This document provides an infection control checklist for healthcare organizations and pharmacy staff. It outlines precautions that should be taken to reduce the risk of acquiring and transmitting infections. The checklist covers topics like infection risk identification and reporting, cleaning and disinfection, attire, hygiene, isolation precautions, and sterile compounding area requirements. It is intended to help assess compliance with standards from The Joint Commission, CDC, and USP Chapter <797> regarding infection prevention and control.
The document discusses USP 797 compliance for compounding sterile preparations. It explains that USP 797 provides practice standards to ensure high quality compounded sterile preparations by reducing potential for microbial contamination. Compliance requires designated cleanroom facilities, environmental monitoring, personnel training, and standard operating procedures. The guidelines establish low, medium, and high risk levels for sterile preparations based on complexity of compounding and exposure to non-sterile conditions. Ongoing compliance requires updated documentation, training, and environmental monitoring.
WHO Good Practices for Pharmaceutical Microbiology LaboratoriesPostgradoMLCC
This document provides guidelines for good practices in pharmaceutical microbiology laboratories. It outlines requirements for personnel, facilities, equipment, reagents, reference materials, sampling, testing procedures, quality assurance and reporting. The document establishes procedures for method validation, equipment qualification, environmental monitoring, cleaning and waste disposal. It provides guidance on conducting sterility testing and maintaining reference cultures in compliance with international standards. Comments on the draft are requested by October 2010.
Hospitals stock a variety of IV fluids including isotonic crystalloids like normal saline, hypotonic fluids like D5W, and colloids like albumin. Normal saline and D5W come in large volumes up to 1 liter while albumin and other blood products are available in smaller volumes. Pharmacists must carefully consider each fluid's tonicity and ingredients when compounding medications to avoid harming patients.
The document outlines three contamination risk categories for compounded sterile preparations (CSPs): low-risk, medium-risk, and high-risk. It defines each risk category based on factors like the complexity of compounding and potential for contamination. For each risk category, it provides examples and establishes maximum storage times in the absence of passing a sterility test. It also describes an immediate-use provision for emergency situations. Low-risk CSPs allow for the longest storage times of up to 48 hours at room temperature, while high-risk CSPs allow for the shortest storage of 24 hours. Medium-risk CSPs fall between the other two categories.
OSHA regulations aim to ensure employee safety in veterinary practices. Employers are responsible for providing training on hazards like zoonotic diseases, safe chemical handling, and emergency procedures. Proper personal protective equipment and hygiene help control disease transmission. The written safety plan and regular staff training address risks from animal handling, radiation, waste disposal and other aspects of veterinary medicine. Compliance with OSHA standards helps protect workers' health and safety.
Cytotoxic agents used in chemotherapy have anti-cancer effects but can also damage normal tissues. Proper handling and protective measures are needed due to their hazardous nature. The document outlines guidelines for safely receiving, compounding, and administering cytotoxic drugs, even in resource-limited settings. Key recommendations include restricting access to drug storage areas, adhering to work practices to minimize exposure, using proper personal protective equipment, and following aseptic technique during compounding. The overall goal is to minimize risks to healthcare workers through application of hazard control measures.
The document discusses USP 797 compliance for compounding sterile preparations. It explains that USP 797 provides practice standards to ensure high quality compounded sterile preparations by reducing potential for microbial contamination. Compliance requires designated cleanroom facilities, environmental monitoring, personnel training, and standard operating procedures. The guidelines establish low, medium, and high risk levels for sterile preparations based on complexity of compounding and exposure to non-sterile conditions. Ongoing compliance requires updated documentation, training, and environmental monitoring.
WHO Good Practices for Pharmaceutical Microbiology LaboratoriesPostgradoMLCC
This document provides guidelines for good practices in pharmaceutical microbiology laboratories. It outlines requirements for personnel, facilities, equipment, reagents, reference materials, sampling, testing procedures, quality assurance and reporting. The document establishes procedures for method validation, equipment qualification, environmental monitoring, cleaning and waste disposal. It provides guidance on conducting sterility testing and maintaining reference cultures in compliance with international standards. Comments on the draft are requested by October 2010.
Hospitals stock a variety of IV fluids including isotonic crystalloids like normal saline, hypotonic fluids like D5W, and colloids like albumin. Normal saline and D5W come in large volumes up to 1 liter while albumin and other blood products are available in smaller volumes. Pharmacists must carefully consider each fluid's tonicity and ingredients when compounding medications to avoid harming patients.
The document outlines three contamination risk categories for compounded sterile preparations (CSPs): low-risk, medium-risk, and high-risk. It defines each risk category based on factors like the complexity of compounding and potential for contamination. For each risk category, it provides examples and establishes maximum storage times in the absence of passing a sterility test. It also describes an immediate-use provision for emergency situations. Low-risk CSPs allow for the longest storage times of up to 48 hours at room temperature, while high-risk CSPs allow for the shortest storage of 24 hours. Medium-risk CSPs fall between the other two categories.
OSHA regulations aim to ensure employee safety in veterinary practices. Employers are responsible for providing training on hazards like zoonotic diseases, safe chemical handling, and emergency procedures. Proper personal protective equipment and hygiene help control disease transmission. The written safety plan and regular staff training address risks from animal handling, radiation, waste disposal and other aspects of veterinary medicine. Compliance with OSHA standards helps protect workers' health and safety.
Cytotoxic agents used in chemotherapy have anti-cancer effects but can also damage normal tissues. Proper handling and protective measures are needed due to their hazardous nature. The document outlines guidelines for safely receiving, compounding, and administering cytotoxic drugs, even in resource-limited settings. Key recommendations include restricting access to drug storage areas, adhering to work practices to minimize exposure, using proper personal protective equipment, and following aseptic technique during compounding. The overall goal is to minimize risks to healthcare workers through application of hazard control measures.
This document discusses best practices for dispensing operations to ensure they are safe, compliant, and sustainable. It emphasizes the importance of preventing contamination, cross-contamination, mix-ups and maintaining traceability through controlled environments, equipment, material flow, handling, gowning/gloves and coordinated operations. Specific hazards are identified like working in a common environment with common tools. Regulatory requirements are reviewed around protecting materials, sampling, and layout/design of dispensing areas. The presentation provides examples of past issues and recalls caused by unsafe practices and contamination during dispensing. It stresses the need to logically design dispensing booths and control factors like air flow, filtration and equipment placement/height.
Control & Judgmental Errors Ending up on Mix up or Potential to Mix up in Pha...Obaid Ali / Roohi B. Obaid
1. During manufacturing of an oral liquid product, there are three possible main routes of mix up: powder mix up, material mix up, and batch mix up.
2. Line clearance involves supervising two lines simultaneously, which can lead to loss of attention and critical issues being ignored due to unawareness if the person is untrained or overwhelmed.
