Summary:
Summary Statement of Deficiencies 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 review of laboratory records and interview with the laboratory director (LD); the laboratory failed to establish policies and procedures to assess competency for personnel involved in microbiology testing. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of all personnel involved in dermatophyte test medium (DTM) cultures and potassium hydroxide (KOH) preparations. 2. On survey date 08-22-2019 at 3:30 pm, the LD confirmed the laboratory failed to establish a competency assessment policy for personnel involved in microbiology testing. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 review of laboratory records and interview with the laboratory director (LD); the laboratory's test reports failed to indicate the name and address where testing was performed for 5 of 5 pathology test reports reviewed. Findings Include: 1. Review of 5 of 5 patient test reports (Patient Identifiers: P6, P7, P8, P9, P10) for pathology testing failed to indicate the following: a. The name and address of the laboratory location where the grossing and interpretation of pathology slides was performed. 2. During survey date on 8-22-2019, at 3:30 pm, the above findings were confirmed by the LD. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the technical consultant (TC) failed to ensure competency of testing personnel (TP) was complete in 2017 through the date of survey in 2019 for 4 of 4 moderate complexity testing personnel listed on the CMS-209 (Laboratory Personnel Report). Findings Include: 1. Review of the laboratory's policy and procedure manual failed to identify a competency assessment policy for personnel performing dermatophyte test medium (DTM) cultures and potassium hydroxide (KOH) preparations. See D5209. 2. Review of the laboratory manual found copies of a form titled, "Competency Assessment By Direct Observation", which had been partially completed. The form identified the procedures DTM cultures and KOH preparations and indicated that performance was acceptable and the employee was competent to perform the procedures, however the space for employee name was left blank. 3. Review of competency assessment records found the partially completed form, "Competency Assessment By Direct Observation" used for the competency assessments for 3 of the testing personnel (TP#5, TP#7, and TP#8), listed on the CMS-209 laboratory personnel report in 2017, 2018, and 2019. 4. Further review of the competency assessment records in 2017, 2018 and 2019 revealed that the competency assessments for DTM cultures and KOH preparations failed to address the follow: a. Monitoring the recording and reporting of test results. b. Review of intermediate test results or worksheets, quality control records, proficiency testing records, and preventative maintenance records. c. Assessment of test performance through internal blind samples or proficiency testing samples. d. Assessment of problem solving skills 5. Review of competency assessment records found no competency assessments were completed for TP#6. 6. On survey date 8-22-2018, at 3:30 pm the LD confirmed the direct observation competency assessment form had been filled out prior to the competency assessments of TP#5, TP#7, and TP#8 in 2017 through 2019 and failed to cover all six elements of competency. Additionally, no competency assessments had been completed for TP#6. 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. -- 2 of 4 -- 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to employ testing personnel (TP) who meet the qualification requirements of 493.1423. Findings Include: 1. TP#6, as listed on the CMS-209 (Laboratory Personnel Report), failed to have documented training prior to analyzing patient specimens for moderate complexity dermatophyte test medium (DTM) cultures. See D6066. 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: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to have training documentation for 1 of 1 new moderate complexity testing personnel (TP) performing dermatophyte test medium cultures (DTM) prior to patient testing. Findings Include: 1. Review of laboratory personnel records found no training documentation for TP#6, as listed on the CMS-209 (Laboratory Personnel Report) prior to analyzing patient specimens for dermatophyte test medium (DTM) cultures. 2. On survey date 08-22-2019, at 3:30 pm, the LD confirmed the laboratory failed to have training documentation for TP#6 prior to analyzing patient specimens. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require