Dr. T Nirmal Fredrick
Managing Director,
Nirmals Eye Care Hospital,
Tambaram, Chennai
Dr. Suneeta Dubey
Medical Director, Shroff
Charity Eye Hospitals,
New Delhi
Dr. D Chandrashekhar
Consultant,
Narayana Nethralaya,
Bengaluru
Dr. Gagan Dudeja
Consultant,
Aravind Eye Hospitals,
Coimbatore
Infection control and patient safety are aspects of prime concern for any clinical setup. The only way to achieve satisfactory outcomes is to have robust practices and protocols which should be meticulously followed and monitored. Every day over a million people are treated safely and successfully in our hospitals and a large number undergo surgery. Patients express faith in the healthcare systems and medical errors cause devastating emotional and physical consequences for patients and their families. The worst form probably are surgical site infections which not only lead to a risk of blindness for the patients but also cause the staff involved to get distressed, demoralized and disrepute.
Quality of health care and the initiatives taken to address various risk and safety issues in the hospitals have become a subject of debate. External assessment is increasingly used to regulate, improve and market health care providers, especially hospitals. The commonest models are peer review, accreditation, statutory inspection, ISO certification and evaluation against the ‘business excellence’ framework. One of the most accepted and effective methods is accreditation. Accreditation is a framework, which helps hospitals establish objective systems aimed at quality and patient safety. The standards provide a basic format to organise and develop a quality management system that is focused on error prevention and continuous improvement. It emphasizes the participation of various stakeholders and is more acceptable than regulations alone.
There has been a growth in the number of clinical establishments going in for accreditation. This is possible due to the rapid development in the accreditation processes and customized requirements being generated for different types of institutions. One specific example is the introduction of Eye care organization as a separate category in NABH accreditation as against being clubbed with other small hospitals earlier.
The module of NABH for infection control entails that the clinical establishment have
(1) an infection control team
(2) a designated and qualified infection control nurse for this activity
(3) Accessible hand-washing facilities in all patient care area
(4) Monitoring of proper hand washing,
(5) Availability of isolation/barrier nursing facilities,
(6) adequate gloves, masks, soaps, and disinfectants.
JCI in its manual has a prevention and control of infection standard which states that the hospital reduces the risk of infections associated with medical/surgical equipment, devices, and supplies by ensuring adequate cleaning, disinfection, sterilization, and storage; and implements a process for managing expired supplies. It then describes appropriate methods of cleaning, disinfection and sterilization. It also describes appropriate storage techniques.
A standard also mentions the appropriate reuse of single use devices (something important in the field of ophthalmology). If these standards are properly followed, then there would be a significant reduction in the chance of infections from the hospital.
Unfortunately despite the availability of accreditation facilities and modules, only a very limited number of clinical establishments are accredited. In this article we examine infection control and patient safety in light of processes defined by the NABH and discuss the role and benefits of accreditation. AIOS Times has interviewed key opinion leaders in the field of NABH accreditation for ophthalmology clinical establishments. They are Dr. Nirmal Fredrick, who is a Principal Assessor with NABH QCI and practices in Tambaram, Chennai, Dr Suneeta Dubey, who is associate medical director with Shroff Charity eye hospitals, New Delhi, Dr D Chandrashekhar, who is a medical Consultant with Aravind eye hospitals, Coimbatore and a certified professional for quality implementation in hospitals and Dr Gagan Dudeja, who is a consultant with Narayana Nethralaya and an assessor with NABH.
Q1. What role does having an accreditation with a healthcare accreditation body play for ensuring better infection control standards?
Dr. TNF : Accreditation is usually a voluntary program in which trained external peer reviewers evaluate a healthcare organization’s compliance and compare it with pre-established performance standards. Hospital is responsible for ensuring the safety of patients and staff. Protecting them from infection is an important element of this responsibility. When there is a proper accreditation system in place, the components of providing an effective infection control service is established and monitored.
Accreditation implies:
• Assigning roles and responsibilities for infection control throughout the hospital, with clear lines of accountability
and delegation
• Planning infection control activities through internal audit and regular surveillance
• Ensuring that infection control activities are appropriately staffed and
• Obtain assurance about the quality of infection control systems and practices in hospital. So Accreditation ensures, that there is a proper infection control system in place and monitors the effectiveness of infection control in the hospital on a regular basis.
