Summary:
Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to submit the College of American Pathologists (CAP) Hematology with Auto Differential PT results for event FH13-B 2018 on time. The TP # 1 listed on the CMS form 209 confirmed on 1/8/19 at 1:30 pm that the above results were not returned to the provider in required time frame . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: a. Based on surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow the instructions on the CA form to correctly assess CA on three of three testing personnel in 2017. The findings include: 1. The laboratory failed to use the Competency Evaluation Tools listed on the CA form. 2. The TP #1 listed on CMS form 209 confirmed on 1/8/19 at 12:30 pm that CA form was not followed. b. Based on surveyor review of the CA records and interview with the TP, the laboratory failed to 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 -- establish and follow an accurate CA form in the calendar year 2018. The findings include: 1. The CA form did not include: a. Monitoring the reporting and recording results. b. Assessment of test performance. c. Assessment of problem solving skills. 2. The TP #1 listed on CMS form 209 confirmed on 1/8/19 at 12:35 pm that an accurate CA form was not established. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to review and evaluate PT results obtained from the College of American Pathologists (CAP) for Hematology with Auto Differential events performed in 2018. The findings include: 1. There was no evaluation documented when the laboratory received an exception code of 26 (Educational Challenge) for Blood Cell Identification in FH13-A and C. 2. There was no evaluation documented when the laboratory received an exception code of 26 (Educational Challenge) for nucleated Red Blood Cell (percent and absolute) in FH13- A and C. 3. The TP #1 listed on CMS form 209 confirmed on 1/8/19 at 1:45 pm that the laboratory did not review and evaluate all PT results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to establish a written procedure for verification of new controls used in Hematology tests from 2/3/17 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 1/8/19 at 1:50 pm a written procedure was not established. b) Based on surveyor review of the PM and interview with the TP, the laboratory failed to follow the procedure for Critical Values (CV) in August 2018. The finding includes: 1. The CV procedure stated "Notify the attending physician and document notification by writing CBC verified by repeat" but there was not documented evidence the PM was followed for four of four patients reviewed with CV. 2. The TP #1 listed on CMS form 209 confirmed on 1/8/19 at 2:10 pm the PM was not followed. c. Based on surveyor review of the PM and interview with the TP, the laboratory failed to follow the procedure for reviewing results with flags obtained on the Unicel DXH 600 analyzer used for Hematology testing in August 2018. The findings include: 1. A review of 11 patient results with flags revealed: a. "R" PM stated: Review result and parameter derived from from R flag cannot be recalculated until flag is edited. b. "c" PM stated: critical limit exceeded c. "a" PM stated: action -- 2 of 5 -- limit exceeded 2. There was no documented evidence of review of flags. 3. The TP # 1 listed on the CMS form 209 confirmed on 1/8/19 at 2:35 pm that the laboratory did not follow the procedure for result review. 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)