentation of MTS Dispenser volume verification checks performed more than six months apart with dates documented as: 8/15/2023, 4/1/2024, 11/26 /2024, 7/31/2025. 3b. The "MTS Pipettor: Periodic Accuracy and Precision Checks" form included documentation of MTS Pipettor accuracy and precision checks performed more than six months apart with the three pipettor settings (10 microliters (uL), 25 uL, 50 uL) performed as follows: -10 uL: 1/25/2024, 9/23/2024, 6/12/2025 -25 uL: 1/23/2024, 9/20/2024, 6/12/2025 -50 uL: 1/23/2024, 9/23/2024, 6/12/2025 3c. "Ortho Workstation: Periodic (As Needed) Checks" form revealed frequency of testing recorded as "every 6 months" and included documentation of centrifuge speed and timing, and incubator temp and timing performed more than six months apart with dates documented as: 8/25/2023, 4/1/2024, 11/26/2024, 7/31/2024. 4. Interview with Staff A on August 14, 2025, at 2:10 PM, confirmed that the procedure did not define frequency of function checks, and that the laboratory had not performed function checks at the frequency stated by Staff A. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Item 1: Based on review of the procedure manual, observation in the laboratory, and interview with testing personnel (Staff A), the laboratory did not specify the number, type, and frequency of testing control materials in use for one of one rapid plasma reagin (RPR) procedure. Findings include: 1. Review of RPR Testing Procedure, "ASI RPR Card for Syphilis Procedure (September 20, 2021)", revealed that the procedure did not include number, type, and frequency of testing control materials, and steps for conducting quality control on the RPR test system. 2. Observation of the RPR Test Kit in the laboratory on August 14, 2025, at 11:45 AM, revealed kit contents including three vials of controls. 3. Interview with Staff A on August 14, 2025, at 11:50 AM, confirmed that the RPR procedure did not specify the number, type, and frequency of testing control materials in use. Item 2: Based on review of individualized quality control plans (IQCPs), and interview with testing personnel (Staff A), the laboratory did not specify the type of quality control material used for two of two IQCPs. -- 2 of 4 -- Findings include: 1. Review of the "BD Affirm VPIII IQCP" and "X-Pert Risk Assessment Policy IQCP" revealed that the IQCPs did not specify the type of testing control materials used. 2. Interview with Staff A on August 14, 2025, at 11:00 AM, confirmed that the laboratory did not specify the type of external controls required in the two IQCPs. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on observation in the laboratory, review of the procedure manual, and interview with the testing personnel (Staff A), for one of one type of growth media used in the laboratory, the laboratory did not perform quality control and did not establish a control procedure that includes checking each batch of media for sterility, checking for its ability to support or inhibit growth, and documenting and reporting to manufacturer if batch of media appears compromised or deteriorated prior to use. Findings include: 1. The surveyor observed vials of Lim broth in the laboratory on August 14, 2025, at 11:00 AM. 2. Review of the procedure manual revealed no evidence of a quality control procedure or individualized quality control plan (IQCP) for the Lim broth media used in the procedure for testing Group B Streptococcus (GBS) on the GeneXpert. 3. Interview with Staff A on August 14, 2025, at 1:00 PM, confirmed that the laboratory did not establish a quality control procedure or IQCP, and did not perform quality control testing of the Lim broth media. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the technical consultant (Staff B), the laboratory director did not document competency for technical consultant responsibilities and delegated responsibilities for performing competency assessments for the last two years for three of three staff. Findings include: 1. Review of the competency assessment records revealed that testing personnel (Staff A) had assessed competency for testing personnel (Staff C), and Staff C had conducted the -- 3 of 4 -- observational components of the competency assessment procedures for Staff A in the last two of two years. 2. Review of the laboratory records revealed no evidence that the laboratory director had documented competency for testing personnel (Staff A and Staff C) who had performed competency assessments for other testing personnel. 3. Review of the laboratory records revealed no evidence that the laboratory director had documented competency for technical consultant responsibilities for Staff B. 4. Interview with Staff B on August 14, 2025, at 4:10 PM, confirmed that the laboratory director did not document competency for technical consultant and for testing personnel who conducted competency assessments of other testing personnel for the last two of two years. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (Staff A), for the year 2025, the laboratory director did not meet the requirement for conducting and documenting an onsite visit for one of one visit required in the first six months of 2025. Findings include: 1. Review of laboratory records revealed that as of August 14, 2025, there was no evidence the laboratory director conducted an onsite visit in the first six months of the year 2025. 2. Interview with Staff A on August 14, 2025, at 4: 05 PM, confirmed that the laboratory director had not yet conducted an onsite visit in 2025. -- 4 of 4 --

