Attachment 1 - Lab Accreditation Requirements Questions.pdf
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- Attached to
- R420--Lab Accreditation - Follow-on
- Solicitation number
- 36C10G25Q0036
About this file
This is a list of 32 detailed questions from the Department of Veterans Affairs (VA) seeking information about laboratory accreditation services capabilities. The questions focus on key areas including CMS deemed accreditation status, surveyor qualifications (particularly the requirement for board-certified pathologists), standards and inspection processes, online portal capabilities, and support services.
The VA is specifically seeking accreditation services for approximately 260 laboratories across all 50 states plus Hawaii, Alaska, Philippines, and Puerto Rico, with about 175 labs classified as VA Medical Centers or having pathology services. Key requirements include the ability to provide accreditation for all CLIA specialty/subspecialties except Immunohematology and Histocompatibility, incorporation of VA Directive 1106 standards, coordination with AABB accreditation for immunohematology, and the ability to manage electronic portals that can accommodate VA's 7-region organizational structure. The questions indicate the VA needs a provider who can transition existing accreditation cycles with minimal disruption and provide comprehensive support services including education, training, and customer service.
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Lab Accreditation Services
Requirements Questions for Business Concerns:
1. Is your organization a CMS deemed accreditation organization for inspection and accreditation of clinical laboratories?
2. The VA is seeking laboratory accreditation services for every CLIA specialty/subspecialty except Immunohematology and Histocompatibility. Are there any specialties/subspecialties you are not deemed to accredit?
Surveyors
3. What type of surveyors you utilize, what are the experience requirements to become a surveyor and what is your surveyor method of training? How are your surveyors assessed for competency and ensure it is maintained?
4. There are about 175 VA labs that have pathology service or are classified as a VA Medical Center. The VA requires board certified pathologists to serve surveyors for these high complex VA labs or labs performing pathology services.
How many pathologists do you have on staff/affiliated now that serve as surveyors for your organization? If you were awarded the VA work, how would you meet this requirement? Do you currently provide similar services to a similar sized and similar complexity organization as the VA?
5. How are your on-site inspections surveyors allocated? Is there an inspector for each major area of the laboratory? A set number of inspectors based on laboratory size/complexity?
Standards
6. The VA requires all clinical lab inspections to be minimally based off the CMS CFR 42 part 493 standards. What additional standards or inspection criteria is included in your organization’s inspection process? How will your organization incorporate VA custom standards from VA Directive 1106 into your inspection process?
7. Please provide examples of how your standards are written. What inspection standards do you get the most questions about or you find your current laboratories have the hardest time interpreting? Do you offer examples of ways to meet the standards?
8. How are your standards arranged, written standards vs. checklist?
9. Does your organization provide custom standards list based on the testing performed by individual CLIA laboratory? Are there section or specialty specific standards?
10. Does your organization share information to download customized standards into document control systems?
11. What is the process to get clarification on standards interpretation?
12. How are standards updated? How are standard updates communicated? Is there a method to submit standards feedback for review?
13. Do you include a definition of terms used in your standards? Days, monthly, competency, training, test system etc.
Inspections
14. What type of inspection model do you use? Please walk through a routine inspection process.
15. The VA is its own CLIA provider and does not need all accreditation activity that may be offered by a deemed organization. For example: the VA does not require blood bank accreditation or proficiency testing monitoring/reviews as part of this solution. How would your organization address these types of issues within your accreditation model?
16. All VA laboratories are AABB accredited in immunohematology, if they offer that specialty. Does your inspection process allow for coordinated accreditation or co-inspection with AABB? Has your organization worked with the AABB using this process in the past?
17. The VA has several laboratories that perform Therapeutic Phlebotomy outside the oversight of the Blood Bank. These alternate locations are not covered under the AABB accreditation. Do you have a process to survey Therapeutic Phlebotomy as part of your overall laboratory accreditation?
18. Do you perform any of your audit documentation review prior to on-site survey?
19. There are VA labs located across all 50 state including in Hawaii, Alaska, as well as the Philippines and Puerto Rico. Is your organization able to offer on-site inspection or activity services to these remote location labs?
20. What is the most commonly cited deficiencies?
21. What is the rate of overturned/challenged deficiencies/non-conformances?
Please describe the process of challenging deficiencies/non-conformances.
Online portal
22. Does your organization have an electronic portal to manage the accreditation process? If so, please show some screen shots and examples of functions.
23. Does your organization allow for electronic updating of laboratory demographics or organizational profiles through an online portal? How is access managed?
24. How are survey process notifications sent? Can you customize to allow multiple recipients for notifications?
25. The VA laboratories are arranged into 7 regions for the central office staff, would your electronic portal be able to accommodate central office accounts with regional or all VA site access?
26. How would you handle a customer’s feedback on changing the functionality of your online portal? If you chose to adopt and implement a change to your online portal, what steps would need to be taken? What would be the estimated timeline of changes to the online portal?
Support services
27. The VA is seeking services for about 260 laboratories with existing accreditation cycles, how would your organization manage a transition with minimal interruption to the existing accreditation cycles? Can you give an example implementation plan for this size organization with existing accreditation cycles?
28. The VA requires that an activity menu must be verified against proficiency testing ordering at least every 6 months. Does your organization require laboratories to keep an up-to-date analyzer specific laboratory testing menu? How would you approach performing a proficiency testing ordering verification check?
29. VA requirements may not match exact commercial processes. Are you able to customize communications to VA customers?
30. What accreditation activity or monitoring activity does your organization offer as part of your full accreditation service? Example: Self-inspection process or standard guidance interpretation.
31. What other resources does your organization provide as part of accreditation service? Such as education, training, webinars, example documents.
32. What type of customer service options do laboratories have for routine and urgent inspection day questions?
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