Cleveland Urology Associates - Antenucci

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the laboratory failed to ensure that the accurate name and address of the laboratory location where the tissue biopsy testing procedures performed in the subspecialties of Histopathology and Cytology was indicated on the patient's final test report. This deficient practice had the potential to affect 2,000 out of 2,000 patient final test reports generated from 11/02/2022 through 10/28/2024. Findings Include: 1. Review of three out of three of the laboratory's Histopathology and Cytology final test reports revealed an incorrect address (19250 Bagley Road, Suite 107, Middleburg Heights, OH 44130) of where the tissue biopsy, fish and cytology slides were interpreted. 2. The LC confirmed the incorrect address was indicated on the patient's final test reports reviewed. The interview occurred on 10/28/2024 at 3:05 PM. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to provide technical oversight in accordance with 493.1413 of this subpart. This deficient practice had the potential to affect 4,050 out of 4,050 patient test results in the subspecialties of Bacteriology in this laboratory between 11/02/2022 through 10/28/2024. Findings Include: 1. The Technical Consultant (TC) failed to include and document monitoring the recording and reporting of test results in the evaluation of the competency of two out of four Testing Personnel (TP). (Refer to D6048) 2. The Technical Consultant (TC) failed to include and document the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of the competency of two out of four Testing Personnel (TP). (Refer to D6049) 3. The Technical Consultant (TC) failed to include and document direct observation of performance of instrument maintenance and function checks in the evaluation of the competency of two out of four Testing Personnel (TP). (Refer to D6050) 4. The Technical Consultant (TC) failed to include and document the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in the evaluation of the competency of two out of four Testing Personnel (TP). (Refer to D6051) 5. The Technical Consultant (TC) failed to include and document the assessment of problem solving skills in the evaluation of the competency of two out of four Testing Personnel (TP). (Refer to D6052) 6. The Technical Consultant (TC) failed to evaluate and document the second semi-annual competency of two out of four Testing Personnel (TP) who were responsible for moderate complexity urine culture (UCx) growth/no growth testing procedures during the first year the individuals tested patient specimens. (Refer to D6053) D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to include and document monitoring the recording and reporting of test results in the evaluation of the competency of two out of four Testing Personnel (TP). This deficient practice had the potential to affect 2,700 out of 2,700 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#6 from 07/31/2023 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director on 09/04/2024, revealed four individuals were indicated as TP to performed UCx growth/no growth testing procedures. 2. Review of the laboratory's policies and procedures, provided on the date and within seven days of the inspection found instructions for competency assessment only on the "Performance Assessment" worksheet. 3. Review of the laboratory's "Performance Assessment" worksheets for UCx growth/no growth for TP#4's initial (07/31/23) and six month (01/22/24) assessments and TP#6's initial (07 /24/24) assessment did not find any indication that monitoring the recording and -- 2 of 13 -- reporting of test results was included in the evaluation of competency. 4. The Inspector requested the laboratory's competency assessment policy and procedure and the 2023 and 2024 UCx growth/no growth testing competency assessment records for TP#4 and TP#6 that included monitoring the recording and reporting of test results in the evaluation of the competency from the LC. The LC confirmed the laboratory did not include and document monitoring the recording and reporting of test results in a policy and procedure or in the evaluation of the competency of TP#4 and TP#6, as required, and was unable to provide the requested documentation on the date or within seven days of the inspection. The interview occurred via electronic mail on 11/01 /2024 at 2:18 PM. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to include and document the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of the competency of two out of four Testing Personnel (TP). This deficient practice had the potential to affect 2,700 out of 2,700 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#6 from 07/31/2023 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director on 09/04/2024, revealed four individuals were indicated as TP to performed UCx growth/no growth testing procedures. 2. Review of the laboratory's policies and procedures, provided on the date and within seven days of the inspection found instructions for competency assessment only on the "Performance Assessment" worksheet. 3. Review of the laboratory's "Performance Assessment" worksheets for UCx growth/no growth for TP#4's initial (07/31/23) and six month (01/22/24) assessments and TP#6's initial (07 /24/24) assessment did not find any indication that the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records was documented in the evaluation of competency. 