Welcome to Section C, Outbreaks and Safe Injection Practices. This is the 3rd section of the state approved educational course required for

Transcription

1 Welcome to Section C, Outbreaks and Safe Injection Practices. This is the 3rd section of the state approved educational course required for compliance with the NC Rule.0206 Infection Control in Health Care Settings. This course is specifically designed for Out-patient Practice Settings. Thanks to Dr Melissa Schaefer in the Div of Healthcare Quality Promotion at the CDC for giving permission to use her slides for this presentation, and Drs. Joseph Perz and Arjun Srinivasan, also of the DHQP at the CDC, for materials used here from the webinar Safe Injection Practices. 1

2 The objectives for this section are that at completion, the participants will be able to: Describe safe injection and other basic infection control practices and be able to recognize and correct unsafe practices. Be able to understand the need for monitoring healthcare personnel practices in your facility relating to injection safety. Describe the potential consequences of syringe reuse and other unsafe practices, and Locate related CDC Infection control guidance and educational materials for safe injection practices. 2

3 Let s review the general outline of this presentation. First, I will define what is meant by the term injection safety and give some examples of unsafe practices. I ll review recent outbreak investigations in the out-patient setting. Then I ll review what is meant by the concept of indirect transmission. I ll review recommendations and strategies aimed at the prevention of disease transmission from unsafe injections. And finally I will provide CDC internet resources for educational and promotional materials for safe handling of sharps. 3

4 In the past decade, healthcare delivery in the United States has shifted from the acute care, inpatient hospital to a variety of ambulatory and community based settings. Ambulatory care is provided in hospital based and non-hospital based outpatient clinics and physician offices, public health clinics, free standing dialysis centers, ambulatory surgical centers, urgent care centers, and others. In 2000, there were 83 million visits to hospital outpatient clinics and more than 823 million visits to physician offices; ambulatory care now accounts for most patient encounters with the health care system. 4

5 This slide shows the news headlines that transmission of bloodborne pathogens, hepatitis B, C, and rarely HIV, in outbreaks, sometimes involving hundreds of patients, continues to occur in outpatient settings. These headlines make it clear that the topic of injection safety and outbreaks, resulting from poor infection control practices in the Ambulatory Care settings, has generated a great deal of attention in recent years. 5

6 There is a growing concern that the CDC, state and local public health departments have investigated an increasing number of outbreaks related to unsafe injection practices, as well as other breeches in very basic infection control practice. The trend is concerning in that detection of transmission of this type of infection can be haphazard. Just using the hepatitis viruses as an example, acute or new infections are often asymptomatic and do not come to the attention of medical providers. Also there is a low index of suspicion because we trust that healthcare in our country is safe; it s sometimes hard to make the connection to those healthcare exposures. Consider, too, that hepatitis C and some of the other infections that we ll talk about have a long incubation period. Outbreaks are occurring across the spectrum of healthcare in the US. Examples include ambulatory care facilities, home care, long term care, and as we know these are settings where unlike hospitals, formal infection control infrastructure programs and oversight are often lacking. 6

7 Let s review some basics in terms of transmission of bloodborne pathogens and infections. Indirect transmission refers to the transfer of an infectious agent through a contaminated intermediate object or person. Examples of this transmission include the hands of healthcare personnel, patient care devices, instruments and equipment that are reused or not adequately disinfected. 7

8 Here in simple visual terms is the idea that two patients, who may never have been in direct contact with one another, can actually be part of a chain of transmission. This can occur if the source patient has a particular infection, for example hepatitis B, and has a routine procedure like blood glucose testing or insulin injection, and then the contaminated equipment comes into contact with a second case. Transmission can occur whether that equipment is a glucometer, syringe, or medications. The contaminated equipment such as a glucomter may be contaminated with BBPs whether it is visibly contaminated or not. Because glucometers have been associated with numerous BBP outbreaks, the CDC recommends that glucometers be cleaned and disinfected between each patient use, if not dedicated to a single patient. 8

9 So what is injection safety? Injection safety includes practices intended to prevent transmission of infectious diseases between one patient and another, or between the patient and the healthcare provider, and also to prevent harm such as needle stick injuries. Recognizing that the exposures and infection risks to healthcare workers are fairly well understood and have been covered in earlier sections, I ll be focusing on the risk to patients in this section. Another way to define safe injection is that a safe injection does not harm the recipient nor does it expose the provider to any avoidable risks and does not result in waste that is dangerous to the community. 9

