LABORATORY DOCUMENTATION

Effective Date: 
Tue, 06/12/2012
Reviewed: 
Tue, 01/10/2017
Policy: 

PURPOSE

Laboratory documentation is a term to describe  the manuals, logs, files, reports, records, and printed materials that come with instruments and test kits provided by a manufacturer.

Laboratory documents provide the means to review laboratory activities. They provide an audit trail to demonstrate to an inspector that certain activities have taken place. Excellent documentation is proof that patient testing is accurate, precise, and reliable.

Written records are required for  the following:

  • quality control and quality assurance
  • test requisitions, records, and reports
  • procedure manuals
  • preventative maintenance manuals
  • corrrective action manual
  • personnel records

In the sections below are a list of policies, manuals, logs, reports, records, and instrument printouts that are located in the laboratory and/or the administrators office.

PERSONNEL RECORDS

Persons employed in the SHC laboratory must have a personnel file that contains the following information: copies of diplomas, transcripts, currrent licenses, job description, job reviews, and disciplinary actions.  In addition to the usual contents within a personnel file, the file should contain information about the employees immune status, OSHA blood borne pathogens training, CPR, and so forth.

PROCEDURE MANUAL

The procedure manual in the laboratory contains instructions for every test on the test menu including specimen collection and handling. The manual is the "bible" and is a ready reference for testing personnel. It also acts as training manual and provides testing uniformity from month to month and person to person.

INSTRUMENT LOG

A log is kept for each instrument in the laboratory. It contains the following information: name, purchase date, model, serial numbers, warranties, manufacturer sales and technical support contact numbers, and record each time the instrument is serviced.

MAINTENANCE LOG

A log is kept in the laboratory for each instrument. It contains information about annual maintenance and instrument function checks. The log is a chart or checklist and documents the date, activity, and the signature of the person who performed the maintenance. The instrument and the maintenance log are frequently combined

CALIBRATION LOG

Calibration should be noted in the instrument/maintenance log. Calibration is required every six months for moderately complex instruments, for example the Coulter AcT diff2 hematology analyzer.

QUALITY CONTROL

Several different logs are necessary to keep track of quality control activities. Control results for each kit, test, or instrument used in the laboratory need to logged.

Levy-Jennings graphs are evaluated weekly and monitored for shifts and trends. The mean, coefficient of variation, and standard deviation should be evaluated for quantative controls.