Urological Associates, Pc

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 lack of proficiency testing records, review of the Laboratory Test List & Annual Volume form and confirmed by laboratory personnel identifier #3 (refer to Laboratory Personnel Report) at approximately 9:45 am on 02/14/2024, the laboratory failed to enroll in an approved proficiency testing program for antimicrobial susceptibility testing. The findings include: 1. The laboratory performs antimicrobial susceptibility testing on urine cultures using the Pathnostics molecular test system. 2. At the time of the survey, the laboratory did not enroll in proficiency testing for antimicrobial susceptibility testing on urine cultures. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of training and competency assessments and interview with laboratory personnel #3 (refer to the Laboratory Personnel Report) at approximately 9: 45 am on 2/14/24, the laboratory failed to follow written policies documenting laboratory personnel competency for one out of seven testing personnel in 2023 and 2024. The findings include: 1. Laboratory Personnel identifier #3 had a competency assessment performed on 8/9/2023 and 2/14/2024. 2. The laboratory director performed and signed off as the evaluator on both competencies. The competencies stated the evaluator performed: *GX-7 Spec Plate ABR Assay: direct observation of routine best performance; monitoring the recording & reporting review worksheets, QC, PM, maintenance records; direct observation of performance instrument maintenance, Assessment of test performance (PT/blind sample); and Assessment of problem solving skills. *GX-017 Integra Viaflo: direct observation of routine best performance; monitoring the recording & reporting review worksheets, QC, PM, maintenance records; direct observation of performance instrument maintenance, Assessment of test performance (PT/blind sample); and Assessment of problem solving skills. *GX8 CHROMagar ESBL Assay: direct observation of routine best performance; monitoring the recording & reporting review worksheets, QC, PM, maintenance records; direct observation of performance instrument maintenance, Assessment of test performance (PT/blind sample); and Assessment of problem solving skills. 3. Interview with testing personnel identifier #3, revealed that the laboratory director did not visit the laboratory in 2023 or 2024 to perform the direct observations as part of the competency assessment. 4. Additionally, testing personnel identifier #3 also performed semen analysis testing using the SQA vision analyzer. The laboratory did not document competency for this test system in 2023 and 2024. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of a centrifuge function check procedure, review of centrifuge records, and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 12:30 pm on 2/14/2024, the laboratory failed to define the frequency for performing centrifuge speed and time checks. In addition, the laboratory failed to perform centrifuge speed and timer checks on one out of three centrifuges in 2022 and three out of three centrifuges in 2023. The findings include: 1. The blood centrifuge, serial number 211013G4302 had speed and timer checks performed on 10/4/2021. 2. The urine centrifuge, serial number 21021036 had speed and timer checks performed on 1/7/2022. 3. The urine centrifuge, serial number 21729 has speed and timer checks performed on 9/2/2022. 4. The laboratory did not have a policy that defined the frequency for performing centrifuge speed and timer checks. 5. The laboratory did not perform routine speed and timer checks on the above centrifuges. -- 2 of 3 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: A. Based on observations during the survey, review of patient test reports and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 9:40 am on 2/14/2023, the laboratory failed to have the correct name and address of the testing facility for two out of two patient test reports that had urine culture identification and antimicrobial sensitivity testing performed in November 2023. The findings include: 1. Patient identifiers A & B both had urine culture identification and antimicrobial sensitivity testing performed in November 2023. 2. Laboratory personnel identifier #3 stated that the laboratory performed urine culture identification at the Urological Associates PC, Moline, Illinois (14D0909901). Urological Associates, PC, Davenport, Iowa (16D0666021) performed the urine antimicrobial sensitivity testing. 3. Observation made during the survey confirmed the laboratory did not have equipment available to perform urine culture identifications, they only had equipment for performing urine antimicrobial sensitivity testing. 3. The test reports for patient identifiers A and B did not differentiate which laboratory performed which testing. The reports indicated that Urological Associates PC, Moline, Illinois (14D0909901) performed both tests. B. Based on review of patient test reports and confirmed by laboratory personnel identifiers #1, #4 and #5 (refer to the Laboratory Personnel Report) at approximately 11:30 am on 2/14/2024, the laboratory failed to have the correct name and address of the testing facility for three out of three patients that had histology and cytology testing performed from 11/1/2023 - 2/14/2024. The findings include: 1. Patient identifier C had a biopsy performed in November 2023 which included gross interpretation of the specimen and slides stained and interpreted. 2. Patient identifier D had a biopsy performed in February 2024 which included gross interpretation of the specimen and slides stained and interpreted. 3. Patient identifier E had non-gynecological testing performed in February 2024 on a urine specimen which include gross interpretation and slides stained and interpreted. 4. Laboratory personnel #1, #3 and #4 all confirmed that the gross examination of the specimens and processing of the slides took place at Urological Associates PC, Davenport, IA (16D0666021). The laboratory then sent the stained slides to Cross Medical Laboratories, Iowa City, Iowa (16D0386471) where the slides were read and interpreted. 5. The test report for patient identifiers C, D and E did not differentiate which laboratory performed which testing. The reports indicated that Urological Associates PC, Davenport, Iowa (16D0666021) performed all of the testing. -- 3 of 3 --

