Eastern Ct Hematology & Oncology Associates

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Eastern CT Hematology & Oncology Associates laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 proficiency testing (PT) data report (Report 155) and graded results from, American Proficiency Institute (API), the laboratory failed to successfully participate for the regulated analyte sodium. The laboratory had unsatisfactory scores for the 3rd event 2018, the 2nd event 2019, the 1st event 2020 and the 2nd event 2020. See 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 review of data from proficiency test (PT) reports and the laboratory's PT results from American Proficiency Institute (API) and phone interviews with the practice manager, the laboratory failed to achieve satisfactory performance for the sodium analyte in the subspecialty of routine chemistry and has sustained a subsequent occurrences of unsuccessful participation in PT. Findings include: 1. The laboratory obtained an unsatisfactory score of 60% for the sodium analyte in the third event of 2018. 2. The laboratory obtained an unsatisfactory score of 40% for the sodium analyte in the second event of 2019. 3. The laboratory obtained an unsatisfactory score of 60% for the sodium analyte in the first event of 2020. 4. The laboratory obtained an unsatisfactory score of 60% for the sodium analyte in the second event of 2020. 5. Staff interview with the practice manager on 6/4/2020 at 4:10 PM confirmed the laboratory failed to achieve satisfactory performance for the sodium analyte in the third event 2018, the second event for 2019 and the first event 2020. 6. Staff interview with the laboratory director (LD) on 9/29/2020 at 12:15 PM confirmed the laboratory failed to achieve satisfactory performance for the sodium analyte in the third event 2018, the second event for 2019, the first event 2020 and the second event 2020. The LD indicated the laboratory stopped performing patient testing for sodium on June 5, 2020. 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 proficiency testing (PT) data report (Report 155) and calendar years 2018, 2019 and 2020 of the American Proficiency Institute PT results ( 6 testing events), the laboratory director failed to ensure effective remedial action was instituted in response to unsatisfactory PT results resulting in the third unsuccessful performance for the regulated analyte sodium. Refer to D2016 and D2096. -- 2 of 2 --

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate or take remedial action when unacceptable Proficiency Testing (PT) scores are received. Findings include: 1. Record review on 12/6/19 of the laboratory's American Proficiency Institute (API) PT records revealed: a. Unacceptable chloride test results for 2018 events 1 and 3 and 2019 event 2. b. Unacceptable calcium test results for 2018 event 2 and 2019 event 1. c. Unacceptable alanine aminotransferase test results for 2018 event 3. d. Remedial action was not taken or documented for the above unacceptable PT events. e. The PT events were signed as reviewed by the laboratory director. 2. Record review on 12/6/19 of the laboratory's 'Proficiency Testing' procedure revealed, "Unacceptable PT result - In the event that a result is returned with an unacceptable grade, the API checklist for

Summary Statement of Deficiencies D0000 A proficiency testing (PT) desk review of the Eastern CT Hematology & Oncology Associates Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 proficiency testing (PT) record review, the laboratory failed to successfully perform in two consecutive testing events in the specialty of chemistry for the regulated analyte sodium (Na). Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report on 8/12/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores 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 -- for two out of three consecutive PT events for analyte # 0475 'Na' as follows: Year /Event # Score 2018 Event - 3 60% 2019 Event - 2 40% 2. Record review of the American Proficiency Institute (API) PT results on 8/15/19 confirmed the above unsatisfactory scores. Refer to citation tag: D2096. 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 Proficiency Testing (PT) record review the laboratory failed to achieve successful performance for the same analyte in two out of three consecutive PT events in the specialty of chemistry. Findings include: 1. Record review of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report on 8/12/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for two out of three consecutive PT events for analyte # 0475 sodium (Na) as follows: Year/Event # PT Score 2018 - Event 3 60% 2019 - Event 2 40% 2. Record review of the American Proficiency Institute (API) PT results on 8/15/19 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores in two out of three consecutive PT events as evidenced below. Year/Event # PT score 2018 - Event -3 60% 2019 - Event -2 40% 3. This is the first unsuccessful performance for the regulated analyte Na. 4. The laboratory performs 142,702 comprehensive metabolic panel tests annually in the specialty of chemistry. -- 2 of 2 --