GAIMS Safety Manual 12.05.22

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 301 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL CHEMICAL RESTRAINTS  These are medication used for the purpose of restraining patients involuntarily to prevent them from harming themselves or staff. The intent of such medications is long duration of action compared to the brief conscious sedation commonly used to facilitate procedures such as suturing, scanning, and joint aspiration. ADVANTAGES OF CHEMICAL RESTRAINTS  Control violent behaviour and patient agitation  May reduce need for physical restraints  Allow examination and performance of radiographic imaging DISADVANTAGES OF CHEMICAL RESTRAINTS  May result in complications, such as respiratory depression and loss of gag reflex  Occasional paradoxical reaction results in increased agitation  Limit mental status assessment and neurologic examination during sedation  Agents commonly used to achieve rapid tranquilization fall into categories of benzodiazepines, major tranquilizers/ neuroleptic agents PRECAUTIONS  Patient dosing is very variable. More medication may be administered if inadequate sedation results after initial dose.  Monitor for respiratory depression and loss of gag reflex.  Immediate inadequate sedation may not mean that medication is inappropriate for the patient.  The peak effect may be delayed, or additional doses may be required.  Consult appropriate references for full prescribing and adverse effect information. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 302 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Chemical restraints can be an effective adjunct or replacement for physical restraints RESPONSIBILITY  Clinician In-charge,  Nursing Staff,  Medical officers. RECORDS  Restraint consent  Restraint form  Restraint monitoring form 41. PRESCRIPTION AND ORDER OF MEDICATION POLICY  All medication prescriptions shall be in consonance with good practices and as per guidelines for rational prescription of medications.  Only authorized Clinicians of the hospital shall prescribe medications.  Organization has defined minimum requirement of a prescription.  In all patients’ drug allergy and previous adverse drug reaction is ascertained before prescribing.  Verbal orders should ensure medication safety.  Audit of medication prescriptions should be carried out with analysis and corrective / preventive actions.  Reconciliation should be carried out at each transition points of patient care. PURPOSE Prepared by Reviewed by Approved by Signatory Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 303 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  To prescribe medication safely and rationally to avoid adverse event and achieve desired results. SCOPE  OPD and IPD patients PROCEDURE 1. Rational use of medication  All medication prescriptions OPD and IPD are prescribed by the privileged clinicians. All medication prescriptions are in consonance with good practices and as per guidelines for rational prescription of medications.  Rational use of medicine requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at lowest cost.  Procedure for rational drug prescription comprises 6 steps- o Determining patient’s problem -setting diagnosis o Determining object of treatment-defining therapeutic goal o Verification of the suitability of the treatment to specific patient. -listing effective medication o Onset of treatment- selecting group of drug depending on efficacy, safety, indication and cost. o Information, instructions and precautions o Monitoring of treatment  Clinicians are sensitized in the pharmaco-vigilant monthly meetings. 2. Requirement of prescription  For In-Patients, the orders shall be written at a uniform location in the progress notes. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 304 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  For OPD patients the orders shall be written only on GAIMS Hospital prescription pad.  Organization follows ISMP (Institute for Safe Medication Practices) guidelines for prescription. The medication order shall be clear, legible, dated, timed, named and signed.  It includes in superscription Date, CR No., patient details, GAIMS hospital address, and contact number.  All medication inscriptions specify the drug name, dosage range or dosage form, the route of administration, the frequency and duration of medication administration. It is signed by consultant with name and registration number. Medication orders are traceable with master signature list in Medical record department.  Drug allergies and previous adverse drug reactions are identified and documented on assessment forms and on each page of case sheet in IPD patient.  Drug -drug, food-drug interaction, therapeutic duplications and dose adjustment is captured by clinical pharmacist and is discussed with the consultant. 3. Safe prescriptions – does and don’ts  Abbreviations for drug names are not to be written.  Clinicians shall prescribe only those drugs listed in the Formulary, except in specific instances.  Any drug allergy shall be recorded in the medical records.  The verbal order for Inpatients shall be noted in the patient’s medical record as per verbal order procedure.  