Aw Dermatopathology Service

Summary Statement of Deficiencies D0000 A Recertification survey was performed at AW Dermatopathology Service, CLIA ID 19D1016329, on June 18, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: Based on review of the laboratory's policies, personnel records, and interview with personnel, the Laboratory Director failed to ensure annual competency assessments for three (3) of five (5) testing personnel were performed in 2022 and 2023. Refer to D6128. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, personnel records, and interview with personnel, the Technical Supervisors failed to perform competency assessments annually in 2022 and 2023 for three (3) of five (5) testing personnel reviewed. Findings: 1. Review of the laboratory's "Assessing competency:Technician" policy revealed "The performance of a technician is evaluated at training, then by a semi- annual evaluation in the first year, and by annual evaluation in the following years." 2. Review of the laboratory's "Assessing competency: Pathologist" policy revealed "Additionally, the pathologists are evaluated yearly, specifically on documented incidence of medicolegal dispute and on any major discrepancies on diagnosis." 3. Review of personnel records revealed the annual competency assessments were not performed for the following personnel: Laboratory Director (pathologist): 2022 and 2023 Testing Personnel 1 (technician): 2022 Testing Personnel 2 (technician): 2022 4. In interview on June 18, 2024 at 9:40 am, Testing Personnel 1 confirmed the 2022 competency assessment for technicians was not performed. 5. In further interview on June 18, 2024 at 10:45 am, Testing Personnel 1 confirmed the laboratory did not have documentation of performance of an annual competency assessment for the Laboratory Director for 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on July 19, 2022 at AW Dermatopathology, CLIA ID # 19D1016329. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 the laboratory's policies, personnel records, CMS 209 form, and interview with personnel, the laboratory failed to establish written procedures to assess competency for one (1) of two (2) personnel serving as Clinical Consultant, Technical Supervisor, and General Supervisor. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) revealed the Laboratory Director and Clinical Consultant 2 served as Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. 2. In interview on July 19, 2022 at 9:59 am, Testing Personnel 1 stated Clinical Consultant 2 was hired on November 29, 2021. 3. Review of the laboratory's policies revealed the laboratory did not have a written policy related to competency assessments for personnel serving as Clinical Consultant, Technical Supervisor, and General Supervisor, including, frequency of performance. 4. Review of the personnel records for Clinical Consultant 2 revealed a competency assessment; however, it did not include assessment for their duties related to Clinical Consultant, Technical Supervisor, and General Supervisor. 5. In interview on July 19, 2022 at 9:59 am, Testing Personnel 1 confirmed the laboratory did not have competency assessments for the duties of Clinical Consultant, Technical Supervisor, and General Supervisor for Clinical Consultant 2. 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 -- D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Laboratory Director failed to ensure one (1) of five (5) Testing Personnel reviewed were approved to perform grossing of Histopathology samples. Findings: 1. In interview on July 19, 2022 at 9:59 am, Testing Personnel 1 stated Testing Personnel 3 was hired March 2021. 2. Review of personnel records for Testing Personnel 3 revealed an initial training was performed March 29, 2021; however, the laboratory did not have documentation of the Laboratory Director's approval/signature for patient testing. 3. In interview on July 19, 2022 at 9:59 am, Testing Personnel 1 confirmed the Laboratory Director did not approve/sign-off Testing Personnel 3 for testing after her initial training. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Findings: 1. The laboratory failed to establish written procedures to assess competency for one (1) of two (2) personnel serving as Clinical Consultant, Technical Supervisor, and General Supervisor. Refer to D5209. 2. The Technical Supervisor(s) failed to perform the semi-annual competency assessment for one (1) of five (5) testing personnel reviewed. Refer to D6127. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form, personnel records, and interview with personnel, the Technical Supervisor(s) failed to perform the semi-annual -- 2 of 3 -- competency assessment for one (1) of five (5) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the Laboratory Director and Clinical Consultant 2 serve as Technical Supervisors. 2. In interview on July 19, 2022 at 9:59 am, Testing Personnel 1 stated Testing Personnel 3 was hired March 2021. 3. Review of personnel records for Testing Personnel 3 revealed the competency assessment was performed at three (3) and six (6) months. The semi-annual competency assessment for Testing Personnel 3 was performed by Testing Personnel 2, not a Technical Supervisor. 4. In interview on July 19, 2022 at 9: 59 am, Testing Personnel 1 stated Testing Personnel 2 performed the semi-annual competency assessment for Testing Personnel 3. Testing Personnel 1 confirmed the semi-annual competency for Testing Personnel 3 was not performed by a Technical Supervisor. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed at AW Dermatopathology Service-CLIA # 19D1016329 on February 12, 2021. AW Dermatopathology Service was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1443 CONDITION: Laboratories Performing High Complexity Testing; Laboratory Director 42 CFR 493.1487 CONDITION: Laboratories Performing High Complexity Testing; Testing Personnel 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 the laboratory's competency assessment policy for testing personnel and interview with personnel, the laboratory failed to ensure the laboratory's competency assessment policy included frequency requirements. Findings: 1. Review of the laboratory's "Assessing competency: Technician" policy revealed the laboratory did not include semi-annual assessment as part of the frequency requirements of performance. 2. In interview on February 12, 2021 at 10:41 am, Testing Personnel 2 confirmed the laboratory's competency assessment policy for testing personnel did not include a semi-annual assessment. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. 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 CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. Findings: 1. The Laboratory Director failed to ensure all personnel had the appropriate education for performing high complexity testing. Refer to D6102. 2. The Laboratory Director failed to ensure policies and procedures for assessing personnel competency were complete. Refer to D6103. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must 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 perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure all personnel had the appropriate education for performing high complexity testing. Refer to D6171. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were complete. Refer to D5209. 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 record review and interview with personnel, the laboratory failed to provide documentation to ensure testing personnel met educational requirements for performing high complexity testing. Refer to D6171. -- 2 of 4 -- 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 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 -- 3 of 4 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the laboratory failed to provide documentation that one (1) of three (3) testing personnel met the educational qualifications for performing high complexity testing. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed the laboratory had three (3) testing personnel listed. 2. Review of personnel records for Testing Personnel 3 revealed the laboratory did not have documentation of education that met the minimum qualifications for high complexity testing. 3. In interview on February 12, 2021 at 10:03 am, Testing Personnel 3 confirmed she did not have documentation of education that met the minimum qualifications for high complexity testing. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on May 29, 2018 at AW Dermatopathology Service-CLIA ID # 19D1016329. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for the Clinical Consultant, Technical Supervisor, and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 1 and Personnel 2 serve as the laboratory's Clinical Consultants, Technical Supervisors, and General Supervisors. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Clinical Consultant, Technical Supervisor, and General Supervisor. 3. Review of personnel records for Personnel 2 revealed competency assessments for the duties of Clinical Consultant, Technical Supervisor, and General Supervisor were not performed. 4. In interview on May 29, 2018 at 10:07 am, Personnel 3 stated the laboratory did not perform competency assessments for Personnel 2's duties as Clinical Consultant, Technical Supervisor and General Supervisor. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to verify the accuracy of the performance of molecular testing at least twice annually. Findings: 1. Review of the laboratory's Task 1 and 3 form revealed the laboratory performs molecular testing for T-cell and B-cell rearrangements in skin specimens. 2. In interview on May 29, 2018 at 11:00 am, Personnel 3 stated the laboratory uses College of American Pathologists (CAP) to verify the accuracy of molecular testing twice a year. 3. Review of the laboratory's proficiency testing (PT) records for 2017 revealed the laboratory had enrolled in "Molecular Hematologic Oncology" with the College of American Pathologists (CAP). 4. Further review of the laboratory's 2017 College of American Pathologists (CAP) records revealed the laboratory performed one event for "Molecular Hematologic Oncology." 5. In interview on May 29, 2018 at 11:00 am, Personnel 3 further stated the laboratory performed one CAP survey in 2017. Personnel 3 confirmed the laboratory did not verify the accuracy of molecular testing at least twice annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY from survey date November 22, 2016*** Based on observation, record review and interview with personnel, the laboratory failed to ensure reagents were stored per manufacturer requirements. Findings: 1. Review of the manufacturer's instructions for reagents utilized in molecular testing revealed the following storage requirements: a) Applied Biosystems AmpliTaq Gold DNA Polymerase with Gold Buffer and MgCl2: Store -15 to -25 degrees Celsius b) Invivoscribe IGK Gene Clonality Assay Gel Detection: Store -65 to -85 degrees Celsius c) Invivoscribe TCRB and TCRG T-Cell Clonality Assay Gel Detection: Store -65 to -85 degrees Celsius d) Invivoscribe IGH Gene Clonality Assay Gel Detection: Store -65 to -85 degrees Celsius 2. Review of the "TCRG Gene Clonal Assay" procedure under "Storage Conditions" revealed "PCR master mixes are sensitive to freeze/thaw cycles. Therefore, for any duration other than immediate use, our master mixes and assay kits should be stored at -65 degrees Celsius to -85 degrees Celsius." 