Dr. SD : The Accreditation body provides the standard guidelines on Hospital Infection Control and emphasizes on the need to have an effective and documented Infection Control Program in the organization which aims at reducing/eliminating infection risks to patients, visitors and healthcare providers. The accreditation body also lays down Biomedical Waste (BMW) management guidelines stating appropriate and safe handling of Bio-medical waste
preventing hazards and infections.It also guides the organization on Needle stick injury policies. The accreditation body encourages the hospital to perform surveillance activities in order to capture and monitor infection prevention and control data. The organization needs to identify and take appropriate action to control outbreaks of infections.
The body also emphasizes the need for training of staff and employees in all aspects of infection control. So, by laying down the guidelines for proper documentation and appropriate monitoring mechanisms for asepsis, sterilization, isolation, hygiene, accreditation body ensures that the infection rate in any organization is at the minimum and to a large extent negligible.
Dr. DC : Accreditation has two important roles:
a. The Protocols of Procedures and continuous Surveillance ensure proper implementation of acceptable standards.
b. Periodic Internal Auditing contributes to Effective Hospital Infection Control
Dr. GD : NABH accreditation standards make it mandatory for hospital to have hand wash facilities at all patient care areas in hospital. Adherence to hand hygiene is monitored regularly. As per accreditation standards focus on
having infection control procedures in patient areas such as Operation Theatre. There is mandatory surveillance to ensure that these procedures are followed. Do you recommend that all practitioners should aim towards a healthcare
accreditation?
Q2. Do you recommend that all practitioners should aim towards a healthcare accreditation?
Dr. TNF : Yes. Accreditation program not only improves the process of care provided by healthcare services, but also improves the business and financial aspects of a practice. There is considerable evidence to show that accreditation programs improve patient safety and clinical outcomes of a wide spectrum of clinical conditions. Accreditation programs can be used as Branding, Marketing and financial tool to improve the quality of healthcare services.
Dr. SD : Definitely yes, Accreditation:
• Ensures a safe environment that reduces risk for care recipients and caregivers
• Offers quantifiable benchmarks for quality and patient safety
• Stimulates and demonstrate continuous, sustained improvement through a reliable process
• Provides hospitals with public recognition of their achievements and commitment to excellence
• Improves outcomes and patient satisfaction, Hence Quality of care
• Enhances efficiency
Dr. DC : All Practitioners involved with various procedures and surgeries must aim at getting Accreditation.
Q3. Does having a healthcare accreditation act as a legal safeguard?
Dr. TNF : Yes. Accreditation ensures patient satisfaction through better communication , documentation and improved outcomes. Most of the medicolegal risks are due to poor communication, poor maintenance of facility and equipment, improper consent, patient safety events and healthcare associated infections. A well-structured and monitored accreditation reduces these risk factors and improve patient safety.
Dr. SD : Yes, healthcare accreditation can act as a legal safeguard both directly and indirectly. Formulation of plan for the treatment of all patients, policies for surgery and follow up and a system of extensive documentation can help reduce errors to the minimum and at the same time act as an evidence of good practice in legal confrontations.
Dr. DC : As of Now in India NABH is the Only Governmental Organization giving accreditation based on Standardized acceptable norms and should give maximum legal protection.
Dr. GD : Healthcare Accreditation demands that the hospital complies with state and national legal requirement. It also ensures that the medical records are complete and audited. There is an emphasis on effective communication,
transparency, patient education & patient feedback. Informed consent is insisted upon for all patients. Incidents and untoward events are captured analyzed and corrective actions are taken. All these measures add up to better patient experience and indirectly reduce the instances of legal intervention from patients
Q4. In your survey for NABH/JCI accreditation, what common lapses regarding infection control practices have you noted?
Dr. TNF : Common lapses:
• Poor understanding of infection control activities – overusage of fogging and chemical sterilisation
• No supervision of infection related activities by management
• Poor hand hygiene practice by healthcare workers
• Reuse of instruments, sharing of consumables
• Poor Biomedical waste segregation
• Poor documentation of infection sterilization validation and recall.
• No training on infection control activities to healthcare workers
Dr. SD : Common Lapses:
• Hand hygiene practices
• OT surveillance
• Validation of sterilization process related to CSSD
• Validation of AHU
• Recall policy
• Post exposure prophylaxis
• Reuse of consumables
Dr. DC : The Protocols and SOP’s are all as per needs. After getting accreditation continuation of the same as per need becomes lax. 100% Compliances like Hand Washing, In between and cleaning between patients in the OPD is not there; strict stepwise of sterilization break down is not followed uniformly in all hospitals be it small or big.
