Common Pitfalls: CAP inspection

Inspection coming up?

CAP inspections are necessary to maintain high standards and patient safety. Each year, the CAP gathers a list of the most common deficiencies that are found during inspections. By understanding and addressing possible issues, laboratories like yours can better prepare for inspections and avoid all the bad stuff.

We will now cover the top ten deficiencies cited by the CAP in 2023.

1. Competency Assessment

The most commonly cited deficiency relates to assessing the competency of personnel performing non waived testing.

Laboratories must evaluate employees on the 6 required points of competency assessment for each type of testing that they do. The CAP has a ton of CE courses to help, like this.

2. Instrument Comparability

Laboratories using more than one instrument to test for a given analyte must perform comparability studies at least twice per year. The CAP has a a slideshow that helps get this under wraps. This ensures that results from different instruments are consistent and accurate.

3. Activity Menu

The laboratory's activity menu, which lists all tests and activities performed, must be kept up-to-date in the CAP's records. The inspectors will check to ensure that the laboratory is only performing tests listed on the menu.

4. Policy and Procedure Manual

Laboratories must maintain a complete, current policy and procedure manual that is available to all personnel. There are a ton of software tools that can help with this such as Medialab or Sharepoint. The manual should include detailed instructions for all tests and procedures performed in the lab.

5. PT and Alternative Assessment Review

The laboratory director or designee must review and evaluate all proficiency testing (PT) and alternative assessment results, taking corrective action for any unacceptable results. The CAP has a document here to help. Records of these reviews and corrective actions must be maintained.

6. Maintenance and Function Checks

Laboratories must perform and document regular maintenance and function checks on all instruments and equipment, following the manufacturer's recommendation or using the supervisors best judgement.

The CAP states, “Maintenance and function checks may include (but are not limited to) cleaning, electronic, mechanical and operational checks.

The purpose of a function check is to detect drift, instability, or malfunction, before the problem is allowed to affect test results.” source

7. Instrument Records Review

The laboratory director or designee must review instrument and equipment records at least monthly to identify any issues and take corrective action. This ongoing monitoring helps catch potential problems early before they hinder the workflow.

8. PT Attestation Statement

The PT attestation statement must be signed by the laboratory director and all personnel involved in the testing process. The instructions to the PT kit and result form resource from the CAP is found here.

9. Temperature Checks

Laboratories must regularly monitor and record temperatures for all temperature-dependent equipment such as refrigerators, freezers, and incubators. Specimens and reagents can be stored and tracked on the same maintenance and function checklist cited earlier.

10. Correction of Records

When errors are made in laboratory records, they must be corrected using approved techniques that preserve the original entry. Corrections must be dated and initialed by the person making the change. The laboratory must have a written procedure for making corrections to both paper and electronic laboratory records, such as quality control data, temperature logs, and intermediate test results or worksheets.

By focusing on these top 10 areas and performing regular internal audits, you can spot potential issues before an inspection and take effective corrective measures. Remember that the CAP says that consistent training, well-documented policies and procedures, and continuous quality monitoring are very important for maintaining compliance and upholding the highest standards of laboratory excellence.

FAQ:

What are the top 10 deficiencies cited by the CAP in 2023?

The most common deficienciesfound during2023 CAP inspections were:

1. Competency assessment of personnel performing non-waived testing

2. Comparability studies for laboratories using multiple instruments

3. Keeping the laboratory's activity menu up-to-date

4. Maintaining a current and complete policy and procedure manual

5. Review of proficiency testing (PT) and alternative assessment results

6. Performing and documenting instrument maintenance and function checks

7. Monthly review of instrument and equipment records

8. Signing of PT attestation statements

9. Monitoring and recording temperatures of storage equipment

10. Proper correction of errors in laboratory records

What happens if deficiencies are found during an inspection?

If deficiencies are identified, the laboratory must submit a plan of corrective action to the CAP within 30 days.