Dana Greenwood, RN, BSN, MPH Chief Nurse Consultant Immunization Division IN State Dept of Health

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(1)Dana  Greenwood,  RN,  BSN,  MPH   Chief  Nurse  Consultant   Immunization  Division   IN  State  Dept  of  Health  .

(2) Learning  Objec-ves   1. Describe  how  to  respond  to  common  vaccine  . administration  errors  .   2. List  strategies  to  prevent  vaccine  administration  . errors  .

(3) Vaccine  Administra-on  Errors  Cause…..   ü Patients  inadequately  protected  from  disease   ü Recall  of  patients  who  received  compromised  . vaccine  or  invalid  doses  of  vaccine  . ü Dissatisfied  parents  or  patients   ü Extra  cost   ü Bad  publicity  .

(4) VERP Website: http://verp.ismp.org/.

(5) Ins-tute  for  Safe  Medica-on   Prac-ces  (ISMP)  VERP   — 433  errors  reported  Sept  ’12  –  Oct  ’13   — Outpatient  medical  clinics  (35%)   — Physician  practice  (29%)   — Public  health  clinics  (24%)     — Most  common  error  reported  were  flu   — Vaccine  to  patients  who  were  not  within  age  indication   — Wrong  route    .

(6) When  Do  Vaccina-on  Errors  Occur?   — Storage  and  Handling   — Preparation     — Administration   — Documentation  .  .

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(8) Ques-on   “Our  vaccine  coordinator  was  on  vacation  and  her   back-­‐up  failed  to  check  the  min/max  temps  each   morning.  When  the  coordinator  ran  the  report  from   our  new  digital  data  logger,  she  realized  the  temps  in   our  fridge  dipped  below  35  degrees”.    .

(9) Proper  Vaccine  Storage  &  Handling   — Appoint    vaccine  manager  and  back-­‐up   ü Train  all  staff  on  vaccine  management  plan  and  emergency   plans   — Store  vaccines  at  recommended  temperatures  at  all  . times  (even  transport  or  temporary  storage)  . ü ü . Immediately  unpack  new  vaccine  shipments  and  deliveries     Use  only  approved  storage  units  . — Monitor  and  record  temps,  including  min/max  . temperatures,  at  least  twice  daily  . ü ü . Continuous  temp  monitoring  of  vial  temps  is   recommended   Use  certified  calibrated  thermometers  .

(10) Take  immediate  ac-on  for  out-­‐of-­‐range   temperatures  . It is better not to vaccinate then to administer a dose of potentially compromised vaccine.

(11) Vaccine  S&H  Resources   — IIC’s  Vaccine  Storage  and  Handling  Guide   — CDC’s  Vaccine  Storage  and  Handling  Toolkit   — AAP’s  Checklist  for  Proper  Storage  and  Handling  . Practices   — IAC’s  Vaccine  Storage  &  Handling  Website   — CHIRP  Document  Center   — Temperature  Logs   — Vaccine  Management  Plan  and  Emergency  Plan   — Immunization  Division  Policies  &  Procedures  .

(12) CDC  Resources   NEW! Resources from CDC in May 2014.

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(14) Types  of  Vaccine  Prepara-on  &   Administra-on  Errors   — Wrong  Patient   — Wrong  Vaccine  or  Diluent   — Wrong  Time   — Wrong  Dosage   — Wrong  Route  or  Needle  Size   — Wrong  Site  .  .

(15) The  “Rights”  of  Medica-on  Administra-on   • The  Right  Patient   • The  Right  Vaccine  or  . Diluent   • The  Right  Time*   • The  Right  Dosage   • The  Right  Route,  Needle-­‐ length  &  Technique   • The  Right  Site   • The  Right  Documentation     *correct  age,  interval  and   product  prior  to  expiration  . Pink  Book  Appendix  D  .

(16) Ques-on     “A  mother  brought  in  her  2  children,  ages  2  &  4  years.  It   was  very  chaotic  in  the  exam  room  with  the  children   crying  and  the  mother’s  increasing  anxiety….     I  inadvertently  administered  the  vaccines  for  the  2  year   old  to  the  4  year  old.”    .

