HospitalInspections.org

Based on observation, document review, staff interview and review of nationally recognized guidelines, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibility of the operation and management of the facility.

Findings include:

1. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with 482.42 Infection Control. (Cross refer to Tag 747).

Based on observation, document review and staff interview, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

1. The facility failed to develop and implement a policy for the immunization health status for all employees including volunteers regarding communicable diseases as recommended by nationally recognized guidelines. (Cross refer to Tag 748)

2. The facility failed to ensure that the infection control officer or officers developed a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. (Cross refer to Tag 749)

Based on staff interview and facility document review, it was determined that the facility failed to develop and implement a policy for the immunization health status for all employees including volunteers regarding communicable diseases as recommended by nationally recognized guidelines.

Findings include:

Reference: www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.pdf; VPD Surveillance Manual, 6th Edition, 2013 Measles: Chapter 7-17, states, "... 7 ... Health care settings: Persons who work in health care facilities (including volunteers, trainees, nurses, physicians, technicians, receptionists, and other clerical and support staff) are at an increased risk of exposure to measles and at increased risk of transmission to persons at high risk of severe measles. All persons who work in such facilities in any capacity should have presumptive evidence of immunity to measles to prevent any potential outbreak. ..."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. On 5/30/17 at 1:50 PM, a request was made to Staff #2, #31, and #32 for a policy and procedure for the health requirements, including immunization status for volunteers.

a. Staff #2, #5, and #32, confirmed there is no policy and procedure for volunteer health requirements including immunization status. Employee health uses a health history questionnaire only.

2. The facility failed to develop policies that govern control of infections and communicable diseases that includes all personnel exposed while working in the facility.

3. Staff #2 confirmed there is no record of immunity for the facilty's volunteers.

A. Based on staff interview, it was determined that the facility failed to ensure a system for identifying and evaluating measures that control and prevents infections and communicable diseases of patients and personnel that require negative pressure airflow ventilation.

Findings include:

Reference: www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.pdf; VPD Surveillance Manual, 6th Edition, 2013 Measles: Chapter 7-17, states, "... 7 ... Health care settings: Persons who work in health care facilities (including volunteers, trainees, nurses, physicians, technicians, receptionists, and other clerical and support staff) are at an increased risk of exposure to measles and at increased risk of transmission to persons at high risk of severe measles. All persons who work in such facilities in any capacity should have presumptive evidence of immunity to measles to prevent any potential outbreak. ... Health care personnel (HCP) have slightly different criteria for acceptable presumptive evidence of immunity. All persons who work in health care facilities should have presumptive evidence of immunity to measles. This information should be documented and readily available (ideally through electronic medical records) at the work location. Presumptive evidence of immunity to measles for health care personnel includes any of the following: * written documentation of vaccination with 2 doses of live measles or MMR vaccine administered at least 28 days apart. *Laboratory evidence of immunity. *Laboratory confirmation of disease, or *Birth before 1957. Although birth before 1957 is considered as presumptive evidence of immunity, for unvaccinated HCP born before 1957 that lack laboratory evidence of measles immunity or laboratory confirmation of disease, health care facilities should consider vaccinating personnel with two doses of MMR vaccine at the appropriate interval. ..."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. On 5/30/17 at 1:50 PM, an interview was conducted with Staff #31 and Staff #32 regarding volunteer staff at the facility and the following was revealed:

a. The facility utilizes adult and junior (college-age) volunteers. The process for becoming a volunteer includes an interview, facility orientation that includes receiving educational material regarding patient confidentiality information. In addition, employee health clears them with a health history questionnaire only.

(i) The only immunization requirement for volunteers is a two (2) step Mantoux skin test for adults or medical clearance by the volunteer's primary physician. Junior volunteers get a 1-step Mantoux skin test and if a positive result occurs, they need medical clearance by their primary physician.

b. At 2:10 PM, Staff #9 confirmed that documentation of immunization status is not required by volunteers. A Mantoux test is the only immunization test conducted initially and annually on all volunteers. In the facility's Hospice-End of Life care program, the volunteers and volunteer nurses do require documented titers for measles, mumps, rubella, Hepatitis B and C.

3. The facility failed to develop and implement infection prevention and control measures and precautions that includes all hospital personnel in accordance with CDC guidelines and recommendations.







