http://www.ivis.org Proceeding of the Biennial Conference of the Association for Applied Animal Andrology July 28-29, 2012 - Vancouver, Canada 9th Association for Applied Animal Andrology Biennial Conference will be held in 2014. Visit www.animalandrology.org for more information and updates Reprinted in the IVIS website with the permission of the Association for Applied Animal Andrology - AAAA
Developing an NAAB/CSS semen quality control program Jere R. Mitchell * National Association of Animal Breeders and Certified Semen Services, Columbia, MO, USA Abstract Certified Semen Services, Inc. (CSS), a subsidiary of the National Association of Animal Breeders (NAAB), added the area of semen quality control to its audit program in 2011.This followed an extensive review process and resulted in minimum semen quality control provisions being included in the CSS Agreement with participating artificial insemination businesses. This includes semen quality control procedures, sperm numbers per breeding unit, post thaw quality values, qualifications and exceptions, guided training and competency. A detailed questionnaire covering current quality control procedures was completed by participants and reviewed during the annual audit visit. Responses were important to help guide the initial audit for each business. A new committee was also established to provide additional input on development of the semen quality control audit program. They are currently developing a guidance document of recommended quality control procedures focusing on sperm concentration, motility and morphology assessment. In addition, a semen quality workshop/training session will be held September 2012 during the biennial NAAB Technical Conference on Artificial Insemination and Reproduction. This new program is applicable to all CSS participating businesses and aimed at helping to insure each breeding unit contains semen of adequate quantity and quality to achieve fertility in producer herds Keywords: Artificial insemination; Semen; Quality control; NAAB; CSS; Audit 1. Introduction In January 2011, Certified Semen Services, Inc. (CSS) a subsidiary of the National Association of Animal Breeders (NAAB) added the area of Semen Quality Control to its established audit program. Certified Semen Services provides artificial insemination (AI) industry self-regulation in areas of semen identification, health of donor sires, disease control of semen and AI center animal management practices. Compliance with CSS minimum standards and guidelines is assessed through annual audits of the participating businesses. The structure and operational details of CSS have been described previously [1,2] and information is available on-line at www.naab-css.org. This new undertaking was the culmination of a two year process that entailed numerous discussions, meetings, conference calls and consultations. The NAAB Technical Committee and Association staff developed the structural outlines of the semen quality control program and * Correspondence: National Association of Animal Breeders and Certified Semen Services Inc., Columbia, MO, USA; E-mail: jmitchel@naab-css.org 1
recommended that it be implemented for all NAAB/CSS organizations. Both NAAB and CSS Boards of Directors approved the program, and it has been included as a part of the CSS Audit Agreement [3] that each participating organization must enter into on an annual basis. A main goal of the program is to provide a uniform framework to enhance consistency among organizations in their minimum quality control procedures. Integral areas to be addressed in the new program as described by Kaproth et al. [4] include the following: 2. Procedures I. Semen quality control procedures utilized by the AI business to determine neat sperm concentration, sperm number per breeding unit, pre-freeze and post-thaw semen evaluation are documented and reviewed during an unannounced CSS audit inspection and by ad hoc communication. II. Each AI business must provide the details of its quality control procedures, minimum standards for pre-freeze and post-thaw semen quality, and sperm numbers per breeding unit, for review and approval during the CSS audit. These established quality control minimum standards and quality control procedures are privately held. III. A library of NAAB/CSS guidance on procedures, contributed by member organizations, will be organized and made available to any NAAB regular member organization requesting guidance. 3. Sperm numbers I. Sperm counting procedures are observed and reviewed during the CSS audit. Recommendations are made on procedures, calibration method and frequency, equipment condition, type, and age. II. To monitor all steps critical for sperm numbers (e.g., sampling and measuring during initial determinations, dilution during processing, and uniformity in mixing prior to straw filling) AI businesses will routinely verify sperm numbers in processed straws. a) Sampling of straws for sperm numbers will cover the range of sperm concentrations utilized. b) AI businesses utilizing increased extension rates are to use a sufficient sampling frequency. c) Viewed audit records demonstrate targeted sperm numbers are met within tolerance. III. To achieve efficient utilization of elite genetics, many AI businesses practice increased extension rates in a strategic manner understood and referred to as the NAAB/CSS semen extension rate pyramid (Figure 1). a) Stepwise increases in extension rates are a consequence of obtaining expanded and favorable semen quality and fertility information. b) A written procedure is in place to accommodate stepwise extension rate changes in response to semen quality and fertility information. c) Where sires are processed at high extension rates, data supporting semen quality, field fertility, and (or) dose response trials are reviewed during the CSS audit. IV. An agreed upon minimum and maximum sperm number per breeding unit will be identified. 2
a) Care is taken so that no perception can be made that low sperm quality is being masked by excessive sperm numbers. b) A very low extension rate is generally outside of industry experience set for safe sanitation and antibiotic efficacy procedures in the breeding unit. Figure 1. The NAAB/CSS semen extension rate pyramid conceptualizes stepwise increases in semen extension rate as more favorable semen quality and fertility information is available or specialized techniques are utilized. Figure is from Kaproth et al [4]. 4. Measured values of post-thaw quality I. Due diligence requires AI businesses to identify and discard semen batches that should not be inventoried and used. Discard records and statistics are made available and reviewed during CSS audit inspection. II. AI businesses must perform and record the results of a visual post thaw microscopic evaluation of sperm motility for each collection code of semen frozen. III. The CSS audit ensures equipment and training are creditable, task-sufficient, and accurate. 3
a) Additional objective sperm quality control procedures are highly encouraged for their ability to confirm internal training, provide controls on lab and bull variability and detection of unexpected adverse outcomes. This is certainly expected where sires are processed at high extension rates. IV. The CSS audit includes a review of all supplemental evaluation procedures and equipment. a) Written procedures, including internal standards and minimums are viewed. b) This critique is to ensure all procedures are science-based, effectively implemented, and data is appropriately interpreted as it relates to either (1) controlling laboratory or bull variability, or (2) adding to estimates of potential field fertility. c) The CSS auditor will consult with outside experts to assist in approval/validation of novel semen evaluation technologies as necessary. 5. Qualifying and exceptions I. Samples failing to achieve quality control minimums are typically discarded from normal inventory, however there are provisions for exceptions. II. In the event of such exceptions, each AI business must record a predetermined plan to follow in the event that any sub-standard semen is to be released for field use. III. Release of such semen could be based on various considerations such as, the superior (genetic) value of the sire, imminent demise of the sire, or at request of the bull s owner, etc. IV. This Exception provides a physical identifier (cane color, straw message, etc), and (or) other employed procedures to ensure the customer is aware the semen does not meet the AI business semen quality control minimums. 6. Guided training and documented competence AI businesses must provide evidence that internal checks of competency are routine. I. Opportunities to participate in a guided curriculum for basic and advanced training in semen evaluation and bovine reproductive physiology will be developed. Approved entities such as commercial semen processors and (or) academic institutions will contribute to this development. II. Each CSS approved laboratory must provide evidence that employees and laboratory supervisors are adequately trained for their assigned tasks. a) Attendance in an NAAB-guided training course is not a requirement provided similar outcomes in content, competence and training are obtained. b) Advanced training is highly desirable, and completion of NAAB/CSS guided training will be desirable and noteworthy. III. A mechanism is provided whereby outside inquiries and disputes are directed to academically qualified and professionally trained third party laboratories (experts). 4
7. Background, implementation and next steps The various discussions that led to implementation of our semen quality control initiative were comprehensive and there was abundant discourse regarding: diversity among members as to business model, their semen quality control standards and methodologies, field fertility information for owned and customer bulls, and lack of correlation between fertility and many measures of semen quality. There was also recognition that a related organization was proposing minimum semen quality standards for frozen bovine semen that although well meaning were arbitrarily derived and lacked information known to the semen processing business. In addition they appeared not to accommodate new technological advances. Another consideration discussed was the potential for onerous international regulations regarding semen quality if left to be defined by non-stakeholders. Overall, it was determined that there was a need to develop an AI industry semen quality control program that was science based, meaningful to members and that would demonstrate the AI industry s commitment to semen quality with customers, related associations, regulators and others interested parties. The NAAB/CSS program was phased in during 2011. In the first year the CSS Service Director reviewed, during the annual audit visit, responses to a detailed questionnaire that had been sent to all participants previously covering their current quality control practices. These responses were very important to help guide the initial semen quality control audit for each organization. In addition an audit checklist on semen quality was completed and information included in their subsequent audit report. A Semen Quality Control Committee was appointed to further develop the program details in areas of competency, training and compliance. Their charge is to recommend compliance requirements including minimum equipment, calibration schedules and procedures for semen quality assurance, among others. The committee will provide input to the CSS Service Director and Board of Directors and be a sounding board on topics pertinent to the Semen Quality Control Audit program. Their first meeting was held in September of 2011 and they are currently developing a guidance document of recommended procedures focusing on three areas of semen evaluation: sperm concentration, sperm motility and sperm morphology. It is planned that the resulting document will be published in the Proceedings of 2012 NAAB Technical Conference. The committee is also organizing a training/education session to be held in conjunction with the September 2012 NAAB Technical Conference. 8. Conclusion Following a comprehensive review process, NAAB/CSS has established a minimum semen quality control audit program. The standards, guidelines and requirements are applicable to all CSS participating AI businesses for the purpose of helping to insure that each breeding unit contains sperm of adequate quality and quantity to achieve normal fertility in producer herds. Through education, training and validation, CSS-audited businesses are expected to be expert in procedures and interpretation of semen quality control. It follows that bull owners and end users should be confident that these AI businesses are providing extraordinary attention to quality control. 5
References [1] Mitchell, J.R. 1992. CSS-organization and audit. Proc 14 th Tech Conf Artif Insem and Reprod, NAAB, pp. 115-120. [2] Mitchell, J.R. 2002. Certified Semen Services update. Proc 20 th Tech Conf Artif Insem and Reprod, NAAB, pp. 102-105. [3] NAAB/CSS website. 2011. Certified Semen Services, Inc. CSS participation agreement-- for semen Identification, semen quality control and sire health auditing service. http://www.naab-css.org/about_css/ [4] Kaproth, M. T., R. Hanson, J. R. Mitchell. 2010. The NAAB brand : characteristics of an NAAB-guided semen quality control program. Proc 23rd Tech Conf Artif Insem and Reprod, NAAB, pp. 10-12. 6