Prior to writing a new order, the previous orders shall either be cancelled or kept on hold. It shall be clearly specified in the patient’s progress notes. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 305 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  The high risk medications list is defined by GAIMS Hospital. The Clinician shall take special care while prescribing high risk medication.  Medication orders must include medication name, dose, route, frequency, signature, and date and time order written.  The orders are written at a predefined uniform location only.  Medication orders are clear (no overwriting), legible (typed or capital letters when hand written).  Orders may not be crossed out or written over. If a change in the order is needed, the order should be single stroked through and must be re-written.( Drug and Cosmetic Act and Code of Medical Ethics.)  Medications only from the formulary shall be prescribed.  If medication order is time sensitive (STAT), the time the order is written must be included. Write a large ‘STAT’ when an order is time sensitive.  Wherever possible, usage directions should specify time (6 am, 2pm, and 10 pm) rather than only specifying frequency (3 times a day).  Especially a relationship to meals for orally consumed medications should be mentioned, where applicable.  Generic names are preferable. Combination products containing two or more drugs within one formulation can be ordered by brand name e.g. Bactrim DS.  When writing multiple orders for a given patient, segregate orders by type, i.e. medication orders together, lab orders together, etc.  All drug orders for narcotics, sedatives, hypnotic anticoagulants, antibiotics shall be automatically discontinued after 48 hrs. unless the order indicates exact number of doses to be administered or the attending physician re-orders medication.  Avoid the use of unofficial names or abbreviations for drugs.  Use exact metric amounts when ordering drug doses. Prescribing only by “amps, tabs, and ml” is ambiguous and leads to dosing errors since most medications are available in more than one strength or concentration. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 306 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Orders must specify the medication dose for liquid dose.  Careful use of decimal points to avoid ambiguity- e.g. Avoiding unnecessary decimal points: a prescription shall be written as 5 ml instead of 5.0 ml to avoid possible misinterpretation of 5.0  Always using zero before decimals: e.g. 0.5 instead of .5 to avoid misinterpretation of .5 as 5.  Avoiding subsequent zeros on decimals; e.g. 0.5 instead of .50 to avoid misinterpretation of .50 as 50.  Avoiding units such as “teaspoons” and “tablespoons”.  Write microgram or mcg; ug is not acceptable.  Write out units for heparin, insulin, etc. orders with u are not acceptable.  Write out day or dose; d alone is not acceptable. 4. Pediatric Orders  Above Prescribing Guidelines should also be observed.  Patient weight used must be included with the order when using weight. The weight must be calculated in kilograms. 5. Prescribing Controlled Substances  They are prescribed as per FDA guide line o Above Prescribing Guidelines should also be observed. o FORM of Preparation, for example, tablet or capsules o NAME of Preparation o STRENGTH of Preparation (where necessary) o DOSE – vague terms such as a sos, etc., are NOT acceptable as doses. o SIGNED and DATED by the PHYSICIAN  The prescription shall be prepared in triplicate.  Staff responsible for dispensing and administering medications for the High Risk Medication. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 307 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  List shall verify with the order before dispensing and administering such medications. 6. Routinely used/ accepted abbreviations are: Sr. no. Abbreviations Meaning Sr. no. Abbreviations Meaning 1 Oint. Ointment 2 Tsp. Teaspoon 16 SOS When required 3 subcut Subcutaneous 4 IM 17 Syp. Syrup 5 PV Intramuscular 6 PR 18 Cap. Capsule 7 Neb Per vaginal 8 P.O Per rectal 19 Units International 9 NBM Nebulization unit 10 STAT Per oral 11 IV Fluids Nil By Mouth 20 Tab. Tablet Immediately 12 Inj. KCl Intravenous 21 Inj. Injection 13 Inj. MVI 14 Inj. NTG Fluids 22 Amp. Ampoule 15 PCM Inj. Potassium 23 Mcg microgram Chloride Inj. Multivitamin 24 Ml milliliter Inj. Nitroglycerin 25 IV Intravenous Paracetamol 26 ASV Anti-Snake Venom 27 ART Anti-Retroviral Therapy 28 NS Normal Saline 29 DNS Dextrose Normal Saline 30 RL Ringer Lactate 7. Audit of medication orders Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 308 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  For safe and rational prescription audit of medication order / prescription is carried out daily by team of clinical pharmacist, nurses and doctors. Scope of audit is as follows- o Legibility, use of capitals in written order o Appropriateness of drug, dose, frequency, route of administration o Presence of therapeutic duplication o Possibility of drug interaction and measures taken to avoid it o Possibility of food drug interaction and measures taken to avoid it. o Minimum requirement of prescription completed o Compliance to verbal order protocol o Reconciliation occurs at each transition point o Once in a month audit findings are analysed, corrective and preventive actions are taken. RESPONSIBILITY  Consultants RECORDS  Prescription Form  Medication Chart  Care Plan 42. SAFE DISPENSING OF MEDICATION POLICY  Pharmacy should document policy for safe dispensing of medicine.  