3. Mix ups can occur due to issues like poor controls, unattended materials, lack of physical barriers between products, and failure to follow procedures. Having strict controls and ensuring unidirectional flow of materials and products can help prevent mix ups.
This document discusses USP 797 regulations regarding environmental quality control for sterile compounding facilities. It outlines the need for regular air and surface sampling to test for microbial contamination where sterile compounds are prepared. Facilities must determine the risk levels of the compounds they produce to ensure sampling frequency and action levels meet USP 797 guidelines. If contamination exceeds allowed levels, facilities must take steps to eliminate the issue and re-sample to confirm. Outsourcing environmental sampling to qualified labs can help facilities achieve and maintain compliance.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document outlines procedures for a Hazard Analysis and Critical Control Points (HACCP) food safety and quality assurance manual. It includes definitions of key food safety terms, as well as policies and procedures for management, hiring, emergencies, food safety, employees, sanitation, and quality assurance forms. The goal is to prevent foodborne illness through error-free food production by identifying critical control points and monitoring temperatures, times, and procedures.
Hand Hygiene Requirements and JCAHO National Patient Safety Goals in VHA 2003Noel Eldridge
Special TIPS (Topics in Patient Safety) newsletter issue on Hand Hygiene and the JCAHO (before rename to JC) NPSGs. The Summary of the CDC's guidance, if I remember correctly, is what was attached to the USH's memo to all VA facilities, if I remember correctly...
Biohazardous wastes are the most promising sections to manage in the present condition.There are many rules to be folowed in disposal,transportation and treatment of biohazardous waste.
Issues and challenges in Hospital Waste Management By Dr. Kunal RawalDrKunal Rawal
Biomedical Waste- Hospital waste and its components, biomedical waste and types, sources, Principles of BMW, Schedules and Classification of BMW, Colour coding and types of containers used for BMW management, Waste management process, issues of managing general waste during COVID-19, BMW guidelines for COVID-19, BMW treatment and disposal techniques, Benefits of BMW, Challenges of Healthcare waste management practice in India.
Methods for disposal of laboratory wasteMicrobiology
This document provides procedures for the disposal of various types of laboratory waste at UBC, including sharps, photographic waste, unknown chemicals, explosives, waste oil, and laboratory glass. Sharps, chemicals, explosives and other hazardous wastes require specialized containers and may need to be disposed of by an external contractor. Photo chemicals, waste oil and glass can be disposed of on campus following labeling and container requirements. Proper decontamination, containment and identification procedures are outlined for each waste type to ensure safety during disposal.
KILL KINETICS “Emerging Trends in Sterile Supply by Dr.Mahboob ali Khan Phd.Healthcare consultant
“KILL KINETICS “Emerging Trends in Sterile Supply by Dr.Mahboob Khan Phd
CSSD's role lies in receiving, cleaning, packing, disinfecting, sterilising, storing and distributing instruments as per well-delineated protocols and standardised procedures
Dr.Mahboob ali khan Phd
The Central Sterile Supply Department (CSSD) in recent times has expanded from a mere support entity which consisted of steam sterilisation units to process instrument and linen packs. Today, CSSD is the heart of hospital infection control and the most important unit of clinical support services.
Bioburden Validation Strategy for Cleaning Validationangelsalaman
This document discusses cleaning validation and bioburden method suitability testing. It outlines the cleaning validation process, including defining cleaning procedures, developing sampling methods and acceptance criteria. It notes that recovery of microorganisms from surface sampling methods like swabbing is typically low. The document also discusses different types of surfaces found in manufacturing facilities and how surface properties like porosity can influence the ability of microbes to adhere. Method suitability testing is recommended using representative surfaces under controlled laboratory conditions.
Hospital waste is categorized as hazardous or non-hazardous. Hazardous waste includes infectious waste like human tissues, sharps that can transmit disease, and expired pharmaceuticals. Proper management of hospital waste involves segregating, collecting, storing, transporting, and treating waste. Common treatment methods are incineration, chemical disinfection, and autoclaving to reduce pathogens before waste is disposed of safely. Proper hospital waste management is important to protect staff, patients, and the environment from disease and contamination.
The document discusses guidelines issued by the FDA and Europe in 2004 regarding aseptic processing and sterile drug production. It outlines the importance of process control and describes how media fills are used to simulate aseptic filling processes to evaluate contamination levels. Key aspects of designing an effective media fill process are highlighted, including mimicking the actual aseptic process as closely as possible and using an appropriate growth medium to support the growth of a wide range of microorganisms.
This document provides guidelines for the shipment of pharmaceutical products. It discusses general principles for distribution including quality maintenance, legislation, GMP/GDP standards, and collaboration across the supply chain. It also outlines specific requirements for organization, personnel, traceability, premises, vehicles, storage conditions, dispatch/receipt, transportation and handling of hazardous products. The guidelines aim to ensure product quality and safety throughout the distribution process.
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Fda regulations for pharmaceutical packagingPrem Patil
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
This document discusses infection control and asepsis procedures in a healthcare setting. It begins by describing the characteristics of pathogenic microorganisms and the chain of infection process. It then discusses the body's immune response mechanisms and types of infections. The document outlines OSHA standards for exposure control plans, potentially infectious materials, and protocols for disposal of biologic waste. It explains principles of asepsis including proper hand hygiene, and differentiates between sanitization, disinfection, and sterilization. The role of the medical assistant in maintaining asepsis to prevent transmission of infection is also summarized.
This document discusses healthcare associated infections (HAIs) and standard precautions to prevent their transmission at Sandhills Endoscopy Center. It outlines objectives to understand what HAIs are, how to stop their spread, and the importance of following standard precautions protocols. The document reviews guidelines from the CDC and ASGE for using standard precautions like hand hygiene, personal protective equipment, cleaning equipment and the environment to minimize infection risks during GI procedures and within the endoscopy unit.
safe injection practice as per NABH.pptxanjalatchi
Safe injection practices are intended to prevent the transmission of infectious diseases between patients or between patients and healthcare personnel. The key steps of safe injection practices include cleaning the work space, proper hand hygiene, using sterile syringes and needles for each patient, properly disinfecting medication vials, safely collecting sharps, and properly disposing of waste. Healthcare facilities should provide regular training to all personnel on safe injection practices and periodically observe practices to ensure they are being followed correctly.
The document discusses good distribution practices for medical products. It emphasizes the importance of quality management systems and risk management throughout the supply chain. Key points include establishing a quality policy and procedures for facilities, storage, documentation, complaints, and receiving products. All entities must implement quality systems, standard operating procedures, and controls to ensure medical products are properly handled and distributed.
The document discusses guidelines for developing and implementing an effective infection control program in hospitals, including establishing an infection control team, conducting surveillance to monitor infection rates, implementing standard precautions like hand hygiene and proper waste disposal, and using antimicrobials appropriately through an understanding of their mechanisms of action and developing resistance.