Dr. GD : Improper cleaning of operation Theatres, Non-use of proper indicators for validation of sterilization, sharing instruments/consumables for more than one patient. No awareness and nonadherence to universal precautions and hand hygiene. Absence of recall process for instruments and consumables in case of breakdown or
outbreak of infection
Q5. In your survey for NABH/JCI accreditation, what common problems regarding OT setup have you noted?
Dr. TNF :
• Poor Infrastructure – small OT size, No zoning, sterilization space is too small and mixing of sterile and non-sterile areas/products
• Infrastructure deficiencies in operation theatres – No zoning, No space for recovery and disposal corridor
• Defective Air quality norms and engineering standards – window and split AC without laminar flow or HEPA filter
• Multiple tables and too many people leading to defective clean room standards
• Primitive cleaning and disinfection methods
• Limited or no back up for Water and electricity
• No recording or surveillance systems
Dr. SD : Common Lapses:
• OT Zoning
• Fire safety
• Air conditioning in OT
• Unidirectional flow for sterile supply
Dr. DC : Older Hospitals lack proper Zoning; Air Quality with proper effective Positive unidirectional flow with HEPA system and 24 AHU on is not evident universally.
Dr. GD :
1. Absence of Zoning/ unidirectional flow
2. Multiple tables in single OT
3. Inadequately spaced CSSD /TSSU esp. the space provided for instruments washing, drying and packing
4. Nonuse of biological indicators
5. Nonuse of Bowie dick or leak rate test or similar engineering validations for Autoclave
6. Non use of newer Class V chemical sterilization indicators
7. Sharing of gloves, consumables, instruments, vitrectomy cutters and phaco handpieces & tips for multiple patients without ensuring proper sterilization in between cases.
Q6. How often have you noted non conformity with regard to medication safety, sterilization and disinfection processes in NABH accredited clinics during routine survey?
Dr. TNF : Very often. Most often healthcare workers, including doctors are not trained or oriented to documenting what they do and their knowledge of accreditation norms is limited. Prescription norms are not followed, Misuse of antibiotics for trivial conditions, low/high dose for medications, illegible, not dated, unsigned prescriptions, medication interactions are not taught to patients etc. It’s heartening to know that big hospitals have upgraded their
sterilization process to efficient mopping and cleaning of OT surfaces, use of standard precautions in OT sterilization, use of class B class autoclaves, improved storage areas and use of ETO system. Unfortunately majority of small eye centres are still stuck with older methods like fogging, vertical autoclaves and chemical sterilization. I hope with the renewed focus on infection control, these practices are upgraded and updated.
Dr. SD : Common Non conformities include-
• LASA drugs storage
• Documentation of medication errors
• Documentation of Adverse drug events/ adverse drug reactions
• Validation of sterilization process
• Recall process for instruments and patients
Dr. DC : Random surprise visits have shown Medication safety compromised at various levels of documentation to be around 30% but many seem to have been near miss. Actual Errors due to Swiss Cheese model of protection are actually prevented. Currently Sterilization and Disinfection protocols are being strictly followed in a majority of
Hospitals already accredited and those who are in the process of preparing to it.
Dr. GD : Most of the hospitals have one of these non-conformances at start of their Accreditation Process.
Q7. What data is routinely collected by healthcare accreditation organizations to keep a track of infection control practices in clinical setups?
Dr. TNF : The data includes: Quality indicators – Clinical and Non clinical data are obtained from all accredited organisations. This is used to analyse the trend and deviations and also help in benchmarking across zone, state and national levels. The following indicators are usually assessed during audits and data obtained
1. Hand hygiene compliance
2. Surgical Site Infection (SSI) or endophthalmitis rate
3. Sterilization validation report of OT and other areas
4. Validation reports of instruments / sets
5. Re do / exploration rates after surgeries
6. Cluster infections – trends and analysis
7. Antibiotic policy / usage audit
Dr. SD: An organization should collect data to safeguard the patients as well as the health care workers. Documentation of all processes dealing with patient care should be done. This includes maintaining data for OT sterilization like culture reports, autoclave records, Biomedical waste (BMW) management etc. To add on to it we routinely collect the crude infection rate, SSI rate, needle stick injury data, hand wash audit data on a monthly basis.
