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Based on records reviewed and interviews, the Hospital failed to fully inform patients exposed to potential bloodborne pathogens (breaches in cleaning dialysis machines between patients), so that patients could make an informed decision about follow up counseling and testing.


Findings include:


The Hospital Quality Council minutes, dated 4/13/16, indicated that, on April 1st 2016, there was a telephone call with Department of Public Health. The Hospital was instructed to send letters to patients informing them that they were potentially exposed to bloodborne pathogens during dialysis.

A letter from the Massachusetts Department of Public Health (DPH), Bureau of Health Care Safety and Quality, dated 3/17/17, communicated additional requirements related to the investigation including the following:

1. Notify exposed Patients in writing, all patients who received dialysis treatment at the hospital from 1/1/1015 to 2/10/16.

2. Exposed Patients are offered counseling and recommended testing for Hepatitis B, Hepatitis C and HIV (human immunodeficiency virus) as well as a signed statement from each patient who refuses the recommended testing.

The Surveyor interviewed the Vice President (VP) of Medical Affairs at 2:00 P.M. on 8/26/16. The VP of Medical Services said that the Hospital was directed by the Department of Epidemiology to inform all exposed patients in writing of their potential exposure risk and to recommend testing for Hepatitis B, Hepatitis C and HIV.

The post exposure notification letters, dated 4/7/16 and 4/21/16, were sent to 575 patients. The letters did not adequately inform the 575 patients dialyzed at the the Hospital between 1/1/2015 through 2/10/16 of the potential exposure to bloodborne pathogens. Sixty patients did not respond to the letters for counseling or testing related to potential exposure to bloodborne pathogens.

The Hospital notification letter, dated 4/7/16 and 4/21/16, did not adequately inform 575 patients of the potential risk of bloodborne pathogen disease. This letter indicated,"We have no basis that issues identified by DPH caused illness to any patient." These letters did not contain the recommendations to inform the patients of the bloodborne pathogen risk as requested by the Massachusetts DPH.

The Surveyor interviewed the VP of Medical Affairs on 8/26/16 at 2:00 P.M. The VP of Medical Affairs said that despite receiving contact from Department of Public Health (DPH) Epidemiology Program and DPH Bureau of Health Care Safety and Quality, he thought the requirements were only suggestions. He said he did his own research for the post exposures and then recommended testing, disregarding DPH's requirements.

Based on records reviewed and interviews, the Hospital failed to collect data regarding the 575 patients exposed to bloodborne pathogens in the Dialysis Unit to improve patient safety.


Findings include:


The Performance Improvement and Patient Safety Plan for 2016 stated that the Hospital Mission was to improve the health of the people in the community every day with quality.
A program objective was to reduce health systems errors, transmission of infectious agents and hazardous conditions by utilizing continuous improvement and use of best practice methods to support the organizational safety climate as a part of a proactive effort to promote patient safety.

The Surveyor interviewed the Director of Performance Improvement on 8/25/16 at 12:45 P.M., The Director of Performance Improvement said that there was no data that tracked the patients safety or adequacy of the post exposure interventions. Instead, she said that Physicians were reporting information to the Performance Improvement Coordinating Committee.

The Surveyor interviewed the Chief Infection Control Officer on 8/25/16 at 2:15 P.M. The Chief Infection Control Officer said that the Infection Control Committee was not tracking or analyzing the data for the patient bloodborne exposures.

Based on records reviewed and interviews, the Hospital failed to collect data regarding the 575 patients exposed to bloodborne pathogens in the Dialysis Unit to improve patient safety.


Findings include:


The Performance Improvement and Patient Safety Plan for 2016 stated that the Hospital Mission was to improve the health of the people in the community every day with quality.
A program objective was to reduce health systems errors, transmission of infectious agents and hazardous conditions by utilizing continuous improvement and use of best practice methods to support the organizational safety climate as a part of a proactive effort to promote patient safety.

The Surveyor interviewed the Director of Performance Improvement on 8/25/16 at 12:45 P.M., The Director of Performance Improvement said that there was no data that tracked the patients safety or adequacy of the post exposure interventions. Instead, she said that Physicians were reporting information to the Performance Improvement Coordinating Committee.

The Surveyor interviewed the Chief Infection Control Officer on 8/25/16 at 2:15 P.M. The Chief Infection Control Officer said that the Infection Control Committee was not tracking or analyzing the data for the patient bloodborne exposures.

Based on observations, records reviewed and interviews, for 1 of 6 surgical patients (#4), the Hospital failed to ensure Circulating Nurse #1 and Registered Nurse #2 followed Hospital Policy and Manufacturer's recommendations in the Operating Room for patient safety.


Findings include:


a. The Hospital's Policy on Electrosurgery, dated 1/13/14, indicated its purpose was to provide for use of electrosurgical equipment. To ensure patient safety intraoperatively when cutting and coagulating body tissues, the dispersive electrode pad is placed on the positioned patient on clean dry skin over a large muscle mass and as close to the operative site as possible.

b. The manufacturer's recommendation for this adult cauterizing (electrode) pad indicated to apply it to the upper arm, trunk, or upper thigh. There is a manufacturer's warning to follow all directions on the product package for proper electrode placement to avoid electrosurgical burns beneath the patient's electrode.

Patient #4's medical record, dated 8/26/16 indicated that the patient had a bilateral myringotomy (tubes placed in the ear drums), tonsillectomy and adenoidectomy.

The Surveyor observed in Operating Room #1, on 8/26/16 at 8:54 A.M., Circulating Nurse #1 instruct Registered Nurse #2 to apply the electrode pad to Patient #4's calf. Registered Nurse #2 applied the electrode pad to Patient #4's left calf which was not consistent with the Hospital policy or manufacturers recommendations.

The Surveyor interviewed Registered Nurse #2 on 8/26/16 at 9:26 A.M. Registered Nurse #2 said that the electrode pad was applied to the calf because it was easier to apply and remove if placed in this location. Registered Nurse #2 was not aware of the manufacturer's guidelines.

Based on records reviewed and interviews for 4 of 6 Surgical Patients (#2, #3, #4 and #5), the Hospital failed to obtain a properly executed consent prior to scheduled procedures/surgery.

Findings include:

The Hospital Policy on Consent and Refusal of Treatment, dated 3/25/15, indicated that for surgical and diagnostic procedures, the Surgeon who is performing the surgery or procedure is responsible for obtaining informed consent (the only person qualified to explain the procedure, risks benefits and alternatives). If the patient or patient representative consents to treatment a consent form must be completed including the patient's or authorized representative signature, date and time. Obtaining informed consent is not within the role of the registered nurse.

1. Patient #2's surgical consent was signed by Patient #2's Legal Representative 23 minutes before Patient #2's Surgeon signed the informed consent.

2. Patient #3's surgical consent was signed by Patient #3's Legal Representative 25 minutes before the Surgeon signed the informed consent.

3. Patient #4's surgical consent dated 8/26/16, was signed by Patient #4's Legal Representative 18 minutes before Patient #4's Surgeon signed the informed consent form. This is inconsistent with policy requirement after explaining the risks, benefits and alternatives.

4. Patient #5's surgical consent was signed by Patient #5's Legal Representative 50 minutes before Patient #5's Surgeon signed the informed consent form.

The Surveyor interviewed the Director of Surgery at 4:30 P.M. on 8/30/16. The Director of Surgery said that the information (to explain the procedure, risks benefits and alternatives) for the surgical informed consent is frequently provided to patients/and or the Legal Representative in the Physician's office.