Laboratory Resources

NEW LABORATORYDIRECTOR RESOURCE GUIDE What Every New Laboratory Director Needs to KnowPathology & laboratoryMedicine serviceFoundation for quality Veterans’healthcare

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Table of ContentsOrganizational Structure............................................................................................................................. 3Getting Started ........................................................................................................................................... 5Education Resources................................................................................................................................... 7 National P&LMS Contracted Education and Training Solutions .............................................................. 7 VA Training and Education Resources..................................................................................................... 8Communication .......................................................................................................................................... 8 Electronic Communication Tools ............................................................................................................ 8 o VANTS ......................................................................................................................................... 8 o Lync............................................................................................................................................. 8 o Outlook ....................................................................................................................................... 9 Email Etiquette ....................................................................................................................................... 9 National P&LMS Mailgroups (Email) ....................................................................................................... 9 Other P&LMS Communication Tools..................................................................................................... 11National Agreements ................................................................................................................................ 12Proficiency Testing and Accreditation....................................................................................................... 12Data Reporting and Frequency ................................................................................................................. 16 Mandatory Reporting ........................................................................................................................... 16 Voluntary Reporting.............................................................................................................................. 17Laboratory Data Standardization .............................................................................................................. 17Links to Laboratory Related Resources ..................................................................................................... 19Appendix A: Scheduling VANTS Lines........................................................................................................ 21Appendix B: Scheduling meetings............................................................................................................. 22 via Outlook............................................................................................................................................ 22 via Lync ................................................................................................................................................. 22References ................................................................................................................................................ 23New Laboratory Director Resource Guide 2

NEW LABORATORY DIRECTOR RESOURCE GUIDEOn behalf of the Pathology & Laboratory Medicine Service (P&LMS)National Director, welcome aboard. This guide is the P&LMS Program andNational Enforcement’s Offices’ way of preparing you for success in athriving service that embraces and celebrates diverse talents andcontributions. Designed with you in mind, we have outlined some of themost important and useful things that you will need to know as you beginyour career in the VA as a laboratory director.Organizational StructureAt the base level, P&LMS is aligned under VHA Office Patient Care Services (PCS). The Office of PatientCare Services (Figure 1) is dedicated to ensuring the full continuum of health care, which compriseshealth promotion, disease prevention, diagnostics, therapeutic and rehabilitative care, recovery andpalliative care. PCS provides care through policy and program development that promotes dignity andrespect, and is achieved by utilizing innovative approaches and technologies through interdisciplinarycollaboration both within and outside of VHA.As a service within the Patient Care Services umbrella, Diagnostic Services (Figure2) convenesinterdisciplinary groups among diagnostic services employees (physicians, nurses, technicians,technologists, administrators, program assistants, and analysts) to share technical knowledge and bestpractices. Overseen by a Chief Consultant, Diagnostic Services is comprised of:  Pathology and Laboratory Medicine Services (P&LMS)  National Nuclear Medicine and Radiation Safety Services  RadiologyNew Laboratory Director Resource Guide 3

 TeleRadiologyThe P&LMS National Director is responsible for the strategic vision, advocacy, and direction of VAP&LMS. The Director is supported by the Program Office, and the National Enforcement Office.  Program Office (PO/PMO) - based in VACO, Washington DC, responsible for input into policies that impact laboratories and laboratory services. Serve as champions for projects and initiatives for the benefit of key customers (laboratories and Veterans seeking laboratory services) and other stakeholders.  National Enforcement Office (NEO) – Virtually located, with ten (10) established regional positions, the NEO is the national compliance arm for P&LMS. Each region has a Regional Commissioner (pathologist) and a Regional Technologist (medical technologist).Full description of function and assigned personnel is located on the P&LMS intranet. Figure 1 VHA Organizational Chart 4New Laboratory Director Resource Guide

Figure 2 P&LMS Organization ChartGetting StartedWhen you take on directorship, there are some resources that should be reviewed and kept on hand tohelp you understand your new position and remind you of your role and responsibilities as a laboratorydirector. There are also people you should know and tasks that must be completed. Get a copy and familiarize yourself with Directive 1106 Pathology and Laboratory Medicine and Handbook 1106.01 Pathology and Laboratory Medicine (P&LMS) Procedures –the authoritative resources for the overall function of VA P&LMS. Review Clinical Laboratory Improvement Amendments (CLIA) – Laboratory Director Responsibilities (What Are My Responsibilities As A Laboratory Director) Introduce yourself to your Regional Commissioner and Technologist. See Regional Map to identify contact information. Request addition to role specific P&LMS mailgroup(s). Use this link to see which mailgroups are appropriate, based on your role, and email the designated mailgroup owner. Update Accreditation & Regulatory Registrations (see Table 1):New Laboratory Director Resource Guide 5

