Initial Comments:
This report is the result of an offsite complaint investigation (JOH19C028J) completed on June 16, 2021, with Conemaugh Memorial Medical Center. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 PA Code, Part IV, Subparts A and B, November 1987, as amended June 1998.
Plan of Correction:
103.4 (3) LICENSURE
FUNCTIONS
Name - Component - 00
(3) Take all reasonable steps to
conform to all applicable Federal,
State, and local laws and
regulations.
Observations:
Based on a review of facility documents and interview with facility staff (EMP), it was determined that the facility failed to conform to all applicable State Laws.
Conemaugh Memorial Medical Center was not in compliance with the following State Law related to Chapter 27 of PA Communicable and Non-Communicable Diseases issued and amended under the Disease Prevention and Control Law of 1955 (35 P.S. 521.1-521.21)
27.3. Reporting outbreaks and unusual diseases, infections and conditions.
(a) A person required to report under this chapter shall report an outbreak within 24 hours, and in accordance with 27.4 (relating to reporting cases).
(b) A person required to report under this chapter who suspects a public health emergency, shall report an unusual occurrence of a disease, infection or condition not listed as reportable in Subchapter B (relating to reporting of diseases, infections and conditions) or defined as an outbreak, within 24 hours, in accordance with 27.4.
(c) Any unusual or group expression of illness which the Department designates as a public health emergency shall be reported within 24 hours, and in accordance with 27.4.
This was not met as evidenced by:
Based on a review of facility documents and staff interviews (EMP), it was determined that the facility failed to follow their adopted policies and guidance issued by Pennsylvania Health Advisory Network (PA HAN) by failing to report a vape related lung injury in one of one patient (MR1).
Findings Include:
Conemaugh Memorial Medical Center ... PolicyStat ID: 6413620 ... Policy Area: Infection Prevention-Operational ... Administration of Epidemiology, Prevention and Infection Control Program policy and procedure dated July 2019. "... Purpose The purpose of this plan is to provide for a program of surveillance, prevention, and control of infection. The purpose of the Epidemiology, Prevention and infection control program is to identify, and develop approaches to reduce the risk of healthcare-associated infections (HAI) among patients, employees, physicians, residents, volunteers, contract workers, students and visitors. The program's focus includes: (1) keeping abreast of the community-acquired diseases that are currently prevalent in our geographic region; ... Communication ...
External Reporting to the Pennsylvania Department of Health and Centers for Disease Control and Prevention is done as required by Public Health Law. ... Surveillance Strategies. Surveillance strategies have been identified which are of epidemiological importance to Memorial Medical Center and the population served. ... Strategies are derived from evidence-based practice, national guidelines and expert consensus. ... ."
Review of "Annual Evaluation of the Infection Prevention and Control Plan for Memorial Medical Center 2019, revealed, "Overview of Infection Prevention Risk Assessment and Prioritization of Goals ... The annual Infection Prevention and Control Risk Assessment helps focus our activities on those tasks that are most essential to reducing critical infection risks. The assessment determines potential threats associated with equipment and devices, treatments and services, procedures, employees, the environment and the patient population served. ... Consideration is given to changes in regulatory requirements, patient and employee safety initiatives, evidence-based recommendations and MMC strategic initiatives. The plan and risk assessment are reviewed at least annually and whenever significant changes occur in the elements that affect risk. ... 2019 Surveillance Plan ... The Surveillance Plan is a written description of the activities, including surveillance, to minimize, reduce, or eliminate the risk of infection for our patients, visitors and staff. The program must be dynamic and agile to respond to changes and demands of healthcare environment. ... Surveillance of the Population Which Influences Risk ... 2. Monitoring and methodology according to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) surveillance methodology and the Pennsylvania Department of Health (PA DOH). Surveillance includes all CDC-defined event types and specific events. ... Communication ... 8. Continued review and sharing of advisories with key stakeholders and the medical staff from the Pennsylvania Health Alert Network (PA-HAN) via email. Regulatory Compliance 1. Compliance with regulations of the PA DOH, TJC, CMS and OSHA. ... ."
Conemaugh Memorial Medical Center ... PolicyStat ID: 6413592 ... Policy Area: Infection Prevention-Operational ... Act 52, Pennsylvania Department of Health policy and procedure dated July 2019. "Active Surveillance Processes ... Health Alert Network (HAN) The Pennsylvania Department of Health HAN alerts are distributed to the Medical Staff, Residents and other health care worker staff as appropriate. The Director of Quality, Infection Preventionists, Director of the Laboratory and other Lab personnel subscribe to the alert system. ... ."
1. MR1 dated August 22, 2019, through September 3, 20219, revealed:
"ED Provider Notes ... 08/22/19 1129 ... Patient reports pt. vapes and is concerned pt has a lung infection. Pt states pt uses THC cartridges. Pt reports pt was watching the News last night and became concerned after seeing a story stating that vaping can cause lung infections. ... ."
"ED Provider Notes ... 08/22/19 1328 ... Chief Complaint: Patient Presents with Chest Pain, Cough. ... ED Course User Index ... Chest x-ray did show bilateral groundglass opacities. ... The patient does vape and has been vaping THC. ... ."
