Welcome Doctors! As a healthcare professional, ensuring that your X-ray clinic or imaging center meets the necessary standards is crucial for both patient safety and regulatory compliance.
Whether you’re offering X-rays, CT scans, OPG and dental X-rays, DSA (Digital Subtraction Angiography), or DEXA (Dual-Energy X-ray Absorptiometry) scans, following these minimum standards will help you provide high-quality care while meeting legal and safety requirements.
In this guide, we will walk you through the essential standards for running an X-ray clinic or imaging center. These guidelines will help ensure the safety of your patients, the proper functioning of your equipment, and a smooth, efficient practice.
Definition of Services Provided by an X-Ray Clinic
An X-ray clinic encompasses a wide range of diagnostic services using various imaging modalities. These include:
- Portable/mobile X-rays and installed X-ray machines for general imaging.
- Fluoroscopy, including procedures such as Cath Lab for interventional radiology.
- Dental imaging like Intraoral Periapical X-rays (IOPA), OPG (Orthopantomogram), and Cone Beam CT (CBCT).
- Mammography for breast cancer detection.
- DEXA scans for bone density measurements, particularly useful in osteoporosis diagnosis.
The scope of services should match the specific capabilities of your equipment, ensuring that each service provided is compatible with the machine’s specifications for optimal diagnostic accuracy.
Scope of Services Offered by X-ray Clinic
An important aspect of your clinic is determining the range of investigations carried out by the X-ray machines. The following services should be offered based on your machine’s capabilities:
- Portable X-ray: For patients who are bedridden or in critical care.
- Fixed/Installed X-ray: For routine imaging.
- Fluoroscopy: Especially important in interventional radiology, such as Cath Lab procedures.
- Dental X-ray: IOPA, OPG, and CBCT scans for dental diagnoses.
- Mammography: For early breast cancer detection.
- DEXA: A scan to measure bone mineral density and diagnose osteoporosis.
It is important to note that the scope of services should align with the specifications of your equipment to ensure the safety and effectiveness of the diagnostic procedures.
Physical Infrastructure Requirements
Your X-ray clinic must meet specific infrastructure requirements to provide a safe, efficient, and comfortable environment for both patients and staff. The following details outline the essential physical infrastructure:
Informative Signage
To ensure clear communication and transparency, the following signs must be displayed:
- Radiologist’s Name and Qualifications: This should include certification from the Atomic Energy Regulatory Board (AERB) for safety and installation, along with the registration number.
- Model of Equipment: The specific model of X-ray machines used.
- Broad Services Offered: A clear description of the services provided at the clinic.
- Timings of the Facility: Displayed for patients to understand when services are available.
- Fee Structure: The pricing for different investigations should be visible to all.
- Safety Signage: Relevant signs highlighting any specific safety protocols.
Safety Hazard and Caution Signs
- Fire Exit Signage: Appropriate fire exit signs for emergency evacuation.
- Radiation Protection Devices: Devices to protect and monitor radiation exposure for staff.
The proper signage and safety measures ensure that both staff and patients are well-informed and safe.
Space Requirements
Complying with the space requirements outlined by AERB is essential. This includes:
- Reception and Waiting Area: For patient registration and waiting for the procedure.
- Space for X-ray Equipment: Sufficient space to accommodate the X-ray machine as per AERB guidelines.
- Reporting Room: For radiologists to review the images and prepare diagnostic reports.
- Toilets: Separate male and female toilet facilities.
- Patient Preparation Area: A space to prepare patients before the imaging procedure.
- Electrical Facilities: Ensure stable power supply, including UPS and generators.
- Space for Monitoring Equipment: Adequate space for patient monitoring and resuscitation equipment during procedures that involve sedation.
These space requirements contribute to the smooth functioning of the clinic and ensure patient comfort and safety.
