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Unlocking Excellence: CAP Checklist Changes – Your Path to Quality Assurance

Carol Lynn Curchoe, PhD, HCLD | Oct 26, 2023

In the ever-evolving world of IVF lab accreditation and quality management, there are numerous standards and frameworks to choose from, such as ASRM and ESHRE. However, there’s one accreditation agency that stands out as the optimal choice – the College of American Pathologists (CAP). If you’ve just stumbled upon CAP Accreditation, don’t fret; this comprehensive guide will walk you through the ins and outs, helping you determine if CAP Accreditation is right for your lab and, if so, how to embark on the journey toward excellence.

What is CAP IVF Lab Accreditation?

The CAP Checklist for IVF lab accreditation is a remarkable publication brought to you by the College of American Pathologists. It is more than just a checklist; it’s a meticulously detailed roadmap designed to ensure and enhance quality management in clinical embryology, andrology, and endocrinology labs. Specifically, these standards are meticulously crafted to align with and uphold the USA federal CLIA88 guidelines for clinical laboratories.

Who Needs CAP Accreditation?

CLIA88 isn’t just a suggestion; it’s a legally mandated framework. By law, every clinical laboratory must be in strict compliance with CLIA 88. But what sets CAP Accreditation apart is its capacity to not only meet but exceed these standards. So, whether you’re running an established IVF lab or venturing into this cutting-edge field for the first time, CAP Accreditation is your key to unlocking a world of quality, precision, and excellence.

Staying Ahead of the Curve with CAP Checklist Updates

The College of American Pathologists understands the importance of maintaining consistency and stability in their checklists. While the world of IVF lab accreditation is dynamic, CAP strives not to make major changes to the checklists. This dedication to stability allows IVF labs to maintain their focus on quality assurance without the constant disruption of adapting to significant updates.

For IVF labs, this commitment to minimizing major changes in the checklists is a relief. It allows you to build a strong foundation of quality practices and focus on continuous improvement rather than navigating extensive checklist revisions.

To help you stay informed and up-to-date, we’ve still analyzed the minor changes in recent CAP Checklist updates and compiled them into a convenient reference table for your convenience.

CAP Checklist Update Key Changes & Updates

Previous Current
GEN.41304 Patient Data Accessibility Patient Data Accessibility
There is a written policy to ensure that patient data are accessible in a timely manner only to those individuals who are authorized to review test results.

NOTE: Only those healthcare personnel authorized to review a patient’s test results should have access to those results.

Laboratories subject to US regulations must provide final test results to the patient or the patient’s personal representative upon request.

For completed tests, these results must generally be provided no later than 30 days after such a request.

Under the HIPAA Privacy Rule, only the patient or a personal representative, defined as an individual who has authority under applicable law to make health care decisions for the patient, can be given access to a patient’s personal health data. Laboratories must take reasonable steps to verify the identity of the patient and the authority of a personal representative to have access to an individual’s protected health information. The Rule also allows for the release of test reports to authorized persons responsible for using the test reports and to the laboratory that initially requested the test, if applicable.

For additional information see Department of Health and Human Services, Medicare and Medicaid Services, “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports; Final Rule.” Fed Reg 79:7290 (2014); 45CFR164.502(g); 45CFR164.514.

The laboratory ensures that patient data are accessible in a timely manner only to those individuals who are authorized to review test results.

NOTE: Only those healthcare personnel authorized to review a patient’s test results should have access to those results.

Laboratories subject to US regulations must provide final test results to the patient or the patient’s personal representative upon request.

For completed tests, these results must generally be provided no later than 30 days after such a request.

Laboratories must also comply with other federal and state laws on patient access to laboratory and pathology results.

Under the CLIA Program and HIPAA Privacy Rule, Patients’ Access to Test Reports, only the patient or a personal representative, defined as an individual who has authority under applicable law to make health care decisions for the patient, can be given access to a patient’s personal health data. Laboratories must take reasonable steps to verify the identity of the patient and the authority of a personal representative before granting access to an individual’s protected health information. The Rule also allows for the release of test reports to authorized persons responsible for using the test reports and to the laboratory that initially requested the test, if applicable.

GEN.61300 Climate Control Climate Control
The room temperature and humidity are adequately controlled in all seasons.

