Adult And Pediatric Urology & Urogynecology Pc

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) (a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on surveyor observation of laboratory space and interview with technical supervisor #3, as listed on the CMS 209 form, the laboratory failed to have a uni- directional workflow in the laboratory for quantitative polymerase chain reaction testing. 1. Surveyor observation of the laboratory revealed the laboratory performs specimen preparation, amplification, and reagent preparation on the same laboratory bench. 2. Interview with technical supervisor #3, as listed on the CMS 209 form, on 6 /10/2025 at 2:56 PM, confirmed the laboratory performs specimen preparation, amplification, and reagent preparation without following a uni-directional workflow. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of patient sample report, review of proficiency testing documentation, and interview with the technical supervisor #3, as listed on the CMS 209, the laboratory failed to have a system for verifying the accuracy of Citrobacter freundii, Citrobacter braakii, Enterococus faecium, Entereococcus faacalis, Klebsiella Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Proteus vulgaris, and resistance genes at least twice annually for 2024 and 2025. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performs Citrobacter freundii, Citrobacter braakii, Enterococus faecium, Entereococcus faacalis, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Proteus vulgaris, and resistance genes quantitative polymerase chain reaction (qPCR) testing. 2. Interview with technical supervisor #3, as listed on the CMS 209 form, on 6/10/2025 at 12:35 PM , confirmed the laboratory did not have documentation of verification of accuracy for Citrobacter freundii, Citrobacter braakii, Enterococus faecium, Entereococcus faacalis, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Proteus vulgaris, and resistance genes quantitative polymerase chain reaction (qPCR) testing performed in 2024 and 2025. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory's general policies and procedures, surveyor review of specimen documentation, and interview with the technical supervisor #3, as listed on the CMS 209 form, the laboratory failed to follow its policies and procedures. 1. Review of laboratory's general policies and procedures on specimen rejection criteria indicate "abnormal results from temperature, specific gravity, pH, or creatinine indicate an invalid specimen." 2. Surveyor review of specimen documentation did not include testing of sample temperature and creatinine. 3. Interview with the technical supervisor #3, as listed on the CMS 209 form, confirmed the laboratory did not follow the laboratory's policies and procedures. 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 lack of uni-directional workflow (Refer to 3005), lack of twice annual accuracy verification (Refer to 5217), lack of establishing performance specifications (Refer to 5423), lack of comparison of test results (Refer to 5775), and lack of

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the laboratory's 2024 proficiency testing (PT) records and a phone interview with the technical consultant, on 1/3/2025, it was determined the laboratory failed to successfully participate in proficiency testing for the subspecialty of general immunology, analyte AFP tumor marker, analyte IgE, subspecialty of endocrinology, analyte cortisol, analyte free thyroxine, analyte HCG, analyte T3 update, analyte triiodothyronine, analyte TSH, and analyte TY. Refer to D2076, D2084, D2099, and D2107. D2076 GENERAL IMMUNOLOGY 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 -- CFR(s): 493.837(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review and interview with the technical consultant on 1/3/2025 at 9:48 AM, the laboratory failed to attain an overall testing event score of at least 80%. Findings include: 1. 2024 second event, subspecialty - general immunology, score of 0% 2. 2024 third event, subspecialty - general immunology, score of 0% 3. Interview with the technical consultant confirmed the scores. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review and interview with the technical consultant on 1/3/2025 at 9:48 AM, the laboratory failed to achieve satisfactory performance for the same anlyte in two consecutive testing events for the anlaytes AFP tumor marker and IgE. Finding include: 1. 2024 second event, analyte - AFP tumor marker, score of 0% 2. 2024 third event, analyte - AFP tumor marker, score of 0% 3. 2024 second event, analyte - IgE, score of 0% 4. 2024 third event, analyte - IgE, score of 0% 5. Interview with the technical consultant confirmed the scores. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review and interview with the technical consultant on 1/3/2025 at 9:48 AM, the laboratory failed to attain an overall testing event score of at least 80%. Findings include: 1. 2024 second event, subspecialty - endocrinology, score of 0% 2. 2024 third event, subspecialty - endocrinology, score of 0% 3. Interview with the technical consultant confirmed the scores. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on proficiency testing desk review and interview with the technical consultant on 1/3/2025 at 9:48 AM, the laboratory failed to achieve satisfactory performance for the same anlyte in two consecutive testing events for the anlaytes cortisol, free TY, HCG, T3 uptake, triiodothyronine, TSH, and TY. Findings include: 1. 2024 second event, analyte - cortisol, score of 0% 2. 2024 third event, analyte - cortosol, score of 0% 3. 2024 second event, analyte - free TY, score of 0% 4. 2024 third event, analyte - free TY, score of 0% 5. 2024 second event, analyte - HCG, score of 0% 6. 2024 third event, analyte - HCG, score of 0% 7. 2024 second event, analyte - T3 uptake, score of 0% 8. 2024 third event, analyte - T3 uptake, score of 0% 9. 2024 second event, analyte - triiodothyronine, score of 0% 10. 2024 third event, analyte - triiodothyronine, score of 0% 11. 2024 second event, analyte - TSH, score of 0% 12. 2024 third event, analyte - TSH, score of 0% 13. 2024 second event, analyte - TY, score of 0% 14. 2024 third event, analyte - TY, score of 0% 15. Interview with the technical consultant confirmed the scores. -- 3 of 3 --

Summary Statement of Deficiencies 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 lack of documentation and interview with laboratory director on 3/21/2019 at 11:30 AM the laboratory failed to have proof of education on 1 out of 3 testing personnel performing high complexity testing. 1. No proof of education documentation for 1 testing personnel performing high complexity testing was presented. 2. Interview with laboratory director confirmed no documentation was available. 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, 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 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 -- 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 lack of documentation the laboratory failed to have proof of education on 1 testing personel performing high complexity testing. Refer to D6168. -- 2 of 2 --