Dispensing procedure should address medication recall procedure.  Near expiry drugs shall be handled effectively. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 309 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Dispensed medications should be labelled. PURPOSE  Safe dispensing of medicine SCOPE  OPD and IPD patients PROCEDURE  The Pharmacist has privilege to dispense drug .All drugs are dispensed by the pharmacist registered with the state Pharmacy Council.  Drug shall be dispensed either on receiving a valid prescription for outpatient and inpatient.  The pharmacy shall check carefully the name of drug, dosage, route and date of prescribing and the name of Clinician who has prescribed the drug.  In case the Pharmacist finds the prescription unclear to read, he shall consult with the concerned Clinician and only then dispense the appropriate drug.  If a non-formulary/non-available drug is prescribed, the Pharmacist shall contact the Clinician and inform of the respective available/alternate brand drug. Only with the Clinician’s consent the formulary drug/alternative brand drug can be dispensed.  All the ‘recall drugs’ shall be removed immediately from the Pharmacy and also from Floor stock on receiving the ‘recall notification’ and clinician shall be informed. An alternative drug shall be dispensed as per the Clinician’s order.  Pharmacist prior to dispensing checks generic composition, batch number and expiry dates. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 310 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Prior to dispensing the required drugs to the patient, the Pharmacist shall recheck the drugs and dosage to verify that they are as per the prescription.  High risk medications should be verified prior to dispensing by two pharmacists.  High risk medications are verified before dispensing.  These medications are dispensed with red bar code on a medication.  In case a particular brand is not available, but substitute is in the stock then physician is consulted. The customer is also informed regarding the substitution.  While dispensing narcotic drugs statutory requirements are followed. Handling of near expiry drugs  Dispensed medications are labelled  When medicine is dispensed to OPD patients all medicines are stamped for label. It mentions instruction in the manner patient can understand.  While dispensing in cut strip specifies Drug Name, Strength, Batch No, Expiry Date & dose of medication in legible writing on loose packing.  Indents / prescriptions received for partial strip then strip is cut so that batch No. and expiry date will remain visible on existing cut strip and strip which is to be dispensed is given in pouch on which following information is mentioned: Drug Name: …………… Strength: ……………….. Batch No: …………….….. Expiry: …………………. Quantity: ……………….. Dose: ……………….. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 311 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL RESPONSIBILITY  Head of Pharmacy  Senior Pharmacist 43. SAFE MEDICATION ADMINISTRATION POLICY  Only privileged doctors and nurses can administer medication at GAIMS Hospital.  Ten rights to be observed while giving medication. PURPOSE  To administer medication safely.  To minimize the medication errors  Patient should get right medicine at the right time. PROCEDURE  Hospital gives privilege to doctors and nurses can administer medication. All ACLS / BLS qualified doctors are privileged for administering emergency drugs.  While administrating medicine following rights are followed. o Right patient: Patients name and CR number to be checked. o Right drug: Check the full name of the drug if any doubt asks the on duty doctor. o Right dose: Check the dose ordered and available on the drug. Check for the dilution of the drug. o Right route: Check the route IM/IV, etc. o Right time: Check for the time, frequency of administration. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 312 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL o Right Assessment o Right reason o Right to refuse: if the patient refuses the medicine, immediately inform to on duty RMO and consultant and take the consent of refusal of treatment. o Right documentation o Right evaluation  Prepared medication shall be labelled prior to preparation of second drug.  Given medication should be documented in patient’s medical record with date, time and sign.  If the substitute is administered or two tabs of diff strength administered that should be documented in detail.  Self-administration of medication is not practiced in the Hospital.  Patient shall be monitored after medication administration.  Outside medications allowed provided same drug is brought by the relatives from outside pharmacy with proper details of the bill where Batch number of medication is mentioned. ENVIRONMENTAL QUALITY AND SAFETY  WHO gives the basic recommendations for preparing the drug or IV preparations: o Keep the preparation area clean and free of clutter. o Clean the preparation area with Spirit swab. o Assemble equipment needed for injection. o Adopt the Principle : “One syringe, One Needle ,Only one time” o Disinfect the IV/Three way ports with 70% isopropyl alcohol before injecting any Solution or Injection. o Disinfect the IV bottle nozzle and vial cap with spirit swab/ Sterilium before inserting the intravenous set into IV bottle. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 313 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL o Do not touch the tip of IV set to any surfaces. GENERAL GUIDELINES TO BE KEPT IN MIND WHILE GIVING MEDICATIONS:  Read all the medication orders carefully confirm that the patient is identified correctly.  Two identifiers to be used to administer or perform any procedure. (Name of the patient and CR number)  Ensure that all the equipments used for the medication administration are assembled and disinfected with 70 % Alcohol before initiating administration.  Preferably use single dose ampoules or vials.  Follow the principle “One Needle, One Syringe, Only One Time”.  Check the following: o Expiry date of Each medicine o Integrity of containers, Vial or packaging o Storage of medications as per the manufacturer. o Beware of risk of LASA. Read all the labels carefully. Do not depend on colour caps and similar Names on the drug.  Verify the following are true: o The formation, Dose, Diluents, Infusion fluid and rate of Administration as per the order of the Drug.  The allergy status of the patient.  Method of preparation and the method of administration  Calculate the volume of and dose of prescribed order.  Prepare the label for prepared medicine. (Name and dose of the drug for Single dose syringe)  For Bolus or IV fluids ( Name of the Baseline solution and additive drug and its volume and dose, Started time)  Clean your hand before preparation and administrations as per the protocol. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 314 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Dispose the BMW in proper color coded bags immediately after administration.  All the antibiotics to be given after sensitivity test before giving the full dose and it is documented. RESPONSIBILITY  Nurses  Doctors RECORD  Medication chart 44. MONITORING OF MEDICATION ADMINISTRATION POLICY  All patients should be monitored after administration of medication.  The hospital defines the situations where close monitoring is required.  Staff captures near misses, medication errors and adverse drug reaction.  Staff reports near misses, medication errors and adverse drug reaction within stipulated time.  All near misses, medication errors and adverse drug reactions are analysed and corrective and preventive actions are taken. PURPOSE  To monitor indented effect of medication.  To identify near miss, medication errors, and drug reactions. PROCEDURE Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 315 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Whenever drugs or dye is administered nurses, doctors monitor vitals of the patients. Monitoring is done in a collaborative manner.  It helps to identify near misses, medication errors and adverse drug reaction. Also it helps in verifying indented effects.  Active monitoring is done if patient tells any inconvenience.  Passive monitoring of the patient is done to prevent the ADE. In the defined situations necessarily, proactive monitoring is done. Following are the situations where frequent monitoring is done after drug administration. o High risk medications o Concentrated Electrolyte administration o Intravenous anticoagulant (Heparin) o Iron preparation. o Chemotherapeutic drugs o Contrast o Narcotics  Monitoring is documented in the medical record.  When any deviation in vitals or discomfort is observed in the patient it is immediately informed to the medical officer /consultant. Medications are changed or antidotes are given as per the order as a corrective order. Help of laboratory reports also taken to monitor when needed.  If any above situation is observed staff fills up medication error/Adverse drug reaction form and submit it to the medical administration dept. Medication error forms are submitted to Quality department. A multidisciplinary committee (medical director, medical administrator, nursing superintendent, physician/ pharmacist) analyses ADR forms and decides Corrective and preventive actions within 48 hours. Adverse Drug Event is a clinical event that results in unintended harm to the patient by an act of commission or omission rather than an underlying disease or the condition of patient resulting in physical or physiological injury to the patient. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 316 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL ADE covers following o Medication Errors (Medication error form) o Adverse Drug Reactions (ARD form) o Near Misses 1. MEDICATION ERRORS  It is any Preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in control of the staff. Such events may be caused by gaps in prescribing orders, labelling, packaging and nomenclature, dispensing and administration etc. 2. ADVERSE DRUG REACTIONS  An Adverse drug reaction is any noxious, unintended, undesirable, or unexpected response to a drug that occurs at doses used in human for prophylaxis, diagnosis or therapy, excluding therapeutic failure. 