NYSIIS. Immunization Evaluator and Manage Schedule Manual. October 16, Release 1.0

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1 NYSIIS Immunization Evaluator and Manage Schedule Manual October 16, 2007 Release 1.0

2 Revision History Release Modifications Author Revision Date 1.0 Initial Draft R Savage 10/16/2007

3 INTRODUCTION: 1 BUILDING OR MAINTAINING A SCHEDULE: 1 Creating a schedule 2 Setting up the base schedule 3 Inter-group conflicts 3 Creating a series: 4 Acceptable Vaccines Tab 5 Maximum Doses 6 Trade name 6 Alternate Series 7 Invoke Rules 7 Invoke on Use: 7 Invoke on Valid Only: 7 Invoke on Age: 7 Invoke on High Risk: 7 Invoke on Comment: 8 Result Rules: 8 Result Interval: 8 Over-ride Primary: 9 Creating Dose Records: 9 Interval after a not valid dose: 9 Booster: 9 Age Rules: 9 Adjacent Dose Interval Rules: 10 Non-adjacent Interval Rules: 10 Unacceptable vaccine: 10 Unacceptable vaccine group: 10 Jump forward: 11 Notes On Setting Up The Jump Rule For HIB: 11 Minimum Interval to Validate: 12 Minimum Age to Validate: 12 IR IMMUNIZATION EVALUATOR PROCESS AND RULE SETS 12 Introduction: 12 Select candidate series: 13 Evaluate series: 13 Select best series: 13 Best series rules: 13 Determine Next Doses Due: 14 Rules: 14 Determine reference dates and validate: 14 Age Rules 15 Adjacent Dose Interval Rules 15 Minimum interval to validate 16 Minimum age to validate 16 Interval After a Not Valid Dose: 16 Non-adjacent dose interval: 17 Inter-Group interval rule: 17

4 Grace Period: 18 Rules associated with formulation and size: 18 Trade Name / Age rules: 18 Trade name specific rules: 18 Vaccine is not acceptable for this dose: 18 Dose size rule / Adequate dose rule: 19 Partial Dose Rule: 19 Acceptable vaccine rule: 19 Rules associated with smallpox: 20 Dose Immunity Rule: 20 Dose result interval rule: 20 Rules that allow skipping of doses: 20 Jump forward rule: 20 Series Alternate rule: 21 Acceleration rule: 21 Restart Series Rules: 21 Vaccine group over-ride rule: 22 Rules triggered by patient comments and conditions: 22 Contraindication Rules: 22 Immunity Rules: 22 Maximum Doses Rule: 22 Invoke on comment: 23 Rules that control inclusion of vaccine groups in patient schedule: 23 Invoke on use rule: 23 Invoke on valid only rule: 23 Invoke on age rule: 23 Invoke on high risk: 23 Release Date: 24 Highlight recommendations if the recommended dates for a combination immunization are different from each other: 24 MISSED OPPORTUNITIES: 24

5 Introduction: This manual is designed to guide the user in creating or modifying immunization schedules. A schedule 1 is a collection of series, owned or maintained by a provider organization. A series is the constellation of doses that satisfy the requirements for a vaccine group. A patient is recommended to get each dose in a series at the ages and intervals assigned in the rules. Rules apply at schedule, series and dose level. Rules are table driven. Manage Schedules allows you to set up the rules that apply to a vaccination. (See Business Rules for specifics) The first section of this document outlines the process of setting up and modifying a schedule or series. The next section contains a more detailed description of the application processes and business rules. Finally, it has a glossary for term definition. Building or Maintaining a Schedule: The major activities allowed by Manage Schedules include: View Schedule List View Schedule Print Schedule Create Schedule Modify Schedule Delete Schedule Create Series Modify Series Delete Series Only users that have Administrator privileges may access these services. One schedule is owned and maintained by the NYSIIS System Administrator. This schedule is based on the ACIP schedule. It is the default schedule and is available to all users. No one else may modify this schedule. View Schedule List: Clicking on the Manage Schedule menu item, brings you to the list of Schedules available to you, based on your organization. The list has hyperlinks for each schedule that will take you to the View Schedule page. You may delete a schedule that you own. You may create a schedule from this page. View Schedule: The View Schedule page allows you to view and modify the schedule wide data. The ACIP schedule is shown as a read only view (View Complete) to all but the NYSIIS 1 See Glossary for definition of terms. Page 1 of 24

