Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to attest that proficiency testing (PT) samples were performed in the same manner as patient specimens. Findings include: 1. Record review of the 2017 American Proficiency Institute Hematology/Coagulation Event 3 attestation page on 2/14/18 revealed the attestation page had the name of the LD printed in the signature section. 2. Staff interview with the lead laboratory tech and the center adminin on 2/14/18 at 12:30 PM confirmed the PT testing personnel printed the name of the LD in the LD attestation section and the LD did not sign the attestation page. 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: Based on record review and staff interview the laboratory failed to ensure moderate complexity testing personnel (MCTP)received the appropriate training and have demonstrated they can perform all testing operations reliably to provide and report accurate results. Findings include: 1. Record review of the Laboratory's, 'Laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Director: Duties and Responsibilities' policy on 2/14/18 revealed, "The laboratory director's duties include the following: a. Responsible for the employment of personnel who are qualified and competent to perform their assigned duties and annual evaluation and documentation of the performance of testing personnel. b. Responsible for the orientation and training of new employees. c. Responsible for assuring compliance with all applicable regulations. d. Ensure that the testing personnel are performing the test methods as required for accurate and reliable results. e. Ensure that prior to testing patient specimens, testing personnel receive the appropriate training for the type and complexity of testing to be performed. Testing personnel must demonstrate that they can perform reliably and provide and report accurate results." 2. Record review of the laboratory's Procedure Manual, 'Section II Personnel' policy on 2/14/18 revealed the following: a. "Employees will be evaluated on their knowledge of the training manual with a written examination. The examination will take place at the commencement of employment, at 6 months, and annually thereafter. b. Testing personnel will receive formal training on the operation of each laboratory instrument and procedure on commencement of employment. c. The laboratory director will evaluate testing personnel performance prior to the start of patient sample testing, at or before 6 months of commencement of employment and annually thereafter. An evaluation form for this purpose will cover compliance with standard operating procedures, competency in test performance and instrument maintenance and function checks and participation in proficiency testing when applicable. d. Annually, all laboratory employees will review the sections of the laboratory policy and procedure manual as they pertain to their duties. This review will be documented. " 3. Record review of the laboratory's 2017 and 2018 training records on 2/14/18 revealed the following: a. The laboratory did not have documentation for 4 of 4 MCTP's written examination as written in the above procedure. b. 2 of 4 MCTP did not have any training records before performing complete blood count (CBC) testing. c. 1 of 4 MCTP did not have completed training records before performing CBC's. d. 4 of 4 MCTP were not evaluated to assess their competency to perform CBC's prior to testing patient samples. 4. Record review of the laboratory's Procedure Manual, 'Laboratory Staff Attestation 2017' sheet on 2/14/18 revealed 1 of 4 testing personnel failed to sign indicating they have read the manual prior to testing patient samples. 5. Staff interview with the lead laboratory tech and the center admin on 2/14/18 at 11:30 AM confirmed the above findings. 6. The laboratory performs approximately 3,600 moderate complexity test per year in the specialty of hematology. 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 record review and staff interview the laboratory failed to review Proficiency Testing (PT) reports when results are received. Findings include: 1. Record review of the Laboratory's, 'Laboratory Director: Duties and Responsibilities' policy on 2/14/18 revealed, "The laboratory director's duties include the following: Review and sign the proficiency test reports and ensure the appropriate staff also reviews the reports to evaluate the laboratory performance and identify problems requiring