BIO MEDICAL WASTE MANAGEMENT CERTIFICATION

Transcription

1 BIO MEDICAL WASTE MANAGEMENT CERTIFICATION First edition - January 2015

2 Foreword With the increasing awareness among patients, patient safety and transparency among the healthcare providers is a growing concern. In India, a large part of the healthcare needs are taken care by the private sector and a comparatively smaller proportion by the government sector. Hence there is a growing concern about patient related issues. Accreditation is an important tool for demonstrating the stake holders (patients) that international standards of best practices are followed and practiced. Also it is a guarantee that the center confirms with the global benchmarks. The accreditation and quality assurance systems help organizations to streamline their processes, provide timely services and thereby enhance patient outcomes. MOCA Healthcare was born with the purpose of improving the patient safety and transparency among the healthcare providers and contributing to the improvement of healthcare scenario in India. MOCA standards focus on state-of-the-art performance and improvement strategies that help healthcare organizations to improve the safety and quality of care continuously, which can reduce the risk of error or low quality care. We intend to help the patient, community as well as the healthcare providers in improving the provision of healthcare services in India. It is hoped that with the release of these standards more centers will get accredited and help create a hub of quality accreditation for national as well as international patients. Regards Team MOCA 2

3 Table of Contents PART A GENERAL INFORMATION 4 SECTION 1 About MOCA Introduction MOCA International Quality Standards Code of conduct Roles and Responsibilities Auditors 6 SECTION 2 Overview of the process Application to the evaluation process Phases of the audit process Multiple standards applications 8 SECTION 3 Working with the standards Assessing your performance Rating system Essential criteria Not applicable criteria Survey arrangements 10 SECTION 4 Award and maintenance of accreditation Achievement of accreditation Decision process The award Post-audit evaluation Maintaining the award Appeal 12 PART B STANDARD SPECIFIC INFORMATION General Considerations 14 CHAPTER 1 Regulations 15 CHAPTER 2 Procedures 18 CHAPTER 3 Training 21 CHAPTER 4 Safety 25 CHAPTER 5 Handling 29 CHAPTER 6 Needles 33 CHAPTER 7 Providers 37 CHAPTER 8 Social 40 Glossary General Information 43 3

4 PART A GENERAL INFORMATION SECTION 1 ABOUT MOCA 1.0. Introduction The present document aims to be a guide for organizations and surveyors using MOCA International Quality Standards. It outlines the steps to be taken when undergoing a MOCA Certification process, the roles and responsibilities, the rating system and the principles. MOCA Healthcare measures and shares with the world the best practice solutions related to quality in healthcare and patient safety. We provide excellence and innovative solutions that help healthcare organizations to improve performance and to consolidate results in all environments. MOCA mission is: We aim to change the lives of millions of people, helping the health care providers to help patients. MOCA Healthcare aims to improve the medical service received by any patient in the globe, touching the life of millions of people MOCA International Quality Standards MOCA launched different international quality standards that have the aim to provide a customized solution to the different players present in the Healthcare sectors. MOCA Unique quality standards lines are: Institutional Accreditation Competence Certification Personnel Certification All the services offered by MOCA are voluntary and all of them are entered by application Code of conduct MOCA personnel, including surveyors will: Act professionally, Act ethically Act impartially Respect confidentiality Be competent to undertake the work and given assignments; and Ensure that complaints about any MOCA s personnel or service are fairly investigated and resolved wherever possible Aims of MOCA International Standards MOCA International Quality Standards have been developed for the assessment, accreditation and certification of healthcare providers around the globe. 4

5 The different standards take into account the regulations of the different regions around the world Roles and Responsibilities Governance of MOCA MOCA is governed by Board of Directors. The Board oversees the standards development, analyzes the external evaluations and assessment methodologies, advising on the development of new standards, and evaluating the professionalism, impartiality and effectiveness of the different departments involved during the certification process Accreditation Committee The Accreditation Committee (AC) delegates its accreditation recommendation to a committee formed by international doctors with different fields of expertise. The AC is responsible for: Reading the report to ensure it is clear. Ensure that the report will provide the organization with the directions needed to continually improve to meet the principles. Ensure that reports have incorporated all the evidences founded during the evaluation process. Ensure that timings are met during the entire process Ensure that the HQAS reports provides all information, defining clearly which are weaknesses and strengths of each analyzed area. Ensure that comments reflect that the appropriate rating has been applied; The Accreditation Committee once has proved that all accreditation requirements have been met, will award the organization with the MOCA Stamp MOCA Accreditation Staff. MOCA Staff work with each evaluated organization and: Allocate surveyor and validate panel members Issue the critical path details for surveys Carry our technical reviews Review that all the documentation and evidences are correct Collect all need information required by the HQAS system, Carry our review of the report, and Prepare reports for the accreditation committee 5