10 What are some of the incorrect practices that have resulted in transmission of pathogens? One example is using the same syringe to administer medication to more than one patient; in other words, direct reuse of the syringe from one patient to the other even if the needle was changed. Another example is using a common bag of saline or other IV fluid for more than one patient. Leaving an IV set for dispensing fluid was observed in an outbreak of Gram negative bacteria causing bloodstream infections. Another incorrect practice is to access the bag of saline or shared container with a syringe that s already been used to administer medications to another patient. And finally there s something that is similar to the accessing of a saline bag with a syringe that s been used, accessing any shared medication vial with a syringe that s already been used to administer medication to a patient. 10

11 Next, I ll talk about what happens when health care facilities fail to adhere to safe injection practices, especially important if using IV sedation medication therapy, or any other medications that are injected. 11

12 In a recent 2009 report in the Annuals of Internal Medicine by the CDC, the authors summarized 33 outbreaks of HBV and C viruses that occurred in 15 states, involving 12 outpatient clinics, 6 dialysis centers, and 15 LTCFs identified between 1998 and

13 This slide is a summary from the CDC report by Thompson et al, of the common themes and findings from many outbreaks that have occurred between 2001 and First, all investigations are resource intensive and disruptive to patients and providers, and to the public health system. And yes, there has been a reported BBP outbreak involving Hep C virus in 2008, from exposures that occurred in a cardiology clinic which I will go into more detail about in the next slides. 13

14 On May 16, 2008, the Division of Public Health was contacted by a repeat blood donor after HCV was detected following blood donation. They were able to document recent negative tests and subsequent seroconversion. This person had no traditional risk factors for HCV infection but did have multiple medical procedures during the likely exposure period, including myocardial perfusion study (MPS) at Clinic A To Pursue or not to pursue was the first issue because the patient was asymptomatic and did not meet acute HCV case definition. NC DPH does not routinely investigate non-acute HCV infections. But the Nevada outbreak experience was published in MMWR the same day and the patient specifically reported endoscopy during the likely exposure period. 14

15 Following a visit to Clinic A, the NCDPH was notified of a second patient with acute HCV with no traditional risk factors who also had a myocardial perfusion study procedure at the same cardiology clinic 6 months before the index patient. Then the patient had onset of symptoms 7 weeks later In a review of the literature only one previous HCV outbreak was linked to myocardial perfusion studies due to contamination of radiopharmaceuticals. Pharmaceuticals were exposed to blood in a nuclear pharmacy during the compounding process. There were no previous outbreaks reported in association with infection control lapses in cardiology clinics. 15

16 This cardiology clinic performed 3 8 myocardial perfusion studies per day, but did no other invasive procedures or administered any other parenteral medications. One nuclear technologist was responsible for all aspects of myocardial perfusion studies including IV placement and medication infusions. The investigation found that one saline 30 ml vial was used to flush resting and stress doses. In reviewing purchasing invoices it was found that the clinic ordered <1/2 the number of saline vials required to perform procedures as described and witnessed. The technologist subsequently acknowledged that vials were sometimes used to flush the stress dose for same patient. Thus saline vials were routinely re-entered with a contaminated needle and syringe after the resting dose. This was the most likely potential mode of patient-to-patient transmission. 16

17 To determine if there were other clusters, the Department of Public Health mailed letters to all patients who had undergone myocardial perfusion studies during June 25, 2007 August 26, This was the largest patient notification ever undertaken by NC Division of Public Health with 1,205 patients from both NC and SC. Also a press release was issued. The results were that >700 patients were tested at three primary sites, with prevalence comparable to national estimates; however over 1200 patients were put at risk. In summary, there were two clusters at this cardiology clinic identified as HCV positive: Cluster X where all 4 patients had myocardial perfusion studies on the same date in June, 2007, and Cluster Y where 3 out of 6 patients had myocardial perfusion studies on the same date in December, There were 7 newly identified HCV infections total, including two likely source patients 17

18 Unsafe injection practices put patients at risk for a wide variety of adverse events and have been associated with a wide variety of procedures. Examples include administration of anesthetics for outpatient surgical, diagnostic, and pain management procedures, the administration of other IV medications including chemotherapy, cosmetic procedures and alternative medicine. Examples include chelation therapy or injection of vitamins or steroids, flushing IV lines or catheters and in some cases administration of intramuscular vaccines inappropriately. 18

19 Here are 3 examples of inappropriate practice leading to adverse events that did not involve blood borne pathogens but instead involved vegetative bacteria. The first outbreak was in a pain clinic where 7 cases of Serratia marcescens from spinal injections using a common saline bag for flushing. Two outbreaks of Staph aureus in primary care clinics resulted in joint and or soft tissue infections that required hospitalization of the patients. 19

