Q&A with Heather Hurley, BS
Executive Director, Laboratory Business Development
The Joint Commission

MedicalLab Management: What areas comprise The Joint Commission’s primary focus on clinical laboratory compliance today?

Heather Hurley: The Joint Commission’s primary focus is providing safe and effective care of the highest quality and value across the entire continuum of care. Our clinical laboratory standards specific to non-waived testing address processes and activities that help to produce test results that are meaningful, reproducible, useful, valid, dependable, and specific to the needs of the population the laboratory serves.

In addition to our comprehensive and robust standards for non-waived testing, The Joint Commission recognizes the tremendous impact the laboratory has on patient care quality and safety and its critical role in the diagnosis and treatment of disease. Our Laboratory National Patient Safety Goals were developed to help accredited organizations address specific areas of concern in regard to patient safety, including patient identification, staff communication, and infection prevention. The Joint Commission’s Laboratory Services: 2017 National Patient Safety Goals can be accessed at: www.jointcommission.org/lab_2017_npsgs/

MLM: What benefits can The Joint Commission provide to clinical laboratories that seek its accreditation?

Hurley: Accreditation by The Joint Commission is widely recognized as the most comprehensive evaluation process in the health care industry. As we accredit across the entire continuum of care, having your laboratory accredited by The Joint Commission creates a bridge between the laboratory and the hospital, enabling everyone to speak the same language across the organization. Achieving accreditation from The Joint Commission for both your hospital and laboratory helps highlight the value of the laboratory, and the critical role it plays in patient quality and safety, to hospital administration and staff.

The Joint Commission’s Laboratory Accreditation program is designed to help laboratories achieve and maintain consistent excellence in the services they provide to patients. Achieving accreditation by The Joint Commission demonstrates to patients and the community that a laboratory is committed to providing the highest-quality services. Accreditation also may assist with reimbursement from insurers, as we are recognized by a significant number of payers and state regulatory agencies.

Joint Commission accreditation delivers Robust Process Improvement (RPI) concepts to assist organizations in continuously improving quality and enabling the standardization of process. Our goal is to help laboratories become highly reliable organizations and we offer many resources to support this endeavor.

MLM: Can you briefly outline The Joint Commission’s eligibility requirements for laboratory accreditation?

Hurley: The Joint Commission currently accredits laboratories within hospitals, community clinics, ambulatory surgery centers, and physician offices, as well as independent reference laboratories that are performing non-waived testing (as defined by CLIA). Non-waived testing refers to both moderate and high complexity tests, and CLIA requires an on-site survey or inspection by an approved accreditor, such as The Joint Commission.

Additionally, organizations must meet all requirements below to be eligible to apply for laboratory accreditation from The Joint Commission:

• The laboratory is in the United States or its territories or, if outside the United States, is operated by the US government or under a charter of the US Congress.
• If required by law, the laboratory has a facility license, CLIA license, or registration to conduct its scope of services.
• The laboratory can demonstrate that it continually assesses and improves the quality of its care, treatment, and/or services. This process includes a review by clinicians or qualified designee as defined by CLIA, including those knowledgeable in the type of care, treatment, and/or services provided at the laboratory.
• The laboratory identifies the services it provides, indicating which care, treatment, and/or services it provides directly, under contract, or through some other arrangement.
• The laboratory provides services that can be evaluated by The Joint Commission’s standards.

MLM: What have been the most challenging standards for clinical laboratories this year?

Hurley: The top non-compliant requirements for 2016 can be found in FIGURE 1, as the data for 2017 has not yet been published. For a more comprehensive list of challenges facing other areas of health care, visit medlabmag.com/jointcommissiontop5lab

Click here to see FIGURE 1.

MLM: What is new this year that laboratory managers should be aware of for Joint Commission surveys? 


Hurley: In 2017, The Joint Commission rolled out a new scoring methodology for all accreditation programs called the SAFER Matrix, which stands for Survey Analysis for Evaluating Risk. This matrix approach identifies and communicates risk levels associated with deficiencies cited during surveys, and allows organizations to prioritize and focus their corrective action efforts. The SAFER Matrix offers a complete visual representation of all Requirements for Improvement (RFIs) plotted based on the likelihood to cause harm and how widespread the issue is based on the surveyor’s observations. An online resources page focused on the SAFER Matrix is available at: www.jointcommission.org/topics/safer_matrix_resources.aspx

In addition, the revised laboratory standards for the Life Safety (LS) and Environment of Care (EC) chapters of the laboratory accreditation manual are posted on our website and will remain available until January 1, 2018 when they go into effect. The standards are available here: www.jointcommission.org/standards_information/prepublication_standards.aspx

The revisions to the LS and EC chapters include new, revised, and relocated elements of performance (EPs) that address topics including the following:

• Testing of emergency lighting systems.
• Inspection and testing of piped medical gas and vacuum systems.
• Updating pertinent NFPA code numbering in references.
• Adding more specificity to existing EPs.

