Iowa Clinic Pathology Laboratory, The

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 annual gynecologic cytology proficiency test (PT) program instructions, annual gynecologic cytology PT participation records and interviews the laboratory failed to meet the specified requirements for gynecologic cytology PT examination in 2022, 2023 and 2024. The laboratory failed to administer the annual gynecologic cytology PT as required by the PT program's instructions in 2022, 2023 and 2024 (refer to D2015). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- 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 review of annual gynecologic cytology PT program instructions, annual gynecologic cytology PT participation records and interviews the laboratory failed to administer and document the PT examination as required by the PT provider's laboratory proctor instructions in 2022, 2023 and 2024. Findings Include: 1. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS PAP PT PROCTOR PACKET INSTRUCTIONS which stated: "Record each examinee's start time in the area located on the individual test form." "Record the examinee's end time and collect all test materials from them after 2 hours, whether or not he or she has completed the test." a. During an interview on March 12, 2024 at 9:25 AM, the Histotechnician stated the examinee's recorded their own start and end time. The Histotechnician further stated the examinee's took the proficiency test separately. b. The Survey Team reviewed records titled GYNECOLOGIC CYTOLOGY PAP PT INDIVIDUAL RESULT FORM for 2022 and 2023. c. Two of two Technical Supervisor's started the proficiency test and ended the proficiency test at the same date and time in 2022. -Technical Supervisor A -Kit #35063248, Slideset #34456 Ten slides Test date: 02/22/2022 Start time: 08:30 AM Stop time: 09:00 AM -Technical Supervisor B -Kit #35063247, Slideset #34456 Ten slides Test date: 02/22/2022 Start time: 08:30 AM Stop time: 09:00 AM d. Technical Supervisor B started the proficiency test at the same time Technical Supervisor A ended the proficiency test in 2023. -Technical Supervisor A -Kit #36144162, Slideset #37184 Ten slides Test date: 02/21/2023 Start time: 11:20 AM Stop time: 11:30 AM -Technical Supervisor B -Kit #36144163, Slideset #37184 Ten slides Test date: 02/21/2023 Start time: 11:30 AM Stop time: 11:40 AM e. During an interview on March 12, 2024 at 9:25 AM, the Survey Team asked the Histotechnician if the COLLEGE OF AMERICAN PATHOLOGISTS GYNECOLOGIC CYTOLOGY PROFICIENCY TESTING PROGRAM KIT INSTRUCTIONS were reviewed with the examinee's. The Histotechnician stated "clearly they have done it before. They don't need any instructions." . 2. The laboratory failed to follow the COLLEGE OF AMERICAN PATHOLOGISTS PAP PT PROCTOR PACKET INSTRUCTIONS which stated: "Fax the result form immediately after the examinee is done. Do not wait until the end of the PAP PT event to fax the result form(s)." a. The Survey Team reviewed records titled GYNECOLOGIC CYTOLOGY PAP PT INDIVIDUAL RESULTS FORM for 2022. -Technical Supervisor A -Kit #35063248, Slideset #34456 Ten slides Test date: 02/22/2022 Start time: 08:30 AM Stop time: 09:00 AM Fax confirmation date and time: 02/23/2022 7:53 AM -Technical Supervisor B -Kit #35063247, Slideset #34456 Ten slides Test date: 02/22/2022 Start time: 08:30 AM Stop time: 09:00 AM Fax confirmation date and time: no fax confirmation -Cytotechnologist -Kit #35063249, Slideset #34456 Ten slides Test date: 02/22/2022 Start time: 07:45 AM Stop time: 08: 15 AM Fax confirmation date and time: 02/22/2022 8:59 AM b. The Survey Team reviewed records titled GYNECOLOGIC CYTOLOGY PAP PT INDIVIDUAL RESULTS FORM for 2023 -Technical Supervisor A -Kit #36144162, Slideset #37184 Ten slides Test date: 02/21/2023 Start time: 11:20 AM Stop time: 11:30 AM Fax confirmation date and time: 02/21/2023 11:49 AM -Technical Supervisor B -Kit #36144163, Slideset #37184 Ten slides Test date: 02/21/2023 Start time: 11:30 AM Stop time: 11:40 AM Fax confirmation date and time: 02/21/2023 11:53 AM - Cytotechnologist -Kit #36144164, Slideset #37184 Ten slides Test date: 02/21/2023 Start time: 08:00 AM Stop time: 08:32 AM Fax confirmation date and time: 02/21 -- 2 of 16 -- /2023 09:28 AM c. The Survey Team reviewed records titled GYNECOLOGIC CYTOLOGY PAP PT INDIVIDUAL RESULTS FORM for 2024. -Technical Supervisor A -Kit #37283223, Slideset #34295 Ten slides Test date: 03/04/2024 Start time: 01:00 PM Stop time: 01:15 PM Fax confirmation date and time: 03/04/2024 2: 51 PM 03/04/2024 2:23 PM - fax busy 03/04/2024 2:38 PM - fax busy -Technical Supervisor B -Kit #37283222, Slideset #34295 Ten slides Test date: 03/04/2024 Start time: 01:45 PM Stop time: 02:00 PM Fax confirmation date and time: no fax confirmation -Cytotechnologist -Kit #37283224, Slideset #34295 Ten slides Test date: 03/04/2024 Start time: 08:00 AM Stop time: 08:30 AM Fax confirmation date and time: no fax confirmation 3. During an interview on March 12, 2024 at 2:30 PM, the Laboratory Director/Technical Supervisor A confirmed the records titled GYNECOLOGIC CYTOLOGY PAP PT INDIVIDUAL RESULT FORM were not faxed immediately after the examinee's completed the test and stated the Histotechnician was performing duties in the histology laboratory during the proficiency test. The Laboratory Director/Technical Supervisor A further stated the Laboratory Director/Technical Supervisor A and Technical Supervisor B took the proficiency test separately. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to follow two written policies and procedures (refer to D5401); failed to establish written policies and procedures for eight laboratory test processes (refer to D5403); failed to ensure six of 47 written policies and procedures were approved, signed and dated by the current Laboratory Director (refer to D5407); failed to establish and follow manufacturer's instructions (refer to D5411 and D5423); failed to ensure the required maintenance for the Hologic ThinPrep Genesis Processors was performed (refer to D5429); failed to test staining materials for intended reactivity of the Diff-Quick stain used to stain nongynecologic cytology slides for each day of use (refer to D5473); failed to establish and follow written policies and procedures for a program to compare clinical information with cytology reports and to compare all gynecologic cytology reports with a diagnosis of high grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or malignant neoplasms with available histopathology (refer to D5623); failed to follow written policies and procedures to review prior gynecologic cases and identify cases with a more significant lesion (refer to D5625); failed to establish and follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to follow written policies and procedures to ensure corrected final cytology test reports indicated the basis for correction on the corrected final cytology test report (refer to D5659); and failed to maintain records of the date the search and retrospective review was performed for current HSIL or malignant cases (refer to D5787). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 3 of 16 -- 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 47 laboratory policies and procedures, lack of laboratory records and interviews the laboratory failed to follow two written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure QUALITY ASSURANCE, which stated: "Daily stain checks performed for gyn and non-gyn slides" a. The Survey Team requested and the laboratory failed to provide records documenting an assessment of the characteristics of the Diff Quick stain used to stain nongynecologic cytology slides for each day of use in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. 2. The laboratory failed to follow the procedure ANNUAL STATISTICAL EVALUATION POLICY, which stated, "The laboratory performs and documents an annual statistical evaluation of the following:" "Number of LSIL+ gynecologic cases where cytology and available histology results are discrepant" "Number of LSIL+ gynecologic cases for which histology results were not available to compare with malignant or pre malignant cytology cases" a. The Survey Team requested and the laboratory failed to provide the following records for 2022 and 2023: -Number of low grade squamous intraepithelial lesion (LSIL)+ gynecologic cases where cytology and available histology results are discrepant -Number of LSIL+ gynecologic cases for which histology results were not available to compare with malignant or pre malignant cytology cases 3. During an interview on March 11, 2024 at 2:30 PM, these findings were confirmed with the Cytotechnologist. 4. During an interview on March 12, 2024 at 2:30 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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 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: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #4 (refer to the Laboratory Personnel Report) at 9:53 am on 10/26 /2023, the laboratory failed to perform a self evaluation when it received five ungraded PT scores from three out of four PT testing events from 01/01/2022- 10/26 /2023. The findings include: 1. For 2022 testing event 1, the laboratory received ungraded PT test scores for the following: *HER2- A 2022: core 08 (specimen HER2- 01) and core 07 (specimen HER2-02) 2. For 2022 testing event 2, the laboratory received ungraded PT test scores for the following: *HER2- B 2022: core 01 (specimen HER2-04) and core 09 (specimen HER2-04) 3. For 2023 testing event 1, the laboratory received ungraded PT test scores for the following: *HER2- A 2023: core 03 (specimen HER2-02) 4. At the time of the survey, the laboratory did not have additional documentation or

