Potomac Urology Center, Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Potomac Urology Center, PC on February 26, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of procedures, manufacturer user manual, and interviews, it was observed that the laboratory failed to: 1. follow the written/approved safety protocols in the Reverse Transcription- Polymerase Chain Reaction (RT-PCR) laboratory after a physical move on February 26, 2024 for twelve (12) of 12 months up to the date of the inspection, February 26, 2025 - CROSS REFERENCE D5401; 2. follow the manufacturer's instructions for contamination prevention in the RT-PCR laboratory during twenty-two months of review (timeframe: April 25, 2023 to the date of the recertification inspection on 2/26/25) - CROSS REFERENCE D5411. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- (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 a tour, review of procedures, and interviews, it was observed that the laboratory failed to follow the written/approved safety protocol in the Reverse Transcription- Polymerase Chain Reaction (RT-PCR) laboratory after a physical move on February 26, 2024 for twelve (12) of 12 months up to the date of the inspection, February 26, 2025. Findings include: 1. During a tour of the RT-PCR laboratory on 2/26/25 at 11 AM, the inspector noted no eye wash or safety goggles located near the entrance nor within the PCR laboratory. The inspector inquired regarding the location of an eye wash or safety wash shower and the location of safety eyewear storage. The office manager and primary testing personnel stated on 2/26/25 at 11:30 AM, "We moved to this new laboratory location in February 2024 and have not added an eye wash yet. We do not have safety goggles". 2. Review of the RT-PCR laboratory procedures revealed protocol instructions: Section 13.4 Protective Equipment - "Standard safety precautions should be utilized when performing these procedures. In the event of a spill, an emergency eyewash is located less than 10 feet from the laboratory testing area." ThermoFisher RT-PCR Site Preparation Check List - "The following required safety equipment must be available at the installation site: eyewash, safety shower, eye protection" 3. An exit interview with the primary testing personnel and the practice general manager on 2/26/25 at 2:00 PM confirmed the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 a tour, review of procedures, manufacturer user manual, and interviews, the laboratory failed to follow the manufacturer's instructions for contamination prevention in the Reverse Transcription- Polymerase Chain Reaction (RT-PCR) laboratory during the twenty-two months of review (timeframe: April 25, 2023 to the date of the recertification inspection, February 26, 2025). Findings include: 1. During a tour of the laboratory on 2/26/25 at 11 AM, the inspector noted a ThermoFisher QuantStudio 3 thermocycler in use (serial number 272312229) for RT-PCR. The inspector noted that laboratory coats were not visibly present near the entrance nor within the RT-PCR laboratory. The inspector also noted refrigerators in the dedicated PCR laboratory that were marked as in use for storage of microbiology/fungal RT- PCR patient and clinical trial testing and that the lead testing personnel wore a personal hooded type jacket over a scrub top. 2. Review of the laboratory developed test (LDT) procedure (RT-PCR's- Detection of Pathogens, Antibiotic Resistance Markers, and Fungi) revealed a protocol statement under Section 13.2, "All appropriate measures should be taken to avoid contamination of patient specimens. Lab coats must be worn". 3. Review of the ThermoFisher QuantStudio 3 user guide -- 2 of 3 -- revealed manufacturer's instructions: General Procedures: Preparing Reactions - "Follow manufacturers procedures to prepare reactions. Good RT-PCR laboratory practice includes wearing clean gloves and a clean lab coat. Do not wear the same gloves and lab coat that you have previously used when handling amplified products or preparing samples."; Installation and Operation: - "Ensure lab coats are available before installation and use of the instrument." 4. The inspector inquired as to the location/storage of dedicated RT-PCR laboratory coats utilized for reduction of contamination during the high sensitivity techniques. The primary testing personnel stated on 2/26/25 at 12:30 PM, "I have not been using laboratory coats.". The office manager also stated at 12:30 PM, "We have not provided PCR lab coats" 5. An exit interview with the primary testing personnel and the practice general manager on 2/26 /25 at 2:00 PM confirmed the above findings. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) CLIA database, CMS CLIA Certification form (CMS 116), laboratory tour, review of analyzer performance verification records, lack of documentation, and an interview, the technical supervisor (TS) failed to document performance specification validation for laboratory developed testing (LDT) after the Reverse Transcription- Polymerase Chain Reaction (RT-PCR) analyzer was moved and installed in a new physical location in February 2024 up to the date of the inspection on February 26, 2025 prior to the laboratory reporting fifteen thousand nine hundred eight (15,098) patient pathogen test results. Findings include: 1. During pre-survey preparation, the inspector noted in the CMS CLIA database that the laboratory provided the following request on 2/26/24: Change of physical address from 1800 North Beauregard St- Suite 300 in Alexandria, Virginia 22311 to 3700 Joseph Siewick Dr. Ste 300 in Fairfax, Virginia 22033. The inspector noted that the laboratory director's submitted recertification CMS 116 form confirmed the Fairfax, Virginia address. 