20 This was one of the four outbreaks reported in the MMWR in This collection of outbreaks was something of a wake-up call for the US, that this problem of unsafe injection practices, which was not always associated with US healthcare, could in fact be a problem here as well in the developing world. The Oklahoma Pain Remediation Clinic outbreak is an example of how overt reuse of a syringe from one patient to another can transmit infection. This outbreak was not detected until 6 patients with acute hepatitis C were diagnosed. All had received treatment at a single pain clinic and the clinician who noted that reported the cases to the health department. This was an outpatient clinic but was affiliated with a hospital. Anesthesia staff were contractors. This pain clinic was operated just one afternoon a week. A nurse anesthetist working in the facility had been reported for poor practice but unfortunately the first report was not acted upon by the managers. The second report in June 2002 did result in a formal reprimand and change in practice. The Department of Health was notified; at that time the disease transmission had not been recognized. 20

21 This slide shows a little more detail about what happened. The anesthetist had the routine practice of filling a single syringe with sedation medication in quantities sufficient enough to treat all the patients they would see that afternoon. This medication was administered through heparin locks. Subsequently the anesthetist, upon interview, indicated that, it was his perception that he had a sterile field given that there was a length of IV tubing and the heparin lock. The look back investigation for the entire 2 year time period of clinic operation resulted in notifying 900 patients. Nearly 800 had serologic results available; 71 of these had clinic associated hepatitis C virus infections; 31 had clinic associated HBV infections, several patients unfortunately acquired both infections. And one outcome of this outbreak was a very large lawsuit. 21

22 This MMWR report describes the largest look back investigation in US history that began in January of 2008, involving an outbreak of Hepatitis C virus in an endoscopy clinic in Las Vegas, Nevada. 22

23 In January of 2008, a cluster of 3 acute HCV cases were identified by the Las Vegas local health department. All 3 cases had undergone procedures at the same endoscopy clinic during the incubation period. A visit to the clinic found that about 50 to 60 upper and lower endoscopies were performed daily in 2 procedure rooms. A massive look back investigation was begun by screening thousands of patients and identified 3 additional clinic-associated cases. 23

24 What went wrong? Induction by anesthesia started with a syringe with lidocaine and propofol into the IV. If the patient needed more anesthesia, and many did, the needle was replaced and the same syringe was used to draw more propofol. The medication remaining in the single dose propofol vial was used to sedate the next patient. 24

25 Propofol has been identified in several outbreaks. Propofol only comes in single-dose medication vials. The FDA has approved only for use on a single patient for a single procedure. The facility purchased cc vials but only used about cc per patient. The healthcare providers have reused the single patient use vials routinely, sharing the remaining contents with the next patient 25

26 This illustration shows that healthcare workers can begin an injection procedure with a clean needle and syringe and a new vial, draw medication, administer it using the same syring,,and if the patient is infected with a blood borne virus (in this case HCV or HBV) there is the potential for backflow of blood or virus into the syringe. If that patient then requires additional anesthesia and that same vial is used to withdraw additional medication, even if the needle is changed, blood can be introduced or virus can be introduced into what was a clean vial. If that vial is then used for a subsequent patient using a clean needle and a clean syringe, that patient or subsequent patients exposed to that vial are at risk. 26

27 The local health department immediately advised the clinic to stop using unsafe injection practices. Nevada revoked the business license and the clinic was closed. Through interviews with the nurse anesthetist, it was revealed that these unsafe practices had been commonly used by some of the staff at the clinic for at least 4 years. The Health Dept then began notifying 40,000 persons to recommend HBV, HCV, and HIV screening. 27

28 The results of the investigation and look back bloodborne pathogen screening found transmission clearly occurred on 2 separate dates in July and September of 2007 for a total of 8 HCV cases. In addition, the Southern Nevada Health District identified 77 cases of HCV that were potentially associated with the clinic. Another issue with these outbreaks is adding to the reservoir of infected individuals. Also recognized was that CMS surveyors had recently visited the clinic and given it passing marks. This has led to massive action by the CDC working with CMS to improve the survey process and focus on infection control practices in the ambulatory settings. 28

29 The endoscopy clinic had not undergone full inspection by state surveyors in 7 years due to state and federal cutbacks. The public trust in healthcare was damaged, and as a result, Nevada requested assistance with infection control assessments at all of its ambulatory surgical centers. The CDC developed a tool that the CMS surveyors could use to aid their investigation of safe injection and infection control practices. CMS surveyed in what was considered a blitz - visited all 50 Nevada ambulatory surgical centers clinics in 30 days. 29

30 For all these investigations there were some common themes and findings: First, all of these investigation were resource intensive and disruptive to patients, providers and to the public health system. Just one example is that these investigations often require the notification, testing and counseling of hundreds and even thousands of patients. The MMWR report also revealed that there was often delayed recognition and missed opportunities to intervene. Transmission occurred over a prolonged period and in some of the outpatient settings with patients returning for recurring care, for example, chemotherapy or, in one example, patients were coming back every couple of weeks for vitamin shots. We see then a growing reservoir of infected patients and potential for a large outbreak. It was also noted that infection control programs are lacking or responsibility is unclear in many of these outbreak facilities. This situation is entirely preventable by applying standard precautions and basic principles of aseptic technique. 30

