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Tag No.: A0118
Based on a review of the facility's policy, documents, medical record (MR) and interview with staff (EMP), it was determined that the facility failed to follow their adopted policy for resolution of complaint and grievance.
Findings include:
A review of the facility's policy "Response to Patient's and Family Members' Complaints and Grievances" last revised November 2, 2016, revealed "...2. A patient grievance, as defined by CMS is any complaint that meets the criteria listed below: a) A formal, informal written, or verbal complaint made by a patient or their representative received by an department...This includes faxes, emails, and letters or notes attached to any patient satisfaction survey other than general comments...c) A written complaint (including e-mails and faxes) is always considered a grievance, whether from an inpatient/outpatient, released/discharged patient or their representative regarding the patient care provided, abuse or neglect, or the compliance with the CMS Conditions of Participation."
A review of the facility's policy "Response to Patient's and Family Member's Complaints and Grievances" last revised November 2, 2016, revealed ".3...b) Every attempt will be made to resolve the grievance within 7 days of receipt. If the grievance is unable to be resolved within 7 days of receipt or if the investigation is not or will not be completed within 7 days, the complainant will be notified that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within 30 days..h) When a patient communicates a grievance to the hospital via email the hospital may respond via email. When the email response contains the information stated in this requirement, the email meets the requirement for a written response.
A review of facility document, "Email" dated October 30, 2016, revealed "...I am glad to hear that HUP (Hospital University of Pennsylvania) is taking aggressive measures to do a microbiology analysis of the joint debris..., and to inform the company and the FDA of this potential infectious disease risk...It is hard to envision a scenario in which contaminated joints on the patient's side of the bed do not pose a biohazard to recovering patients, especially in the ICU setting. ___(name redacted) and I ask that the hospital take steps in the direction of following the FDA (Food Drug Administration) self-reporting requirements for medical devices-so as to provide the FDA with the necessary information it can use to generate a nationwide warning to all provider facilities."
An interview conducted on May 1 2017, at 9:45AM with EMP1 and EMP4 confirmed EMP4 received the email dated October 30, 2016, from the family member of MR1. EMP4 further confirmed that upon receiving the email on October 30, 2016, EMP4 contacted EMP14 on that same day to further discuss the details of the email. It was also confirmed that EMP4 and EMP14 did not respond to the email from the family member of MR1.
A review of facility document "Email" dated November 10, 2016, from the family member of MR1 addressed to EMP4, EMP15, local newspapers, the Food Drug Administration, the "Department" and government officials revealed "...Is it possible for you to share the culture results from the joint alcoves with me and with the Inquirer?"
An interview conducted on May 1, 2017, at 9:50AM, with EMP4 confirmed the email dated November 10, 2016, was received by EMP4. EMP4 also confirmed that the facility did not respond with a written response. EMP4 also stated that the facility failed to follow their policy.
A review of facility document "Email" dated November 14, 2016, from the family member of MR1 addressed to EMP6, local newspapers, the Food Drug Administration, the "Department" revealed "...I am not certain what you are trying to accomplish by claiming that such debris is "harmless" and poses "no risk" to patients. This statement has shocked many of your colleagues as a corporate response not a medically or ethically sound one, I assure you. Of course, NO accumulated debris in a patient bed is ever acceptable or safe-especially in the ICU setting. Please let me known when you plan to delineate how you came to the conclusions that you arrived at for the ____(name redacted) reporters."
A review of a news article "Physician , Congressman say Hospital Beds accumulate debris" published November 11, 2016, revealed EMP6 stated in the news article "University of Pennsylvania infectious disease staff analyzed the debris and found it harmless. These particular beds were examined, and we found no risk to patients."
A telephone interview conducted on May 2, 2017, at 9AM with EMP6, confirmed that EMP6 remembered the incident and confirmed giving a statement to the local newspaper about the incident. EMP6 further stated "I have never spoken to the patient or the patient's family member about this incident."
A telephone conference call conducted on May 30, 2017, at 2:00PM with EMP1 revealed that EMP4 and EMP15 did not consider emails to the facility, with news agencies copied on the email to be a grievance that required a referral to the hospital's Patient and Guest Relations Department for follow-up. Further interview confirmed that the facility had not responded to the email correspondence received on October 30, 2016, November 10, 2016, and November 14, 2016, as defined in the facility's policy.
Tag No.: A0747
Based on a review of facility documents, and interview with staff (EMP), it was determined the facility failed to ensure patient beds in the Intensive Care Unit (ICU) were properly cleaned according to the manufacturer's instructions.
Findings include:
A review on May 1, 2017, of facility documents revealed pictures from October 2016, of the intensive care (ICU) beds which contain debris in the alcoves of the side rail joints located on Founders 5 (Heart and Vascular ICU), Rhoads 5 (Surgical Intensive Care Unit), Rhoads 2 (NeuroIntensive Care Unit), Founders 9 (Medical Intensive Care Unit) and Founders 8 (Cardiac Care Unit).
An interview conducted on May 1, 2017, at 3:47PM with EMP1 and EMP9 confirmed EMP9 had completed an observational tour of the ICU beds at the request of MR1's family member in October 2016. EMP9 confirmed the results of the observational tour revealed the ICU beds labeled as "clean" contained debris in each of the alcoves of the side rail joints.
An interview conducted on May 1,2017, at 9:55AM with EMP4 revealed "We did not complete a microbiology analysis test on the material found in the alcove areas of the ICU patient beds. We believed the substance to be dust and lint."
An interview conducted on May 1, 2017, at 10:15AM with EMP1 and EMP5 confirmed that the alcoves of the side rail joints had not been an area the environmental staff was trained to clean and disinfect prior to November 2016. EMP5 further confirmed that removal of the debris in the alcove areas should have been identified and removed during the cleaning and disinfecting process of the ICU beds.