This document discusses best practices for dispensing operations to ensure they are safe, compliant, and sustainable. It emphasizes the importance of preventing contamination, cross-contamination, mix-ups and maintaining traceability through controlled environments, equipment, material flow, handling, gowning/gloves and coordinated operations. Specific hazards are identified like working in a common environment with common tools. Regulatory requirements are reviewed around protecting materials, sampling, and layout/design of dispensing areas. The presentation provides examples of past issues and recalls caused by unsafe practices and contamination during dispensing. It stresses the need to logically design dispensing booths and control factors like air flow, filtration and equipment placement/height.
Control & Judgmental Errors Ending up on Mix up or Potential to Mix up in Pha...Obaid Ali / Roohi B. Obaid
1. During manufacturing of an oral liquid product, there are three possible main routes of mix up: powder mix up, material mix up, and batch mix up.
2. Line clearance involves supervising two lines simultaneously, which can lead to loss of attention and critical issues being ignored due to unawareness if the person is untrained or overwhelmed.
3. Mix ups can occur due to issues like poor controls, unattended materials, lack of physical barriers between products, and failure to follow procedures. Having strict controls and ensuring unidirectional flow of materials and products can help prevent mix ups.
This document discusses USP 797 regulations regarding environmental quality control for sterile compounding facilities. It outlines the need for regular air and surface sampling to test for microbial contamination where sterile compounds are prepared. Facilities must determine the risk levels of the compounds they produce to ensure sampling frequency and action levels meet USP 797 guidelines. If contamination exceeds allowed levels, facilities must take steps to eliminate the issue and re-sample to confirm. Outsourcing environmental sampling to qualified labs can help facilities achieve and maintain compliance.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document outlines procedures for a Hazard Analysis and Critical Control Points (HACCP) food safety and quality assurance manual. It includes definitions of key food safety terms, as well as policies and procedures for management, hiring, emergencies, food safety, employees, sanitation, and quality assurance forms. The goal is to prevent foodborne illness through error-free food production by identifying critical control points and monitoring temperatures, times, and procedures.
Hand Hygiene Requirements and JCAHO National Patient Safety Goals in VHA 2003Noel Eldridge
Special TIPS (Topics in Patient Safety) newsletter issue on Hand Hygiene and the JCAHO (before rename to JC) NPSGs. The Summary of the CDC's guidance, if I remember correctly, is what was attached to the USH's memo to all VA facilities, if I remember correctly...
Biohazardous wastes are the most promising sections to manage in the present condition.There are many rules to be folowed in disposal,transportation and treatment of biohazardous waste.
Issues and challenges in Hospital Waste Management By Dr. Kunal RawalDrKunal Rawal
Biomedical Waste- Hospital waste and its components, biomedical waste and types, sources, Principles of BMW, Schedules and Classification of BMW, Colour coding and types of containers used for BMW management, Waste management process, issues of managing general waste during COVID-19, BMW guidelines for COVID-19, BMW treatment and disposal techniques, Benefits of BMW, Challenges of Healthcare waste management practice in India.
Methods for disposal of laboratory wasteMicrobiology
This document provides procedures for the disposal of various types of laboratory waste at UBC, including sharps, photographic waste, unknown chemicals, explosives, waste oil, and laboratory glass. Sharps, chemicals, explosives and other hazardous wastes require specialized containers and may need to be disposed of by an external contractor. Photo chemicals, waste oil and glass can be disposed of on campus following labeling and container requirements. Proper decontamination, containment and identification procedures are outlined for each waste type to ensure safety during disposal.
KILL KINETICS “Emerging Trends in Sterile Supply by Dr.Mahboob ali Khan Phd.Healthcare consultant
“KILL KINETICS “Emerging Trends in Sterile Supply by Dr.Mahboob Khan Phd
CSSD's role lies in receiving, cleaning, packing, disinfecting, sterilising, storing and distributing instruments as per well-delineated protocols and standardised procedures
Dr.Mahboob ali khan Phd
The Central Sterile Supply Department (CSSD) in recent times has expanded from a mere support entity which consisted of steam sterilisation units to process instrument and linen packs. Today, CSSD is the heart of hospital infection control and the most important unit of clinical support services.
Bioburden Validation Strategy for Cleaning Validationangelsalaman
This document discusses cleaning validation and bioburden method suitability testing. It outlines the cleaning validation process, including defining cleaning procedures, developing sampling methods and acceptance criteria. It notes that recovery of microorganisms from surface sampling methods like swabbing is typically low. The document also discusses different types of surfaces found in manufacturing facilities and how surface properties like porosity can influence the ability of microbes to adhere. Method suitability testing is recommended using representative surfaces under controlled laboratory conditions.
Hospital waste is categorized as hazardous or non-hazardous. Hazardous waste includes infectious waste like human tissues, sharps that can transmit disease, and expired pharmaceuticals. Proper management of hospital waste involves segregating, collecting, storing, transporting, and treating waste. Common treatment methods are incineration, chemical disinfection, and autoclaving to reduce pathogens before waste is disposed of safely. Proper hospital waste management is important to protect staff, patients, and the environment from disease and contamination.
The document discusses guidelines issued by the FDA and Europe in 2004 regarding aseptic processing and sterile drug production. It outlines the importance of process control and describes how media fills are used to simulate aseptic filling processes to evaluate contamination levels. Key aspects of designing an effective media fill process are highlighted, including mimicking the actual aseptic process as closely as possible and using an appropriate growth medium to support the growth of a wide range of microorganisms.
This document provides guidelines for the shipment of pharmaceutical products. It discusses general principles for distribution including quality maintenance, legislation, GMP/GDP standards, and collaboration across the supply chain. It also outlines specific requirements for organization, personnel, traceability, premises, vehicles, storage conditions, dispatch/receipt, transportation and handling of hazardous products. The guidelines aim to ensure product quality and safety throughout the distribution process.
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Fda regulations for pharmaceutical packagingPrem Patil
The document discusses guidelines for packaging and labeling of active pharmaceutical ingredients (APIs). It outlines requirements for packaging materials, labeling, storage conditions, and expiration dating to ensure quality. Proper documentation of material specifications, examination and testing is required. Labels must include accurate information and be stored securely to prevent mix-ups. APIs should be packaged and labeled in a way that protects against deterioration and contamination during transport and storage.
This document discusses infection control and asepsis procedures in a healthcare setting. It begins by describing the characteristics of pathogenic microorganisms and the chain of infection process. It then discusses the body's immune response mechanisms and types of infections. The document outlines OSHA standards for exposure control plans, potentially infectious materials, and protocols for disposal of biologic waste. It explains principles of asepsis including proper hand hygiene, and differentiates between sanitization, disinfection, and sterilization. The role of the medical assistant in maintaining asepsis to prevent transmission of infection is also summarized.