4. The Inspector requested the laboratory's competency assessment policy and procedure and the 2023 and 2024 UCx growth/no growth testing competency assessment records for TP#4 and TP#6 that included the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in the evaluation of the competency from the LC. The LC confirmed the laboratory did not include and document the review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records in a policy and procedure or in the evaluation of the competency of TP#4 and TP#6, as required, and was unable to provide the requested documentation on the date or within seven days of the inspection. The interview occurred via electronic mail on 11/01/2024 at 2:18 PM. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not -- 3 of 13 -- limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to include and document direct observation of performance of instrument maintenance and function checks in the evaluation of the competency of two out of four Testing Personnel (TP). This deficient practice had the potential to affect 2,700 out of 2,700 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#6 from 07/31/2023 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director on 09/04/2024, revealed four individuals were indicated as TP to performed UCx growth/no growth testing procedures. 2. Review of the laboratory's policies and procedures, provided on the date and within seven days of the inspection found instructions for competency assessment only on the "Performance Assessment" worksheet. 3. Review of the laboratory's "Performance Assessment" worksheets for UCx growth/no growth for TP#4's initial (07/31/23) and six month (01/22/24) assessments and TP#6's initial (07/24/24) assessment did not find any indication that direct observation of performance of instrument maintenance and function checks was included in the evaluation of competency. 4. The Inspector requested the laboratory's competency assessment policy and procedure and the 2023 and 2024 UCx growth/no growth testing competency assessment records for TP#4 and TP#6 that included direct observation of performance of instrument maintenance and function checks in the evaluation of the competency from the LC. The LC confirmed the laboratory did not include and document direct observation of performance of instrument maintenance and function checks in a policy and procedure or in the evaluation of the competency of TP#4 and TP#6, as required, and was unable to provide the requested documentation on the date or within seven days of the inspection. The interview occurred via electronic mail on 11/01/2024 at 2:18 PM. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to include and document the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in the evaluation of the competency of two out of four Testing Personnel (TP). This deficient practice had the potential to affect 2,700 out of 2,700 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#6 from 07/31/2023 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director on 09/04/2024, revealed four individuals were indicated as TP to performed UCx growth /no growth testing procedures. 2. Review of the laboratory's policies and procedures, provided on the date and within seven days of the inspection found instructions for competency assessment only on the "Performance Assessment" worksheet. 3. Review of the laboratory's "Performance Assessment" worksheets for UCx growth/no growth -- 4 of 13 -- for TP#4's initial (07/31/23) and six month (01/22/24) assessments and TP#6's initial (07/24/24) assessment did not find any indication that the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples was included in the evaluation of the TP competency. 4. The Inspector requested the laboratory's competency assessment policy and procedure and 2023 and 2024 UCx growth/no growth testing competency assessment records for TP#4 and TP#6 that included the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in the evaluation of the competency from the LC. The LC confirmed the laboratory did not include and document the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples in a policy and procedure or in the evaluation of the competency of TP#4 and TP#6, as required, and was unable to provide the requested documentation on the date or within seven days of the inspection. The interview occurred via electronic mail on 11/01/2024 at 2:18 PM. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to include and document the assessment of problem solving skills in the evaluation of the competency of two out of four Testing Personnel (TP). This deficient practice had the potential to affect 2,700 out of 2,700 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#6 from 07/31/2023 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, approved and signed by the Laboratory Director on 09/04/2024, revealed four individuals were indicated as TP to performed UCx growth/no growth testing procedures. 2. Review of the laboratory's policies and procedures, provided on the date and within seven days of the inspection found instructions for competency assessment only on the "Performance Assessment" worksheet. 3. Review of the laboratory's "Performance Assessment" worksheets for UCx growth/no growth for TP#4's initial (07/31/23) and six month (01/22/24) assessments and TP#6's initial (07 /24/24) assessment found "Assessment of Problem Solving" with blank lines next to "Satisfactory" and "Unsatisfactory". 