31 Let s now review what are some of the common breaches found in these outbreak investigations. 31

32 First is the issue of syringe reuse direct syringe reuse means using the same syringe from patient to patient, with/without the same needle. Compare this to indirect syringe reuse, which is using the same syringe to access medications from vials that will be used on subsequent patients, with/without the same needle. 32

33 Syringes and needles are single use devices and should never be reused. 33

34 An important principle of adding a layer of patient safety is that minimizing the use of shared medications reduces patient risk. Single use vials, for example propofol, should never be used for more than one patient. Propofol does not come in multi-dose vials from the manufacturer. It comes only in single use vials. Leftover parenteral medications from a single use vial should never be pooled. 34

35 The environment where syringes are prepared is also important. This slide illustrates the fact that injection infection preparation on surfaces where contaminated substances are handled can lead to the spread of infections. This picture is taken from the New York City outbreak that involved the injection of vitamins and steroids. As can be seen, the limited space available to prepare injections in this preparation room included the storage of multi-dose vials and preparation of injections in the same area that used needles and syringes were actually being dismantled and discarded. 35

36 An important document was published in 2007: Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. This is a publication of the CDC s Healthcare Infection Control Practices Advisory Committee, often called HICPAC. The link provided will give you access to the entire document. 36

37 In the Isolation Guideline, thee is a set of safe injection practice recommendations. 37

38 For safe injection practices, always use aseptic technique in the handling, preparation and storage of medications and all supplies used for injections and infusions; use syringes, needles and IV tubing in a manner that prevents contamination. Begin with performing proper hand hygiene before handling medications. Next needles, cannulae and syringes are sterile single use items that should NOT be reused for another patient even if the needle is changed on the syringe. Nor should a syringe be reused to access medications from a vial that may be used on multiple patients because of the risk of contaminating the vial. 38

39 Multi-dose medications should be dedicated to single patient use whenever possible. The multi-dose vials should be entered only with sterile needle and a sterile syringe. Each multi-dose vial should be dated when first used, and discarded within 28 days of opening or sooner according to the manufacturer s instructions or any time there is concern regarding the sterility of the medication. As we saw from lessons learned in the New York City outbreak, multi-dose medications should not be kept in the immediate patient care or treatment area. Medications should be drawn up in a designated clean medication preparation area. In general, any item that could have come in contact with blood or body fluids should be kept separate from that area. 39

40 It is important to maintain the sterility of vials and use the recommended practices for parenteral medications. Do not administer medications from single dose vials to multiple patients. Left over parenteral medications from single dose vials in particular, but also IV bags, should never be pooled for later administration. A needle or other device should never be left inserted into a medication vial septum for multiple uses as this provides a direct route for microorganisms to enter the vial. Always use a new sterile syringe and needle to draw up medications. These recommendations for safe injection practices come from the CDC Guidelines for Isolation Precautions in

41 It is important to develop a culture of safety. And one way to do that is through administrative measures. So it is recommended that: Infection control measures are tailored to the individual practice setting That responsibility for oversight and monitoring personnel are clearly designated to include infection control. That Infection control practices be reviewed periodically, at least annually. That office practices and clinics establish procedures and responsibilities for reporting and investigating any breach in the infection control policy. 41

42 In addition, on the CDC website at the link listed here has much more information for health care providers on injection safety. 42

43 The CDC has also created the One and Only Campaign with the website provided here. The idea being promoted to the front line healthcare provider is One Needle, One syringe, used only One time. 43

44 This campaign has a host of public health, healthcare associations, and industry interested in promoting safe injection practices represented in the One and Only Campaign. 44

45 The CDC has many creative safe injection promotions and instructional materials available that can be downloaded from the website provided on this slide or by searching the CDC website. 45

46 Another example of the One and Only Campaign is to make health care providers aware of what would not be acceptable: for example, to reuse a used Q-tip, and to remind healthcare providers that the same aesthetics should be used for syringes and medications. 46

47 These are just a couple of examples of materials that the CDC has made available for safe injection promotion. 47

48 This slide is to give you more information on where you can find tools that have been developed by the CMS to assess safe injection safety practices and can be used by the healthcare facilities and practices to measure their compliance. 48

49 In conclusion, infection safety is a basic expectation in patient safety. Safe practices should not be sacrificed to save time or money. If you have to justify or defend your injection practices, you might be doing something wrong. Thank you for your time and attention. 49

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