6 System administrator. The view that allows editing has two tabs. The first is a list of all series. The second gives access to schedule wide inter-group conflicts. (One example of this is the conflict between MMR and varicella.) This screen also includes Schedule Name, Schedule Description and Grace Period. It is where you can lock the schedule to changes by other users. You may click from here to the View Complete page. You may see the View Complete screen from the View Schedule screen by clicking the View Complete Button. Print Schedule You may print the schedule from the View Complete screen. If you do not want the menu items along the side of the screen to print, click the Printable Version button. Click the Print button on your browser. Create Schedule To create a schedule, begin at the View Schedules list page. (Detailed instructions can be found below). Modify Schedule Click from the schedule list page to the series page. If you have rights to change the schedule, you will see a list of series links. Click on the link of the series you wish to modify a series. Click Add Series to add a new series. See Create Schedule below for detailed instructions. Delete Schedule To delete a schedule that you own, click the delete button to the right of the schedule name in the schedule list. This will permanently remove the schedule and all of its components. Add Series See Creating a series below for detailed instructions. Modify Series In order to modify a series, select that series from the list on View Series list page. Follow the principals described in Create Series. Delete Series Select the series check box to the right of the series name and click delete button. You may select more than one series to delete. Creating a schedule Schedules are complex sets of rules and parameters. By taking a systematic approach, the complexity can be minimized. Any time a series is changed or created, careful testing of the impact should be instituted. This testing should not be limited to the specific series created or modified, but rather to other series that may interact with the modified series. Page 2 of 24

7 Remember that you must Save any changes before leaving Manage Schedules or changes will be lost. Saving occurs in 2 phases. You may add to or change a schedule. Changes are saved in memory until you click Save schedule. Then data is saved in the database. Setting up the base schedule 1. Select Manage Schedules from the menu. 2. You will go to the View Schedules screen. 3. Enter a schedule name (required). The name should be unique to your provider organization so that you know them apart. 4. You may use another schedule as the base template by copying it into the new schedule. This saves you lots of effort. We will assume that this is your plan. Select a schedule to copy from the pick list. 5. You may add a description of the schedule. 6. If you plan to allow a grace period for validating immunizations, enter this number. This grace period is the number of days an immunization may be early or in some cases, late, and yet be considered valid. It is not used in recommending next vaccinations. You may allow this grace period to apply to the earliest and/or latest dates for doses in a series. You may set a series to disregard grace period. Both of these actions are performed at the series level. For complete description, see below. 7. You may enter the standard interval after a not valid dose. This will apply to any series, except those that are set to ignore this. 8. If you don t want others to be able to alter this schedule, select the Lock to Others check box. This may only be unlocked by the owner and the NYSIIS system administrator. 9. Click Create Schedule button and go to the View Schedule list page. If you are creating a schedule from scratch you are not finished. Every schedule must have at least one series. You may modify or delete existing series or add new series. Inter-group conflicts You now add or delete any inter-vaccine group interval conflicts, such as the conflict between varicella and MMR. Click on the inter-group conflict tab. Adding inter-group conflict 1. Select a vaccine group from the left pick list to create a record in the list below. ( You will need to create a record for both directions of a conflict. That is varicella to MMR and MMR to varicella) A vaccination from this vaccine group Page 3 of 24

8 will be not valid if a dose from the other vaccine group was given within the interval specified. 2. Select a vaccine group from the right pick list to add conflicting vaccine to the list below. 3. Enter a number for the beginning of the conflict period, for instance 1 day. Note that this can be a negative number. 4. Enter a time unit (D, M, Y). 5. Enter a number for the ending of the conflict period, for instance 30 days. 6. Enter a time unit. A begin interval of 1 day and an end interval of 28 days means that vaccinations from the conflicting vaccine groups will not be valid if received between 1 and 27 days (inclusive) of each other. 7. Repeat until done. Delete an inter-group conflict 1. Select the conflict(s) you wish to delete by checking the box next to them. 2. Click the Delete button. There are 3 primary tabs for the series view. Complete Series shows a summary of all settings for the series. The Series tab displays a page with sub-tabs that allow you to view and alter series wide parameters. The Doses tab displays another page with sub-tabs that allow you to alter individual doses and add or delete new doses. Creating a series: A Series must have at least 1 dose. It is not released for use until you indicate it is done. This is done by clicking the Manage Another Series button and then clicking the Save button. Saving prior to completion may be possible, but can cause users of that series to experience unexpected behavior. Therefore, be sure that you are done before saving the schedule. The new schedule is built when the last updated date/time for the schedule in the database is greater than the last updated date/time in the schedule in memory. Page 4 of 24

9 Note that you need to have at least 1 dose and that dose must have either an age or interval rule. If you leave the series before you have these, you will not have your series saved. The process is: Create the series, Manage another series (saves series changes to memory) Save (saves to database) 1. Click Add to begin a new series. You will see the Complete Series tab. Since the series has no data, you only see the headers. 2. Click the Series button. 3. Name the series. 4. Indicate if the minimum grace period 2 applies to this series. 5. Indicate if the maximum grace period applies to this series. 6. Indicate if interval after not valid applies. (Default = Y) This is not a simple as it appears. Do NOT allow maximum grace period to apply if a pediatric series has a maximum age and is followed by an adult series with a minimum age. Acceptable Vaccines Tab This tab allows you to indicate all of the potential vaccines that can satisfy this series. You may also set the vaccine up so that the age of the patient and dose size have an impact of validity. (E.g. If an adult received a single pediatric dose of Hep B, this is not valid. Receiving 2 doses of pediatric vaccine will be valid.) In addition, you may indicate if age and trade name impact the validity differently than the age rules applied to the whole series. Indicate the acceptable vaccines for this series 1. Select the vaccines that are acceptable for ANY dose in this series. ( You will be able to indicate any that are not acceptable for specific doses later. 3 ) 1.1. You must select at least 1 acceptable vaccine. 2 When a schedule has a grace period and the series allows the grace period to be used for earliest acceptable date, then the Immunization Evaluator will consider a dose valid, even if it was given up to the grace period early. 3 Note that Trihibit (DTAP/Hib) is only acceptable for a Hib series if it is the final dose in a multi-dose series. We set DTAP/HIB as an acceptable vaccine for the series, but set it as unacceptable for all doses except the last dose in the series. Page 5 of 24