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B. Based on review of medical records, facility documents, and staff interview, it was determined that the facility failed to develop a system for identifying, reporting, and controlling infections and communicable diseases of patients and personnel.

Findings include:

Reference: Facility policy titled, "Reporting Requirements for Communicable Diseases and Work-Related Conditions" states, "Confirmed or suspect cases telephone Immediately to the Local Health Department... Measles... If the individual does not live in New Jersey report the case to the New Jersey Department of Health at..."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. On 5/26/17 at 2:49 PM, interview with Staff #11 revealed the following:

a. Staff #11 indicated that on 5/13/17, he/she received a phone call from the Nursing Supervisor regarding Patient #1.

(i) The Nursing Supervisor reviewed the History and Physical and the order for the measles IgG and notified Staff #11.

(ii) Staff #11 advised him/her that the patient should be placed in a negative pressure room.

(iii) Staff #11 indicated that Patient #1 was placed on Airborne Isolation in an Airborne Infection Isolation Rooms (AIIR).

3. On 5/26/17, review of Medical Record #1 revealed the following:

a. At 9:13 PM, there was a physician order to transfer Patient #1 to Surgical Bergen 2B Unit (2B) to be placed in a negative pressure room for Airborne Isolation Precautions.

b. At 11:15 PM, a nursing note indicated that Patient #1 was transferred from the Pediatrics-Phillips 2E unit to the Surgical-Bergen 2B unit, where he/she was placed on Airborne Isolation Precautions.

4. On 5/16/17 at 9:14 AM, Staff #11 indicated in the Electronic Medical Record (EMR), "Case reported to health department as a possible measles. Upon reporting, state health department contacted infection control and requested additional testing for Rubeola IGM. Contacted microbiology lab manager who states blood specimen is still available and test can be added to existing/pending lab work. ..."

5. The facility reported to the Department after Patient #1 was discharged from the facility on 5/16/17.

6. Staff #11 failed to report suspicion of measles, to the Department, in a timely manner.

7. The facility failed to ensure implementation measures to report communicable diseases within the facility.

8. The facility failed to follow its policy of "Reporting Requirements for Communicable Diseases and Work-Related Conditions."

9. Staff #2 confirmed the above findings.












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C. Based on review of medical records, facility documents, video surveillance, and staff interview, it was determined that the facility failed to implement and evaluate measures governing the prevention and control of infections and communicable diseases within the hospital.

Findings include:

Reference #1: CDC, Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007, pg. 68 ...pg. 112 states, " ... III.B.3. Airborne precautions. Airborne Precautions prevent transmission of infectious agents that remain infectious over long distances when suspended in the air (e.g., rubeola virus [measles], varicella virus [chickenpox], M. tuberculosis, and possibly SARS-CoV. ... The preferred placement for patients who require Airborne Precautions is in an airborne infection isolation room (AIIR). An AIIR is a single-patient room that is equipped with special air handling and ventilation capacity that meet the American Institute of Architects/Facility Guidelines Institute (AIA/FGI) standards for AIIRs ... III.C. Syndromic and Empiric Applications of Transmission-Based Precautions. Diagnosis of many infections requires laboratory confirmation. Since laboratory tests, especially those that depend on culture techniques, often require two or more days for completion, Transmission-Based Precautions must be implemented while test results are pending based on the clinical presentation and likely pathogens. Use of appropriate Transmission-Based Precautions at the time a patient develops symptoms or signs of transmissible infection, or arrives at a healthcare facility for care, reduces transmission opportunities. While it is not possible to identify prospectively all patients needing Transmission-Based Precautions, certain clinical syndromes and conditions carry a sufficiently high risk to warrant their use empirically while confirmatory tests are pending ... Table 2. Clinical Syndromes or Conditions Warranting Empiric Transmission-Based Precautions in Addition to Standard Precautions ... Disease: Rash or Exanthems, Generalized, Etiology Unknown ... Clinical Syndrome or Condition: Maculopapular with cough, coryza and fever ... Potential Pathogens: Rubeola (Measles) virus ... Empiric Precautions (Always Includes Standard Precautions): Airborne Precautions. ... ."

