CDC Update

Lab Quality: Vision for the Future of CLIA

May 11, 2010

MariBeth Gagnon, MS CT(ASCP)HTLLaboratory Science and Regulation

Laboratory Science Policy and Practice Program Office (proposed)

Centers for Disease Control and Prevention

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Overview

• Organizational Improvement• CDC’s Current Activities

CLIAC activitiesLaboratory Medicine Best Practices projectGenetic testing quality improvement

activitiesRapid influenza testing surveysLaboratory Medicine Roadmap and

Integrations WorkgroupsAssessment of cytology practices

Organizational Improvement

Based on Dr. Frieden′s five priorities:• Strengthen surveillance, epidemiology,

laboratory services• Improve ability to support state, tribal,

local, and territorial public health• Increase global health impact• Increase policy impact• Better prevent illness, injury, disability,

and death

CLIAC Activities

• GoalManage CLIAC and

subcommittees/workgroups to meet the needs of the CLIA program and assure compliance with the Federal Advisory Committee Act (FACA)

• Status2 meetings per year – February and

SeptemberWorkgroups

o Active – Proficiency Testingo Inactive – Molecular and Biochemical Genetic Testingo Inactive – Waived testing

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Health Information Technology and Electronic Health Record

• February 2010 CLIAC meeting presentationsOffice on the National CoordinatorAgency Updates – CMS, CDC, and FDAEngleberg Center for Healthcare Reform

@ the Brooking InstituteManufacturers perspective – Sunquest

Information Systems

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EHR Incentive Program

• American Recovery and Reinvestment Act (ARRA) bills that apply to laboratoriesONC interim rule standards and

certification criteriaCMS proposed rule on incentives program

(meaningful use)ONC proposed rule on certifying programs

• CLIA IssuesAuthorized userPerceived impediments to exchange of

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Proficiency Testing Workgroup

• MembersChair: James Nichols, Ph.D.Microbiology Co-Chair: Gerri Hall, Ph.D.Members represent stakeholders with

respect to proficiency testing and include:

o Laboratory experts o Proficiency testing program expertso Accreditation/state licensure expertso Government ex officios

Proficiency Testing Workgroup

• ChargeProvide input to CLIAC for consideration in

making recommendations to HHS regarding revisions to the CLIA requirements for proficiency testing (PT) specified in subparts H and I of the regulations

• Proficiency Testing Workgroup ScheduleMeeting dates: March 10-11, 2010Follow-up teleconferences are ongoingCLIAC report: September 1-2, 2010

Proficiency Testing Workgroup

•Topics to AddressUpdate list of CLIA-regulated analytesRevise the criteria for acceptable performance

for CLIA-regulated analytes (target values acceptable limits, current and proposed)

Changes to specialties or subspecialties that do not have regulated analytes (microbiology)

Clarification of the requirements for PT referralAppropriate PT for evolving technology, such

as telemedicine Other changes needed to update and improve

CLIA PT

Molecular Genetic Testing

Molecular Genetic Testing Activities

• Published commentaries and articles• Created fact sheets for laboratorians

and clinicians • Assist CLSI with guidance document

(MM20) on quality management• Presented at professional conferences

(AMP, ACMG, SIMD, AACC)• Developing training courses and

workshops

Biochemical Genetic Testing

• Workgroup – Carol Greene, chair• Workgroup report presented to CLIAC

– February 9, 2010• CLIAC made recommendations• Writing MMWR R&R Good Laboratory

Practices Biochemical Genetic Testing

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Waived Testing

Waived Testing Activities

• Developed poster or postcard “Top Ten” good laboratory practices for waived testing

• Publish educational booklet for those who perform waived testing (in clearance)

• Developing booklet for directors and/or supervisors

• Developing on-line training course for non-laboratorians

Waived Testing

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Laboratory Medicine Best Practices

• GoalMake evidence-based recommendations

for quality improvement in the practice of laboratory medicine

• StatusDeveloped methods for evaluating quality

improvement evidence of effectiveness

• ProjectsSystematic ReviewsQuality/Performance Measures

Systematic Reviews

• 3 pilot test topics & 7 practicesImproving specimen identification

o Barcoding o POCT barcoding

Improving critical values reportingo Automated electronic notificationo Call center

Reducing blood culture contamination

o Venipuncture vs. Cathetero Phlebotomy teamo Commercial prep kit

4/7 practices had sufficient evidence to recommend as a best practice

Plans for Systematic Reviews

• Manuscript on LMBP methodology used for conducting the systematic reviews

• Technical guide on transparent procedures for replication of the study methods

• Manuscripts for the topic-specific evidence reviews

• Web-based tutorial to increase awareness of LMBP methods and key components of providing evidence for reviews