Evidence of Compliance:

✓ Temperature and humidity records, if specific ranges are required for instrument and/or reagent use

The room temperature and humidity are adequately controlled in all seasons.

NOTE: Laboratories must follow manufacturer’s instructions for temperature and humidity for proper functioning of instruments, equipment, and test systems.

Evidence of Compliance:

✓ Temperature and humidity records, if specific ranges are required for instrument and/or reagent use

✓ Records of corrective action when specific ranges are exceeded

GEN.73400 Safe Work Practices Review Safe Work Practices Review
There are records of periodic review (at least annually) of safe work practices to reduce hazards. 

NOTE: Review must include bloodborne hazard control and chemical hygiene. If the review identifies a problem, the laboratory must investigate the cause and consider if modifications are needed to the safety policies and procedures to prevent reoccurrence of the problem or mitigate potential risk. 

Evidence of Compliance:

✓ Safety committee minutes OR records of regular safety inspections OR incident reports and statistics OR another method defined by the laboratory director

The laboratory evaluates safe work practices at least annually to identify hazards, investigate problems, and take actions to prevent recurrence or mitigate potential risks, as appropriate.

NOTE: Review must include assessment of work practices for infection control (eg, bloodborne pathogens, highly infectious pathogens), fire prevention and control, electrical safety, chemical safety, radiation safety, personnel and patient security incidents, and environmental safety.

Appropriate risk assessment processes must include the following steps, as applicable:

Identifying risks

Planning for prevention and mitigation of safety risks

Implementing risk mitigation plans

Assessing incidents and incorporating those assessments into goals and plans

Evaluating the effectiveness of the plan either annually, or when risks change significantly

Communicating the findings of assessments with the institutional safety committee and/or other stakeholders.

Evidence of Compliance:

✓ Safety committee minutes for discussion of inspection findings or incident review OR

✓ Safety inspection records OR

✓ Incident report review records and statistics OR another method defined by the laboratory director AND

✓ Records of investigation and action taken for identified problems

GEN.76400 Chemical Hazard Emergencies Chemical Hazard Emergencies
Explicit instructions are posted, and appropriate supplies available, for the emergency treatment of chemical splashes and injuries and the control of chemical spills wherever major chemical hazards exist.

NOTE: Spill kits must be handled in accordance with manufacturer’s instructions. If no expiration date is assigned, the spill kit must indicate the date it was put into service and the laboratory director or designee must periodically assess its usability.

Explicit instructions are posted, and appropriate supplies available, for the emergency treatment of chemical splashes and injuries and the control of chemical spills wherever major chemical hazards exist.

NOTE: Spill kits must be handled in accordance with manufacturer’s instructions. If no expiration date is assigned, the spill kit must indicate the date it was put into service and the laboratory director or designee must assess its usability at least annually.

GEN.73800 Emergency Preparedness & Response Emergency Preparedness & Response
There are written policies and procedures defining the role and responsibilities of the laboratory in emergency preparedness for harmful or destructive events or disasters.

NOTE: The specific elements to be included in the emergency preparedness plan must be based on a risk assessment using an “all-hazards” approach to evaluate the types of hazards most likely to occur that would potentially disrupt services. Written policies and procedures must be developed to support the execution of the laboratory’s emergency response plan and the path of workflow, including a communication plan. Laboratories located within a healthcare facility or integrated health system may participate in development of a facility or system-wide emergency preparedness plan rather than an individual laboratory plan, but must ensure that policies and procedures for the plan are clearly defined and address the relevant site-specific risks.

Examples of events that may be addressed in the emergency preparedness plan include situations such as unexpected system failures (eg, HVAC, water, communication, computer system), power failures, natural disasters (eg, tornado, hurricane, earthquake, fire, flood), emerging public health threats, cyber-attacks, terrorist events, or workplace violence.

NOTE: The specific elements to be included in the emergency preparedness and response plan must be based on a risk assessment using an “all-hazards” approach to evaluate the types of hazards most likely to occur that would potentially disrupt services. The laboratory’s emergency preparedness and response plan must include processes for initiating, managing, and terminating the response, as well as recovery phases.