(17) Right  Pa-ent   — Verify  patient  name  &  DOB   — Has  patient  used  another  name  previously?   — Ask  the  parent  or  patient  to  provide    you  with  the   patient  name  and  DOB,  never  ask  “are  you  ______?”     — Has  patient  been  screened  properly  for  . contraindications?     — Do  you  have  a  current  copy  of  patient’s  . immunization  record?  Have  you  reviewed  the   patient’s  record?    .

(18) Screening   — The  key  to  preventing  the  majority  of  serious  . adverse  reactions  is  screening  .   — Every  person  who  administers  vaccines  should  . screen  every  patient  for  contraindications  and   precautions  before  giving  the  vaccine  dose  .  .

(19) Screening  Checklist  . http://www.immunize.org/handouts/view-all.asp.

(20) Ques-ons   “When  I  was  doing  my  vaccine  inventory  this  past   month,  I  noticed  that  our  clinic  is  running  out  of   diluent  for  the  rotavirus  (Rotarix)  vaccine.  Can  we   order  more  diluent?”     “We  accidently  administered  a  dose  of  DTaP-­‐IPV/Hib   (Pentacel)  without  mixing  in  the  Hib  component.   What  do  we  do?”     “A  new  employee  accidently  reconstituted  ActHIB  with   sterile  water.  Is  this  dose  still  valid?”    .

(21) Recons-tuted  Vaccines   — There  are  12  vaccines  with  specific  diluents  and  2  . vaccines  with  two-­‐component  containers  that  must   be  mixed  prior  to  vaccine  administration   — Always  reconstitute  vaccines  per  manufacturer’s  . guidelines  .  . — Live  virus  vaccines  and  some  inactivated                                      . vaccines  must  be  administered  within  a  certain  time   after  reconstitution  .   — If  not  administered  within  the  time  limit,  these  . vaccinations  need  to  be  discarded.  .

(22) +. Never  mix  two  doses  of   vaccine  into  one   syringe  when  they   should  be  given  in  two   separate  syringes  . Adapted CDC.

(23) ARer  Recons-tu-on   Administer  the  following  vaccines  within:    . < 30 minutes. *immediately 8 hours 24 hours 35 days. Varivax Proquad Menhibrix* MMR. Pentacel* Zostavax. Menveo. ActHIB Hiberix Rotarix Menomune (multidose).

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(25) Errors  with  Diluent   Administering  only  the  diluent  or  only  1  of  2  vaccine   components  accounted  for  6%  of  errors  reported  to   VERP  during  the  first  year  of  the  program.     Most  reports  involved  multiple  patients        .

(26) Wrong  Diluent   — If  the  wrong  diluent  is  used,  repeat  the  dose  of  . vaccine.    . The  exception  is  the  diluent  used  for  the  MMR,  MMRV,   Varicella  and  Zoster  vaccines.  These  are  the  same  (sterile   water)   —  Must  wait  4  weeks  to  repeat  dose  of  live  vaccine  if    error  discovered  not  no  same  clinic  day    . — If  only  the  diluent  is  administered,  administer  vaccine  . as  soon  as  possible    There  is  additional  guidance  for  Pentacel  and  Menveo    .  .

(27) Ques-ons    “I  accidently  gave  a  5-­‐year-­‐old  a  dose  of  Tdap,  instead  . of  a  DTaP.  What  should  I  do?”     “A  20  year  old  hospital  employee  was  inadvertently   given  a  dose  of  shingles  vaccine  when  he  should  have   received  varicella.  Is  this  dose  valid?”     “I  accidently  gave  a  child  who  received  Pediarix  a  dose   of  Hep  B  instead  of  Hib”.    .

(28) Wrong   V accine      . Administration  of  the  wrong  vaccine  is  most  frequently   reported  with  vaccines  whose  generic  or  trade  name   look  or  sound  alike,  or  vaccines  that  have  similar   packaging.        .

