Alfred B Rosenstein Md

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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Association of Bioanalysts (AAB) PT program, the laboratory failed to successfully participate in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA (D2130). D2121 HEMATOLOGY CFR(s): 493.851(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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Association of Bioanalysts (AAB) PT program, the laboratory failed to attain a score of 80% for each analyte in the AAB PT program for hematology testing. The following analyte was noted as failed in the 2020 1st event. Findings: 1. AAB 2020 1st event White Blood Cells 60% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Association of Bioanalysts (AAB) PT program, the laboratory failed to achieve satisfactory performance for the same analyte in 2 consecutive hematology testing events. The following analyte was noted as failed in the 2020 2nd and 3rd events. Findings: 1. AAB 2020 2nd event Cell Identification or White Blood Cell Differential 60% 2. AAB 2020 3rd event Cell Identification or White Blood Cell Differential 73% 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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the American Association of Bioanalysts (AAB) PT program, the laboratory director failed to ensure that the laboratory successfully participated in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA (D6019). D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, interview with the testing person, and the technical consultant, the laboratory did have all documents obtained during proficiency testing (PT). Findings: 1. American Association of Bioanalysts 2019 1st event hematology, the laboratory did not have the attestation nor the raw data. 2. American Association of Bioanalysts 2018 3rd event microbiology and hematology, the laboratory did not have the attestation nor the raw data. 3. American Association of Bioanalysts 2018 2nd event microbiology and hematology , the laboratory did not have the attestation nor the raw data. 4. American Association of Bioanalysts 2017 3rd event microbiology, the laboratory did not have the attestation. 5. American Association of Bioanalysts 2017 2nd event hematology, the laboratory did not have the attestation nor the raw data. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- (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 review of proficiency testing data, interview with the technical consultant and the testing person, the laboratory failed to successfully participate in the American Associates of Bioanalyst program for hematology testing, in which the laboratory is certified under CLIA. Findings: The laboratory failed the American Association of Bioanalysts 2019 1st event microbiology score 40%. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the written procedure manual, interview with the technical consultant (TC), and the testing person (TP), the laboratory did not have written procedures for all examinations performed by laboratory personnel. Findings: 1. The laboratory did not have step by step instructions for TP to follow for holding patient specimens when the hematology analyzer did not meet the laboratory's criteria of acceptability. 2. January 23, 2019 the hematology analyzer startup failed 18 times. The analyzer print out displayed " start up failed, check reagents" service was scheduled and patient testing was not performed. 3. The TP stated that patient samples were held until the analyzer was functioning properly and testing was resumed when service was performed by the manufacturer the next day on 1/24/19. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on review of the hematology quality control (QC) results, interview with the testing person (TP), and the technical consultant (TC), the laboratory did not ensure that hematology QC meet the laboratory's criteria of acceptability prior to performing testing patients. Findings: 1. The hematology "Quality Control" procedure states that controls must be acceptable and in range prior to patient results released and if controls are out of range start troubleshooting procedures. Steps include remix the QC, ensure that QC is not expired and rerun, open new QC if values are still unacceptable, perform a cleaning of the analyzer and rerun QC, contact the TC, and when needed if QC is still unacceptable contact technical support. 2. March 7, 2019 the TP stated that she did not run QC. The QC was ran by the shared lab personnel. 3. March 5, 2019 the laboratory was unable to locate the low level QC. The TP stated that she was unsure if she ran QC on that day or if the shared lab personnel ran the QC. 4. January 22, 2019 the hematology analyzer failed the startup and QC was not ran. The LD approved for patient testing to be performed and results released. 5. January 26, 2018 all three levels of QC was not within acceptable range for hemoglobin. The TP did not run the QC. The QC was ran by the shared laboratory personnel. Troubleshooting procedures were not performed by the TP. 6. January 25, 2018 the TP did not run the QC. The QC was performed by the shared laboratory personnel. Two out of the three levels of QC was not within the acceptable range. Troubleshooting procedures were not performed by the TP. Patient testing was performed and results were released. 7. January 5, 2018 the TP did not run QC. The QC was ran by the shared lab personnel. The TP initialed the QC because she didn't know who performed the QC. 8. April 16, 2018 The TP did not run QC. The QC was ran by the shared lab personnel. Two out of three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. Patient testing was performed and results released. 9. April 10, 2018 two out of three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. The LD approved the QC acceptable. Patients were tested and results released. 10. July 31, 2018 QC was not performed by the TP. The QC was performed by the shared lab personnel. The note on the printed QC record stated that the person running QC was not aware that when QC is out patient testing should not be performed. 11. July 23, 2018 two out of three levels QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. The LD approved the QC acceptable. Patients were tested and results released. 12. July 28 and 31, 2018 two of the three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. 13. July 21, 2018 the TP did not run QC. The QC was ran by the shared lab personnel. One out of the three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. Patient testing was performed and results released. 14. October 11, 2018 two out of three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. The LD approved the QC acceptable. Patients were tested and results released. 15. October 9, 2018 two out of three levels of QC was not within acceptable range. Troubleshooting procedures were not performed by the TP. The LD approved the QC acceptable. Patients were tested and results released. 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. -- 3 of 8 -- This CONDITION is not met as evidenced by: Based on review of proficiency testing records, interview with the testing person, and the technical consultant, the laboratory director failed to maintain all documents obtained during proficiency testing (Refer to D2015); And Based on review of the written procedure manual, interview with the technical consultant, and the testing person, the laboratory director failed to have written procedures for all examinations performed by laboratory personnel (Refer to D5401). D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require