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: 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; laboratory director 493.1421 Condition: Laboratories Performing Moderate Complexity Testing;testing personnel D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The Laboratory Director failed to provide overall management and direction. THIS IS A REPEAT DEFICIENCY FROM THE JUNE 26, 2017 INSPECTION. 1. The laboratory director failed to ensure that all testing personnel received the appropriate training prior to testing patient specimens. (See D6029) 2. The laboratory director failed to ensure that all testing personnel were evaluated for competency semiannually during the first year of testing and annually every year thereafter. (See D6030) D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Review of the CMS report 209 Laboratory Personnel Report, personal records and interview facility personnel found that the laboratory director failed to ensure that one of four testing personnel had received the appropriate training prior to testing patient specimens for urinalysis sediment examination. (See D6066)THIS IS A REPEAT DEFICIENCY FROM THE JUNE 26, 2017 INSPECTION. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Review of the CMS report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that the laboratory director failed to ensure that four of four testing personnel were evaluated for competency in performing urine sediment microscopic examination, semiannually in the first year of testing and annually every year thereafter.THIS IS A REPEAT DEFICIENCY FROM THE JUNE 26, 2017 INSPECTION. Findings included: 1.Review of the CMS report 209 Laboratory Personnel Report found the laboratory designated four testing personnel performing moderate complexity procedures (urine sediment microscopic examination). 2. Review of personnel records found no documentation of semiannual competency assessments for testing persons one and two. Testing person one ( hired February 17, 2014) had no documentation of annual competency assessment for 2017, 2018 or 2019. Testing person two (hired February 4, 2008) had no documentation of annual competency assessment for 2017, 2018 or 2019. Testing person three (hired October 30, 2017) had no documentation of semiannual competency assessments in 2018. Testing person four (hired February 6, 2018) had no documentation of semiannual competency assessment for 2018. 3. Interview of the Laboratory Quality Manager conducted on February 19, 2019 at 3:10 PM confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: -- 2 of 3 -- Review of the CMS 209 Laboratory Personnel Report, testing personnel records and interview of facility personnel found the laboratory failed to ensure that one of four testing personnel had documentation of training for moderate complexity procedures (urine microscopic sediments examination) prior to testing patient specimens. (See D6066)THIS IS A REPEAT DEFICIENCY FROM THE JUNE 26, 2017 INSPECTION. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Review of the CMS report 209 Laboratory Personnel Report, personal records and interview facility personnel found that one of four testing personnel had no documentation of initial training prior to testing patient specimens for urine sediment microscopic examination.THIS IS A REPEAT DEFICIENCY FROM THE JUNE 26, 2017 INSPECTION. The findings included: 1. Review the CMS report 209 Laboratory Personnel Report found that the laboratory designated four testing personnel performing moderate complexity testing procedures (urine sediment microscopic examination). 2. Review of personnel files found no documentation of initial training for testing person three listed on the CMS report 209 Laboratory Personnel Report . 3. Interview of the laboratory, quality manager conducted on February 19, 2019 at 3:00 PM confirmed that there was no documentation of initial training other than the test given to testing personnel. -- 3 of 3 --