Summary:
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 staff interview, the laboratory failed to successfully participate in a hematology proficiency testing (PT)program in 2020. Findings include: 1) The laboratory failed to achieve satisfactory scores in two of three PT events in 2020 for complete blood count analytes resulting in unsuccessful participation. Refer to tag D2130. 2) The laboratory failed to obtain an overall hematology specialty testing event score of satisfactory performance in two consecutive events in 2020. Refer to tag D2131 D2130 HEMATOLOGY 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 -- 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 record review and staff interview, the laboratory failed to achieve satisfactory performance for all analytes included in a complete blood count (CBC) in two of three proficiency testing (PT) events in 2020. Findings include: 1) Review on 1 /6/2021 of CLIA CASPER Report 0155D Individual Laboratory Profile revealed an unsatisfactory score of 0% in American Proficiency Institute (API) events 2 and 3 in 2020 for all six CBC analytes (white blood count, red blood count, hemoglobin, hematocrit, platelet count and white blood cell differential). 2) Review on 1/6/2021 of API 2020 Hematology / Coagulation - 2nd and 3rd Events revealed the laboratory failed to participate in the CBC PT event resulting in an unsatisfactory score of 0% for all six CBC analytes in those events. 3) Interview by phone on 1/6/2021 at 10:15 a.m. with the Laboratory Director confirmed the laboratory failed to participate in API PT events 2 and 3 for CBC testing in 2020. D2131 HEMATOLOGY CFR(s): 493.851(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 record review and staff interview, the laboratory failed to obtain an overall hematology testing event score of satisfactory performance in two consecutive events in 2020 resulting in unsuccessful performance. Findings include: 1) Review on 1/6 /2021 of CLIA CASPER Report 0155D Individual Laboratory Profile revealed an unsatisfactory score of 0% in American Proficiency Institute (API) events 2 and 3 in 2020 for the hematology specialty. 2) Review on 1/6/2021 of API 2020 Hematology / Coagulation - 2nd and 3rd Events revealed the laboratory failed to participate in the PT event resulting in an unsatisfactory score of 0% for the hematology specialty. 3) Interview by phone on 1/6/2021 at 10:15 a.m. with the Laboratory Director confirmed the laboratory failed to participate in API PT events 2 and 3 for the hematology specialty in 2020. -- 2 of 2 --