2. During a tour of the laboratory on 2/26/25 at 11:00 AM, the inspector noted a ThermoFisher QuantStudio 3 thermocycler (serial number 272312229) in use for RT-PCR LDT. The inspector inquired if the analyzer was moved from the Alexandria, Virginia location in 2024 and inquired regarding the laboratory's policy for verification/validation after a physical move. The primary testing personnel stated that the analyzer was moved in 2024 and a decision was made to run a calibration after the move. 3. Review of the RT-PCR LDT performance validation notebook revealed one method validation study for the analyzer outlined above (reviewed and approved by the laboratory director on 4 /23/21). The inspector requested to review verification studies reviewed/approved by the TS after the physical move in 2024. Documentation was not available for review. 4. Review of the patient test logs revealed three hundred eighty-eight (388) patient panels analyzing 15,098 pathogen results were reported during the twelve months after moving to the new laboratory location. 5. An exit interview with the primary testing personnel and the practice general manager on 2/26/25 at 2:00 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Potomac Urology Center, PC on April 25, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following CLIA Condition: 493.1250 D5400: Analytic Systems. The specific deficiencies cited are as follows: D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of laboratory's policies and procedures, method validation records, patient records, lack of documentation and interviews, the laboratory failed to: 1. follow their established policy for acceptable specimens for a laboratory developed test (LDT), the "UTI+ Method", for five-hundred fifty (550) rectal swab specimens from August 2021 until the date of the survey on April 25, 2023 (see D5401); 2. validate the performance specifications of a laboratory developed test (LDT), "UTI+ Method" utilizing rectal swab specimens, prior to reporting 550 patient results from August 2021 until the date of the survey on April 25, 2023 (see D5423). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- 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 a tour of the laboratory, review of the laboratory's policies and procedures, method validation records, patient records, lack of documentation and interviews, the laboratory failed to follow their established policy for acceptable specimens for a laboratory developed test (LDT), the "UTI+ Method", for five-hundred fifty (550) rectal swab specimens from August 2021 until the date of the survey on April 25, 2023. The findings include: 1. During a tour of the laboratory on April 25, 2023, at approximately 10:30 AM, the surveyor observed a specimen rack on a shelf in the laboratory containing ten (10) plastic tubes of liquid labeled with patient information. The surveyor inquired with the primary testing personnel (TP) as to the type of specimen contained in the tubes. The TP stated the test tubes contained a liquid suspension prepared from individual patient rectal swabs for analysis utilizing the laboratory's "UTI+ Method". 2. Review of the laboratory's policies and procedures revealed a protocol, "UTI+ Method" (signed by the laboratory director on 5/4/2021), which detailed instructions for collection of urine samples by males and females. The protocol lacked documentation of instructions for the collection of rectal swabs. The surveyor requested to review the collection instructions for rectal swabs for analysis utilizing the "UTI+ Method". The laboratory provided no documentation to review. 3. Review of the laboratory's records revealed a validation record for the "UTI+ Method", "Validation for Molecular Urinary Tract Infection and Antibiotic Resistance Testing by Real Time PCR" (signed by the laboratory director on 4/23/2023). The validation record lacked documentation of the performance of validation of the rectal swab specimen type. The surveyor requested to review the validation documentation for the "UTI+ Method" utilizing the rectal swab specimen type. The laboratory provided no documentation to review. 4. Review of patient records from August 2021 until the date of the survey on April 25, 2023 revealed 550 rectal swab specimens were collected and analyzed utilizing the "UTI+ Method". 5. In an exit interview with the laboratory director and testing personnel on April 25, 2023, at approximately 1:00 PM, the above findings were confirmed. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, method validation records, Food and Drug -- 2 of 3 -- Administration's (FDA's) CLIA test categorization database, patient records, lack of documentation and interviews, the laboratory failed to validate the performance specifications for the rectal swab specimen type prior to testing patients utilizing the "UTI+ Method", laboratory developed test (LDT), for five-hundred fifty (550) rectal swab specimens from August 2021 until the date of the survey on April 25, 2023. The findings include: 1. During a tour of the laboratory on April 25, 2023, at approximately 10:30 AM, the surveyor observed a specimen rack on a shelf in the laboratory containing ten (10) plastic tubes of liquid labeled with patient information. The surveyor inquired with the primary testing personnel (TP) as to the type of specimen contained in the tubes. The TP stated the test tubes contained a liquid suspension prepared from individual patient rectal swabs for analysis utilizing the laboratory's "UTI+ Method". 