MLM: What are the key areas to identify and target when conducting an internal audit?

Hurley: Review of the 2016 most cited standards for the laboratory setting is a good place to start. It is helpful to review CLIA guidelines for laboratory director requirements as well, especially for moderately complex point-of-care testing. Pay close attention to requirements for reagent and solution labeling and be sure to include preparation and expiration dates consistently across all laboratory specialties.

Review the required written documentation chapter in the laboratory accreditation manual for a complete list of all EPs requiring written documentation for laboratory and point-of-care testing. Other areas to pay close attention to are personnel qualifications, proper documentation for proficiency testing, IQCP implementation, review of new test validations, and compliance with all state-specific requirements.

MLM: What measures can the laboratory take to prepare for an accreditation survey?

Hurley: When preparing for an accreditation survey, laboratories should review all lab policies and procedures to ensure they are up to date and being followed, as written, by all laboratory staff. Laboratories should review the standards, including any changes or updates, since their last on-site survey to ensure continuous compliance throughout the two-year accreditation cycle. Resources such as prompts to assess your compliance and written document checklists are included by chapter in the laboratory accreditation manual to assist laboratories in preparing for their on-site survey.

The Joint Commission’s survey process includes our unique tracer methodology, which not only focuses on the laboratory test itself, but on the pre- and post-analytics and the impact on patient quality and safety. We encourage laboratories to perform their own mock tracers during their accreditation cycle to assess interrelationships among departments and identify strengths and weaknesses. Following are some tips from our tracer methodology toolkit for laboratories to consider when performing a mock tracer:

• Focus on issues of particular concern for laboratories and process interfaces with clinical staff.
• Consider your laboratory’s past testing activity as a starting point.
• Select the medical record of a patient who received multiple laboratory tests, including tests performed at the point-of-care.
• Instead of one person conducting the tracer, consider performing it as a group.
• Review the beginning and end of a process, not just the outcome.

In preparation for an on-site survey, the following information and documentation should be available:

• Name of key contact person who can assist in planning tracer selections.
• CLIA certificates, specialties and subspecialties, state licenses, and personnel license or certification, if required by the state or organization policy.
• An organizational chart and map of the facility (include all CLIA required roles).
• Ability to retrieve testing records for patients who have had laboratory tests or other services for the past 24 months (4 months if an initial survey).
• Performance improvement data for the past 24 months (4 months if an initial survey).
• Proficiency data by CLIA number for the past 24 months.
• Results of periodic laboratory environment inspections from the safety committee or safety officer.
• Manifests for the disposal of hazardous waste for the past 24 months (4 months if an initial survey).
• A list of tests performed (test menu) and instruments used including all ancillary and point-of-care sites.
• Employee personnel files.

MLM: What resources are available to lab managers for further information on Joint Commission surveys and compliance?

Hurley: The Joint Commission provides numerous resources for our accredited laboratories as well as laboratories looking to become accredited by The Joint Commission. Joint Commission accredited laboratories have access to resources such as our Leading Practices Library, Standards BoosterPaks, laboratory tools including CLIA resources and IQCP examples, and our Perspectives newsletter via The Joint Commission Connect extranet site. The Joint Commission Perspectives is the primary source for official news, including changes to accreditation and certification standards, requirements, and Joint Commission initiatives. Accredited organizations also have direct access to our experts in the Standards Interpretation Group to answer questions and provide guidance on standards compliance. Additional resources for laboratories interested in becoming accredited by The Joint Commission include:

• A 90-day trial access to the E-dition, the electronic version of the Comprehensive Accreditation Manual for Laboratories, the manual of our standards and policies. The E-dition includes prompts to assess compliance, document checklists listing EPs requiring written documentation that a surveyor may ask to review during a survey to show compliance with a standard. The tracer methodology toolkit provides a detailed review of the on-site activity.
• A survey activity guide to help prepare for the survey.
• A dedicated account executive to answer your questions throughout the application submission and the accreditation process.

For laboratories seeking more information on becoming accredited by The Joint Commission, contact qualitylabs@jointcommission.org.

Heather Hurley, BS, is the executive director of Laboratory Business Development at The Joint Commission where she is responsible for leading business strategies and activities, including the development and implementation of products and services, for The Joint Commission’s Laboratory Accreditation Program. Heather began her professional career as a laboratory technologist in the department of molecular genetics at The Cleveland Clinic working in the area of gene expression.