The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|HARRISON MEDICAL CENTER||2520 CHERRY AVENUE BREMERTON, WA 98310||Jan. 25, 2017|
|VIOLATION: PATIENT RIGHTS: INFORMED CONSENT||Tag No: A0131|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on interview and review of the hospital's policy and procedure, the hospital failed to inform family members and/or surrogate decision maker of a confirmed health-care-acquired (HCA) infection on a patient (Patient #1).
Failure to inform a patient, family member, or surrogate decision maker of a health-care-acquired infection disregards the right to be informed of an unanticipated outcome, and risks potential exposure.
1. The hospital's policy and procedure titled "Disclosure of Unanticipated Patient Outcomes (ID 39, Approved: 9/2016) read in part under, "Policy. It is the policy of this organization to promote open, honest and continuous communication with patients...unanticipated outcome of care means a result that causes patient harm and that differs from what was expected to occur...not as a result of the natural course of the patient's underlying condition...9. A discussion with the patient, family and/or surrogate decision maker is noted in the progress notes..."
2. On 1/14/2017, surveyor #2 reviewed the medical record for Patient #1 which revealed a [AGE]-year-old patient who underwent an extensive surgical heart procedure and then transferred to the hospital's intensive care unit (ICU) on 10/13/2016. The patient was placed on mechanical ventilation, with only a brief period off the ventilator, but become critical and was placed back on mechanical ventilation, 12/4/2016. A pulmonary bronchoscopy was performed and secretions removed from the lungs, on 12/6/2016. The respiratory secretions were sent to the lab for testing, which resulted positive for a legionella infection. The patient's overall condition continued to deteriorate, and he/she eventually expired on [DATE].
3. In an interview with surveyor #2 on 1/25/2017 at 2:25 PM, the hospital's risk manager (Staff Member #12) confirmed that Patient's #1 family were not informed of the legionella infection. The investigation found no evidence in the patient's medical record that a discussion took place with the primary physician and family.
|VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS||Tag No: A0726|
Based on observation, policy and procedure review, and interview the hospital failed to ensure that operating room humidity and temperature were recorded daily per hospital policy.
Failure to ensure that operating room temperature and humidity are within industry standard ranges places patients at risk for unsafe care.
1. The hospital policy titled " Temperature and Humidity Monitoring - Anesthetizing areas " (Rev 6/23/2016) states in part, " Policy: 2. Temperature and humidity will be monitored and recorded daily in Anesthetizing locations, Sterile Processing Decontamination Areas, Sterile Processing, Sterile Supply Storage Areas with blue cloth wrapped and sterile supplies not protected by plastic storage using the Temperature and Humidity Log-Addendum A. "
2. On 1/24/2017 at 14:37 PM, Surveyor #1 observed a between case cleaning procedure in the hybrid surgical suite. During the procedure, the surveyor reviewed the document titled, " Temperature and Humidity Log - Addendum A ". Five out of a possible 23 daily checks for the month were not documented on the form. The operating room manager (Staff Member #13) confirmed the finding.
|VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES||Tag No: A0749|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on interview, record review, and review of the hospital's surveillance plan for infection prevention, the hospital failed to implement an effective surveillance plan, following a confirmed legionella infection on a patient (Patient #1).
Failure to follow recommended surveillance, or identify new cases, and control exposure, risks transmission of health-care-acquired infections in patients.
Reference: Guidelines for Preventing Health-Care--Associated Pneumonia, 2003. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR March 26, 2004 / 53(RR03); 1-36 ..."Maintain a high index of suspicion for the diagnosis of health-care associated Legionnaires disease and perform laboratory diagnostic tests (both culture of appropriate respiratory specimen and the urine antigen test) for legionellosis on suspected cases, especially in patients who are at high risk of acquiring the disease (e.g., patients who are immunosuppressed, including HSCT or solid-organ-transplant recipients; patients receiving systemic steroids; patients aged >65 years; or patients who have chronic underlying disease such as diabetes mellitus, congestive heart failure, and COPD...When a single case of laboratory-confirmed definite health-care-associated Legionnaires disease is identified ...begin an intensive prospective surveillance for additional cases of health-care-associated Legionnaires disease."
