David R Mandel Md Inc

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 record review and an interview with the sole Testing Personnel (TP), the laboratory failed to successfully participate in a Proficiency Testing (PT) program for the urea testing performed under the subspecialty of routine chemistry. All patients who had urea testing in this laboratory from the first testing event of 2022 on 03/23 /2022 to 06/23/2022 had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to achieve a PT score of 80% (percent) for the analyte urea in the first and second PT events in 2022 in the specialty of Chemistry. (Refer to D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review and an interview with the sole Testing Personnel (TP), the laboratory failed to achieve a Proficiency Testing (PT) score of 80% (percent) for the analyte urea in the first and second PT events in 2022 in the specialty of Chemistry. All patients who had urea testing in this laboratory from the first testing event of 2022 on 03/23/2022 to 06/23/2022 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's 2022 College of American Pathologists (CAP) PT documentation revealed the analyte urea was scored of 20% for for the first testing event and 40% for the second testing event of 2022. 2. The TP confirmed the laboratory did not achieve satisfactory PT performance for the analyte urea in the first two consecutive testing events in 2022. The interview occurred on 08 /04/2022 at 1:27 PM. -- 2 of 2 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to attain a proficiency testing (PT) score of at least 80 percent of acceptable responses for the analyte Vitamin D (VitD) in the first testing event and for the analyte Complement (C3) in the third testing event of 2020 in the subspecialty of General Immunology. All patients tested for VitD between the first and second testing events of 2020 and for C3 between the third testing event of 2020 and the first testing event of 2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Quality Assessment" policy and procedure, provided on the date of the inspection and approved by the Laboratory Director via signature and date on 03/15/2011, found a section titled "Proficiency Testing" that revealed the following statement: "2. Unsatisfactory performance: a score of less than 80% for an analyte" 2. Review of the laboratory's 2020 and 2021 American Proficiency Institute (API) PT documentation, provided on the date of the inspection, revealed an analyte testing score of 50% for VitD in the first testing event and 60% for C3 in the third testing event of 2020. 3. The GS confirmed the laboratory did not achieve a PT analyte testing score of at least an 80% for VitD in the first testing event and for C3 in the third testing event of 2020. The interview occurred on 01/13/2022 at 10:15 AM. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to attain a proficiency testing (PT) score of at least 80% (percent) of acceptable responses for the analyte blood urea nitrogen (BUN) in the first testing event of 2021 in the subspecialty of Routine Chemistry. All patients tested for BUN between the first and second testing events of 2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Quality Assessment" policy and procedure, provided on the date of the inspection and approved by the Laboratory Director via signature and date on 03/15/2011, found a section titled "Proficiency Testing" that revealed the following statement: "2. Unsatisfactory performance: a score of less than 80% for an analyte" 2. Review of the laboratory's 2020 and 2021 American Proficiency Institute (API) PT documentation, provided on the date of the inspection, revealed an analyte testing score of 0% for BUN in the first testing event of 2021. 3. The GS confirmed the laboratory did not achieve a PT analyte testing score of at least an 80% for BUN in the first testing event of 2021 due to clerical errors. The interview occurred on 01/13/2022 at 10:15 AM. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to attain a proficiency testing (PT) score of at least 80 percent of acceptable responses for the analyte mean corpuscular hemoglobin (MCH) in the second testing event of 2021 in the specialty of Hematology. All patients tested for MCH between the second and third testing event of 2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Quality Assessment" policy and procedure, provided on the date of the inspection and approved by the Laboratory Director via signature and date on 03/15/2011, found a section titled "Proficiency Testing" that revealed the following statement: "2. Unsatisfactory performance: a score of less than 80% for an analyte" 2. Review of the laboratory's 2020 and 2021 American Proficiency Institute (API) PT documentation, provided on the date of the inspection, revealed an analyte testing score of 40% for MCH in the second testing event of 2021. 3. The GS confirmed the laboratory did not achieve a PT analyte testing score of at least an 80% for MCH in the second testing event of 2021. The interview occurred on 01/13/2022 at 10:15 AM. 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 -- 2 of 3 -- 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 General Supervisor (GS), the laboratory failed to consistently include the correct address of the laboratory location in which the laboratory testing was conducted on the final test report. This deficient practice had the potential to affect all patients tested at this laboratory location under the sub-specialties of General Immunology, Routine Chemistry and Hematology. Findings Include: 1. Review of 36 out of 36 of the laboratory's final patient test reports revealed six final test reports that did not indicate the correct address of the laboratory location in which laboratory testing was conducted. The six final test reports indicated the address of a second office location that has since closed on 01/01 /2022. 2. The GS confirmed the laboratory did not consistently indicate the correct address of the laboratory location in which the laboratory testing was conducted on the final patient test report. The interview occurred on 01/13/2022 at 10:45 AM. -- 3 of 3 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: **This is a repeat deficiency as cited on the 09/07/2017 CLIA inspection** Item 1: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to attain a proficiency testing (PT) score of at least 80 % (percent) of acceptable responses for the analyte albumin (Alb) which resulted in three out of five acceptable results or a score of 60 % for the third testing event of 2018. All patient Alb testing performed in this laboratory from June 2018 (last successful Alb score for the 2nd event 2018) through March 2019 (next successful Alb score for the 1st event 2019) had the potential to be affected by this unacceptable PT analyte score. Findings Include: 1. Review of the laboratory's 2018 and 2019 College of American Pathologists (CAP) PT documentation, provided on the date of the inspection, revealed an Alb analyte testing score of 60% for the third testing event of 2018. 2. Review of the laboratory's PT evaluation revealed the unacceptable results to be clerical errors with reporting the ALT results instead of the Alb results as listed below: PT Alb ALT Alb Result Expected Specimen Result Result Reported Result CHM-14 3.2 162.0 162.0 2.8-3.5 CHM-15 3.7 134.0 134.0 3.3-4.1 3. The GS confirmed the laboratory did not achieve a PT analyte testing score of at least 80% for Alb and stated their PT evaluation revealed their clerical error and the Alb results achieved were within CAP's expected range for the third testing event of 2018. The interview occurred on 08/19/2019 at 10:15 AM. Item 2: Based on record review and an interview with the General Supervisor (GS), the laboratory failed to attain a proficiency testing (PT) score of at least 80 % (percent) of acceptable responses for the analyte total bilirubin (Tbil) which resulted in two out of five acceptable results or 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 -- a score of 40 % for the second testing event of 2019. All patient Tbil testing performed in this laboratory from March 2019 (last successful Tbil score for the 1st event 2019) through date of inspection had the potential to be affected by this unacceptable PT analyte score. Findings Include: 1. Review of the laboratory's 2018 and 2019 College of American Pathologists (CAP) PT documentation, provided on the date of the inspection, revealed an analyte testing score of 40% for Tbil for the second testing event of 2019. 2. Review of the laboratory's PT evaluation revealed the unacceptable results and the evaluation of the re-run PT specimens as listed below: PT Tbil Result Tbil Expected Specimen Achieved/Reported Re-Run Result CHM-06 0.5 1.0 0.8-1.7 CHM-07 0.8 1.6 1.2-2.1 CHM-09 0.5 0.8 0.7-1.6 3. The GS confirmed the laboratory did not achieve a PT analyte testing score of at least 80% for Tbil for the second testing event of 2019 and stated their PT evaluation included a review of Tbil quality control and calibrations, a review of all patient Tbil testing and a review of the policies and procedures. The interview occurred on 08/19/2019 at 10:15 AM. -- 2 of 2 --