(29) DTaP  and  Tdap  Administra-on  Errors   Error:  . Action:  . — DTaP  given  to  person  . — Count  dose  as  valid  . >  7  years  .   — Tdap  given  to  child  <7  . years  as  DTaP  #1,  2,  or   3  .  .  . — Dose  is  not  valid.  . Administer  repeat   dose  as  soon  as   possible  . — Tdap  given  to  child  <  7   — Count  dose  as  valid  . years  as  DTaP  #4  or  #5  .

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(31) Varicella  Administra-on  Errors   Action:  . Error:     — Varicella  administered  . — Dose  is  not  valid.  Must  wait  4  .      .    . when  shingles  vaccine  is   indicated  . weeks  to  administer  shingles  if   vaccine  cannot  be  repeated  on   same  day.  . — Consider  dose  valid.  2nd  dose    . — Shingles  administered  when  . varicella  is  indicated  . should  be  administered  4-­‐8  weeks   later  (if  indicated)  .

(32) Wrong  Vaccine   — An  extra  dose  of  a  vaccine  or  a  dose  that  is  larger  than  . recommended  may  lead  to  a  stronger  local  reaction   — Will  rarely  cause  a  serious  complication  or  reaction   — Apply  cold  compress  to  site,  consider  giving  pain  . reliever  or  anti-­‐itch  medications  if  reaction  does  occur  .  . — Always    check  the  vaccine  and  diluent  label  3  times   — Before  drawing  up  the  vaccine   — After  preparation   — Prior  to  administration  .  .

(33) Ques-ons   “A  child  received  a  dose  of  MMR  10  days  prior  to  his   first  birthday,  does  this  dose  need  to  be  repeated…he   was  practically  1  at  the  time  of  the  appointment!”.     “  A  6  month  old  has  already  received  3  doses  of   Hepatitis  B  vaccine.  The  final  dose  was  given  at  4   months.  Why  is  CHIRP  forecasting  another  dose?”      .

(34) Minimum  Intervals  and  Ages   — Vaccine  doses  are  not  to  be  given  at  less  than  the  . minimum  intervals  or  earlier  than  the  minimum  age    . — Decreasing  the  interval  between  doses  may  interfere  . with  antibody  response  and  protection  . — Increasing  the  interval  between  doses  does  not  . diminish  the  effectiveness  of  the  vaccine  . — Never  restart  a  series  or  add  doses  of  any  vaccine  due  to  . an  extended  interval  between  doses  .  .

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(36) Live  Virus  Vaccines  –  Minimum  Interval   If  live  virus  vaccines  (MMR,  Varicella,  Yellow  Fever  and   LAIV)  are  not  administered  during  the  same  visit,  the   doses  of  vaccine  should  be  separated  by  a  minimum   of  4  weeks  (28  days).       Doses  administered  on  the  same  day  a  few  hours  apart   are  considered  to  be  valid  .

(37) Four  Day  Grace  Period   — ACIP  recommends  that  vaccine  doses  given  up  to  4  . days  before  the  minimum  interval  or  age  be  counted  as   valid   } Exception:  interval  between  live-­‐virus  vaccines  must   be  at  least  28  days     — A  dose  given  >4  days  early  is  invalid     } Dose  must  be  repeated  after  waiting  the  minimum   interval  from  that  invalid  dose  or  after  the  child   reaches  the  minimum  age     — ISDH  Immunization  Program  adopted  the  four  day   grace  period  for  ‘specific  and  limited’  use  only  .

(38) Ques-ons   “Today  (August  20,  2013)  I  administered  a  dose  of   injectable  influenza  vaccine.  The  vaccine  expiration   date  was  6/30/2013.  Will  this  harm  the  patient?”     “The  expiration  date  on  the  vaccine  vial  is  06/19/2014,   can  I  use  the  vaccine  today?”  .

