Urology Of Virginia, , Pllc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology of Virginia, PLLC on August 14, 2024 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: 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: A. Based on a review of the laboratory's maintenance logs, procedures, and interviews, the laboratory failed to document performance of cytology instrument monthly preventative maintenance per written procedure for four (4) of twenty-three (23) months reviewed (survey timeframe: September 2, 2022 up to the date of the inspection on August 14, 2024). Findings include: 1. Review of the laboratory's Non- GYN Cytology Maintenance Logbook for the survey timeframe of 9/2/22 to 8/14/24 revealed monthly Thin Prep 2000 Processor Maintenance Schedule log sheets that delineated a General Cleaning protocol to be checked off monthly. The inspector noted that the logs for June 2023, November 2023, February 2024, and April 2024 lacked documentation that the monthly General Cleaning protocols were performed. 2. Review of the laboratory's Non-GYN Cytology Procedure Manual revealed the following titled procedure protocols Tissue Tek DRS 2000 Automatic Slide Stainer Preventative Maintenance for Cytology - "The Tissue Tek DRS 2000 is an automatic precision instrument that should be kept in optimal operating condition by performing the required preventative maintenance. The solution reservoirs and slide baskets are washed with tap water, mild detergent, and/or a 10% bleach solution once a month." 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 -- Recording Routine Maintenance Protocol - "Principle-It is important to keep all routine/preventative maintenance performed in the cytology laboratory. Monthly preventative maintenance is to be performed on the ThinPrep once a month and documented on the maintenance schedule via initial/date. Perform all general maintenance listed on the cytology lab maintenance logs and document via initial/date that you have done so." 3. The inspector requested documentation that the monthly maintenance outlined above was performed per procedure in June, November of calendar year 2023 and February, April of 2024. No additional documentation was available for review. 4. An interview with the Director of Laboratory Services on 8/14 /24 at 3:30 PM confirmed the above findings. B. Based on a review of cytology maintenance logs, procedures, and interviews, the laboratory failed to document, per written procedure, monthly centrifuge maintenance for 4 of 23 months, and fume hood maintenance for three (3) of 23 months reviewed (survey timeframe: September 2, 2022 to the date of the inspection on August 14, 2024). Findings include: 1. Review of the laboratory's Non-GYN Cytology Maintenance Logbook for the survey timeframe of 9/2/22 to 8/14/24 revealed Cytology Lab Maintenance Schedule log sheets that delineated the following protocols to be checked off monthly: Clean and Lubricate Centrifuge, Check Fume Hood Filter. The inspector noted there was no documentation for the monthly maintenance during the following months: Clean /Lubricate Centrifuge - June 2023, November 2023, January 2024, April 2024; Check Hood Filter- June 2023, December 2023, April 2024; Seven (7) of 23 months reviewed lacked maintenance documentation. 2. Review of the laboratory's Non-GYN Cytology Procedure Manual revealed the following titled procedure protocols: Preventative Maintenance Megafuge Centrifuge Protocol - "Clean the centrifuge and grease the trunnions of the swing out rotors monthly"; LabConco Fume Adsorber Preventative Maintenance Protocol - "Replacement of the activated charcoal filter is indicated after first odor breakthrough monitored/documented by personnel"; Tissue Tek DRS 2000 Automatic Slide Stainer Preventative Maintenance for Cytology - "Replace the activated carbon filter monthly, or sooner if fume monitoring reveals elevated reagent vapors." Recording Routine Maintenance Protocol - "Principle-It is important to keep all routine/preventative maintenance performed in the cytology laboratory. Perform all general maintenance listed on the cytology lab maintenance logs and document via initial/date that you have done so." 3. The inspector requested to review documentation that the monthly maintenance outlined above was performed per log and procedure instructions for the 4 months in calendar year 2023 and 3 months in 2024 as noted above. No additional documentation was available for review. 4. An interview with the Director of Laboratory Services on 8/14/24 at 3:30 PM confirmed the above findings. 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 a review of manufacturer operator's manual, maintenance logs, and interview, the laboratory failed to document performance of semi-annual cytology instrument preventative waste tube maintenance per manufacturer's instructions in calendar year 2023 and up to the date of the inspection on August 14, 2024. Findings include: 1. Review of the laboratory's CYTYC Corporation ThinPrep 2000 Operator's -- 2 of 3 -- Manual revealed the following required preventative maintenance protocol (Section 5 Maintenance, Waste Tube Replacement/Semi-Annual) that stated, "The tubing inside the waste control box must be replaced every six months." 