Whole Woman's Health Of Minnesota

Summary Statement of Deficiencies D0000 The Whole Women's Health of Minnesota laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on February 13, 2024. The following standard-level deficiencies were cited: 493.801 Enrollment and testing of samples 493.1291 Test report 493.1407 Laboratory director responsibilities . 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 document review and interview with laboratory personnel, the laboratory failed to ensure Immunohematology proficiency testing (PT) samples from five of six PT events in 2022 and 2023 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Rhesus Factor (Rh) testing under the specialty of Immunohematology as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 02/13/24. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The Proficiency Testing procedure found in the CLIA Manual indicated PT samples would be tested in the same manner as patient specimens. 4. Rh PT samples were tested by multiple testing personnel (TP) in five of six PT events events completed in 2022 and 2023 as indicated on API attestation statements. See below. 2022 - 1st Immunohematology event Tested by: TP5 and former TP KS and JO on 03/29/22 2022 - 3rd Immunohematology event Tested by: TP6 on 11/29/22 and TP5 and TP6 on unknown date* 2023 - 1st Immunohematology event Tested by: TP4 on 003/28/23 and TP4 and TP5 on 04/03/23 2023 - 2nd Immunohematology event Tested by: TP5 on 08/09/23 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 -- and TP6 on 08/08/23 2023 - 3rd Immunohematology event Tested by: TP3 and TP4 on 12/01/23 5. In an interview at 11:20 a.m. on 02/13/24, TP1 confirmed the above finding and indicated patient specimens would not be tested by multiple TP or on multiple days. *The 2022 - 3rd Immunohematology event attestation statement was dated 04/03/23 by the laboratory director, TP5, and TP6. **This is a repeat deficiency from the 04/05/22 survey** . 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 document review and interview with laboratory personnel, the laboratory failed to retain required proficiency testing (PT) testing records from six of six testing events in 2022 and 2023. Findings are as follows: 1. The laboratory performed Rhesus Factor (Rh) testing under the specialty of Immunohematology as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 02/13/24. 2. The laboratory performed PT using the American Proficiency Institute PT provider. 3. Test result, testing personnel, and test kit lot number and expiration date testing records from three of three API PT events completed in 2022 were not found. Testing personnel, test kit lot number and expiration date testing records were not found for three of three API PT events in 2023. The laboratory was unable to provide the missing documentation upon request. 4. In an interview at 11:15 a.m. on 02/13/24, TP1 confirmed the above finding. TP1 explained testing personnel entered the PT result on the API provided result sheet. No other documentation was completed. The API result sheets from 2022 were not retained. **This is a repeat deficiency from the 05/17/18 survey and the 04/05/22 survey (at D3037).** . D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to establish a written corrected reports procedure. Findings are as -- 2 of 3 -- follows: 1. The laboratory performed Rhesus Factor (Rh) testing under the specialty of Immunohematology as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 02/13/24. 2. An Eldon Biologicals EldonBag RhD-25 containing Eldon Cards was observed as present and available for use during the tour. 3. A corrected reports procedure was not found during review of laboratory policies and procedures located in the CLIA Manual. The laboratory was unable to provide a corrected reports procedure upon request. 4. In an interview at 12:50 p.m. on 02/13 /24, TP1 confirmed the above finding. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on document review and interview with laboratory personnel, the laboratory director failed to ensure proficiency testing (PT)samples were tested as required. Findings are as follows: 1. The laboratory performed Rhesus Factor (Rh) testing under the specialty of Immunohematology as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 02/13/24. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The laboratory director failed to ensure Immunohematology proficiency testing (PT) samples from five of six API PT events in 2022 and 2023 were tested consistent with the number of times the laboratory routinely tested patient specimens. See D2010 4. During an interview at 11:20 a.m. on 02/13/24. TP1 confirmed the above finding. . -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on April 5, 2022. During the survey, it was determined that Immediate Jeopardy existed for the following condition-level deficiency: Analytic Systems - 42 CFR 493.1250 . 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 document review and interview with laboratory personnel, the laboratory failed to ensure Immunohematology proficiency testing (PT) samples from two of five PT events from late 2020 through 2022 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 04/05/22. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The Proficiency Testing procedure found in the CLIA manual indicated PT samples would be tested in the same manner as patient specimens. 4. The Rhesus Factor (Rh) PT samples were tested by multiple testing personnel (TP) prior to the event submission deadline for two of five PT events events reviewed as indicated on attestation statements. See below. 2021 - 1st Immunohematology event Submission deadline: 04/14/21 Samples: RH-01 through RH-05 Tested by: TP1, TP2, and former TP EG and AL on 04/05/21 2022 - 1st Immunohematology event Submission deadline: 04/13/22 Samples: RH-01 through RH-05 Tested by: TP1, TP2, and TP3 on 03/29/22 5. In an interview at 12:50 p.m. on 04/05/22, TP1 indicated patient specimens would not be tested multiple times and confirmed the above finding. . D3037 RETENTION REQUIREMENTS 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 -- 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 document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records for at least 2 years. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 04/05/22. 2. The laboratory performed Rhesus Factor PT using the American Proficiency Institute (API) provider. 3. The following PT documentation was not present in laboratory records on date of survey. The laboratory was unable to provide these documents upon request. Event: 2020 3rd Immunohematology event Missing Item: Attestation Statement Event: 2021 2nd Immunohematology event Missing Item: Attestation Statement Event: 2021 3rd Immunohematology event Missing Item: Attestation Statement 4. In an interview at 12:47 p.m. on 04/05/22, TP1 confirmed the above findings. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate one unacceptable Immunohematology proficiency testing (PT) result in 2021. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 04/05/22. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory received one unacceptable PT result of 15 Rhesus Factor (Rh) testing challenges in 2021. See below. 