CCMA · Testing and Laboratory Procedures · 8 min read
Requisitions, CLIA Rules and Quality Control
- Identify the required components of a laboratory requisition, including patient identifiers, provider information, and specimen documentation.
- Explain the regulatory framework established by the Clinical Laboratory Improvement Amendments (CLIA) and the medical assistant's scope of practice regarding CLIA-waived testing.
- Differentiate between quality assurance and quality control, detailing proper reagent management, control documentation, and error prevention across all testing phases.
The Laboratory Requisition and Patient Preparation
A laboratory requisition or electronic order communicates the tests requested and information needed by the laboratory; not every outpatient test requires a separate requisition. Before any specimen is collected, the medical assistant must carefully review this document to ensure all mandatory information is complete and accurate. A laboratory requisition must contain the patient and ordering information required by the receiving laboratory and applicable regulations; acceptable patient identifiers are not limited to a full legal name and date of birth. In addition, the requisition must explicitly specify the tests ordered and include the diagnosis or ICD code whenever required by the reference laboratory or the third-party payer.
Accurate identification is the single most critical step in specimen collection. Prior to obtaining any specimen, the medical assistant must verify at least two patient identifiers against the laboratory requisition, such as asking the patient to state their full legal name and date of birth while cross-referencing the paperwork. Once the specimen is obtained, the medical assistant must record the specimen collection date and time directly on the requisition or accompanying collection record. When relevant to the specific test, the anatomical source of the sample must also be clearly documented on the record to ensure the laboratory processes the specimen appropriately.
Patient preparation directly impacts the validity of diagnostic findings and must be thoroughly confirmed before proceeding. The medical assistant must document relevant patient preparation, such as fasting status, as required by the laboratory or the test order. For example, if a provider orders a test that requires the patient to fast, the medical assistant must ask the patient whether fasting instructions were followed and record that status. Furthermore, the medical assistant must document medications that may affect the ordered test whenever requested by the provider or the testing laboratory. When a requisition is marked with the label STAT, it indicates that the order requires immediate collection, processing, and reporting to support urgent clinical decision-making.
Common mistakes
- Assuming an internal control line on a point-of-care test cassette eliminates the need for external controls; external quality controls must still be run at specified intervals or for new lots/shipments as required.
- Proceeding with patient testing when a quality control check fails; testing must stop immediately, and patient specimens must not be processed until troubleshooting and corrective actions are completed.
- Modifying manufacturer test procedures, such as altering incubation times or specimen quantities; this automatically reclassifies a CLIA-waived test into a high-complexity test.
- Receiving a verbal critical laboratory value without performing an immediate read-back to confirm accuracy before notifying the provider or designated licensed clinician.
Key points
- A laboratory requisition must include the patient and ordering information required by the receiving laboratory and applicable regulations, the tests ordered, and diagnosis information when required; the medical assistant must verify the patient's identity using at least two identifiers before collection.
- Specimen documentation must include the collection date, time, and anatomical source when relevant, along with confirmed patient preparation details such as fasting status and interfering medications.
- CLIA establishes federal standards for test accuracy, reliability, and timeliness, dividing tests into waived, moderate-complexity (including provider-performed microscopy procedures), and high-complexity categories.
- Medical assistants perform CLIA-waived tests under licensed provider supervision, must follow manufacturer package inserts without modification, and cannot independently interpret results or diagnose conditions.
- Quality assurance oversees the entire testing system, whereas quality control verifies specific instruments, reagents, and procedures; failed controls require troubleshooting, corrective action, and withholding patient testing.
- The pre-analytical phase accounts for the greatest proportion of testing errors, encompassing mistakes in patient identification, fasting verification, tube additives, sample hemolysis, and insufficient volume.
- Critical laboratory values may indicate an immediately dangerous condition; when authorized by policy to receive a verbal result, the medical assistant must document and read it back, promptly notify the provider or designated licensed clinician, and follow the escalation protocol if needed.
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