13. VACCINE STORAGE UNITS

Transcription

1 13. VACCINE STORAGE UNITS The fllwing infrmatin utlines the strage unit requirements f the Mntana VFC Prgram. General Requirements Refrigeratrs and freezers used fr string VFC vaccine must: Maintain required vaccine strage temperatures year-rund: Refrigeratr: 35 t 46 F (2 t 8 C) Freezer: 5 F r clder (-50 t -15 C) Hld the year s largest inventry plus ice packs (freezer) and water bttles (refrigeratr) t stabilize temperatures In each unit have a wrking Natinal Institute fr Standards and Testing (NIST)- r American Sciety fr Testing and Materials (ASTM)-calibrated thermmeter that cmplies with the Mntana VFC Prgram thermmeter plicy (See Sectin 14) Be dedicated t vaccine strage (Fd and beverages are nt allwed in vaccine strage units.). Nt be a drmitry-style appliance (see sectin belw). New r replacement units cannt be cmbinatin units where bth the refrigeratr and freezer are used t stre VFC vaccine (See Cmbined vs. Stand Alne Units sectin belw) Have the pwer supply prtected by means f DO NOT DISCONNECT warning signs n electrical utlets and circuit breakers r a pwer lss preventin system with apprpriate plicies/prtcls. Drmitry-Style Strage Units are Prhibited Drmitry-style (als called bar-style ) refrigeratr/freezer units are thse where the freezer is cntained within the refrigeratr, and bth are accessed by ne external dr. Please nte that the term drmitry-style des nt refer t the size f the unit. It refers t the lcatin f the freezer within the refrigeratr cmpartment. These units cannt reliably maintain vaccine strage temperatures. Figure 1 Drmitry- Style Refrigeratr/Freezer The CDC and the Mntana prhibit the use f drmitry-style strage units fr string VFC vaccine. By signing the Prvider Agreement each year, yu certify that yur facility des nt use drmitry-style strage units t stre public vaccine. MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 49 f 85

2 Cmbined vs. Stand-Alne Units Definitins: Cmbined units have a refrigeratr and freezer cmpartment in ne appliance. Stand-alne units have just ne cmpartment that is either a refrigeratr r freezer. Currently, nly varicella-cntaining vaccines require frzen strage. If yu d nt administer varicella-cntaining vaccines at yur facility then yu d nt need a freezer fr vaccine strage. The CDC-recmmended best practice fr vaccine strage is t use stand-alne refrigeratrs and freezers. This can be accmplished by using a stand-alne refrigeratr and stand-alne freezer r by using just the refrigeratr in a cmbined unit and a stand-alne freezer. If freezer strage is nt required, yu can just use the refrigeratr in a cmbined unit. The cmbined units cannt be drmitry-style. Starting Octber 1, 2013, the Mntana prhibits VFC prviders frm acquiring new r replacement strage units that are cmbined refrigeratr/freezers where bth cmpartments will be used t stre vaccine. Prviders currently using the refrigeratr and freezer in a cmbined unit can cntinue t d s as lng the units have been apprved by the (see Strage Unit Apprval, page 49) and the data lggers shw that they reliably hld vaccine strage temperatures. Hwever, if yu are a new prvider r are btaining new r replacement equipment, yu must fllw the recmmended best practice and btain stand-alne units. Please cntact the befre purchasing new r replacement vaccine strage units. Cmbined units regulate temperature by sharing cled air between the refrigeratr and freezer cmpartments. This makes temperature regulatin in bth cmpartments difficult. Please be aware f the fllwing issues when using cmbined refrigeratr/freezers fr vaccine strage: Avid units with a single cntrl fr bth the refrigeratr and the freezer. This cnfiguratin makes it difficult t maintain apprpriate temperatures in bth cmpartments and increases the likelihd f freezing vaccine in the refrigeratr. Never place vaccine r thermmeters (i.e., data lggers) near vents and fans in the refrigeratr. These areas may be markedly cler than the rest f the cmpartment (even freezing!). When making adjustments in ne cmpartment, always carefully mnitr temperatures in bth cmpartments. This is especially true when adjusting the freezer as this culd cause the refrigeratr t drp belw freezing. Dmestic Grade vs. Pharmaceutical Grade Dmestic (r husehld ) quality strage units are thse typically fund in hmes and sld at retail appliance stres. The Mntana allws the use f dmestic-grade appliances t stre VFC vaccine as lng as they are nt drmitry-style strage units, if acquired after Octber 1, 2013, are nt cmbinatin MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 50 f 85