2. Review of the laboratory's Non-GYN Cytology Maintenance Logbook for the timeframe of calendar year 2023 and up to 8/14/24 revealed one record for the semi-annual ThinPrep 2000 waste tube maintenance outlined above (documented on 10/2/23). 3. The inspector requested to review additional documentation that the waste tube semi-annual maintenance was performed in calendar year 2023 and year to date 2024. No additional records were available for review. 4. An interview with the Director of Laboratory Services on 8/14/24 at 3:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urology of Virginia, PLLC on August 31, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is 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 a review of the laboratory's policy and procedure manual, Fluorescence in- situ Hybridization (FISH) equipment logs, patient logs, lack of documentation, and interviews, the laboratory failed to document performance of weekly maintenance /cleaning for three of three pathology laboratory instruments (one Abbott tissue processor and two Abbott Molecular ThermoBrite System units) per the written procedure for twelve (12) weeks during a twenty (20) month review (timeframe January 2021 through August 2022) while processing eighty-seven (87) patient pathology cases. Findings include: 1. Review of the laboratory's FISH procedure manual revealed the following three protocols: VIP 2000 Operating Procedure and Maintenance Policy that outlined: "Weekly/After Each Use: Clean up drips/spills inside the VIP 2000 tissue processor. Gently wipe temperature probes to remove liquid. The safety hood should be wiped. Clean and inspect the reagent bins."; ThermoBrite Operating Procedure and Maintenance Policy that outlined: "After Each Use: wipe off condensation from inside lid, remove the slide separator and remove rubber cement from the underside using forceps. Clean the warmer plate with 70% alcohol. Allow the inside lid and warmer plate to air dry before closing lid."; Weekly 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 -- Maintenance and Cleaning Log with duty check list instructions: "VIP 2000 Processor: Clean reagent bins and surrounding areas, wipe temperature probes, clean safety hood, inspect all reagent bins. ThermoBrite: Wipe down heater plate with 70% alcohol, dry condensation on inside lid, remove glue from slide separator". 2. Review of FISH equipment and patient logs from January 2021 through August 2022 revealed no documentation of the Abbott VIP 2000 and ThermoBrite weekly procedures outlined above on the following weeks of testing and number of patient cases processed: 01/04/21 - 1 accession (UVM21-0003); 01/06/21 - 2 accessions (UVM 21- 0043, -0050); 01/07/21 - 1 accession (UVM21-0070); 01/08/21 - 1 accession (UVM21-0079); 01/21/21 - 3 accessions (UVM21-0198, -0217, -0194); 01/22/21 - 1 accession (UVM21-0231); 01/25/21 - 1 accession (UVM21-0232); 01/26/21 - 1 accession (UVM21-0247); 01/27/21 - 2 accessions (UVM21-0265, -0266); 01/29/21 - 3 accessions (UVM21-0278, -0280, -0285); January 2021 - two of four weeks lacked records for outlined protocols while reporting sixteen patient cases. 02/09/21 - 4 accessions (UVM21-0385, -0386, -0387, -0389); 02/10/21 - 1 accession (UVM21- 0410); 02/11/21 - 1 accession (UVM21-0426); 02/12/21 - 1 accession (UVM21- 0442); February 2021 - one of four weeks lacked records for outlined protocols while reporting seven patient cases. 03/15/21 - 1 accession (UVM21-0800); 03/17/21 - 2 accessions (UVM21-0809, -0817); 03/19/21 - 1 accession (UVM21-0868); 03/22/21 - 1 accession (UVM21-0873); 03/23/21 - 2 accessions (UVM21-0882, -0888); 03/24/21 - 1 accession (UVM21-0908); 03/25/21 - 5 accessions (UVM21-0915, -0916, -0918, -0923, -0920); March 2021 - one of four weeks lacked records for outlined protocols while reporting thirteen patient cases. 05/06/21 - 1 accession (UVM21-1338); 05/10 /21 - 1 accession (UVM21-1367); 05/12/21 - 1 accession (UVM21-1390); 05/14/21 - 1 accession (UVM21-1406); May 2021 two of four weeks lacked records for outlined protocols while reporting four patient cases. 06/02/21 - 1 accession (UVM21-1546); 06/03/21 - 2 accessions (UVM21-1585, -1598); 06/07/21 - 1 accession (UVM21- 1624); 06/09/21 - 3 accessions (UVM21-1653, -1657, -1658); June 2021 - one of four weeks lacked records for outlined protocols while reporting seven patient cases. 07/01 /21 - 1 accession (UVM21-1891); 07/09/21 - 2 accessions (UVM21-1957, -1960); 07 /12/21 - 1 accession (UVM21-1962); 07/13/21 - 1 accession (UVM21-1983); 07/14 /21 - 2 accessions (UVM21-1996, -2004); 07/15/21 - 2 accessions (UVM21-2013, -2024); 07/16/21 - 2 accessions (UVM21-2041, -2043); July 2021 - two of four weeks lacked records for outlined protocols while reporting eleven patient cases. 