Agency When How to submit change(s)FDA Department of Veteran Affairs Medical Facilities Form FDA-2830, Blood EstablishmentAABB Blood Bank/Transfusion Services are required to Registration and Product Listing, is register with the FDA, pursuant to section 510 of used for submission of registration and the Federal Food, Drug, and Cosmetic Act. Blood product listing information to the FDA. Bank/Transfusion Services must register within 5 The form (and accompanying days of beginning operation, and annually instructions) may be downloaded to between November 15 and December 31. complete and submit by mail. Preferably, the information may be AABB requires that an accredited facility notify the submitted electronically. Instructions AABB National Office Accreditation Department, for completing the electronic form are within 30 days, of any changes in any aspect of the available at: facility’s status or operation that affects the https://www.accessdata.fda.gov/scripts/c facility’s: ber/CFApps/Login/Index.cfm?CFID=14371 273&CFTOKEN=3bf68105249a55d0-  Premise, location or contact information. A85D0D0F-1372-5AE1-  Organizational structure and 674338933A9DF71D management, including mergers with Notification of change can be sent via other facilities. e-mail to [email protected].  Facility personnel designated as responsible for AABB accreditation activities.  Capabilities, including any regulatory actions, stated scope of accredited activities, or compliance with the requirements in this document or any other relevant criteria of competence specified by AABB.  A change in lab leadership (i.e. director or medical director). In this instance, a current CV plus evidence of qualifications as defined in current Standards must be submitted to AABB with the written notification.New Laboratory Director Resource Guide 6

CAP Accreditation by the CAP does not automatically The CAP website includes the continue after there is a change in location, following instruction document and director, or ownership. Notification of such the forms that must be completed changes must occur no later than 30 days prior to when there is a new Laboratory the change(s); or, in the case of unexpected Medical Director. Forms may be changes, no later than 2 working days afterwards. submitted electronically.CLIA (VA) All hospital based and standalone clinical  Instructions for Changing laboratories (independently accredited) within Laboratory Information VHA are required to register with the Pathology & Laboratory Medicine Service National  Notification of Change Form Enforcement Office and to be issued a CLIA number and certificate. Renewals are required  Medical Director Qualification every two years. Changes during this two year and Responsibility Form window in name, address, director, type of laboratory, specialty testing performed and/or of  For changes in name, address, laboratory closure/discontinuation of testing must director, and/or of laboratory be provided to the National Enforcement Office closure/discontinuation of testing within 30 days of such changes. use the following form: Department of Veterans Affairs – CLIA Certificate Change Request Form.  For changes in type of laboratory (complexity), or specialty testing performed use the following form: Department of Veterans Affairs CLIA Application for Certification Form. All forms may be obtained from your Regional Technologist.Table 1 Agency UpdatesEducation ResourcesThere are a wide variety of venues and modalities for continuing education and training. Some arepurchased via contracts managed by the P&LMS Program Office and some are institutional training andeducation modules developed and provided by the VA.National P&LMS Contracted Education and Training Solutions-(Note: These resources are subjectto the continued availability of national funding)  Medical Training Solutions (MTS) - Online Training and Competency Assessment for the Clinical Lab and Point of Care. With over 50 hours of Continuing Education (CE) credit additional benefits include the abilities to document and track individual training and to create local testing. Laboratories wanting to take advantage of this resource must appoint a local administrator to manage registration, training assignments etc.…Contact the P&LMS Program Office for details.  Clinical and Laboratory Standards Institute (CLSI) eCLIPSE – 24/7 online access to the full library of laboratory standards. Access for laboratory personnel uses. Users may request accessNew Laboratory Director Resource Guide 7