6 Participating organizations All participating organizations should agree to abide the terms and conditions of MOCA evaluation process and adhere to the timescales as set in the critical path. As part of the application process they nominate a contact for all correspondence with MOCA and keep MOCA updated with any changes of these details Auditors MOCA Auditors are internationally based in 5 different continents representing doctors, managers and auditors from senior position within the health and social care sector. All MOCA surveyors have been recruited, trained and qualified in MOCA Quality standards Survey Team The number of team members will depend on the center characteristics. MOCA form a team of different professionals that will better fit the healthcare organization needs. MOCA will appoint a surveyor as a team leader also known as Chief Auditor. The role of the survey team is to validate the organization s self-assessment through interviews, evidence collection, and document collection on how compliance to each criterion is achieved. The organization is requested to formally accept the survey team but if there is any objection to a selected surveyor, or a conflict of interest, MOCA accreditation manager should be informed of the reasons of objection within 5 days. The reasons have to be sent by paper to MOCA accreditation manager. MOCA will review the reasons of objection and make the final decision to remove or retain the surveyor on the team Chief Auditor (CA) The CA is ultimately responsible for the audit being carried out in a suitable manner and in accordance with the original plan. The CA, therefore, is responsible for making the necessary decisions in each phase of the process, for leading the auditing team during their investigations and for acting as intermediary between the audited party and the auditing team, and between the auditing team and the customer Auditor. The members of the audit team are responsible for carrying out the tasks assigned to them by the CA. Those members who also act as Team Leaders will assume the responsibilities set out in the previous section. Auditors will carry out the following functions: Prior to the audit: Analyze the documentation to be used during the audit which has been provided by the CA. Collaborate with the CA producing of any working documents required for the audit performance. 6

7 During the audit: Carry out the relevant investigations, in accordance with the audit plan. Periodically inform the CA of the results of their investigations. Notify the CA of any complications or problems that may arise during the audit On completion of the audit: Present the CA with the results of the investigations carried out by each team member together with the corresponding working documents. Present the CA with the test documentation assigned at the beginning of the audit. Answer any doubts or questions the CA may have Experts. On several occasions audit teams are accompanied by experts with in-depth knowledge of the activity sector of the audited party. These experts should only act as consultants for the auditing team and it is the CA s responsibility to ensure that they stick to their assigned functions at all times. An expert may not undertake investigations without the accompaniment of a team member who is qualified to undertake said investigation. 7

8 SECTION 2 OVERVIEW OF THE PROCESS 2.0. Application to the evaluation process All organizations must complete an application form prior to entry into the evaluation process. Once this has been received and the payment is made to MOCA to access the standards and tools, MOCA allocates a date for the survey. For organizations undergoing a maintenance accreditation or a renewal accreditation, the next survey will be scheduled at least three months prior to the current expiry date to enable all steps of the process to be completed Phases of the audit process Phase I. Initial meeting. Before beginning the evaluation process, the evaluation team will hold a meeting with representatives of the healthcare center. The meeting will be overseen by the CA and its objective will be to deal with the following: Present and describe the functions of the evaluation team and other participants in the evaluation (observers, for example). Confirm the scope, objectives and criteria of the evaluation. Describe the program for the evaluation, including the date and time of the final meeting. Explain any last minute changes and coordinate visits to other centers, if applicable. Describe the methodology and procedures to be followed during the evaluation. Establish formal communication channels between the evaluator and the center. Notify the center that, during the evaluation, they will be notified of the progress being made and of possible changes in the program Phase II. Evaluation process. Each evaluator will investigate their corresponding points via analysis of the applicable documentation, corresponding registers and through observation of specific activities. All members of the evaluation team will require to contact and interview the representatives of the areas in question as well as the personnel who carry out the activities Phase III. Final meeting. Once the evaluation has been completed, a meeting will be held with representatives of the organization, if possible, the same people who attended to the initial meeting, in order to clarify any doubts that may arise during the evaluation Multiple standards application Generally each organization applies to MOCA standard on individual basis, but, if the organization wishes to apply for more than one MOCA standard at the same time, the organization will have to submit a report to MOCA where needed actions will be defined to be taken by the center to guarantee that the impartiality and the timings are respected. MOCA will determine if a different audit is needed for each applied standards or on the other hand if the different standards can be evaluated under the same audit. 8

