2 The Health Care Industry Designed by: Sunil Kr. SagarThe Health Care IndustryGone are the days when you could walk into the doctors office and he would call you by your first name and ask how you grandfather is doing.Modern method of healthcare and healthcare benefits has increased the paperwork necessary to keep all the records. The medications prescribed, the insurance carrier, type of coverage provided and so on.Fortunately Information Technology has also evolved to keep the computerized records, provide information at the finger tips for both, the attending physician and the patient.Easy identification and transfer of data is critical to the success of any technology upgrade.
3 NEED Medication Error: Scope of Problem Designed by: Sunil Kr. SagarNEED Medication Error: Scope of ProblemPatient impactUp to 98,000 people per year die of preventable medical errors; serious medication errors leading to death have doubled between 1983 and 200320% of families report serious medication error during hospitalizationHealthcare facilities experience one error per five doses administeredHospital ImpactCost burden: legal staff to handle patient claims; labor costs to process / litigate claims; cost of settlements; insurance costsImpact on reputation: Increasing awareness of quality of care as an issue of importance to patientsRoot cause18% of preventable adverse drug effects (ADE’ s) arise from insufficient patient dataHalf of all ADE’s result from inadequate availability of drug informationOvertaxed and under-resourced nursing staff frequently fail to accurately verify patient identity and/or medication dose
4 Medication Error: Many Causes of Error - Often Process Failure Designed by: Sunil Kr. SagarMedication Error: Many Causes of Error - Often Process FailureType of ErrorDescriptionPrescribing errorIncorrect drug selection (based on indications, known allergies, existing drug therapy), dose, dosage form, quantity, route, concentration, rate of administration or instructions for drug useOmission errorFailure to administer ordered dose to patient before the next scheduled dose, if anyWrong timeAdministration of medication outside of prescribed time intervalUnauthorized drugAdministration of medication not authorized by a legitimate prescriber for patientImproper doseAdministration of dose greater or less than amount ordered by prescriber or administration of a duplicate doesWrong formAdministration of a drug in a different dosage for than ordered by prescriberWrong drug preparationDrug product incorrectly formulated or manipulated before administrationWrong administration techniqueInappropriate procedure or improper technique in the administration of a drugDeteriorated drugAdministration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromisedMonitoring errorFailure to review prescribed regimen of detection of problems, or failure to use appropriate clinical or lab data for adequate assessment of patient responseCompliance errorInappropriate patient adherence to a prescribed medication regimen
5 Market Drivers for IT-based Solutions (Specifically RFID) Designed by: Sunil Kr. SagarMarket Drivers for IT-based Solutions (Specifically RFID)Pharmaceutical-initiatedMotivation to leverage RFID for many purposes, including supply chain improvements, FDA-recommended anti-counterfeit efforts, Wal-Mart mandate> 500% increase in number of drugs over last 10 years -- more than 17,000 drugs marketed in North America; greater need for automated tracking capabilitiesHospital-initiatedIncreasing IT spend to reduce operating costs & improve staff efficiency; CPOE (Computerized Patient Order Entry) projects are widespreadGreater awareness of medication error and a desire improve processesHeightened competition for patients; increased access to and awareness of hospital performance metrics, including quality of careRegulatory (FDA)Most prescription and commonly used over-the-counter drugs must be bar-coded with the National Drug Code (NDC) number by end of 2005All blood components intended for transfusion must have machine-readable labels identifying collecting facility, lot no., product code, donor blood group & typeRule will likely be amended to either require or allow for RFID labels
6 Medication Error: How RFID Can Help? Designed by: Sunil Kr. SagarMedication Error: How RFID Can Help?Drug IdentificationAutomatically, accurately and instantaneously can identify any drugIdentification can be made at any level of granularity, down to the “unit dose”How: RFID can be added to existing drug labelingPatient IdentificationAutomatically, accurately and instantaneously can identify any patientHow: RFID can be added to existing patient ID wristbandsPrescription VerificationNurse-carried RFID-enabled handhelds can verify prescription against patient & drug, time & route
7 The ConceptIt is proposed to introduce a novel cost effective and user friendlyRFID based Smart Cardsolution to integrate the process of availinghealth care facilities and ease of process in an Hospital.Designed by: Sunil Kr. SagarRFID based Smart Card solutions have gained acceptance due to theadvantages over bar code \ magnetic stripe solutions in recent times due to:Information stored on the IC chip is very secure and cannot be duplicated.Ability to store multiple applications on the single IC also allows easy manipulation of data.Off line verification allows instant identification of the cardholder for accurate and timely treatment.Mag stripe cards allow read only access on the point of usage locations which makes it very difficult to update the data.Data density is about 200 characters for mag stripe, where as today smart cards can store up to 4MBSmart Cards provide convenience, portability, durability, security, and ability to check forgery.
