Drs Levine, Reigle, Schneider And Davili, Inc

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 interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the laboratory failed to enroll with a proficiency testing (PT) provider for the urine microscopic testing performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of urine microscopic PT procedures. 2. The Inspector requested the laboratory's approved PT policies and procedures, PT enrollment documentation and 2022, 2023 and 2024 PT documentation for urine microscopic testing from the OM and LMA. The OM and LMA confirmed the laboratory did not establish any PT policy and procedure, was not enrolled with a PT provider and did not perform and document any PT activities for urine microscopic testing. The interviews occurred on 04/10/2024 at 2:10 PM. D5433 MAINTENANCE AND FUNCTION CHECKS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the laboratory failed to establish maintenance and service protocols that ensured equipment and test system performance necessary for accurate and reliable urine microscopic test results and test result reporting in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of maintenance and service instructions for the centrifuge and microscope utilized for urine microscopic testing procedures. 2. Review of the laboratory's "Drs. Levine, Reigle, and Schneider Daily CLIA requirements-Mayfield Heights" worksheet found a section labeled and documented as the following: "Microscope: Daily cleaning (wipe down with clean dry cloth) yes" 3. The Inspector requested the laboratory's maintenance and service policies and procedures for the centrifuge and microscope utilized for urine microscopic testing procedures as well as their 2022, 2023 and 2024 service documentation from the OM and LMA. The OM and LMA confirmed the laboratory did not establish any policies and procedures for maintenance and service of the centrifuge and microscope and did not perform and document any service activities since 07/08/2022. The interviews occurred on 04/10 /2024 at 2:18 PM. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to provide overall management and direction in accordance with 493.1407 of this subpart for urine microscopic testing procedures in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. The Laboratory Director failed to ensure that the laboratory was enrolled in an HHS approved proficiency testing (PT) program for the urine microscopic testing procedures performed in the subspecialty of Urinalysis. (Refer to D6015) 2. The Laboratory Director failed to ensure that a quality control (QC) program was -- 2 of 6 -- established and maintained to assure the quality of urine microscopic testing procedures performed in the subspecialty of Urinalysis. (Refer to D6020) 3. The Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of urine microscopic testing procedures performed in the subspecialty of Urinalysis. (Refer to D6021) 4. The Laboratory Director failed to ensure that final test reports included all of the pertinent information required for interpretation of urine microscopic testing procedures performed in the subspecialty of Urinalysis. (Refer to D6026) 5. The Laboratory Director failed to ensure that four out of four testing personnel (TP) who conducted all phases of urine microscopic testing were competent and maintained their competence to perform and report accurate and reliable test results promptly and proficiently in the subspecialty of Urinalysis. (Refer to D6030) 6. The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the urine microscopic testing procedures performed in the subspecialty of Urinalysis. (Refer to D6031) D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that the laboratory was enrolled in an HHS approved proficiency testing (PT) program for the urine microscopic testing procedures performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of urine microscopic PT procedures. 2. The Inspector requested the laboratory's approved PT policies and procedures, PT enrollment documentation and 2022, 2023 and 2024 PT documentation for urine microscopic testing from the OM and LMA. The OM and LMA confirmed the laboratory did not establish any PT policy and procedure, was not enrolled with a PT provider and did not perform and document any PT activities for urine microscopic testing. The interviews occurred on 04/10/2024 at 2:10 PM. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that a quality control (QC) program was established and maintained to assure the quality of urine microscopic testing procedures performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of urine microscopic QC procedures. 2. Review of the laboratory's "Drs. Levine, Reigle, and Schneider Daily CLIA requirements-Mayfield Heights" worksheet found a section labeled and documented as the following: "Urine Sediment: Daily quality control performed: yes Testing Personnel #1(initials and result): 'TP1' Testing Personnel #2 (initials and result): 'TP1' (Testing Personnel #1 and #2 may be the same if only one physician in office that day)" 3. The Inspector requested the laboratory's approved QC policy and procedure and 2022, 2023 and 2024 QC documentation for urine microscopic testing from the OM and LMA. The OM and LMA stated the providers were instructed how to document the QC on this worksheet, however they did not perform any actual QC testing. The OM and LMA confirmed the laboratory did not establish any QC policy and procedure and did not perform any actual QC activities for urine microscopic testing. The interviews occurred on 04/10/2024 at 2:35 PM. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that a quality assessment (QA) program was established and maintained to assure the quality of urine microscopic testing procedures performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of urine microscopic QA procedures. 