Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of proficiency testing records and confirmed by laboratory personnel, identifier #4 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 1/20/2021, the laboratory failed to enroll in a proficiency testing program for the anlaytes: erythrocyte count, hematocrit, hemoglobin, leukocyte count, platelet count, and automated white blood cell differentials in 2021. The findings include: 1. The laboratory began performing erythrocyte count, hematocrit, hemoglobin, leukocyte count, platelet count, and automated white blood cell differential on 1/7/2021. 2. At the time of the survey, the laboratory did not have proficiency testing records or a confirmation of PT enrollment for the listed analytes. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- This STANDARD is not met as evidenced by: Based on lack of Cell-Dyn Emerald instrument printouts, review of patient test reports, and confirmed by laboratory personnel identifier #4 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 1/20/2021, the laboratory failed to retain the Cell-Dyn Emerald complete blood cell (CBC) instrument printouts for three out of three patients from 1/7/2021 - 1/20/2021. The findings include: 1. Patient A had a CBC performed on 1/10/2021. 2. Patient B had a CBC performed on 1/13/2021. 3. Patient C had a CBC performed on 1/14/2021. 4. The laboratory manually entered the CBC results from the Cell-Dyn Emerald instrument printout into the Laboratory Information System (LIS). The laboratory shredded the Cell-Dyn Emerald instrument printouts after entering patient results into the LIS. 5. At the time of the survey, the laboratory did not have the CBC Cell-Dyn Emerald instrument printouts for patient identifiers A, B and C. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observations made at the time of the survey; lack of Cell-Dyn Emerald instrument printouts and performance specification records; review of Form CMS-116 Clinical Laboratory Improvement Amendments Application for Certification, patient test reports, the Laboratory Procedure Manual, temperature records, Cell-Dyn 18 Plus quality control assay sheets and background checks; and confirmed by laboratory personnel identifier #4 (refer to the Laboratory Personnel Report); the laboratory failed to meet hematology requirements for: establishing procedures for specimen labeling as specified in standard D5311; establishing procedures for defining critical values and the course of action to take when a test system becomes inoperable as specified in standard D5403; ensuring the laboratory director approves, signs and dates the procedure manual as specified in standard D5407; monitoring temperature storage of quality control and calibration materials as specified in the standard D5413; documenting quality control expiration dates as specified in standard D5415; verifying performance specifications as specified in D5421; documenting function checks as specified in the standard D5431; and ensuring the test report indicates the name and address of the testing facility as specified in the standard D5805. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: -- 2 of 14 -- Based on review of the Laboratory Procedure Manual and confirmed by laboratory personnel identifier #4 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 1/20/2021, the laboratory failed to have a written policy that included the process for labeling specimens, including patient name or unique patient identifier and, when appropriate, specimen source. At the time of the survey, the specimen collection policy did not include specimen labeling criteria. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)