4. The Inspector requested the laboratory's competency assessment policy and procedure and 2023 and 2024 UCx growth/no growth testing competency assessment records for TP#4 and TP#6 that included the assessment of problem solving skills from the LC. The LC confirmed the laboratory did not include and document the assessment of problem solving skills of TP#4 and TP#6, as required, and was unable to provide the requested documentation on the date or within seven days of the inspection. The interview occurred via electronic mail on 11/01/2024 at 2:18 PM. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least -- 5 of 13 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Consultant (LC), the Technical Consultant (TC) failed to evaluate and document the second semi-annual competency of two out of four Testing Personnel (TP) who were responsible for moderate complexity urine culture (UCx) growth/no growth testing procedures during the first year the individuals tested patient specimens. This deficient practice had the potential to affect 1,350 out of 1,350 patient urine culture (UCx) growth/no growth performed by TP#4 and TP#5 from 01/22/2024 through 10/28/2024. Findings Include: 1. Review of the laboratory's Form CMS-209, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 09/24/2024, revealed four individuals were indicated as TP to performed UCx growth/no growth testing procedures. 2. Review of the laboratory's "Quality Assurance Policy" policy and procedure, provided on the date of the inspection, approved, signed and dated by the Laboratory Director on 01/01/2017, did not find any instructions regarding the frequency of competency assessments and only found the following statement: "Personnel Assessment: will be reviewed annually. All employee files will be screened for evidence of personnel competency assessment." 3. Review of the laboratory's 2023 and 2024 competency assessment records, provided for the inspection, did not find any record of the following second semi-annual competency assessments during the TP's first year of patient UCx testing: first second Initial semi- annual semiannual TP#4 07/31/23 01/22/24 not done TP#5 08/07/23 02/14/24 not done 4. The Inspector requested the laboratory's competency assessment policy and procedure to include the required frequency of competency assessments and the semiannual competency assessment records for TP#4 and TP#5 from the LC. The LC confirmed the laboratory did not include the required frequencies of competency assessment in any policy and procedure and the TC did not assess and document the second semiannual competency of TP#4 and TP#5 during their first year of testing patient specimens according to the CLIA regulations and was unable to provide the requested documentation on the date of the inspection. The interview occurred via electronic mail on 11/01/2024 at 2:18 PM. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interviews with the Laboratory Consultant, the Laboratory Director failed to provide overall management and direction in accordance with 493.1445 of this subpart. This deficient practice had the potential to affect 21,400 out of 21,400 patient test results in the subspecialties of Bacteriology, Routine Chemistry and Endocrinology in this laboratory between 11/02/2022 through 10/28 /2024. Findings Include: 1. The Laboratory Director failed to ensure that testing systems developed for prostatic specific antigen (PSA), free PSA (fPSA) and Testosterone (Testo) tests performed in the laboratory provided quality laboratory services for all aspects of the test performance in the subspecialties of Routine Chemistry and Endocrinology. (Refer to D6082, Item 1) 2. The Laboratory Director -- 6 of 13 -- failed to ensure that testing systems developed for urine culture (UCx) growth/no growth performed in the laboratory provided quality laboratory services for all aspects of the test performance in the subspecialty of Bacteriology. (Refer to D6082, Item 2) 3. The Laboratory Director failed to ensure that testing systems developed for tissue biopsy slide interpretations performed in the laboratory provided quality laboratory services for all aspects of the test performance in the subspecialties of Histopathology and Cytology. (Refer to D6082, Item 3) 4. The Laboratory Director failed to ensure that test accuracy verification (TAV) studies were adequate to determine the accuracy and precision for the prostatic specific antigen (PSA) and testosterone (Testo) tests conducted in the subspecialties of Routine Chemistry and Endocrinology. (Refer to D6086) 5. The Laboratory Director failed to enroll with a proficiency testing (PT) provider for urine culture (UCx) growth/no growth of bacteria for the tests performed in the subspecialty of Bacteriology. (Refer to D6088) 6. The Laboratory Director failed to establish and maintain a quality control (QC) program to assure the quality of the prostatic specific antigen (PSA), free PSA (fPSA) and testosterone (Testo) tests conducted in the subspecialties of Routine Chemistry and Endocrinology and identify failures as they occurred. (REfer to D6093, Item 1) 7. The Laboratory Director failed to establish a quality control (QC) program and ensure it was maintained to assure the quality of the urine culture (UCx) growth/no growth tests conducted in the subspecialty Bacteriology and to identify failures as they occurred. (Refer to D6093, Item 2) 8. The Laboratory Director failed to ensure the quality assessment programs were established and maintained to assure the quality of the laboratory services provided and to identify failure in quality as they occurred in the subspecialties of Bacteriology, Routine Chemistry and Endocrinology. (Refer D6094) 9. The Laboratory Director failed to ensure that patient prostatic specific antigen (PSA), free PSA (fPSA) and testosterone (Testo) test results were not reported until all

