Unitypoint Health Marshalltown

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 review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing records, the Laboratory Test List & Annual Volume form, observations made during the survey, and confirmed by interview with General Supervisor (GS) #2 at 8:40 am on 11/05/2024, the laboratory failed to enroll in an HHS approved proficiency testing program for the analyte, human immunodeficiency virus (HIV) 1/2 antibody/antigen, for two out of two years from 1/1 /2023 - 11/05/2024. The findings include: 1. The Laboratory Test List & Annual Volume form stated the laboratory performed HIV 1/2 antibody/antigen testing using the Abbott Determine HIV-1/2 Ag/Ab combo kit. 2. A tour of the laboratory confirmed the presence of Abbott Determine HIV-1/2 Ag/Ab combo kits on the shelves. 3. At the time of the survey, GS #2 confirmed the laboratory did not enroll in proficiency testing for the analyte, HIV 1/2 antibody/antigen, in 2023 or 2024. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- 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: A. Based on review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing records and confirmed by interview with General Supervisor (GS) #2 at 8:40 am on 11/05/2024, the laboratory failed to perform a self evaluation when the laboratory received 10 ungraded PT scores from three out of six testing events from 01/01/2023- 11/05/2024. The findings include: 1. For 2023 2nd event, the laboratory received ungraded PT test scores for the following: *CAP C-B 2023 General Chemistry/Therapeutic Drugs: alanine aminotransferase (ALT)- specimens CHM-06, CHM-07, CHM-08, CHM-09, and CHM-10. 2. For 2023 3rd event, the laboratory received ungraded PT test scores for the following: *CAP C- C 2023 General Chemistry/Therapeutic Drugs: ALT- specimens CHM-11, CHM-12, CHM-13, CHM-14, and CHM-15. 3. At the time of the survey, GS #2 confirmed the laboratory did not perform a self evaluation for the ungraded PT test scores listed above. B. Based on review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) #2 at 8:40 am on 11/05/2024, the laboratory failed to perform a self evaluation when the laboratory received a score of zero for one out of six testing events from 01/01/2023- 11/05/2024. The findings include: 1. For 2024 testing event 2, the laboratory received a score of zero for failure to submit PT results before the submission deadline for the following: CAP C-B 2024 General Chemistry/Therapeutic Drugs: blood urea nitrogen (BUN) (specimens CHM-06, CHM-07, CHM-08, CHM-09, and CHM-10). 2. At the time of the survey, GS #2 confirmed the laboratory did not perform a self-evaluation for the failed PT scores. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing (PT) records and confirmed by interview with General Supervisor (GS) #2 at 8:40 am on 11/05/2024, the laboratory failed to take and document

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on May 2, 2024, the laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6076 - 42 C.F.R 493.1441 Condition: Laboratory Director, high complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the College of American Pathologists 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 -- (CAP), the laboratory failed to successfully participate in three consecutive testing events in the subspecialty of compatibility testing. The laboratory had unsatisfactory scores for 2023 event 3, 2024 event 1, and 2024 event 2. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance (100% or greater) for three consecutive testing events in the subspecialty, compatibility testing. The findings include: 1. For 2023 event 3, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 2. For 2024 event 1, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 3. For 2024 event 2, the laboratory received an unsatisfactory performance score of 80% for the subspecialty, compatibility testing. 3. The CASPER 155 report and graded results from CAP confirm the findings listed above. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the College of American Pathologists (2023 event 3, 2024 event 1, and 2024 event 2), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the College of American Pathologists, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2181. -- 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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, partial pressure of oxygen (PO2), for two out of three consecutive proficiency testing events: 2022 event 2 and 2023 event 1 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, partial pressure of oxygen (PO2), , for two out of three consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 20% for 2022 testing event 2 and 40% for 2023 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies 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 activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Clinitek Advantus quality control and maintenance records and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 12/8/2022, the laboratory failed to retain the Clinitek Advantus quality control records and maintenance records for 31 out of 31 days in August 2022. At the time of the survey, the laboratory could not locate the Clinitek Advantus quality control records or the maintenance records from August 2022. 