Reference #2: Facility policy titled "Patients Entering the Emergency Department (ED) with a Febrile Vesicular or Pustular Rash" states, "... 2. The triage nurse will put on an N 95 respirator and go to the triage entrance hallway to accompany patient to a negative pressure room. (The Charge nurse will assure that the negative pressure room is vacated). Physician will be called to evaluate the rash and determine further treatment. ... ."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. Review of Medical Record #1 on 5/26/17, revealed the following:

a. On 5/13/17 at 9:15 AM, Patient #1 arrived at the Emergency Department (ED) with a complaint of fever, sore throat, rash, and eye irritation.

b. On 5/13/17 at 10:00 AM, the ED Physician note indicated the following:

(i) The History of Present Illness narrative states, "16-year-old [gender] from India who traveled to the United States on May 4 for a trip presenting with fever, rash, sore throat, and eye pain. The patient was doing well until May 9 when [he/she] developed a fever up to 101-102 F. ... 2 days ago, as [his/her] fever continued, [he/she] developed a sore throat... Last night the patient noted a rash and by this morning the rash had spread over [his/her] body. ... The patient's vaccine status is not definitively known. ... ."

(ii) Review of Systems states, "... Skin: Diffuse blanching erythematous maculopapular rash primarily over the face and torso. ... ."

(iii) The Course Narrative states, "Differential diagnosis includes but is not limited to viral exanthema, adenovirus, rubella, measles, ... . Given the history presented, findings on exam, and the patient's travel [name of physician] from pediatric infectious diseases was contacted to discuss the case. ... ."

c. The Pediatric Infectious Disease consult note on 5/13/17 at 1:39 PM indicates, "... Given that the patient is within the incubation period if [sic] requiring [sic] infectious illnesses from India, Measles, ... should be considered in the differential. ... ."

d. A STAT add on test for Rubeola (Measles) IgG was ordered on 5/13/17 at 1:44 PM.

(i) The Serology Report on 5/13/17 at 2:16 PM indicates, "... Rubeola IgG - Negative. No IgG antibody detected. Patient is presumed not to have had a previous exposure through infection or vaccination. ... ."

3. On 5/26/17, interview with Staff #3 indicated that Patient #1 arrived at the main lobby of the hospital on 5/13/17, and was escorted to Pediatric ED Room #9. Patient #1 was placed on standard isolation precautions.

a. Staff #3 indicated that Patient #1 was never placed in a negative pressure room while in the Pediatric ED, as per CDC guidelines in Reference #1.

4. On 5/26/17 during interview, Staff #15 was questioned what he/she would do if he/she was working triage and a pediatric patient presented to the ED with a fever and rash, and indicated that they recently traveled to a foreign country. Staff #15 stated that he/she would put a mask on the patient and place the patient in Room #12. Room #12 is the negative pressure room that is used by the Pediatric ED.

5. The facility failed to follow its policy regarding patients presenting to the ED with a rash. (Refer to Reference #2)

6. The facility failed to implement measures to prevent and control communicable diseases within the facility.










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Reference #3: CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings I.B.3.c. Airborne transmission states, "Airborne transmission occurs by dissemination of either airborne droplet nuclei or small particles in the respirable size range containing infectious agents that remain infective over time and distance... . Microorganisms carried in this manner may be dispersed over long distances by air currents and may be inhaled by susceptible individuals who have not had face-to-face contact with (or been in the same room with) the infectious individual. Preventing the spread of pathogens that are transmitted by the airborne route requires the use of special air handling and ventilation systems (e.g., AIIRs [Airborne Infection Isolation Rooms) to contain and then safely remove the infectious agent. Infectious agents to which this applies include... rubeola virus (measles). ... II.A.3. Adherence of healthcare personnel to recommended guidelines. Adherence to recommended infection control practices decreases transmission of infectious agents in healthcare settings. ...

Reference #4: Facility policy titled, "Airborne Precautions" states, "Policy: In addition to Standard Precautions, Airborne Isolation Precautions are used for patients known or suspected it be infected with microorganisms transmitted by airborne droplet nuclei small particle residue...or evaporated droplets containing microorganisms that remain suspended in the air and can be dispersed widely by air currents within a room or over a long distance. Examples of illnesses requiring Airborne Isolation Precautions: ...Measles...C. Patient Transport: ...2. If transport or movement is necessary, minimize patient dispersal of droplet nuclei by placing a surgical mask on the patient."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. On 5/26/17, review of Medical Record #1 revealed the following:

a. On 5/13/17 at 3:36 PM, Patient #1 was transferred from the Pediatric Emergency Department (ED) to the Pediatrics-Phillips 2E unit.

