Chapter 45: Orientation to the Physician Office Laboratory (POL) Laboratory Operations and Safety

Learning Outcomes for Laboratory Orientation

  • 45.1: Describe the purpose of the physician’s office laboratory (POL).
  • 45.2: Identify the medical assistant’s duties in the physician’s office laboratory.
  • 45.3: Identify important pieces of laboratory equipment.
  • 45.4: Illustrate measures to prevent accidents within the lab setting.
  • 45.5: Describe the goal of a quality assurance program in a physician’s office laboratory.
  • 45.6: Carry out effective communication with patients regarding test preparation and follow-up procedures.
  • 45.7: Carry out accurate documentation, including all logs related to quality control.

Introduction to Laboratory Management and CLIA '88

  • Medical Assistant Knowledge Base: A medical assistant must have a firm understanding of common laboratory equipment, safety protocols in the laboratory, and specific steps required to prevent accidents.
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA '88): The impact of this legislation is significant, governing the following areas in the lab:
    • Quality assurance programs.
    • Quality control procedures.
    • Comprehensive record keeping.

Role of Laboratory Testing in Patient Care

  • Fluid Analysis: Testing involves the analysis of blood, urine, and other body fluids.
  • Clinical Objectives:
    • Identify diseases or other physiological problems.
    • Confirm or contradict an initial diagnosis made during the clinical exam.
    • Determine and monitor the appropriate dosage of a medication.

Comparison of Laboratory Facilities

  • Reference Laboratory: This is an outside facility usually run by an organization separate from the medical practice.
    • Provides access to specialized technological resources not available in smaller settings.
    • Frees up the medical practice staff for direct patient care duties.
    • Some managed care companies require subscribers to use a specific designated reference laboratory.
  • Physician’s Office Laboratory (POL):
    • Commonly provides a quicker turnaround on results.
    • Eliminates the need for patient travel to a separate facility.
    • Focuses on the accurate and timely processing of routine tests.
  • Types of Tests Performed in the POL:
    • Chemical analysis.
    • Hematologic tests.
    • Microbiologic tests.
    • Urinalysis.

Medical Assistant’s Role and Responsibilities

  • Core Testing Procedures: The medical assistant is responsible for the entire cycle of testing in the POL, which includes:
    • Preparing the patient for the procedure.
    • Collecting the specimen sample.
    • Completing the actual laboratory test.
    • Reporting the results to the physician.
    • Communicating testing information and results to the patient (following physician review).
  • Additional Administrative and Clinical Duties:
    • Understanding and complying with lab regulations.
    • Actively preventing accidents and managing waste disposal.
    • Maintaining the laboratory through housekeeping and equipment maintenance.
    • Managing quality assurance and quality control programs.
    • Maintaining records of test specimens, procedures, and official results.
    • Inventory management, including ordering equipment and supplies.
    • Utilization of reference materials located in the POL.
    • Screening and performing follow-up on test results.

Physician’s Office Laboratory Equipment

  • Autoclave: Used to sterilize the surfaces of instruments and equipment to ensure a sterile environment.
  • Centrifuge: A device that spins at high speeds to separate a specimen into its component parts.
  • Electronic Equipment: Includes computers and software used to create and maintain clinical data. These tools are often more accurate, safer, and more efficient than manual methods.
  • Photometer: A specific piece of electronic equipment used to measure light intensity.
  • Measurement Tools: Precise measurement is critical in the POL. Common tools include:
    • Pipettes.
    • Flasks or beakers.
    • Hemocytometer (specifically calibrated to count cells).
    • Thermometers.

The Optical Microscope

  • Overview: The microscope is the most frequently used piece of equipment in a POL, often used for on-site blood smear evaluation.
  • Regulatory Note: Provider-performed microscopy procedures must be approved under CLIA guidelines.
  • Microscope Types:
    • Optical Microscope: Uses light to project an image.
    • Compound Microscope: Utilizes two lenses to magnify the image.
  • Structural Components:
    • Oculars (Eyepieces): Can be monocular (one eye) or binocular (two eyes). They contain a magnifying lens, typically a 10×10\times lens.
    • Objectives: Located on a revolving nosepiece; they contain additional magnifying lenses that are moved under the ocular as needed. There are typically three objectives: two dry and one oil-immersion.
    • Arm: Attaches the oculars and objectives to the body tube and base.
    • Focus Controls: Located on the arm; used to focus the object. Includes fine and coarse adjustment knobs.
    • Stage: The platform where the slide is placed, often held by slide clips.
    • Substage: Found under the stage; contains the condenser (concentrates light) and the iris.
    • Light Source: Located under the stage and substage with adjustable intensity.
    • Base: Supports the entire structure.
  • Care and Maintenance:
    • Clean the microscope after every use.
    • Store under a plastic cover to prevent dust accumulation.
    • Always move the microscope by holding the arm and supporting the base.
    • Be aware of artifacts during viewing.

Safety in the Laboratory

  • Standard Precautions: These must be used at all times to ensure laboratory safety.
  • Specific Safety Guidelines:
    • Wear gloves and change them between every patient.
    • Wash hands immediately after removing gloves.
    • Consistently use Personal Protective Equipment (PPE).
    • Avoid sharps injuries by following proper handling and disposal protocols.
    • Use only the recommended instruments and equipment for each task.
    • Work to prevent spills and splashes; if they occur, disinfect the contaminated areas immediately.
    • Dispose of all waste correctly, particularly biohazardous materials.
    • Remove all protective gear before leaving the laboratory area.
  • Biologic Safety: Treat all specimens as if they are contaminated and follow Standard Precautions.
  • Accident Reporting: In the event of an accident, refer to the specific office policy and ensure all OSHA (Occupational Safety and Health Administration) requirements are met.
  • Housekeeping: Reduce the risk of contamination by cleaning equipment after use and following all office policies and procedures.