10 1.2. Indicate if this is the primary vaccine for this series. (This sets the vaccine groups that are associated with this vaccine. In the case of a combo vaccine, both vaccines will be set.) Only one primary vaccine is allowed If there is a minimum dose size 4 and dose multiplier for this vaccine to be used in this series, enter this information for each vaccine. (This will be ignored if the immunization is not from registry inventory.) The Immunization Evaluator will multiply the dose size (ml) from the associated vaccine lot and dose multiplier to arrive at the total volume required to be acceptable. (Dose multiplier = 1, dose size = 0.5 ml will give a total dose size of 0.5 ml) 1.4. If this series has different age rules depending on trade name and patient age, then add trade name age rules. There must be either a minimum or maximum age and trade name. Both age parameters can be entered Indicate the minimum age and age attribute (e.g. 6 M). If this is null or 0 then there is no minimum age Indicate the maximum age and age attribute (e.g. 3 Y). If this is null or 0, then there is no maximum age Indicate which trade name applies Save/Add this rule Repeat as needed. Note that this is different from the Trade name rule. The Trade name rule requires a dose to be from the specified trade name or it will be not valid, regardless of other rules. This rule says that if this dose is from the indicated trade name, it must be between the ages given or it will be not valid. This is also different from the Age rules that apply to individual doses. However, if these age rules are outside the regular age rules, you will get unexpected behaviors. Maximum Doses If there are a maximum number of doses recommended for an immunization, regardless of validity then the max doses rule applies. 1. Enter information for this rule. (e.g. A patient who receives 6 or more doses of DTAP before the age of 7 years is not recommended to get more DTAP. In this case, we would enter 6 as the max doses and 7 years as the max age.) Trade name If this series can only be satisfied by a trade named vaccine, enter information for this rule. 1. Select any trade names from the list on the left into the list on the right. More than one tradename may satisfy this series. 4 Dose size is the volume (e.g. 0.5 ml). Multiplier is number of doses of the given size delivered. So a double dose of pediatric Hep B would have a multiplier of 2. Page 6 of 24

11 Only enter a trade name rule if this series can ONLY be satisfied by the trade name(s) selected and not just the vaccine. Alternate Series If there are other series that can replace doses in this series, add that information. 1. Select the alternate series. 2. Enter the age and age attribute for the starting dose in the alternate series. 3. Enter the relationship symbol (>, >=, =, <=, <) for the age relationship. This will control how the age at immunization for the first dose is related to the age entered above. For example if the age is 1 year and the relationship symbol is <, then we would say, if the age at immunization is < 1 year for the first dose, then use this rule. 4. Enter the number of doses recorded in the alternate series. 5. Enter the number of doses that will be replaced by the alternate series for the combination of age and doses listed in the rule. 6. Enter the vaccine group of the alternative series being evaluated. This is used if the vaccine given is a combo vaccine. We are only interested in one component of that combo. 7. Click the Add button. 8. Repeat as needed. NOTE: The ages and relationships MUST be mutually exclusive. In addition, the alternate series is presumed to be prior to the series using it as an alternative. In situations where the alternate is recorded as after the series, the Immunization Evaluator will not apply the alternative rule correctly. Invoke Rules The invoke rules invoke the vaccine group(s) of the primary vaccine for this series. This forces them to be included for consideration. If no Invoke rules are set, then the vaccine group is always considered by the Immunization Evaluator. For example, if Comvax(Hep B/HIB) is set to invoke on use then Hep B and HIB will be included in the recommendations. Invoke rules do not invoke the specific series. Invoke on Use: If you only want to see the vaccine group evaluated if a patient has received at least one dose of this vaccine, then select Invoke on Use. Invoke on Valid Only: If you only want to invoke this vaccine group if VALID doses have been recorded, select this check box. Invoke on Age: If you only want to see the vaccine group evaluated if a patient has reached a minimum age, then select Invoke on Age. Invoke on High Risk: Page 7 of 24

