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Biomedical subjects

Ira A Shulman

Publications and source records attributed to Ira A Shulman.

11 recordsLinked to original sources
PubMed2005

Critical laboratory value notification: a failure mode effects and criticality analysis.

BACKGROUND: The Failure Mode Effects and Criticality Analysis (FMECA) was applied to improve the timeliness of reporting and the timeliness of receipt by the responsible licensed caregiver of critical laboratory values (CLVs) for outpatients and non-critical care inpatients. METHODS: Through a risk prioritization process, the most important areas for improvement, including contacting the provider, assisting the provider in contacting the patient, and educating the provider in follow-up options available during off hours, were identified. ACTIONS TAKEN: A variety of systemic improvements were made; for example, the CLV notification process was centralized in the customer service center, with databases to help providers select options and make arrangements for follow-up care and an electronic abstract form to document the CLV notification process. Review of documentation and appropriateness of CLV follow-up care was integrated into the quality monitoring process to detect any variations or problems. RESULTS: The average CLV notification time for the month steadily declined during an eight-month period. Compliance was 100% for the "read-back" requirement and documentation in patient's health record. DISCUSSION: This proactive risk assessment project successfully modified the CLV notification program from a high- to a low-risk process, identified activities to further improve the process, and helped ensure compliance with a variety of requirements.

California↗
PubMed2005

The transfusion services committee--responsibilities and response to adverse transfusion events.

Healthcare institutions in the United States must review blood transfusion practices and adverse outcomes in order to receive payments from the Centers for Medicare/Medicaid program, but it is not required for a specific committee to be assigned to oversee the review process. Regardless of the group or individuals responsible, the review process must include a program of quality assessment and performance improvement that is ongoing, hospital-wide, and data-driven, reflects the complexity of the hospital's organization and services, and involves all hospital departments and services (including those contracted). To be most effective, the performance improvement activity should be prioritized around high-risk, high-volume activities and/or in problem-prone areas. Even if a hospital elects not to receive payments from Medicare, it must still comply with applicable sections of the Code of Federal Regulations pertaining to transfusion services such as the follow up of adverse outcomes of transfusion.

Aged↗
PubMed2005

Phenotype matching of donor red blood cell units for nonalloimmunized sickle cell disease patients: a survey of 1182 North American laboratories.

CONTEXT: The transfusion of donor red blood cell units (RBCs) that lack certain red cell antigens (such as C, E, and K) when the corresponding antigens are absent from the recipient's red cells has been shown to reduce the risk of red cell alloimmunization in sickle cell disease patients. However, data are limited regarding the extent to which transfusion services routinely perform red cell antigen phenotype testing of nonalloimmunized sickle cell disease patients, and then use that information to select donor RBCs lacking 1 or more of the red cell antigens that the patient's red cells do not express. OBJECTIVE: To determine the extent to which transfusion services routinely perform red cell antigen phenotype testing of nonalloimmunized sickle cell disease patients, and then use that information to select donor RBCs lacking 1 or more of the red cell antigens that the patient's red cells do not express. DESIGN: An educational subsection of a College of American Pathologists Proficiency Testing Survey (J-C 2003) assessed transfusion service practices regarding performance of red cell antigen phenotype testing of nonalloimmunized sickle cell disease patients and how transfusion services use this information for the selection of donor RBCs. The data analysis of the survey included 1182 North American laboratories. RESULTS: Data from 1182 laboratories were included in the survey analysis, of which the majority (n = 743) reported that they did not routinely perform phenotype testing of sickle cell disease patients for antigens other than ABO and D. The other 439 laboratories reported that they did routinely perform phenotype testing of sickle cell disease patients for antigens in addition to ABO and D. The majority of these 439 laboratories (three fourths; n = 330) reported that they used these patient data for prophylactic matching with donor RBCs when sickle cell disease patients required transfusion. When phenotype-matched donor RBCs were used, the antigens most commonly matched (85% of the time) were C, E, and K. CONCLUSIONS: The majority of North American hospital transfusion service laboratories do not determine the red cell antigen phenotype of nonalloimmunized sickle cell disease patients beyond ABO and D. Those laboratories that do determine the red cell phenotype of nonalloimmunized sickle cell disease patients beyond ABO and D most commonly match for C, E, and K antigens when phenotype-matched donor RBCs are used.

ABO Blood-Group System↗
PubMed2005

Storage and transfusion of infected autologous blood or components: a survey of North American laboratories.

