Brookhaven Urology

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls, quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 11/1/21 through 5/27/22, and patient test results, at least one of two levels of control failed to meet the manufacturer's criteria for acceptability for four days during these seven months, when a total of forty-one patient prostate specific antigen (PSA) tests were performed and reported. Findings include: Review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls - Level 1, Lot #35271, and Level 3, Lot #35273, QC records for the Beckman Coulter Access 2 immunoassay system from 11/1/21 through 5/27/22, and patient test results revealed on the following days Level 3, of the two levels of control, was outside the manufacturer's acceptable range when the patient PSA tests listed below were performed and reported: 1/25/22 - Patients #49551, #6102, #42014, #7363, #45809, #41380, #23463, #46689. 1/28/22 - Patients #54520, #54130, #53392, #52731, #42391. 2/2/22 - Patients #30363, #54426, #28283, #54526, #26025, #49487, #42031, #50525, #9846, #20474, #53071, #43141, #353, #51865, #9484. 2/4/22 - Patients #50495, #50439, #51538, #7251, #54497, #47524, #25312, #52157, #51336, #41294, #52525, #40963, #43524. THIS IS A REPEAT DEFICIENCY. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) 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 -- Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls, quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 11/1/21 through 5/27/22, and patient test results, the testing personnel responsible for moderate-complexity PSA testing failed to identify problems that could adversely affect test performance and failed to correct the problem or immediately notify the technical consultant or laboratory director when one of two levels of control failed to meet acceptable criteria for four days, when a total of forty-one patient PSA tests were performed and reported. Refer to D5481 (Failure to ensure controls were acceptable before reporting patient test results). -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of daily quality control (QC) records and patient test results from the Beckman Coulter Access 2 immunoassay system from 10-1-19 through 2-27-20 and confirmation by Testing Personnel #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, on 3-3-20 at 1:30 p.m., the laboratory failed to include at least two levels of control on 2-14-20 when a total of seven patient prostate specific antigen (PSA) tests were performed and reported. Findings include: Review of daily QC records and patient test results from the Beckman Coulter Access 2 immunoassay system from 10-1-19 through 2-27-20 revealed the laboratory failed to include at least two levels of control on 2-14-20, when the following patient PSA tests were performed and reported: Patients #27460, #5711, #49418, #26194, #42044, #21594, #27004. Testing Personnel #2 confirmed on 3-3-20 at 1:30 p.m. that no quality control testing was performed on 2-14-20. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls, quality control (QC) records for the Beckman Coulter Access 2 immunoassay system from 11/1/21 through 5/27/22, and patient test results, at least one of two levels of control failed to meet the manufacturer's criteria for acceptability for four days during these seven months, when a total of forty-one patient prostate specific antigen (PSA) tests were performed and reported. Findings include: Review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls - Level 1, Lot #35271, and Level 3, Lot #35273, QC records for the Beckman Coulter Access 2 immunoassay system from 11/1/21 through 5-27-22, and patient test results revealed on the following days Level 3, of the two levels of control, was outside the manufacturer's acceptable range when the patient PSA tests listed below were performed and reported: 1/25/22 - Patients #49551, #6102, #42014, #7363, #45809, #41380, #23463, #46689. 1/28/22 - Patients #54520, #54130, #53392, #52731, #42391. 2/2/22 - Patients #30363, #54426, #28283, #54526, #26025, #49487, #42031, #50525, #9846, #20474, #53071, #43141, #353, #51865, #9484. 2/4/22 - Patients #50495, #50439, #51538, #7251, #54497, #47524, #25312, #52157, #51336, #41294, #52525, #40963, #43524. THIS IS A REPEAT DEFICIENCY. