Indravadan K Shah 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) evaluation reports, the laboratory failed to maintain satisfactory performance in White Blood Cell Differential (WBC) for the 3rd event of 2018 and 2nd and 3rd events of 2019 resulting in the second unsuccessful performance occurrence. (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) performance summary, the laboratory failed to maintain satisfactory performance in White Blood Cell Differential (WBC) for the 3rd event of 2018 and 2nd and 3rd events of 2019 resulting in the second unsuccessful performance occurrence. The findings include: 1. Review of the CMS 153 & 155 report revealed a score of 0% for the 3rd event 2018, 73% for the 2nd event 2019 and a 20% for the 3rd event 2019. 2. Review of API performance summary revealed a score of 0% for the 3rd event 2018, 73% for the 2nd event 2019 and a 20% for the 3rd event 2019. 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 a review of the laboratory's unsatisfactory performance of proficiency testing (PT) second unsuccessful performance, the laboratory director failed to maintain satisfactory performance White Blood Cell Differential (WBC) for the 3rd event of 2018 and 2nd and 3rd events of 2019 resulting in the second unsuccessful performance occurrence. (Refer to D6004). D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 153 & 155 (CMS 153 & 155) and American Proficiency Testing (API) performance summary, the laboratory director failed to maintain satisfactory performance in White Blood Cell Differential (WBC) for the 3rd event of 2018 and 2nd and 3rd events of 2019 resulting in the second unsuccessful performance occurrence. The findings include: 1. Review of the CMS 153 & 155 -- 2 of 3 -- report revealed a score of 0% for the 3rd event 2018, 73% for the 2nd event 2019 and a 20% for the 3rd event 2019. 2. Review of API performance summary revealed a score of 0% for the 3rd event 2018, 73% for the 2nd event 2019 and a 20% for the 3rd event 2019. -- 3 of 3 --

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 a desk review of the Centers for Medicare and Medicaid Services CASPER report 155 & 153 (CMS 153&155) and the proficiency testing agency, American Proficiency Institute (API) perfromance summary determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology in event 3 in 2018 and event 1 in 2019 resulting in the first unsuccessful occurrence. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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: 1. Review of the CMS Casper 155 report revealed the following: 3rd event 2018 Cell I. D. or White Blood Cell (WBC) Diff, Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB, White Blood Cell (WBC) and Platelets (PLT) with a score of 0%. 2nd event 2019 Cell I. D. or White Blood Cell (WBC) Diff score of 73% Red Blood Cell (RBC) with a score of 60% Hematocrit (HCT) with a score of 60% Hemoglobin (HGB) with a score of 60% Platelets (PLT) with a score of 60% 2. Review of API performance summary revealed the following: 3rd event 2018 Cell I. D. or White Blood Cell (WBC) Diff, Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB, White Blood Cell (WBC) and Platelets (PLT) with a score of 0%. 2nd event 2019 Cell I. D. or White Blood Cell (WBC) Diff score of 73% Red Blood Cell (RBC) with a score of 60% Hematocrit (HCT) with a score of 60% Hemoglobin (HGB) with a score of 60% Platelets (PLT) with a score of 60% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of patient uric acid test records for 2017, lack of calibration records and an interview with the laboratory supervisor, the laboratory failed to retain chemistry calibration printouts for two (2) years. Findings include: 1. Review of one (1) of one patient chemistry uric acid test record disclosed that calibration printouts were not retained from September 19, 2017. 2. In an interview, on May 6, 2019, at 11: 45am, the laboratory supervisor confirmed that chemistry uric acid calibration printouts were not retained for 2 years as required. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Quality Assurance (QA) Plan, testing personnel records, and an interview with the Laboratory Supervisor, determined the laboratory failed to follow written policies to assess testing personnel competency annually for Complete Blood Counts (CBC's) and Routine Chemistry for 2017-19. The findings include: 1. A review of the QA Plan revealed that testing personnel competencies would be 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 -- assessed annually by the Laboratory Director. 2. A review of the personnel records revealed that testing personnel number 1-3 had competencies without the 6 minimum required areas documented for CBC testing and the wrong Chemistry analyzer (EON 300 vs the new Envoy 500+) for 2017-19. 3. An interview with the Laboratory Supervisor at approximately 10:15a.m. May 6, 2019 confirmed the laboratory failed to follow QA Plan for assessing annual competency for testing personnel number one through three for CBC and chemistry testing for the two year period. -- 2 of 2 --

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: ___________________________________ Chemistry: The laboratory failed to maintain satisfactory participation in two out of three events for the Sodium Analyte, resulting in the first unsuccessful proficiency testing (PT) participation for Sodium (Refer to D2089 and D2097). ___________________________________ D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in 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 2 -- score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: ___________________________________ Based on a desk review of the 2017 CMS CASPER Report 0155D and the Laboratory's 2017 PT (Proficiency Testing) records, the laboratory failed to participate in event two for Chemistry resulting in a 0% score for the Sodium Analyte. The findings include: 1. Review of the CASPER Report 0155D revealed 0% score for event two of 2017 for Sodium. 2. Review of the Laboratory's 2017 event two PT report revealed "Failure to Participate" resulting in a score of 0% for Sodium. ___________________________________ D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a desk review of the CMS 0155D report and the Laboratory's 2017 and 2018 PT program evaluations, the laboratory failed to maintain satisfactory performance for the Sodium Analyte, event two 2017 and event one 2018, resulting in the first unsuccessful participation for the Sodium Analyte. The findings include: 1. Review of the CMS 0155D report revealed the 2017 event two score as 0% for Sodium for "Failure to Participate" and the 2018 event one score as 60%. 2. Review of the laboratory's 2017 event two PT program evaluation report revealed "Failure to Participate", resulting in a score of 0%. 3. Review of the laboratory's 2018 event one PT program evaluation report revealed sample numbers CH-03 and CH04 with unacceptable grades for Sodium, resulting in a score of 60%. ___________________________________ -- 2 of 2 --