2. Review of the FDA's database revealed no listing or categorization for the "UTI+ Method". 3. Review of the laboratory's method validation records revealed a validation record for the "UTI+ Method", "Validation for Molecular Urinary Tract Infection and Antibiotic Resistance Testing by Real Time PCR" (signed by the laboratory director on 4/23/2021). The validation record lacked documentation of the validation of the performance characteristics for the "UTI+ Method" when utilizing the rectal swab specimen type. The surveyor requested to review the validation documentation for the "UTI+ Method" when utilizing the rectal swab specimen type. The laboratory provided no documentation to review. 4. Review of patient records from August 2021 until the date of the survey on April 25, 2023 revealed 550 rectal swab specimens were collected and analyzed utilizing the "UTI+ Method". 5. In an exit interview with the laboratory director and testing personnel on April 25, 2023, at approximately 1:00 PM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Potomac Urology Center, PC on August 11, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: 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 the laboratory's policies and procedures, quality control (QC) documentation, patient logs, Individualized Quality Control Plan (IQCP) and interviews, the laboratory failed to follow their established protocol for the performance of weekly controls prior to reporting patient results in the laboratory's electronic health record (EHR) for four weeks out of 13 months reviewed (June 2020 until July 2021). Findings include: 1. Review of the laboratory's procedure manual revealed a protocol for "Determination of Urinary Tract Infection Pathogens using Real-Time Reverse transcriptase Quantitative Polymerase Chain Reaction (RT-QPCR) -UTI+" which stated, "4.2 Test Procedure An Analytical run begins with a weekly calibration plate (Figure 1) containing: 1.) One set of positive controls (each containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control containing known amounts of DNA or RNA templates); 2.) One set of no template controls (containing Taq polymerase, reverse transcriptase, Primers and probe for each pathogen and the endogenous control, no template DNA or RNA is included)" and "6.6 Acceptable limits for Controls The positive control and endogenous control must show amplification to pass. 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 4 -- negative control must be negative to pass If all controls pass, then the patient results can be reviewed and released." 2. Review of the laboratory's records revealed a document, "Clinical Molecular Biology Individualized Quality Control Plan (IQCP)" with laboratory director approval on 04/01/2020, which stated "2.0 Quality Control Plan-Molecular Testing Assays Functional Testing documentation-FREQUENCY- Weekly and upon receipt of a new lot of reagents." 3. Review of the laboratory's "QC Control Information Weekly" log sheets from June 2020 until July 2021 (13 months) revealed a lack of documentation of QC performed for the RT-QPCR UTI method for the following weeks: 09/28/2020-"No QC Run." 10/05/2020-"No QC Run." (QC ran 10/10/20.) 06/21/2021-"No controls run lack of inventory." 06/28/2021-"No controls run lack of inventory." (QC ran 7/6/2021.) The surveyor requested to review documentation of the QC for the weeks listed above. The laboratory provided no documentation for review. 4. Review of the laboratory's Excel spreadsheet of patient's tested with the RT-QPCR UTI method revealed the following: 09/28/2020 to 10/10 /2021-103 patients; 06/21/2021 to 07/07/2021-124 patients. A total of 227 patients. 5. In an exit interview with the laboratory director, medical director/owner, general manager, and testing personnel on August 11, 2021 at approximately 12:45 PM, the findings were confirmed. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of the Laboratory Director/Technical Supervisor who performed microscopic evaluation of cytology specimens in 2017, 2018 and to the date of the survey in 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy or procedure to assess the competency of the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for the Laboratory Director/Technical Supervisor for 2017, 2018 and to the date of the survey. 3. During an interview on October 22, 2019 at 11:45 AM the Laboratory Director/Technical Supervisor confirmed these findings. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and 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 -- interview it was determined that the laboratory failed to follow written policies and procedures to ensure workload limits were reassessed at least every six months for the Laboratory Director/Technical Supervisor in 2017, 2018, and to the date of the survey in 2019. Findings include: 1. The laboratory failed to follow the written procedure titled PATHOLOGIST'S WORKLOAD LIMITS which stated "The pathologist's tracking data will be reviewed and initialed twice annually by the Medical Director." 