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of manufacturer's acceptable ranges for BioRad Liquichek Immunoassay Plus controls, daily QC records for the Beckman Coulter Access 2 immunoassay system from 10-1-19 through 2-27-20, and patient test results, the technical consultant failed to ensure the quality control program was maintained throughout the entire testing process on 2-14-20, when two levels of control were not performed, and for five days during this time frame, when at least one of two control results failed to meet the manufacturer's criteria for acceptability before reporting patient test results. Refer to D5447 (Failure to ensure two levels of control were performed each day of patient testing). Refer to D5481 (Failure to ensure two levels of control met criteria for acceptability each day of patient testing). -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records since the last survey on 4-27-16, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and personnel records, proficiency testing was not rotated among the four testing personnel, who performed patient prostate specific antigen (PSA) testing during this time frame. Findings include: Review of the CMS 209 personnel form and PT records since the last survey on 4-27-16 revealed Testing Personnel #1, listed on the CMS 209 personnel form, performed four of the five PT events since 4-27-16, and Testing Personnel #2 performed one of the five PT events. There was no documentation that Testing Personnel # 3 and #4 participated in performance of proficiency testing since 4-27-16. Review of personnel records since 4-27-16 revealed Testing Personnel #3 and #4 performed patient PSA testing during this time frame. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This CONDITION is not met as evidenced by: Based on the number of deficiencies cited for analytic systems, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 or 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. Refer to D5411 (Failure to follow manufacturer's instructions for frozen storage of controls). Refer to D5417 (Failure to ensure controls were not used past the open-vial stability date). Refer to D5431 (Failure to ensure weekly System Checks were within the manufacturer's limits before patient testing was performed). Refer to D5481 (Failure to ensure results of quality control testing were acceptable before reporting patient test results). D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation of frozen unopened vials of BioRad Liquichek Immunoassay Plus Controls stored in the freezer compartment of the laboratory refrigerator on 3-7- 18 at 10:05 a.m., the manufacturer's instructions, and the freezer temperature logs since the BioRad Liquichek Immunoassay Plus Controls were put in use for PSA testing on 4-11-17, the laboratory failed to follow manufacturer's instructions for frozen storage of unopened vials of BioRad Liquichek Immunoassay Plus Controls. Findings include: Manufacturer's instructions for BioRad Liquichek Immunoassay Plus Controls state, "This product will be stable until the expiration date when stored unopened at minus 20 degrees to minus 70 degrees Celsius." Ten unopened vials of BioRad Liquichek Immunoassay Plus Controls Lot #40951, eleven vials of Lot #40953, twelve vials of Lot #40961, and twelve vials of Lot #40963 were observed stored in the freezer compartment of the laboratory refrigerator on 3-7-18 at 10:05 a. m. Review of temperature logs for the freezer compartment of the laboratory refrigerator since the BioRad Liquichek Immunoassay Plus Controls were put in use for PSA testing on 4-11-17 revealed the freezer compartment daily temperatures fell outside the manufacturer's acceptable range for frozen storage every day the temperature was recorded from 4-11-17 through 3-7-18. 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 observation of opened vials of BioRad Liquichek Immunoassay Plus Controls, currently in use for prostate specific antigen (PSA) testing, in the laboratory refrigerator on 3-7-18 at 10:00 a.m. and review of the manufacturer's instructions, the -- 2 of 8 -- laboratory failed to document an open date to ensure the controls were not used past the manufacturer's open-vial stability of fourteen days. Findings include: Manufacturer's instructions for BioRad Liquichek Immunoassay Plus Controls state, "Once thawed, opened, and stored tightly capped at 2 to 8 degrees Celsius, this product will be stable for 14 days." Observation of opened vials of BioRad Liquichek Immunoassay Plus Controls, currently in use for PSA testing (Level 1 - Lot #40951 and Level 3 - Lot #40953), in the laboratory refrigerator on 3-7-18 at 10:00 a.m. revealed no open date to determine if the vials of control were used past the stability date. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of weekly System Check Reports from 10-25-17 through 3-7-18 for the Beckman Coulter Access 2 Immunoassay System, used for patient prostate specific antigen (PSA) testing, Access 2 Immunoassay System Instructions for Use, patient test results, and lack of documentation of