Written policies and procedures must be developed to support the execution of the laboratory’s emergency response plan and the path of workflow, including a communication plan. Laboratories located within a healthcare facility or integrated health system may participate in development of a facility or system-wide emergency preparedness plan rather than an individual laboratory plan, but must ensure that policies and procedures for the plan are clearly defined and address the relevant site-specific risks.

Examples of events that may be addressed in the emergency preparedness plan include situations such as unexpected system failures (eg, HVAC, water, communication, computer system), power failures, natural disasters (eg, tornado, hurricane, earthquake, fire, flood), emerging public health threats (eg, increased numbers of potentially infectious patients or patient specimens), cyber-attacks, terrorist events, or workplace violence.

GEN.76710 A properly functioning fume hood (or chemical filtration unit) is available for any procedures using volatile chemicals.
COM.30695 Biological Safety Cabinet
A certified biological safety cabinet (BSC) is available and used when appropriate.

NOTE: The biological safety cabinet must be certified when installed, whenever moved, and at least annually to ensure that filters are functioning properly and that airflow rates meet specifications.

A BSC is used when protection of personnel, product, and/or the environment is needed for certain types of testing or procedures, including:

● Handling specimens potentially containing infectious pathogens considered highly transmissible by airborne routes or with potential for aerosolization or risk of splashes

● Prevention of DNA/RNA contamination for molecular testing procedures

● Maintaining sterility of cell cultures.

The laboratory director is responsible for ensuring a risk assessment is conducted, and for defining and implementing work practice controls to minimize identified risks, including installation and proper use of the appropriate type of biological safety cabinet.

The 6th edition of Biosafety in Microbiological and Biomedical Laboratories provides guidance for safe conduct of work from a biosafety perspective. It can be used as a tool for assessing and mitigating risk. Refer to Section II – Biological Risk Assessment, Appendix N – Clinical Laboratories, Section IV – Laboratory Biosafety Level Criteria and Table 1. Summary of Laboratory Biosafety Levels (BSLs) for specific information.

Evidence of Compliance:

✓ Defined work practice controls appropriate for the assessed level of risk AND

✓ Maintenance and function check schedule AND

✓ Records of testing and certification

RLM.03953 Alarm Response Plan & Records Alarm Response Plan & Records
The laboratory follows a well-defined, written plan for responding to alarms during work and non-work hours and retains records of alarm responses.

NOTE: The laboratory must be able to demonstrate that the response plan ensures timely response to both audible (in laboratory) and remote alarms.

Personal responsible for responding to alarms must be trained to follow written procedures to correct the problem or take alternative measures.

Records retained for alarm response must include:

● Name of the individual responding to the alarm

● Description of the problem encountered

● Actions taken to correct the problem

● Timing of the response and the notification.

If an alarm response involves the loss of reproductive cells or tissues due to a failure in storage conditions, the laboratory must conduct a root cause analysis (refer to GEN.20310) and implement appropriate risk-reduction strategies.

Evidence of Compliance:

✓ Records of response to the alarm

DRA.10475 Director Responsibility – New Method Validation/Verification Director Responsibility – New Method Validation/Verification
The laboratory director ensures that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing.

NOTE: Specific requirements are in the All Common Checklist (Instruments & Equipment, Test Method Validation/Verification, and Method Performance Specifications sections) and in other checklists.

Evidence of Compliance:

✓ Written procedures for validation/verification studies AND

✓ Records of new method validation/verification approval and supporting data

The laboratory director ensures that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing.

NOTE: Specific requirements are in the All Common Checklist (Instruments & Equipment, Test Method Validation/Verification, and Method Performance Specifications sections) and in other checklists.

Artificial intelligence and machine learning algorithms implemented by the laboratory for patient testing are subject to this requirement.

Evidence of Compliance:

✓ Written procedures for validation/verification studies AND

✓ Records of new method validation/verification approval and supporting data

As a reminder, if you’re looking for a “Turn Key” set of IVF lab Standard Operating Procedures (SOPs), you can find them within the ART Compass IVF Lab Management platform. These SOPs are designed to seamlessly integrate with the latest CAP Checklist updates, making your journey toward CAP Accreditation smoother and more efficient.

Stay with us as we continue to unravel the secrets of CAP IVF Lab Accreditation, equipping you with the knowledge and insights needed to not only meet industry standards but to stand out as a beacon of excellence in the field of IVF.