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 15 am on 8/19/2021, the laboratory failed to document correction action when the laboratory received unacceptable PT scores for one out of five PT events (2020 - event 1) from 1/1/2020 - 8/19/2021. The findings include: 1. For 2020 PT event 1, the laboratory received unacceptable scores of 80% for albumin, 80% for calcium, and 40% for sodium. 2. At the time of the survey, the laboratory did not have documented

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel, identifer #5 (refer to the Laboratory Personnel Report) at approximately 1: 30 pm on 1/29/2020, the laboratory failed to take and document

Summary Statement of Deficiencies 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 review of AAB proficiency testing (PT) attestation statements for 2016- 2017 and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 03/08/2018, the laboratory failed to maintain a copy of the attestation statement signed by the laboratory director and testing personnel for six out of six PT testing events (2016 events 1, 2, and 3; 2017 events 1, 2, and 3) in 2016-2017 . The findings include: 1. The laboratory director did not sign the attestation statements for the following testing events: *2016 event 1- Chemistry, Comprehensive *2016 event 1- Special Chemistry *2016 event 1- Basic Chemistry *2016 event 1- Hematology *2016 event 2- Hematology *2016 event 3- Chemistry, Comprehensive *2016 event 3- Special Chemistry *2016 event 3- Basic Chemistry *2016 event 3- Hematology *2017 event 1- Chemistry, Comprehensive *2017 event 1- Special Chemistry *2017 event 1- Basic Chemistry *2017 event 1- Hematology *2017 event 2- Chemistry, Comprehensive *2017 event 2- Special Chemistry *2017 event 2- Basic Chemistry *2017 event 2- Hematology *2017 event 3- Chemistry, Comprehensive *2017 event 3- Special Chemistry *2017 event 3- Basic 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 -- Chemistry *2017 event 3- Hematology 2. The laboratory director and testing personnel did not sign the attestation statements for the following testing events: *2016 event 2- Chemistry, Comprehensive *2016 event 2- Special Chemistry *2016 event 2- Basic Chemistry 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 confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at approximately 12:15 pm on 03/08/2018, the laboratory failed to verify the accuracy for reading biopsy slides and cytology slides twice annually for two out of two time periods in 2017. At the time of the survey, laboratory personnel identifier #5 confirmed that the laboratory did not verify the accuracy for reading biopsy slides and cytology slides in 2017. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of maintenance records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:20 am on 03/08/2018, the laboratory failed to perform and document monthly maintenance on the ACE Axcel Clinical Chemistry System for three out of 12 months (July, August, and September) in 2017. The findings include: 1. The ACE Axcel Clinical Chemistry System maintenance log listed the following as monthly maintenance items: * Rinse probe and fluid lines with 10% bleach * Clean bottle caps and cap connectors * Clean ISE sample port * Perform touch plate assembly cleaning procedure 2. At the time of the survey, the laboratory did not have documentation of monthly maintenance performed in July, August, and September of 2017. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or -- 2 of 3 -- negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: Based on lack of statistical records and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 03/08 /2018, the laboratory failed to document an annual statistical evaluation including: the number of cytology cases examined, the number of specimens processed by specimen type, and the number of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) for 2017. 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 review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:20 am on 03/08/2018, the laboratory director failed to ensure that prior to testing patient specimens, all testing personnel performing moderate complexity testing received the appropriate training for one out of one new testing personnel (laboratory personnel identifier #6). The findings include: 1. The laboratory hired personnel identifier #6 in September 2017. The testing personnel currently performs post vasectomy testing. 2. At the time of the survey, the laboratory did not have post vasectomy testing training records available for laboratory personnel identifier #6. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 9:20 am on 03/08/2018, the laboratory failed to assess and document the competency of individuals performing post vasectomy testing at least annually for three out of three testing personnel (identifiers #2, #3, and #4) as part of their competency assessments in 2016 and 2017. At the time of the survey, laboratory personnel identifier #2 confirmed that annual competency assessments did not include post vasectomy testing. -- 3 of 3 --