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 review of proficiency testing records and the Laboratory Test List & Annual Volume form and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 9:15 am on 12/8/2022, the laboratory failed to verify the accuracy for reticulocyte count and manual white blood cell differentials twice annually for 4 out of 4 time periods from 1/1/2021 - 12/8/2022. 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 -- The findings include: 1. The Laboratory Test List & Annual Volume form confirmed the laboratory performed reticulocyte counts and manual white blood cell differentials. 2. For 2021 and 2022, the laboratory did not enroll in proficiency testing for either reticulocyte counts or manual white blood cell differentials. 3. At the time of the survey, the laboratory did not have documentation that the laboratory had performed a twice annual verification for reticulocyte counts or manual white blood cell differentials. 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 review of laboratory policies and procedures and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 12/18/2022, the laboratory failed to have procedures for the following test systems and/or analytes: ABL 90 blood gas analyzer, Clinitek Advantus urinalysis analyzer, and urine sediment examination. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and the Echo Lumena verification of performance specification records and confirmed by laboratory personnel identifiers #1 and #2 (refer to Laboratory Personnel Report) at approximately 11:00 am on 12/8 /2022, the technical supervisor failed to document training for the Echo Lumena blood bank test system for seven out of 14 high complexity testing personnel. The findings include: 1. The laboratory started using the Echo Lumena blood bank test system to perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification and compatibility testing in September of 2021. 2. At the time of the survey, the laboratory did not have training records for high complexity testing personnel identifiers #3 - #9 for the Echo Lumena test system. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of ACL Top 350 coagulation reagent verification records from March 2020, observations of the coagulation analyzer and confirmed by laboratory personnel identifiers #1 and #2 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 01/13/2021, the laboratory failed to program the correct normal patient mean for the current thromboplastin reagent in use (lot N0796941, expiration 07/2021) into the ACL Top 350 coagulation analyzer (SN16110382). The findings include: 1. The laboratory established a normal patient mean of 11.0 seconds for thromboplastin lot number N0796941 (expiration 07/2021) in March 2020 for the ACL Top 350 coagulation analyzer (SN16110382). 2. At the time of the survey, observation of the ACL Top 350 coagulation analyzer (SN16110382) revealed that the laboratory had programmed a normal patient mean of 11.1 seconds into the instrument. 3. Observation of thromboplastin reagent in the laboratory's refrigerator confirmed current use of lot N0796941 (expiration 07/2021). 4. Laboratory personnel identifiers #1 and #2 confirmed that the laboratory did not have the correct established normal patient mean programmed into the coagulation analyzer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) 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 2 -- laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of ACL Top 350 calibration records, lack of calibration verification records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 01/13/2021, the laboratory failed to perform and document calibration verification every six months on the ACL Top 350 test system for the analyte, D-dimer, for one out of two time periods from 01/01/2020- 01/08/2021. The findings include: 1. The laboratory performs D-dimer testing on two ACL Top 350 coagulation instruments: serial number SN17100744 and serial number SN16110382. 2. The ACL Top 350 instrument with serial number SN17100744 has been in use since the last survey on 10/16/2018. The laboratory implemented and began using the ACL Top 350 instrument with serial number SN16110382 in March 2020. 3. The laboratory performed calibrations on new lots of HemosIL D-dimer reagent using 5 levels of calibrator on the following dates: * SN17100744: 02/07 /2020, 05/13/2020 and 01/08/2021 * SN16110382: 05/13/2020 and 01/08/2021 2. At the time of the survey, the laboratory did not have additional calibration or calibration verification records for the time period between 05/13/2020 and 01/08/2021 for either instrument. -- 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 review of proficiency testing records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analytes, pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2), for two consecutive proficiency testing events: 2019 events 1 and 2 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analytes, pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2), for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2019 events 1 and 2. -- 2 of 2 --