{"id":1926,"date":"2015-05-21T18:18:38","date_gmt":"2015-05-22T01:18:38","guid":{"rendered":"https:\/\/hartleymedical.com\/?page_id=1926"},"modified":"2023-06-15T22:05:57","modified_gmt":"2023-06-16T05:05:57","slug":"due-diligence","status":"publish","type":"page","link":"https:\/\/hartleymedical.com\/due-diligence\/","title":{"rendered":"Due Diligence"},"content":{"rendered":"

This is a list of questions a provider should ask a compounding pharmacy before approving them. It is not a Hartley driven questionnaire. Rather, its intent is to educate.<\/p>\n

All questions are intended to be open-ended in order to provide the opportunity for the provider to learn more. We welcome your questions and invite your on-site inspections.<\/p>\n<\/div>

<\/i><\/div>How many years experience does your facility\/team have in sterile compounding?<\/h2>\n<\/div>
<\/div><\/div>

<\/i><\/div>In regards to your sterile compounding staff . . .<\/h2>\n
    \n
  • Do you have an employee training and evaluation program in compliance with USP <797> \/ Board of Pharmacy? Please describe.<\/li>\n
  • What are your policies and procedures for hand washing, gowning, and gloving?<\/li>\n
  • Does your staff perform media fills in compliance with USP <797>?<\/li>\n<\/ul>\n<\/div>
    <\/div><\/div>

    <\/i><\/div>Is your sterile compounding pharmacy accredited by an acknowledged sterile compounding association?<\/h3>\n<\/div>
    <\/div><\/div>

    <\/i><\/div>Do you have a set of policies and procedures, or checks and balances, to guide the sterile compounding process? Please describe.<\/h3>\n<\/div>
    <\/div><\/div>

    <\/i><\/div>Do you have adequate space for compounding sterile products?<\/h3>\n
      \n
    • Do you have a dedicated, separate, and contained sterile preparation area?<\/li>\n<\/ul>\n<\/div>
      <\/div><\/div>

      <\/i><\/div>In regards to the United States Pharmacopoeia (USP) guidelines for the sterile preparation area . . .<\/h3>\n
        \n
      • What is the air quality classification of your IV hoods or Laminar Air Flow Workbenches? Please explain what this means to you.<\/li>\n
      • How often are your sterile preparation rooms and IV hoods certified?<\/li>\n<\/ul>\n<\/div>
        <\/div><\/div>

        <\/i><\/div>In regards to your environmental monitoring . . .<\/h3>\n
          \n
        • Will you describe this process?<\/li>\n
        • Do you test for air microbial bioburdens? How often?<\/li>\n
        • Do you test for particulates in the air? How often?<\/li>\n
        • Do you perform surface and fingertip microbial testing? How often?<\/li>\n<\/ul>\n<\/div>
          <\/div><\/div>

          <\/i><\/div>In regards to the cleaning and disinfection program for your sterile environment . . .<\/h3>\n
            \n
          • Will you describe this process?<\/li>\n
          • How often is it employed?<\/li>\n<\/ul>\n<\/div>
            <\/div><\/div>

            <\/i><\/div>What is your delivery process?<\/h3>\n<\/div>
            <\/div><\/div>

            <\/i><\/div>Do you perform in-house auditing to expose discrepancies in prescriptions and billing?<\/h3>\n<\/div>
            <\/div><\/div>

            <\/i><\/div>Do you provide access to a clinical support team who can help with formulation questions and other clinical concerns?<\/h3>\n<\/div>
            <\/div><\/div>

            <\/i><\/div>Do you have at least five (5) references who may be contacted to testify to the quality of your products and satisfaction of your customer service?<\/h3>\n<\/div>
            <\/div><\/div>

            <\/i><\/div>Do you have a network of health professionals for referrals regarding additional needs?<\/h3>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"yoast_head":"\nDue Diligence - Hartley Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hartleymedical.com\/due-diligence\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Due Diligence - Hartley Medical\" \/>\n<meta property=\"og:url\" content=\"https:\/\/hartleymedical.com\/due-diligence\/\" \/>\n<meta property=\"og:site_name\" content=\"Hartley Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2023-06-16T05:05:57+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/hartleymedical.com\/due-diligence\/\",\"url\":\"https:\/\/hartleymedical.com\/due-diligence\/\",\"name\":\"Due Diligence - 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