Dr. DC : The data collected includes:
a. Surgical Site Infection
b. Hand Washing Compliance
c. Needle Stick Injuries
d. Spill Management
e. OT Surveillance – Air Validation, Class V or VI Indicators, Bowie Dick’s Test, Biological Indicator, Periodic Cultures
Dr. GD : The Organizations collect microbiological surveillance data, engineering validation of equipment and AHU, Monitor surgical site infections, Water quality monitoring, Hand Hygiene monitoring, Kitchen Monitoring Data, Linen and laundry monitoring data & data for Antibiotic policy.
Q8. What is your view on the recently reported cluster infections in ophthalmology? Are they all avoidable with proper practices?
Dr. TNF : Cluster infections are sentinel events in any Institution. It continues to happen across the country, even in big hospitals, more so in the community hospitals. This will continue to occur, unless we improve the designs and system in our hospitals and centres. For any risk / disaster management, we need to do a root cause analysis and then take corrective and preventive measures. The root cause analysis of most of the Cluster infection in India points to:
1. Poor Infrastructure in Operation Theatres
2. Infection source identified as BSS or Ringer lactate – This risk can be reduced by improving the supply chain management, stringent quality control norms in packing, improving the storage conditions in hospitals and training of OT team to check the bags and bottles
3. Multiple teams and tables in operation theatres compromising on patient safety:
ideal would be one OT, one surgical team, one table and one patient at a time. Our patients deserve this focused approach to patient safety.
4. Sharing and reuse of consumables to reduce cost, and compromising on the sterilization controls.
Dr. SD : Cluster infections recently reported were most common with intravitreal Avastin injections for which several factors were responsible:
1. Strict aseptic precautions not being followed with a breach in protocols
2. The availability of spurious drug due to improper disposal of used vials which could be refilled and sold and lack of drug control
3. A single vial used for multiple patients with non-availability of dispensing pharmacies
It is unfortunate for the patients and the institute to have such outbreaks. Again, good practice and quality checks can ensure that such outbreaks are best avoided. Periodic check of the drugs and fluids used for intraocular surgery, microbiological survey of fresh batches of BSS/RL, sutures and anti VEGFs along with strictly following protocols for OT sterilization can go a long way to prevent such outbreaks.
Dr. DC : Clusters are 99% preventable with Strict Protocols and surveillance. Proper work up of cluster infections can in majority of the cases give a clue to the cause for sterilization breakdown. Unfortunately, sometimes in spite of strict protocols, medication or devices got from companies turn out to be the cause of cluster infections.
Dr. GD : Cluster infections may nor be completely avoidable but with proper practices their frequency can be brought down and with proper monitoring the response to these also would be better.
Q9. Do you send out any advisory to clinical organizations or conduct focus audits after cluster infection outbreaks are reported in the news?
Dr. TNF : Yes. Surprise assessments are part of the accreditation programme. Whenever there is an authentic complaint or grievance from patients or third parties, they are investigated suo-motto either by asking for a report from HCO or scheduling a surprise assessment by a senior assessor. The report is analysed and follow up measures are taken as per requirement.
Dr. SD : We conduct OT surveillance and hand wash audits on a regular basis & emphasize the need to monitor infection control practices. We as a team or as individuals in our organization are attached to different other clinical organization and decision making bodies like the AIOS, vision 2020, Orbis. We routinely share our experience as and when required with these bodies.
Dr. DC : As an organization the Top Management takes all steps and advice based on the scenario
Dr. GD : No there is no such practice in vogue at present
Q10. How difficult is it for single practitioners in smaller setups to adapt accreditation standards?
Dr. TNF : Well the problem with single practitioner is twofold.
1. Lack of resources – Monetary resources, human resources and time
2. Lack of focus and commitment – Accreditation requires commitment from the doctor and his small team to implement and integrate the standards. The single doctor has to get oriented to the standards, get trained and form a small team to help him/her. The team should work cohesively, do internal audits and follow them to its logical
conclusion.
Good news is that many single doctors clinics have improved their structure, process and outcomes with accreditations standards and reaped rich dividends and progressed to the next level in their practice. So implementing accreditation standards is not a difficult job for a single practitioner, on the other hand it will be a wonderful branding and marketing tool for the practice without spending much for the marketing.