Human Resource Requirements
To maintain a high standard of care and operational efficiency, it is vital to have qualified and experienced personnel. The following staff members are required:
- Radiologists: At least one MD/DMRD or DNB Radiology qualified radiologist must be available, either full-time, part-time, or visiting, depending on the volume of work.
- Nurses: Having qualified nurses on-site is desirable. They assist with patient preparation and monitoring during procedures.
- Radiography Technicians: At least one qualified radiography technician with a recognized qualification in radiology technology is necessary. Additionally, the clinic should have an RSO (Radiation Safety Officer) with an MCI/NBE-recognized degree to oversee safety protocols.
- Support Staff: Proper scavenging and support staff must be available for maintaining cleanliness and assisting with patient logistics.
- Policy on Staff Engagement: A policy for staff posting, rotation, and engagement must be established to ensure fair distribution of workload.
- Health Check-ups: A periodic health check-up and vaccination program should be mandatory for all employees to minimize health risks and ensure a healthy work environment.
Equipment, Instruments, and Consumables for X-ray Clinic
Maintaining a detailed list of required equipment, instruments, and consumables is essential for smooth clinic operation:
- Equipment: The list should cover all X-ray machines (portable, installed), fluoroscopy units, and specialized equipment like mammography machines or DEXA scanners, as per the scope of services.
- Small Instruments: Essential items like BP apparatus, pulse oximeters, and anaesthesia equipment for procedures under sedation.
- Consumables: Items such as films, envelopes for reports, CDs/DVDs for soft copies, and injector syringes, tubing, and IV catheters should be readily available.
- Maintenance Protocol: Ensure annual maintenance of all equipment, with clear records for compliance and safety.
Support Services
In the case of any adverse event, your clinic should have provisions for patient transfer in case of emergencies or complications. It is essential to have staff trained and ready to handle any unexpected situations.
Legal and Statutory Requirements
Complying with legal and statutory regulations is non-negotiable. The X-ray clinic must be registered under the Atomic Energy Regulatory Board (AERB) as per the Atomic Energy Act to ensure the proper use of radiology equipment and safeguard against radiation hazards.
Record Maintenance and Reporting
Accurate and timely record-keeping is crucial in an X-ray clinic. The following records must be maintained:
- Patient Records: A list of patients, including diagnosis, referral hospital, and dates of reports, ideally linked to the patient UID.
- Medicolegal Records: Maintain MLC forms and consents for procedures involving contrast agents or sedation.
- Technician and Support Staff Records: Maintain a record of all technicians and support staff, including their qualifications, registration, and training.
- Duration of Record Maintenance: Ensure that records are kept in compliance with current Acts and Rules in force.
Basic Process Standards
In your clinic, you must adhere to specific process standards to ensure smooth, safe, and efficient operations:
- Infection Control: Strict protocols for infection control and waste management must be in place to prevent contamination.
- Safety Protocols: Ensure fire safety, patient safety, and overall safety standards are followed.
- Patient Education: Provide patient information and education on procedures, ensuring they are well-informed.
- Report Preparation: Ensure timely preparation and dispatch of reports, with clear documentation.
- Patient Transport: Trolleys for patient transport should be available to ensure patient mobility during procedures.
- Grievance Redressal: Have a grievance registration and disposal mechanism in place to address any complaints or concerns raised by patients or staff.
- Air-conditioning: While air-conditioning is desirable, it ensures patient comfort during imaging procedures.
See Also: How To Open A CT Scan Center In India: A Complete Guide
Ensuring Compliance and High-Quality Care
In conclusion, adhering to these minimum standards for an X-ray clinic or similar imaging facility is crucial for providing high-quality diagnostic services.
These standards help ensure patient safety, operational efficiency, and legal compliance. By following the guidelines outlined above, you can establish a well-functioning, safe, and patient-friendly facility that meets both the expectations of your patients and the regulatory authorities.
As healthcare professionals, it’s essential to stay up-to-date with these requirements and continuously strive to improve your facility’s standards, ensuring the best possible care for your patients. All the best!
