310- lecture - Lab and Pharmacy (1)

Laboratory and Pharmacy Overview

Page 1

• Laboratory and Pharmacy

Page 2: The Evolution of Clinical Laboratory Tests

• A century ago, few clinical laboratory tests existed for physicians.

• The first recorded test involved a urine examination for sweetness in 1674.

• Today, there are hundreds of clinical laboratory tests available.

Page 3: Laboratory Functions

• Examination of bodily fluids and tissues for disease identification and treatment.

• Procedures to determine the presence or absence of substances or organisms in the body.

Page 4: Understanding Pathology

• Definition: The study of the causes and effects of disease or injury.

• Example: Cancer cell analysis.

• A physician practicing pathology is called a pathologist.

Page 5: Divisions of the Laboratory

Anatomical Pathology

• The most complex division, managed by a board-certified pathologist.

• Responsibilities include examining tissue and cell samples and performing autopsies.

Clinical Pathology

• Operated under the technical direction of a pathologist.

• Divided into functional sections or departments.

Page 6: Certification and CLIA

• Clinical Laboratory Improvements Act (CLIA): Established minimum standards for labs.

• Founded in 1988 to address misreading of PAP smears.

• Sets minimum education and experience standards for lab personnel.

• Defines testing categories by complexity.

Page 7: CLIA Proficiency Testing

• Clinical labs performing moderately or highly complex testing must enroll in proficiency testing.

• Regular samples of tests are sent for external evaluation to ensure accuracy.

Page 8: Laboratory Accreditation

• In addition to CLIA, laboratories may be accredited by:

  • College of American Pathologist (CAP)

  • Joint Commission

  • American Association of Blood Tests (AABB) for blood banks.

• Focus on quality control and continuous improvement.

Page 9: Future of Laboratories

• Molecular Diagnostics: Searching patient samples for specific RNA/DNA sequences.

• Disease Monitoring: Identifying risks and selecting suitable therapies.

• Biomarkers: Molecules in blood used for disease identification (e.g., fasting blood glucose for diabetes).

Pharmacy Overview

Page 10: Pharmacy Responsibilities

• Dispensing and compounding drugs and therapeutic substances.

• Services provided include outpatient and inpatient care.

Page 11: Pharmacist Qualifications

• Pharm.D. Degree: Required educational qualification.

• Licensed by the state.

• Responsibilities include interpreting medical orders and providing consultative advice.

• Special preparations for IVs, nutritional solutions, and chemotherapeutic agents.

Page 12: Pharmacy and Therapeutics Committee (P&T)

• Functions primarily as a liaison between medical staff regarding pharmacy activities.

• Members include physicians, pharmacists, nurses, and administrators.

• Duties: developing a drug formulary, educating staff, and reviewing drug reactions.

Page 13: Pharmacy Quality Improvement

• Example of efforts by the P&T Committee: identifying drug misuse and enhancing patient education on health literacy.

Page 14: Drug Distribution System

• Unit Dose System: Pharmacy packages or pre-packages a 24-hour supply of medications.

• Medications stored in patient drawers or medication carts, like the Pyxis System.

Page 15: Medication Dispensing Errors

• Focus on patient safety and security as priority.

• The five rights of medication safety:

  1. Right Medication

  2. Right Route

  3. Right Time and Frequency

  4. Right Patient

  5. Right Dose

Page 16: Control of Narcotics and Barbiturates

• Require documentation and counting at each shift.

• Must comply with state and federal laws and include narcotic license numbers.

Page 17: Debate on Generic vs. Brand-Name Drugs

Generic Drugs

• Cost less and made under the same FDA standards.

• Encouraged by federal agencies.

• Hatch-Waxman Act: Streamlines generic pharmaceutical approvals while preserving innovation incentives.

Brand-Name Drugs

• Patented for 20 years from the filing date, protecting new compositions.

Page 18: Selling Drugs to Hospitals

• Group purchasing for volume discounts through pharmaceutical reps.

• Open Payments: Requires collection of payment info from drug/device companies to hospitals.

• Example: Sunshine Act requires disclosure of payments to healthcare providers.

Page 19: Telepharmacy

• Provides 24-hour pharmacy services, particularly for rural hospitals.