This document discusses healthcare associated infections (HAIs) and standard precautions to prevent their transmission at Sandhills Endoscopy Center. It outlines objectives to understand what HAIs are, how to stop their spread, and the importance of following standard precautions protocols. The document reviews guidelines from the CDC and ASGE for using standard precautions like hand hygiene, personal protective equipment, cleaning equipment and the environment to minimize infection risks during GI procedures and within the endoscopy unit.
safe injection practice as per NABH.pptxanjalatchi
Safe injection practices are intended to prevent the transmission of infectious diseases between patients or between patients and healthcare personnel. The key steps of safe injection practices include cleaning the work space, proper hand hygiene, using sterile syringes and needles for each patient, properly disinfecting medication vials, safely collecting sharps, and properly disposing of waste. Healthcare facilities should provide regular training to all personnel on safe injection practices and periodically observe practices to ensure they are being followed correctly.
The document discusses good distribution practices for medical products. It emphasizes the importance of quality management systems and risk management throughout the supply chain. Key points include establishing a quality policy and procedures for facilities, storage, documentation, complaints, and receiving products. All entities must implement quality systems, standard operating procedures, and controls to ensure medical products are properly handled and distributed.
The document discusses guidelines for developing and implementing an effective infection control program in hospitals, including establishing an infection control team, conducting surveillance to monitor infection rates, implementing standard precautions like hand hygiene and proper waste disposal, and using antimicrobials appropriately through an understanding of their mechanisms of action and developing resistance.
This document discusses infection control, including definitions, objectives, strategies, and the importance of infection control. It describes the components of an infection control program in a hospital setting, including establishing an infection control committee and team. The roles and responsibilities of the committee and team are outlined. Standard precautions like hand washing, barriers, and sharp disposal are also detailed.
The document outlines the key components of an effective hospital infection control program, including establishing an infection control team, committee, and manual. It emphasizes the importance of surveillance to monitor infection rates, preventive activities like standard precautions, and staff training. Standard precautions include proper hand hygiene, use of barriers like gloves and gowns, safe handling of sharps and contaminated materials, and maintaining a clean patient environment. The goal of the program is to reduce infection risk and increase safety.
Ppt hospital infection control for small scale hospitalsDrNeha Sharma
This document outlines the policies and procedures for infection control and prevention in a hospital setting. It discusses establishing an infection control team to develop, implement, and monitor infection control programs and training. The roles and responsibilities of different departments in preventing infection transmission are defined. Standard precautions like hand hygiene, use of personal protective equipment, safe disposal of sharps and waste, and cleaning/disinfection of equipment and environment are emphasized. Surveillance activities to monitor infection rates and identify outbreaks are also summarized.
The document discusses biosafety and waste management in histopathology labs. It outlines biosafety level guidelines which classify medical labs and microorganisms into four levels based on architectural features, ventilation, and safety equipment. It describes the basic lab and containment lab designs and safety practices like limited access, decontamination, and personal protective equipment. It also categorizes pathological waste, discusses principles of effective waste management including segregation, collection, storage, transportation, and treatment, and provides recommendations to improve biosafety standards.
Its time to put your two compliance plans all together into one u.docxchristiandean12115
It's time to put your two compliance plans all together into one unified Word document. Be sure to implement your faculty member's suggestions throughout and proofread all your work one last time. In addition, check the requirements in the original assignment in Module 02 Course Project - Introduction.
Be sure to write a summary statement and insert it at the end of the project before the References Page. (See outline below.) In your summary statement, describe your own journey in working on this project. Explain how this project has strengthened your understanding of compliance rules and regulations.
Your final plan should include the following. Note the overview at the beginning and the summary statement at the end. Remember to check details to insure that your plans will be understood by all employees at a large medical facility where you are the Compliance Officer.
Cover PageOverview of ComplianceFirst Compliance Plan
· Policies
· Procedures
· Monitoring Tools
Second Compliance Plan
· Policies
· Procedures
· Monitoring Tools
Summary Statement
· How this project has strengthened your understanding of compliance rules and regulations.
References Page
· At least twelve research references for both compliance plans.
ALL I NEED IS THE SUMMARY STATEMENT
The paper is included for you to go by
Overview of Compliance Plans
The first compliance plan incorporates the implementation of a hand hygiene program which targets clinics, hospitals and other sort of health centers where patients are treated accordingly. This plan is meant to sensitize the clinical health practitioners to always ensure that they wash their hands regularly and effectually prior to handling any medicine and/or medical equipment while handling patients. Moreover, it is aimed at facilitating the improvement of hygienic standards in these health centers. In order to effectively deploy the plan, there are several prerequisites which must be put in place in every facility so as to optimally execute the plan for maximal productivity. For example, putting up of rub dispensers (alcohol based) and antibacterial soaps just at the immediate exterior of every room for the purpose of encouraging the patients as well as health practitioners to wash hands regularly. (Mayo Clinic, 2016) Once this is successful, they would gain a hand washing culture which will immensely perk up their hygienic standards in conformation to the WHO guidelines.
The hand hygiene compliance plan is essential in many ways. Firstly, it will ensure that the employees are well shielded from bacterial infections which might result to coming into contact with contaminated surfaces. These include medical equipment, beddings and patients’ skin among others. An importance from adhering to the response and prevention element of the compliance plan is that the patients will have a smooth time recovering from infections. This is because they will be treated in an absolutely safe environment without further exposure to infe.
This document discusses infection control and reducing nosocomial infections. It defines key terms like infection control, nosocomial infections, disinfection and sterilization. It outlines the objectives of understanding infection control concepts and programs. It describes the epidemiology of common nosocomial infection sites and microorganisms. It explains the goals and functions of an infection control committee. It provides strategies to reduce nosocomial infections through hand hygiene, isolation protocols, ensuring clean environments, and sterilization of instruments. It emphasizes the importance of employee health programs and antimicrobial monitoring by the infection control committee and drug and therapeutics committee.
1 week 6 assignment ebp change process form ace star model SUKHI5
This document outlines a nursing student's plan to implement a change project to reduce postoperative surgical site infections. Specifically, the student proposes prohibiting artificial nails among clinical staff members. The rationale is that artificial nails harbor pathogens and have been linked to outbreaks of similar infections in surgical patients. The student identifies relevant stakeholders, including nurses, technicians, managers, and administrators. The plan involves educating staff on the new policy, conducting audits to collect infection rate data before and after implementation, and reporting outcomes to stakeholders. If successful, the policy would become permanent. The goal is to improve patient outcomes and safety by reducing opportunities for infection transmission in the operating room.
Dr. Prince is an experienced Microbiology teacher with 24 years of experience in teaching various medical and paramedical students.
