Summary:
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 surveyor's review of the laboratory's available quality control records and confirmed in an interview with the laboratory director, the laboratory failed to have complete quality control (QC) records available for the Coulter AcT Diff hematology analyzer. Findings: The Laboratory Director confirmed, on October 30, 2018 at approximately 9:30 AM, the surveyor findings that QC records for the Coulter AcT Diff were not available from January 2017 through December 2017. Approximately 50 patient specimens were tested and reported for hematology during the above time frame. PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON DECEMBER 29, 2016. 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. This STANDARD is not met as evidenced by: Based on the surveyor's review of American Academy of Family Physicians (AAFP) Proficiency Testing (PT) reports and an interview with the laboratory director/testing person, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2017 second event: Red Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- blood cells (RBC) = 60% Hematocrit (HCT) = 80% White Blood Cells (WBC) = 80% 2017 third event: RBC = 80% Cell ID = 93% HCT = 80% Hemoglobin (HGB) = 60% WBC = 20% Monocytes = 80% 2018 first event: Cell ID = 93% Lymphocytes = 80% 2018 second event: HGB = 80% PLEASE NOTE: THIS IS A RECITE FROM THE SURVEY CONDUCTED ON DECEMBER 29, 2016. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of policies and procedures and confirmed in an interview with the laboratory director/testing person at the time of this survey, the laboratory failed to establish and follow a written Quality Assessment (QA) policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor's review of records and an interview with the technical consultant, the laboratory failed to: 1. Ensure that the laboratory discontinued the use of expired QC materials. Refer to D5417; 2. Perform and document calibration for hematology. Refer to D5437; 3. Ensure that hematology QC test results were within acceptable range prior to testing patient specimens. Refer to D5481; 4. Ensure that