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Description : Check out this medical presentation on Radiology and Imaging, which is titled "PLANNING A MODERN IMAGING DEPARTMENT", to know about legal and ethical issues while planning a modern imaging department.

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Slide 1-

PLANNING A MODERN IMAGING DEPARTMENT ETHICS AND LEGAL ISSUES in radiology
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Radiology department is one of the focal point of any hospital or a medical centre and setting up such a facility requires a very careful planning and a vision for the future. Scope of a modern radiology setup is not only limited to imaging studies but also has a therapeutic role in the form of minimal invasive interventional radiology setup.
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STRATEGIC PLANNING Feasibility of setting up an imaging centre in a given area – 1st step Need for such services in the given area Presence of other centres Status and acceptability of referring physicians Presence of larger hospitals in area Further planning can be undertaken once it is clear that there is a need for the same
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2 types of radiology centres - Radiology departments in a hospital setting Dedicated radiology centres, that works on referrals Difference – patient referral
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LOCATION Preferably on the ground floor Sophisticated machines like CT and MRI are best placed on the ground floor In addition to walk in patients, the department also caters to emergency patients who may not be able to walk or need urgent scanning for establishing the diagnosis Should be easily accessible to OPD patients, inpatients emergency department.
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GROUND FLOOR EMERGENCY OPD AJHRC
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EQUIPMENTS Digital X-rays Fluoroscopy units Mammography unit Dual energy X-ray absorptiometry (DEXA) unit Ultrasonography units Multislice CT 1.5 T/3 T MRI Digital subtraction angiography unit Positron emission tomography – computed tomography (PET-CT)
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MRI PET / CT MAMOGRAPHY XRAY/FLURO DEXA USG USG USG RECEPTION DSA REPORTING ROOM CHANGING / TOILET HANGING / TOILET
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LAYOUT Reception area Preprocedural and changing rooms Investigation rooms Reporting room
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CHANGING / TOILET HANGING / TOILET MRI PET / CT MAMOGRAPHY XRAY/FLURO DEXA USG USG USG RECEPTION DSA REPORTING ROOM
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RECEPTION AREA Patient entering should immediately know where to go /approach Well lit, adequate space for sitting trolleys and wheel chairs Person-in-charge  qualified and well versed with various types of radiological studies; prime responsibility of scheduling the studies for the patients RECEPTION
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PREPROCEDURE AND CHANGING ROOMS Nearly every radiological investigation needs some type of preparation To remove any metallic clips or rings for X-rays Changing into hospital gown Screening for any metallic item on the patient before MRI
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INVESTIGATION ROOMS A modern radiological setup should have minimum of one digital X-ray unit, one fluoroscopic unit and one mammographic unit, one sonographic unit, one CT scan, one MRI unit X-ray, fluoroscopic and CT scan emit ionising radiation  special care required for construction of rooms
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Amendment to AERB Safety Code for Medical Diagnostic X- ray Equipment and Installations, [Code No. AERB/SC/MED-2, (Rev.01), 2001]
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Location of X-Ray Installation Rooms, housing diagnostic X-ray units and related equipment, shall be located as far away as feasible from areas of high occupancy and general traffic, such as maternity and paediatric wards and other departments of the hospital that are not directly related to radiation and its use. If the installation is located in a residential complex, it shall be ensured that – Wall(s) of the X-ray rooms on which primary X-ray beam falls is (are) not
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Room size and shielding appropriate area to facilitate easy movement of staff and patient positioning.  Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of the room doses received by workers/public are should not exceed the respective annual effective doses dark room to ensure that the undeveloped X-ray films are not exposed to more than 10 μGy per week. The room shall not be less than 18 m2 for general purpose radiography and conventional fluoroscopy equipment. Also, not more than one unit of any type shall be installed in the same room, and no single dimension of these x-ray rooms shall be less than 4 m.
