Laboratory of Pathology - Staff

Policies and Procedures

Standard operating procedures (SOPs) for clinical equipment and instruments must be readily available to all staff responsible for operating the equipment.

SOPs must have defined procedures for start-up, operation, shutdown, quality assurance / quality control, and maintenance.

Instructions for minor instrument or equipment troubleshooting, such as a manufacturer's service manual or instructions in the SOP, must be available to staff responsible for using the equipment.

All staff responsible for operating laboratory instruments or equipment must be initially trained and annual competency assessed to ensure staff are competent on use of clinical instruments and equipment  

Maintenance and Function Checks

Manufacturer-recommended maintenance and function checks must be performed and recorded for all instruments (e.g. analyzers, stainers, processors), clinical equipment (e.g. centrifuges, refrigerators, ovens, microscopes) and laboratory equipment (e.g. eyewash, biological safety cabinets) following a defined schedule.

Staff must document all maintenance checks, and corrective actions if necessary. For unmodified manufacturer’s equipment, instruments, or test systems, the section must perform and document the following:

• Maintenance and function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer.
• Function checks must be within limits defined by manufacturer before patient testing is conducted.

For equipment, instruments, or test systems developed in-house, commercially available and modified by the lab, or when the manufacturer does not provide protocols maintenance and function checks, the section must do the following:

• Establish, perform, and document maintenance and function checks (including appropriate background or baseline checks) necessary for accurate and reliable test results and test reporting.
• Function checks must be within limits defined by manufacturer before patient testing is conducted.

Performance Verification

All clinical instruments and equipment must have performance verification completed prior to initial use, after major maintenance or service, or after relocation to ensure they function according to expectations. This does not include a need to re-validate performance for a move within the same laboratory space or room.

Methods for performance verification:

• Patient correlations, commercial validation material analysis, or manufacturer-recommended or manufacture-performed instrument validations for new instruments or equipment.
• Running a set of patient samples pre- and post- major maintenance, service or relocation to a new environment.
• Correlations should include a mix of positive and negative test samples, and a minimum mix of two cases for low occurrence case types and five cases for more common tests.

Function check tolerance limits are defined based on manufacturer recommended specifications, or established by the laboratory for instruments that do not have manufacturer standards. Function checks must be within defined tolerance limits prior to use for patient testing.  The laboratory section must troubleshoot and take corrective action when tolerance limits for acceptable function of instruments and equipment are exceeded. Records of troubleshooting and corrective actions must be documented in the equipment's maintenance records. 

Comparability of Instruments and Methods

The College of American Pathologists require biannual comparability of laboratory instruments and methods for non-waived testing if the laboratory uses more than one instrument/method to test for a given analyte. This requirement applies to tests performed on the same or different instrument makes/models or by different methods. 

• The purpose of the requirement is to evaluate the relationship between test results using different methodologies, instruments, or testing sites.
• This requirement only applies when the instruments/reagents are producing the same reportable result.

Although the intent of this standard is for instrument producing reportable results, each LP clinical section conducts periodic comparability of instrument or methodologies. Examples include:

• Automated stainers (e.g. Ventanas and Dakos) and manual stains have comparability staining conducted biannually. 

• Flow Cytometry instrument comparability is determined monthly or more by acquiring one specimen on both cytometers.  The designee reviews and records √ as acceptable qualitative cluster matching for all populations in all cocktails.  Any cluster discrepancies between instruments are brought to the attention of the director.  See also Synchronization of cytometers for comparability.

  • Twice annually:  Using more than one flow cytometer requires a minimum of twice annual “Comparability of Instruments” to verify both instruments yield comparable results.    One representative case will be parallel tested on both instruments at least once a month or as often as once a week.  Within a 6 month period, the majority of all cocktails routinely used in patient panels should be tested, reviewed and evaluated by the laboratory director or designee.

  • At the end of each month, the parallel cases are reviewed, signed and collated by the antibody QC designee.  Prior to review, both sets of parallel files are analyzed side by side to compare significant antibody pair patterns.  

Any discrepancies noted between instruments or procedures at any time during acquisition, analysis or monthly review must be reported to the laboratory director or designee section supervisor.

Annual Result Comparison

For Immunohistochemical and in-situ hybriziation (ISH) tests performed on breast carcinoma that provide independent predictive information, the IHC and molecular ISH methods are compared at least annually against published benchmarks.

Inter-observer variability among pathologists scoring IHC is evaluated by the Immunohistochemistry section at least annually. 

Intra-operative/Final Diagnosis Disparity

The Laboratory of Pathology reviews all surgical intra-operative to Final Diagnoses for potential disparity monthly, and results are reported to the Quality Management Committee and Medical Director.  When significant disparity exists between initial intra-operative consultation (e.g. frozen section, intra-operative cytology, gross evaluation) and final pathology diagnosis, it is reconciled and recorded in the surgical pathology report and in the departmental quality management file.

Instrument / Equipment Record Review

All clinical laboratory instrument and equipment maintenance, function checks, performance verification, and service and repair records are promptly available to, and usable by, the technical staff operating the equipment. The ability to review past performance issues and corrective actions can be useful in identifying issue trends, and allow staff to know if recurrent issues need to be escalated.

Instruments and equipment maintenance and function check records are reviewed and assessed at least monthly by the laboratory's technical supervisor or designee.

Necessary corrective actions must be addressed and documented for any errors identified.

Common LP equipment review templates are found in the Forms and Checklists page.