STANDARD 24: Laboratory and Transfusion Management

24.1 General

1. The healthcare organization shall maintain, or have available, adequate laboratory services to meet the needs of its patients.

2. The laboratory shall have a documented procedure for identification, collection, retention, indexing, access, storage, maintenance, and safe disposal of clinical samples.

3. The laboratory shall define the length of time clinical samples are to be retained. Retention time shall be defined by the nature of the sample, the examination, and any applicable requirements.

4. The healthcare organization’s laboratory services, including any outsourced services, shall be integrated into its healthcare organization management system.

24.2 Adequacy of Services

1. Emergency laboratory services shall be available continually within the healthcare organizations including off-site access.

2. The healthcare organization shall develop a process for reporting critical laboratory tests results (See 4.1.3.–4.1.5.).

3. At a healthcare organization with off-campus locations the medical staff shall determine which, if any, laboratory services shall be immediately available to meet the emergency laboratory needs of the patients who are likely to seek care at each off-campus location.

4. A written description of services provided shall be available to the medical staff.

5. The laboratory shall make provision for proper receipt and reporting of specimens.

6. The laboratory shall maintain the appropriate resources including reagent and calibration requirements in order to assure the intended outcome of its processes.

7. The results of each examination shall be reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedures.

8. Laboratory processes of critical impact on patient safety shall be reported in keeping with requirements of the healthcare organization and standard of care.

NOTE 1 The licensure may be accomplished by having one certificate for the entire healthcare organization’s laboratory services, by having one certificate for each laboratory, or by the healthcare organization having a mixture.

NOTE 2 The emergency laboratory services available shall reflect the scope and complexity of the healthcare organization’s operations at the location and be provided in accordance with applicable laws and regulations, and guidelines and acceptable standards of practice.

24.3 Blood Transfusion

1. Blood transfusions and intravenous medications shall be administered in accordance with medical staff policies and procedures. If blood transfusions and intravenous medications are administered by LIPs other than physicians, these personnel shall have special training for this duty.

2. For intravenous medication and blood transfusion administration, the following competencies shall be required and documented in the nurse’s personnel record. Knowledge of and competency in:

a) fluid and electrolyte balance;

b) venipuncture techniques, including both demonstrations, and supervised practice.

3. The healthcare organization shall have a defined blood transfusion process addressing the following:

a) blood components;

b) blood administration procedures based on healthcare organization policy, and standard of care;

c) requirements for patient monitoring, including frequency and documentation of monitoring;

d) the process for verification of the right blood product for the right patient;

e) identification and treatment of transfusion reactions.

24.4 Blood Supply and Management

1. The healthcare organization shall have a blood use policy based on current scientific knowledge and that reduces unnecessary transfusions and minimizes the risks associated with transfusion. The policy shall describe the appropriate use of alternatives to transfusion where possible.

2. Blood and blood products used for patient care shall be subject to quality-assured screening for transfusion transmissible infections, including HIV, hepatitis B, hepatitis C, Treponemapallidum (Syphilis) and, where relevant, other infections that pose a risk to the safety of the blood supply, such as Trypanosomacruzi (Chagas disease) and Plasmodium species (malaria); as well as testing for blood groups and compatibility.

3. If a healthcare organization uses the services of an external blood bank, it shall have an agreement with the blood bank that governs the procurement, transfer, and availability of blood and blood products and to ensure blood and blood products comply with the requirements.

4. The healthcare organization shall maintain adequate records, which identify the source and disposition of all units of blood and blood components for no less than ten (10) years from the date of disposition, and they shall be stored in such a manner they are available for prompt retrieval.

5. The preparation of blood and blood products used for patient care shall be prepared:

a) in units that have effective quality systems, including quality management in place;

b) using quality standards;

c) in units that have effective documentation systems in place;

d) using appropriately trained staff;

e) subject to regular quality assessment.