1. The hospital's document titled "Surveillance Plan & Goals for Infection Prevention FY 2016 (July 1/15-June 30/16) read in part under, "D. Communicable/Infectious Disease Exposure Investigation and Follow - Up. This will become an immediate priority whenever a patient and/or employee is involved in an exposure to a communicable disease. Infection Prevention and Employee Health will work collaboratively to implement the "Exposure Protocol" which includes: 1. Determining nature of exposure and level of infectiousness...3. Notifying the involved employees, the involved patient's attending physicians...Department of Health (when appropriate), and patient family members...5. Conducting/completing the appropriate follow-up and reports..."
2. During an interview with surveyor #2 on 1/24/2017 at 11:30 AM, the hospital's infection control director (Staff Member #9), confirmed that a patient (Patient #1) tested positive for a legionella infection by a respiratory specimen culture, collected December 6, 2016. The patient underwent an extensive surgical heart procedure and then transferred to the hospital's intensive care unit (ICU) on 10/13/2016. The patient remained on mechanical ventilation, with only a brief period off the ventilator, but become critical and was placed back on mechanical ventilation, 12/4/2016. A pulmonary broncoscopy was performed and secretions removed from the lungs, on 12/6/2016. The respiratory secretions were sent to the lab for testing, which resulted positive for a legionella infection. The patient's overall condition continued to deteriorate and eventually he/she expired on [DATE].
a. The director went on to explain that this case was the only legionella case identified in the last 6 months, which he/she confirmed by performing a retrospective medical record review. The case was reported to the local public health jursidiction and the state Department of Health. Both agencies provided recommendations for the investigation and surveillance. An environmental sampling was collected in the identified patient rooms and other areas in the hospital. Results were pending at the time of the onsite survey. An email addressed to the infection prevention director, dated Thursday, January 5, 2017, from the county's public health nurse, included recommendations from the Washington State Department of Health epidemiologist/healthcare associated infections program manager, which state: "...We recommend following CDC guidelines to help determine the source of the infection and prevent additional cases. The CDC outlines the following key elements when conducting such investigation..." And, "the following measures are recommended to ensure that all potentially healthcare-associated cases are identified: a) conduct a 6 month retrospective review for additional cases, b) Implement active clinical surveillance for 6 months following identification of the last possible or definite health-care associated case ...c) Order culture of lower respiratory specimens for legionella, in addition to urinary antigen testing, for all newly diagnosed pneumonia..."
b. According to the director, the hospital's plan for clinical surveillance will be to: "Focus on patients managed in the ICU, perform sputum testing for legionella in ICU patients that develop ventilator assisted pneumonia [greater than or equal to] 3 days after admission." He/she stated that the hospital's plan will be implemented if the pending environmental samples come back positive for legionella. The director added that if the test samples return a negative result, then there will be no need for further clinical testing.
Item #2 -Retrospective Review
Based on interview, record review, and review of professional healthcare infection control recommendations, the hospital failed to conduct a thorough retrospective review investigation to identify previous cases/potential previous cases (Patient #2).
Failure to identify previous Legionnaires disease cases and control exposure, risks transmission of health-care-associated infections to patients.
Reference: Guidelines for Preventing Health-Care--Associated Pneumonia, 2003. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR March 26, 2004 / 53(RR03); 1-36... "When a single case of laboratory-confirmed definite health-care-associated Legionnaires disease is identified... Conduct an epidemiologic investigation through a retrospective review of microbiologic, serologic, and postmortem data to identify previous cases..."
1. Surveyor #2 requested medical records for previous patients managed in the ICU who eventually expired for the past 4 months. On 1/25/2017 at 12:30 PM surveyor #2 reviewed the medical records. The medical record for Patient #2 revealed a [AGE] year-old patient experiencing rapid heart rate, respiratory failure secondary to health-care associated pneumonia, and a history of advanced cystic fibrosis. The patient was in critical condition and admitted on [DATE] at 7:40 PM. He/she was placed on a mechanical ventilator. On 11/19/2016, the patient underwent a pulmonary bronchoscopy, and secretion specimens were sent to lab for testing. One specimen was labeled, ordered, and sent to a Spokane reference lab for testing (test for legionella Patient #1 acquired). Upon further review of the medical record, no results were found for the legionella specimen. Patient #2 expired on [DATE], thirteen days prior to patient's #1 death.
