scholarly journals The American Society for Veterinary Clinical Pathology Regulatory Affairs Committee's clinical pathology best practices recommendations will impact the discipline of veterinary toxicologic clinical pathology

2013 ◽  
Vol 42 (3) ◽  
pp. 247-249
Author(s):  
William J. Reagan
Keyword(s):  
Best Practices ◽  
Clinical Pathology ◽  
Regulatory Affairs ◽  
American Society

scholarly journals Principles for Assessing Adversity in Toxicologic Clinical Pathology

2017 ◽  
Vol 45 (2) ◽  
pp. 260-266 ◽  
Author(s):  
Lila Ramaiah ◽  
Lindsay Tomlinson ◽  
Niraj K. Tripathi ◽  
Laura C. Cregar ◽  
Allison Vitsky ◽  
...  
Keyword(s):  
Clinical Pathology ◽  
Integrated Approach ◽  
Data Interpretation ◽  
Weight Of Evidence ◽  
Regulatory Guidance ◽  
Regulatory Affairs ◽  
Safety Studies ◽  
American Society ◽  
The Impact

There is limited direction in the literature or regulatory guidance on determination of adversity for clinical pathology (CP) biomarkers in preclinical safety studies. Toxicologic clinical pathologists representing the American Society for Veterinary Clinical Pathology—Regulatory Affairs Committee and Society of Toxicologic Pathology—Clinical Pathology Interest Group identified principles, overall approach, and unique considerations for assessing adversity in CP data interpretation to provide a consensus opinion. Emphasized is the need for pathophysiologic context and a weight-of-evidence approach. Most CP biomarkers do not have the potential to be adverse in isolation, regardless of magnitude of change. Rather, they quantify or describe the impact of effects, provide adjunct or supportive information regarding a process or pathogenesis, and provide translational biomarkers of effect. Most often, CP changes are part of a constellation of findings that collectively are adverse. Thus, most CP changes must be interpreted in conjunction with other study findings and require contextual and integrative interpretation. Exceptions include critical CP changes without correlates that indicate a health risk in the tested species. Overall, CP changes should not be interpreted in isolation and their adversity is best addressed with an integrated approach.

scholarly journals STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies

2016 ◽  
Vol 44 (2) ◽  
pp. 163-172 ◽  
Author(s):  
Lindsay Tomlinson ◽  
Lila Ramaiah ◽  
Niraj K. Tripathi ◽  
Valerie G. Barlow ◽  
Allison Vitsky ◽  
...  
Keyword(s):  
Best Practices ◽  
Vaccine Development ◽  
Clinical Pathology ◽  
Data Interpretation ◽  
Recovery Phase ◽  
Development Programs ◽  
Toxicity Studies ◽  
Delayed Toxicity ◽  
American Society ◽  
Pathology Data

The Society of Toxicologic Pathology formed a working group in collaboration with the American Society for Veterinary Clinical Pathology to provide recommendations for the appropriate inclusion of clinical pathology evaluation in recovery arms of nonclinical toxicity studies but not on when to perform recovery studies. Evaluation of the recovery of clinical pathology findings is not required routinely but provides useful information on risk assessment in nonclinical toxicity studies and is recommended when the ability of the organ to recover is uncertain. The study design generally requires inclusion of concurrent controls to separate procedure-related changes from test article–related changes, but return of clinical pathology values toward baseline may be sufficient in some cases. Evaluation of either a select or full panel of standard hematology, coagulation, and serum and urine chemistry biomarkers can be scientifically justified. It is also acceptable to redesignate dosing phase animals to the recovery phase or vice versa to optimize data interpretation. Assessment of delayed toxicity during the recovery phase is not required but may be appropriate in development programs with unique concerns. Evaluation of the recovery of clinical pathology data for vaccine development is required and, for efficacy markers, is recommended if it furthers pharmacologic understanding.

ESTABLISHING IN-HOUSE REFERENCE INTERVALS FOR DOGS IN VETERINARY CLINICS

2016 ◽  
Vol 42 (02) ◽  
pp. 53-67
Author(s):  
Shang-Hsiu Chung ◽  
Li-Wen Chang ◽  
Tsun-Li Cheng ◽  
Chen-Jou Lin ◽  
Wen-Ying Chen ◽  
...  
Keyword(s):  
Uric Acid ◽  
Bile Acid ◽  
Biochemical Parameters ◽  
Clinical Pathology ◽  
Reference Interval ◽  
Reference Intervals ◽  
Gamma Glutamyl Transferase ◽  
Coagulation Parameters ◽  
American Society ◽  
Glutamyl Transferase

Reference interval (RIs) were critical to the identification of illness. However, RIs set in one laboratory may not be appropriate for another because of biological, geographical and instrumental factors. Interpretation of clinical data using inappropriate RIs may cause misclassification of results and misdiagnosis that lead to improper treatment. RIs in Taiwan have been mostly referencing from foreign resources, it is desirable to establish one that is closer to the overall conditions in Taiwan (such as breed, climate, diseases, etc.) and to investigate its differences to foreign RIs. The present study used the American Society for Veterinary Clinical Pathology (ASVCP) guidelines to establish in-house RIs for hematological, biochemical and coagulation parameters using dogs in middle Taiwan. The results were also compared to two foreign and one local RIs. The results suggested that the hematological RIs are more comparable to foreign RIs than the biochemical and hemostatic parameters. Differences were found for biochemical parameters including gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, uric acid, bile acid, bilirubin and magnesium; and coagulation parameters including prothrombin time (PT) and activated partial thromboplastin. In all, 18% (7/40) of the all tested parameters were different from the local RI while 38% (18/48) and 41% (19/46) of the parameters were different from the two foreign RIs. The differences in more than 30% RIs and better similarities to local RIs underscore the importance of having own RIs if possible.

scholarly journals Contemporary Cardiac SPECT Imaging—Innovations and Best Practices: An Information Statement from the American Society of Nuclear Cardiology

2018 ◽  
Vol 25 (5) ◽  
pp. 1847-1860 ◽  
Author(s):  
Brian G. Abbott ◽  
James A. Case ◽  
Sharmila Dorbala ◽  
Andrew J. Einstein ◽  
James R. Galt ◽  
...  
Keyword(s):  
Best Practices ◽  
Nuclear Cardiology ◽  
Spect Imaging ◽  
Cardiac Spect ◽  
American Society

Examining the Quality of Rectal Cancer Operative Reports in Teaching Institutions: Is There an Opportunity for Resident Education?

2016 ◽  
Vol 82 (10) ◽  
pp. 1023-1027
Author(s):  
Aaron B. Parrish ◽  
Yas Sanaiha ◽  
Beverley A. Petrie ◽  
Marcia M. Russell ◽  
Formosa Chen
Keyword(s):  
Rectal Cancer ◽  
Best Practices ◽  
Resident Education ◽  
Cancer Surgery ◽  
Teaching Hospitals ◽  
Rectal Cancer Surgery ◽  
Technical Quality ◽  
American Society ◽  
Junior Residents

The American Society of Colon and Rectal Surgeons rectal cancer checklist describes a set of best practices for rectal cancer surgery. The objective of this study was to assess the quality of operative reports for rectal cancer surgery based on the intraoperative American Society of Colon and Rectal Surgeons checklist items. Patients undergoing rectal cancer surgery at two public teaching hospitals from 2009 to 2015 were included. A total of 12 intraoperative checklist items were assessed. One hundred and fifty-eight operative reports were reviewed. Overall adherence to checklist items was 55 per cent, and was significantly higher in attending versus resident dictated reports (67% vs 51%, P < 0.01). Senior residents had significantly higher adherence to checklist items than junior residents (55% vs 44%, P < 0.01). However, overall adherence to rectal cancer checklist items was low. This represents an opportunity to improve the quality of operative documentation in rectal cancer surgery, which could also impact the technical quality of the operation itself.

scholarly journals American Society for Clinical Pathology’s 2019 Wage Survey of Medical Laboratories in the United States

2020 ◽  
Author(s):  
Edna Garcia ◽  
Iman Kundu ◽  
Karen Fong
Keyword(s):  
Urban Areas ◽  
Clinical Pathology ◽  
The United States ◽  
Washington Dc ◽  
Laboratory Personnel ◽  
Education Marketing ◽  
And Performance ◽  
Board Of Certification ◽  
American Society ◽  
Laboratory Information Systems

Abstract Objectives To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. Methods The 2019 Wage Survey was conducted through collaboration of the American Society for Clinical Pathology (ASCP) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Results Compared with 2017, results show an overall increase in salaries for most laboratory occupations surveyed except cytogenetic technologists, laboratory information systems personnel, and performance improvement or quality assurance personnel. Geographically, laboratory professionals from urban areas earned more than their rural counterparts. Conclusions As retirement rates continue to increase, the field needs to intensify its efforts on recruiting the next generation of laboratory personnel. To do so, the report urged the field to highlight advocacy for better salaries for laboratory personnel at the local and national levels when developing recruitment and retention strategies.

scholarly journals Suggested guidelines for validation of real-time PCR assays in veterinary diagnostic laboratories

2020 ◽  
Vol 32 (6) ◽  
pp. 802-814
Author(s):  
Kathy Toohey-Kurth ◽  
Monica M. Reising ◽  
Rebecca L. Tallmadge ◽  
Laura B. Goodman ◽  
Jianfa Bai ◽  
...  
Keyword(s):  
Real Time ◽  
Real Time Pcr ◽  
Animal Health ◽  
Clinical Pathology ◽  
Nucleic Acid Detection ◽  
Diagnostic Laboratory ◽  
Consensus Document ◽  
American Society ◽  
Laboratory Technology ◽  
The U.S

This consensus document presents the suggested guidelines developed by the Laboratory Technology Committee (LTC) of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for development, validation, and modification (methods comparability) of real-time PCR (rtPCR) assays. These suggested guidelines are presented with reference to the World Organisation for Animal Health (OIE) guidelines for validation of nucleic acid detection assays used in veterinary diagnostic laboratories. Additionally, our proposed practices are compared to the guidelines from the Foods Program Regulatory Subdivision of the U.S. Food and Drug Administration (FDA) and from the American Society for Veterinary Clinical Pathology (ASVCP). The LTC suggestions are closely aligned with those from the OIE and comply with version 2021-01 of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, although some LTC recommendations are more stringent and extend beyond the AAVLD requirements. LTC suggested guidelines are substantially different than the guidelines recently published by the U.S. FDA for validation and modification of regulated tests used for detection of pathogens in pet food and animal-derived products, such as dairy. Veterinary diagnostic laboratories that perform assays from the FDA Bacteriological Analytical Method (BAM) manual must be aware of the different standard.

scholarly journals Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries

2013 ◽  
Vol 42 (3) ◽  
pp. 252-269 ◽  
Author(s):  
Lindsay Tomlinson ◽  
Laura I. Boone ◽  
Lila Ramaiah ◽  
Kelley A. Penraat ◽  
Barbara R. von Beust ◽  
...  
Keyword(s):  
Best Practices ◽  
Clinical Pathology
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