through the Program Office at this link. Alternatively, request link can be found on the P&LMS intranet under “Directives & References – CLSI Access Request”.  AABB – accreditation, educational webinar, and access to Standards and other documents for VA transfusion services. Access to Standards library given to one person per registered transfusion service. Accreditation is not a prerequisite for webinar or standard access. See intranet for details.(Note add doc like CLSI and add to intranet about access and how to sign up for webinars)VA Training and Education Resources  VA Learning University (VALU) - As part of Human Resources & Administration (HR&A), VALU is VA's corporate university that supports the agency’s mission and business objectives through high quality, cost-effective continuous learning and development that enhances leadership, occupational proficiencies, and personal growth. VA’s Talent Management System (TMS), Skillsoft courses and Books24/7 are some of the resources offered in their toolbox.  VA eHealth University (VEHU) –VeHU is VA’s major annual training conference that provides education on the Computerized Patient Record System (CPRS) and related clinical software (VistA) developed by the Veterans Health Administration (VHA). Each year, VeHU highlights innovations towards patient care through over 200 training classes on VHA’s clinical informatics products. One of their websites, MyVeHU Campus, brings the training offered annually at VeHU to all VA staff and the VistA user community. It is primarily intended for use by those familiar with VA clinical software (VistA and CPRS) and its related terminology. Available 365 days/year from anywhere there is an internet connection www.MyVeHUCampus.com.CommunicationWorkplace communication is important because it allows organizations to beproductive and operate effectively. Employees can experience an increase inmorale, productivity and commitment if they are able to communicate up anddown the communication chain in an organization. Workplace communication isthe transmitting of information between one person or group and another person or group in anorganization. It can include emails, text messages, voicemails, notes, etc. 1 Electronic Communication Tools: o VANTS - Veterans Affairs National Telecommunications System: VANTS serves as the primary teleconferencing system for VA employees. Only VA employees are authorized to make reservations and/or serve as the primary moderator for conference calls. Use of the VANTS system is for official use only. See Appendix A: Scheduling VANTS Lines for details on how to set up a VANTS call. o Lync – As an alternate to VANTS, Microsoft Lync, (tool provided to all VA computer users) is a single interface that includes voice communications, IM, and audio, video, and Web conferencing. The tool’s sharing and collaboration features include application sharing, whiteboard, and annotation tools, polling, and PowerPoint presentations. ItNew Laboratory Director Resource Guide 8

also offers recording and playback for meetings. See Appendix B for how to schedule ameeting using Lync.o Outlook (for email and meeting scheduling) - Microsoft Outlook is the agency’s choice for email service. Outside a face to face or the telephone, email is the most used and expedient method of communication. In addition to email, Outlook also provides calendar, task, contact and meeting management. See Appendix B for how to schedule a meeting using Outlook.Email Etiquette – It is incredibly important to remember some key etiquette rules when sendingand receiving -email. Be courteous. Make sure your emails begin with the individual’s name to whichyou are writing, and end with a salutation and your name. A “safe” salutation is“Regards”. DON’T USE ALL CAPS. Caps make the receiver believe you are shouting. CAPSshould only be used for emphasis within a sentence, NOT for the entiresentence. Use short paragraphs. A paragraph When sending email to a large should only contain 3 lines, or 17 to 20 group, to avoid email clutter for words. This makes for easier reading for your recipient, and will help you keep yourself and others you may your thoughts organized as you write. want to consider using the “do Remember your recipient. Don’t use not reply all” template.email to vent or to communicatenegative thoughts or feelings. Have a purpose. Email can be effectivewhen communicating short, meaningful messages. Don’t send out short novelsto individuals; they don’t have time to read them, and your email will end up inthe “delete” box. Don’t use more than 2 font colors. Emails are difficult enoughto read if you are a “visual” person. Color is great for emphasis on importantitems, but using more than 2 font colors will easily tire the eyes and will deteryour recipient from wanting to read further. Use “Plain Text” language. While “Rich Text” can be fun, and can allow you toincorporate smiley faces and other points of emphasis, most recipients(especially at work) will only be able to receive Plain Text emails. Attachments. When you need to send an email with extensive information, useWord or Excel file attachments. The recipient will then be able to open theattachments at their leisure and ready them more easily. Subject Line. Every email should have a specific subject line. With all the emailsthat flood one’s inbox, it is critical that your subject be specific to the content ofyour email. This will enable your recipient to know quickly what is containedwithin the email, and will help them manage their email effectively. Reading emails. If you use email for work purposes, one way to effectivelymanage your time is to designate certain times of the day to read and respondto emails. This will help you stay focused on quick responses and concise emails.National P&LMS Mailgroups (Email) – National mailgroups are established and managed by theP&LMS Program Office with the purpose of fostering up and down communications with and toNew Laboratory Director Resource Guide 9