2. Surveyor #2 conducted an interview on 1/25/2017 at 1:00 PM with the hospital's lab manager (Staff Member #10) and lead lab assistant (Staff Member #11). They revealed that the pulmonary specimen was rejected due to an incorrect testing order and destroyed. The lab assistant stated no communication occurred between the hospital's lab and the reference lab regarding the incorrect order, but a new order was needed to process the specimen. The assistant cancelled the specimen order after he/she was aware of the patient's demise. There was no evidence in the record that the attending physician was notified.
Item #3 - Semi-Critical Device Reprocessing
Based on observation, interview, and document review, the hospital failed to ensure that manufacturer ' s instructions for disinfectants and test strips were followed when reprocessing semi-critical devices.
Failure to properly utilize disinfecting products during semi-critical device reprocessing places patients at risk for infection.
1. The manufacturer ' s instructions for use for MetriCide OPA Plus test strip state in part, " Read the results of the color reaction present on the indicating pad at 60 seconds after the test strip is removed from the solution. "
The manufacturer ' s instructions for use for MetriCide OPA Plus Solution state in part, " 5) High-level Disinfection. Manual Processing: Immerse the pre-cleaned and dried instrument completely in the MetriCide OPA Plus Solution for 12 minutes at a minimum of 20 degrees Celsius (68 degrees Fahrenheit) for high-level disinfection. "
2. On 1/24/2017 at 2:00 PM, Surveyor #1 observed a high-level disinfection procedure in the central processing unit for a transesophageal echocardiography (TEE) probe (a device used to take images of a heart). The sterile processing technician (Staff Member #1) conducting the procedure used test strips to verify the efficacy of the MetriCide OPA (a disinfectant). S/he placed the test strip into the OPA solution and read the test strip immediately after removing it from the solution rather than 60 seconds later.
3. Following testing of the solution, the technician inserted the TEE probe into the solution and started a timer that counted up from 0:00. S/he stated that the probe needs to be submerged in the OPA solution for 12 minutes. S/he removed the probe from the disinfectant solution when the timer read 6 minutes rather than letting it sit in disinfectant until the timer reached 12 minutes.
Item #4 - Surgical Room Cleaning
Based on observation, interview, and document review, the hospital failed to ensure that staff performed surgical room terminal cleanings per hospital procedures.
Failure to follow hospital procedures when performing surgical cleanings places patients at risk of infection.
1. The Hospital procedure training document titled " CHI Franciscan Health: Environmental Services Cleaning Operating Suite " (Rev. 11/2016) states in part, " What should be cleaned first? Clean from: top to bottom ... "
2. On 1/24/2017 from 10:00 PM to 11:00 PM, Surveyor #1 observed a terminal cleaning procedure of an operating room. The surveyor interviewed the environmental services technician (Staff Member #2) regarding the order in which items were cleaned. S/he stated that a clockwise order is performed to ensure that all items are cleaned. S/he also stated that following equipment cleaning, the walls and ceiling are cleaned, followed by the floor.
3. The technician performed the room cleaning as stated in the interview. The staff member employed a top down cleaning procedure for the equipment, cleaning lights and high dusting prior to performing disinfections of items lower to the ground. The wall and ceiling cleanings were conducted following the equipment cleaning. Cleaning in this order has the potential to introduce contaminants from the wall and ceiling back to the recently cleaned operating room equipment.
Item #5 - Proper use of Disinfectants
Based on observation, document review, and interview, the hospital failed to ensure that staff knew the contact time for disinfectants used in the surgical suites.
Failure to properly use disinfectants and know how long they must remain on surfaces to effectively kill pathogens places patients and staff at risk of infection.
1. The manufacturer ' s instructions for use for Expose II 256 (Diversey)state in part, " Contact Time: Allow surface to remain wet for 1 minute to kill HBV, HCV, and HIV-1 and 10 minutes to kill all other organisms. "
2. On 1/24/2016 from 10:00 PM to 11:00 PM, Surveyor #1 observed a terminal cleaning of an operating room. The surveyor asked an environmental services technician (Staff Member #2) what disinfectant was used to clean the surgery suite. S/he stated that Exopse II 256 by Diversey is used. The surveyor then asked the technician what the contact time of the product is to ensure effective killing of pathogens on environmental surfaces. S/he stated that the contact time was 10-15 seconds. The Environmental Services Operations Manager (Staff Member #3) confirmed to the surveyor that the contact time is 10 minutes.