Dr. SD : It’s not difficult for single practitioners in smaller setups to adapt accreditation standards if they believe in adopting best practices and are committed to provide quality care. They need a vision and mission to make a change in their system by adhering to the standard practices as guided by the Accreditation body. However, they need to spend time in proper planning and implementation of accreditation standards and develop monitoring mechanisms to maintain the quality standards. Thus, they need to follow the concept of Juran’s Triology- Quality Planning, Quality Improvement and Quality Control.
Dr. DC : It is a lot easier for a single Doctor and small setup. With little modifications and fewer departments and staff easier to implement
Dr. GD : NABH as an accreditation body provides option of various standards as per need and size of organization. Pre Accreditation Entry Level SHCO standards are available for small practices. Larger eye care center have the option for Eye Care tandards, which were developed jointly by AIOS & NABH. Large Tertiary level training and teaching eye hospitals can opt for NABH HCO standards, which also have international recognition by ISQUA.
Q11. If you were to give one advice to a practitioner with regard to infection control practices what would it be?
Dr. TNF : Single Advice: Focus on Structure, Process and Outcomes. Improve infrastructure, control and audit all infection control practices, do a thorough corrective and preventive actions on all deviations and deficiencies found
in the internal audit, be part of your team in sterilization and surveillance activities, have proper documentation
of all aspects of infection control and study your visual and patient satisfaction outcomes.
Dr. SD : Complete documentation and monitoring of all the processes and systems in the organization should be done and hygienic practices (Hand hygiene, use of PPE etc) should be followed in the healthcare setup.
Dr. DC : Every Patient be it in OPD or OT should be treated with utmost care. Our practices should take maximum steps to ensure that hospital should not be the cause to spread Infections between Patients, Employees and Attendants.
Dr. GD : Define, Document, follow and monitor protocols – sterilization, cleaning, Pre and post op care of patient in your practice.
Q12. How can AIOS help improve clinical practice of its members with regard to infection control and sterilization?
Dr. TNF : As a professional society, AIOS is already doing a great job on the academic front. With reference to infection control and sterilization, AIOS has a great role to play with reference to following:
1. Issue guidelines to members on infection control activities
2. Help members improve their knowledge and skill in infection control
3. Collect nationwide data, analyse the data and promote best practices
4. Support to the member organization to investigate and face cluster infections – specially managing the Press / Media Politicians and Public image.
5. Help Improve the quality of services by member organizations by engaging with payers like Government, Insurance and 3rd party payers
6. Be proactive and device short and long term plans for national infection control policy for ophthalmology centers and surgeries.
Dr. SD : AIOS has been actively involved in promoting safe practices through their conferences, CMEs and by issuing various guidelines on infection control (endophthalmitis guidelines etc). It can further add to it by organizing workshops to promote and help single practitioner to adapt accreditation and quality standards. Encouraging all ophthalmologists for a common goal can go a long way for infection control. Having workshops on topics like Universal precautions, PPE, Needle stick injuries, Sterilization and Disinfection, Isolation precautions, Bio-medical waste management etc can be organized by AIOS to create awareness and share knowledge. Providing guidance on infection control practices to the stakeholders by experts. Encouraging data sharing among the members on HIC Indicators. Recognizing & rewarding organizations with robust infection control program and improving on the terms of infection rates. AIOS can also act as a uniform platform for evaluation of these data and further formulate new policies or make amendments in the existing one.
Dr. DC : AIOS has already conducted an AIOS Workshop on Infection Control and brought out guidelines. This need to be revised now based on Accreditation standards and also keep in mind the need for us to tackle blindness in performing surgeries to eliminate needless blindness. AIOS and NABH have made a huge stride in bringing out
Exclusive NABH Eye Care Standards. AIOS can initiate a series of Workshops in various parts of the country with the help of Local Support and Expertise to Sensitize the Need. AIOS can form an Expert Group of Quality Committee to help implementation of NABH standards be it Regular standards or Entry Level. This will prevent 3rd party consultants from making huge money by taxing Health Care Organizations.
Dr. GD : AIOS can recommend basic Good Clinical Practices regarding infection control and sterilization for various
ophthalmic sub specialties. It can also address the issues for sharing consumables and reuse of single use devices. These will help in having a common minimum standard across country and can also be used legally.
AIOS Times thanks the Experts for sparing time and sharing their views. We are certain these will help the readers get stimulated for achieving best standards in their establishments and avoid common mistakes.