12 If you only want to see the vaccine group evaluated if a patient is designated as high risk, then select Invoke on High Risk. Note that the patient is designated as High Risk if the Provider Organization viewing the record is set to High Risk. Invoke on Comment: To invoke the vaccine group if the patient has a specific comment recorded, click this check box and indicate if a history of immunization against this antigen is required. You must also select a specific comment to trigger this invoke. This is used for selecting between Rabies pre and post exposure series. Note that the invoke rules interact with each other. If any invoke rule causes a vaccine group to be required, it will trump all others. Gender specific rule: The gender rule determines if a series is included in the schedule for a patient. If the patient meets the requirements of a gender rule, then the vaccine group will be included in the evaluation and recommendations. If the patient does not meet the rule, then the vaccine group will be unevaluated and no recommendations will be made. The rule first determines if the patient is of a specified gender. If the patient is of the specified gender then they meet the requirements for this rule. If they do not, the outcome depends on whether the schedule allows the series to be invoked on use for other genders. If invoke for other genders is true and the patient has at least one dose, then the vaccine group will be included, otherwise it will not be include. Result Rules: The result rules and result interval are used when setting up smallpox vaccination in the Immunization Evaluator. You may enter any number of result rules, but they each should be unique. You may add or delete rules. 1. Select a result for the rule. 2. Indicate if a history of immunization is required by the rule Indicate if the series is satisfied (patient is presumed to be immune). 4. Add the rule. To delete a rule, select it with the checkbox and click Delete. When you are done, click to another tab or Manage another schedule. Result Interval is required, if there are result rules. Result Interval: 1. Indicate the minimum and maximum read intervals. 2. Indicate the recommended and overdue intervals. 5 History is any smallpox vaccination, regardless of read. Page 8 of 24

13 Over-ride Primary: In some situations, a clinician may assume that the patient has received the primary series needed to begin a booster series. In this situation enter the minimum age and age attribute to allow this to occur. Click to another tab or Manage another series to store the information. This will allow users to over-ride the primary. Note: We assume that the first dose given is set to Ignore primary series. If the dose set is later than the first, the Immunization evaluator will not function properly. Creating Dose Records: Now you need to create a record and rules for each dose and booster in the series. For any entry that requires an age or an interval, you should leave it set to 0(zero), if you don t need to enter anything. For instance, if there is no minimum age for dose 2 in a series, leave it set at 0 days. The interval rule will set the reference date. Note that you do not want a minimum interval for first doses. There is a rule that determines the minimum interval after a Not Valid dose. The process is to apply any rules for the selected dose. (This is indicated by yellow highlighting for the dose row.) Repeat for each dose in the series. Interval after a not valid dose: If you do not want the interval after a not valid to apply to this series, select that on the screen. This is important for series that have very short intervals, such as rabies. Booster: Indicate if this dose is a booster. Remember that boosters are only allowed for the last dose in a series. Boosters can be repeated as often as needed. In other words, boosters allow unlimited doses. Age Rules: If age rules apply to THIS dose, then enter the ages and attributes required. 1. Enter a number and time unit for each age that applies. (e.g. 42 D) Remember that the minimum age must be <= recommended age, etc. The exception to this is if a 0 D is entered for one of the ages to the right of a non-zero age. That is the Maximum age may be set to 0 if no there is no maximum age. 2. You may add another dose at this time or you may finish entering information on other tabs for this dose. Note that the maximum age is the age at which the patient should not receive this vaccination. For example, if the DTAP is set to 7 Y, the immunization will become Not valid if received on or after the 7 th birthday. Maximum grace period may be applied and shift the maximum age by the grace period. Page 9 of 24

14 Adjacent Dose Interval Rules: If there are rules that are used for this dose that relate to the immediately previous dose, then enter intervals and interval attributes that apply. 1. Enter a number and time unit for each interval that applies. (e.g. 42 D) Remember that the minimum interval must be <= recommended interval, etc. The exception to this is if a 0 D is entered for one of the interval to the right of a non-zero interval. 2. You may add another dose at this time or you may finish entering information on other tabs for this dose. Note that when an alternate series has replaced some doses for the series under consideration, the interval between the dose being evaluated and the dose in the alternate series that proceeded it is evaluated. For example if the primary doses in the Td series are replaced by DTAP, then the minimum interval to the Td booster would be based on the interval since the final dose in the DTAP series. Non-adjacent Interval Rules: If there are intervals between this dose and a non-adjacent previous dose in the series that apply, then enter the interval and attribute. 1. Enter the dose number of interest. (e.g. 1 for dose 1) 2. Enter the number and time unit for the interval (e.g. 112 D) Unacceptable vaccine: If there are vaccines that are unacceptable for this dose in a series, but acceptable for another dose in a series, then enter this information. 1. Select the vaccine that is unacceptable for this dose. (It must already be in the Series Acceptable vaccines.) Note: This rule combines with Acceptable Vaccines to allow Trihibit to be used for the final dose in a multi-dose series of HIB. Set DTAP/HIB as acceptable for the series. Then for each dose other than the final dose, set DTAP/HIB as unacceptable. We must also set up a 1 dose series for HIB after 15 months. Trihibit (DTAP/HIB ) is not included in the Acceptable Vaccines for this series. Unacceptable vaccine group: If a series for a combination vaccine applies to only one member vaccine group, set the other vaccine group(s) to unacceptable. The example is Pediarix. There will be a pediarix hep B series, but not one the polio or DTAP components. Page 10 of 24