discipline specific interest groups and/or key leader roles. See table below for listing of nationalmailgroups.MAILGROUP PURPOSE/Target membershipVHA CO General Pathology A large diverse mailgroup that includes most of the discipline specific laboratory mailgroups as well as others that have an interest in laboratory issues i.e. Product Support. Use when broadest possible distributed is warranted such as monthly call agendas, newsletter releases.VHA PLMS MICROBILOGYVHA Pathology ChiefsVHA Ancillary Testing CoordinatorsVHA Blood Bank SupervisorsVHAASH SPVRMEDTECHS(Supervisory Technologists)VHA LIM-L LISTSERVVHA Regional CommissionersPMOVHA FIELD ADVISORYVHA PLMS SafetyTable 2 P&LMS MailgroupsNotes: See the P&LMS website (http://vaww.lab.med.va.gov/components/National_Mailgroups.asp) for PointOf Contact to request addition/deletion to a mailgroup. Only request addition if it is appropriate for your jobfunction. Limiting based on need and role allows communication and response from/to authoritative sources.New Laboratory Director Resource Guide 10

Other P&LMS Communication Tools - Traditional methodologies/modalities/media are used tocommunicate with stakeholders on an ongoing basis. See table below.Modality Purpose/What Frequency Additional InformationNational P&LMS Call A forum for the National Monthly at 1PM  Agenda sent out priorNewsletter-“Laboratory Matters” Director and invited guest to Eastern. to the calls via the provide information about Dial in using VANTS at VHA CO General issues, initiatives, and other 1-800-767-1750. Pathology mailgroup. matters that affect the Access code: 16250#  Issue for the open operation of VA laboratories. discussion should be Also provides an opportunity submitted prior to the for the field to ask questions. call so that proper research can be done. Use this link to submit open forum discussion topics.  Minutes of prior calls are posted on the P&LMS website at this link.  Distribute the agenda to staff to ensure all are informed. Encourage participation as allow by workload. Published by the NEO and 2-3 times per year  This publication is for Program Offices for the the consumers so laboratory community, the input (suggestions, newsletters strive to focus articles, general on issues and provide feedback) is highly solutions to some of the encouraged. common accreditation and regulatory shortfalls;  Previous newsletters highlight the good things are posted on the happening in laboratories, P&LMS website at this and introduce upcoming link changes that may affect laboratories.New Laboratory Director Resource Guide 11

P&LMS Intranet Intranet presence for the Maintained by the  Materials posted and laboratory community. Place P&LMS Program updated on a where documents, Office. continual basis. references, guidance, and a host of lab specific materials  Link: place here can be found. Unlike the internet, the P&LMS intranet  site is a private network  accessible only to VA staff. Documents on the intranet can be downloaded, printed and/or saved for further use.VBECS ListServLIM ListServTable 3 Other P&LMS Communication ToolsNational AgreementsNational Agreements in the form of MOAs, MOU, and Supplier Qualifications have been establishbetween P&LMS and some servicing/partnering agencies and organizations that provide services on anenterprise level. These agreements are reviewed, updated and/or renegotiated as required or deemednecessary. All such agreements are posted on the P&LMS intranet. Current agreements:  VBECS – Vista Blood Establishment Computer Software: The only VA authorized computer system for transfusion services. Developed in-house by OIT, VBECS is an FDA cleared medical device.  JPC – Joint Pathology Center: the federal government's pathology reference center. The JPC provides diagnostic subspecialty consultation at agreed upon prices to the VA.  DoD Blood Program – DoD Blood Programs offers blood products to the VA on a first come first served basis. Notifications about the types and quantity of available products are made through their listserv. Individual sign up for the notifications is required.(insert link to listserv)  CDC NHSN – The purpose of the National Healthcare Safety Network (NHSN) Hemovigilance (HV) Module is to implement national surveillance of transfusion-associated adverse events with a goal the improving patient safety, minimizing morbidity and mortality of transfusion recipients, and identifying emerging complications and pathogens associated with blood transfusion. The VA entered into a MOU with CDC which allow VA Transfusion Services to provide data to the Network. Protocols and POCs are located in the P&LMS intranet. Registration and training are required. Participation is voluntary.Proficiency Testing and AccreditationTo take advantage of economies of scale, reduce redundancy in contracting efforts, and ensureappropriate enrollment and compliance, the NEO established centralized contracts for proficiencytesting (PT) and accreditation of VA laboratories. Current vendors are College of American PathologistsNew Laboratory Director Resource Guide 12