CONTEXT: Many patients request that autologous blood or components be collected and available for use during scheduled surgical or invasive medical procedures to avoid exposure to human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) from allogeneic transfusions. Some patients from whom autologous blood is collected are themselves infected with HIV, HBV, or HCV. However, unlike HIV-, HBV-, or HCV-infected allogeneic blood and components, which must be excluded from the community blood supply, infected autologous blood and components are allowed to be stored in hospitals and transfused back to the patients (autologous donors) from whom the blood was collected. Although the transfusion of HIV-, HBV-, or HCV-infected autologous blood or components does not present a risk to the autologous donor, such a transfusion presents a risk to other patients, considering that at least 1 in every 25,000 transfusions are administered to the wrong individual. OBJECTIVE: To determine if hospital transfusion services store and/or transfuse autologous blood or components infected with HIV, HBV, and/or HCV. DESIGN: An educational enhancement subsection of a College of American Pathologists Proficiency Testing Survey (J-C 2003) assessed transfusion service practices for storing and/or transfusing HIV-, HBV-, and HCV-infected autologous blood and components. SETTING AND PARTICIPANTS: A total of 4251 participants were asked whether they stored and/or transfused autologous blood or components and whether these stored blood products included those that were infected with HIV, HBV, or HCV. RESULTS: Of the 4251 survey respondents, 3561 provided data regarding their autologous blood and component storage and/or transfusion practices. A total of 2988 participants reported that they store and/or transfuse autologous blood or components. A total of 2390 respondents reported that they do not test autologous donations collected in their own institution for evidence of infection with HIV, HBV, or HCV. Most survey participants reported that even if an autologous donation is tested and found to be infected they would still be willing to store and transfuse the blood component, according to which agent was causing the infection: HIV (n = 1867), HBV (n = 2158), or HCV (n = 2233). CONCLUSION: Most North American hospitals do not test autologous blood donations that they collect in their own institution for evidence of infection with HIV, HBV, or HCV, leading to the conclusion that infected autologous blood components are being stored and transfused. Even when autologous donations are tested and found to be infected with HIV, HBV, or HCV, most North American hospitals would be willing to store and/or transfuse the infected autologous blood components.

Blood Banks↗
PubMed2005

North American pretransfusion testing practices, 2001-2004: results from the College of American Pathologists Interlaboratory Comparison Program survey data, 2001-2004.

CONTEXT: Pretransfusion testing of whole blood and red blood cell recipients is regulated by the federal government under the authority of the Clinical Laboratory Improvement Amendments of 1988. Regulated tests include determination of ABO group, Rh D type, antibody detection, antibody identification, and crossmatching. A wide variety of methods and reagents are available for these regulated tests. During 2001-2004, the College of American Pathologists (CAP) Interlaboratory Comparison Program (Proficiency Testing) J-Survey collected data from more than 4000 laboratories regarding their pretransfusion testing practices. Those data are presented in this report. OBJECTIVE: To assess current testing practices for ABO grouping, Rh D typing, antibody detection, and crossmatching in North America. DESIGN: Data collected for the CAP Interlaboratory Comparison Program (Proficiency Testing) J-Survey were analyzed for trends in laboratory testing practice during 2001- 2004. The data were grouped for analysis by peer group (testing method used) for ABO grouping, Rh D typing, antibody detection, and crossmatching and then analyzed. SETTING, PATIENTS, OR OTHER PARTICIPANTS: Subscribers to the CAP Interlaboratory Comparison Program Transfusion Medicine J-Series. RESULTS: The most common testing schemes used in North America during 2001-2004 are as follows: ABO grouping (most laboratories perform tube testing: 97.6% in 2000 and 91.1% in 2004); Rh D typing (most laboratories perform tube testing: 97.7% in 2001 and 91.1% in 2004); antibody detection (most laboratories perform tube testing: 69.7% in 2001 and 55% in 2004, most frequently with the low ionic strength solution anti-human globulin [AHG] method, 48.3% in 2001 and 39.9% in 2004; as of 2004 slightly more laboratories use the gel AHG method [42%] than the low ionic strength solution AHG tube method); crossmatching for alloimmunized patients (most laboratories perform tube testing using a low ionic strength solution AHG method; 55.8% in 2001 and 47.6% in 2004); and crossmatching for nonalloimmunized patients (tube testing using an immediate spin method; 42% in 2001 and 40.4% in 2004). CONCLUSIONS: Most North American laboratories currently favor tube methods when performing ABO grouping, Rh typing, antibody screening, and crossmatching. However, there has been a significant increase in the use of gel-based methods in recent years, especially for antibody detection and crossmatching. Data collection and data analysis of CAP Interlaboratory Comparison Program Survey results allow for assessment of laboratory proficiency and provide insights into current North American practice trends in pretransfusion compatibility testing.

Blood Banks↗
PubMed2004

A comprehensive assessment program to improve blood-administering practices using the FOCUS-PDCA model.

BACKGROUND: The Joint Commission on the Accreditation of Healthcare Organizations requires that hospitals have a planned approach to systematically collect data on processes related to the use, ordering, and administering of blood components. This study describes how a comprehensive blood-administering assessment program and the FOCUS-PDCA approach improved overall blood-administering practices. STUDY DESIGN AND METHODS: Nurses were trained to observe blood issuance, blood administering, and patient monitoring steps, and to audit patient's charts to measure compliance with blood-ordering procedures. The observations were recorded on a standardized scannable form, which allowed automatic entry of recorded data directly into a computer database. RESULTS: A total of 982 assessments were completed during the 51-month study period. Documentation of informed consent improved from 80 percent to 100 percent. Compliance with a California law that requires patients to receive information on the risks, benefits, and alternatives to transfusion rose from 30 percent to 100 percent. Physicians' compliance in specifying the rate of blood administration improved from 30 percent to 100 percent, and verification of information on the patient's identification band with the patient's self-identification rose from 50 percent to 100 percent. For all other blood-administering steps, compliance remained high throughout the study period. For the past 9 months, 100-percent compliance has been maintained for all transfusion processes, and during this period no mistransfusions or blood administration near-misses have been reported. CONCLUSION: The blood-administering assessment program described above has improved transfusion practice, reduced the number of near-miss events, and may have prevented mistransfusions.

Blood Transfusion↗
PubMed2003

Patient safety and blood transfusion: new solutions.

Current risk from transfusion is largely because of noninfectious hazards and defects in the overall process of delivering safe transfusion therapy. Safe transfusion therapy depends on a complex process that requires integration and coordination among multiple hospital services including laboratory medicine, nursing, anesthesia, surgery, clerical support, and transportation. The multidisciplinary hospital transfusion committee has been traditionally charged with oversight of transfusion safety. However, in recent years, this committee may have been neglected in many institutions. Resurgence in hospital oversight of patient safety and transfusion efficacy is an important strategy for change. A new position, the transfusion safety officer (TSO), has been developed in some nations to specifically identify, resolve, and monitor organizational weakness leading to unsafe transfusion practice. New technology is becoming increasingly available to improve the performance of sample labeling and the bedside clerical check. Several technology solutions are in various stages of development and include wireless handheld portable digital assistants, advanced bar coding, radiofrequency identification, and imbedded chip technology. Technology-based solutions for transfusion safety will depend on the larger issue of the technology for patient identification. Devices for transfusion safety hold exciting promise but need to undergo clinical trials to show effectiveness and ease of use. Technology solutions will likely require integration with delivery of pharmaceuticals to be financially acceptable to hospitals.

Blood Transfusion↗
PubMed2003

Retrospective targeted HCV lookback using centralized contracted notification service.

BACKGROUND: Mandated HCV 2.0 lookback significantly challenged the human and financial resources available to the six Los Angeles County Department of Health Services (DHS) hospital blood banks. To comply with FDA requirements, DHS developed a centralized process that utilized the services of a contract vendor for performing HCV lookback. STUDY DESIGN AND METHOD: A DHS public health nurse acted as HCV lookback coordinator and as liaison with the vendor. Cases were electronically forwarded to the vendor, who then reviewed the patient's chart to obtain information necessary for tracking the patient through commercial databases. The vendor was responsible for notifying the recipient for pretest counseling and for providing documentation of all efforts. RESULTS: In total, 411 recipients were identified, of which, 168 cases were completed by the hospitals, 243 were forwarded to the vendor, 50 percent were deceased, 21 percent were contacted, and 28 percent could not be contacted, and 1 percent could not be located on any databases. The vendor contacted 35 of 66 cases that the hospitals had unsuccessfully attempted to contact. Of the cases forwarded to the vendor, 82 percent were completed on time. Delays were attributable to the vendor in less than 2 percent of cases. The cost per case forwarded to the vendor was 322 US dollars. CONCLUSION: Utilizing a professional service to conduct HCV recipient notifications is an effective strategy for meeting FDA deadlines and for freeing transfusion service staff to perform critical functions. It remains to be seen whether such strategies offer a cost savings.

Blood Donors↗
PubMed2003

Management of patients refractory to platelet transfusion.

OBJECTIVE: To present a current assessment and practical approach to the diagnosis and management of patients who are refractory to platelet transfusions. DESIGN: A task force was convened by the College of American Pathologists under the auspices of the Transfusion Medicine Resource Committee for the purposes of outlining current concepts in the definition and diagnosis of this difficult clinical management problem and selection of the optimal platelet component for these patients. RESULTS: This article represents a contemporary approach to the diagnosis and management of patients who are refractory to platelet transfusions. This document is based on a current literature review and dialog among members of the task force convened to address the subject. CONCLUSIONS: It is hoped that this document will represent a resource and practical approach to the issue of diagnosis and management of patients who are refractory to platelet transfusions.

Case Management↗