15 1. Add each unacceptable vaccine group to the list on the right. 2. Tab to another page or Manage Another Series. Jump forward: In cases where a patient is behind schedule, the series accelerates and doses may be skipped. For instance, if patient receives DTAP #4 after age 4 years, this is treated as dose #5 and the series is complete. In these cases, enter the minimum age and attribute for this acceleration to occur. Also indicate the number of doses to skip. In the example above, you would enter 4 years as the minimum age and 1 as the number of doses to skip on dose 4. You may have more than 1 jump forward rule per dose. This information is stored with the dose where the jump will begin. In the example above, this is dose 4. The rules that are specific to the dose jumped to will apply (e.g. interval, age, etc) For example, you might record a jump for dose 2 of 1 dose for minimum age 11 months. You might record another to jump 2 doses for minimum age 13 months. In this case, if the patient were 11+ months old they would jump 1 and 13+ months old, they would jump 2. A jump is only allowed once per dose. Notes On Setting Up The Jump Rule For HIB: The HIB schedule is quite complex. The number of doses required changes based on current age, number of doses and vaccine. Trihibit may only be used as the final dose in a multi-dose series. Pedvax and Comvax may be used in 3 dose series or as part of any of the other series for HIB. The normal series assumes that the series starts before age 6 months, followed every 2 months for 2 more doses and is completed by a dose given after age 12 months. This schedule is adjusted depending on the age of first dose and the current age. To accomplish these interacting goals we create 4 series: HIB (normal 4 dose), HIB 1 dose, Pedvax and COMVAX. Pedvax and COMVAX are trade name specific series and require a vaccine to be of the appropriate trade name to be valid. The HIB 1 dose series will not allow Trihibit to be used and has a minimum age of 15 months. The HIB series (normal 4 dose) allows Trihibit (DTAP/ HIB ) to be used, because it is an acceptable vaccine, but it disallows it s use in dose 1-3. The jump rules skip doses, based on the age of the current dose under consideration. The Immunization Evaluator allows only one jump per dose. That is, if the patient is old enough on dose 1 to jump to dose 3 and old enough to jump to dose 4 for the third dose, we only allow the first jump. Based on this the rules are as follows: HIB (4 dose) Age Dose being Doses to Skip Note evaluated 7 m 11 m 1 1 So we begin by evaluating dose 2. >=12 m 1 2 So we begin by evaluating dose 3 >= 12 m 3 1 So we evaluate dose 4. Page 11 of 24

16 Pedvax Age Dose Doses to skip Note >= 12 m 1 1 So we begin by evaluating dose 2 > 15 m 1 2 So we evaluate dose 3 > 15 m 2 1 So we evaluate dose 3 Note that we require the dose to be Pedvax. There is no jump for 7-11 month olds. Minimum Interval to Validate: There are doses in series that are valid, in spite of being received prior to the minimum interval. The minimum interval is still applied to recommendations. In these cases, enter the minimum interval and attribute that will apply to this dose. For example, dose 4 of DTAP may be valid between 4 and 6 months after dose 3. Set the minimum interval to validate to 4 and the date attribute to M for months. Minimum Age to Validate: If there is the minimum age when a dose is valid is different from the minimum recommended age, then this rule allows you to specify what that age is. Enter the minimum age and age attribute on the dose. IR Immunization Evaluator Process and Rule Sets Introduction: The goal of the immunization evaluator is to validate the immunization history for a patient. In addition, the process makes recommendations for the next doses due. The overall process is: Select candidate series Evaluate doses in the series. Select the best series for a vaccine group, based on a weighted score. Determine the schedule for next doses due for each vaccine group for those series that are not complete and can be completed. Determine the completion status for each series. Return the validated series and recommendations Page 12 of 24

17 Select candidate series: The goal of the select candidate series function is to create a list of vaccine groups that will be included for the patient. For each of these vaccine groups, we select all series that could apply. We determine the vaccine groups by first determining the all of the vaccine groups in the data base. We then remove vaccine groups that do not apply. Vaccine groups will be removed if there are no series and the patient has no doses for that vaccine group. In addition, we remove vaccine groups where the patient has no doses and are too old to complete the series. We remove vaccine groups if a series for a vaccine associated with that group has has an invoke rule associated with it and does not meet the criteria for that rule. That is, rabies will not be included if the patient does not have a dose of rabies, because it has an invoke rule in the ACIP schedule and has no doses. If the patient does not meet the gender rule for a series with this rule, the vaccine group is removed. The process also removes vaccines that have release dates that are before the patient could finish a series, if there are no doses for that series. Evaluate series: Rules may apply to a whole vaccine group, a series or a dose. Evaluation proceeds dosewise. So, if a series is trade name specific. Each dose is interrogated to see if it complies with the trade name rule. If not, the dose is set to not valid. This does not mean that the trade name series won t end up being the best series, so we proceed with the next dose. This process generates an evaluated history of doses for the patient for each series evaluated. Each rule that is not satisfied and causes the immunization to be invalid will recorded for that immunization and an associated message will be returned for display to user on request. These messages are listed below with each rule. Select best series: The immunization evaluator determines the best series for each vaccine group. If there is only one series, that is obviously the best series. Otherwise, the evaluator determines a score, based on a number of factors. This series will be the one passed to the next dose scheduler and returned to the application. Best series rules: If there is only one series, that is best. If there are more than 1 series, then we weight various factors. If series is tradename specific and all doses valid then add weight. If series is complete, then add weight. If series is not complete, but can be completed add weight. If all doses are valid, then add weight. If some doses are not valid and series has earliest valid dose, then add weight. Select the series with the highest score (more than one is possible). If there is only one selected then that is best series. Otherwise, select the series with the highest % valid doses > 0. (more than one possible). Page 13 of 24