• Scientific presentations

Evidence-Based Lab Medicine Quality/Performance Measures

Cooperative agreements – 3rd and final year

• Kaiser Permanente -Laboratory tests for chronic kidney disease

• Texas Dept of State Health Services - Newborn screening timeliness of diagnosis/ treatment

• Univ. of Colorado (Denver) - Pre and postanalytic laboratory medicine indicators

• Standardized, evidence-based quality measures developed for diverse lab settingsPrepaid health plans - outpatient

chronic disease - 4 measuresPublic health labs – newborn screening

- 16 pre- and 18 post-analytic measures

University hospitals – anatomic pathology -6 quality indicators

Evidence-Based Lab Medicine Quality/Performance Measures

• Planned ActivitiesPilot test identified measures Collect data collection to verify QI

outcomePublish methods and findings peer-

reviewed journals Disseminate information at

professional conferences

Evidence-Based Lab Medicine Quality/Performance Measures

Genetic Testing in Clinical Practice: A Team ApproachInteractive Multimedia Learning

Focus: Learning about the use of genetic tests in clinical practice through simulation

Users: Clinicians, Medical Schoolshttp://iml.dartmouth.edu/education/cme/Genetics/index.html

Genetic Testing Quality Improvement

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A A CollaborativeCollaborative CDC-based program to improve the CDC-based program to improve the availability of reference materials for genetic testingavailability of reference materials for genetic testing

Academic, Clinical Genetic Testing Labs

Government Agencies

Cell Repositories

IVD Manufacturers

Professional Organizations

Patient Advocacy Groups

Genetic Testing Quality Improvement

GeT-RM Projects

Completed Projects• Fragile X• Huntington Disease• Cystic Fibrosis• Ashkenazi Jewish Panel

9 disorders including Tay-Sachs and Canavan disease

• BRCA1/2• MTHFR• Multiple endocrine

neoplasia Type 2A• Alpha1-antitrypsin

deficiency

Ongoing Projects• Pharmacogenetic• (20 markers!)• Newborn Screening• Cytogenetics• Molecular oncology• Biochemical Genetics

Over Over 200200 DNA RM DNA RM characterized by characterized by GeT-RMGeT-RM

Rapid Influenza Testing Survey with the Joint Commission

• GoalTo assess rapid influenza test usage in -

Emergency Dept. (ED) Community health centers (CHC) Physician office laboratories (POLs)

o Types of rapid influenza tests in useo Training and competency of personnelo Adherence to “Good Laboratory Practices”o Impact on treatment - antivirals and

antibioticso Perceived utility of test

• Second survey (2010)Revised based on H1N1 outbreakSensitivity 40-70% for Influenza A H1N1 Changes in testing practices since H1N1Impact of H1N1 on diagnosis and

treatment of patients with Influenza Like Illness

Rapid Influenza Testing Survey

with The Joint Commission

Laboratory Medicine Roadmap Workgroup

• GoalCreate an action plan to help the laboratory

community move from the present state to optimized patient care (6 IOM domains)

• Status Paper to describe the actions that increase

the value of laboratory medicine through research & innovation, information technology, outreach, incentives, prioritization and implementation of activities

Laboratory Medicine Integrations Workgroup

• GoalDevelop systems to improve selection and

interpretation of laboratory tests

• StatusDevelop algorithms for test selectionDefine challenges in test ordering & result

interpretationo Focus groups for clinicianso Survey of medical school curriculaoDevelop clinical vignettes for testing residentsoDevelop protocol for inspecting clinical pathology

residency programs to assess consultation education provided

Assessment of Cytology Practices

• Cooperative agreementsCollege of American PathologistsMichigan Public Health InstituteGoals of two are complimentaryFunded for 2010-2011

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Assessment of Cytology Practices

• College of American PathologistsSurvey all cytology labsReview current practices (specimen

types/methods, QC, PT, problem solving)Analyze responsesPost on CAP website for commentConvene a consensus conference in

2011

Assessment of Cytology Practices

• Michigan Public Health InstituteSurvey pap smear providers Review test request and report formats,

lab role in clinical managementPartner with MI Cancer Consortium

CDC Contact Information

• CDC CLIA website: http://wwwn.cdc.gov/clia/

• CLIA phone line: 404-498-2290

• MariBeth Gagnon: 404-498-2745 or mbg0@cdc.gov

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