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and an interview with the Consultant, the laboratory failed to enroll in a Proficiency Testing (PT) program for the subspecialties of general immunology, endocrinology, urinalysis and bacteriology that met the criteria in subpart I of this part for the year of 2018. All 9,250 patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of policies, procedures, and documentation found the lab failed to enroll in a PT program for the subspecialty of general immunology that met the criteria of subpart I for the year of 2018. (Refer to D2003.) 2. Review of policies, procedures, and documentation found the lab failed to enroll in a PT program for the subspecialty of endocrinology that met the criteria of subpart I for the year of 2018. (Refer to D2003.) 3. Review of policies, procedures, and documentation found the lab failed to enroll in a PT program for the subspecialty of urinalysis that met the criteria of subpart I for the year of 2018. (Refer to D2003.) 4. Review of policies, procedures, and documentation found the lab failed to enroll in a PT program for the subspecialty of bacteriology that met the criteria of subpart I for the year of 2018. (Refer to D2003.) 5. The Consultant confirmed, on 4/17/19 at 2:09 pm, that the lab failed to enroll in a PT program for the subspecialties of general 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 -- immunology, endocrinology, urinalysis and bacteriology that met the criteria in subpart I. (Refer to D2003) D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and an interview with the Consultant, the laboratory failed to maintain the accuracy of its testing procedures for the analyte Serum Free PSA (prostate-specific antigen) in the subspecialty of general immunology, and the subspecialties endocrinology, urinalysis, and bacteriology at least twice annually for the year of 2018. All 9,250 patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of the laboratory's CMS "Annual Test Volume" form found that the following number of tests in their respective subspecialties were performed in the year of 2018: General Immunology Serum PSA: 1,000 tests Serum Free PSA: 500 tests Endocrinology Serum Testosterone: 750 tests Urinalysis Microscopic Urine Sediment: 5,000 tests Bacteriology Urine Culture Colony Count: 2,000 tests 2. Review of the laboratory's "Policy and Procedure for Method Accuracy Verification (MAV) serum PSA's, serum Free PSA's, serum Testosterone" found the frequency of MAV listed as quarterly as of 1/1/17, and changed to annually as of 5/1 /18. 3. Review of the laboratory's "Policy and Procedure for Method Accuracy Verification microscopic urine sediment" found the frequency of MAV listed as quarterly as of 1/17/19, changed to bi-annually as of 12/13/17, and changed to annually as of 11/27/18. 4. Review of the laboratory's "Policy and Procedure for Method Accuracy Verification urine culture colony count" found the frequency of MAV listed as quarterly as of 1/1/17, and changed to annually as of 1/28/18. 5. Review of the laboratory's MAV documentation found the laboratory verified the accuracy of the analyte serum PSA, in the subspecialty of general immunology, twice annually in the year of 2018, in accordance with 493.1236(c)(1). The serum PSA MAV events were listed as: Patient 90924 on 8/20/18 Patient 90267 on 8/20/18. 6. Review of the laboratory's MAV documentation found the laboratory failed to verify the accuracy of the analyte serum Free PSA, in the subspecialty general immunology, at least twice annually. The only serum Free PSA MAV event in 2018 was listed as: Patient 90267 on 8/20/18. 7. Review of the laboratory's MAV documentation found the laboratory failed to verify the accuracy of the analyte serum Testosterone, in the subspecialty endocrinology, at least twice annually. The only serum Testosterone MAV event in 2018 was listed as: Patient 12278 on 8/20/18. 8. Review of the laboratory's MAV documentation found the laboratory failed to verify the accuracy of the analyte microscopic urine sediment, in the subspecialty urinalysis, at least twice annually. The only microscopic urine sediment MAV event in 2018 was listed as: Patient 1 on 12/31/18. 9. Review of the laboratory's MAV documentation found the laboratory failed to verify the accuracy of the analyte urine culture colony count, in the subspecialty bacteriology, at least twice annually. The only urine culture colony count MAV event in 2018 was listed as: Patient 93082 on 8/20/18. 10. An interview with the Consultant confirmed, on 4/17/19 at 2:09 pm, that the laboratory failed to establish and maintain the accuracy for the analyte Serum Free PSA in the -- 2 of 3 -- subspecialty of general immunology, and the subspecialties endocrinology, urinalysis, and bacteriology at least twice annually for the year of 2018; thus not complying with 493.1236(c)(1). -- 3 of 3 --