09/07/21 - 2 accessions (UVM21-2614, -2619); 09/08/21 - 4 accessions (UVM21-2624, -2626, -2636, -2637); 09/09/21 - 1 accession (UVM21-2653); September 2021 - one of four weeks lacked records for outlined protocols while reporting seven patient cases. 05/23 /22 - 12 accessions (UVM21-1878, -1880, -1875, -1888, -1888, -1889, -1915, -1931, -1927, -1929, -1974, -1975); May 2022 - one of four weeks lacked records for outlined protocols while reporting twelve patient cases. 06/16/22 - 10 accessions (UVM21-2171, -2179, -2208, -2218, -2222, -2252, -2274, -2282, -2288, -2289); June 2022 - one of four weeks lacked records for outlined protocols while reporting ten patient cases. The above outlined dates lacked VIP 2000 and ThermoBrite weekly maintenance and cleaning procedure documentation for the 87 patient cases processed. 3. The inspector inquired regarding the discrepancies of the patient FISH log sheets with the lack of maintenance recorded on the VIP 2000/ThermoBrite FISH lab logs for dates of patient testing. During a follow up interview with the laboratory tech and director of laboratory operations on 9/1/22 at approximately 11 AM, the cytologist explained that "the instrument logs are typically recorded on the day or the day after the FISH runs are completed". No additional documentation was available for the inspector to review to verify the maintenance procedures were followed /completed for the above outlined cases processed in the FISH laboratory room. 4. A follow up interview with the director of laboratory operations on 9/1/22 at -- 2 of 3 -- approximately 11:30 AM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced Clinical Laboratory Improvement Amendments (CLIA) complaint investigation (Complaint #VA00043659) was conducted at Urology of Virginia, PLLC on October 11, 2018 by a Medical Facilities Inspector from the Virginia Department of Health, Office of Licensure and Certification. The laboratory holds a Certificate of Compliance and operates under CLIA # 49D0964598. Based on the review of the documents and interview with the Laboratory Director, Clinical Operations Manager, Director of Facilities, and Clinical Manager of Urology Department, the inspector found one (1) of two (2) complainant's allegations to be substantiated. Related deficiency cited as follows: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 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 a tour, review of the laboratory's policies and procedures, and interviews, the laboratory failed to follow their policy for labeling urine samples using two (2) patient identifiers (patient's full legal name and date of birth) and time of collection on forty-six (46) of 46 samples observed on October 11, 2018. Findings include: 1. During a facility tour with the laboratory director (LD), at approximately 10:30 AM, the inspector observed the following 46 patient urine samples in the five (5) laboratory specimen collection areas: POD A - Fourteen (14) urine samples with patient last name only, no time of collection, three (3) urine samples with patient last name only, date of birth, no time of collection; POD B - Seven (7) urine samples with patient first and last name, no date of birth, no time of collection; POD C - Fourteen (14) urine samples with patient first and last name, date of birth, no time of collection; 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 -- POC D - Five (5) urine samples with patient first and last name, date of birth, no time of collection; POD E- Three (3) urine samples with patient first and last name, date of birth, no time of collection. The inspector asked the LD to describe the process of labeling patient urine samples. The LD stated: "our policy requests that the patient full legal name and date of birth be labeled on the urine cup. We now also ask the time of collection be added to the label. We have had to add the time of collection for accepting urine cytology and microbiology testing that may be added by a provider". 2. Review of the policies and procedure manual revealed a quality assurance (QA) procedure (Specimen Handling and Patient Identification, review date 9/9/16) that stated: "to ensure Urology of Virginia standing protocols are correctly performed by all clinical staff for quality results and specimen integrity, urine specimen cups will be labeled with patients' full legal name and date of birth." Review of the policies revealed a revision addendum issued for the Specimen Handling and Patient Identification procedure, dated 6/4/18, that stated: "as an additional part of the workflow, staff will be required to initial and write the time of collection on urine samples". 3. In an exit interview with the LD, Clinical Manager, Clinical Operations Manager, and the Director of Facilities, at approximately 1:30 PM, it was confirmed that the laboratory failed to ensure that their QA policy for labeling urine samples, using two (2) positive unique identifiers (patient full name and date of birth) with the time of collection, was followed for the 46 of 46 samples observed during the laboratory facility tour on 10/11/18. -- 2 of 2 --