3 refrigeratr/freezers in which bth chambers are used, and data lgger data shw that they hld prper vaccine strage temperatures (See Drmitry-Style Units and Cmbined vs. Stand-Alne Units abve). Labratry- r pharmacy-grade refers t strage units that are specifically designed t stre vaccine and pharmaceuticals in a labratry r pharmacy setting. These are the highest quality ptin fr string vaccine. Labratry-grade appliances cme with safety, temperature cntrl, and security ptins typically nt fund n dmestic units. Althugh usually mre expensive, they cme in a wide variety f sizes, cnfiguratins, and prices, including mderately priced under-cunter mdels ideally suited fr small clinics. Freezers Frst-free vs. Manual Defrst The Mntana allws bth frst-free (autmatic defrst) and manual defrst freezers fr vaccine strage. Definitins: Frst-free units cycle t a warmer temperature rughly nce every 24 hurs t melt ice ff the inside f the freezer cmpartment. Manual defrst units d nt have a defrst cycle and accumulate ice n the inside f the cmpartment. They require peridic manual defrsting t melt the ice. There are disadvantages t bth defrst scenaris and facilities must decide which feature best fits their situatin: The temperature cycling parameters in frst-free units must meet Merck specificatins (cntact the fr details). Als fr frst-free units, temperature mnitring equipment (i.e., data lggers) must be adjusted s the utf-range alarm is nt triggered with each defrst cycle (See the current Data Lgger Instructin Manual). Manual defrst units typically hld vaccine strage temperatures steady and d nt rutinely cycle ut-frange, but alternate vaccine strage and temperature tracking must be arranged while yu defrst yur appliance. Other Recmmended Features: Fully adjustable shelves Dr lcks Dr ajar alarm Battery back-up Size Determinatin Yur VFC vaccine strage unit must be able t stre the year s largest supply f vaccine including ice packs and water bttles used t stabilize temperatures. It als must be large enugh t allw spacing between vaccine packages fr prper air circulatin (See Vaccine Placement, page 51). T determine the size strage unit yu need, calculate the largest number f dses yu will have n hand during the year fr bth yur refrigeratr and freezer. Be sure t include seasnal influenza and private stck if it will all MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 51 f 85

4 be stred in the same unit. Multiply the maximum dses by 1.25 t accunt fr package spacing. Use this number (maximum dses) and the chart belw t determine the minimum cubic feet f strage space yu will need. Table 1 Recmmended Minimum Cubic Feet f Strage Space Based n Maximum Dses Refrigeratr Freezer Maximum Dses Minimum Cubic Feet Required Maximum Dses Minimum Cubic Feet Required Setting Up yur Strage Unit Fllw the prcedures belw when acquiring a new strage unit, mving an existing unit, r reestablishing a unit after a pwer utage r repair. Unit Placement Place the unit clse t a reliable electrical utlet (See Electrical Supply belw). Lcate the strage unit in a well-ventilated space away frm direct sunlight with 4 inches between the unit and surrunding walls, cabinets, and appliances. Fllw any minimum clearance guidelines in yur appliance dcumentatin. D nt blck the mtr cmpartment, which is usually lcated n the back r side f the unit. Electrical Supply Place the strage unit near enugh t an utlet s that the crd is nt a tripping hazard and an extensin crd is nt necessary. If pssible, d nt plug mre than ne appliance int the utlet t avid tripping the circuit breaker. Make sure the utlet is nt cntrlled by a light switch. Prtect the pwer supply t yur vaccine strage units: Fr facilities withut sphisticated pwer lss preventin systems, pst a DO NOT DISCONNECT sign next t the utlet and circuit breaker supplying yur strage units. If these are nt accessible r visible, place the sign such that anyne accessing the utlet r circuit breaker is likely t see it. Facilities with sphisticated pwer lss preventin systems d nt need DO NOT DISCONNECT signs, but must have written plicies detailing measures taken t prevent accidental lss f pwer. Systems shuld be in wrking rder and tested regularly. MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 52 f 85