(CAP) and American Society for Clinical Pathology (ASCP).New Laboratory Director Resource Guide 13

Contract Vendor Purpose OrderinAccreditation CAP Central contract for the N/A – mProficiency CAP procurement of CAP in cTesting (PT) accreditation services for VA with NEO laboratory testing facilities. Systems Central contract for the Annually procurement of proficiency October testing materials for VA order) laboratory testing facilities. Complies with accreditation Weekly and regulatory (for chan requirements. initial orLMIP CAP Central contract for the Annually procurement of the October Laboratory Management order) Index Program (LMIP) that uses quarterly laboratory metrics to create reports describing individual laboratory cost- effectiveness, productivity, and utilization as well as performance against peer VA laboratories.New Laboratory Director Resource Guide

ng Frequency Additional Informationmanaged by Questions regarding the accreditation application processconsultation should be directed to your Regional Technologist. O Health s Specialist.y - late  National contract funding covers costs of items usedr (for initial for Proficiency Testing only.- Jan-Nov  Orders for contracted items must be routed throughnges torder) your Regional Technologist. Facilities cannot call CAP directly for items on the contract.  Other items available in catalog, but not on the VA contract, termed “self-pay”, may be purchased directly from CAP by the individual laboratory. Examples include linearity material, quality checks, competency assessments, etc. These self-pay orders are not routed through your Regional Technologist.  Non-gyn cytology material is not covered under the national PT contract. See non-gyn cytology (ASCP).y - late  P&LMS mandates all VA laboratories participate inr (for initial the LMIP program.  New orders or changes to existing orders for the LMIP program must be routed through the LMIP Coordinator in the PLMS Program Office. Facilities cannot call CAP directly to either enroll or remove themselves from the contract.  Each VA laboratory must designate a point-of contact responsible for program data submissions that is familiar with laboratory fiscal operations, staffing levels/FTEE, and Standardized Billable Test (SBT) workload.  POC is the LMIP Program Manager. 14

Non-GYN Digital ASCP Central contract for the AnnuallyAssessment procurement of non-GYN manageProgram Cytopathology Proficiency coordina Assessment for Pathologists consulta and Cytopathologists. Regiona Complies with accreditation Technol and regulatory COR/HS requirements.Drug Free Work Elsohly/UPS Blind Quality Control N/A – blPlace (current specimens that evaluate the are randvender: reliability and accuracy of to or pic drug testing results under varying V the VA Drug Free Work laborato Place program.Table 4 Centralized PT & Accreditation ContractsNew Laboratory Director Resource Guide

y – Locally Each VA laboratory designates a “site coordinator”. Siteed by site coordinators: ator, ination with a) Provides participant list to NEO COR/HHS annuallyal b) Reports participant list changes to NEO COR/HSS, aslogist or NEO S. needed c) Receives annual program binder, coordinates testing events d) Secures performance results.lind samples Nonedomly sentcked up fromVAories. 15

Data Reporting and FrequencyIn accordance with Handbook 1106.01 and other directives (if ID for example) ……. (some words)Mandatory ReportingData Source Frequency Additional InformationAutopsy Data Monthly – Data submission by the 15th of Data submitted electronically the next month using VA 10-0424 Form SubmissionTransfusion Utilization Biennially - Data collected and submitted  Data entered in SharePointData for two(2) reporting periods: Jan – June portal NLT two (2) months and Jul-Dec. following the reportingBlood Product period.Deviations (BPD) Under 21 CFR 606.171(c), you should report a biological product deviation as soon as  Link to portal provide byLaboratory possible, but you must report at a date not P&LMS Program Office.Management Index to exceed 45 calendar days from the date Same link is used for eachProgram (LMIP) that you, your agent, or another person reporting period. who performs a manufacturing, holding, or distribution step under your control, Submit electronically to FDA at acquire information reasonably suggesting https://www.accessdata.fda.gov that a reportable event has occurred. /scripts/cber/CFApps/Login/Inde All Laboratories are required to send their x.cfm?CFID=18727110&CFTOKE previous month’s workload statistics to N=b276708ffd83745f- both the Austin National Database (AITC) 9CC1A259-1372-5AE1- and the Dallas Message Repository by the 6AE2288D64AF9922 10th working day of the month. AUSTIN EMAIL ADDRESS using VistA Mailman: [email protected] DALLAS EMAIL ADDRESS using VistA Mailman: g.lmi@fo- dallas.med.va.gov Additional information about LMIP is located on the LMIP SharePoint. You can also contact the LMIP Program Manager.Others like infectiousdisease?Table 5 Data Reporting - MandatoryNew Laboratory Director Resource Guide 16

