Milwaukee Womens Medical Services

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) and laboratory records and interview with the Technical Consultant, two testing personnel repeated testing of two of the five proficiency samples from the first immunohematology event in 2024 while a single testing person performs patient tests once. Findings include: 1. Review of the API PT 'Attestation Statement 2024 Immunology / Immunohematology -1st Event' showed two testing personnel signed the attestation statement for each of two immunohematology samples. The document showed Staff A and B tested sample Rh-01 and Staff C and D tested sample Rh-02. 2. Review of the 'Daily Laboratory Log Sheet' from April 2, 2024, showed testing personnel A and B performed Rh testing on sample Rh-01 and testing personnel C and D performed Rh testing on sample Rh-02. 3. Interview with the Technical Consultant on September 24, 2024, at 12:30 PM confirmed a second testing person does not repeat patient testing and confirmed the laboratory performed two of the five PT samples from the first event in 2024 twice when they routinely test patient samples once. This is a repeat deficiency previously cited on May 18, 2016. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. 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 CONDITION is not met as evidenced by: Based on surveyor review of laboratory procedures and records, observation in the laboratory and interview with the laboratory director, the director did not provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: 1. The director did not ensure testing personnel only performed moderate complexity test systems. See D6004. 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 procedures and records, observation of reagents, and interview with the Laboratory Director, the director did not ensure the laboratory limited its testing to moderate complexity tests to comply with applicable regulations. The laboratory performed 92 of 92 patient Rh tests since March 2024 using a high complexity test system. Findings include: 1. Review of laboratory procedures showed the laboratory used ALBAclone Anti-D blend reagent for Rh patient typing since the laboratory started testing in March 2024. 2. Observation of supplies in the laboratory refrigerator on September 24, 2024, at 1:00 PM revealed an open bottle of ALBAclone Anti-D blend reagent and a box of unopened ALBAclone Anti-D blend reagent. No other reagents for Rh testing were evident in the laboratory. 3. Interview with the Laboratory Director on September 24, 2024, at 12:15 PM revealed the laboratory had used ALBAclone Anti-D blend reagent for Rh typing starting on March 7, 2024, confirmed testing with the ALBAclone Anti-D blend reagent was high complexity, and confirmed the laboratory was no longer using the ALBAclone Anti-D blend reagent for Rh tests. 4. Review of records the Technical Consultant provided by email on September 27, 2024, at 9:33 AM showed the laboratory performed 92 patient Rh tests from March through September 23, 2024. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) attestation statements and daily logs and interview with the technical consultant, testing personnel did not perform proficiency tests in the same manner as patient tests for three of three immunohematology events in 2021. Findings include: 1. Review of API PT attestation statements showed two testing personnel signed the attestation statement for the same immunohematology samples for RH-03 and RH-05 for event 1 and RH-08 for event 2 in 2021. 2. Review of daily patient testing logs showed two testing personnel recorded PT results for the same immunohematology samples for RH-11 and RH-12 for event 3 in 2021. Further review of daily patient testing logs showed one testing personnel recorded results for patient tests. 3. Interview with the technical consultant on April 6, 2022 at 9:25 AM confirmed two testing personnel do not perform patient testing per specimen and did not perform the proficiency tests in the same manner as patient tests for three of three immunohematology events in 2021. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 survey review of personnel records and interview with the technical consultant, the technical consultant could not provide semiannual competency evaluation documentation for one of one new testing personnel during the first year the individual performed patient testing. Findings include: 1. Review of personnel records for staff A showed initial training performed in February 2021 and annual competency evaluation in February 2022. Further review showed no documentation of a semiannual competency evaluation. 2. Interview with the technical consultant on April 6, 2022 at 9:15 AM confirmed the technical consultant could not provide semiannual competency evaluation documentation for one of one new testing personnel during the first year the individual performed patient testing. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor review of procedures and laboratory records, and interview with the clinic director, the laboratory has not verified the accuracy of the provider performed microscopy testing performed by the laboratory director. Findings include: 1. Review of laboratory procedures revealed a current procedure for the microscopic evaluation of vaginal wet preparations. 2. Review of laboratory records showed no evidence of proficiency testing or other verification of accuracy for the wet preparation procedure. 3. Interview with the clinic director, staff A, on October 5, 2020 at 11:50 AM confirmed the laboratory director occasionally performs vaginal wet preparation exams. Further interview confirmed the laboratory had no process in place to verify the accuracy of the procedure twice annually. 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 surveyor observation of laboratory test supplies, review of laboratory procedures and interview with the clinic director, the laboratory did not have a written 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 -- procedure for Rh testing performed with Quotient Anti-D blend reagent since testing started on July 11, 2019. Findings include: 1. Observation of test supplies in the laboratory refrigerator on October 5, 2020 at 11:00 AM revealed Quotient Anti-D blend reagent available for testing. 