The ARTC Digital Lab Playbook February Quality Audit focuses on documenting the biennial IVF lab policy and procedures review. When should IVF Lab policies be updated? What elements make an effective policy? How should they be reviewed? What is sufficient evidence that each policy has been reviewed?! This month’s quality audit answers all of these questions and more!
This quality management process ensures policies and procedures are up-to-date, and that all staff members who must comply with your policy or monitor their implementation have been throughly trained. It may be useful for your organization to develop a communication strategy that identifies everyone who needs to be aware and comply with the policy. Scheduled review dates ensure continuous improvement when:
A gap/need is identified.
A serious or critical incident has occurred, requiring an urgent review.
Changes occur in the operating environment
Changes in laws, regulations, government policies, or CAP.
There are several objectives to policy and procedure review and sign off. The CAP All Common checklist, COM.10200 says that the laboratory director must review and approve all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. A paper or electronic signature review of records is required, but a secure electronic signature is highly recommended. When a policy or procedure is discontinued, a paper or electronic copy must be retained for at least two years, with a record of the initial date of use, and retirement date.
With respect to procedures, the CAP says that a complete procedure manual should be available in a paper-based, electronic, or web-based format at the workbench or in the work area. A schedule should be developed where roughly 1/24 of all technical policies and procedures are reviewed monthly, in order to minimize the burden on the laboratory and reviewer(s).
After review, a paper or electronic signature must be recorded at the level of each policy or procedure. A single signature on a Title Page or Index is not sufficient to record that each policy or procedure has been carefully reviewed.
According to CAP general requirement GEN.20375, IVF laboratories must have a document control system to manage policies, procedures, and forms that are subject to CAP accreditation. All of these objectives are easily met by the documents and forms control module in ART Compass.
Purpose: A statement that explains the goal(s) the policy is intended to achieve.
Findings: Brief statements of fact and /or statistics that outline the issue being addressed and support the need for the policy.
Definitions: Detailed explanations of the key terms in the policy.
Provisions: The main policy provisions state the prohibitions and/or requirements of the
policy and identify the parties to whom the provisions apply.
Exemptions: Any exemptions or exceptions to the prohibitions or requirements that are necessary to achieve the purpose of the policy.
Enforcement: An Enforcement section identifies the parties responsible for enforcement, outlines the enforcement procedures, any penalties or fines that may be imposed, and any appeal process.
Implementation: The implementation section states the effective date for the policy and the steps to
disseminate and publicize the policy.
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Research and Analysis | Analyze CAP Checklist to determine if new policies need to be written or existing policies updated. Cap Checklist Management Tools are available in ART Compass. |
| Distribution | The policies and procedures has been distributed to those expected to implement it and follow up feedback will be sought to ensure the policy is understood and applied. Use the “Assign” function in ART Compass! |
| Dates | Check that policies and procedures include the implementation date when the policy becomes active, dates and notes about changes or edits, and end use dates. |
| Review Schedule | Policy includes a review date – recommended 1/24 per month to completion every two years. |
| Supporting Documents | Supporting documents, such as forms, checklists or guidelines that will assist staff to implement policy have been developed. |
| Policy Scope | The scope of the policy lists all staff positions with responsibility for implementing the policy. |
| Critical or Panic Values | Policies identify what constitutes a breach of the policy and what the consequences are, and/or panic values that require immediate notification of a physician. |
| Sign Off! | IVF Lab Director, Medical Director and Technologists acknowledge they have read and understand the policies and procedures, supporting documents, and checklists. All employees can record their sign off on each P&P in ART Compass. |
The CAP requires various policies. Do you have a policy to address each of the following?
| GEN.20310 | Written QM policy and processes for performing a root cause analysis or investigation of non-conforming events |
| GEN.20340 | Written policy for the handling of recalls and notifications |
| GEN.20374 | The laboratory has a policy for ensuring compliance with applicable national, federal, state (or provincial), and local laws and regulations. |
| GEN.20377 | Written policy for retention of records, specimens, and slides |
| GEN.20450 | The laboratory follows a written policy for the management and correction of laboratory records, including quality control data, temperature logs, and intermediate test results or worksheets. |
| GEN.26791 | The laboratory has a written policy that addresses compliance with the CAP terms of accreditation. |
| GEN.40492 | The laboratory has a written policy regarding correction of information on specimen labels. |
| GEN.40506 | Written policy defining criteria for storage of and access to specimens collected by chain-of-custody procedures |
| GEN.40509 | Written policy addressing restricted access to secured records and record retention. |
| GEN.40935 | Personnel receiving verbal or phone orders read back the entire order to verify accuracy of transcription. |
| GEN.41304 | 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. |
| GEN.41345 | Written policy defining test reporting turnaround time and process for communication of delays in turnaround time |
| GEN.43325 | Written policy defining mechanism for data protection |
| GEN.54200 | Written policy for continuing laboratory education |
| GEN.59980 | The laboratory has a written policy for restricting access to the laboratory to authorized individuals. |
| GEN.74400 | There is a written policy that prohibits smoking, vaping, eating, gum chewing, drinking, application of cosmetics and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work areas. |
| GEN.77300 | The laboratory has a policy to protect personnel from excessive noise levels. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | |
| April | |
| May | |
| June | |
| July | |
| August |