3. NEAR MISSES  These apply to all the above categories. A Near miss is defined as an act of commission or act of omission that could have harmed the patient but did not do so as result only by the virtue of good luck, skilful management and/or prompt evasive action.  E.G. The patient received a contraindicated drug but did not experience an adverse drug reaction  Prevention (a potentially lethal overdose was prescribed but the clinical pharmacist/ nurse identified the error before administering the medication)  Mitigation (a lethal overdose was administered but countered with an antidote). Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 317 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL RESPONSIBILITY  Nurses and Doctors 45. NARCOTIC’S DRUGS PURPOSE  To provide guidelines governing adequate control for procurement, proper storage, dispensing and record keeping of Narcotic and Psychotropic Drugs in a Hospital. RESPONSIBILITY  Anaesthetist  Consultant in charge  Pharmacist in-charge  Nursing Sister in-charge of respective departments of the hospital  Medical Administration SCOPE  All patients receiving Narcotic drugs. POLICY  GAIMS Hospital has the policy for safe usage of Narcotic and psychotropic substances as per the Narcotic Drugs and Psychotropic Substances (NDPS) act. PROCEDURE FOR NARCOTIC AND PSYCHOTROPIC SUBSTANCES Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 318 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Pharmacy have separate license for procurement, storage and distribution of Narcotic and Psychotropic Drugs from the local Excise Department.  Narcotics & Psychotropic substances are stored in Double Lock & Key in the Pharmacy.  The Key of the two lock should be with on duty two Pharmacists.  The keys should be handed over to the person on duty after each shift.  NDPS Stock to be taken in every shift by Pharmacist on duty.  Pharmacist on duty should verify the physical stock with the system stock.  The consultant prescribes the medication on the triplicate prescription pad (As per the NDPS Act) to the pharmacy and is dispensed from the Pharmacy.  The following are to be verified Date of the Narcotic Prescription: o Name of the Patient o Address & Contact Details of the Patient o Name of the Drug o Quantity of the Drug o Name and Registration Number of the consultant prescribing the Narcotic Medicine o Signature of the consultant prescribing the Narcotic Medicine.  A Prescription should contain only one drug name, for multiple narcotics different prescription to be used.  Narcotics should not be dispensed on old date prescription or if the prescription is not legible or changes are made to the original prescription.  If changes are made to the original prescription it should be signed by the consultant at appropriate place where change has been done.  After confirming all details on the prescription, narcotics are dispensed by the Pharmacist to the Patient (For e.g. Out Patient) and to the Staff Nurse/ Doctor (for In Patient). When the dosage form of the Narcotic is tablet/ capsule, the number of units dispensed should be equal to the number of units prescribed.  Entries of dispensing to be done in “Narcotics Drug Issue Register”. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 319 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  A separate register to be maintained in the Pharmacy for different Narcotics stored.  One copy of the prescription stamped with “Dispensed Medicine” with signature of dispensing Pharmacist to be given to Patient (To be kept in Patient File for In Patient) along with the bill.  Empty Ampoule Register to be maintained in the Pharmacy.  The Empty ampoule received from the unit should match to the dispensed quantity in that unit.  Empty Ampoule should be returned with patient sticker attached to it.  Method of Discard of Empty Ampoules: Crushing of the empty ampoule should be done by Pharmacist in presence of Pharmacy In charge & record to be maintained for the same. OR  The Empty Ampoule is immersed in 1% Hypochlorite solution in presence of the Competent Authority and the entry for the same is made in the register and signed by the appropriate authority and should be available for inspection as deemed needed  For returning of the unused Narcotic vials/ ampoules, prescription in triplicate to be received in the Pharmacy with “Return” mentioned on the top of the three prescriptions, and the details to be verified before returning the medicine. After returning the medicine entries to be made in the Narcotics register.  The staff Nurse should indent the Narcotics, through the system based on the requirement of the patient. Usage in patient care areas:  Prescription in triplicate to be send to Pharmacy by the Staff Nurse to the Pharmacy for the procurement.  Three Prescriptions should be clear & as per provision of FDA guidelines. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 320 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  The Pharmacist will dispense the indent only when the triplicate prescriptions are received by the pharmacist in the Pharmacy.  Once the triplicate prescription is received in the Pharmacy, the medicines are dispensed through the system and two printouts of the indents are generated.  The Pharmacist hands over the narcotic medicine to concerned staff nurse, and signature of the staff nurse is taken on the Narcotic register.  The Narcotic Drug shall be prepared and administered by the assigned Nurse in the presence of the Nurse Incharge / only, who both has to document the same.  The Patient care area to maintain their “Narcotic Usage Register”.  The staff Nurse will make an entry into the Narcotics Usage Register after administration of the drug.  This register is to be periodically checked by Nursing In charge. Unused or the left over drug shall be kept in Narcotics Cupboard.  Narcotic Cupboard should have Double Lock & Key  Narcotic Injection to be disposed if it is not used after 24 hour of preparation, it should be disposed immediately in to the sink with tap open to flush out the drug in the presence of witness and the same shall be documented in the “Narcotic Usage Register” Patches to be folded with the sticky ends together and discarded in dustbin.  In case of accidental breakage of any ampoule, an Incident form shall be filled handed over to the Nursing incharge as per the defined protocol.  Empty Ampoule should be returned with patient sticker attached to it.  Documentation for returning the empty ampoule should be done in Narcotic Usage Register, mentioning the pharmacist name to whom it was returned.  Any excess ampoules not utilized for patients (after discontinuation of use or death of patient) the unused vials are sent back to the pharmacy with proper documentation immediately. Accidental breakage of Narcotic injection Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 321 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Fill the incidence form  Handover the broken ampoules in separate container.  Update the incidence in Narcotic register record with two witnesses.  Pharmacy will report the incidence to FDA.  Upon the approval of FDA, dispensing register to be updated for broken ampoules. Unused leftover drug Discard record  For eq:  In 1 ampoule o 100mg o 60 mg administered o 40mg Unused  Flush under running water in a sink in presence of witness,  Document in Narcotic register along with witness signature. RECORDS  Narcotic register in Pharmacy and in wards  Narcotic prescription 46. IDENTIFICATION REPLACEMENT AND DISPOSALOF MATERIAL NOT IN USE. POLICY  GAIMS hospital has a system of identification, replacement and disposal of material not in use.  Equipment’s/material which are beyond repairable /not in use or clinically/Technically obsolete, declared end of life or support are replaced and Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 322 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL disposed of in a systematic manner considering, strategic plans, upgrade/update path and equipment log.  Condemnation committee is established which gives report on final condemnation as well as extension of life by up gradation & usage with proper analysis & justification CONDEMNATION COMMITTEE  A condemnation committee is called twice in a year and as and when required.  Members: Medical Administrator, Nursing Superintendent, Finance Controller, Head purchase & commercial, Sr. Executive operations, Store In charge, Maintenance and facility In charge, IT in charge, Head Operations, Biomedical Engineer  Responsibility: Condemnation Committee, Maintenance and biomedical engineering department, store and purchase dept. PROCEDURE  Condemnation check to be performed and certified by Engineers / Vendor & Necessary support documents to be obtained  A committee/group should assess all factors, equipment history and then approve for condemnation/disposal  Condemned equipment to be removed from inventory or in-use list & properly tagged  Condemned equipment should be disposed properly as per regulatory guidelines  Biomedical engineer, maintenance and IT Departments identify the equipment for condemnation in following ways :  Conduct an audit at the end of financial year for identifying the list of equipment’s for replacement/ condemnation. o Based on breakdown o Major physical damage Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 323 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL o equipment life, o efficiency for the equipment o Repairs and service cost  Condemnation report is prepared considering above parameters for each equipment which is near & ready for end of the life. (Ref. Equipment plan).  Condemnation check to be performed and certified by Engineers / Vendor & Necessary support documents to be obtained.  Condemned equipment should be disposed properly as per regulatory guidelines.  All condemned machinery report prepared should be submitted to condemnation committee.  All condemned machinery report prepared should be submitted to condemnation committee for validation & approval.  Condemnation committee will validate the condemnation report & give the approval for replacement of the equipment’s required & also suggest the equipment’s which are in priority for replacement.  