Effective Date: 
Tue, 06/12/2012
Thu, 05/27/2021
Tue, 04/17/2018


Laboratory documentation is a term to describe  the on-line and written 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.

 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
  • recall and sentinel notifications

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.


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.


The on-line 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.


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.


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 should be noted in the instrument/maintenance log. Calibration is required every six months for moderately complex instruments, such as the Alere Triage Meter Pro used for D-dimer testing.  The Sysmex Beyond Care Quality Management systems provides a daily calibration for the instrument which can be accessed on the provided laptop.


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.


A binder containing the above notifications will be maintained according Health Center policy.  See attached policy: RECALL OF DRUGS, MEDICAL / SURGICAL SUPPLIES, DEVICES OR EQUIPMENT.  All recall notices will be immediately investigated by lab personnel and named equipment, if part of the lab inventory, will be  properly disposed of and replaced if necessary.

Sentinel notifications of ongoing public health investigations will be noted and communicated to the provider group as applicable.