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

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.

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

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

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

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

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

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

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

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

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.