‘WELLSPAN® York Hospital October 23, 2015 Questions? (666) 217-2870 Dear Wiliam Acker, | am writing to you because yeu had an open-heart surgery procedure at WellSpan York Hospital between October 1,2014 and July 24, 2016, We have learned that eight patents who had this same surgery during this time became sick with bacterial infection. is possibi that you may have been exposed to this bacteria during your surgery. This type of bacteria is called Nontuberculous Mycobacteria, or NTM. It grows slowly and is commonly found in sol and water, including tap water. Its Usually not harmful, but in some cases it can cause infections in patents wi have had invasive health care procedures ~ such as open-heart surgery — and those who may have weakened immune systems. We sincerely regret that this may cause anxiety for you and your family. We want to explain what ‘occurred and reassure you that we, along with the physicians and nurses in cur organization and ‘community will do as much as we can to answer your questions and address your concerns. What are your chances of having this infection? We know today that es than 1 percent of the patients who hed open-heart surgery at Welipan York Hosp bobieen Octobe, 2041 and uly 24 2018 acre the infection. That means thet ess than ane out of every 100 patios er average, has acquired ths infection Whi the chances of you geting ths infection sre(entremely lw} we wart you to know about his risk so hat yu and your rary care doctor ean be avare of the symptoms. tis important to realize the infection can usually be treated successfully once it is identified. The bacterium is not contagious, so this cannot be spread to your family and friends, Unfortunately, because the bacterium grows slowly, itcan take up to several months for it to develop into an infection land years before the infection is correctly diagnosed, unless patients and ther clinicians ae alert to the possibilty of NTM infection. —— i How aid this happen? |WollSpan York Hospital staf became aware of this issue in July 2015 and immediately contacted the Pennsylvania Department of Health (DoH). The DoH, the Centers for Disease Control and Prevention (CDC) and WellSpan York Hospital all worked together to conduct a thorough review.‘The CDC shared ther findings with us last week. As soon as we received tis information, we began Working with our physicians on a plan to notify and provide information to you and the other 1,300 Patients who may have been exposed to this bacteria, Based on what we learned, we believe thatthe bacteria is inked to heater-cooler devices, which are used during open-heart surgeries. Federal health ‘authorities are concerned that this device issue may be widespread and have issued health advisories te hospitals across the country in an effort to alert them of this issue and prevent infections in other patients. Our own internal review identified that our cleaning protocols forthe heater-cooler devices did ‘ot align perfectly with the original uidelines provided by the device manufacturer. The menufacturer recently alerted customers across the United States of enhanced cleaning procedures to address NTM contamination concems, ‘Wetsipan York Hosptal has thoroughy addressed the cause of he bacterial occurrence. There is no Tanger a risk ofthis bacioral exposure. Immesiately upon consutaton wth the DoH and the COC, WellSpan York Hospital completely replaced its heatr-conler devices with new equipment on July 25, 2015, The new equipment i beng meticulously mainiained according to the most recent enhanced Clearing procedures provided by the manufacturer and FDA guidelines. In adtion, the hospital is ering to the highest standards of disinfection, maintenance and curing fr these devices, What should you do? ‘There are no urgent steps that you must take, However, we do recommend that you schedule an {ppoiniment with your primary care physician. Your physician can further discuss ths issue with you {and help monitor any symptoms that could be associated with a possible NTM infection. This infection ‘can be treated iit is identified Itmay be helpful for you to take a copy of this letter with you to your doctors appointment. fit is determined that you have a confirmed NTM infection within four years of your open heart surgery at ‘WellSpan York Hospital, we will ensure you receive the care and treatment you need. ‘We fully expect you to have questions pnor to your primary care appointment. Thats why we are providing the following resources: 1 For more information, we have created a website (wivw.WellSpan.org/YorkOpenHeart), which Contains additional resources, inching frequently asked questions, '= Ifyou have questions prior to contacting your physicians, our nurses are prepared to speak with you. The numberof this nurse call center is (868) 217-2870, and our nurses will be available 24- hours a day. We understand that tis news may be concerning, and we sincerely regret any distress that it may create for you and your family. Please know that we remain fully committed to ensuring that you Rave all the information, care and treatment that you require regarding this Issue. {you have additional questions or concerns, please call our toll-free nurse call center at (866) 217- 270, o- visit our decicated web page for more information at ww WellSpan.ora/YorkOpenHear. Sincerely, Keith D. Noll ‘Senior Vice President, WellSpan Health President, WellSpan York Hospital