Condemned equipment to be removed from inventory or in-use list & properly tagged by the departments.  Equipment recommended for replacements are allocated with the budget & quotations are invited & collaborative Purchase procedure carried out for new equipment.  Condemned equipment should be disposed properly as per regulatory guidelines Identification of Material Not in Use  All the materiel which are not is used /excess in quantity/ unwanted material will be forwarded to central store by the user department along with the form (Breakage/Loss/ Not in Use/No repairable Information Form) identifying following issue: - o Material can be used by another department Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 324 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL o Stand by Equipment’s/furniture if any o Examples of not in use material Non-functioning item, o Excess unwanted material., o Scrap material.  Store will collect and store the material in safe manner in a designated place.  Material will be issued to desired department by proper indenting procedure.  All the forms and format which are obsolete from the department will directly go to store with scrap report along with signature of HOD. Material will be disposed of according to condemnation committee. Procedure for Disposal  All the item in the hospital is disposed of only on approval of condemnation committee. Once the condemnation of equipment is finalized store dept. will take steps to disposal of equipment’s and other items.  Store will prepare a list of material to be dispose in general disposal register according to category.  Quotation will be asked from various supplier according to the category of material o Electronic equipment’s- engineering waste material o Instruments o General plastic and other items o Linen o Paper scarp  Once the quotation is received comparative will be done and final approval will be taken by director  The entries in the general disposal register should tally with the items condemned and reduced in the main asset register of instruments, accessories, furniture etc. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 325 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  All biomedical equipment’s, CRT monitor, LCD, PC, Laptops and other electronic waste send to authorized vendor who collect the material, dismantled and recycled in a manner that is environmentally safe. Linen and Other Item  Operations, nursing and CSSD department is responsible for the condemnation of linen.  The linen will be checked on monthly basis by the in charge and all torn linen will be forwarded to store for replacement.  A list is prepared by the department and approved by HOD for replacement  Store will prepare a list of linen to be condemned and forward it to condemnation committee,  All papers scarp and linen will be shredded and given to supplier. Scraps of Other Material All the scrap material collected from various process is scraped on daily basis.  Cardboards, general waster and biomedical wastes.  Biomedical wastes are send on daily basis to life secure agency for disposal  Other scarp is sell to vendor on daily basis according to weight.  General waste is collected in separate area for final disposal. RECORD  Condemnation report from. 47. RECALL PROCEDURE FOR MEDICAL EQUIPMENTS & DEVICES POLICY Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 326 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  GAIMS hospital biomedical engineering department monitors of medical equipment and medical devices related to adverse events and compliance hazard notices on recalls. PURPOSE To monitor all medical device-related adverse events.  To adhere statutory requirements and procedures.  Comply with letters/hazard notices on recalls from manufacturer or regulatory authorities.  To participate take part in materio-vigilance programme of India SCOPE  Applicable for Medical Equipments and Devices PROCEDURE  The hospital should immediately act when it receives a recall notice from company and become aware of such recalls.  Upon identification by biomedical engineer or notification from company biomedical engineering department will be responsible for:- o Whenever Hospital Authorities receive such recalls biomedical engineer immediately acted upon and inform to user department for specific recall. o Whenever biomedical engineer notices any equipment or device for recall or feedback from user department or patient, it is informed to regulatory authorities and manufacturer. o Ensure the medical equipments are not be put into further clinical use till the issue is resolved. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 327 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL o After Resolving issue company person will give a report of confirmation of resolving problem then only user can use the Equipment for clinical purpose. RESPONSIBILITY  Biomedical Engineering Department and User Department 48. VULNARABLE PATIENTS POLICY  Organization identifies and manages vulnerable patients  All vulnerable patients shall undergo risk assessment and receive safe, secure environment.  