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>4m >18m2 Single unit XRAY/FLURO >4m
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Control Panel In case of room housing general purpose radiography and fluoroscopy equipment, chest stand shall be located in x-ray room such that no significant stray radiation reaches at control console/entrance door. The control panel of diagnostic x-ray equipment operating at 125 kVp or above shall be installed in a separate room located outside but contiguous to the x-ray room and provided with appropriate shielding, direct viewing and oral communication facilities between the operator and the patient. In case of x-ray equipment operating up to 125 kVp, the control panel can be located in the x-ray room. The distance between the control panel and the x-ray unit/chest stand shall not be less than 3 m.
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XRAY/FLURO <125KVp XRAY- = 125KVp >3m
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DARK ROOM Made completely dark and normal light is excluded to allow the processing of X-ray films Door systems – single/double door, maze type, revolving type Equipments used – Processing tanks, cassettes, safelight, hangers and automatic processors The dark room shall be located such that no significant primary or secondary x- rays reach inside the dark room. 2m 2.6m 15cm thick WET DRY SINK 1.2m
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Floor area not less than 2.6x2m Room made completely lightproof Should not be damp or subjected to extreme of temperature Water and electrical outlets provided Sufficient space to accommodate a dry bench (3x2), a wet bench and a sink. Should be near the x-ray examination area Walls of solid concrete (15cm thick) Lead box inside to store boxes of unexposed films
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Processing Tanks Developer, rinsing, fixer and washing Made of stainless steel to avoid erosion 1 to 10 gallon Cassettes Used to hold the X- ray film and intensifying screens Excludes all light from entering the cassette Safelight Lamp used which doesn’t affect the X- ray film processing Gives sufficient light to facilitate work Must be atleast 1.2m above the work area
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Hangers Instrument or device for holding radiographic film during processing procedure Made of stainless steel Clip, channel and spring types Automatic processor Fast efficient method for processing film Developer, fixer, washing, dryer Contains rollers instead of rinsing
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PASS BOX Cassette Transfer Cabinet – allows cassettes to be transferred to and from the darkroom without the worry of light or radiation entering. Extra heavy duty constructions with double light and radiation traps, welded doors (2) WET DRY SINK
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Mobile Equipment Movement of mobile x-ray equipment shall be restricted within the institution for which it is registered. The distance between operator and x-ray equipment shall not be less than 2 m during exposure. Operator shall always use radiation protection devices such as protective apron while operating the x-ray equipment. Fluoroscopy shall not be carried out with mobile equipment. >2M AJHRC XRAY PORTABLE NO FLUROSCOPY
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Safety Personnel Every X-ray department shall have a Radiological Safety Officer (RSO) having qualifications as prescribed and approved by the competent authority from time to time. The RSO has responsibility of ensuring compliance with appropriate radiation safety/regulatory requirements applicable to his/her X-ray installation
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Radiologist All installations having x-ray unit with fluoroscopy facility, and all establishments performing special procedures, shall have the services of a qualified radiologist or related medical practitioner, with adequate knowledge of radiation protection for interpretation and reporting. X-ray Technologist All x-ray installations shall have a radiologist/related medical practitioner or a qualified x- ray technologist, with adequate knowledge of radiation protection, to operate the x-ray unit. Service Engineer All manufacturers, suppliers and service agencies of diagnostic x-ray equipment shall have qualified service engineers for installation, servicing and maintenance of the equipment.
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Responsibilities of Manufacturer
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PRIOR LICENCE FOR COMMERSIAL PRODUCTION IMPORT PERMISSION FOR XRAY TUBES AND INSERTS TYPE APPROVAL CERTIFICATE Prototype of every model of equipment DATA of testing of x-ray tubes and equipment INSPECTION shall make premises available Responsible for ensuring compliance with terms and conditions of Licence and Type Approval.