This ppt explains the types of hospital acquired infection and their control methods.
Discuss one cause of foodborne illness..Not E coli ... State why it .pdfarishmarketing21
Discuss one cause of foodborne illness..Not E coli ... State why it is a public health problem?
The discuss why this problem occurs, Also discuss current control measures recommended and
used to prevent and control the foodborne illness that is the focus of your discussion. Finally, you
should propose a new control strategy or measure(s) that, if implemented, you believe would
reduce or eliminate the problem that you have characterized earlier Your proposal for improved
prevention and control practice should utilize terms and concepts,You should explain how your
proposal relates to the problem that you identified earlier in the paper, why you believe that it
will work, and how your proposed measure(s) fill gaps in the current public health response.
Solution
- Listeriosis is a serious infection caused by the germ Listeria monocytogenes. People usually
become ill with listeriosis after eating contaminated food. The disease primarily affects pregnant
women, newborns, older adults, and people with weakened immune systems. It\'s rare for people
in other groups to get sick with Listeria infection.
Listeriosis is usually a mild illness for pregnant women, but it causes severe disease in the fetus
or newborn baby. Adults 65 years and older and people with weakened immune systems most
commonly develop severe infections of the bloodstream (causing sepsis) or brain (causing
meningitis or encephalitis). Listeria infections can sometimes affect other parts of the body,
including bones, joints, and sites in the chest and abdomen.
- it is a public health problem because Recognized as an important public health problem in the
United States, Listeria monocytogenes is a ubiquitous, intracellular pathogen known to cause
food-contaminating outbreaks. These microorganisms have the ability to multiply within host
cells and spread from cell to cell
- control measures -
Avoiding Outbreaks
A clean, dry environment is of utmost importance in controlling Listeria. Common processing
facility contamination sites include floors, walls, ceilings, food contact surfaces, cleaning aids,
drains/wash areas, and heating, ventilation, and air conditioning (HVAC) systems. Potential
problem areas should be identified at each processing facility
Without meticulous and proper cleaning, plant equipment, including any equipment used for
refrigeration and HVAC, can become breeding grounds for microorganisms. Intermittent defrost
systems, which are subject to frequent washdowns, encourage microbial growth. Because they
often contain moisture from standing water or condensation, special attention should be paid to
these systems to prevent their contamination.
Among the many general guidelines for keeping a food processing facility clean, visual
inspection and routine testing are important. While regular cleaning can help prevent outbreaks,
continuous monitoring is needed to assess further control measures. Determine sample points
and frequency for routine environmental testing, food cont.
Bio medical waste management and handling rules 1998ARUNAYESUDAS
The document provides guidelines for managing hospital waste according to the World Health Organization. It discusses proper handling, storage, treatment, transport, and disposal of hospital waste. It emphasizes the importance of staff training, proper personal protective equipment, immunization, and monitoring worker health and safety to prevent injury and exposure when handling hospital waste.
The document discusses nosocomial (hospital-acquired) infections. It notes that nosocomial infections occur in 5-8% of hospitalized patients, with 1/3 being preventable. They can be transmitted through direct or indirect contact with patients or contaminated surfaces/instruments. Proper infection control practices are important to prevent transmission and protect patients and healthcare workers. These include standard precautions like hand hygiene and use of personal protective equipment, as well as isolation precautions depending on the type of infection.
TIPS issue on the 2004 Joint Commission National Patient Safety Goals (NPSGs) - Starting with this issue, I authored or co-authored every annual issue on the NPSGs through 2010.
We can can minimize the risks of disease transmission to our self and to the patients in the dental office through carefully following the infection control and safety guidelines,
Dr. Hesham Dameer
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
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1. 1
CHAPTER 9
Infection Control Checklist
The Joint Commission, in its prevention and control of
infection (IC) standards, requires organizations to take
precautions to reduce the risk of acquiring and transmit-
ting infections. Organizations must have effective, orga-
nization-wide IC programs. All departments and services
must participate in the organization’s IC efforts.
Note: Organizations surveyed under the Comprehen-
sive Accreditation Manual for Hospitals: The Offi-
cial Handbook (CAMH) must comply with the IC stan-
dards that are applicable to them. Organizations sur-
veyed under other Joint Commission accreditation
manual(s) should review the appropriate manual. (See
Chapter 1.)
Checklist Organization
This chapter presents infection control precautions for
health care personnel in a checklist format. They are con-
sistent with The Joint Commission’s IC standards,1
cur-
rent Centers for Disease Control and Prevention (CDC)
hand-hygiene guidelines2
(see NPSG 7 in Chapter 6), and
the provisions of the United States Pharmacopeia (USP)
Chapter <797>.3
(See Chapter 19.)
Note: Although this checklist does not address these
precautions completely, it should help to reduce the
risk of acquiring and transmitting infections. Health
care organizations should check for new and updated
standards on The Joint Commission’s Web site, and
for new and updated hand-hygiene guidelines on the
CDC’s Web site. (See Appendix.) Pharmacies should
contact their board of pharmacy and other state agen-
cies to determine how their state integrates USP
<797> provisions into its regulations.
The notes are compliance expectations and suggestions
that are based on the authors’ personal experiences, reports
from surveyed organizations, and surveyors’ statements.
Some notes reflect legal requirements, previous Joint Com-
mission standards, or commonly accepted standards of prac-
tice. Others note variations in interpretation of the standards.
Some notes are referenced to the standards.
Checklist Symbols—Special attention should be paid to
EPs preceded by an icon. The checklist uses a icon be-
fore an EP if documentation is required, and an ! icon
before an EP if noncompliance is likely to create an im-
mediate risk to patient safety or to the quality of care pro-
vided. An icon before an EP indicates that a Measure
of Success (MOS) is required if the EP is scored non-com-
pliant during a survey.
Checklist Usage Suggestions
To assess compliance, use the checklist and proceed sys-
tematically. Mark the item “Yes” if you are currently com-
pliant and are sure you will continue to be compliant. Mark
the item “No” if you are currently not compliant (even if
you are sure you will be compliant later). If you are not
sure of your answer, leave a blank response. A few items
may be not applicable (“NA”). Answer honestly, use a pen-
cil (so you can change your answers), and make notes on
the pages (e.g., reasons for noncompliance and location
of documents). Concentrate your efforts on resolving all
“No” and blank responses.
2. 2 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Yes No NAChecklist
Infection Risk Identification
Accidents, incidents, unsafe practices, and unsanitary conditions that pose a risk of
infection for patients, visitors, and staff are identified.
Infection Risk Reporting
Accidents, incidents, unsafe practices, and unsanitary conditions that pose a risk of
infection for patients, visitors, and staff are reported.
Note: Infection control–related incidents are usually reported to the Infection
Control Committee or a designated individual. The organization’s infection con-
trol plan should contain specific information on how to submit these reports.
