Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.801 Condition: Enrollment and Testing of Samples 493.1215 Condition: Hematology 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director 493.1409 Condition: Laboratories performing moderate complexity testing; Technical Consultant 493.1421 Condition: Laboratories performing moderate complexity testing; Testing Personnel 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 a review of the laboratory testing records, CMS report 155, and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for each of the specialties and subspecialties for which it seeks certification (Hematology, Microbiology, and Urinalysis ). The findings included: 1. A review of facility records found no documentation of the laboratory being enrolled in or participating in a CMS approved proficiency testing program for Hematology in 2016, 2017 or 2018 . The laboratory tested 6312 patient specimens for Complete Blood Counts using the Coulter AcT 2 diff Hematology analyzer in between Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- September 26, 2016 and January 16, 2019. The laboratory failed to enroll in a CMS approved proficiency testing program for microbiology. The laboratory performed 82 patient tests annually in the specialty of microbiology according to the CMS 116 provided during the January 8, 2019 inspection. The Laboratory failed to enroll in a CMS a proficiency testing program for urinalysis. The laboratory performed 3084 urinalysis procedures according to the CMS 116 provided during the January 8, 2019 inspection. 2. Review of the CMS report 155 and report 153 found no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 3. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted on January 8, 2019 at 9:21 AM confirmed that the laboratory did not enroll in, or participate in a proficiency testing program for Hematology. 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: Review of personnel files, laboratory records, quality control records and interview of facility personnel found the laboratory failed to meet the requirements for the specialty of Hematology. Findings Included: 1. The laboratory failed to have a written policy to assess the competency of the technical consultant or testing personnel. (See D5209) 2. Laboratory failed to have a procedure available to testing personnel that had been approved signed and dated by the current laboratory director. (See D5401, D5403) 3. The laboratory failed to define and monitor the proper temperature and humidity consistent with the manufacturers' instructions for operation of the Coulter AcT 2 diff Hematology Analyzer . (See D5413) 4. The laboratory failed to verify the accuracy, precision, reportable ranges and reference intervals used for the Coulter AcT 2 diff Hematology Analyzer. (see D 5421) 5. The Laboratory failed to perform and document all maintenance procedures for the Coulter AcT 2 diff Hematology Analyzer. (See D5429) 6. The Laboratory failed to have a procedure for the performance of calibration procedures for the Coulter AcT2 diff Hematology Analyzer. (See D5437) 6.The Laboratory failed to establish and maintain a quality control program for the Coulter AcT 2 diff Hematology Analyzer. (See D5441) 7. The laboratory failed to verify or establish its own mean and limits when using the Coulter 4C ES cell control to ensure the accuracy of results obtained on the Coulter AcT 2 diff hematology analyzer. (See D5469) 8. The laboratory failed to establish written policies and procedures (Quality Assurance) for an ongoing mechanism to monitor, assess and correct problems identified in the hematology analytic system for testing on the Cell Dyn Emerald Hematology Analyzer before, during and after verification in order to ensure accurate patient results. (See D5791) 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. -- 2 of 15 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted CMS form 209, policies and procedures, review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have a procedure for assessing the competency of all supervisors, consultants and testing personnel and no documentation of competency assessments performed for testing personnel. The findings included: 1. A review of the laboratory's submitted CMS form 209 found that the laboratory identified three testing personnel performing non-waived testing, and no technical consultant. 2. Review of policies and procedures found no procedure for assessing the competency of all supervisors, consultants and testing personnel. 3. A review of the laboratory's personnel records found no competency assessments performed for three of three testing personnel listed on the CMS form 209. 4. An interview with testing person one on the CMS report 209 Laboratory Personnel Report conducted on January 8, 2019 at 9:23 AM AM confirmed that the laboratory did not have a procedure for assessing the competency of all technical consultants and testing personnel. She went on to confirm that competency assessments had not been performed for three of three testing personnel. 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: Observations, review of the procedure manual, and interview of facility personnel found that the laboratory failed to have a written procedure available to all testing personnel for the use of the Coulter AcT 2 diff hematology analyzer. Findings included: 1. Observations made during the tour the facility found no operators manual or users guide for the Coulter AcT 2 diff hematology analyzer. 2. Review of procedures in the BSA FMC procedure manual found copies of pages from the Coulter AcT 2 diff Operators Guide as follows: pages 2-12 through 2-14 (Running Samples) page 3-1 Sample Requirements. Pages 2-8 through 2-13 (Entering Cell Control Information) Pages 2-14 through 2-15 (Update the Printer Information) 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on January 8, 2019 at 09:23 AM confirmed that the laboratory did not have an operators guide for the Coulter AcT2 diff hematology analyzer or any other procedures available to testing personnel for the operation of the instrument. 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 -- 3 of 15 -- 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)