(39) Administering  Expired  Dose  of   Vaccine   — Repeat  dose  of  vaccine  if  expired  vaccine  is  used.   — If  this  is  a  live  vaccine,  wait  4  weeks  to  administer   repeat  dose  .   — For  certain  vaccinations,  there  is  the  option  of  . performing  serologic  testing  to  check  for  immunity   — (e.g.  Hep  A,    measles,  mumps,  rubella)  .  .

(40) Vaccine  Expira-on  Dates   — Rotate  vaccine  and  diluent  stock  weekly  to  ensure  products  . with  closest  expiration  date  are  used  first  .   — If  normal  in  appearance  and  stored  and  handled  properly,  . product  can  be  used     — through  end  of  day  indicated  if  expiration  date  is  mm/dd/ yyyy  (e.g.,  06/30/2014  -­‐  use  through  06/30/2014)   — through  end  of  month  indicated  if  expiration  date  is  mm/ yyyy            (e.g.,  06/2014  -­‐  use  through  06/30/2014)  .   Multi-­‐dose  vials  can  be  used  through  the  expiration  date  on  the   label  unless  otherwise  indicated  in  the  manufacturer’s  package   insert   Chapter 5 CDC’s Pink Book.

(41) Ques-ons   “I  inadvertently  administered  a  dose  of  intradermal  flu   (Fluzone)  to  a  67  year  old  patient.  The  product  is  only   recommended  for  patients  18-­‐64  years.  Do  I  need  to   repeat  the  dose?”     “I  administered  the  wrong  brand  of  flu  vaccine  to  a   child.  The  product  was  not  indicated  for  children  his   age.  Will  this  dose  protect  him  against  flu?”      .

(42) Influenza  Vaccines  .

(43) Ques-on   “I  accidently  gave  a  pediatric  dose  of  the  Hepatitis  A   vaccine  to  25  year  old.  Is  this  dose  valid?”     “I  administered  a  0.5  mL  flu  dose  to  a  2  year  old.  What   should  I  do?”      .

(44) Wrong  Dose   — If  less  than  the  age-­‐appropriate  dose  is  administered,  . the  dose  is  invalid  and  needs  to  be  repeated  . — Administer  additional  dose  during  same  visit  if  possible  .   — If  more  than  the  age-­‐appropriate  dose  is  . administered  consider  the  dose  valid  . — Administering  larger  than  recommended  doses  does  . not  negate  the  need  for  future  doses  .

(45) Ques-on   “I  accidently  gave  a  dose  of  MMR  vaccine  IM  instead  of   SC.  Will  this  dose  count?”     “I  gave  a  vaccine  by  mistake  in  the  gluteal  muscle”        .

(46) Vaccine  Routes  of   Administra2on   Oral   Intranasal   Intradermal  (ID)   Subcutaneous  (SC)   Intramuscular  (IM)     PPSV23  and  IPV  can  be   administered  SC  or  IM  .

(47) Proper  Injec-on  Technique  . SC Injection. IM Injection.

(48) Intramuscular  (IM)  Injec-ons   Needle  should  be  at    90  degree  angle   Patient Age Site. Needle Size. Infants (birth to Vastus lateralis 12 mos) muscle. 5/8” to 1” needle 23 - 25 gauge. Young children Vastus lateralis (12 to 36 mos) until deltoid muscle is adequate. 5/8” to 1” needle 23 - 25 gauge. Older children (>36 mos) & adults. Thickest portion 1” to 2” needle of deltoid muscle 23 - 25 gauge.

(49) Subcutaneous  (SC)  Injec-ons   Needle  should  be  at  a  45  degree  angle   Patient Age Site. Needle size. Infants (birth to 12 mos). Fatty area of the thigh. 5/8” to 1” needle 23 - 25 gauge. Young children (12 to 36 mos). Fatty area of thigh or outer aspect of upper arm Outer aspect of upper arm. 5/8” to 1” needle 23 - 25 gauge. Older children (>36 mos. of age) & adults. 5/8” to 1” needle 23 - 25 gauge.