3. Review of the laboratory's "DNA and reagent storage conditions" policy revealed the following: a) "If there is a short term malfunction of the freezer identified (the content of the freezer is not melted), the condition of the DNA sample and reagents will be checked and documented. The reagents will be checked to make sure their activity is adequate. Otherwise the content of the freezer will be disposed." b) "The specimens may be transferred to Tulane University for storage if a predicted long term power outage or malfunction of the freezer will occur." 4. Observation during the laboratory tour on May 29, 2018 at 9:19 am revealed the following -- 2 of 5 -- reagents were stored in the So-Low Ultra Low Freezer at -38 degrees Celsius: a) Applied Biosystems AmpliTaq Gold DNA Polymerase with Gold Buffer and MgCl2 b) Invivoscribe IGK Gene Clonality Assay Gel Detection c) Invivoscribe TCRB and TCRG T-Cell Clonality Assay Gel Detection d) Invivoscribe IGH Gene Clonality Assay Gel Detection 5. In interview on May 29, 2018 at 9:28 am, Personnel 3 stated the -80 degrees Celsius freezer has been down for about a month. 6. Further observation during the laboratory tour on May 29, 2018 revealed no reagents were stored in the VIP Plus -80 degrees Celisus freezer. 7. In further interview on May 29, 2018 at 11:50 am, Personnel 3 stated the master mixes and quality controls for molecular testing are stored in the So-Low Ultra Low Freezer since the -80 degrees freezer has been broken. 8. Review of the 2018 temperature log for the VIP Plus -80 degrees Celsuis freezer revealed the laboratory documented the freezer as "at repair shop" as of March 15, 2018 through May 24, 2018. Further review of the temperature log revealed temperatures of -79 degrees Celsius documented as of May 25, 2018. 9. Review of the 2018 temperature log for the So-Low Ultra Low Freezer revealed the freezer had documented temperatures between -37 to -42 degrees Celsius since March 15, 2018. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY from survey date November 22, 2016*** Based on observation and interview with personnel, the laboratory failed to ensure reagents have not exceeded their expiration dates. Findings: 1. Observation by surveyor during laboratory tour on May 29, 2018 revealed the following expired item: Stored in Slo- Low Ultra freezer: a) Invivoscribe IGK Gene Clonality Assay Gel Detection, Lot # G0001134, Expiration Date: 2018-04, Quantity: one (1) box 2. In interview on May 29, 2018 at 9:31 am, Personnel 3 confirmed the identified item was expired. Personnel 3 stated the IGK kit was not used and unaware it was expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY from survey date November 22, 2016*** Based on observation, record review and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to verify the accuracy of the performance of molecular testing at least twice annually. Refer to D5217. 2. The laboratory failed to ensure reagents were stored per manufacturer requirements. Refer to D5413. 3. The laboratory failed to ensure reagents have not exceeded their expiration dates. Refer to D5417. D6103 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 5 -- CFR(s): 493.1445(e)(13) The laboratory director must 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: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D5209. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisors failed to ensure the procedures to assess personnel competency were complete. Findings: 1. Review of the laboratory CMS-209 (Laboratory Personnel Report) revealed the following testing personnel: Personnel 1 Personnel 2 Personnel 3 Personnel 4 2. Review of the laboratory's personnel records revealed the laboratory utilizes an "Assessment of competency" form to assess competency for molecular diagnostics and gross technique for Histopathology; however, this form did not not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 3. In interview on May 29, 2018 at 10:00 am, Personnel 3 stated the laboratory utilizes the "Assessment of competency" form. Personnel 3 confirmed the form did not include at a minimum the required six (6) procedures. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (3) The director or technical supervisor may delegate to the general supervisor the responsiblity for providing orientation to all testing personnel; and (4) Annually evaluating and documenting the performance of all testing personnel. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the General Supervisors failed to ensure competency assessments for testing personnel were performed annually. Findings: 1. Review of the laboratory CMS-209 (Laboratory Personnel Report) revealed the following testing personnel: Personnel 1 Personnel 2 Personnel 3 Personnel 4 2. Review of the laboratory's personnel records revealed the laboratory did not document competency assessments for 2017 for the following personnel: Personnel 1 Personnel 2 Personnel 3 Personnel 4 3. In interview on May 29, 2018 at 10:00 am , Personnel 3 stated the laboratory did not document competency assessments in 2017. -- 5 of 5 --