Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records, manual, and an interview with the testing personnel (TP); the laboratory failed to test proficiency testing (PT) samples with the personnel who routinely perform the test in the laboratory, affecting 3 out 5 TP. Findings: 1. The CMS 209 lists 3 licensed practitioners and 2 licensed physicians performing Potassium Oxide (KOH) testing in the laboratory 2. For the years of 2017 through 2018, the PT records and patients' test logs revealed the following: a). The laboratory participated in 6 out of 6 PT events for KOH testing during this period. b). The PT signature statements attests that 2 TP of the 5 TP; ("TP- AA" listed on line 1 and "TP-7Z" listed on line 4); participated in the 6 PT events. c). The patients' test log show that all 5 TP were performing KOH testing during this period. d). No other documentation was provided as evidence that the remaining 3 TP (listed on lines 5 thru 7); had participated in any PT event since 2016. 3. On a Recertification survey conducted on 02/07/2019 at 12:30 PM, the TP confirmed the above findings. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's manuals, records, and an interview with the testing personnel (TP); the laboratory failed to establish written policies and procedures to assess employees performing Potassium Oxide (KOH) testing, affecting 5 out of 5 testing personnel (TP). Findings: 1. The CMS 209 lists 3 licensed practitioners and 2 licensed physicians performing KOH testing in the laboratory. 2. The personnel files revealed that 5 out of 5 TP had not received competencies for the years of 2017 thru 2018, but were performing patient testing during this period. 3. The laboratory's manual does not have an established competency policy and step-by-step procedure for TP performing KOH testing. 4. No documentation was provided as proof that the TP's competency had been assessed with a protocol that include these required criteria: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b). Monitoring the recording and reporting of test results (for example, recording patients and their results in the labs' test log and/or EMR system); c). If applicable, review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d). Direct observation of performance of instrument maintenance and function checks (i.e. microscope maintenance, etc.); e). Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f). Assessment of problem solving skills; and g). Evaluating and documenting the performance of individuals responsible for moderately complex testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually. 5. On a Recertification survey conducted on 02/07/2019 at 12:30 PM, the TP confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing (PT) reports, records, manual, and an interview with the testing personnel (TP); the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH) preparations it performs at least twice annually, affecting 50 patients' tests. Findings: 1. The laboratory participates in the American Proficiency Institute (API)-PT program for its KOH testing to fulfill the twice annual accuracy verification requirement for the procedure. 2. The scores received from API-PT for KOH testing are as follows: a). Event #1 of 2017, the KOH score received is '50%'; and b). Event #3 of 2017, the KOH score received is '0%'; 3. No documentation was provided as evidence that the laboratory chose another method to verify the accuracy of its KOH testing during the PT failure period. 4. The laboratory was performing KOH testing during the period when the accuracy of the KOH test had not been verified. 5. No documentation was presented as evidence that the laboratory evaluated or investigated the 2 PT failed events, and assessed if patients tested during this period were affected. 6. On a Recertification survey conducted on 02/07/2019 at 12:00 PM, the TP confirmed the above findings. -- 2 of 4 -- D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the testing personnel (TP), the laboratory failed to employ individuals who meet the qualification requirements of 493.1489 for high complexity testing. Finding: 1. The laboratory failed to ensure laboratory personnel meet the qualification requirements for performing highly complex testing in the specialty of Histopathology. See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard -- 3 of 4 -- laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the testing personnel (TP); the laboratory failed to ensure laboratory employees meet the qualification requirements for performing highly complex testing in the specialty of Histopathology. Findings: 1. The CMS 209 list 1 TP performing tissue grossing and processing for Mohs procedures (a high complexity test and procedure) in the laboratory. 2. The employee file of TP 'PK3', listed on line 3, included a Diploma from Everest College for Medical Assisting and a certificate of histotechnician training from the American Society for Mohs Surgery (ASMS) dated 11/11/2018. 3. No documentation (e.g., transcript) was provided to show that the education requirement) as defined 493.1489(b) (1) - (7) for high complexity TP was meet by TP-PK3. 4. On a Recertification survey conducted on 02 /07/2019 at 12:00 PM, the TP confirmed the above findings. -- 4 of 4 --