Quality Assurance and CLIA Regulations

  • Quality Assurance (QA) Programs: These programs serve to monitor the quality of patient care, ensure the safety of healthcare workers, and assess the overall quality of the tests performed. The governing philosophy is that "Quality is #1."
  • CLIA '88 Legislation: Enacted in $1988$ and updated in $1992$, the Clinical Laboratory Improvement Amendments represent federal regulation of all laboratory facilities. Standards, fees, enforcement, and accreditation programs depend on the complexity of the tests performed.
  • Complexity Levels:
    • Certificate of Waiver Tests: Simple tests with accurate results that pose an insignificant risk to the patient if performed or interpreted incorrectly. Many are approved by the FDA for home use.
    • Moderate-Complexity Tests: Accounts for approximately $75\%$ of all lab tests. Requires qualified laboratory personnel, a formal QA program, and is subject to random inspections.
    • High-Complexity Tests: Includes tests for specialties and subspecialties. Requires highly qualified personnel, formal QA programs, and random inspections.

Quality Control, Maintenance, and Documentation

  • Quality Control (QC): A component of QA aimed at ensuring test accuracy.
    • Calibration: Ensures equipment is operating correctly using specific standards.
    • Control Samples: Used each time a patient sample is processed. These have known values and are used to verify qualitative test responses or quantitative test results.
    • Reagent Control: Reagents must be monitored; a reagent control log must be maintained.
  • Maintenance: Follow the manufacturer’s guidelines for all equipment, troubleshoot problems as they arise, and maintain a detailed maintenance log.
  • Documentation Requirements: Detailed logs must be kept for:
    • Quality control results.
    • Reagent control.
    • Equipment maintenance.
    • Reference laboratory interactions.
    • Daily workload.
  • Proficiency Testing Programs: Used to measure the accuracy of test results and the staff's adherence to standard operating procedures (SOPs).
  • Training and Education: Employers must provide opportunities for training and continuing education along with written reference materials. Employees are responsible for consulting these materials and participating in training.

Patient Communication and Documentation Procedures

  • Filling Out a Laboratory Requisition Form: This is a primary MA responsibility and must include:
    • Patient information.
    • Insurance information.
    • Physician information.
    • Specimen information (source, date, time).
    • Specific test(s) requested.
    • Preliminary diagnosis.
  • Communicating Before Testing: Provide clear instructions (oral and written) and verify that the patient has followed the necessary preparation (e.g., fasting).
  • Communicating During Collection: Identify the patient, provide instructions for the collection process, and offer reassurance.
  • Communicating After Collection: Provide post-test instructions, schedule further testing if needed, and handle results carefully.
  • Reporting Results: Report findings to the physician first for interpretation. Only after the physician has reviewed them should the results be reported to the patient and their questions answered.
  • Record Keeping:
    • Inventory control involves maintaining a list of items used and reordering systematically.
    • Patient records should be monitored to identify unusual findings.
    • Specimen identification must include the patient’s info, the collector's name, the date and time of collection, and the ordering physician.
    • Handle unidentified or misidentified specimens per strict office protocol.

Questions & Discussion

  • Q: Compare a reference laboratory and the POL.
  • A: A reference laboratory is usually run by a separate organization and possesses technologies beyond a standard POL, though patients may need to travel there. A POL provides quicker turnaround and allows testing during an appointment without the patient leaving the office, but it is more limited in the types of tests performed.
  • Q: What are the duties of a medical assistant related to testing done in the POL?
  • A: Primary duties include preparing the patient, collecting the sample, running the test, reporting results to the physician, and communicating results to the patient after physician review.
  • Q: Identify the following equipment functions:
    • Measures light intensity: Photometer.
    • Platform for slide: Stage.
    • Contains magnifying lens: Ocular.
    • One is an oil-immersion: Objective.
    • Condenser to concentrate light: Substage.
    • Move body tube up and down: Focus controls.
    • Calibrated to count cells: Hemocytometer.
  • Q: List guidelines for maintaining safety in a POL.
  • A: Wear and change gloves, wash hands, use PPE, avoid sharps injuries, use recommended equipment, prevent/disinfect spills, dispose of waste correctly, and remove gear before leaving the lab.
  • Q: What is the purpose of a quality assurance program for a laboratory?
  • A: To monitor the quality of patient care, ensure worker safety, and assess the quality of tests performed.
  • Q: Mr. Jones called for his laboratory results but the physician has not reviewed the results. What should the medical assistant do?
  • A: Inform Mr. Jones that the physician must review the results before they can be released. Advise him that he will be called once the review is complete.
  • Q: When reviewing Mr. Jones’ laboratory results, the medical assistant notes that his glucose is elevated. What should she do?
  • A: Identify the out-of-range result by circling or underlining it, according to the specific office policy.

Summary

  • The POL processes routine tests (usually blood/urine) accurately and timely.
  • Accident prevention begins with safety guidelines, standard precautions, timely accident reporting, and proper housekeeping.
  • The goal of QA is to monitor the quality of patient care provided by the lab.
  • Medical assistants must ensure patients receive clear pre-test instructions in both oral and written forms.
  • Accurate QC documentation requires a reference laboratory log and a daily workload log.
  • "Quality is not an act, it is a habit." — Aristotle