18 If there is only one, then that is best series. Otherwise, if series have at least 1 valid dose, select the one with the earliest minimum valid dose. If there is only one, then that is best. If we have not selected a best series yet (so > 1 returned above or all not valid), then we begin a new weighting system. If a series is trade named decrease the weight. If a series can be completed, increase the weight. If a series has the maximum earliest date and the min date is < today, then add weight. We select the series with the highest weight. Determine Next Doses Due: Each series that is not complete or contraindicated is processed to determine the dates for the next dose due. Each series will have an Earliest, Recommended, Overdue and Latest (if applicable) date. If a series is complete, then we return that. Rules: There are several classes of rule. One determines the appropriate dates that a dose may be given. Another evaluates if the dose is of the correct formulation and size. A third allows skipping of doses. Fourth are rules related to patient conditions, such as immunity. Finally, there are rules that relate to small pox vaccination. Note that the rules are applied at the dose level, even when they are series wide rules. Determine reference dates and validate: There are a number of reference dates that may be of interest. These include: The earliest valid date The earliest date to use for recommendation The recommended date The over-due date The latest date. These dates are determined based on age, adjacent dose interval, non-adjacent dose interval and interval to other vaccine groups or series. In most cases a grace period (set in the schedule) may be applied to allow, but not recommend that doses may be given up to the grace period early or late. The various age and interval rules interact so that the dose should not be given too early, based on any of the rules. For the earliest date to use for recommendation, the wizard would use the later of: Date patient reached earliest age for dose Minimum interval since previous dose date Minimum interval since non-adjacent dose date First day after conflict period Page 14 of 24

19 Interval since not valid dose date In addition, the recommended date may be accelerated to the earliest date, if the previous dose was over-due when given. Age Rules Goal: The age rules are used to produce dose specific date benchmarks based on the age of the patient. Is satisfied is true if vaccination date is >= minimum age date and <= maximum age date (if assigned). Minimum Age: Minimum Date = Birthdate + minimum age Dose given prior to this date is not valid. If dose is not given, then this is the earliest date to recommend. Message: This dose was given before the earliest acceptable date. 1. Maximum Age: Maximum Date = Birthdate + maximum age Dose given after this date is not valid. If dose is not yet given, then this is the latest date recommended. Message: This age at immunization for this dose exceeded the maximum age. 2. Recommended Age: Recommend Date = Birthdate + recommended age If dose is not yet given, then this is the recommended date. Note that acceleration rule can set to Minimum Age. 3. Overdue Age: Overdue Date = Birthdate + overdue age If dose is not yet received, then this is the over due date. Note that acceleration will change this to recommended age. Adjacent Dose Interval Rules Goal: The adjacent dose interval rules produce dates that take the date of the previous dose in series into account when adjusting the various dates. Is satisfied is true if vaccination date is >= minimum interval date. 1. Minimum Interval: minimum interval date = date of previous dose in series + minimum interval. Note that if minimal interval date is > minimum age date, then minimum interval date trumps minimum age date. Otherwise, minimum age date wins. 2. Recommended interval: Recommended interval date = date of previous dose in series + recommended interval. This date is only used for making Page 15 of 24

20 recommendations. Note that the later of recommended interval date and recommended age date becomes the recommended date. 3. Overdue Interval date: Overdue interval date = date of previous dose in series + overdue interval. Note that the later of overdue interval date and overdue age date becomes the overdue date. Message: This dose was given too soon after the previous dose. Minimum interval to validate Goal: This is used to validate specific doses that are given earlier than normally recommended. The date does NOT change recommended dates. Is satisfied is true if vaccination date is >= minimum interval to validate date. 1. Minimum interval to validate date: Date of previous dose in series + minimum interval to validate => minimum interval to validate. If this rule applies, the vaccine dose must be received on or after the minimum interval to validate date to be considered valid. This trumps the normal minimum interval date. It does NOT trump the minimum age date. The message is set when this rule IS SATISFIED. Message: This vaccination met the minimum interval to validate. Minimum age to validate Goal: This rule is used to validate specific doses that are given at a younger age than normally recommended, but which are valid none the less. It does not change the recommended dates. Is satisfied is true if the vaccination date is >= minimum age to validate date. Birth date + minimum age to validate => minimum age to validate date. This rule is only tested if the vaccination date is < the minimum recommended age date. The message that is set when this rule is satisfied is: This vaccination was given on or after the minimum age to validate. Interval After a Not Valid Dose: Goal: Validate and recommend next dose after a not valid dose. This is set for the entire schedule. It may be ignored by individual series. If a dose is not valid, set the interval after a not valid for the next dose in the series to the value set in the schedule. When validating or recommending the next dose, use the later of: Page 16 of 24