Infection Control Surveillance
Each department or service participates in infection control surveillance activities
as required by the organization.
Cleaning and Disinfecting
The pharmacy and areas where medications are stored, compounded, dispensed, pre-
pared, and administered are clean.
Staff uses organization–approved cleaning procedures and cleaning and disinfecting
agents.
There are an adequate number of sinks and sufficient space and materials for clean-
ing equipment and washing hands.
Note: Cleaning should be coordinated with housekeeping personnel, and clean-
ing agents and procedures approved by the Infection Control Committee must
be used. Particular attention must be given to prepackaging, compounding, and
sterile preparation areas as well as areas likely to harbor microorganisms that
could contaminate medications or transmit disease to staff.
Alcohol-based hand rub containers are appropriately located.
Cleaning agents and supplies are available to staff.
Cleaning and disinfecting agents are appropriately diluted.
Cleaning and disinfecting agents are appropriately labeled.
Equipment is kept clean and stored in a clean area.
Note: Areas under sinks are not clean areas. Mortars, pestles, glassware, and
other equipment that must be kept clean must be stored in a clean area.
3. 3Chapter 9: Infection Control Checklist
Yes No NA
Drug preparation, packaging, and dispensing devices (e.g., mortars, pestles, pill crush-
ers, pill splitters, counting trays, graduated cylinders, unit-dose packaging devices,
and balances) are cleaned after each use and disinfected if necessary.
Devices used for crushing or splitting tablets are cleaned immediately after use
according to manufacturers’ recommendations and instructions.
Medication carts, drawers, and bins containing individual patient’s medications are
kept clean.
Automated dispensing cabinets and bins are cleaned according to the manufacturer’s
recommendations and instructions.
Note: Many organizations develop a schedule for cleaning equipment and de-
vices.
Boxes
Cardboard boxes are stored off the floor.
Note: This is not specifically required by the standards. However, some organi-
zations and surveyors insist that they be stored off the floor.
Shipping containers are not stored or opened (i.e., torn or cut) in any area reserved
for prepackaging medications or compounding sterile preparations.
Note: Handling and storing shipping containers (e.g., cardboard boxes) must be
done with minimal air disturbances and dissemination of dust particles. Intrave-
nous (IV) bags and bottles and related supplies must be removed from cartons
and wiped with an approved disinfecting agent prior to placing them in the ster-
ile preparation area.
Waste
Staff disposes of waste in accordance with the organization’s infection control poli-
cies and procedures.
Waste does not create a nuisance or a breeding place for insects, rodents, and ver-
min or otherwise permit the transmission of disease.
Waste disposal containers are close to the area of use.
Noninfectious waste is not mixed with infectious waste.
Note: Check the organization’s policies on disposal of noninfectious waste and
infectious waste.
Infectious Waste
Staff disposes of infectious waste in accordance with the organization’s infection
control policies and procedures.
Infectious waste does not create a nuisance or a breeding place for insects, rodents,
and vermin or otherwise permit the transmission of disease.
4. 4 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Infectious waste disposal containers are close to the area of use.
Infectious waste is placed in specially marked containers (e.g., red bags) and dis-
posed of separately from routine trash.
Note: Check the organization’s policies on disposal of trash and infectious waste.
Items used in patient rooms are not returned to the pharmacy.
Attire
Personnel wear appropriate attire in non-sterile areas.
Attire worn in the sterile compounding area is clean and minimizes the potential for
shedding and contamination, and meets the organization’s policy and state regula-
tions.
Note: Many organizations require personnel who compound sterile preparations
to wear hospital-laundered scrubs in the buffer area.
Note: USP <797> has specific requirements for garb (e.g., attire). (See Chapter
19.)
Personnel remove jewelry and cosmetics prior to compounding sterile preparations.
Hygiene
Personnel are attentive to personal cleanliness and hygienic practices.
Personnel with rashes, sunburn, weeping sores, conjunctivitis, or active respiratory
infection do not prepare sterile preparations.
Fingernail length complies with the organization’s policies and procedures.
The use of artificial fingernails complies with the organization’s policies and proce-
dures.
Note: Artificial nails or extenders may not be worn by personnel who com-
pound sterile preparations. Organizations often prohibit the wearing of artifi-
cial fingernails by individuals who have contact with patients.
Immunizations
Pharmacy staff participate in the organization’s annual influenza vaccination pro-
gram. (See IC.02.04.01, EP 1.)
Note: The organization must offer immunization against influenza to staff and
licensed independent practitioners. (See IC.02.04.01.) The organization must
provide access to influenza vaccination at an accessible site. (See IC.02.04.01,
EP 3.)
5. 5Chapter 9: Infection Control Checklist
Yes No NA
Education about the following is provided to pharmacy staff:
• Influenza vaccination
• Non-vaccine control and prevention measures (i.e., the use of appropriate
precautions)
• The diagnosis, transmission, and impact of influenza. (See IC.02.04.01,
EP 2.)
Note: The organization must annually evaluate vaccination rates and reasons for
nonparticipation in the immunization program. The organization must imple-
ment enhancements to the program to increase participation. (See IC.02.04.01,
EP 4 and EP 5.)
Employee Health Program
Staff participate in the organization’s employee health program as required (e.g.,
tuberculin skin testing).
Note: Most organizations provide an employee health program. This program
often includes pre-employment physical examinations, blood tests, chest x-rays,
and tuberculin skin tests (and annual follow-ups as required) as a condition of
employment to ensure that employees are free from communicable diseases.
Note: The employee health program may restrict the activities of employees
and visitors. For example, persons with communicable diseases may be prohib-
ited from contact with patients.
Note: All staff must participate in the organization’s employee health program
and comply with the organization’s employee health policies and procedures.
Furthermore, staff must be examined, treated, and immunized as required by the
organization.
Hand Washing (Routine)
Hand washing is the single most important procedure for preventing health care-
associated infections. The organization’s infection control policies and procedures
must address hand washing and require staff to comply with hand-hygiene guide-
lines.2,4,5
Note: The Joint Commission requires organizations to comply with either cur-
rent World Health Organization (WHO) hand-hygiene guidelines or CDC hand-
hygiene guidelines. Most organizations follow the CDC guidelines. (See
NPSG.07.01.01 in Chapter 6.)
Routine hand washing is performed at the beginning of the shift, after visiting the
restroom, before and after eating, and when the hands are obviously soiled. (The
areas under the fingernails must be kept clean.)
6. 6 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Personnel who have contact with infected or potentially infected patients, body flu-
ids, and contaminated or potentially contaminated objects wash their hands promptly
after such contact.
Staff uses a hand washing technique and cleaning agent that are approved by the orga-
nization.
Note: The following routine hand washing technique is typical of most organi-
zation-approved techniques:
• Use liquid soap and cool or lukewarm (not hot) water. (Cool or lukewarm
water removes less oil from the skin and is less drying.)