"Consults ... 08/30/10 0903 ... Service: Infectious Disease ... Persisting high grade fevers following 9 days of various abx combinations for presumed PNA. CT PE Angio reviewed-no true lobar infiltrates but ground glass opacities R>>L upper lobes. Patient gives a 3 month hx of daily THC cartridge vaping illicitly obtained from a Pharmacy dispensing medically necessary THC (for a friend) as well as Street drug THC the latter possibly intermingled with impurities, chemicals, possible noxious substances. I suspect this patient has acute lung injury, DAD, Lipoid pneumonia or some form of chemical pneumonitis d/t vaping THC. Doubtful this is an infection. ... A/P THC Vaping lung injury. Doubtful PNA. Already started on steroids with which I agree. ... The patient was seen and examined on 8/30/2019. ... Physical Exam: ... Chest: Coarse breath sounds bilateral ... Assessment & Plan: ... #Possible vaping induced lung injury ... Recommendations ... We do not think this [sic] infection. With her significant history of continuous vaping for the last 3 months, we do think that it could be vaping induced lung injury. Recommend steroid 1 mg/kg daily. DC all IV antibiotics. ... ."
"Progress Notes ... 08/31/19 1854 ... Service: Pulmonology ... Daily Progress Note. Hospital Day: 10. Subjective: ... Assessment: Bilateral pneumonia/pneumonitis. Possible chemical/autoimmune pneumonitis secondary to vaping injury ... ."
"Progress Notes ... 09/01/19 1123 ... Service: Pulmonology ... Hospital Day: 11 Subjective ... Working diagnosis is pneumonitis related to vaping. ... ."
2. "Pennsylvania Department of Health 2019-PAHAN-454-08-16-ADV Severe Pulmonary Disease Associated with Using E-Cigarette Products" dated August 16, 2019, revealed, "... Surveillance. The identification of cases will be critical in order to fully access the impact as well as investigate the cause and prevent further harm. If you suspect a case of lung injury related to vaping, please call Pennsylvania's Poison Centers at 1-800-222-1222. The Poison Centers can provide assistance in the evaluation and potentially management of patients. Additionally, cases reported to poison centers will be catalogued in the National Poison Data System which will greatly strengthen the public health response to this potential threat. ... Please see the link below to the newsletter, CDC Urges Clinicians to Report Possible Cases of Unexplained Vaping-associated Pulmonary Illness to their State/Local Health Department from the CDC Clinician Outreach and Community Activity: https://emergency.cdc.gov/newsletters/coca/081619.htm. ... ."
"Pennsylvania Department of Health 2019-PAHAN-454-08-16" dated August 16, 2019, was sent by the Pennsylvania Health Alert Network to EMP2 on August 16, 2019, at 5:51 PM and then emailed from EMP2 to the Medical Staff Office on August 17, 2019, at 8:22 PM with a message to share the attachment with the medical staff and residents.
3. "Pennsylvania Department of Health 2019-PAHAN-456-09-03 Severe Pulmonary Disease Associated with Using E-Cigarette Products" dated September 3, 2019, revealed, "... This is an official CDC Health Advisory ... Recommendations for Clinicians 1. Report cases of severe pulmonary disease of unclear etiology and a history of e-cigarette product use within the past 90 days to your state or local health department. ... ."
4. Review of facility electronic mail documentation from EMP1 dated June 3, 2021, at 4:17 PM revealed, "IP response ... 'EMP3 reviewed the admit from 8/22 to 9/3/19. So the answer is it was not reported because it preceded the HAN of 10/4/19. ... .'"
Review of facility electronic mail documentation from EMP2 dated June 3, 2021, at 3:28 PM revealed, "... Lung injury associated with vaping is not an 'infectious' cause that Infection Prevention would monitor or report. It is a chemical exposure. If a clinician suspected that an inpatient's lung injury/condition was associated with vaping, Infection Prevention would certainly assist the Clinician with reporting should the Clinician reach out to us."
Review of electronic mail documentation from EMP2 dated June 15, 2:47 PM revealed that EMP4 could not recall receiving the PA-HAN via email from the Medical Staff Office and that EMP4 recalled this case being early in the reports of these types of injuries and that when EMP4 heard the patient's history, "it fit."
Plan of Correction:The Infection Prevention department shares the PA-HANs within 24 hours of receipt of the email
Medical Staff (MS) office and the Resident/Graduate Medical Education (GME) office will distribute the information via email to the physicians, residents and allied health practitioners within 24 hours of receipt. The email will be marked "high importance". The MS office and the resident/ GME office have created an archive folder to keep a copy of all HANs that are sent to the doctors, residents, and allied health practitioners
A specific email address has been developed that goes to the medical staff (MMCdocnews). Physicians will be informed that the MMCdocnews email address is associated with important education and they must read this content. Physicians will be educated by email regarding this new email address.
Physicians, residents, and allied health practitioners will be educated on the process of the PA HANS distribution by July 31, 2021. The education will consist of receipt of the HANS information and a review of the actual reporting process.
Compliance of the education will be reported out at Medical Executive Committee on August 16, 2021.
Compliance will be audited by the MS office and GME office on the next 5 PA-HAN alerts received.
1. PA-HANs received from Infection Prevention within 24 hours of receipt.
2. PA-HANs issued to the physicians, residents, and allied health practitioners within 24 hours of receipt.
Audits will be reported out through the following committees:
Performance Excellence Steering (PES) committee on August 11, September 8, October 13, November 10
Performance Excellence Committee (PEC) of the board on August 18, September 15, October 20, November 17
Compliance will be reported out at the November 15, 2021 Medical Executive Committee.
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