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, observation and interviews it was determined the laboratory failed to follow written policies and procedures to ensure positive patient identification on gynecologic specimen vials (refer to D5203); failed to establish written policies and procedures to assess the competency of the Technical Supervisors, Cytotechnologists, and Pathology Technician (refer to D5209); failed to establish written policies and procedures for three laboratory test processes (refer to D5403); failed to follow manufacturer's instructions (refer to D5411); failed to test staining materials for intended reactivity (refer to D5473); failed to follow written policies and procedures to determine the cause of discrepancy between cytology cases and the histopathology diagnosis (refer to D5623); failed to follow written policies and procedures to ensure that the search and review of prior negative gynecologic specimens received within the previous five years was documented (refer to D5625 and D5627); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory (refer to D5657); failed to establish written policies and procedures to ensure corrected test reports indicated the basis for the correction (refer to D5659); and failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the analytic phases of cytology testing (refer to D5791). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interview it was determined that the laboratory failed to follow written policies and procedures to ensure positive patient identification at the time of receipt into the laboratory. The laboratory failed to ensure that the patient identification on specimen vials matched the patient identification on the corresponding requisitions for three of three gynecologic specimens from December 7, 2021. Findings include: 1. The procedure titled PROCESSING PROCEDURE FOR THINPREP PAP TEST stated: "1. Unload - remove containers and requisitions from individual bio-hazard bags and check to be sure patient IDs match." 2. The Survey Team observed the Pathology Technician unpack and accession three gynecologic specimens on December 7, 2021 at 8:30 AM. The Pathology Technician failed to ensure that the patient identification on the specimen vials matched the patient identification on the corresponding requisitions for three of three specimens. Specimens include: -G21-13161 -G21-13165 -G21-13191 3. During an interview on December 7, 2021 at 3:00 PM these findings were confirmed by the Laboratory Director/Technical Supervisor A. 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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors and Cytotechnologists. The laboratory failed to provide records of competency assessment for two of two Technical Supervisors and one of three Cytotechnologists in 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of Technical Supervisors and Cytotechnologists. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for two of two Technical Supervisors in 2020 and to the date of the survey in 2021. Technical Supervisors include: - Laboratory Director /Technical Supervisor A -Technical Supervisor B 3. The Survey Team requested and the laboratory failed to provide records of competency assessment for one of one Cytotechnologist in 2020 and to the date of the survey in 2021. Cytotechnologist includes: -Cytotechnologist C 4. During an interview on December 8, 2021 at 1:45 PM these findings were confirmed by the Laboratory Director/Technical Supervisor A and Technical Supervisor B. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 10 -- 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 D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, observation and interviews it was determined the laboratory failed to follow written policies and procedures to ensure positive patient identification on gynecologic specimen vials (refer to D5203); failed to establish written policies and procedures to assess the competency of the Technical Supervisors, Cytotechnologists, and Pathology Technician (refer to D5209); failed to establish written policies and procedures for three laboratory test processes (refer to D5403); failed to follow manufacturer's instructions (refer to D5411); failed to test staining materials for intended reactivity (refer to D5473); failed to follow written policies and procedures to determine the cause of discrepancy between cytology cases and the histopathology diagnosis (refer to D5623); failed to follow written policies and procedures to ensure that the search and review of prior negative gynecologic specimens received within the previous five years was documented (refer to D5625 and D5627); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory (refer to D5657); failed to establish written policies and procedures to ensure corrected test reports indicated the basis for the correction (refer to D5659); and failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the analytic phases of cytology testing (refer to D5791). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interview it was determined that the laboratory failed to follow written policies and procedures to ensure positive patient identification at the time of receipt into the laboratory. The laboratory failed to ensure that the patient identification on specimen vials matched the patient identification on the corresponding requisitions for three of three gynecologic specimens from December 7, 2021. Findings include: 1. The procedure titled PROCESSING PROCEDURE FOR THINPREP PAP TEST stated: "1. Unload - remove containers and requisitions from individual bio-hazard bags and check to be sure patient IDs match." 2. The Survey Team observed the Pathology Technician unpack and accession three gynecologic specimens on December 7, 2021 at 8:30 AM. The Pathology Technician failed to ensure that the patient identification on the specimen vials matched the patient identification on the corresponding requisitions for three of three specimens. Specimens include: -G21-13161 -G21-13165 -G21-13191 3. During an interview on December 7, 2021 at 3:00 PM these findings were confirmed by the Laboratory Director/Technical Supervisor A. 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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors and Cytotechnologists. The laboratory failed to provide records of competency assessment for two of two Technical Supervisors and one of three Cytotechnologists in 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of Technical Supervisors and Cytotechnologists. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for two of two Technical Supervisors in 2020 and to the date of the survey in 2021. Technical Supervisors include: - Laboratory Director /Technical Supervisor A -Technical Supervisor B 3. The Survey Team requested and the laboratory failed to provide records of competency assessment for one of one Cytotechnologist in 2020 and to the date of the survey in 2021. Cytotechnologist includes: -Cytotechnologist C 4. During an interview on December 8, 2021 at 1:45 PM these findings were confirmed by the Laboratory Director/Technical Supervisor A and Technical Supervisor B. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 10 -- 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 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: Based on review of proficiency testing (PT) records and confirmed by the Laboratory Administrator at approximately 11:45 am on 09/24/2019, the laboratory failed to perform a self evaluation of ungraded PT scores for four out of four PT testing events in 2018 and 2019 (2018 events 1 and 2 and 2019 events 1 and 2). The findings include: 1. For 2018 testing event 1, the laboratory received ungraded PT test scores for the following: *HER2-A 2018 HER2 Immunohistochemistry Survey- Core 05, specimen HER2-02 (Score 3+) 2. For 2018 testing event 2, the laboratory received ungraded PT test scores for the following: *HER2-B 2018 HER2 Immunohistochemistry Survey- Core 04, specimen HER2- 03 (Score 3+) 3. For 2019 testing event 1, the laboratory received ungraded PT test scores for the following: *HER2-A 2019 HER2 Immunohistochemistry Survey- Core 09, specimen HER2-01 (Score 3+) *HER2-A 2019 HER2 Immunohistochemistry Survey- Core 10, specimen HER2-02 (Score 0) 4. For 2019 testing event 2, the laboratory received ungraded PT test scores for the following: *HER2-B 2019 HER2 Immunohistochemistry Survey- Core 07, specimen HER2-04 (Score 1+) 4. At the time of the survey, the laboratory did not have additional documentation or