8 Medication Error: Multiple Levels of Error Prevention Designed by: Sunil Kr. SagarMedication Error: Multiple Levels of Error PreventionLEVEL 4Blood Transfusion Safety • Lab Specimen Tracking • Medical/Legal MARLEVEL 3Max Daily Dose • Look-Alike/Sound-Alike Alerts • High-Risk Med WarningsClinical Action Reminders • Near-Miss Reporting • Order ReconciliationLEVEL 2Drug Reference • Formulary CommentsLiterature Review • Nursing ToolsLEVEL 1‘Five-Rights’ Checker
9 RFID & Medication Error “Five Rights” Checking using RFID Designed by: Sunil Kr. SagarRFID & Medication Error “Five Rights” Checking using RFIDFive RightsRight drug, time, dose, patient & method of administrationData RequirementsPatient Identification: RFID wrist-bands linked to patient databaseDrug Identification: RFID-labeled “unit doses” linked to NDIC (National Drug Identification Code)Prescription Data: Wireless access to prescription database for time, dose, method of administrationConfigurationHandheld device with RFID reader to check Patient ID, Drug IDWireless access to network for access to Prescription Data
10 RFID & Medication Error Higher Level Checking Designed by: Sunil Kr. SagarRFID & Medication Error Higher Level CheckingAdditional Checks on Prescription & PatientPrescription falls within range of reasonable doseDrug does not exceed maximum daily doesPatient does not have existing allergy to drugPotential adverse drug interaction with other prescriptionsData RequirementsAccess to database of “reasonable” dosagesAccess to patient record data (allergies, other prescriptions)ConfigurationWireless access to key patient/drug databasesAdvanced user interface
11 RFID & Medication Error: Technical Challenges Designed by: Sunil Kr. SagarRFID & Medication Error: Technical ChallengesRead rangeToo close … Small antenna sizes may require reader to be very close to tagToo far … unintentional reading of RFID tags if the read range is not close enoughCPOE IntegrationComputerized Patient Order Entry - electronic prescription input (vs. handwritten)Projects are underway at many hospitalsExtent of integration - time of data entry vs. time of administration?Standards & FormatsWhat RFID data standards will apply?Consistency with existing medical standards (NDIC) and emerging EPC standardsTag formats: frequency, read/write
12 RFID & Medication Error: Operational Challenges Designed by: Sunil Kr. SagarRFID & Medication Error: Operational ChallengesRFID LabelingLabeled at the source (drug manufacturer)? At the distributor? At the hospital pharmacy?Quality control and introduction of error when labelingLabeling on tiny unit does (e.g. individual pills in “blister packs”)Existing ProcessesMany hospitals use automated dispensing for access control & theft deterrenceNurses often prepare medications at nursing stations, prior to enter hospital roomsNew process introduction: what to do when an error is detected; false/missed errors?Costs & ImplementationCost of RFID vs. Bar-codeTiming: When to implementationPilot testing to establish improvement and benchmarks
13 RFID & Medication Error: Future Challenges RegulatoryFDA has two different proposals to tagging of drugs: RFID for anti-counterfeit; bar-coding for medical errorIntegration of FDA mandatesFocusMajority of RFID efforts currently focused on supply chain and retail / CPG applicationsEqual effort must be expended on medical / pharmaceutical applicationsCollaborationMany organizations and constituencies involvedNeed to coordinate efforts between clinicians, nurses, pharmacists, distributors, manufacturers, regulators
14 RFID: Major Improvement Over Bar Code Designed by: Sunil Kr. SagarRFID: Major Improvement Over Bar CodeIdentifies class SKU (class of items)Contains only characters of dataReaders use lasers/LEDs to scan tagLine of sight required to read tagBar codeRFID tagChipPackagingAntennaPassive RFID Tag• Uniquely identifies individual item• Can store hundreds of characters• Receivers scan radio signal from tag• No line of sight required
15 Cross sections of the Health Industry being benefited Designed by: Sunil Kr. SagarCross sections of the Health Industry being benefitedIn the Pathological LabsIn the blood banksIn the HospitalsReview patient historyInventoryPharmaceutical CompaniesAnti CounterfeitingPharma Supply Chain
16 RFID Card Capabilities Designed by: Sunil Kr. SagarSpecial featuresThe RFID based Health care card will contain:Personal details for identificationHealth insurance policy particularsMedical historyAny other information requiredRFID Card CapabilitiesServes as an ID card:-The card holder can get the treatment without going through a long process of verifying the identification \ insurance detailsServes as medical file:- brief details of the ailment \ treatment can be written into the cardResults of all lab tests can be storedRecords of prescriptions can be maintainedFunction of the RFID cardThe type of policy and coverage being available can be verified by the hospital \ lab.by reading the cardThe treatment particulars and bill amount can be printed and also written into the cardThe relative bills can be either downloaded or fed into the computer at the health care companyThe same will be forwarded to the respective insurance company for paymentThe reconciliation process between the insurance company and hospital would be automatic
17 In the Pathological Labs Designed by: Sunil Kr. SagarIn the Pathological LabsRFID cards containing the unique Patient ID can be issued to the patients coming for testing for the first time.As per the prescription, the test numbers are assigned against the patient ID and the labels containing the test numbers are pasted into the tubes/plates containing his/her sample.After the test status comes , test tubes/plates are scanned and the status against them is fed into the system.While generating the test report, system attaches the test status of the test numbers to the particular patient ID against which they were originally assigned, and generate the report.When a particular patient comes for collecting the report, his/her RFID card is scanned and matched against the Patient ID mentioned in the report and the same is handed over to the him/her without any possibility of wrong reporting.Whenever the same patient comes for any further examination, his RFID card is scanned and the cardholder's previous medical history is fetched from the database for referencing and the same process can be repeated again.