5 If yu d nt have a backup pwer supply, arrange at least ne alternate vaccine strage lcatin that has prper refrigeratr and freezer units, temperature mnitring capability, and backup pwer where yur vaccine can be mved in the event f a pwer utage. Recrd this infrmatin in Sectin 12. Temperature Stabilizing Plug the unit int the electrical utlet and set the temperature t fall within the fllwing ranges: Refrigeratr: Freezer: 35 t 46 F (2 t 8 C) 5 F r clder (-15 C r clder) If the unit has a thermstat, set t the fllwing target temperatures: Refrigeratr: 40 F r 4 C Freezer: -5 F r -20 C If the unit has a cntrller with numbers r wrds (e.g., clder ), set as fllws: Refrigeratr: Freezer: Set slightly warmer than mid-range. Set t mid-range. Please nte Fr mst numbered temperature dials, the higher the number the clder the temperature. Check yur wner s manual t avid imprper adjustments. Place a wrking prgram-cmpliant thermmeter (data lgger) inside each strage cmpartment in a central lcatin near vaccine but away frm ceilings, walls, flrs, vents, fans, cils, and cling plates (stand-alne refrigeratrs). The Mntana supplies data lggers t VFC prviders (see Sectin 14). Place several cntainers f water alng the inside walls, in dr racks, and vegetable bins ( crispers ) f the refrigeratr, and several frzen packs alng the walls and in the dr rack f the freezer. These will help stabilize temperatures when the dr is pen and in the event f a pwer utage. D nt impede air flw by ver-filling with water bttles and ice packs. Make sure drs clse tightly and seals are intact. Allw the unit t stabilize vernight and check temperatures in the mrning. Adjust the dial r thermstat until the target temperature is achieved and held fr at least ne week. Lg temperatures at least twice a day, and dwnlad and review data lgger data as needed during the adjustment perid (See Data Lgger Instructin Manual). Strage Unit Apprval The must apprve all strage units and thermmeters used t stre and mnitr VFC vaccine. T have a strage unit/thermmeter apprved, prviders must submit: One week f temperature (data lgger) data (See Sectin 14 and yur Data Lgger Instructin Manual fr details) One week f paper temperature lgs Strage unit make/mdel infrmatin. This requirement applies t: MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 53 f 85