(i) At 8:39 PM, the physician ordered Patient #1 to be placed on contact and droplet isolation precautions.

(ii) At 9:13 PM, a physician ordered Patient #1 to be transferred to Surgical-Bergen 2B unit for Airborne Isolation Precautions.

(iii) At 11:15 PM, a nursing note indicated that Patient #1 was transferred from the Pediatrics-Phillips 2E unit to the Surgical-Bergen 2B unit, where he/she was placed in a negative pressure room for Airborne Isolation Precautions.

(iv) There was no documented evidence in the medical record that Patient #1 was wearing a surgical mask during transport from the Pediatrics-Phillips 2E unit to the Airborne Infection Isolation Room (AIIR) on Surgical-Bergen 2B unit.

3. On 5/26/17, interview with Staff #19 confirmed that Patient #1 was not in an AIIR while on Pediatrics-Phillips 2E unit.

4. On 5/26/17, review of the facility document titled, "Patient Assignment Sheet," which is used to document patient room assignment; patient diagnosis and staff that are working on the unit, revealed the following:

a. The document is dated 5/13/17 at 4:23 PM; Location Pediatrics-Phillips 2E.

(i) In the "Room" column, Patient #1 was listed as being in room PEDTREAT; his/her age (16 y.o.) and a diagnosis of "fever, rash, R/O [rule out] Measles."

5. The facility failed to follow its "Airborne Precautions" policy. (Refer to Reference #4)

a. Suspected measles patients should be placed on Airborne Isolation Precautions to reduce the risk of transmission.

(i) Placing a surgical mask on the patient, during transport outside of the AIIR, reduces the risk of transmission.

6. The facility failed to ensure implementation measures to prevent and control communicable diseases within the hospital.

(i) There was an exposure period from 5/13/17 at 9:15 AM until 11:15 PM, when Patient #1 was not on Airborne Isolation Precautions.

Reference #5: CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings...Appendix A states, "Appendix A... Type and Duration of Precautions Recommended for Selected Infections and Conditions... Infection/Condition... Measles (rubeola)...Type of Precaution... Airborne + Standard...Duration of Precautions... 4 days after onset of rash; ..."

1. On 5/26/17, interview with Staff #8, confirms the facility follows Centers for Disease Control and Prevention (CDC) guidelines for infection control.

2. On 5/26/17, review of Medical Record #1 revealed the following:

a. On 5/13/17, Patient #1 was admitted to the facility.

(i) Medical Record #1 indicates that the patient's onset of rash was 5/13/17.

(ii) On 5/15/17 at 2:00 PM, the facility document titled "Discharge Summary" states, "Hospital Course ...I discussed the lab findings below with Dr [Doctor] [name of physician] (pedi [pediatric] ID). Dr [name of physician] is comfortable with removing Patient #1 from any isolation and discharging [him/her] from Valley Hospital."

(iii) On 5/15/17 at 2:38 PM, a physician ordered discharge home and to transport the patient to the lobby by wheelchair.

(iv) At 2:55 PM on 5/15/17, the nursing note states that the patient was discharged, accompanied by his/her legal guardian and transported by a transport aide.

(v) Review of the facility's video surveillance on 5/15/17, demonstrated that there was a period from 5/15/17 at 3:00 PM until 4:06 PM, where Patient #1 was still contagious and sitting in the main lobby as indicated in Reference #5.

3. On 5/26/17 at 4:18 PM, review of the security video surveillance with Staff #2 and Staff #27 in the security control room revealed:

a. On 5/15/17 at 3:50 PM, Patient #1 and a male/female adult came into view in the front lobby exit. Patient #1 remained in an enclosed waiting area in the lobby without a surgical mask in place.

b. On 5/15/17 at 4:06 PM, Patient #1 is observed walking out of the facility.

4. The facility failed to follow the CDC guidelines (Reference #5) and keep Patient #1 on Airborne Isolation Precautions for four (4) days after the onset of the rash.