2. The Inspector requested the laboratory's approved QA policy and procedure and 2022, 2023 and 2024 QA documentation for urine microscopic testing from the OM and LMA. The OM and LMA confirmed the laboratory did not establish any QA policy and procedure and did not perform any QA activities for urine microscopic testing in 2022, 2023 and 2024 to current date. The interviews occurred on 04/10/2024 at 2:13 PM. -- 4 of 6 -- D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that final test reports included all of the pertinent information required for interpretation of urine microscopic testing procedures performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect two out of five of the reviewed patient urine microscopic final test reports from 01/10/2023 through 01/23/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the Laboratory Director and provided on the date of the inspection, did not find any mention of urine microscopic test ordering and resulting procedures. 2. Review of five of the laboratory's final test reports for urine microscopic testing revealed the following: Date Test Microscopic Tested Ordered Results Reported 1/10/23 w/microscopy no 4/5/23 w/microscopy no 7/11/23 w/microscopy yes 10/19/23 w/microscopy yes 1/23/24 w/microscopy yes 3. The Inspector requested the laboratory's approved policy and procedure for urine microscopic test ordering and resulting procedures from the OM and LMA. The OM and LMA confirmed the laboratory did not establish any policy and procedure for urine microscopic ordering and resulting. The OM and LMA also confirmed that two out of five test reports reviewed had "UA dip stick/reagent auto w/microscopy" ordered, however the microscopy results were not reported on the final test report. The interviews occurred on 04/10/2024 at 3:15 PM. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that four out of four testing personnel (TP) who conducted all phases of urine microscopic testing were competent and maintained their competence to perform and report accurate and -- 5 of 6 -- reliable test results promptly and proficiently in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, unapproved by the current Laboratory Director and provided on the date of the inspection, revealed a policy and procedure titled "Personnel Competency Assessment - Microscopic Urine CLIA PPMP Moderate Complexity" and found instructions to assess the competence of testing personnel "... every six months for the first year and then annually thereafter." 2. Review of the laboratory's CMS-209, provided on the date of the inspection found four individuals listed and credentialed to perform moderately complex urine microscopic testing procedures. 3. The Inspector requested the laboratory's 2022, 2023 and 2024 competency assessment documentation for TP#1, TP#2, TP#3 and TP#4 for the urine microscopic testing procedures performed from the OM and LMA. The OM and LMA confirmed the laboratory did not assess the competencies of TP#1, TP#2, TP#3 and TP#4 in 2022, 2023 and 2024, as required and per their established policy and procedure for urine microscopic testing procedures and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 04 /10/2024 at 1:34 PM. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interviews with the Office Manager (OM) and Lead Medical Assistant (LMA), the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the urine microscopic testing procedures performed in the subspecialty of Urinalysis. This deficient practice had the potential to affect 17,200 out of 17,200 patient urine microscopic tests performed in this laboratory from 05/11/2022 through 04/10/2024. Findings Include: 1. Review of the laboratory's "Levine, Reigle, Schneider, & Davili, Inc." policy and procedure manual, provided on the date of the inspection, found it to be unapproved by the current Laboratory Director and lacked urine microscopic policies and procedures with regard to ordering, testing and resulting, equipment maintenance, quality control, proficiency testing and quality assessment. 2. The Inspector requested the laboratory's policies and procedures, approved by the current Laboratory Director, to include all aspects of urine microscopic testing from the OM and LMA. The OM and LMA confirmed the laboratory was lacking several required policies and procedures, the current Laboratory Director did not approve any policy and procedure for any aspect of urine microscopic testing procedures and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 04/10/2024 at 1:03 PM. -- 6 of 6 --

Summary Statement of Deficiencies D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the Laboratory Director (LD) failed to ensure that an approved procedure manual was available to all personnel responsible for the urine microscopic procedures performed in the specialty of Chemistry. All 1544 patient urine microscopic procedures performed from 03/31/2021 to 05/11/2022 had the potential to be affected by this deficient practices. Findings Include: 1. Review of the laboratory's CMS-209 forms found 4 individuals credentialed by the LD, by signature and date, as TP to perform moderate complexity urine microscopic examination. 2. Review of the laboratory's CMS-116 form found the annual volume of urine microscopic examinations under the speciality of chemistry to be 5,115 total tests. 3. The Inspector requested the laboratory's approved urine microscopic policies and procedures on the date of inspection, 05/11/2022. 4. An interview with TP #1, on 05/11/2022 at 2:12 PM confirmed that the urine microscopic policy and procedure manual could not be found. Note: Past CLIA surveys in 2018 and 2020 found an approved urine microscopic policy and procedure manual that complied with the applicable CLIA regulations. 5. An interview with TP #1 via video phone call on 05/18/2022 at 1:36 PM confirmed that the urine microscopic policy and procedure manual was found; however, the manual was unapproved by the current LD, who took over that regulatory role as of 03/31/2021. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --