August 2017 Changes. Reproductive Laboratory Checklist. CAP Accreditation Program

Transcription

1 August 2017 Changes Reproductive Laboratory Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL

2 Disclaimer and Copyright Notice On-site inspections are performed with the edition of the Checklists mailed to a facility at the completion of the application or reapplication process, not necessarily those currently posted on the website. The checklists undergo regular revision and a new edition may be published after the inspection materials are sent. For questions about the use of the Checklists or Checklist interpretation, accred@cap.org or call or (international customers, use country code 001). The Checklists used for inspection by the College of American Pathologists' Accreditation Programs have been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying and use of the checklists by CAP inspectors in conducting laboratory inspections for the Commission on Laboratory Accreditation and by laboratories that are preparing for such inspections. Except as permitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the Checklists constitutes infringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legal action to protect these copyrights. All Checklists are College of American Pathologists. All rights reserved.

3 Using the Changes Only Checklist 3 of 9 This document contains new checklist requirements, major and minor requirement revisions, and changes to explanatory text. Changes appear in a track changes format that compares the previous checklist edition to the August 21, 2017 edition. Requirements with major revisions will display a Revised flag. These changes may affect your laboratory operations. Requirements with minor revisions will not display a Revised flag. They are editorial changes that are not likely to affect your laboratory operations. Information regarding requirements that have been combined, moved, resequenced or deleted, as applicable, appears in table format below CHECKLIST EDITION CHANGES DELETED, MERGED, AND MOVED REQUIREMENTS * 2016 Requirement Action Taken 2017 Requirement RLM Merged GEN GEN GEN RLM Merged RLM *Merged Combined the requirement with a similar requirement in the same or different checklist *Moved Relocated the requirement to another checklist or resequenced it within the same checklist INTRODUCTION This checklist is used in conjunction with the All Common and Laboratory General Checklists to inspect a reproductive laboratory. Note for non-us laboratories: Checklist requirements apply to all laboratories unless a specific disclaimer of exclusion is stated in the checklist. Checklist requirements for laboratory director, supervisory personnel, and testing personnel vary depending on the type of testing or services performed. The following table includes information to identify appropriate requirements for inspecting personnel qualifications. Checklist Requirements for Personnel Qualifications Position Checklist Requirement Type of Testing/Services Andrology and other CLIA-related Testing Laboratory Director TLC All Andrology and CLIA-related Testing Section Director/Technical GEN High Complexity Testing Supervisor General Supervisor GEN High Complexity Testing Technical Consultant GEN Moderate Complexity Testing Clinical Consultant GEN Moderate & High Complexity Testing Testing Personnel GEN Moderate & High Complexity Testing Embryology Embryology Laboratory Director RLM Assisted Reproductive Technology Procedures Embryology Supervisor RLM Assisted Reproductive Technology Procedures

4 4 of 9 Embryology Laboratory Personnel RLM Assisted Reproductive Technology Procedures ANDROLOGY AND EMBRYOLOGY AUTOMATED SEMEN ANALYSIS INSTRUMENTS Calibration and Quality Control RLM Calibration Verification Criteria Phase II There are written criteria for method calibration verification. NOTE: Criteria for determining the need for calibration verification typically include: 1. At complete changes of reagents, unless the laboratory can demonstrate that changing reagent lots does not affect either the range used to report patient test results or the control values, 2. When QC materials reflect an unusual trend or shift or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem 3. After major maintenance or service, 4. When recommended by the manufacturer, 5. At least every six months. For automated semen analysis instruments, requirements for calibration verification may be considered met if the laboratory follows the manufacturer's instructions for instrument operation and tests two levels of control materials each day of testing. The control results must meet the laboratory's criteria for acceptability. MANUAL SEMEN ANALYSIS Sperm Concentration RLM Counting Chamber and Optical Grid Quality Phase I The lines in theall counting or motility chambers, ocular micrometers, and optical grids are bright, and the chambers are clean and free offrom scratches, dirt, or debris. **REVISED** 08/17/201621/2017 RLM Manual Cell Count Controls Phase II AtFor manual sperm counts, at least one cell count control specimen is analyzed in duplicate, or a procedural control used, for each eight hours of patient testing. NOTE: This requirement can be met with assayed liquid control material, a previously assayed patient sample, or a procedural control. (An example of a procedural control is correlation of the

5 5 of 9 cell count with the cellularity of a stained slide prepared by a standard, validated method.). Liquid controls performed in a hemocytometermaterials must be runtested in duplicate. RLM Semen Analysis Procedure Phase II For samples counted using a standard hemocytometermanual sperm counts, each sperm sample is counted in duplicate. NOTE: Defined limitstesting records must reflect the performance of the counts in duplicate for all counting chambers. Limits of agreement between replicate counts must be establisheddefined. Semen Stained Smear - Sperm Differential RLM Stain QC Phase II AllQuality control of all stains are checkedis performed and recorded to check for contamination and intended reactivity each day of use. **NEW** 08/21/2017 RLM Ocular Micrometer Calibration/Recalibration Phase II The ocular micrometer (when required) has been calibrated for the microscope(s) in which it is used, and it is recalibrated each time the eyepieces or objectives are changed. NOTE: An ocular micrometer is required for certain sperm morphology classification methods, including Kruger Strict and World Health Organization (WHO) sperm morphology methods, as referenced in the 3rd, 4th, and 5th editions of the WHO laboratory manual for the examination and processing of human semen. Calibrations can be checked against a micrometer or other objects of known dimensions. If there are no changes to a particular microscope's optical components, there is no need to recheck calibration. ANDROLOGY PERSONNEL The laboratory should have an organizational plan, personnel policies, and job descriptions that define qualifications and duties for all positions. Personnel files must contain diplomas or transcripts, references, competency assessments, health records, and continuing education records for each employee. Ideally, these files should be located in the laboratory. However, they may be kept in the personnel office or health clinic if the laboratory has ready access to them (i.e. easily available to the inspector). The section director of the andrology laboratory must have the appropriate training and background to assume responsibility for the overall operation and administration of the laboratory, including hiring competent personnel, formulating laboratory policies and protocols, and communicating regularly regarding patient progress and patient protocols as they affect laboratory aspects of treatment. The andrology section director must be accessible to the laboratory for on-site, telephone or electronic consultation as needed.

6 6 of 9 RLM Personnel Qualifications Phase II The andrology section director and all other personnel in the andrology laboratory meet the requirements described in the Laboratory General Checklist and the Team Leader Assessment of Director and Quality Checklist. NOTE: The andrology section director must have two years experience in a laboratory performing andrology procedures. This experience should include quality management, quality control, inspection, accreditation and licensing procedures, as well as andrology procedures. Evidence of Compliance: Records of qualifications including degree or transcript, certification, current license (if required) and work history in related field REFERENCES 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1056[42CFR ], 1058[42CFR ], 1066[42CFR ], 1067[42CFR ], 1070[42CFR ] EMBRYOLOGY Embryology laboratories may have separate andrology facilities that are not accredited by the College of American Pathologists. However, if the embryology laboratory either processes sperm for therapeutic insemination, oocyte insemination, or performs any form of a semen analysis, it must complete requirements in the preceding SPERM PROCESSING FOR THERAPEUTIC INSEMINATION section and/or the ANDROLOGY section. Genetic testing on embryo biopsy specimens must be performed by a CAP accredited laboratory or other laboratory meeting the referencereferral laboratory selection criteria defined in the Laboratory General Checklist (GEN.41350). If no embryology procedures are performed in the laboratory continue with the Cryopreservation of Sperm, Oocytes, and Embryos section. CULTURE OF SPERM, OOCYTES, AND EMBRYOS **REVISED** 08/17/2016 RLM Embryo Biopsy/Specimen Preparation Training Phase II There is a written program to train personnel and evaluate competence in the performance of embryo biopsy and specimen preparation. NOTE: This training must include the process for identifying and labeling individual biopsy specimens to ensure that records of genetic testing performed on each biopsy specimen can be correlated to the native embryo. Evidence of Compliance: Records of training and competency EMBRYOLOGY PERSONNEL

7 7 of 9 The requirements in this section apply to embryology services only. Personnel requirements for andrology and other CLIA-related testing are found in the Laboratory General Checklist and Director Assessment Checklist. A table with information for identifying the applicable checklist requirements based on tests or services performed is found in the Introduction section of this checklist. EMBRYOLOGY SECTIONLABORATORY DIRECTOR RLM Embryology SectionLaboratory Director Qualifications Phase II The section director of the embryology laboratory director has proper qualifications through education and experience to provide direction and administration of the laboratory. NOTE: The section director of the embryology laboratory director must have at least two years of experience in a laboratory performing in vitro fertilization or assisted reproductive technologiesrelated procedures. Section directors of embryology laboratories who are not physicians or qualified doctoral scientists, but who were functioning as embryology directors on or before July 20, 1999 are considered in compliance with the personnel requirements in the Laboratory General Checklist, as long as they meet all other requirements. and meet the following requirements: MD or DO licensed (if required) in the jurisdiction where the laboratory is located; or Doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; or Individual functioning as an embryology director on or before July 20, Effective January 1, 2006, all new laboratory directors must hold HCLD (High Complexity Laboratory Director), ABB-ELD (American Board of Bioanalysis Embryology Laboratory Director), or equivalent certification. If the laboratory is also performing testing for the purpose of diagnosis (e.g. semen analysis, hormone assays), the laboratory director must meet the personnel requirements defined in the Team LeaderDirector Assessment of Director and Quality Checklist. If more stringent state or local regulations are in place for supervisory qualifications, including requirements for state licensure, they must be followed. *For embryology laboratory directors newly employed on or after January 1, 2018, the training and qualifications of personnel trained outside of the United States must be evaluated to determine equivalency to an education obtained in the United States, with records of the evaluation available in the personnel file. Equivalency evaluations must be performed by a nationally recognized organization, such as the National Association Credential Evaluation Services, Inc. (NACES) ( and the Association of International Credential Evaluators, Inc. (AICE) ( RLM Assisted Reproductive Technology (ART) - Personnel Qualifications Phase II Embryology All embryology laboratory personnel performing assisted reproductive technology (ART) procedures must have appropriate education and records of training. NOTE: Embryology laboratory personnel must have records of training for each of the ART laboratory procedures performed. An embryologist must have ameet the following minimum of a bachelor'srequirements:

8 8 of 9 Bachelor's degree in a chemical, physical, biological, medical technology, clinical, or reproductive laboratory science from an accredited institution. Embryologists*; or Individuals performing ART laboratory procedures prior to January 1, 2012, are considered in compliance with this requirement, as long as there is recorded training for the ART laboratory procedures performed and the embryologist meets the laboratory's meet laboratory-defined personnel qualifications. and have records of training for the ART laboratory procedures performed. NOTE: If embryologymore stringent state or local regulations are in place for personnel qualifications, including requirements for state licensure, they must be followed. Embryology personnel are also performingwho perform testing for the purpose of diagnosis (e.g. diagnostic semen analysis, hormone analysis), the embryologist) must also qualify under the testing personnel requirements defined in the Laboratory General Checklist. (GEN.54750). *For personnel newly employed on or after January 1, 2018, the training and qualifications of personnel trained outside of the United States must be evaluated to determine equivalency to an education obtained in the United States, with records of the evaluation available in the personnel file. Equivalency evaluations must be performed by a nationally recognized organization, such as the National Association Credential Evaluation Services, Inc. (NACES) ( and the Association of International Credential Evaluators, Inc. (AICE) ( RLM Embryology Training/Evaluation Phase II There is a written program to train and evaluateare records that all embryology laboratory personnel in their competency to perform embryology, including micromanipulation and otherhave satisfactorily completed initial training for each assisted reproductive technology techniques(art) technique performed. NOTE: For laboratories performing embryology, therethere must be a training program for new personnel, using animal model systems or nonviable human oocytes. The training must include all techniques performed by each individual, such as in vitro fertilization, micromanipulation, and embryo biopsy. It must also include the process for identifying and labeling individual reproductive tissues (gametes, embryos, and biopsy specimens) to maintain the identity of the specimen throughout receipt, storage, processing, and disposition and to ensure that records of genetic testing performed on biopsy specimens can be correlated to the native embryo. Retraining must occur when problems are identified with personnel performance. **NEW** 08/21/2017 RLM Competency Assessment of Embryology Personnel Phase II The competency of each person performing embryology procedures, including micromanipulation and other assisted reproductive technology techniques is assessed. NOTE: Prior to performing embryology procedures each embryologist must have training and be evaluated for proper performance of the techniques used. Retraining and reassessment of competency must occur when problems are identified with an individual's performance. During the first year of an individual's duties, competency must be assessed at least semiannually. After an individual has performed his/her duties for one year, competency must be assessed at least annually. Competency assessment must include all applicable elements described below for each individual. Elements of competency assessment include, but are not limited to:

9 9 of 9 1. Direct observations of routine embryology procedures, including, as applicable, patient identification, specimen collection, handling, and processing 2. Monitoring the recording and reporting of embryology cycle events 3. Review of intermediate test results or worksheets quality control records, proficiency testing results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of internal blind samples or external proficiency testing samples, and 6. Evaluation of problem-solving skills Many of the elements of competency assessment are performed during routine review of personnel throughout the year. Records of these elements, including adherence to laboratory policies and procedures, observation of embryology laboratory procedures, results reporting, instrument maintenance, review of worksheets, recording QC, performance of PT, and demonstration of taking appropriate corrective actions are examples of daily activities that can be used to demonstrate competency. If elements of competency are assessed during routine review, the competency procedure must outline how this routine review is used to evaluate competency. Competency assessment during routine review may be recorded using a checklist. RLM Off-Site Embryology SectionLaboratory Director Visits Phase II For laboratories that do not have an on-site embryology sectionlaboratory director, there must be records of visits from the embryology sectionlaboratory director at a minimum of once per quarter. NOTE: If the laboratory performs andrology testing, state and federal requirements for director visits must be followed, which may be more stringent. RLM Oversight Responsibility Phase II For laboratories that do not have an on-site, full time embryology sectionlaboratory director, or the medical director is also the embryology sectionlaboratory director, there is a designated on-site individual qualified as an embryology supervisor, to provide oversight of daily activities and assist with troubleshooting or other unusual situations. NOTE: The intent is to ensure that the laboratory continues to function properly in the embryology sectionlaboratory director's absence and to ensure that resources are available to quickly assist with unusual problems to minimize any adverse impact on patient care. RLM Back-up Personnel Phase II The laboratory has a policy to provide back-up laboratory personnel as needed, to ensure timely embryology services. NOTE: Staffing levels must be appropriate for the size and volume of the program. If routine staffing of the laboratory does not provide sufficient back up for laboratory personnel, the laboratory must have a policy describing how patient care needs will be met for its laboratory services in the event of a staffing shortage or emergency. The laboratory director is responsible to ensure that the qualifications and training of each individual are adequate for the duties to be performed. For laboratories that are not staffed full-time, appropriately trained personnel are available to routinely monitor storage conditions for cryopreserved specimens