2. The Survey Team requested and the laboratory failed to provide a record of any workload limit review that was initialed twice annually. a. Laboratory records titled ESTABLISHED WORKLOAD LIMITS did not include a reassessment for the Laboratory Director/Technical Supervisor in 2017, 2018 and to the date of the survey in 2019. 3. During an interview on October 22, 2019 at 11:45 AM the Laboratory Director/Technical Supervisor confirmed these findings. 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 laboratory policies and procedures, laboratory records, specimen slides and interviews it was determined that the laboratory failed to have a Laboratory Director who provides overall management and direction in accordance with 493.1445 of this subpart. The Laboratory Director failed to ensure written policies and procedures were established to identify needs for remedial training or continuing education to improve upon diagnostic skills of the Laboratory Director/Technical Supervisor (refer to D6103). The cumulative effect of these systemic problems resulted in the Laboratory Director's inability to provide overall management and direction of cytology in accordance with 493.1445 of this subpart. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, nongynecologic specimen slides and interview it was determined that the Laboratory Director/Technical Supervisor failed to establish policies and procedures to evaluate the competency and training needs for the Laboratory Director/Technical Supervisor who performed microscopic evaluations of nongynecologic cytology during the years 2017, 2018 and to the date of the survey in 2019. The Laboratory Director/Technical Supervisor failed to identify training needs to microscopically identify two of three high grade or malignant urothelial lesions in March 2019. Cross refer to D5209 1. The Survey Team reviewed statistical records of 30 cases reported by the Laboratory -- 2 of 4 -- Director/Technical Supervisor in March of 2019. a. The records reflected one of 30 cases was evaluated and reported by the Laboratory Director/Technical Supervisor as being "Suspicious" for a high grade urothelial lesion or malignancy. 2. The Survey Team microscopically evaluated and identified two additional cases as "Suspicious" for a high grade urothelial lesion or malignancy in March 2019. Cases include: - USC19-0134-1538 -USC19-0134-1621 a. The Laboratory Director/Technical Supervisor confirmed these microscopic interpretations on October 23, 2019. b. The Laboratory Director/Technical Supervisor failed to identify two of the three cases during March 2019 as being "Suspicious" for a high grade urothelial lesion or malignancy. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of nongynecologic specimen slides and corresponding final test reports it was determined that the Technical Supervisor failed to verify the accuracy of two nongynecologic test reports (refer to D6115) and failed to reassess the workload limits at least every six months (refer to D6130). The cumulative effect of these practices resulted in the Technical Supervisor's inability to provide technical supervision requirements of 493.1451 of this subpart. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on the microscopic review of 347 negative nongynecologic cases/slides from June 2018 to October 2019 and confirmation by the Laboratory Director/Technical Supervisor on 10/23/2019 it was determined that the Laboratory Director/Technical Supervisor failed to verify the accuracy of two nongynecologic cytology reports. 1. USC19-0134-1538 3/6/19 ThinPrep Urine LABORATORY DIAGNOSIS: Negative for Malignancy SURVEY TEAM DIAGNOSIS: High Grade Urothelial Carcinoma LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: High Grade Urothelial Carcinoma, retrospectively 2. USC19-0134-1621 3/12/19 ThinPrep Urine LABORATORY DIAGNOSIS: Negative for Malignancy SURVEY TEAM DIAGNOSIS: High Grade Urothelial Carcinoma LABORATORY DIRECTOR /TECHNICAL SUPERVISOR DIAGNOSIS: High Grade Urothelial Carcinoma, retrospectively D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) -- 3 of 4 -- (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the Laboratory Director/Technical Supervisor failed to reassess the workload limits at least every six months and make adjustments when necessary in 2017, 2018 and to the date of the survey in 2019. Cross refer to D5637 D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Potomac Urology Center on January 24, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's Qualigen FastPack analyzers' performance verification records, patient test logs and an interview, the laboratory failed to verify reference (normal) ranges for Prostatic Specific Antigens (PSA) performed on the Qualigen FastPack analyzer prior to reporting patient results from February 1, 2018 until January 24, 2019. Findings include: 1. Review of the laboratory's Qualigen FastPack analyzers' (serial numbers 0984 and 0294 installed February 1, 2018) performance verification documentation revealed the documentation did not include verification of the reference (normal) ranges for PSAs. The surveyor requested to review documentation of the verification and evaluation of the reference (normal) ranges for PSAs on the Qualigen FastPack analyzers' prior to patient testing. The laboratory provided no documentation for review. 2. An interview with the Office 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 -- Manager and Testing Personnel A, at approximately 10:30 AM, confirmed that the laboratory failed to document the verification of PSA reference (normal) ranges prior to patient testing. -- 2 of 2 --