2021 3rd Immunohematology event Sample: RH-15 Laboratory Result: Negative API expected result: Positive 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing procedure located in the CLIA manual. 5. Investigation of the unacceptable Rh PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 12:52 p.m. on 04/05/22, TP1 confirmed the above finding. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: -- 2 of 4 -- . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of five proficiency testing (PT) results when the laboratory received a zero score for non-participation. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 04/05/22. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory failed to submit results to API for five Rhesus Factor (Rh) PT samples prior to the submission deadline for the 2020 Immunohematology second testing event. API assigned a zero score for failure to participate. 4. The laboratory discovered the issue and completed testing on the five samples on 09/17/20 as indicated in laboratory records. A self-evaluation of the five results was not found during review. The laboratory was unable to provide a self-evaluation of the results upon request. 5. Evaluation of non-graded PT results was required as established in the laboratory's Proficiency Testing procedure found in the CLIA manual. 6. In an interview at 12:45 p.m. on 04/05/22, TP1 confirmed the above finding. . 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 review of laboratory policies and procedures, patient testing and quality control logs, direct observation, and interview with laboratory personnel, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Findings are as follows: 1. The laboratory failed to perform quality control each day of patient testing for an Immunohematology test. See D5449 . D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) testing on five of seven days of patient testing between 02/21/22 and 03/31/22 for a qualitative Immunohematology test. Findings are as follows: 1. The laboratory performed Rhesus Factor (Rh) Immunohematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory at 10:05 a.m. on 04/05/22. 2. An Eldon Biologicals EldonBag RhD- 25 containing EldonCards with lot number 21251 and expiration date 2023-06-28 was observed as present and available for use during the tour. 3. Rh QC testing with a -- 3 of 4 -- positive and a negative control material was required upon receipt of new testing kits as established in the Eldon Card Rh Test procedure and on each day of patient testing as established in the Quality Assurance procedure. Both procedures were located in the laboratory's CLIA manual. 4. An Individualized Quality Control Plan (IQCP) to reduce the required daily QC frequency for Rh testing was not found in the laboratory's records. The laboratory indicated an IQCP for this test system had not been completed. 5. The Daily Laboratory Log included QC and patient testing information. The log indicated Rh QC was not performed on five of seven days of Rh testing between 02/21/22 and 03/31/22 and a total of 35 patient samples received Rh testing over those five days. See below. Date Number of tests 02/21/22 1 03/10/22 4 03/17/22 11 03/24/22 12 03/31/22 7 6. In an interview at 1:03 p.m. on 04/05/22, TP1 confirmed the above finding. -- 4 of 4 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director or designee and Testing Personnel failed to attest to the integration of proficiency testing samples into the routine patient workload. Findings are as follows: 1. The laboratory performed Vaginal Preparation microscopic examinations under the specialty of Microbiology and Rh testing under the specialty of Immunohematology as confirmed by the Clinic Manager (CM) during a tour of the laboratory on 05/17/18 at 1:15 p.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) PT provider. 3. The Laboratory Director (LD) or designee and Testing Personnel failed to attest to the integration of PT samples into the routine patient workload for 2 of 11 API PT events reviewed in the January 2016 through May 2018 timeframe. See below. Event Specialty missing attestation 2017-2 Immunohematology 2017-2 Microbiology 4. In an interview on 05/17/18 at 2:50 p.m., the CM confirmed the above finding. 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 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 -- 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 document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing result records. Findings are as follows: 1. The laboratory performed Vaginal Preparation microscopic examinations under the specialty of Microbiology and Rh testing under the specialty of Immunohematology as confirmed by the Clinic Manager (CM) during a tour of the laboratory on 05/17/18 at 1:15 p.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute PT provider. 3. Laboratory testing records from 10 of 11 PT events completed in the January 2016 through May 2018 timeframe were not found. The laboratory was unable to provide the missing documents upon request. 4. In an interview on 05/17/18 at 3:00 p.m., Testing Personnel 1 (TP1) confirmed the above finding. TP1 explained she entered the results directly into the online submission program and did not retain the hand written testing result documents for the PT events. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to evaluate unacceptable proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Vaginal Preparation microscopic examinations under the specialty of Microbiology and Rh testing under the specialty of Immunohematology as confirmed by the Clinic Manager (CM) during a tour of the laboratory on 05/17/18 at 1:15 p.m. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory received unacceptable PT results from API for the samples listed below. Event ID Lab Result API expected 2016-3 VA-03 Yeast seen No yeast seen 2016-3 RH-15 Positive Negative 4. An evaluation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 05/17/18 at 2:50 p.m., the CM confirmed a documented evaluation of the unacceptable results was not performed. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: -- 2 of 3 -- . Based on document review and interview with laboratory personnel, the technical consultant failed to ensure all testing personnel were assessed through testing previously analyzed specimens, blind samples, or proficiency testing samples at least annually. Findings are as follows: 1. The laboratory performed Rh testing under the Specialty of Immunohematology as confirmed by the Clinic Manager (CM) during a tour of the laboratory on 05/17/18 at 1:15 p.m. 2. Requirements to assess testing personnel competency via blind testing using previously analyzed specimens, blind samples or proficiency testing samples were not found in the CLIA procedure manual. Documentation of blind testing was not included on the annual assessment form. 3. Laboratory records indicated 2 of 4 testing personnel (TP) were not assessed through testing previously analyzed specimens, blind samples, or proficiency testing samples in 2016. In 2017, 3 of 5 TP were not assessed in this manner. See below. TP performed proficiency testing as indicated by "x" TP 2016 2017 1 2 x 3 4 N/A x 5 x x *N/A - not applicable, newly hired in 2016 4. In an interview on 05/17/18 at 2:55 p. m., the CM confirmed the above finding. -- 3 of 3 --