Urology Associates Of Delaware, P A

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on May 30, 2024 at approximately 1:00 pm at Urology Associates of Delaware, PA. The laboratory was surveyed according to 42 CFR par 493 Clinical Laboratory Improvement Ammendments (CLIA) requirements. Specific deficiencies are as follows: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Interview and document review. The laboratory failed to have a quality improvement process in place. Findings include: 1. At approximately 2:00 pm on May 30, 2024 during document review, there was no evidence of internal audits to monitor and assess problems in the laboratory to include quality control, equipment maintenance, temperature logs and similar daily laboratory quality assurance activities. 2. At approximately 2:05 pm the LD confirmed that no internal audits were documented, but that they were performed on an informal basis. 3. By the end of the interview at approximately 2:46 pm no internal audit documentation was provided. 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 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 -- 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: interview, observation and document review. The laboratory failed to ensure that all pipette in use had a current calibration. Findings include: 1. At approximately 2:30 pm on May 30, 2024 during observation in the laboratory, the pipette in use, Integra Multiplex 7021980 was noted to have an expired calibration which occured on January 24, 2024. 2. At approximately 2:35 pm, during interview and document review, the Laboratory Director (LD) could not provide current calibration documentation for that pipette but stated that two other pipettes were sent out for calibration. 3. At the end of the interview at approximately 2:46 pm no documentation was provided for the expired pipette and the LD confirmed that it was expired. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, cytology slide preparations, corresponding final test reports and interview with the Laboratory Director/Technical Supervisor, the laboratory failed to establish written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. The laboratory failed to identify and report one of 28 unsatisfactory nongynecologic cytology slide preparations from January to March 2023 as "Unsatisfactory for Evaluation". The laboratory also failed to identify and report one of 28 "Unsatisfactory for Evaluation" nongynecologic cytology slide preparations from January to March 2023 as being "Negative". Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. 2. The laboratory failed to identify and report one of 28 nongynecologic cytology slide preparations from January to March 2023 as being "Unsatisfactory for Evaluation" due to insufficient cellularity. Refer to D6115. Case includes: - UC23-00068 3. The laboratory failed to identify and report one of 28 "Unsatisfactory for Evaluation" nongynecologic cytology slide preparations as being "Negative". Refer to D6115. Case includes: - UC23-00213 4. During an interview on October 4, 2023 at 10:30 AM these findings were confirmed by the Laboratory Director/Technical Supervisor. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) 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 -- 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 287 negative and unsatisfactory nongynecologic cytology cases from January through March 2023, the Technical Supervisor failed to verify the accuracy of two nongynecologic cytology tests. 1. UC23-00068 01/24/2023 CellSolutions preparation LABORATORY DIAGNOSIS: Negative for Malignant Cells SURVEY TEAM DIAGNOSIS: Unsatisfactory, Insufficient Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory on Voided Urine 2. UC23-00213 02/28/2023 CellSolutions preparation LABORATORY DIAGNOSIS: Insufficient Cellularity for Diagnosis SURVEY TEAM DIAGNOSIS: Negative for Malignancy TECHNICAL SUPERVISOR DIAGNOSIS: Negative but Obscurring Inflammation 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. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on June 16, 2022 at approximately 10:15 am at Urology Associates of Delaware, PA. The laboratory was surveyed according to 42 CFR part 493 Clinical Laboratory Imporvement Ammendments (CLIA) requirements. Specific deficiencies are as follows: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: documentation and interview. The laboratory failed to document acceptable temperature ranges for the Heat Block and Incubator to ensure manufacturer's testing requirements are met. Findings include: 1. Temperature controlled spaces, equipment, and instruments must be monitored and results documented for acceptable temperature ranges. 2. At approximately 11:30 am on June 16, 2022 during document review, it was determined that the "Temperature Log", did not include acceptable ranges for the "Heat Block Temperature" or the "Incubator Temperature". 3. Upon review of the Quality Assurance Manual (QAM), there were no temperature ranges noted for either the heat block or the incubator. 4. At approximately 2:25 pm during interview, the Laboratory Director (LD) confirmed that the laboratory failed to include acceptable temperature ranges for the heat block and incubator in the QAM or on the Temperature Log. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: observation and interview. The laboratory failed to establish an expiration date for biology grade water used for testing upon opeing. Findings include: 1.During a tour of the facility at approximately 1:00 pm on June 16, 2022, it was observed that IBI Water Lot#21DC0622A was labeled with a received date of "3/17/22" and an opened date of "5/5/22" handwritten on a laboratory-generated label. It did not, however have an expiration date as required. 2. During interview at approximately 2:20 pm, the LD confirmed the laboratory failed to establish or note an expiration date for the opened bottle of IBI Water. -- 2 of 2 --