Prody Urology Pllc

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 8/15/2023 to 10/30/2023. Prody Urology PLLC clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. The following conditions were not met: 5400- 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 record review, and interview, the laboratory failed to complete performance specifications for the following drug resistance targets :CTX-M -lactamases (CTX-M- Group 1), Vancomycin-Resistant Enterococci(VRE Van A), Staphylococcal chromosome cassette me (Mec A), Vancomycin-resistant enterococci (Vre Van B), dihydrofolate reductase (Dfra), quinolone resistance gene (Qnr) and Sulfonamide Resistance Genes (Sul) for urinary tract infection pathogens using Polymerase chain reaction(PCR) before patient testing on February 2022. (D5423) 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 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 -- 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 record review and interview, the laboratory failed to complete performance specifications for the following drug resistance targets :CTX-M -lactamases (CTX-M- Group 1), Vancomycin-resistant enterococci(VRE Van A),Staphylococcal chromosome cassette me(Mec A), vancomycin-resistant enterococci (Vre Van B), dihydrofolate reductase(Dfra), quinolone resistance gene(Qnr) and Sulfonamide Resistance Genes (Sul) for urinary tract infection pathogens using Polymerase chain reaction(PCR) before patient testing on February 2022. Findings Included: Review of Urinary Tract Infection Pathogens Using Realtime Reverse Transcriptase Quantitative Polymerase chain reaction (RT-PCR) signed by the previous laboratory director on 4 /29/2021 revealed no documentation of performance specifications in accuracy, precision, analytical sensitivity, analytical specificity and interfering substances for CTX-M- Group 1, VRE Van A, Mec A, Vre Van B, Dfra, Qnr and Sul. On 8/15/2023 at 11:00 AM, the lab's General Supervisor stated 736 patients were tested with the UTI PCR panel from February 1, 2022, to August 15th, 2023. On 8/15/2023 at 10:44 AM, the General Supervisor confirmed performance specifications were not completed for CTX-M- Group 1, VRE Van A, Mec A, Vre Van B, Dfra, Qnr and Sul drug resistance targets. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on January 11, 2022. Prody Urology PLLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure one of one testing personnel had documentation (transcripts) of required educational requirements. Findings: Cross Reference D6171. Based on record review and interview, the laboratory failed to ensure that one of one testing personnel had documentation (transcripts) of required educational requirements. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, 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 -- include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure that one of one testing personnel had documentation (transcripts) of required educational requirements. Findings: Review of the CMS 209 Laboratory Personnel Report, signed by the Laboratory Director on 01/11/2021, showed there was one employees listed as high complexity testing personnel. Review of the college degree for the Testing Persons showed the testing personnel had a Bachelor of Arts degree. The college degree did not indicate what the major was for the Bachelor of Arts degree. On 01/11 /2022 at 11:55 AM, the Testing Personnel stated she did not have a copy of her -- 2 of 3 -- transcripts. -- 3 of 3 --