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 survey review of chemistry procedures and interview testing personnel, staff A, the laboratory director did not sign and date seventeen of seventeen QuidelOrtho Vitros XT3400 chemistry procedures prior to patient use. Findings include: 1. Review of chemistry procedures showed no documentation the laboratory director reviewed and signed the "Vitros XT3400 Operation and Maintenance" procedure or any of the sixteen analyte procedures. 3. Interview with the staff A on August 17, 2023, at 2:00 PM confirmed the laboratory director did not sign and date new chemistry procedures prior to patient use. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with testing personnel, staff A, the laboratory did not maintain one of one discontinued procedures with the date the testing was discontinued. Findings include: 1. Review of maintenance records for the Alfa Wasserman ACE AXCEL chemistry analyzer showed testing on the analyzer was discontinued on April 18, 2023. 2. Review of the Alfa Wasserman ACE AXCEL chemistry analyzer procedure showed no 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 -- documentation of discontinuation of the procedure. 3. Interview with staff A on August 17, 2023, at 2:10 PM confirmed the laboratory did not maintain a copy of the procedure related to the Alfa Wasserman ACE AXCEL chemistry analyzer with date of discontinuance. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of proficiency testing records, Laboratory Personnel Report (CLIA) Form CMS-209 (Centers for Medicare and Medicaid Services), and procedures, and interview with the technical consultant, the laboratory referred provider performed microscopy proficiency testing images to another laboratory. Findings include: 1. The laboratory referred proficiency testing images for provider performed microscopy to another laboratory. See D 2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing records, Laboratory Personnel Report (CLIA) Form CMS-209 (Centers for Medicare and Medicaid Services), and procedures, and interview with the technical consultant, the laboratory referred proficiency testing images for provider performed microscopy to another laboratory for analysis for one event in 2018 and two events in 2019. Findings include: 1. Review of proficiency testing records showed the laboratory reported results for fern testing, vaginal wet prep and vaginal KOH (potassium hydroxide) provider performed microscopy tests. Review of the attestation statement for event two in 2018 showed staff A performed these tests on July 17, 2018. The attestation statements for events one and two in 2019 showed staff A performed the testing for event one on March 27, 2019 and event two on July 18, 2019. 2. Review of the Laboratory Personnel Report (CLIA) Form CMS-209 provided during survey and signed by the laboratory director on September 23, 2019, showed the report did not include staff A as testing personnel in this laboratory. 3. The laboratory's "Proficiency Testing" procedure (approved December 23, 2015) states, "The Lab cannot send PT samples to another lab for testing." 4. Staff A from Women's Care of Wisconsin-CLIA #52D2149063 performed proficiency testing for fern, vaginal wet prep and vaginal KOH provider performed microscopy testing for event 2 in 2018 and event 1 and 2 in 2019 on proficiency test kits that were issued to Women's Care of Wisconsin-CLIA ID# 52D0921590 and signed the proficiency testing attestation statement for Women's Care of Wisconsin- CLIA #52D0921590. The proficiency testing results performed by Staff A at Women's Care of Wisconsin-CLIA ID #52D2149063 were then submitted to the proficiency testing provider as samples from Women's Care of Wisconsin-CLIA #520921590 prior to the proficiency testing due date. In an interview with the Technical Consultant, it was confirmed that the proficiency testing samples issued to CLIA ID #52D0921590 for fern, vaginal wet prep and vaginal KOH provider performed microscopy testing for proficiency testing event 1 in 2018 and events 1 and 2 in 2019 were physically taken by the Technical Consultant to Women's Care of Wisconsin-CLIA ID#52D2149063, another CLIA certified laboratory, for analysis and reported the proficiency testing results to the proficiency testing provider prior to the due date for submission. The interview occurred on September 23, 2019 at 10:30 AM and 11:35 AM. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. -- 2 of 5 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)