36C25024Q0630 0005.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis IN 46240

POINT OF CONTACT*

Contract Specialist Teri Miller Teri.Miller@va.gov

Questions shall be emailed to POC above

PLACE OF PERFORMANCE

VISN 10 Pharmacy

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

THE PURPOSE OF THIS SOLICIATION AMENDMENT IS TO PROVIDE ANSWERS TO QUESTIONS FROM INDUSTRY.

Questions and Answers: (Answers are in purple, italicized, and bolded.)

Question 1 On page 5 we note the following: “All learning objectives outlined shall be addressed”, then the “Course Outline and Learning Objectives” follows. Taken literally, we interpret that to mean through pre-work requirements or the live presentation/discussion, all of these topics must be addressed (covered). Is this a correct interpretation?

The answer is, “Yes;” however, not solely through pre-work. Pre-work should be preparedness, not “self-training.” Any pre-work should also be covered during the live presentation/discovery.

Question 2 On page 28 we note:

o Proof that the vendor can provide, at a minimum, the following training elements and/or topics (Documentation, narrative, and/or acknowledgement is sufficient for this response.)

§ Overview of USP Chapters <797>, <800> and <795> § Beyond Use Dating and Quality Release Testing

§ Clean Room Certification and interpreting certification reports

§ Cleaning/disinfecting/sporicidal agents overview and training

§ Cleaning and disinfection practices related to USP <797>, <800> and <795>

§ Examples of Standard Operating Procedures (SOP) for clean room cleaning, maintenance, and common aseptic workflows § Development of a Quality Assurance and Quality Control Program and reports § Hazardous drug spill management § Integrating practices into facility SOPs § Integrating Technology with Workflow Management Systems § Smoke test training inclusive of PEC/SEC hood/room, and suggested techniques for Joint Commission record keeping of testing.

§ Cleanroom suite environmental control, monitoring, and handling of excursions

These training elements are included in the “Course Outline and Learning Objectives” except, for example, the specifics of the highlighted phrases. We can expand the “sample agenda” to include these elements. Will that be adequate documentation/acknowledgement?

The answer is, “Yes,” this would be considered adequate.

Question 3 This statement is on page 28. Proof or sufficient evidence that the vendor is certified to train on USP ,797>, <800>, and <795>. Our course management team and presenters will be Board Certified in Compounded Sterile Preparations Pharmacy Specialty Certification (BCSCP). We are not aware of a “certifier” of training on these topics. Is BCSCP (or the equivalent), what is being referred to?

The answer is, “Yes,” BCSCP trainers (or equivalent) are sufficient.

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Amendment to a Previous Combined Solicitation