Voluntary ReportingData Source Frequency Additional InformationCDC Hemovigilance  Hemovigilance Module Annual Facility See program description and link Survey -at the time of enrollment or to location of protocols under activation of the Biovigilance the “National Agreements” Component and at the beginning of section of this document. each calendar year thereafter. User Support: CDC is available to  Hemovigilance Module Adverse answer questions about the Reactions - reports are to be entered surveillance protocol and to help within 30 days of the month that the navigate the NHSN web reaction occurred. application. Contact them at [email protected]. Type HEMOVIGILANCE MODULE in the subject line for quickest routing to the Biovigilance/Hemovigilance Team.Others?Table 6 Data Reporting - VoluntaryLaboratory Data StandardizationLogical Observation Identifiers Names and Codes (LOINC®) is the standard code set used for laboratorytest result names in the VA to represent what is being reported for the test results in a standardmanner. This standard code set allows for a has been used since 2000 with a centralized effort startingin 2004 to review, monitor and recommend appropriate LOINC codes for the LIM’s to use when mappinga lab test result name to LOINC.Standards and Terminology Service (STS) is responsible for the monitoring of site compliance of mappingtests to LOINC codes. They extract data from each site on a regular basis to review current mappings,identify new tests that have been created and determine if any changes need to be made on existingtests. STS works with the LIM at each site to obtain information about the testing, i.e. units of measure,reference lab used, methodology, etc. to determine the appropriate LOINC to be used. Each quarter,around the 15th of the first month of the quarter, STS will provide a spreadsheet specific to each site thatidentifies the tests that need to be mapped to a LOINC code or tests that need more information todetermine the correct LOINC. The LIM is responsible for mapping each test to a LOINC code and it isrecommended that when the tests are created, the mapping should take place at the time of creation, ifpossible.LOINC is used by many groups that utilize lab data for various purposes. MCA, formally DSS, utilizeLOINC for their reports , Corporate Data Warehouse (CDW) also contains the LOINC code stored whenthe results are verified, the LOINC code allows other groups like IPEC, CCR, etc. to search for tests resultsby LOINC code without having to rely on the variation across sites of the local test names.Contact the P&LMS Program Office for a point of contact Standards and Terminology Service if you haveNew Laboratory Director Resource Guide 17

questions.New Laboratory Director Resource Guide 18

Links to Laboratory Related Resources VA LinksOffice of Inspector General listing of Combined http://www.va.gov/oig/publications/default.aspAssessment Program (CAP) reportsPathology & Laboratory Medicine Service http://vaww.lab.med.va.gov/index.asp(P&LMS) intranetVHA Forms, Publications, Memos & Directives - http://vaww1.va.gov/vhapublications/e.g. Laboratory Handbook 1106.01 or GSA FormsLibraryAlso find State Tax Exempt Forms for TravelVHA Program Offices - Home page of Veterans http://vaww1.va.gov/health/programs.aspHealth Administration Special Programs providinglinks elsewhere including OHS&P and NationalCenter for Patient SafetyVHA Record Control Schedule - VHA record http://vaww1.va.gov/vhapublications/rcs10/rcs10-retention guidelines 1.pdfExternal Federal LinksCDC: Biosafety in Microbiological and Biomedical http://www.cdc.gov/biosafety/publications/bmbl5/Laboratories (BMBL) 5th edition. index.htmGuidelines for Biosafety Level III Laboratories https://www.cms.gov/Regulations-and-CLIA Interpretive Guidelines for Laboratories Guidance/Legislation/CLIA/Interpretive_GuidelinesProvides information on intent of the standard _for_Laboratories.htmland compliance instructions http://www.accessdata.fda.gov/scripts/cdrh/cfdocs /cfcfr/CFRSearch.cfm?fr=607.65CFR-Code of Federal Regulations Title 21 – Food http://www.fda.gov/cber/blood/bldreg.htmand Drugs http://www.fda.gov/BiologicsBloodVaccines/GuidaFDA Blood establishment registration Transfusion nceComplianceRegulatoryInformation/Guidances/BService registration FDA 21 CFR 607.65 lood/ucm073455.htmFDA CBER - Biological Product Deviation http://www.fda.gov/ICECI/ComplianceManuals/CoReporting for Blood and Plasma Establishments mplianceProgramManual/default.htm21 CFR 606.171 07/May/2001 http://www.accessdata.fda.gov/scripts/cdrh/cfdocsFDA-Compliance Program Guidance Manual /cfClia/analyteswaived.cfmChapter 42 – Inspection of Licensed andUnlicensed Blood Banks, Brokers, ReferenceLaboratories, and Contractors – 7342.001Appendix JWaived Tests List - FDA waived test list by analyteNew Laboratory Director Resource Guide 19