• Rub all surfaces of lathered hands together vigorously for at least 15 sec-
onds.
• Rinse hands thoroughly under a stream of water.
• Dry the hands with a disposable (e.g., paper) towel or air dryer.
• Use a towel to turn off the water.
Staff use alcohol-based hand rubs as permitted by CDC hand-hygiene guidelines,
organization policy, and manufacturers’ recommendations.2
Hand Washing (Sterile Preparation Compounding)
Personnel wash their hands thoroughly prior to compounding sterile preparations.
Personnel who leave the sterile preparations compounding area rewash their hands
prior to resuming compounding.
Note: Staff must use a hand washing technique and cleaning agent that meet USP
<797> requirements and are approved by the organization. The following tech-
nique for washing hands prior to compounding sterile preparations is typical of
most organization-approved techniques:
• Remove debris from under fingernails using running warm water and a nail
cleaner
• Moisten hands with water and apply a lather of a cleaning agent approved by
the organization. The lather must extend to the wrists and forearms (i.e., up
to the elbow).
• Wash hands under running water for at least 30 seconds.
• Rinse hands thoroughly under running water. Hold hands so that the direc-
tion of water flow is from the fingertips to the wrists.
• Dry the hands with a lint-free disposable towel or electric hand dryer.
• Apply a waterless alcohol-based surgical hand scrub with persistent activ-
ity following the manufacturer’s recommendations. Allow hands to dry.
• After donning sterile powder-free gloves, apply a waterless alcohol-based
surgical hand scrub with persistent activity to the gloves. Allow the gloves
to dry.
7. 7Chapter 9: Infection Control Checklist
Yes No NA
Standard Precautions
Staff observe standard precautions to reduce the risk of transmission of infection.4
Note: Standard (formerly known as universal) precautions apply to all patients
receiving care in hospitals, regardless of their diagnosis or presumed infection
status. Standard precautions apply to 1) blood; 2) all body fluids, secretions,
and excretions except sweat, regardless of whether or not they contain visible
blood; 3) nonintact skin; and 4) mucous membranes. Standard precautions are
designed to reduce the risk of transmission of microorganisms from both rec-
ognized and unrecognized sources of infection in hospitals.
Note: Occupational Safety and Health Administration (OSHA) rules and regula-
tions (Title 29 CFR §1910.1030)6
require employers to implement plans to
dispose of blood and contaminated waste, provide warnings on such waste, and
keep records that account for the disposal of the waste. Employers must ensure
that health care workers take special precautions to reduce the risk of contract-
ing and transmitting AIDS, hepatitis, and other diseases from exposure to blood
and other body fluids.
Note: Standard precautions must be included in the employer’s Exposure Con-
trol Plan. Health care organizations must regularly educate employees about
their Exposure Control Plan and standard precautions. Organizations must offer
medical attention, evaluation, testing, and treatment in accordance with their
Exposure Control Plan.
Isolation
Staff understand the organization’s isolation policies and procedures.
Only medications needed for the patient’s immediate use are taken into an isolation
room.
Gowning, masking, and gloving are done as specified in the organization’s isolation
policies.
All items taken into an isolation room are placed in a designated receptacle after
use.
Hand-hygiene procedures are performed as specified in the organization’s isolation
policies after leaving the isolation room.
Sterile Preparation Compounding Area
Areas for compounding sterile preparations minimize opportunities for particulate
and microbial contamination of the preparations.
Note: Areas for compounding sterile preparations must meet the requirements
of USP <797> and state regulations. (See Chapter 18.)
8. 8 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Primary Engineering Controls (PEC)
Sterile preparations are compounded in a properly maintained laminar airflow work-
bench, biological safety cabinet, compounding aseptic isolator, or compounding
aseptic containment isolator.
Note: Staff must be aware that primary engineering controls (“hoods”) do not
create a sterile area, but provide a clean area that is suitable for compounding
sterile preparations that will not be used immediately.
Note: Ideally, all sterile preparations are compounded in the pharmacy in a USP
<797> compliant facility. However, USP <797> has provisions for the prepara-
tion of low-risk sterile compounds (e.g., IVs) that will be used immediately. If
permitted by hospital policy, preparing medications with a short stability or for
immediate use is acceptable if done in a clean, well-lighted, functionally sepa-
rate area by competent personnel. There must be no intervening steps between
the compounding and administration of the sterile preparations. (See Chapter
19.)
Compounding of medium- and high-risk preparations, parenteral nutrition, antine-
oplastic and other hazardous agents, cardioplegia, and other preparations that re-
quire specialized knowledge or equipment usually found only in the pharmacy are
compounded in the pharmacy by specially trained staff.
Cleaning the Sterile Preparation Areas
Floors in the ante and buffer areas are cleaned in accordance with USP <797> re-
quirements.
Note: USP <797> contains requirements for cleaning floors, walls, and ceil-
ings in the ante and buffer areas. The housekeeping department must be familiar
with these requirements.
Cleaning and Disinfecting Primary Engineering Controls
Primary engineering control surfaces are cleaned and disinfected frequently, in-
cluding
• at the beginning of each work shift,
• before each batch preparation is started,
• every 30 minutes during continuous compounding activity,
• when spills occur, and
• whenever surface contamination is known or suspected.
USP Purified Water is used to remove water-soluble residues, and then the same
surfaces are disinfected with a non-residue generating agent using a lint-free wipe.
9. 9Chapter 9: Infection Control Checklist
Yes No NA
Note: Most organizations use sterile 70% isopropyl alcohol as the disinfectant.
Other agents may be used if approved by the organization.
All items (including syringes, vials, and other extraneous items) are removed from
the hood before cleaning it.
Note: Infection-control policies and procedures should include a schedule and
technique (including cleaning agent) for cleaning primary engineering controls
(laminar air flow workbenches, biological safety cabinets, compounding asep-
tic isolators, and compounding aseptic containment isolators). Clean the work
surface, side panels, and other accessible surfaces, starting at the top and rear
and working downward and toward the front, unless the manufacturer recom-
mends a different procedure. Be careful to avoid getting the cleaning agent on
the high-efficiency particulate arrestor (HEPA) filter. Document the cleaning.
Surveyors frequently look at documentation of cleaning (e.g., a monthly hood
cleaning log). (See Example 9-1.)
Primary Engineering Control Maintenance
Routine maintenance, such as cleaning or replacing prefilters, is performed regu-
larly and according to manufacturers’ specifications (e.g., monthly or quarterly).
Note: These activities must be documented.
HEPA filters are replaced or repaired when recommended by a qualified certifier.
Environmental Monitoring of Sterile Preparation Area
Environmental monitoring of both non-viable (e.g., particles) and viable (e.g., mi-
crobial or fungal contamination) [au: word missing?] is performed as required
(e.g., by USP <797> and/or state regulations). (See Chapter 19.)