21 minimum age minimum adjacent dose interval from last valid dose ( if given) 6 non-adjacent dose interval interval after a not valid to determine the earliest date to give the dose. Grace period is not applied to interval after not valid rule, but continues to apply to the other rules. The message if the dose is given too soon after a not valid dose is: This vaccination was given too soon after a previous not valid dose. Non-adjacent dose interval: Goal: Validate dose based on interval since a non-adjacent dose in the same series. Is satisfied is true if the vaccination date is >= non-adjacent dose date plus the non-adjacent dose interval. Non-adjacent dose date = vaccination date of the From vaccination date + non-adjacent dose interval. Inter-Group interval rule: Goal: This rule assures that a minimum interval occurs between doses from one vaccine group and another. The example is the live virus interval. This rule is satisfied if a patient has NOT received a dose from a conflicting vaccine group on or after earliest date and before the end date + 1. This rule may adjust the minimum recommended date for a series. For instance, if the dose is due within the conflict interval, the minimum recommended date is pushed to 1 day beyond the end conflict date. The message is returned if the rule is not satisfied. Message: This vaccination conflicts with a dose from another series. Message: This immunization was given too soon after a non-adjacent dose. 6 In the case of the first dose given being not valid, there is no adjacent dose interval. Page 17 of 24

22 Grace Period: Goal: This allows a dose of an immunization to be given before the minimum allowable date or after the maximum allowable date, if it is given no more than the grace period before the earliest date or after the latest date. It is applied after all other rules have been processed. It will not change a recommendation for scheduled vaccinations. The earliest allowable vaccination date for a dose is equal to the earliest allowable date minus the grace period. The latest allowable vaccination date for a dose is equal to the latest allowable vaccination date plus the grace period. Grace period does not apply to inter-group conflicts or interval after not valid doses. Rules associated with formulation and size: Trade Name / Age rules: Goal: Allow different formulations of the same vaccine (with different trade names) to work in the same series. The example is Influenza, which has split virus vaccines with different minimum ages and vaccine administered via the nose with different age requirements. If there are trade name/age rules and the vaccination given has the trade name of interest, then the age at immunization must be >= the minimum age and < the maximum age to be valid. If no trade name is associated with the immunization, the rule will NOT trigger. Trade name specific rules: Goal: Some series are specific to a trade named vaccine. Apply the trade named series to the vaccination series. Is satisfied is true if dose given is from the trade-named vaccine. Message: This immunization is not of the expected trade name. Vaccine is not acceptable for this dose: Goal: This rule disallows a specific vaccine for a specific dose in a series. Is satisfied is true if the vaccine given is included in the list of vaccines to exclude for this series. The example is Trihibit, which may only be given as the final dose in HIB series with more than 1 dose. It would be not acceptable for any other dose in a HIB series. Message: This vaccine is not acceptable for this dose in this series. Page 18 of 24

23 Dose size rule / Adequate dose rule: Goal: This rule determines validity based on whether an adequate dose was given. Where applicable, validate a dose based on the dose size and age of the patient. Allows dose-wise substitution with equivalent doses of vaccine. Is satisfied is true if - The partial dose indicator is set not equal to Y. (used for all vaccinations) - If the dose size rule applies and we know the quantity and the total dose size is >= dose multiplier times the dose volume and the vaccine received matches the vaccine for this rule and the patient was old enough for the series. Vaccine series HepB peds HepB peds HepB adult HepB adult Patient age < 19 yrs < 19 yrs > 19 yrs > 19 yrs Vaccine received HepB peds HepB adult HepB peds HepB adult Dose multiplier Dose size valid >= ml Y >= ml Y >= ml Y >=1 1.0 ml Y The message is returned if the rule is not satisfied. Message: The dose size was not adequate. Partial Dose Rule: Goal: This rule allows recording of incomplete doses of a vaccine that do not impact recommendations. If a dose of vaccine is marked as partial dose, then the dose is not processed. It is not considered when identifying duplicate immunizations. Acceptable vaccine rule: Goal: This rule determines which vaccines may be used to cover this series. In the broadest case, it is like the old vaccine group. It allows you to exclude a vaccine that should not be used for this series. For instance, there are 2 flu vaccines that are not interchangeable. We combine this rule with not acceptable for dose. The primary vaccine for the series must be selected. Page 19 of 24

24 If the vaccine in the immunization is in the list of acceptable vaccinations, then this rule is satisfied. Message: This vaccine is not acceptable for this series. Note that the dose size rule ties into each acceptable vaccine. That is, if there is a dose size rule, it is associated with a unique acceptable vaccine. Rules associated with smallpox: Dose Immunity Rule: Goal: This rule currently applies to interpretation of small pox vaccinations. It utilizes the results of the vaccination take and history of vaccination to determine if the patient is considered immune. This impacts the recommendations for future doses. The patient is considered immune if they have a vaccination, the results are read between the min read and max read dates and the results are significant reaction. They may also be considered immune if there is a recent history of vaccination and that had a result of negative or indeterminate and now have a second vaccination with any result. This rule is satisfied if the immunization was read in the correct interval and the dose is considered to indicate that the patient is immune. (Table based.) Dose result interval rule: Goal: This rule determines if the results of a vaccination are read during the correct interval. There is a minimum interval and a maximum interval. Is satisfied is true if the read is done between the minimum interval and the maximum interval, inclusive. The message is returned if this rule is not satisfied. Message: The reaction was not read in an acceptable interval. Rules that allow skipping of doses: Jump forward rule: Goal: This covers the situations where a patient has passed a minimum age and received a minimum number of doses and may skip doses. Is Satisfied is true when the patient s age exceeds the minimum age for this rule and has received the minimum number of doses, based on table driven rules. Page 20 of 24