9 SECTION 3 WORKING WITH THE STANDARDS 3.0. Assessing your performance The first task is to complete an initial self-assessment of the standards to be surveyed. To do so, it is recommended to take a small team to work with the self-assessment process. This helps with getting all the evidence together, checking details and identifying areas of particular attention. If the teams have any problem with interpreting the Standards or the Indicators, or how much evidence should be provided, MOCA accreditation staff is available to assist with advice. They can also assist with interpretation and clarification on the principles and the survey process. At the end of this exercise, you should have a gap analysis and have identified actions where further work is required. The maximum amount of time provided to make the self-assessment is 3 months for the Institutional Accreditation and 1 month for the Competence Certification Rating system The rating system that applies to MOCA International quality standards is based on the evidence. Any MOCA certificate or accreditation is divided in different chapters based on the areas of study. Each chapter is formed by different standards. To each standard, a list of indicators is assigned that the organization has to comply with. The evaluation team will assign 1 point to each complied indicator. After analyzing all the possible indicators inside a standard point, the evaluation team will add all the obtained points and will divide it by the total possible number of points. The punctuation obtained will be rounded up or down and this will be the punctuation obtained in that particular standard. For example: A standard has 5 different indicators assigned. After making a self-assessment, if you have find evidence for 3 of the 5 indicators, therefore the obtained punctuation will be 60%. Notice that it is extremely important to have identified the evidence previously that will answer all the different indicators. In cases where there is an absence of the evidence, the evaluation team will consider the indicator as null Essential criteria A number of essential criteria have been defined to the principles. The essential criteria include: Central organizational process, Core processes safeguarding competencies, Processes with immediate impact on patient safety and clinical effectiveness, In summary, these are the processes having a direct impact on the center performance. 9

10 These criteria must achieve a rating about 70% or higher for the principle to reach compliance. However an essential standard rating of 60% maybe acceptable, if the risk associated with the criterion is low or moderate and the necessary actions can be achieved within 3-6 months Not applicable criteria Depending on the healthcare center, certain criteria may not be applicable in all sets of standards. Any criterion which is considered Not Applicable should be discussed with MOCA Accreditation staff in advance and agreed by them. Once this is agreed, the Chief auditor will state the not-applicable criteria on the audit plan. The not-applicable criteria will have to be reviewed during the audit beginning meeting. If the audit team finds evidence that the criterion should be applicable, this will be registered on the report and the accreditation committee will decide if the criteria applies to the healthcare center or not Survey arrangements MOCA responsibilities: MOCA is responsible for ensuring that: The survey team has the required documentation, The survey is scheduled. Time frame is adhered to. Award and maintenance of accreditation. 10

11 SECTION 4 AWARD AND MAINTENANCE OF ACCREDITATION 4.0. Achievement of accreditation The accreditation process helps organization to assess their current quality levels and identify where improvements are needed. It is also an objective, measurable approach that is applicable internationally and facilitates consistency among the healthcare providers. For an organization to achieve MOCA Accreditation, an overall compliance rate of 70% of the maximum score must be achieved. Each individual chapter must also achieve a 70% compliance rate against the maximum score of the chapter. The following rules must be met: All core criteria must achieve a 70% rating or more, a rating of 60% can be accepted, if the risk associated with these standards is considered low and moderate. There should not be more than 2 core criteria with a 60% rating. Within 1 chapter there can be only 1 non-essential criterion with a 50% rating or lower. To accept that the organization complies with the indicator stated in the standard, evidence must be provided to the survey team. If the evidence is not consistent enough the evidence become null. If one chapter does not meet the above rules, but the surveyors recommendations can be achieved within 3-6 months, accreditation can be awarded. This decision must be agreed by the chief auditor and the MOCA Accreditation Committee. If two principles do not meet the above rules, depending on the scenario, a decision on the individual reports can be made by the Accreditation Committee and the chief auditor or: Defer an award for 3 months (in institutional accreditation cases) and 1 month (in competence cases), subjected to a written report from the organization Decision process The audit team submits the report and award recommendation to MOCA within one week of the completion. To ensure fairness, consistence and quality assurance of the process, the following steps occur: 1. MOCA staff carries out a review of the draft report to check for technical accuracy, 2. The Chief auditor checks the report prior of it being sent to the organization to review for factual accuracy, 3. The organization undertakes a review of the report to ensure that the surveyor has not misinterpreted evidence or missed information. Any comments from the factual accuracy review are discussed with the chief auditor and the report finalized as appropriate, 4. The final reports, together with all the collected evidences are sent to the Accreditation Committee who makes the final award decision. MOCA ensures there are no conflicts of interest at any stage of the approval process. 11