Other LinksCLSI eCLIPSE – laboratory standards library http://clsieclipseua.org/subscription service. Find details under the http://www.medtraining.org/corpsite/“National P&LMS Contracted Education andTraining Solutions\" section of this document.Medical Training Solutions (MTS) - Laboratorytraining and competency program. Find detailsabout enrollment under the “National P&LMSContracted Education and Training Solutions\"section of this document.Table 7 Links to Lab ResourcesNew Laboratory Director Resource Guide 20

Appendix A: Scheduling VANTS LinesThe phone number to access VANTS lines is 800-767-1750.The phone number to reserve VANTS lines is 304-262-7600.To reserve VANTS lines by phone, you will be asked for:  The title: Name of meeting.  The code: Request the VANTS operator assigns a code for you.  Number of lines required: ask for a minimum of 5 lines.  Starting time: Request the time you need the meeting to start and end. (The operator will set the time based on Eastern Time.)  The amount of time needed. (The duration is not set in hours: for 1 hour you will get 50 minutes so if you need an hour ask for 80 minutes.) During the meeting you can ask for more time if needed: 1. Ten minutes before the meeting is scheduled to end, you will get a warning that the call is about to end. 2. Enter *0. 3. Ask the operator for more time. If additional time is not available, the call will terminate at the original scheduled time. (While talking to the operator, you are out of the call). 4. The operator places you back in the call.To reserve VANTS lines on line, you need to go to the VA Nationwide Teleconferencing System(VANTS) at http://vaww.va.gov/VANTS/Audio-Web-Portal.asp and follow the directions on thefirst page of the sight.On the Login screen:  For the Domain use “YOUR LOCAL DOMAIN” from the drop-down.On the Book Meeting screen:  The Conference Name is (enter name).  Remember the time is always Eastern.  Be sure to add the minutes needed in the Conference Duration as the default is 10 minutes.  Be sure to enter the No. of Participants as the default is 3.  If using a specific participant code go to the advanced tab and remove the check in the moderated conference.Once you have obtain the VANTS call details they can be distributed by inserted them in ameeting announcement, email etc.New Laboratory Director Resource Guide 21

Appendix B: Scheduling meetingsvia Outlook 1. In Microsoft Outlook, Calendar, Other Calendars, open the shared calendars of required attendees and check their availability. 2. As most of the attendees are remote, reserve VANTS lines (at least 5) or use Lync (See via Lync section). 3. Prepare and send out the meeting invitation: a) Open Microsoft Outlook, Calendar, Other Calendars. b) Check the attendees that are to be invited. c) To open an appointment: Select Actions, New Meeting Request With, Select All. d) Include in the invitation:  Subject: The reason for the meeting.  Location: Conference room number. (If using VANTS lines, the phone number is 1-800-767-1750 and the access code to use).  Start Time: Choose Day/Date.  End Time: Choose start and end time.  Attach documents needed or the path to where they can be found. e) Click Send, to send the invitation.via Lync 1. In Microsoft Outlook, Calendar, Other Calendars, open the shared calendars of required attendees and check their availability. 2. On the top Ribbon select New Online Meeting. 3. Subject: [The reason for the meeting]. 4. Attach documents needed or the path to where they can be found, if appropriate.New Laboratory Director Resource Guide 22

References1. Using Email Effectively as a Communication Tool. July 5 2016. http://content.moneyinstructor.com/1534/usingemail.htmlNew Laboratory Director Resource Guide 23