25 Message: The patient s age and history caused the series to jump forward in the series. Series Alternate rule: Goal: This rule specifies an alternative series that can complete a series. It allows substitution of doses, starting at first dose. This rule is satisfied if the series being considered has an alternate series and there is at least 1 dose that can substitute into the series under consideration. These doses must be valid. We allow doses and age at the first dose in alternate series to impact the number of doses replaced. For instance we could specify that DTAP is an alternate series to TD primary. If the patient got the first dose of DTAP before age 1 and received 2 more doses of DTAP, then we substitute those doses for Td primary doses. The message is returned when this rule IS satisfied. Message: Doses in this series were replaced by valid doses in another series. Acceleration rule: Goal: This rule changes the recommended dates for a patient if they were behind schedule on the previous dose. Since this rule does not impact validity, there is not a test for is satisfied. If the patient s previous dose in the series was given after the overdue date, then the schedule accelerates the dates for the dose under consideration. The recommended date is set to the earliest date. Acceleration does NOT set the recommended date earlier than the recommended age, if one is given. Acceleration does occur for booster doses. The message is returned when this rule IS satisfied. Message: Schedule accelerated. Restart Series Rules: Goal: If a clinician wishes to restart patient vaccine series, the clinician can add a comment to the patient that indicates this. This will accommodate the need to restart a patient after chemotherapy, for instance. If a patient has a comment that the clinician has decided to restart a vaccine group and an applies to date, any dose prior to the applies to date is not evaluated by the Immunization Evaluator. The vaccine group is started over and the usual rules will be applied. Note see Invoke on Comment rule below. Page 21 of 24

26 Vaccine group over-ride rule: Goal: This rule allows users to ignore the need for a primary series to be completed. The patient is moved directly into the booster dose. Rules triggered by patient comments and conditions: Contraindication Rules: Goal: This rule prevents vaccine groups from being recommended if they are contraindicated by a comment with an applies to date on or before today or an applies to date on or before today and an end date on or after today. This rule is satisfied if there are contraindications for this vaccine group with an applies to date on or before today or an applies to date on or before today and an end date on or after today. This rule does NOT apply to existing vaccinations and their validity. Message: Vaccine group is contraindicated. Immunity Rules: Goal: If a patient has immunity, based on antibody test, the vaccine group for that pathogen should not be recommended. If a patient has a comment that indicates he/she has immunity to a particular pathogen and an Applies to Date, we presume that they have had an antibody test indicating immunity. In this case, the Immunization Evaluator will not recommend more doses of that vaccine group after the applies to date. Note: These rules are set up by a DBA and are not accessible from the user interface. The tables involved are SCD_COMMENT_DRVR and SCD_COMMENT_DETAIL. They allow one or more comments indicating immunity to contraindicate a vaccine group. Any doses recorded will still be evaluated as usual. The vaccine group will not be recommended. Maximum Doses Rule: Goal: This rule prevents recommendation of more doses. It does not complete the series, and it does not invalidate subsequent doses. (This is the 6 by 7 rule)* This rule is satisfied if the patient has at least as many doses (valid or not) of the vaccine in question. The message will be returned if this rule IS satisfied. Page 22 of 24

27 Message: Maximum number of doses for this series is met or exceeded. * Since DTAP has a max age of 7 we only need concern ourselves with the 6 side of the equation. Invoke on comment: Goal: This rule causes the Immunization Evaluator to select a specific series when a particular patient comment and its applies to date is recorded for a patient. The rule is used to select between rabies pre-exposure, rabies post exposure with history of immunization and rabies post exposure without history of immunization. The Immunization Evaluator determines if the patient has any rabies immunizations prior to the applies to date to classify the patient as having history of immunization or not. Rules that control inclusion of vaccine groups in patient schedule: Invoke on use rule: Goal: This rule causes a vaccine group to be included in the vaccine groups evaluated for a patient if the patient has a vaccination from that group. This rule is satisfied if the patient has a vaccination from this vaccine group. Invoke on valid only rule: Goal: This rule causes a vaccine group to be included in the vaccine groups evaluated for a patient if the patient has a valid vaccination from that group. This rule is satisfied if the patient has a valid vaccination from this vaccine group. Invoke on age rule: Goal: This rule causes a vaccine group to be included in the vaccine groups evaluated for a patient if the patient has reached the minimum age. This rule is satisfied if the patient age is greater than or equal to the minimum age to invoke. Invoke on high risk: Goal: This rule causes a vaccine group to be included in the vaccine groups evaluated for a patient if the provider organization viewing the patient has been designated as high risk. This rule is satisfied if the provider organization is designated as high risk. Gender Rule: The goal of the gender rule is to exclude vaccine groups if the patient does not meet the gender rules for that vaccine group series. Page 23 of 24

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