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Responsibilities of Supplier of x-ray equipment
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AUTHORIZATION from the competent authority NOC FOR IMPORT TYPE APPROVAL CERTIFICATE demostrate Responsible for ensuring compliance with terms and conditions of Authorisation and type approval market equipment of foreign make type approved diagnostic x-ray equipment , installation , commissioning , acceptance testing/quality servicing and maintenance (life-time) supply of radiation protection devices protective barrier, protective apron, lead rubber flaps etc. Responsible for
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Type Approval/ No Objection Certificate Prior to marketing the x-ray equipment, the manufacturer/local supplier of imported equipment shall obtain a Type Approval Certificate from the competent authority, on demonstration of performance of the prototype of x-ray equipment. Import of prototype of x-ray equipment, meant for Type Approval, shall be carried out by the local supplier only after obtaining NOC for import for Type Approval, from the competent authority. Type Approval/NOC will be issued only if the equipment satisfies the safety specifications of this Code and the standards in force. Import of every Type Approved x-ray machine by supplier or any other importing agency, shall be carried out only after obtaining NOC for import of x-ray equipment, from the competent authority. Only type-approved and NOC-validated equipment shall be marketed and used in the country. For import of x-ray tube(s), the importing agency shall obtain NOC for import of x-ray tubes from the competent authority.
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TYPE APPROVAL CERTIFICATE Prototype of every model of equipment MANUFACTURER / LOCAL SUPPLIER NOC FOR IMPORT Importing agency Type Approval/NOC will be issued only if the equipment satisfies the safety specifications of this Code and the standards in force. marketing the x-ray equipment
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Approval of Layout No x-ray unit shall be commissioned unless the layout of the proposed x-ray installation is approved by the competent authority. Operation of X-ray equipment: No diagnostic x-ray equipment shall be operated unless licensee obtains license and/or registration from the competent authority. A modern radiological setup should have minimum of one digital X-ray unit, one sonographic unit, one mammographic unit, one CT scan, one fluoroscopic unit and one MRI unit X-ray, fluoroscopic and CT scan emit ionising radiation  special care required for construction of rooms
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Radiation Sign
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Standard Layout of X-ray Installation
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450 cm 400 cm 23cm thick brick Column Center Spot film device Unit Electronics MPB with lead glass viewing window of 1.7 mm lead equivalence Examination table X-ray Tube Column Stand Chest Stand Control Unit GOPAL SIR
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RADIATION STANDARDS
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Standard Layout of CT Installation
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COMPUTED TOMOGRAPHY ROOM The size of the room housing the gantry of the CT unit shall not be less than 25m2. The control panel of CT shall be installed in a separate room located outside but adjoining to CT room and provided with appropriate shielding, direct viewing and oral communication facilities between the operator and the patient.
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625cm 400 cm 23cm thick brick 200cm Unit Electronics EXAMINATION TABLE Viewing Glass 100 cm X 80 cm of 2.0 mm lead equivalenc > 25m2 Hemachandra SIR
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Standard Layout of Interventional Radiology Installation
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500cm 500 cm 23cm thick brick 200cm Unit Electronics C Arm Fixed radiation shield EXAMINATION TABLE Viewing Glass 120 cm X 100 cm of 2.0 mm lead equivalenc
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Standard Layout of Mammography Installation
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350 cm 300 cm 23cm thick brick Unit Electronics Control Unit 1.5 mm lead equivalence Mammography equipment Changing room
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ULTRASONOGRAPHY ROOM Since ultrasound machines do not emit any ionising radiation, it is possible to house them in a general room without any special construction guidelines. A well designed sonography room should have ambient light control, an examination trolley/bed, a changing room and a washroom
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MRI ROOM MR machine contains a large magnet, which emits strong magnetic field in all directions, so its installation and housing is different from any other radiological equipment. An MR unit has to be shielded in such a way that its magnetic field does not exist outside the room  active shielding, passive cladding and room shielding are done. For patient safety, the access to the MR room should be controlled and clear printed instructions should be displayed at the point beyond which only patients with adequate screening can go.