18 Designed by: Sunil Kr. Sagar In the blood banksThe bottles/containers containing different samples of blood are pasted with RFID labels.Whenever any requirement for a particular sample of blood arises, labels on the bottle/container surface is scanned.The scanned and decoded sample specification is displayed on the Hand Held Terminal of the person incharge, matched against the required specifications and then issued for the surgery.Periodically the issual data can be transferred to the host through a serial port communication dock for the necessary stock updation.
19 In the HospitalsDoctor/the hospital staff can access the necessary information of the patients using their RFID cards/ Patient Wrist Bands and a mobile computer and use them while carrying out surgery, in ICUs, in their offices, in the clinics, at the point of billing, while forwarding the expenditure statement of the patients to the insurance company, which would enable them to streamline various operations like Review patient historyDoctors can download the medical history of the patients from their RFID card and retrieving their information using either a serial port communication dock/through Modem or retrieve online through GSM connectivity on a mobile computer which help them take crucial decisions from remote locationsPharmacy medication administration by nurses/doctors without mistakes : Every hospitalized patient can be given a RFID wrist band tags and the medical/treatment/surgery records can be stored in the computer.Nurses can carry the RF terminals connected wirelessly to the access points to retrieve info from host containing the patient information.They scan the patient RFID wrist band tags and the suggested course of medication flashes on their terminals which can be administered without any possible flaw and then update the patient data using their RF Terminal with regards to the patient's vital information like blood pressure, body temperature, dosage given etc.While making rounds doctors can carry the RF terminals, scan the patient RFID wrist band tags , see and evaluate the necessary information and can decide upon the line of treatment and update the patient data for the future references.While Carrying out Surgery : Surgeons can scan the RFID wrist band tags patient cards before commencing the surgery and retrieve the critical information about the patients online using a RF Hand Held Terminal or a Palmtop with a RF card through wireless connectivity with the host containing the patient information.Designed by: Sunil Kr. Sagar
20 Inventory Incorporation of RFID tags can lead to a much efficient Designed by: Sunil Kr. SagarInventoryIncorporation of RFID tags can lead to a much efficientInventory Control system in the various cross sectionsof the healthcare industry Some of the key benefits are …Fast and accurate information dissemination of the shipment leading to a better control over the inventoryMinimize product obsolescence and Maximize the freshness of the stockImproved control over stock, warehousing and Distribution of DrugsBetter control over reorder levels hence shortening the Reorder CycleEffective practice of Just in time inventory control principleFlawless and speedy performance of periodical cycle countsAutomated invoice generationOverall cost saving in Inventory Control
22 Pharmaceutical Companies Designed by: Sunil Kr. SagarRFIDinPharmaceutical CompaniesAnti-CounterfeitingPharmaceutical Supply Chain
23 Anti-Counterfeiting Mechanical construction Designed by: Sunil Kr. SagarAnti-CounterfeitingMechanical constructionPaper laminate designed to averthorizontal fissionabilityPrinted antenna directly on paperTamper proof (mechanical and electrical)Sophisticated partial cross cutting throughthe layersTuned bonding strength of certainfunctional segments of the electronic partsRFID technology featuresOperating frequency: MHzAnti Collision to allow simultaneous operation with multiple transponders in the fieldUnique 64 bit serial number, each label will be unique2k bit (256 characters) Read / Write EEPROM memorySecure access to Read/Write memory (split access rights)Cryptographic authentication, 64 bit security key lengthPaper selectionApplication specific paper (no commodity)Filled with luminescent fibresInvisible in daylight, but fluorescent in red under UV lightFlow of paper and even waste will be under strict controlPrinting solutionVisible printingInvisible printingBased on transparent inkLuminescent in red when exposed to UV lightInk will be under strict controlBoth printing will be of high quality and accurate registration
24 Pharmaceutical Supply Chain Designed by: Sunil Kr. SagarPharmaceutical Supply ChainBenefits:Reduce product handling timeReduce errorsReduce shrinkageImprove supply-chain visibilityReduce out-of stockImprove shipment identificationMore accurate and timely informationReduce costsProvide security against counterfeiting and tampering
25 Process flow of a Pharmaceutical Supply Chain Designed by: Sunil Kr. SagarProcess flow of a Pharmaceutical Supply Chain
26 Process flow of a Pharmaceutical Supply Chain Designed by: Sunil Kr. SagarRFID integratedProcess flow of a Pharmaceutical Supply Chain