Cabral Internal Medicine

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 review of laboratory policy, review of 2016 and 2017 American Proficiency Institute (API) proficiency testing (PT) records 04/11/18, the laboratory director and testing personnel (TP#1) failed to sign attestation statements for all laboratory PT performed. Review of laboratory policy, "PROFICIENCY TESTING" revealed the following; "The Laboratory Director and all staff performing the testing should sign in the attestation spaces provided on the data sheet." Review of 2016 and 2017 API PT records revealed the laboratory participated in 10 of 12 API PT events. There were no attestation statements signed by the laboratory director or testing personnel for the 10 API PT events: 1. 2016 Chemistry Group 1 - 2nd Event 2. 2016 Chemistry Group 2 - 2nd Event 3. 2016 Hematology/Coagulation - 3rd Event 4. 2016 Chemistry Group 1 - 3rd Event 5. 2017 Hematology/Coagulation - 1st Event 6. 2017 Chemistry - Core - 1st Event 7. 2017 Chemistry - Miscellaneous - 1st Event 8. 2017 Hematology /Coagulation - 2nd Event 9. 2017 Chemistry - Core - 2nd Event 10. 2017 Hematology /Coagulation - 3rd Event D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory policies, review of personnel records, review of 2016 and 2017 API PT records and review of laboratory quality assessment practices 04/11 /18, the laboratory failed to monitor, evaluate and correct problems within the general laboratory system. 1. Review of laboratory policy, "STAFF ORIENTATION, TRAINING AND COMPETENCY" and personnel competency records revealed the laboratory failed to follow competency policy and failed to monitor and evaluate the competency of testing personnel (see D5209). 2. Review of laboratory policy, "PROFICIENCY TESTING" and review of 2016 and 2017 API PT records revealed the laboratory failed to follow proficiency testing policy and failed to verify the accuracy of analytes that scored zero for nonparticipation in PT events (see D5215). 3. Review of 2016 and 2017 API PT records revealed the laboratory failed to verify the accuracy of 25-Hydroxy Vitamin D (25-OH Vitamin D) and Vitamin B-12 at least twice annually (see D5217). 4. Review of laboratory policy "QUALITY ASSESSMENT PLAN" revealed the laboratory failed to follow quality assessment policy and failed to monitor, evaluate and correct problems within the general laboratory system (see D5291). 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 policy and procedure manual, and review of personnel records 04/11/18, the laboratory failed to follow written policies to assess testing personnel competency. Review of laboratory policy, "STAFF ORIENTATION, TRAINING AND COMPETENCY" revealed the following statements under the section "ANNUAL ORIENTATION AND COMPETENCY OF LABORATORY STAFF.... As defined by CLIA, the following six (6) procedures are the minimal regulatory requirements for assessment of competency for all personnel performing laboratory testing: 1. Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing 2. Monitoring the recording and reporting of test results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records 4. Direct observations of performance of instrument maintenance and function checks 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples 6. Assessment of problem solving skills". Review of personnel records for competency revealed an "EMPLOYEE PERFORMANCE AND DEVELOPMENT APPRAISAL FORM" used as documentation for testing personnel competency. The form does not include the minimal regulatory requirements as stated in the laboratory's competency policy. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) -- 2 of 9 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of 2016 and 2017 API PT records and review of laboratory policy 04 /11/18, the laboratory failed to evaluate zero scores for nonparticipation in PT events and failed to verify the accuracy of the analytes that scored zero for nonparticipation. Review of 2016 and 2017 API PT records revealed the following PT events had zero scores for nonparticipation. There was no documentation of an evaluation of the zero scores for nonparticipation. There was no documentation the laboratory had assessed the accuracy of the analytes that scored zero for nonparticipation. 1. 2016 Chemistry Group 2 - 3rd Event 2. 2017 Chemistry - Miscellaneous - 1st Event 3. 2017 Chemistry - Core - 3rd Event Review of laboratory policy, "PROFICIENCY TESTING" revealed "Alternative Assessment Procedures", which the laboratory failed to use to verify the accuracy of the analytes that scored zero for nonparticipation. 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 review of Tosoh A1A-900 system validation records and review of 2016 and 2017 API PT records 4/11/18, the laboratory failed to verify the accuracy of 25- Hydroxy Vitamin D (25-OH Vitamin D) and Vitamin B-12 at least twice annually. Findings: 1. Review of Tosoh A1A-900 system validation records revealed the laboratory started patient testing for 25-OH Vitamin D in May 2016. Review of 2016 and 2017 API PT records revealed the laboratory failed to enroll in PT for 25-OH Vitamin D until the 2017 2nd Chemistry - Miscellaneous test event, approximately 12 months after the initiation of patient testing. There was no documentation to indicate the laboratory performed any other activity to verify the accuracy of its 25-OH Vitamin D testing at least twice from May 2016 - May 2017. 2. Review of Tosoh A1A-900 system validation records revealed the laboratory started patient testing for Vitamin B-12 in May 2016. Review of 2016 and 2017 API PT records revealed the laboratory enrolled in PT for Vitamin B-12, but failed to obtain acceptable PT scores for 3 consecutive test events: a. On the 2016 Chemistry Group 2 - 2nd event, the laboratory provided incorrect responses for both samples and received a score of 0%; b. On the 2016 Chemistry Group 2 - 3rd event, the laboratory failed to participate and received a score of 0%; c. On the 2017 Chemistry - Miscellaneous - 1st event, the laboratory failed to participate and received a score of 0%. There was no documentation to indicate the laboratory performed any other activity to verify the accuracy of its Vitamin B-12 testing at least twice from May 2016 - May 2017. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 3 of 9 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies, review of quality assessment records, review of 2016 and 2017 API PT records, and review of personnel records 04/11/18, the laboratory failed to follow written policies and procedures to monitor, assess, and correct problems within the general laboratory system. Review of laboratory policies revealed the laboratory had established a quality assessment program to monitor, assess and correct problems within the general laboratory systems. Review of laboratory policy, "QUALITY ASSESSMENT PLAN" revealed the following; "Quality Indicators for this facility have been defined as, ......a. Personnel qualifications, training and performance evaluation......f. Evaluation of Proficiency Testing and Split Sample Testing.....Each quality indicator is reviewed according to the annual calendar established, and documented on a quality assessment report form....Included will be ...a summary and analysis of the findings....