Seib Wellness Center Lab

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 reviews of the Temperature Control Log (TCL), the Beckman Coulter (BC) DxH 520 Instruction For Use (IFU) manual and an interview with the Technical Consultant (TC), the laboratory failed to ensure the room temperature for the DxH 520 analyzer was within the manufacturer's acceptable ranges. The room temperature was noted out of acceptable limits for 35 days of the 14 months in the 2024-2025 review period. The findings include: 1. A review of the TCL revealed the room temperature was out of the manufacturer's acceptable limits for the following days: A) January-April 2024; 19 days, B) December 2024; 7 days E) January-February 2025; 9 days 2. A review of the BC DxH 520 IFU manual revealed on page 1-7 the manufacturer's required operational temperature of 18-32 degrees Celsius. 3. During the exit conference with the TC and Director on 05-29-2025 at 1:42 PM, the TC confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency 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 -- specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Hematology maintenance logs, the Beckman Coulter (BC) DxH 520 In-Lab Training Guide and an interview with the Technical Consultant (TC), the laboratory failed to document the monthly maintenance for 5 of the 23 months reviewed, and the annual maintenance in 2023 and 2024. The findings include: 1. A review of the maintenance logs for the BC DxH 520 revealed the following: A) No evidence of monthly maintenance, as follows: a) May and August 2023 b) January and September 2024 c) March 2025 B) No evidence of annual maintenance for 2023 or 2024. 2. A review of the BC DxH 520 In-Lab Training Guide revealed a Cleaning and Replacement Procedure Log Sheet with the following maintenance requirements. A) Monthly or every 1,000 cycles (Bleach Cycle) B) Monthly (Cleaning the WBC Bath Filter) C) Yearly (Lubricating Pistons) D) Yearly or every 18,000 cycles (Replace Rinsing Head O-Ring) 3. During the exit conference with the TC and Director on 05-29-2025 at 1:42 PM, TC confirmed the above findings. 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: Based on a review of the Hematology Quality Control (QC) records and an interview with the Technical Consultant (TC), the laboratory had missing documentation of the mechanism utilized to monitor for shifts and trends of test performance over time. This was noted for six of the twelve months in 2024 and one of three months in 2025. The findings include: 1. A review of the Hematology QC records revealed the following months in 2024-2025 had no evidence of Levey Jennings charts or peer group comparison data: a) 2024: July, August, September, October, November, and December, b) 2025: January. 2. During the exit conference with the TC and Director on 05-29-2025 at 1:42 PM, TC confirmed the above findings. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderate complexity testing must-- (a) possess a current license issued by the State in which the laboratory is located, if such licensing is required; and This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to ensure competency assessments for Testing Personnel (TP) performing moderate complexity testing included the six CLIA minimal regulatory requirements. The surveyor noted six of the six requirements were missing on the semi-annual and annual competencies. The findings include: 1. A review of the 2023-2025 personnel records revealed TP competency assessments for the Hematology specialty had no documentation of the six CLIA minimal regulatory requirements which are as follows: (1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. (2) Monitoring the recording and reporting of test results. (3) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (4) Direct observation of performance of instrument maintenance and function checks. (5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (6) Assessment of problem-solving skills. 2. The TC confirmed the above findings during the exit conference with the TC and Director on 05-29-2025 at 1:42 PM. -- 3 of 3 --

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 a review of WLSH (Wisconsin State Laboratory of Hygiene) Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to ensure PT samples were tested: (A) by personnel who routinely performed the patient testing, (B) during hours of operation when patients CBC's (Complete Blood Counts) were run. This was noted on two of four 2022-2023 survey events. The findings include: 1. A review of the 2022-2023 WLSH PT records revealed the following: A) 2022-Event #2: The Technical Consultant signed the attestation statement as the testing personnel; instrument printouts documented the PT was performed on 6/11/2022 from 1732 to 1745 (5:32 to 5:44 PM). B) 2022-Event #3: Instrument printouts documented the PT was performed on 9/24/2022 from 1703 to 1716 (5:03 to 5:16 PM). 2. A review of the hours of operation on the laboratory's CMS-116 (CLIA Application for Certification) revealed the clinic/laboratory hours were 8:00 AM to 5:00 PM. 3. During an interview on 4/27/2023 at 10:05 AM the surveyor reviewed and confirmed the above findings with the Technical Consultant, who also confirmed she did not do patient testing. The Consultant stated she had run the PT because 2022-Event #2 had been assigned to a testing personnel who was no longer working at the clinic. However, the surveyor noted there are a total of eight testing personnel on the CMS-116 (Laboratory Personnel Report) who routinely ran patient CBC's (Complete Blood Counts). . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- 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 a review of Hematology records, a review of the User's Manual for the new Beckman Coulter (B-C) DxH 520 Hematology analyzer, and an interview with the Technical Consultant, the Laboratory Director failed to review, sign and date approval of the procedures before the Testing Personnel began using the instrument for patient testing. This affected procedures in use for one of one new instruments performing moderate-complexity tests. The findings include: 1. A review of Hematology records revealed the validation records for the B-C DxH 520, installed 12/28/2022. Patient CBC (Complete Blood Count) testing began on 12/30/2022. 2. A review of the "Instructions for Use DxH 520" Manual revealed no documentation of the Laboratory Director's review and approval (as indicated by a signature and date) of the procedures in use by the testing personnel. 3. During an interview on 4/27/2023 at 12:10 PM, the surveyor reviewed CLIA requirements, and confirmed the above noted findings with the Technical Consultant. . 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 a review of the installation and validation records for the Beckman Coulter (B-C) DxH 520 Hematology analyzer, and an interview with the Technical Consultant, the Laboratory Director failed to document review and approval of the procedures as verification of the manufacturer's performance specifications before patient testing began. This affected one of one new instruments performing moderate- complexity tests. The findings include: 1. A review of the validation records for the B- C DxH 520 revealed no documentation (signature and date) of the Laboratory Director's review and approval of the procedures verifying the manufacturer's performance specifications. Patient CBC (Complete Blood Count) testing began on 12 /30/2022. 2. During an interview on 4/27/2023 at 10:35 AM, the surveyor reviewed the records with the Technical Consultant, and confirmed the above noted findings. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of scores for the WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to satisfactorily perform on RBC (Red Blood Cell) in Hematology proficiency testing on two consecutive testing events, 2020-Event #3 and 2021-Event #1. These failures resulted in an initial unsuccessful performance on RBC proficiency testing. The findings include: 1. A review of the CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory scored zero percent (0 %) for RBC in Hematology (Complete Blood Count [CBC] testing) for 2020-Event #3 and, a score of 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 -- 60 % for RBC on 2021-Event #1. These two consecutive failures resulted in an initial unsuccessful performance on RBC proficiency testing. 2. During an interview on 5/24 /2021 at 10:40 AM, the Technical Consultant confirmed the laboratory had failed to perform and submit the results for the 2020-Event #3 survey within the timeframe prescribed by the PT provider, and had received a score of 0 % for the event (including RBC); the laboratory had performed patient CBC testing during this period, and WSLH was not provided with a valid reason for failing to perform the PT. The Technical Consultant further confirmed the laboratory received a failing score of 60 % for RBC on the 2021-Event #1 survey. . D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of scores for the WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to submit the results for the 2020-Event #3 survey within the timeframe prescribed by the PT provider. The findings include: 1. A review of the CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory scored zero percent (0 %) for Hematology (Complete Blood Count [CBC] testing) on the 2020-Event #3 survey. 2. During an interview on 5/24/2021 at 10:40 AM, the Technical Consultant confirmed the laboratory had failed to perform and submit the results for the 2020-Event #3 survey within the timeframe prescribed by the PT provider, and had received scores of 0 %; the laboratory had performed patient CBC (Complete Blood Count) testing during this period, and WSLH was not provided with a valid reason for failing to perform the PT. . D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of scores for the WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to satisfactorily perform on RBC (Red Blood Cell) in Hematology proficiency testing on two consecutive testing events, 2020-Event #3 and 2021-Event #1. These failures resulted in an initial unsuccessful performance on RBC proficiency -- 2 of 3 -- testing. The findings include: 1. Refer to D2016. SURVEYOR ID# 32558 Licensure and Certification Surveyor D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of scores for the WSLH (Wisconsin State Laboratory of Hygiene) proficiency testing (PT) on the CMS (Centers for Medicare and Medicaid) CASPER reports, and an interview with the Technical Consultant, the surveyor determined the Laboratory Director failed to ensure the laboratory submitted results for the 2020- Event #3 survey within the timeframe prescribed by the PT provider. The findings include: 1. Refer to D 2123. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the temperature logs, a lack of documentation of humidity, a review of the reference manual for the Beckman Coulter Act Diff 2, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to monitor and document humidity. The Act Diff 2 reference manual indicated a certain humidity range (20 - 80 percent) for optimal performance of the instrument, used for Complete Blood Count (CBC) testing. This affected the survey review period from 4 /25/17 until 10/23/18. The findings include: 1. A review of the temperature logs revealed no documentation of humidity. 2. When asked what were the humidity requirements for the Act Diff 2, the Technical Consultant (TC) and the surveyor reviewed the instrument's reference manual. The manual revealed the optimal humidity range for operation of the instrument was 20 - 80 % (percent), without condensation. 3. In an interview on 10/23/18 at 12:41 PM, the TC confirmed the laboratory had not monitored the humidity for the survey period reviewed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the 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 -- laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the calibration and quality control (QC) records for the Act Diff 2, an interview with the Technical Consultant (TC), and a review of the reference manual for the instrument, the surveyor determined the laboratory failed to verify the calibration performed on 2/09/18. This affected one of three calibrations reviewed by the surveyor. The findings include: 1. A review of the calibration records for the Act Diff 2 revealed the instrument was calibrated in the PM on 2/09/18. However there was no quality control testing documented after the calibration was performed. 2. The surveyor reviewed the QC and calibration records for 2/09/18 to verify the time of day the quality controls were tested, and if the controls were tested. The review revealed the QC for 2/09/18 was tested in the AM, between 8:50 AM - 9:00 AM, but had not been tested after the calibration. 3. In an interview on 10/23/18 at 12:27 PM, the surveyor asked the TC to review the records to determine if the staff ran quality control after the calibration had been performed. The TC reviewed the calibration and QC records and confirmed there was no documentation of QC after the calibration. 4. A revive of the reference manual for the instrument revealed the manufacturer's instructions to verify the calibration by running the 4C Plus Cell controls. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the personnel and proficiency testing records, a review of a policy and procedure in development, and an interview with the technical consultant and testing personnel, the surveyor determined the Laboratory Director failed to ensure laboratory testing personnel (TP) presented with the appropriate educational credentials, prior to allowing the personnel to test patients' specimens. This affected five of thirteen testing personnel. The Laboratory Director further failed to ensure each employee received appropriate training to perform moderate complexity testing, prior to testing patient specimens. This affected at least two testing personnel of the current thirteen. The findings include: 1. A review of the personnel records revealed no educational documents or verification of education for the following testing -- 2 of 3 -- peronnel: TP #5, #7, #11 #13 and #14. 2. Further review of the personnel records revealed ten of the thirteen testing personnel had initial training documented for August - October of 2018. TP #5 was trained in August, and TP #7, #11, #13 and #15 received training in 10/19/18, without verification of their education. 3. In an interview at 10:04 - 10:19 AM on 10/23/18, the Technical Consultant (TC) verified no educational credentials were included in the records/files for TP #5, 7, #11, #13 and #14. 4. During an interview at 10:42 AM, TP #10, a previously qualified and trained laboratory testing personnel, stated TP #1, whose initial training was documented on 8 /21/18, did not perform CBCs (Complete Blood Counts). However the TC, who started her employment in August of 2018, stated TP #1 did perform CBCs, because she was present when the testing personnel performed CBC testing on a patient specimen. TP #6 had initial training documented on 9/20/18. According to TP #10, TP #6 was performing CBC testing on patient specimens prior to September of 2018. The TC stated she performed and documented the initial training (9/20/18) for TP #6 and for the others, because there was no documented training records in the employees' files. Further review of the proficiency testing records for Hematology revealed TP #6 performed testing Event #2, 2018 CBC testing, also prior to the initial training documentation for this personnel. TP #8 had initial training documented on 8/08/18. TP #10 stated the personnel began CBC testing of patient specimens in 2017. 5. At 11: 00 AM on 10/23/18, the surveyor inquired of the TC the laboratory's policy and procedure on personnel training and competency evaluations. The TC (who started employment in August of 2018) stated she was currently working to develop the policy and procedure, and provided the "Quality Management" plan (not signed by the Laboratory Director), which included the following bullet-point: "...Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of services offered, and have demonstrated that they can perform all tests reliable to provide and report accurate results." Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 3 of 3 --