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MRI ROOM In any MR installation, it is necessary to see the effect of emitted magnetic field in all directions. Any device or equipment, which is sensitive to magnetic fields, should be away from the MR unit or adequately shielded (e.g. Power transformers, CT scanners, ultrasound equipment, etc.) Special planning is done to see that the MR unit is away or well shielded from steel pipes and structural steel. Since device that RF waves, e.g. cell phones, radio transmitters, etc., can cause interference in image reconstruction, the MR unit also needs to be shielded from RF pulses.
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Unit Electronics EXAMINATION TABLE Hemachandra SIR Structural Steel
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REPORTING ROOM In a modern department, nearly all reporting is done on dedicated workstations. Different from conventional setups where first X-ray, CT or MRI images are printed on films and then send for reporting. A filmless setup is cheaper, environment friendly, easier to maintain and useful. Big enough to house separate reporting consoles for all radiologists who are working. Their consoles should be independent and at the same time should be designed in a way that interpersonal communication is not hindered
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ADVANCES IN RADIOLOGY SETUP MOVING TO FILMLESS RADIOLOGY Instead of printing films, the images are viewed on monitor for reporting and then given to patients either in CDS or paper prints or sent to referring doctors electronically via net to their computers. Achieved in two ways – Images can be acquired digitally with the use of modern equipment or images can be digitalised by scanning the films.
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PACS AND HIS For achieving rapid reporting, transfer and storage of images, a system called PACS is installed. PACS – Patient Archiving and Communication System The radiology machines are lined to a central server where all the images are sent. From there, the images are sent for long term storage and also for reporting to individual workstations of the radiologists. PACS is linked to HIS (Hospital Information System) in larger hospital setups. The acquired images can be made available to the referring physicians very soon after they are acquired. Also, the radiologists have access to the clinical and laboratory details of the patients, which go a long way in reaching to a correct diagnosis
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ETHICS AND LEGAL ISSUES
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Radiology is a specialized branch of medicine using medical imaging technologies to diagnose and treat patients. Like other specialties, radiologists are also liable to claims of malpractice due to diagnostic errors. Errors in radiology differ from errors in other clinical specialities as in that, the radiological image is a permanent objective record that can be reviewed to check for missed lesions. Such errors, when causes significant damages to the patients, in the form of injury or death, attract malpractice claims.
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Apart from the medical malpractice, another important area of legal importance for Indian radiologists is Pre-conception and Pre- natal Diagnostic Techniques Act (PCPNDT- Act) which has stringent rules and regulations to curb female feticide. It is important to follow and strictly adhere to the guidelines laid down under the act to avoid legal actions.
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MEDICAL MALPRACTICE AND RADIOLOGY The term “medical malpractice” refers to the professional negligence of doctors, surgeons, nurses and other healthcare professionals. This is the most common complaint registered against a doctor. Medical malpractice is said to have occurred when the healthcare professional discharged a substandard level of care and, as a result of which the patient suffered damages. The three essential components to prove medical malpractice lawsuits are breach of duty, causation and resulting damage.
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Radiologic errors in diagnosis can be of two types, cognitive and perceptual errors. Cognitive errors are those in which an abnormality is seen but its nature is misinterpreted. Perceptual errors or the radiologic ‘miss’, are the one in which a radiologic abnormality is not seen by the radiologist on initial interpretation. Of the two types, perceptual errors resulting in false-negative errors are the most frequent accounting for 80% and the majority of which includes failure to diagnose breast cancer on mammography, lung nodules on chest x-ray and fractures on skeletal radiographs.
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Not all missed findings represent the breach in standard of care. When the radiologist reviews an imaging study obtained with proper technique and exposure and fails to perceive an abnormality, which, in retrospect, is apparent, such ‘error in perception’ cannot be labelled negligence.
