Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with the technical consultant, the individual testing the hematology proficiency test samples and the laboratory director did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings: 1. The attestation statements for proficiency test events were not completed by the testing person and the laboratory director; 2. the second event of 2018 for the complete blood count event was not signed by the testing person and the laboratory director; 3. the second event of 2017 for the complete blood count event was not signed by the testing person and the laboratory director; 4. The first event of 2017 for the complete blood count event was not signed by the testing person and the laboratory director; 5. These findings were confirmed with the technical consultant 2:00 pm on the day of survey. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 test records at the time of survey, the laboratory failed to successfully participate in the proficiency testing program for the hematocrit analyte. The lab obtained a failure of two events out of three proficiency test events. The lab obtained a score of 40% for the non-waived hematocrit on the second event in 2018 and The lab obtained a score of 60% for the non-waived hematocrit on the first event in 2018. 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 proficiency test records at the time of survey, the laboratory failed to acheive satisfactory performance for the hematocrit analyte in two consecutive events. The lab obtained a score of 40% for the non-waived hematocrit on the second event in 2018 and The lab obtained a score of 60% for the non-waived hematocrit on the first event in 2018. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on interview with lab staff, on the day of survey, when asked about safety data sheets, the technical consultant stated that the lab had not ensured safety data sheets are updated to include the current reagents in use. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with lab staff, the laboratory (lab) did not review the results obtained on the hematology proficiency testing. Findings: 1. The lab did not review the results obtained on the hematology proficiency test events for the first, second and third events in 2017. The lab director did not review, sign and date his review of the test event results; and 2. This was confirmed with the technical consultant at 2:00 pm on the day of survey. D5783