Safety and Compliance · 3 min read
Laboratory Standards and Regulations · Quality Control and Quality Assurance
Several agencies and organizations govern laboratory work. Exam questions often describe a rule and ask which body issues or enforces it, so learn each one's role.
| AgencyorOrganization | Role | |
|---|---|---|
| CLIA(ClinicalLaboratory | Federallawsettingqualitystandardsforalltestingonhumanspecimensfordiagnosis prevention , , | |
| ImprovementAmendments) CMS(CentersforMedicare& MedicaidServices) FDA(FoodandDrug Administration) | ortreatment;everysuchtestingsiteneedsaCLIAcertificate 1 AdministersCLIA issuescertificates andoverseesinspections , , Clearsandapprovestestsystemsanddevices includingcollectiontubes andcategorizestestsby , , complexity |
| AgencyorOrganization | Role |
|---|---|
| CDC(CentersforDisease | Issuesinfectioncontrol handhygiene andisolationguidelinesandprovidestechnicalsupportfor , , |
| ControlandPrevention) | CLIA |
| OSHA(OccupationalSafetyand | Setsandenforcesworkplacesafetyrules includingtheBloodbornePathogensStandardandthe , |
| HealthAdministration) | HazardCommunicationStandard |
| NIOSH(NationalInstitutefor | Researchesworkplacehazardsandmakessafetyrecommendations(forexample respirator , |
| OccupationalSafetyand | certification);itdoesnotenforce |
| Health) | |
| TheJointCommission(TJC) | AccreditshospitalsandotherhealthcareorganizationsandpublishestheNationalPatientSafety |
| Goals | |
| CAP(CollegeofAmerican | Accreditslaboratories;CAPaccreditationisrecognizedbyCMSasmeetingCLIArequirements |
| Pathologists) | |
| CLSI(ClinicalandLaboratory | Developsconsensusstandards suchasGP41forvenipunctureandtheproceduresforcapillary , |
| StandardsInstitute) | andarterialcollection |
CLIA Test Complexity
CLIA sorts tests into three categories. Waived tests are simple, low-risk tests cleared for waiver, such as glucose meters, urine dipsticks, urine pregnancy tests, fecal occult blood, and rapid strep tests. A site with a Certificate of Waiver may perform them but must follow the manufacturer's instructions exactly; modifying a waived procedure makes it a high- complexity test. Moderate-complexity and high-complexity tests require more training, qualified personnel, proficiency testing, and inspections.
OSHA Standards Every Phlebotomist Must Know
The Bloodborne Pathogens Standard (29 CFR 1910.1030) requires employers to have a written exposure control plan, reviewed and updated at least annually; to use engineering controls such as safety needles and sharps containers; to provide PPE, training, and the hepatitis B vaccine at no cost within 10 working days of assignment; and to provide post- exposure evaluation and follow-up. The Needlestick Safety and Prevention Act added requirements to use safer sharps devices, to involve frontline workers in choosing them, and to keep a sharps injury log. The Hazard Communication Standard requires labeled chemical containers, Safety Data Sheets, and employee training, using the Globally Harmonized System (GHS) of pictograms and signal words.
The Joint Commission's goals most relevant to phlebotomy are to use at least two patient identifiers (never the room number), to label specimens in the presence of the patient, to report critical results on time, to comply with hand hygiene guidelines, and to prevent health care-associated infections.
Quality assurance (QA) is the overall program that monitors the entire testing process, from the test order through collection, analysis, and the report, and looks for ways to improve it. Quality control (QC) is the set of specific checks that confirm a procedure, instrument, or supply is performing correctly. The preanalytical phase, everything before the specimen is tested, accounts for the majority of laboratory errors (an estimated 46–68%), and it is the phase phlebotomists control.
| TestingPhase | ExamplesofErrors |
|---|---|
| Preanalytical | Wrongpatient wrongtube incorrectorderofdraw prolongedtourniquet hemolysis underfilledtube , , , , , , |
| mislabeling delayedorimpropertransport , | |
| Analytical | Instrumentmalfunction expiredreagents failedqualitycontrol calculationerrorsduringtesting , , , |
| Postanalytical | Transcriptionorreportingerrors resultssenttothewrongprovider delayedcriticalvaluenotification , , |
Quality Control Tools
Standard operating procedures (SOPs) and the facility's specimen collection manual (test directory) state the correct tube, volume, and handling for every test and must be followed as written. Competency assessment confirms that each employee can perform assigned tasks, using direct observation, record review, and written or practical tests. Incident reports document errors, injuries, near misses, and equipment failures so that causes can be found and corrected; they are factual, completed promptly, and kept out of the patient's medical record. Root cause analysis looks for system causes rather than blame, and corrective action (retraining, revising a procedure, replacing equipment) must be documented and checked for effectiveness.
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