June2009 /Vol.

6,Issue2

Responsibilities of a Laboratory Manager

Laboratory Manager is not a term defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988. CLIA regulations do define and describe the responsibilitiesoftheLaboratoryDirector(LD),Technical Consultant (TC) and Testing Personnel (TP) for a facility performingmoderatecomplexitytesting.Thelaboratory manager may qualify to be the director, TC, and TP simultaneously. In contrast, there may be different individuals serving as LD and TC, with many other staff membersperformingtestingandotherduties.

Generally, among small laboratories and local health department laboratories, the term lab manager is synonymous with lab supervisor. The duties of a laboratorymanagermaybeverydifferentdependingon thetypeandsizeofthelaboratory.Inmostsettings,the lab manager should be familiar with regulatory requirements, quality assessment principles, and personnel issues, in addition to possessing advanced laboratory technical skills. The reality is that the lab manager will probably be responsible for at least some of the duties that are assigned to each of the CLIA mandatedpositions.

There are also Occupational Safety and Health Administration(OSHA)regulationsthat applytothe laboratory.Thelabmanagershouldcoordinatewith the agency safety officer to determine if the lab is compliant and uptodate in safety matters. At a minimum, there should be a bloodborne pathogen policy that discusses hazard assessment and personalprotectiveequipment(PPE),andachemical hygiene plan. There should be a policy for handling needlesticks and forms to document any accidents. The lab manager should assure that an annual sharps evaluation is done within the agency and properlydocumented.

Patient confidentiality, as mandated by the Health InsurancePortabilityandAccountabilityAct(HIPAA) andCLIA,mustbemaintainedthroughouttheentire testingprocess.Thelabmanagershouldperiodically reviewlabpracticestoassurecompliance.

Develop and Implement Quality Assessment Plan and Activities

CLIArequiresthatalaboratoryhaveanassessment component [for each quality system] that ensures continuous improvement of the laboratorys performance and services through ongoing monitoring that identifies, evaluates and resolves problems. The lab manager should develop a quality assessment (QA) plan that encompasses all phases of testing and complies with the (above) mandate by defining specific monitors, activities, and followup. All lab staff should be expected to participate in quality assessment, but the lab manager will most likely be the one responsible for reviewingtheactivitiesandmanaginganycorrective actionthatmayneedtobetaken.

Assure Regulatory Compliance

The lab manager should be aware of federal, state and localregulationsthatapplytotheoperationofaclinical laboratory.CLIAregulationsareminimumguidelinesfor any laboratory that performs human testing for the purpose of diagnosis and treatment. Each laboratory mustobtainacertificatefromtheCentersforMedicare and Medicaid Services (CMS) before patient testing can begin. The type of certificate is dependent on the complexityofthetesting,asdeterminedbytheUSFood and Drug Administration (FDA), performed in the laboratory. The regulations also describe the required personnel, qualifications and minimum responsibilities ofthesepersonnelbasedonthatcertificate.

Comprehensivelaboratorypoliciesandprocedures arevitalcomponentsoftheQAplan.Policiesshould CLIA regulations also address competency assessment bewrittentoestablishuniformpracticesforgeneral andproficiencytesting(PT)asameanstodeterminethe operationsinthelaboratory.Technicalprocedures abilityoftheindividualtesterandthelabasawholeto arenotonlyrequiredbyCLIAbuthelpassure generate accurate results. The lab manager may be standardizationoftestingpracticesbyreducing responsible for selecting a PT provider, choosing the variabilitywithinthelaboratory.Thelabmanager appropriatePTmodule,approvingandreviewing must revise policies and procedures, as necessary, PTresults,andfollowingupwithanynecessary tokeepthemcurrent. correctiveactions.

Qualitycontrol(QC)practicesshouldbestatedinthe QAplan.Thelabmanagershouldestablishthetype and frequency of QC after reviewing the manufacturers package inserts for all tests performed along with CLIA regulations. Good laboratorypracticesshouldalsobeconsideredwhen establishing QC guidelines, as well as any other source of technical oversight (such as a contracted labdirectorortechnicalconsultant).Periodicreview of QC by the lab manager should be well documented.

justify the addition of testing personnel. The lab manager may be responsible for creating the work schedule for the lab employees. The schedule should reflect anticipated high volume and low volume workloadperiodsinthefacility.Targetedturnaround times (TAT) are more likely to be met if staffing is appropriate. Work flow can also impact the TAT and should be evaluated periodically to look for opportunitiesforimprovement.

Thelabmanagershouldmaintaindocumentationof proof of education, initial training, and competency of each tester. An orientation checklist is a convenienttoolthatshouldbedevelopedbythelab manager to document that all aspects of lab operations are discussed or demonstrated during initial training. A record of continuing education obtainedbyeachtestershouldalsobemaintainedin thelaboratory.

The lab manager should ensure all reagents and supplies are available when needed and that instrumentation is functioning properly. Inventory needs to be managed to assure sufficient materials without having excessive amounts on hand. Reagents should be organized so the items with the shortest expirationdatesareusedfirst.

Proper specimen collection is a key factor in obtaining quality test results. All lab personnel should be trained in the recommended methods of bloodcollectionandbeobservedbythelabmanager (or designee) before being approved to perform bloodcollectiononapatient.

Alllabstaffshouldbeabletodeterminewhetherdaily QCisacceptableornot,butmayneedtoconsultwith the manager to troubleshoot when QC is unacceptable. The lab manager should notify the appropriate clinic staff if a test system becomes inoperable, whether short or long term. Instrumentation should be maintained according to the manufacturers instructions. Cleaning and disinfection, routine and unexpected maintenance shouldbedocumentedwhenitoccurs.

QA monitors can be selected from any of the three phases of testing (preanalytic, analytic, and post analytic). A log for recording problems that arise in thelaboratoryshouldbeutilizedtodocumentshort term followup and as a tool to help choose areas that need longterm monitoring. The documented problems, followup and monitors should be reportedtotheQAteambythelabmanager.

Demonstrate Professionalism
In many clinical settings the laboratory manager may represent the laboratory as part of the facilitys managementteam.Itisimportantforthelabmanager to interact in a professional manner to encourage others on the health care team to recognize and respect the contributions of the lab. It is equally as important to dress and act in a professional manner wheninteractingwithpatients.Theyonlyhaveabrief encounterwiththelaboratory,soitiscriticalthatthe encounterisapositiveone.

Manage Daily Laboratory Operations

The laboratorys test menu should be based on the type of clinical facility it serves. A public health laboratorymustcoordinatewithprogramswithinits agency to offer the most suitable, costeffective tests possible. The lab manager must select reference laboratories based on quality, customer serviceandcost.AcopyoftheCLIAcertificatefrom allreferencelaboratoriesusedshouldbeobtained andincludedinQAfiles.

Sherri R. Felts, MT(ASCP)SBB References

Federal Register 29 CFR 1910.1030 Bloodborne Pathogens Standard. Bloodborne pathogens. - 1910.1030 Accessed June 2, 2009. Federal Register 42 CFR Part 493 CLIA Regulations Clinical Laboratory Improvement Amendments (CLIA) Accessed June 2, 2009. North Carolina State Laboratory of Public Health CLIA Contract Program Description 2009. Writing Laboratory Policies North Carolina State Laboratory of Public Health Workshop June 3, 2009.

Aclinicallaboratoryneedstohaveadequatestaffto operate efficiently and report accurate results. The numberoflabpositionsisprobablynotdetermined bythelabmanager,butQAmonitorscanbeusedto