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 a review of the laboratory record and an interview with the laboratory supervisor/testing person, the laboratory failed to retain the printouts for the background check of the hematology analyzer. Findings Include: On May 14, 2019, at approximately 11:30 am, the laboratory supervisor/testing person confirmed that the laboratory failed to retain the background check reports for the hematology analyzer, Horiba Micros 60, from July 25, 2017, through the date of this survey. D5303 TEST REQUEST CFR(s): 493.1241(b) The laboratory may accept oral requests for laboratory tests if it solicits a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. This STANDARD is not met as evidenced by: Based on a review of electronic patient's records, and an interview with the laboratory supervisor/testing person, verbal requests are made for hematology, chemistry and endocrinology testing. Findings Include: On May 14, 2019, at approximately 10:45 am, it was confirmed by the laboratory supervisor/testing person that verbal requests 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 -- are made by the physicians for hematology, chemistry and endocrinology testing. A review of six electronic patient charts showed that four of six patient records failed to have written/electronic test orders added within 30 days of the oral request. -- 2 of 2 --