(50) Nonstandard  Route  &  Site  of   Administra-on   — Most  doses  administered  by  the  non-­‐standard  . route  will  be  valid   — Repeat  vaccines  when:     — Rabies  or  hepatitis  B  vaccine  given  in         gluteus  (buttocks)   — Hepatitis  B  vaccine  given  any  route           other  than  IM   — HPV  given  SC    .            .

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(52) Proper  Documenta-on  of  Vaccines   — Vaccine  name   — Date  of  administration   — Name  of  manufacturer   — Lot  number     — Expiration  date  (recommended)   — Name  &  title  of  person  who  administered  vaccine   — Address  where  vaccine  was  given   — Date  that  vaccine  information  statements  (VIS)  was  . given  to  parent/guardian  . — Publication  date  of  VIS  given  .

(53) Vaccine  Informa-on  Statement   — Most  current  Vaccine  Information  Statement    (VIS)  to  . the  parent/guardian  of  each  child  being  vaccinated   — The  VIS  must  be  given  before  every  dose  of  every   vaccine   — Permanent  copy  of  a  VIS  can  be  read  in  the  office   — Federal  law  does  not  require  a  signature  be  obtained   — Can  be  downloaded  into  wireless  devices  .   Sign  up  for  email  alerts  of  VIS  changes:  www.cdc.gov/vaccines/pubs/vis/ default.htm  .  .

(54) Where  to  Find  Current  VIS   — State  and  Local  Health  Departments   — Internet   ◦ CDC   – www.cdc.gov/nip/publications/VIS   ◦ Immunization  Action  Coalition  (IAC)   – www.immunize.org/vis   — Over  30  foreign  languages     — Audio  .

(55) You  Discover  an  Error…What  Next?   — Use  your  resources.  The  dose  may  be  valid  .   — Notify  the  patient  and/or  legal  guardian   — Let  them  know  an  error  occurred   — Ensure  no  adverse  events  have  taken  place   — Explain  any  follow-­‐up  that  is  necessary     — Document  the  incident  following  your  agency’s  policy  .   — Submit  to  VAERS  if  adverse  event  is  reported  or  if  . vaccination  error  poses  safety  risk  to  patient.    .

(56) VAERS  .

(57) References  and  Resources   — Centers  for  Disease  Control  &  Prevention  (CDC)  Pink  . Book:  . http://www.cdc.gov/vaccines/pubs/pinkbook/index.html  . — ACIP  Recommendations:  . http://www.cdc.gov/vaccines/acip/index.html  . — IAC’s  “Ask  the  Experts”  Q&As   http://www.immunize.org/askexperts   — Subscribe  to  IAC  Express  for  weekly  updates  . http://www.immunize.org/subscribe  .  .

(58) More  Help!     — Email  CDC’s  experts:  nipinfo@cdc.gov   — Contact  ISDH  Immunization  Division   — (800)  701-­‐0704   — immunize@isdh.in.gov  . — Contact  your  vaccine  rep  or  call  the  manufacturer   — Contact  information  is  located  on  back  of  temp  logs  .  .

(59) Strategies  to  Prevent  VAE’s   1. Involve  staff  in  selection  of  vaccine  products   2. Place  job  aides  in  highly  visible  locations,  especially   3. . 4. 5. 6. . the  medication  prep  areas   Rotate  vaccine  stock  by  placing  closest  expiration   dates  in  front.  Remove  expired  diluent  and  vaccine   immediately   Place  sound-­‐alike  and  look-­‐alike  products  in   different  areas  of  the  vaccine  storage  unit   Only  administer  vaccines  you’ve  prepared.  Triple   check  your  work   Educate  parents  on  vaccine  schedules  and  the   importance  of  maintaining  records    . Pink  Book  Appendix  D  .

(60) Education is Important! • • • . Ensure new staff are adequately trained on the proper technique for administering vaccines Review package insert for all products prior to administering any doses of vaccine Provide current immunization education • Immunization schedules • Skills assessment.

(61) Questions?   dgreenwood@isdh.in.gov   (317)  233-­‐7560  .

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