6 New VFC prviders Prviders setting up a new VFC strage unit Prviders reinstating a VFC strage unit after a repair Prviders cmmissining a new Data Lgger r ther prgram-cmpliant thermmeter. The reviews yur temperature data and determines whether yur strage unit and thermmeters are ready fr vaccine. D nt use the strage unit until it has been apprved by the Immunizatin Prgram. Vaccine Placement Place vaccine in the middle f the cmpartment away frm ceilings, walls, flrs, vents, fans, cils, and cling plates (stand-alne refrigeratrs). In the refrigeratr cmpartment f cmbined units, keep vaccine away frm vents r fans channeling air frm the freezer. Cnsider putting water bttles r empty cntainers in areas knwn t deviate frm acceptable temperatures (near cling fans r vents) t prevent vaccine frm being placed in these areas. Hwever, DO NOT impede airflw. Never stre vaccine in dr racks r vegetable bins (i.e., crispers ). Cnsider remving vegetable bins t facilitate air circulatin. This will prvide mre space fr water cntainers. Clearly label vaccine VFC and keep it physically separated frm private stck. Keep vaccine in its riginal packaging and rganize by vaccine type. Cnsider physically separating vaccines with similar names, packaging, r antigens t avid administratin errrs. Check expiratin dates n a weekly basis and rganize packages s that nly ne package is pen at a time and shrt-dated vaccine is used first (recrd yur prcess in Sectin 12). Immediately sequester expired, spiled, and wasted vaccine frm active stck (See Expired, Spiled, and Wasted Vaccine page 70) If cntainers are used t rganize vaccine, use nly pen (n lid) cntainers that allw air t circulate, such as wire baskets r cardbard bxes. Never stre fd r beverages in vaccine strage units. Other bilgicals can be stred in vaccine strage units as lng as they are physically separated frm vaccine t prevent cntaminatin and administratin errrs. Diluent packaged with the vaccine shuld be stred at the same temperature as the vaccine. Diluent packaged separately frm the vaccine can be stred refrigerated r at rm temperatures. Rutine Temperature Mnitring VFC prviders are required t mnitr and lg temperatures n VFC vaccine strage units as described belw. Prviders must use the paper lgs prvided by the (available n ur website at This is required even when yur unit has a cntinuus mnitring chart r data lgger, r a temperature alarm (Please refer t the Data Lgger Instructin Manual and Sectin 14 fr mre infrmatin n data lggers). Recrd current temperatures twice per day, mrning and evening by putting an X in the bx next t the apprpriate temperature. Recrd minimum/maximum temperatures nce per day in the mrning by putting an M in the bx next t the apprpriate temperatures. MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 54 f 85

7 Recrd the status f the data lgger LED light by putting a Y fr yes r N fr n in the apprpriate bx f the LED Green rw. Respnd immediately t red warning lights r ut-f-range temperatures (See Out-f-Range Temperature belw). Respnd t requests frm the fr data lgger data and temperature lgs. As a quality cntrl measure, the randmly requests temperature-mnitring infrmatin frm VFC prviders. D nt make temperature adjustments withut infrming yur Vaccine Manager r Alternate Vaccine Manager. Cnsider psting a sign discuraging temperature adjustments by unauthrized persnnel. DO NOT adjust temperatures in the evening r befre a weekend when temperatures cannt be mnitred. When adjusting temperatures, make slight changes t the thermstat r temperature dial and allw the unit t stabilize fr 30 minutes. (Check yur wner s manual t make sure cntrller adjustments are in the prper directin.) Check and recrd the temperature. Repeat, until the temperature is cmfrtably within range and stable. Recrd all temperature adjustments and issues with yur strage unit n a Vaccine Strage Truble- Shting Lg (page 3 f the State-supplied temperature lgs). Lgging these events will cmmunicate vaccine strage issues t all staff, and dcument recurring events befre they lead t majr vaccine lss. Be practive in addressing strage unit issues befre they result in vaccine wastage r patient recall situatins. Out-f-Range Temperatures VFC prviders must take actin if: They register a red warning light n their data lgger r ut-f-range indicatin if using ther cmpliant thermmeters. They recrd a current, minimum, r maximum ut-f-range temperatures n their temperature lgs. Prviders experiencing the ut-f-range temperature indicatins listed abve shuld immediately btain a Vaccine Incident Reprt frm and fllw steps 1 6 n the reprt. Then call r the immediately r hhsiz@mt.gv. D nt cmplete the entire Vaccine Incident Reprt until yu have cnsulted with the. All temperature excursins must be dcumented either thrugh a cmpleted and submitted Vaccine Incident Reprt r an entry in the Vaccine Strage Unit Truble-shting Lg (third page f paper temperature lg), depending n the circumstances and guidance frm the. MT IZ VFC Handbk - Sectin 13 Vaccine Strage Units (revised 04/01/2014) Page 55 f 85