Anne Arundel Urology Pa

Summary Statement of Deficiencies 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 record review, the laboratory did not document its review of the proficiency testing evaluations for Fluorescence in situ hybridization (FISH) testing for events CYI-B of 2023 and CYI-A and CYI-B both of 2024. The laboratory proficiency test records did not show that the results returned from the proficiency test provider were reviewed by the laboratory director and appropriate staff. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with the testing person (TP), the laboratory failed to document the lot number, expiration date, and in use date of reagents used for the molecular urinary tract infection (UTI) panel assay. Findings: 1. The laboratory performed extraction and amplification procedures for the UTI panel assay. 2. Reagent lot numbers were documented on the lot-to-lot verification worksheets, but these did not capture the date the lots were put into use for patient testing. 3. There was a section on the electronic batch worksheet to capture the lot number and expiration date used for each batch tested for both the extraction and amplification reagents. The two batch worksheets that were reviewed did not have the lot numbers 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 -- documented. 4. During the survey on 12/11/2024 at 1:10 PM, the TP confirmed that the lot numbers and expirations dates for the UTI panel reagents were not documented on the electronic batch worksheets and there was no other reagent log that captured the dates the reagents were put into use. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review and interview with the testing person (TP), the laboratory failed to ensure that test results from two polymerase chain reaction (PCR) analyzers were compared at least twice a year. Findings: 1. The laboratory performed patient testing using two QuantStudio 5 PCR analyzers. 2. During the survey on 12/11/2024 at 1:15 PM, the TP confirmed that there was no policy or procedure to compare test results from the two PCR analyzers at least twice a year. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the "Quality Assurance Worksheet" records for the monthly reporting of the quality activities associated with the prostate-specific antigen (PSA) test, the laboratory did not report the month that the quality assurance review was conducted for, on the worksheet. this was confirmed during interview on 12/11/24 at 12:30 pm with laboratory staff. -- 2 of 2 --

Summary Statement of Deficiencies 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 competency assessment records and interviews the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisor. The laboratory failed to assess the competency of one of one Technical Supervisors in 2022 and January 2023 to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for one of one Technical Supervisors in 2022 and January 2023 to the date of the survey in 2023. 3. During an interview on December 4, 2023 at 2:10 PM these findings were confirmed with the Laboratory Manager. 4. During an interview on December 6, 2023 at 9:40 AM these findings were confirmed with the Technical Supervisor. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, nongynecologic cytology slide preparations and corresponding final cytology test reports and interviews the laboratory failed to establish and follow written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. The laboratory failed to identify and report five of nine unsatisfactory nongynecologic cytology slide preparations in October and November 2023 as being unsatisfactory for evaluation. Findings include: 1. The laboratory failed to establish and follow written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. a. The Survey Team identified four of nine nongynecologic cytology slide preparations reported by the laboratory as "Unsatisfactory" for evaluation and interpretation. There were no written policies or procedures to describe the criteria used to identify and report these specimens as being "Unsatisfactory" for evaluation and interpretation. Cases include: -C23-449 -C23-507 -C23-563 -C23-605 b. During an interview on December 5, 2023 at 11:20 AM the Technical Supervisor stated "I don't know if there is a policy but I think our criteria is 100 cells". c. During an interview on December 5, 2023 at 11:45 AM the Laboratory Manager confirmed there was no written policy or procedure to define "Unsatisfactory" for evaluation and interpretation. 2. The Survey Team identified five of nine nongynecologic cytology slide preparations reported by the laboratory as "Negative" in October 2023 and November 2023, as being "Unsatisfactory" for evaluation and interpretation. a. The Technical Supervisor confirmed this finding on December 5, 2023 and December 7, 2023. Refer to D6115 D5657 CYTOLOGY CFR(s): 493.1274(e)(5) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(5) The report contains narrative descriptive nomenclature for all results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interviews the laboratory failed to establish and follow written policies and procedures for the laboratory's descriptive nomenclature used on cytology test reports. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the descriptive nomenclature used during the microscopic examination of nongynecologic urine cytology specimens. 2. During an interview on December 5, 2023 at 11:20 AM when asked what reporting terminology and criteria was used by the laboratory for reporting the patient's test results, the Technical Supervisor replied "I think it might be somewhere. My threshold is high when I report cases". 3. During an interview on December 5, 2023 at 11:45 AM when asked if the laboratory procedure manual provided criteria and description for reporting the patient's test results in the terminology used by the laboratory, the Laboratory Manager replied "I don't think we have that". D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to -- 2 of 4 -- identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the Laboratory Director failed to ensure quality assessment programs were followed to identify, monitor and assess the quality of the analytic cytology services. The Laboratory Director failed to follow and maintain the laboratory's programs to monitor the accuracy of the diagnostic evaluations performed by the Technical Supervisor in 2022 and January 2023 to the date of the survey. Findings include: 1. The Laboratory Director failed to ensure quality assessment programs were followed to identify, monitor and assess the quality of the analytic cytology services. 2. The Laboratory Director failed to follow and maintain the laboratory's quality assessment programs to monitor the accuracy of the diagnostic evaluations performed by the Technical Supervisor. a. The QUALITY ASSURANCE policy titled CONSULTATION REVIEW stated: -"A review of all extra/intra-departmental consultation for pathology cases will be conducted to verify diagnostic consistency and maintain the highest standard of reporting accuracy possible. In addition, this will serve as a feedback mechanism for the pathologist to evaluate their diagnostic skills." b. The QUALITY ASSURANCE DOCUMENTS AND LOGS manual failed to include documentation of the monitoring, assessment or

Summary Statement of Deficiencies 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 test reports sent for accuracy verification and interview with the general supervisor (GS), the laboratory failed to document the steps taken when the pathologist's results did not agree with the results reviewed by a peer pathologist. Findings: 1. The procedure titled "Urothelial OligoFISH, Cytology and Telomerase Outside Review" stated that "The pathologist will randomly select two cytology, two FISH and two telomerase specimens semi-annually. These will be reviewed by a peer pathologist." 2. The procedure stated that if the pathologist "does not agree with the peer pathologist, arrangements will be made for the slides to be sent to a third party for resolution. 3. There were four case reports that were sent to an outside laboratory for peer review: 4339192, 4339177, 4339182, and 4339195. 4. A note stating "Disagree, diagnosis not confirmed by FISH" was handwritten on each report and dated 01/25/2023. 5. There was no additional documentation explaining if patient results were affected by the disagreement in diagnosis, what

Summary Statement of Deficiencies 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 proficiency testing (PT) record review and interview with the general supervisor (GS), the laboratory did not ensure that PT was performed at least twice annually for all tests performed in the laboratory. Findings: 1. The laboratory performed testing on urine cytology specimens using the Human Telomerase Reverse Transcriptase (hTERT) telomerase stain. 2. PT record review from 2019 through 2021 showed that there were no PT records for hTERT testing. 3. During an interview on 7 /13/2021 at 2:00 PM, the GS confirmed that the laboratory was not performing PT for the hTERT telomerase test. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the validation data and final report and interview with the polymerase chain reaction (PCR) testing consultant, the laboratory failed to establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- stability for patient samples tested for microbiology panels using PCR. 1. The document titled "Anne Arundel Stability Study Validation Results" was reviewed and consisted of a single page with two sections for two separate studies. The first study was for analytes tested in semen samples and the second study was for analytes tested in urine samples. 2. The laboratory did not receive and test semen samples for the microbiology panels tested using PCR. The laboratory did test rectal and vaginal swab samples which were not included in the stability study data. 3. Both sections included a brief summary of each study and a table containing the results for the analytes that were tested in each sample matrix. Neither summary included step-by-step instructions detailing how the samples were collected and processed; how and at what concentration each analyte was spiked into the samples; how the samples were tested; the acceptance criteria for evaluating the results; nor how the data was analyzed. 