HospitalInspections.org

Based on interviews, policy and procedure review, and documentation in three of three medical records of patients who exhibited signs and symptoms of suspected communicable diseases (Patient #s 1, 2, and 3) it was determined that the hospital failed to protect patients, staff, and the public from the potential for transmission of infections and communicable diseases. Findings include:

Refer to A749, CFR 482.42(a)(1), Infection Control, which reflects the hospital's failure to report cases of suspected infections and communicable diseases to the local public health authority, in accordance with the reporting requirements of the State of Oregon Communicable Diseases Program.

Based on interviews, policy and procedure review, and documentation in three of three medical records of patients who exhibited signs and symptoms of suspected communicable diseases (Patient #s 1, 2, and 3) it was determined that the infection control officer had failed to develop and implement a system which ensured reporting of cases of suspected infections and communicable diseases to the local public health authority, in accordance with the reporting requirements of the State of Oregon Communicable Diseases Program. Findings include:

1. The Disease Reporting OARs at OAR 333-018-0000 through OAR 333-018-0035 identify health care facilities obligations for reporting of diseases and suspected diseases to the local public health authority. OAR 333-018-0015(1) requires that "Health care providers shall report all human cases or suspected human cases of the diseases, infections, microorganisms, and conditions specified below." OAR 333-018-0015(4) identifies those diseases, infections, microorganisms, and conditions. OAR 333-018-0015(4)(c) requires "Within one local public health authority working day:...Escherichia coli (Shiga-toxigenic, including E. coli O157 and other serogroups)...Mycobacterium tuberculosis and M. bovis (tuberculosis)...and hemolytic uremic syndrome."

2. On 7/29/10 the Centers for Disease Control (CDC) Division of Foodborne, Bacterial, and Mycotic Diseases Internet webpage titled "Escherichia coli O157:H7" was reviewed. The webpage was "last updated" on 7/21/10 and contained the following information:

"Some kinds of E. coli cause disease by making a toxin called Shiga toxin. The bacteria that make these toxins are called " Shiga toxin-producing " E. coli, or STEC for short...The most commonly identified STEC in North America is E. coli O157:H7...

Around 5-10% of those who are diagnosed with STEC infection develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS)...Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.

People of any age can become infected. Very young children and the elderly are more likely to develop severe illness and HUS than others, but even healthy older children and young adults can become seriously ill."

3. On 6/18/2010 the North Central Public Health District (the local public health authority in the community in which the hospital is located) issued a written "Health Alert to Local Patient Care Providers". This document was reviewed and reflected that it was based on the death of an individual in the community who was confirmed to be infected with E. coli O157 and the death of a family member of that individual due to Hemolytic Uremic Syndrome (HUS). The alert indicated that the local public health authority was "...coordinating our efforts with the State Public Health to determine whether there are any indications of a common source outbreak. In Oregon, HUS is most commonly caused by infection with E. coli O157:H7, particularly in children. June is typically the month in which Oregon begins to see the summer rise in E. coli O157 infections." The alert contained several bullet point "Facts" about E. coli O157 which included: "Diarrhea can vary from mild and non-bloody to very bloody. Diarrhea may be accompanied by abdominal cramps, often severe, nausea and vomiting. Fever is generally absent or low-grade." It identified information about the incubation period, communicability, mode of transmission, treatment, etc. The alert concluded with the following: "We are asking you to call us if you see patients for whom you suspect E. coli O157, or if you have further questions...Please do not wait for lab confirmation to call; HUS is a reportable syndrome. Reports should be made within 1 day."

During an interview on 7/22/10 at approximately 1300 the hospital's Infection Preventionist confirmed that the hospital and the hospital's medical providers had received this Health Alert on 6/18/2010.

4. The review of the record of Patient #2 reflected that this 16-year old presented to the hospital's emergency department (ED) on 6/20/10 at 1028 with a chief complaint of severe abdominal pain. The patient also reported nausea, loss of appetite, vomiting, and diarrhea. The patient denied bloody diarrhea and fever. The record reflected that the patient's "neighbor just died of E. coli 0157."

