SOLICITATION NOTICE
U -- Compounded Sterile Preparations Training Amendment 5
- Notice Date
- 7/1/2024 6:49:29 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25024Q0630
- Response Due
- 7/1/2024 10:30:00 AM
- Archive Date
- 08/30/2024
- Point of Contact
- Teri Miller, Contract Specialist
- E-Mail Address
-
Teri.Miller@va.gov
(Teri.Miller@va.gov)
- Awardee
- null
- 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 , and § 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 , and § 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>, , and . 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/a163ca4457ef40fb8665295e025bdc84/view)
- Place of Performance
- Address: Department of Veterans Affairs VISN 10 Pharmacy, USA
- Country: USA
- Country: USA
- Record
- SN07113631-F 20240703/240701230107 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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