The treatment and care shall be provided to vulnerable group complies with the statutory and standard requirements as applicable.  Risk of fall, developing / worsening ulcers, developing DVT shall be identified and managed.  Staff shall be trained to implement Policies and Procedures for taking care of vulnerable patients PURPOSE  To give guidelines for care of patients who are at high risk of mortality and morbidity. SCOPE  Vulnerable patients PROCEDURE Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 328 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Patients who are prone to injury and disease by virtue of their age, sex, physical, mental and immunological status are identified as vulnerable.  The following patients are the examples of vulnerable patient. o Patients above 60 years of age o Infants and children (minors below the age of 18 years) o Differently enabled o Semiconscious and unconscious o Patients under moderate sedation/ anesthesia o Patients requiring end of life care, o immunosuppressive and or chemotherapeutic agents o Patients on dialysis o Unattended female patients o Women in labour. Who identifies vulnerable patients?  Nurses and doctors identify vulnerable patients and record in the patient’s medical record.  In case of vulnerable patients, informed consent is obtained from patient if he is competent; also consent of next to keen is obtained. The next to kin/legal representative shall give informed consent (confirm Implementation) / decision required for treatment, surgery, procedure and investigations of vulnerable patient. Vulnerable patients are provided safe and secure environment  Safe environment is provided to these patients to prevent fall. Grab bars in the wash rooms, ramps with railings, bed and trolley side rails, and wheelchairs with belts are provided. Tiles in the bathroom are non -slippery. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 329 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  Female patients shall be admitted in gender specific wards only. If in any case it is required to admit a female patient in a ward accommodating both the genders, it shall be clearly informed to the patients / relatives.  Staff ensures that the vulnerable patients are adequately dressed and covered in the ward and while leaving the clinical area for any reason.  All the female patients and children are accompanied by female attendants for toileting and bathing purpose.  Patient shall not be asked to take off more clothing than is necessary during examination/ procedure.  Female patients and children shall be accompanied by the staff nurse during physical examination by male doctor.  Curtains/doors are provided and closed during all examinations/ procedures.  A 24 x 7 Security guard is present  Kangaroo Mother Care room is available at the NICU  Beds are provided with side railings.  Pain scale is used to determine the level of pain experienced by the patient. Patient receives appropriate treatment for pain management depending on the pain scale. Patient care  These patients are monitored frequently, once in each shift at least, of all the vulnerable patients by the staff.  Adequate care of tubes and catheters is taken by the staff.  Soiled bed sheets are changed as soon as possible.  Position is changed every 2 hourly or as required in bed ridden patients to avoid bed sores.  Proper care is taken while transferring patient from bed to trolley or from one trolley to another. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 330 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL  While transferring the patient from one clinical area to another or for any investigations, staff nurse and an attendant shall accompany the patient.  Patients are assessed for their nutritional deficiencies by the Dietician. A proper Diet plan is provided to the patient. The patient and family are educated about the diet and nutrition.  Psychosocial support including counseling is provided where required RESPONSIBILITY  Clinician In charge, Staff Nurse, SLM, housekeeping, all health care givers. Record  Clinical records CONCLUSION This SOP is only suggestive and not exhaustive. This is to facilitate all the employees to follow a sequence of actions without any panic thereby minimizing the loss to human lives and the property during any disasters/crisis situations. However, any other action which is considered to be more appropriate during disaster/crisis situation by any competent authority of our hospital can be under taken keeping the primary aim of removing/reducing risk to life and property. Signatory Prepared by Reviewed by Approved by Name Designation Signature

Gujarat Adani Institute of Medical Sciences G. K. General Hospital Document Code: Page no: Page 331 of 331 GAIMS/SFT/MANUAL/01/REV 00 Issue No:01 Issue date: 10/03/2022 Reference : NABH 5th Edition Revision No: 00 Revision date: 10/03/2023 Effective date:10/03/2022 SAFETY MANUAL 15. LIST OF QUALITY INDICATORS Denominator Standardizing Factor Sr. No Indicator Name Numerator 16. LIST OF FORMS, FORMATS & REGISTERS Sr. No. Document Document Type (Register/ Document Number Name Form) Signatory Prepared by Reviewed by Approved by Name Designation Signature