International Organization for Standardization (ISO) 15189.

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program.

Red blood cell transfusion practices: a College of American Pathologists Q-Probes study of compliance with audit criteria in 128 hospitals.

Context: Most information on compliance with audit criteria for red blood cell (RBC) transfusions comes from single institutions; few studies have compared practices among many hospitals.

Objective: To survey a cross-section of hospitals in 2008 for criteria and compliance with RBC transfusion guidelines, using the College of American Pathologists Q-Probes format.

Design: One hundred twenty-eight hospitals, representing about 4.

Blood bank safety practices: mislabeled samples and wrong blood in tube--a Q-Probes analysis of 122 clinical laboratories.

Context: Although a rare occurrence, ABO incompatible transfusions can cause patient morbidity and mortality. Up to 20% of all mistransfusions are traced to patient misidentification and/or sample mislabeling errors that occur before a sample arrives in the laboratory. Laboratories play a significant role in preventing mistransfusion by identifying wrong blood in tube and rejecting mislabeled samples.

Critical values comparison: a College of American Pathologists Q-Probes survey of 163 clinical laboratories.

Context: Critical laboratory values are values that may be indicative of life-threatening conditions requiring rapid clinical intervention. Designation of critical values by clinical laboratories is required by the Clinical Laboratory Improvement Amendments and regulatory agencies. The development of critical values often involves consultation with clinical services.

Future trends.

Several current forces have set anticipated future changes in health care in motion, or, at least, have set the stage for change. End-consumer demand increasingly drives the market; as a result, entire businesses are transforming or emerging anew to meet these demands. In general, consumers demand high quality at reasonable cost, to be delivered as fast as possible with minimal inconvenience.

The role of the medical laboratory director.

The American Medical Association notes in its Principles of Medical Ethics that a physician "shall be dedicated to provide competent medical service with compassion and respect for human dignity." As physicians whose profession involves the medical direction of pathology and clinical laboratory services, pathologists strive to provide high-quality, cost-effective services to support the needs of patient care. These services must be provided under the aegis of extensive legal and regulatory mandates of various governmental and nongovernmental entities.

The origin of reference intervals.

Context: Standards have been developed for establishing reference intervals, but little is known about how intervals are determined in practice, interlaboratory variation in intervals, or errors that occur while setting reference intervals.

Objectives: To determine (1) methods used by clinical laboratories to establish reference intervals for 7 common analytes, (2) variation in intervals, and (3) factors that contribute to establishment of "outlier" intervals.

Design: One hundred sixty-three clinical laboratories provided information about their reference intervals for potassium, calcium, magnesium, thyroid-stimulating hormone, hemoglobin, platelet count, and activated partial thromboplastin time.

Type and screen completion for scheduled surgical procedures. A College of American Pathologists Q-Probes study of 8941 type and screen tests in 108 institutions.

Context: Market-driven changes in the timing of elective surgeries and admissions have introduced barriers to completing pretransfusion testing in a timely manner. Consequently, blood bank personnel may not have adequate time to identify appropriate blood products for scheduled surgeries. Incomplete pretransfusion testing can delay surgery and significantly compromise patient safety.

Q-tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking.

Context: Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome.

Objective: To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine.

Design: Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms.

Operating room blood delivery turnaround time: a College of American Pathologists Q-Probe Study of 12647 units of blood components in 466 institutions.

Objectives: To determine the normative distribution of time elapsed for blood bank personnel to fill nonscheduled operating room (OR) blood component orders in hospital communities throughout the United States, and to examine hospital blood bank practices associated with faster blood component delivery times.

Design: Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the times elapsed for blood bank personnel to fill nonscheduled emergent orders from hospital ORs for red blood cell (RBC) products, fresh frozen plasma (FFP), and platelets (PLTs). Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices.

Quality indicators of fresh frozen plasma and platelet utilization.

Objective: To determine the normative rates of expiration and wastage for units of fresh frozen plasma (FFP) and platelets (PLTs) in hospital communities throughout the United States, and to examine hospital blood bank practices associated with more desirable (lower) rates.

Design: In 3 separate studies, participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data retrospectively on the numbers of units of FFP and PLTs that expired (outdated) prior to being used and that were wasted due to mishandling. Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices.

Autoimmune hemolytic anemia.

Red blood cell (RBC) autoantibodies are a relatively uncommon cause of anemia. However, autoimmune hemolytic anemia (AIHA) must be considered in the differential diagnosis of hemolytic anemias, especially if the patient has a concomitant lymphoproliferative disorder, autoimmune disease, or viral or mycoplasmal infection. Classifications of AIHA include warm AIHA, cold agglutinin syndrome, paroxysmal cold hemoglobinuria, mixed-type AIHA, and drug-induced AIHA.

Complications of blood transfusion.

Preview Severe, life-threatening reactions to blood transfusion are rare but may be clinically similar to minor reactions, which are fairly common. The authors describe the manifestations of various noninfectious reactions and the laboratory workup necessary to discriminate among them. They also discuss the mechanisms of these transfusion reactions and tell how to treat and prevent them.