Chapter 1 review

Approximately 56 percent of laboratory error occurs during the preexamination phase of laboratory testing. Processes that are part of the preexamination phase include:

• Monitoring of specimen ordering

• Correct patient identification

• Patient communication and safety

• Patient preparation

• Timing of collections

• Blood collection equipment

• Collection techniques

• Specimen labeling

• Specimen transport to the laboratory

• Specimen processing

WAIVED TESTING

• Tests that are considered easy to perform by following the manufacturer’s instructions and have little risk of error. No special training or education is required.

• Example: Urine pregnancy test

PROVIDER-PERFORMED MICROSCOPY PROCEDURES (PPMP)

• Microscopy tests performed by a physician, midlevel practitioner, or dentist.

• Example: Microscopic urinalysis

MODERATE COMPLEXITY TESTS

• Tests that require documentation of training in test principles, instrument calibration, periodic proficiency testing and competency assessment, and on-site inspections. Personnel performing moderate complexity tests must have a high school diploma.

• Example: Automated complete blood count (CBC)

HIGH COMPLEXITY TESTS

• Tests that require sophisticated instrumentation and a high degree of interpretation. Proficiency testing and on-site inspections are required. A clinical laboratory science degree is required for personnel performing high complexity tests.

• Example: Urine culture and susceptibilityThe Joint Commission

The Joint Commission (TJC) is an independent, not-for-profit organization that accredits and certifies healthcare organizations. The mission of TJC is to continuously improve the safety and quality of care provided to the public through the provision of healthcare accreditation and related services that support performance improvement in healthcare organizations. To maintain accreditation, organizations must pass an on-site inspection by a survey team every 3 years. Laboratories are inspected every 2 years.

The College of American Pathologists

The College of American Pathologists (CAP) is an organization of board-certified pathologists that advocates for high-quality and cost-effective medical care. The CAP provides laboratory accreditation and proficiency testing for laboratories. CAP accreditation is accepted by both the CMS and TJC and fulfills requirements of Medicare and Medicaid.

COLA, Inc.

COLA, Inc. is a physician-directed accrediting agency popular with POLs and independent laboratories. It enables POLs to meet CLIA and other regulatory requirements.Clinical and Laboratory Standards Institute (CLSI)

• CLSI Standards: Globally recognized standards for laboratory testing, including blood collection, considered the standard of care in legal situations.

• Legal Consequences of Non-Compliance: Failure to respect patient rights or meet the standard of care can lead to legal action, including cases of nerve injury, hemorrhage, specimen collection errors, and misidentification.

• HIPAA Compliance: The Health Insurance Portability and Accountability Act (HIPAA) protects patient privacy, guarantees confidentiality of health information, and requires informed consent.

• Confidentiality Obligation: Healthcare professionals are legally required to maintain the confidentiality of patient information.

• Information Scope: Confidential information includes patient communications, verbal statements, charts, and laboratory results.

• Disclosure Restrictions: Patient information can only be shared with healthcare professionals who have a medical need to know, and laboratory results require patient permission for release.

Informed consent requires that you, as the healthcare professional, explain the blood collection procedure in a manner that the patient will understand stressing that the patient’s healthcare provider ordered the test. Vital to consent is the patient’s belief that you are competent to perform the procedure. You may be legally liable for failing to offer information to patients and for not obtaining informed consent.

Expressed Consent

Expressed consent is required primarily for invasive procedures but can include phlebotomy. As with informed consent, you must explain the procedure, and then the patient gives consent in writing or verbally. The most used and safest method for obtaining expressed consent is in writing. Verbal consent must be documented in the patient’s chart.

Implied Consent

Implied consent is very common in blood collection. You must explain the procedure that will be used to collect the blood specimen. The patient gives consent to collect the blood by extending his or her arm or rolling up his or her sleeve.

Consent for Minors and Incapacitated Patients

Blood collection in minors requires consent of their parents or legal guardians. In addition, a legally responsible person must give consent for patients who cannot communicate, patients who are mentally incompetent, patients in shock or trauma, patients with dementia, or those under the influence of drugs or alcohol. A legal guardian who can give consent may have to be appointed by the courts. Chain of Custody

When collecting specimens used for test results that may be used as evidence in legal proceedings, you must follow stated policies exactly for collecting and handling the specimen. Documentation of specimen handling, called the chain of custody, is essential. It begins with patient identification and continues until testing is completed and results are reported. Special forms are provided for the documentation, and special containers and seals may be required. For each person handling the specimen, documentation must include the date, the time, and the identification of the handler. Patient identification and specimen collection should be done in the presence of a witness, frequently a law enforcement officer. Identification may include fingerprinting or heel printing in paternity cases. Tests most frequently requested are blood alcohol and drug levels and DNA analysis.

The chain of infection is a six-step process that describes how a disease spreads. The six steps are:

Infectious agent: The pathogen, or germ, that causes the disease

Reservoir: The place where the pathogen lives and grows

Portal of exit: How the pathogen leaves the reservoir

Mode of transmission: How the pathogen spreads from one person or place to another

Portal of entry: How the pathogen enters a new host

Susceptible host: The person who is vulnerable to infection

Examples of each step

Infectious agent: Bacteria, viruses, fungi, or parasites

Reservoir: People, animals, insects, medical equipment, soil, or water

Portal of exit: Open wounds, aerosols, or coughing, sneezing, and saliva

Mode of transmission: Direct contact, ingestion, or inhalation

Portal of entry: Broken skin, respiratory tract, mucous membranes, catheters, and lines

• Definition of HAI: An infection acquired by a patient as a result of a healthcare procedure, occurring in various healthcare settings.

• Antibiotic-Resistant Pathogens: MRSA, Enterococcus, and Clostridium difficile are the three most common healthcare-associated antibiotic-resistant pathogens.

• Infection Control Measures: Hand sanitizing, wearing appropriate PPE, changing gloves between patients, and using safety devices for needles are essential to prevent HAIs.Bloodborne Pathogens

• Blood Collection Risks: Exposure to bloodborne pathogens like HIV, HBV, and HCV.

• Standard Precautions: Strict adherence to workstation disinfection and PPE use.

• PPE for Blood Collection: Gloves are mandatory to protect both healthcare workers and patients.

• Respirator Usage: N95 respirators are recommended for collecting blood from patients with airborne diseases like tuberculosis, especially with the rise of antibiotic-resistant strains and new viruses.

• Respirator Fitting: Each N95 respirator must be individually fitted to the wearer.

• Transmission Prevention: Wear appropriate PPE, change gloves between patients, sanitize hands, dispose of biohazardous material and sharps properly, follow illness protocols, maintain immunizations, decontaminate work areas, and avoid eating, drinking, smoking, or applying cosmetics in the work area.

• Sharps Safety Measures: Employers must provide sharps with safety features and involve employees in selecting and reviewing these devices.

• Bloodborne Pathogen Prevention: Strict adherence to safety precautions is crucial to prevent exposure to bloodborne pathogens, especially from contaminated needles.

• Employer Responsibilities: Employers are required to provide sharps disposal containers, safety devices, training, and medical follow-up for employees.

• Laboratory Quality Management Goal: To ensure accurate and reliable test results for quality patient care.

• Factors Affecting Laboratory Quality Management: Blood collection procedures.

• Consultation Recommendation: Consult laboratory personnel for procedure uncertainties.