1. QC,QA and QSE, huh?
What does it all mean?

2. Everything revolves around quality
In the past 20 years regulatory agencies have increased requirements (since CLIA in 1988)
Documentation has become more important
Extensive computer technology has expanded our quality services in more real time
Competency has become more comprehensive and difficult to track.

3. Quality Assurance versus Quality Control
QSE (Quality System Essentials) are becoming the backbone for audit and assessment(See Table 3-2)
Each phase of the laboratory is evaluated and audited (investigation of compliance with policies and procedures) This is a big part of my job
pre-analytic
analytic
post-analytic

4. Personnel and Competencies
We adhere to the CSLI guidelines of competency assessment.
We just redesigned our forms to align with the evaluations required by CAP
This is generating a new industry of tools to track the 6 levels of measurement and the identification of test systems
Job descriptions
See hand-outs

5. SOP’s (standard Operating Procedures)
Rule # ONE, You Must have comprehensive, understandable and easy to follow procedures. (How else to standardize or audit performance??)
Part of my job has been to update, simplify, reorganize and check references
In our lab we are making all the procedures look the same
Policy versus Procedure….what is the difference??
See Example Hand-out
Utilize the package insert/manufacture recommendations

6. Specimen Collection and Labeling
Our Red Rules are Name and Date of Birth
Non-negotiable
Training everyone to check every specimen every time
Blood Banking has the most stringent rules for proper labeling, understandably
This also ties into our Electronic Medical Record
The advent of EPIC, availability of your own medical records

7. Record Keeping
When a document becomes a record..once a record it is a legal piece of paper.
Corrections are made with a single line, dated with initials of ‘owner’ of document
Computer/paper record retention guidelines
Computer validations, building, i.e. Beaker

8. Errors
Our hospital uses a computer based error tracking system. It replaces the paper ‘incident’ reporting. (RER)
Red Rule violations have ACA’s
Investigation of certain types of ‘RER’s is also part of my job, documenting etc.
Each RER should lead to process improvement or retraining.
Sentinel Event/FDA notification

9. Hospital wide audits Patient Satisfaction (If Disney ran a Hospital)
Physician satisfaction
Employee satisfaction
DNV and ISO Standards
So many opportunities

10. Quality Control Check facilities..Temps, products etc.
Quality control run on all antisera and on all cells before patient testing daily
Records of Daily QC include
Date of testing
Lot numbers of Reagents
Expiration Dates
Tech’s initials
Weekly/Monthly cleaning of centrifuges, water baths, heat blocks, Cell washers
Biomed annually check speed and temperature recording devices to ensure they are working correctly
Records have to be kept on all equipment including any maintenance

11. Should include our heat block temp and our ambient temperature
We will do our own Quality Control following the procedure handed out as well as design a recording sheet for our findings
Should include our heat block temp and our ambient temperature
All reactions labeled correctly
Lot number and expiration dates recorded
Each person do there own.
This project was funded at $3,000,000 (100% of its total cost) from a grant awarded under the Trade Adjustment Assistance Community College and Career Training Grants, as implemented by the U.S. Department of Labor’s Employment and Training Administration. Rogue Community College is an equal opportunity employer/program. Auxiliary aids and services, alternate form and language services are available to individuals with disabilities and limited English proficiency free of cost upon request.
This work is licensed under a Creative Commons Attribution 4.0 International License.