Results of environmental monitoring are reported to the organization.
Note: Most organizations report this to the Infection Control Committee.
Certification of Sterile Preparation Areas
Primary engineering controls are checked and certified when they are first placed in
service, at least every 6 months, when maintenance is completed, or they are moved
to a new location.
Note: Certification of primary engineering controls is usually documented by
placing a sticker on the device and keeping inspection records on file. Survey-
ors frequently check these stickers.
Checks of operational efficiency of all primary engineering controls, ante areas,
and buffer areas are performed at least once every 6 months by a qualified certifier.
10. 10 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Primary Engineering Control Techniques
Proper techniques and precautions are observed when using primary engineering
controls.
Note: When using laminar airflow workbenches, the following precautions are
suggested:
• Ensure that the laminar airflow workbench (LAFW) runs continuously or
for the period required by policy (e.g., 30 minutes) prior to compounding
sterile preparations. The manufacturers’ recommendations must be fol-
lowed.
• Assemble and organize all necessary materials in or near the LAFW before
beginning work, and keep unnecessary items (e.g., labels, worksheets,
notepads, and pencils) out of the PEC.
• Work at least 15 centimeters (6 inches) within the hood.
• Keep a clear path between the HEPA filter and sterile objects (i.e., avoid
blocking airflow with vials and equipment).
• Do not allow objects (especially sharp or pointed objects) or liquids to
contact the HEPA filter.
• Avoid unnecessary talking.
Aseptic Technique
Proper aseptic technique is used in compounding sterile preparations.
Note: Touch is the primary source of contamination.
Note: Individuals with open lesions or communicable diseases must not prepare
sterile preparations.
Note: The following aspects of aseptic technique are emphasized:
• Compounding in the pharmacy must comply with USP <797>.
• Perform hand-hygiene procedures before handling drugs and as needed dur-
ing the procedure.
• Don proper garb.
• Work with moderate speed to minimize errors.
• Inspect containers for cracks, holes, leaks, and evidence of contamination
before and after preparation.
• Do not touch sterile areas of containers or allow nonsterile objects to come
in contact with sterile areas.
Note: The exteriors of all containers should be wiped with sterile 70% isopro-
pyl alcohol prior to placement in the ante area or buffer area.
11. 11Chapter 9: Infection Control Checklist
Yes No NA
• Clean diaphragms, injection ports, ampul necks, and vial tops with sterile
70% isopropyl alcohol and allow to dry.
• Cover ampul necks with a sterile pad and break ampuls by snapping toward
the side of the primary engineering control. Use a filter straw to withdraw
contents of the ampule.
• Ensure that seals on syringe and needle packages are intact. Do not use
items if the sterility is questionable.
• Ensure that touch contamination does not occur when attaching needles to
syringes and when mixing drugs and diluents.
• Dispose of used syringes, needles, and other waste in accordance with the
organization’s policies and procedures.
Beyond-Use Dates for Compounded Sterile Preparations
All compounded sterile preparations are labeled with beyond-use dates.
Beyond-use dates for compounded sterile preparations do not exceed the periods
specified in USP <797>. (See Chapter 19.)
Sterile Preparations Inspections
Compounded sterile preparations are quarantined and inspected by a pharmacist prior
to release from the pharmacy.
Note: The inspection must include checking for defective containers, cloudi-
ness, turbidity, leaks, precipitates, particulate matter, evidence of contamina-
tion, and evidence of incompatibility. Labels must be checked for complete-
ness and accuracy. When possible, the individual who performs the inspection
should not be the individual who compounded the preparation. Defective and
doubtful preparations must be destroyed.
Note: The individual who checks the final preparation must verify that the prepa-
ration has passed a final examination and is suitable for administration (i.e.,
compounded accurately and free from incompatibilities and particulate mat-
ter). An individual’s written signature or initials on the label is a common means
of indicating that the preparation has been checked.
Sterile Preparations Storage
Compounded sterile preparations are properly stored.
Note: Compounded sterile preparations should be administered as soon after
preparation as possible. Storage time limits and storage conditions must maxi-
mize stability, minimize microbial growth, and be consistent with the require-
ments of USP <797>. (See Chapter 19.)
12. 12 Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide
Yes No NA
Note: Protection from light may be necessary if the preparation is light-sensi-
tive. Check manufacturer and other literature carefully for stability data and
storage guidelines.
Automated Compounding Devices
Automated compounding devices are cleaned regularly and checked to verify accu-
rate delivery.
Note: Personnel must be knowledgeable about the safe and proper operation of
these devices. USP <797> provides information relating to the use of these
devices. In addition, personnel should consult the manufacturer’s information
for specific instructions. (See Chapter 19.)
Syringes
A sterile syringe is used for each medication withdrawn.
Syringes are used on one patient only and then disposed of properly.
Note: Organizations must be especially attentive to syringes used in anesthetiz-
ing areas and other areas where special procedures are performed.
Needles
A sterile needle is used for each medication withdrawn.
Containers for disposal of used needles and other sharp objects are available, used
properly, and not overfilled.
Single-Use Containers
Single-use containers are not reused.
Note: Single-use containers should be used whenever feasible. The organization’s
infection control policies should prohibit the reuse of single-use containers.
Single-use containers are discarded immediately after use in accordance with the
organization’s policies.
Multiple-Dose Containers
Multiple-dose containers that will be reused after the first puncture are labeled with
an appropriate beyond-use date.
13. 13Chapter 9: Infection Control Checklist
Yes No NA
Note: All multiple-dose containers intended for reuse must be labeled with a
beyond-use date whether they are labeled with the date of the first entry or not.
Multiple-dose containers are not used beyond the time specified by the organization’s
policies.
Note: Some organizations require dating containers when first entered and dis-
carding them after a short time period (e.g., end of the shift or 24 hours). Other
organizations specify a longer time period. The time period must not exceed 28
days unless a longer time period is specifically referenced in the package insert
for the product.7
Whatever the policy, the period must not conflict with the
manufacturer’s recommendations nor extend beyond the manufacturer’s expi-
ration date.
Note: A pharmacy bulk package (PBP) is a container of a sterile preparation for
parenteral use that contains many single doses. The contents are intended for
use in a pharmacy admixture program and are restricted to the preparation of
admixtures for infusion or, through a sterile transfer device, for the filling of
empty sterile syringes.8
PBPs of electrolytes and other products are used in the pharmacy for no more than
4 hours after the initial entry into the container unless the manufacturers’ product
information provides for another time period. Any unused portions are discarded.
Note: This requirement is stated in the package insert of many bulk containers
of electrolytes, other products intended for dilution in intravenous infusions
(i.e., not for direct infusion), and PBPs of IV contrast media.