While in the ED the patient's temperature was within normal limits. Laboratory work was done. A sample of stool obtained rectally was "Strongly heme-positive" which indicated blood was detected in the stool. A stool culture was not done and a physician's note indicated that "No stool available at this time". That note reflected that the patient "does live in proximity of the recent cases of E. coli 0157". The "Clinical Impression" was "Acute abdominal pain of undetermined cause. Vomiting. Diarrhea (Guiac positive)." (A guiac test identifies blood in the stool that is not visibly apparent.)

There was no documentation in the record which reflected that this case was reported to the local public health authority as a suspected case in accordance with the OAR reporting requirements and the local public health authority Health Alert issued two days prior.

During an interview on 7/22/10 at approximately 1300 the hospital's Infection Preventionist stated that the hospital had not reported this case to the local public health authority and further stated that he/she did not know about this case until 7/19/10.

5. The review of the record of Patient #3 reflected that this 14-year old presented to the hospital's ED on 7/11/10 at 0028 with a chief complaint of diarrhea, fever, and abdominal pain. The diarrhea was described as severe, and bloody and watery. The patient reported having had a fever.

While in the ED the patient continued to experience diarrhea. His/her temperature was within normal limits. Laboratory work was done. A sample of stool obtained was "Heme-positive" which indicated blood was detected in the stool. A stool specimen was collected for "testing of fecal leukocytes and ova and parasites and culture." The "Clinical Impression" was "Infectious colitis". The patient was admitted to the hospital for further testing and treatment.

The physician "Discharge Summary" dictated and transcribed on 7/13/10 reflected that during the hospitalization "Stool cultures were sent for pathogens including Salmonella, Shigella, Yersinia, Campylobacter, and E. coli 015787", that there was a "concern for the possibility of infection with E.coli 015787, and potential for development of hemolytic uremic syndrome", and that "there have been several cases of E. coli 015787 positive hemolytic uremic syndrome in this community."

There was no documentation in the record which reflected that this case was reported to the local public health authority as a suspected case in accordance with the OAR reporting requirements and the local public health authority Health Alert.

During an interview on 7/22/10 at approximately 1300 the hospital's Infection Preventionist stated that the hospital had not reported this case to the local public health authority and further stated that he/she did not know about this case until 7/21/10.

6. During an interview about the cases of Patient #s 2 and 3 on 7/26/10 at approximately 1430, the State of Oregon Public Health Division Communicable Diseases Program Manager stated that those cases should have been reported as suspected cases in response to the Health Alert issued by the local public health authority. He stated that for reporting purposes in the event of a possible outbreak "its a case until proven otherwise."

7. The review of the record of Patient #1 reflected that this 25-year old presented to the hospital's ED on 5/1/10 at 2018 with a chief complaint of cough, fever, and muscle aches. The patient reported difficulty breathing and yellow, blood tinged sputum. He/she also complained of pleuritic, well localized left sided chest pains. The patient further revealed that he/she had moved from Mexico six months prior.

At 2045 nursing notes reflected that the patient was moved to the EDs negative pressure room "due to coughing up blood, fever, came from Mexico 6 mos ago." Notes further reflected that the patient was provided with a mask to wear when transported from the room for chest x-rays.

The physician's notes reflected that "Pt has small pleural effusion that needs pleurocentesis for diagnosis, esp. given pt's hemoptysis and recent immigration from Mexico. As we have no beds here recc. transfer...awaiting an isolation bed at [another hospital]...Clinical Impression Pneumonia. Pleural effusion. This may be secondary to pneumonia. [Tuberculosis (TB)] is also a consideration, although [patient's] infiltrate is in the [left lower lobe] which is not classical TB."

Nursing notes reflected that the patient was wearing a mask when he/she left the hospital for transport to the other hospital.

There was no documentation in the record which reflected that this case was reported to the local public health authority as a suspected case of TB in accordance with the OAR reporting requirements and the local public health authority Health Alert.

During an interview on 7/22/10 at approximately 1300 the hospital's Infection Preventionist stated that the hospital had not reported this case to the local public health authority. The Preventionist stated that he/she had been notified of this case by the local public health authority on 5/7/10. He/she stated that the local public health authority had contacted him/her on that date to inform the hospital that a patient who had been seen in the ED (Patient #1) had tested positive for TB at the hospital to which the patient had been transferred.