12 4.2. The award. For the Institutional Accreditation, if the report meets the accreditation requirements, the healthcare center will be awarded accreditation status for 3 years. For the competence Certificates, if the report meets the certification requirements, the healthcare center will be awarded with certification status for 1 year. Following approval, MOCA will send the HQAS report, the Audit report, and will issue a Certificate of Accreditation and will send the MOCA Accreditation logo and the policy, which sets out the requirements for its use. When the healthcare center is awarded accreditation, MOCA will publish details of the award on its website Post-Audit evaluation. MOCA is committed to improve its services and each organization and survey team is asked to complete a satisfaction questionnaire on their experience of the survey Maintaining the award. In order to maintain the status of a certified organization it is necessary to perform periodic visits scheduled during the certification period. The institutional accredited organization will receive 1 maintenance audit annually. To maintain the accreditation, the healthcare organization has to pass successfully the maintenance audit. In order to maintain MOCA accreditation, an organization must report any significant changes, such as new medical service or new equipment investment. Similarly, if MOCA receives a complaint of any accredited organization that goes against the MOCA standards, an investigation will be opened. If the investigation demonstrates that the organization has not been in compliance with MOCA Standards, the organization will have its accreditation suspended for a maximum period of 6 months. During the period the organization has to take the corrective actions needed to solve the nature of the complaint. The organization will have to submit a detailed report of the corrective actions taken. If after the report, MOCA still has doubt, and extraordinary audit will be done in order to see if the complaint has been solved or not. If after the six months period MOCA has not received the report or if after the extraordinary audit MOCA realizes that the nature of the audit persist, MOCA will withdraw the accreditation Appeal If there is dissatisfaction with the accreditation decision, the organization has the right to appeal within 10 days of receiving the final decision, clearly outlining the grounds on which they disagree with the decision. The appeal will be independent of any other process. Grounds for appeal are that: Relevant and significant evidence was not properly considered, or was incorrectly interpreted, Inappropriate weighting was given to the evidence, or 12

13 The original decision making process was inconsistent with the published criteria for accreditation, The appeal will be considered within 15 days of the request being received in writing by MOCA. The appeal committee will consist of three members: A member of the board who will chair the appeals panel; Two independent experts, not involved in the survey. If the appeal results in a recommended change in accreditation status, the decision must be endorsed by the MOCA Accreditation Committee. The AC advises the outcome of the appeal. 13

14 PART B STANDARDS SPECIFIC INFORMATION Standards for Biomedical Waste Management 01. Scope These accreditation standards specify requirements for Biomedical Waste Management for all types of healthcare organizations. 02. Normative reference The standards are based on the Biomedical Management and Handling Rules 1998 (India) and the WHO BMW guidelines. 03. Terms and definitions Biomedical Waste Management is the treatment of the waste of biological and medical activities. Biomedical waste includes liquids such as blood, pathological materials, animal waste, sharps or any material collected during those medical activities which could be infected. Classification of wastes: Urban solid wastes: food wastes, gardening wastes, plastics, empty packs, paper, cardboard or wood. Assimilable to urban waste: disposable textiles with bodily fluids, healing materials, dressing, bandages, used cotton, plaster, drip packs, probes, empty urine bags, single use material for absorbing liquid, paraffin used in rehabilitation, glass tubes with blood or serum samples or urine samples in crystal packs. Specific hospital wastes: sanitary infectious solid wastes, surgery wastes, dialysis equipment wastes, needles, sharps and cytostatics. Other wastes: batteries, laboratory wastes, cooking oil, mercury materials or fluorescent tubes. 04. Exclusions and exceptions There are no exclusions and exceptions since the rules are applicable to all types of healthcare centers. 14

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