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Other infrequent causes – Failure to alert or communicate with the referring clinicians of important but unsuspected findings Failure on the part of the radiologist to suggest appropriate next procedure when diagnostic specificity is required Incorrect examinations obtained on patients Once a person claims a malpractice who is referred to as ‘plaintiff’, should establish the existence of all the three elements of malpractice i.e. breach of duty, causation and damages. If any one element is missing, then the malpractice claim is not valid.
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Radiologist as a defendant in malpractice claim: Do not panic or lose confidence when a malpractice is claimed. One should act calmly. On receiving such court notice, the document should be read carefully to determine the nature of claim. Later, assemble all the related documents i.e. physician referral form, consent form, acquired images, reports etc. Do not alter any medical records. Immediately contact the medical defense lawyer and insurer. An investigation committee will be formed which includes renowned and senior doctors who are experts in the particular discipline. Depending on the committee opinion, if the radiologist is proved negligent, necessary action will be taken up according to the nature of act.
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In Indian Law, doctors can be held responsible under: Civil suit consumer court: Consumer protection act (CPA) considers patient seeking medical care as ‘consumer’ and doctors attending to it as ‘service provider’. Doctor-patient relationship/contract is bound to CPA. Case in medical council: A case against a doctor can also be filed in medical council of the concerned system of medicine. Medical Councils do not have powers to award compensation or to imprison. It can only warn the doctor, suspend or revoke the license. Case of criminal negligence: The main section under which a criminal case is filed against doctors is Section 304A of the Indian Penal Code which deals with causing death due to rash and negligent act. The punishment is two years imprisonment or fine or both. Law of Torts
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“The standard to be applied for judging, whether the person charged has been negligent or not, would be that of an ordinary competent person exercising ordinary skill in that profession. It is not possible for every professional to possess the highest level of expertise or skills in that branch which he practices. A highly skilled professional may be possessed of better qualities, but that cannot be made the basis or the yardstick for judging the performance of the professional proceeded against on indictment of negligence.”
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In order to protect oneself from malpractice litigation, following points should be remembered: Always consider the clinical history viz, history of presenting illness, past history and occupational and drug history. If more information is needed, contact the referring physician directly. Develop good rapport with the patient. To obtain written informed consent after explaining the risks and benefits of the imaging procedure. Explain the limitations associated and available alternatives, if any. To confirm that the patient is subjected to the test requested and follow ALARA principle to limit the radiation exposure. Date and time of the examination should be documented. Regular check on the computer clocks to be done to avoid out of synchronization with the actual date and time. Follow the recommended standard protocols to image the anatomic structure.
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To obtain satisfactory image if the initial image quality is not adequate for interpretation. Consider additional views if necessary. Systematically evaluate the images so that the lesions do not go unnoticed. Always consider and compare previous imaging study if available. Do not jump into conclusion or get biased with the previous report. Document the noted abnormality in the report and reach a conclusion. Proofread the report. Correct the typographical errors. This written report determines whether the radiologic standard of care is conformed to or breached, once a malpractice lawsuit is filed. Suggest further appropriate next step to increase diagnostic specificity, if required.
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Communicate with the referring physician when important unsuspected finding is noted that which require immediate management. While examining female patients, male radiologists should ensure that the examination is carried out in the presence of female attendant. When the radiologist feel that he is not expertise in the diagnostic or interventional procedure requested, consider seeking the help or referral to another colleague. Radiologists should regularly get updated with the new technologies and current practice guidelines.
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CONSENT IN RADIOLOGY PRACTICE Two main indications or instances where consent is necessary in the daily radiology practice are before administering an intravenous contrast and before performing any interventional procedures. Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law. In consent, there are four separate but correlated elements that are: Voluntariness Capacity Knowledge and Decision-making
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CONSENT IN RADIOLOGY PRACTICE It can be either implied or expressed (oral or written). Expressed consent includes informed consent, which is the ideal form of consent because it includes all aspects of meaningful decision-making. Informed consent provides the comprehensive information to patients on the imaging procedure to be performed which includes both advantages and potential risks and complications. Standard hospital consent forms will not be considered as consent for diagnostic procedure or therapeutic treatment.