2. Review of laboratory procedures showed no evidence of a procedure for testing using Quotient Anti-D blend reagent. Further review showed no evidence of the manufacturer's instructions for the Quotient Anti-D blend reagent. 3. Interview with the clinic director, staff A, on October 5, 2020 at 11: 30 AM confirmed the laboratory started using Quotient Anti-D blend reagent for patient testing on July 11, 2019. Further interview confirmed the laboratory did not have a procedure or the manufacturer's instructions for use of the reagent. 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 procedures and interview with the clinic director, the laboratory has not documented dates of discontinuation on procedures that are not in use. Findings include: 1. Review of the laboratory procedure manual showed the manual includes procedures for the ELDONCARD RhD test cards and Ortho Anti-D reagent. Neither procedure shows a discontinued date or any indication that the procedure is not in use. 2. Interview with the clinic director on October 5, 2020 at 11:30 AM confirmed the laboratory only performs Rh testing with Quotient Anti-D blend and also confirmed the laboratory has not maintained the dates of discontinuance or identified the discontinued procedures as such in the procedure manual. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the clinic director, the laboratory director did not ensure the laboratory completed verification procedures to determine the accuracy, precision, and other pertinent performance characteristics of the Quotient Anti-D blend reagents put into use for patient testing on July 11, 2019. Findings include: 1. Review of laboratory records showed no evidence of evaluation of accuracy, precision or other characteristics of the Quotient Anti-D blend reagent prior to using it for patient testing. 2. Interview with the clinic director, staff A, on October 5, 2020 at 11:30 AM confirmed the laboratory did not evaluate accuracy and -- 2 of 3 -- precision of the test system prior to using the Quotient Anti-D blend reagent for patient testing starting on July 11, 2019. This is a repeat deficiency previously cited on April 4, 2018. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory Proficiency Testing (PT) records and interview with testing personnel, the laboratory did not retain records for two of the three PT events in 2016. Findings include: 1. Review of PT records showed no evidence of records from events 2016-2 and 2016-3. 2. Interview with testing personnel, Staff A, on April 4, 2018 at 10:00 AM confirmed all PT records were not retained for two years. 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 surveyor review of laboratory procedures and interview with testing personnel, policies and procedures have not been established to assess employee competency. Findings include: 1. Review of the laboratory's procedure manual shows no procedure for evaluation of competency of testing personnel. 2. Interview with testing personnel, Staff A, on April 4, 2018 at 9:30 AM confirmed that a procedure has not been written for competency evaluation. D5407 PROCEDURE MANUAL 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 -- 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: Item 1: Based on surveyor review of laboratory procedures and State Agency records, and interview with testing personnel, the current laboratory director has not approved the laboratory procedures. Findings include: 1. Review of laboratory procedures showed no evidence of review or approval by the current laboratory director, staff B. 2. Review of State Agency records show the laboratory changed the director to the current director, staff B, effective October 1, 2016. 3. Interview with testing personnel, staff A, on April 4, 2018 at 10:15 AM confirmed the procedures are not signed and dated by the current director, and the director has not documented approval of the laboratory procedures. Item 2: Based on surveyor review of the RhD (Rhesus D antigen) test records and procedures, and interview with testing personnel, the laboratory did not have an approved procedure in place before beginning patient testing with the ELDONCARD RhD test. Findings include: 1. Review of current test records showed the ELDONCARD RhD test was used for patient RhD testing performed after March 20, 2018. 2. Review of laboratory procedures showed no evidence of a procedure for ELDONCARD RhD testing. 3. Interview with testing personnel, staff A, on April 4, 2018 at 10:15 AM confirmed a procedure for ELDONCARD RhD testing had not been approved, signed and dated by the laboratory director before patient test was initiated on March 20, 2018. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and manufacturer's instructions, and interview with testing personnel, room temperature monitoring and recording was not performed since initiating testing with the ELDONCARD RhD system. Findings include: 1. Review of the manufacturer's instructions showed a required storage temperature range of 5-37 degrees Celsius for ELDONCARD test cards. 2. Review of laboratory logs showed no evidence of documentation of room temperature where the cards are stored. 3. Interview with testing personnel, Staff A, on April 4, 2018 at 11: 00 AM confirmed that monitoring of room temperature is not performed. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 3 -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with testing personnel, no verification procedures had been performed before the use of ELDONCARDS for Rh testing of patient samples. Findings include: 1. Review of laboratory records showed no evidence verification studies were performed before patient testing began with the ELDONCARD RhD test system. 2. Interview with testing personnel, Staff A, on April 4, 2018 at 10:30 AM, confirmed that no verification of accuracy or precision had been completed before testing of patient samples with the ELDONCARD RhD kit starting March 20, 2018. -- 3 of 3 --