8. During an interview on 7/27/10 at approximately 1215 the administrator of the North Central Public Health District (local public health authority) expressed the importance of the reporting of suspected cases of infectious and communicable diseases. She stated that the public health response and investigation would begin on the day of reporting and proceed aggressively depending on what other information and identified suspect or confirmed cases public health already had knowledge of.

During the interview the administrator stated that in February of 2009 State and local public health officials had met with hospital staff to review the reporting requirements. This meeting had resulted in part from the hospital's failure to report a suspected case of another reportable disease and cases of animal bites as required in OAR 333-018-0015(4)(c).

9. The hospital's infection control policies and procedures were reviewed.

The Infection Control and Surveillance Plan was dated as last revised on "4/09". The "Program Description" portion of this plan included the statement: "In addition to reporting isolation cases, suspected infections and positive cultures, as well as providing required follow-up information, each department will be responsible for full and timely cooperation with the Infection Control Practitioner to develop and implement remedial/corrective action." The "Policies" section of the plan denoted: "Infection Control policies are based on recognized guidelines, applicable laws and regulations and address measures to prevent the transmission of infections among patients, employees, medical staff, students, volunteers, visitors and the general public." The "Surveillance Strategies" portion of the plan included a requirement that "The lab notifies the Infection Control Practitioner of any positive culture of highly resistant bacteria and any cases of the following:...Any inpatient or employee test results that are included in the [Oregon Health Division] reportable diseases and conditions list". The "Reporting Structure" portion of the plan included: "Mid-Columbia Medical Center personnel and medical staff members share indirect accountability in reporting of isolation cases, suspected infection and reports of positive cultures to the Infection Control Practitioner...Infection Control and the laboratory provide information to the appropriate health department for each reportable infectious disease report that is processed by the hospital laboratory."

Although the hospital's written infection control plan indicated that suspected cases of infection and communicable diseases would be reported, that reporting had not occurred as evidenced by examples in this report, and there were no written policies and procedures or systems in place to ensure that such reporting was done as required.

The Laboratory Department Infection Control Procedure: Reportable Diseases policy and procedure was dated with an effective date of 12/28/2008. The policy required that the laboratory report "After identification of the organism or parasite has been made..." However, the list under the "Reportable Diseases" section of the policy did not include all of the reportable diseases required by OAR 333-018-0015(4). For example: Clostridium botulinum (botulism); Clostridium tetani (tetanus); hepatitis A; hepatitis B; hepatitis C; hepatitis D; HIV infection and AIDS; among others, were not identified on the policy and procedure as reportable.

Although the laboratory policy required reporting of confirmed cases of infections and communicable diseases, that policy was not current and complete.

During an interview on 7/22/10 at approximately 1200 and again on 7/23/10 at approximately 1000 the hospital's Infection Preventionist confirmed that there were no written policies and procedures which specified how "suspected infection" as identified in the Infection Control and Surveillance Plan was reported to the local public health authority. He/she stated that the medical providers were responsible for that reporting and that those reports would "not necessarily" be reported to him/her. He/she verified that there was no system in place, in practice or in writing, which ensured that suspected cases were reported to the Infection Preventionist or to the local public health authority.

Additionally, during the interview on 7/23/10 the Infection Preventionist acknowledged that the laboratory policy for reporting confirmed diseases, infections, and microorganisms was not current.

10. During an interview on 7/22/10 at approximately 1230 the hospital's Vice President stated that the hospital had not reported as required. He/she indicated that the hospital had begun taking corrective actions on 7/19/10 when executive and management staff had become aware of the failures to report.

The findings gathered during the onsite portion of this complaint investigation were shared with the hospital Vice President, the Director of Performance and Quality Systems, The Chief Nursing Officer, and the Infection Preventionist on 7/23/10 at approximately 1430. No additional information was provided which reflected that the hospital had reported the suspected cases identified in this report. Further, no additional information was provided which reflected that the hospital had in place prior to the beginning of this onsite investigation, a formal, written system for reporting suspected cases of diseases, infections, microorganisms, and conditions as required.