4. For both studies, analytes were tested on days 0, 5, 10, and 14 to determine analyte storage stability by specimen type. According to the final report, the laboratory had a PCR microbiology testing panel that included 19 bacteria, 1 yeast, 1 parasite, 10 antibiotic resistance genes, and the 16S gene. 5. The stability study for semen tested 7 analytes targeting 2 bacteria, 2 antibiotic resistance genes (2 targets per gene), and the 16S gene. Of the 7 analytes tested, 1 had results listed for all 4 days tested, 2 had results listed for day 5, 1 had results listed for day 10, and 3 had results listed for day 0 only so that a standard deviation could not be calculated. 6. The summary for semen samples stated that "All results were within 2 standard deviations except 16S. There were multiple inconsistencies throughout the stability study. Due to these inconsistencies, the length of time shown to be an acceptable limit is 5 days for swab samples." The summary did not explain what the inconsistencies were and how they affected the results nor why 5 days was determined to be an acceptable limit. 7. The stability study for urine tested 13 analytes targeting 5 bacteria, 1 yeast, 4 antibiotic resistance genes (6 total targets), and the 16S gene. Of the 13 analytes, 2 had results listed for all 4 days tested, 7 did not have results listed for day 0, 1 had no results listed at all, and 4 had results listed for day 10 only so that a standard deviation could not be calculated. 8. The summary stated that "All results are within 2 standard deviations except S. marcescens and 16S. Due to these out of range result, the length of time shown to be an acceptable limit is 10 days for urine samples." The summary did not explain why 10 days was determined to be an acceptable limit. 9. During a phone interview on 07/13/2021 at 3:30 PM, the PCR testing consultant confirmed that the written summaries did not detail how the specimens were collected nor how and why the acceptable stability limit of 10 days for urine samples was determined. 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 laboratory procedure manual and record review and interview with the general supervisor (GS), the laboratory did not ensure that the laboratory's procedure manual accurately reflected the current practice in the laboratory. Findings: 1. Procedure manual review showed that the laboratory changed its method of staining urine cytology specimens for the Human Telomerase Reverse Transcriptase (hTERT) telomerase stain from its "OligoFISH" method to a new "DiskFISH" method. The -- 2 of 9 -- procedure manual had not been updated to reflect the change; and 2. The procedure, "Quality Assurance," "Histopathology Second Pathologist Review" stated, "As a general rule, any clinically unsuspected malignancy, rare or unusual malignancy, or any case deemed appropriate by the pathologist should be reviewed by a second pathologist." "Reviewed cases will include verification of at least 5 special stains every 6 months." 3. A review of the "Second Opinion Log" from 4/14/2020 to 6/9 /2021 showed that special stains were not included in the slides evaluated for a second opinion. The GS stated at 3:15 PM on the day of the survey that this procedure was not being followed. 4. During an interview on 7/13/2021 at 5:15 PM, the GS confirmed that the laboratory did not ensure that the procedure manual was updated to reflect the current practice of the laboratory. 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record and patient sample log review and interview with the general supervisor (GS), the laboratory did not handle PT specimens in the same manner as patient samples. Findings: 1. Patient samples for pathology testing are recorded on a patient log. 2. A review of pathology patient logs from 2017 to 2018 showed that samples from 4 of 4 PT events were not recorded on the patient log. 3. During an interview on 12/14/18 at 1:45 PM, the GS confirmed that PT samples were not recorded on the patient log in the same manner as patient specimens. 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 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 -- 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 proficiency testing (PT) record review and interview with the general supervisor (GS), the laboratory did not ensure that a copy of all PT records were maintained for a minimum of two years from the date of the PT testing event. Findings: 1. A review of cytology PT records from 2017 to 2018 showed that cytology instrument printouts from 4 of 4 PT events were not available for review at the time of the survey. 2. During an interview on 12/14/18 at 1:45 PM, the GS confirmed that the cytology printouts from the PT events listed above were not maintained with the PT records reviewed. D5781