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TO OBTAIN A LEGALLY VALID CONSENT Comprehensive consent form should enable balanced judgment by the patient and his/her relative by explaining the procedure, its risks and benefits, as well as any alternatives if available. The signature or thumb impression of the patient must be taken. In case of legally incompetent patient, the family of the patient becomes the decision maker. Spouses’ decision is considered the most important, followed by immediate relatives such as parents, children, and siblings. No changes can be made in the form thereafter. Such an attempt raises the possibility of suspicion. Preserve the document in the departmental records.
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PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES ACT (PCPNDT ACT) A national law, Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act (PNDT Act), 1994 was enacted to prevent sex determination and came into force on January 1st, 1996. In the meantime, new techniques had been developed that used pre-conception or during conception sex selection. To bring these new technologies under the purview of the Act, the law was amended in 2003 and is renamed the Pre- conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act (PCPNDT Act), (effective from February 14, 2003). Despite the enactment of the Act in 1996 with subsequent amendment in 2003, the decline in Child Sex Ratio (CSR) from 927 girls per 1000 boys in 2001 to 914 in 2011 was evident, reflecting the continued practice of sex selection. Hence, the Act was again amended in 2012 with steps towards stronger, rigorous and effective implementation of the Act.
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PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES ACT (PCPNDT ACT) Why this act? An Act to provide for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex linked disorders and for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female feticide; and, for matters connected there with or incidental thereto. This act regulates genetic counseling centers, genetic laboratories and genetic clinics (used for conducting pre-natal diagnostic procedures). Use of ultrasound comes under Genetic Clinic.
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WHO CAN SET UP A GENETIC CLINIC? Any person having adequate space and being or employing a Gynecologist having experience of performing at least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis, fetoscopy, fetal skin or organ biopsy or fetal blood sampling etc. under supervision of an experienced gynecologist in these fields, or a Sonologist, Imaging Specialist, Radiologist or Registered Medical Practitioner having post graduate degree or diploma or six months training or one year experience in sonography or image scanning, or a medical geneticist.
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GUIDELINES FOR THE USE OF ULTRASOUND IN GENETIC CLINIC Centers where ultrasound is intended to be carried out should get registered, at least 30 days in advance. All ultrasound machines available at that center along with the qualified doctors performing USG should be registered on the certificate. No doctor other than the one registered in the particular centre is allowed to use the machine. In the case of a locum doctor, the doctor’s name and personal details, state council registration number, and his/her degree certificate need to be sent to the appropriate authority (AA)/ward office, requesting permission for the use of the machine by the locum on the specified dates. The USG machine should not be shifted from one Centre to another.
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Any changes in the center (e.g., change in machine or place of use) should be intimated 30 days in advance of the expected date of such change. Portable ultrasound machines should be used as a part of the registered mobile medical unit, offering other health and medical services. It cannot be used in a vehicle not registered under the Act. Registration and practice of sonography by a radiologist/ sonologist is restricted to two clinics/facilities within a district. The consulting hours by such medical practitioner should be specified by each clinic/centre. Renew the certificate of registration every five years, with application of renewal being applied 30 days before the date of expiry to the AA. A copy of PC-PNDT registration certificate should be displayed in reception area and the USG room.
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A copy of PC-PNDT Act booklet should be made available in both the waiting room and USG room. Sign in English and in the local language must be displayed, indicating that FETAL SEX IS NOT DISCLOSED IN THE CLINIC. Form F must be filled completely. The signed consent of the patient as well as the radiologist signature who performed the procedure should be obtained. A hard copy with patient signature has to be preserved at the clinic when form ‘F’ is submitted online.
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A monthly report should be submitted to the AA regularly, before the 5th of every month. All the records need to be maintained for a minimum of 2 years. If there is any legal proceeding pending in court of law, then these records should not be destroyed till the proceedings have been disposed off. Advertisement and communication of sex selection is strictly prohibited under the act.