department updates from hospital surveys · •provide best practices and action steps to take back...

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Department Updates from Hospital Surveys

Massachusetts Society of Health Care Risk Management September 20, 2019

Objectives

• Share common themes and findings observed from acute care hospital onsite surveys and validation site visits

• Provide best practices and action steps to take back to your organization

2Massachusetts Department of Public Health mass.gov/dph

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Overview

• Onsite Surveys: primarily based upon compliance with Centers for Medicare and Medicaid Services (CMS) State Operations Manual Appendix A - Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals

– Patient Rights

– Compounding Pharmacies

– Maternal and Newborn Services

• Validation Survey: primarily structured on state statute and regulation

– Neonatal Abstinence Syndrome and Substance Exposed Newborns

– Methicillin Resistant Staphylococcus Aureus

– Primary Stroke Service


Patient Rights: §482.13

State Operations Manual Guidance Update A-0144• Issued and Implemented December 29, 2017

§482.13(c) (2) - The Patient has the right to receive care in safe setting. This standard is intended to provide protection for the patient’s emotional health and safety as well as his/her physical safety.

• In order to provide care in a safe setting, hospitals must identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers.


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Patient Rights, Cont’d

• Behavioral health patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation. The protection would be that of utilizing safety measures such as monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.

• Hospital staff must be trained to identify environmental safety risks regardless of whether or not the hospital has chosen to implement the use of an environmental risk assessment tool to identify potential or actual risks in the patient care environment.



• Hospitals must provide the appropriate level of education and training to staff regarding the identification of patients at risk of harm to self or others, the identification of environmental patient safety risk factors and mitigation strategies.

• Hospitals are expected to provide education and training to all new staff initially upon orientation and whenever policies and procedures change. CMS recommends initial training and ongoing training at least every two years.

• Hospitals have the flexibility to tailor the training to the particular services staff provide and the patient populations they serve.

• Staff includes direct employees, volunteers, contractors, per diem staff, and any other individuals providing clinical care under arrangement.


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State Operations Manual Guidance Update A-0206

• Issued and Implemented October 17, 2008

§482.13(f)(2)(vii) - The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

• The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population

• Hospitals are required to provide a safe environment for the patients in their care. When restraint or seclusion techniques are used, patients are placed at a higher risk for injuries or even death. Hospitals must require appropriate staff (all staff who apply restraint or seclusion, monitor, access or provide care for a patient in restraint or seclusion) to receive education and training in the use of first aid techniques as well as training and certification in the use of cardiopulmonary resuscitation.


Maternal Events: Quantifying Blood Loss

• In reviewing several reported maternal adverse events, DPH identified that the outdated practice of visual estimation of blood loss is still commonly used during delivery

• Visually estimating blood loss after a birth is inaccurate and often underestimates the volume

– May delay the recognition of hemorrhage or other complications and therefore delay necessary interventions to address them

• Maternal Newborn Services should review The Association of Women’s Health, Obstetric and Neonatal Nurses Practice Brief on quantifying blood loss and follow the action steps to be able to weigh all blood-soaked materials

Patel et al., 2006, Della Torre et al., 2011


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Maternal Events: Reporting Maternal Death

• 105 CMR 130.332: Serious Reportable Events (SREs)

– Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting

• 105 CMR 130.628: Data Collection and Reporting Systems

– (B) The hospital shall report the death of a pregnant woman during any stage of gestation, labor or delivery or the death of a woman within 90 days of delivery or termination of pregnancy to the Department in accordance with Department guidelines


Pharmaceutical Services

CMS condition for hospitals

• Controlled Substances

• Compounding

10Massachusetts Department of Public Health mass.gov/dph 10Massachusetts Department of Public Health mass.gov/dph

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Pharmaceutical Services: Controlled Substances

• Should you be involved or not?

–Determined by your hospital policies and procedures, which is mentioned within the condition

–Made aware through internal hospital reporting system

• Unaccounted controlled substances

–What next?

• DEA 106, Massachusetts Drug Incident Reporting Form, File Police Report (if applicable)


Pharmaceutical Services: Federal and State Requirements for Reporting

State Requirements

• https://www.mass.gov/service-details/requirements-for-reporting-a-loss-of-controlled-substances

• Report theft/loss immediately to the Drug Control Program (DCP) by phone. In writing, 7 day follow up.

• DCP is primary agency, no longer require reporting to BHCSQ

• Drug Incident Reporting Formhttps://www.mass.gov/files/documents/2016/07/nn/drug-incident-report-form.pdf

Federal Requirements• DEA 106 – loss/theft federal agency

requirement• Scheduled classes II through V• Can be submitted online at

https://www.deadiversion.usdoj.gov/online_forms_apps.html

New England DEA Office 15 New Sudbury Street, Room E-400Boston, MA 02203617-557-2100


https://www.mass.gov/service-details/requirements-for-reporting-a-loss-of-controlled-substances

https://www.mass.gov/files/documents/2016/07/nn/drug-incident-report-form.pdf

https://www.deadiversion.usdoj.gov/online_forms_apps.html

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Pharmaceutical Services: Reporting to DPH

Drug Control Program239 Causeway Street, Suite 500Boston, MA 02114

[email protected]

(617) 973-0800


Pharmaceutical Services: Compounding Pharmacy

• New guidelines and regulations

– Quick survey by show of hands:

• Completed construction

• Undergoing construction

• Unsure, but think pharmacy team is taking care of things

• USP 797 and USP 800 official date: December 1, 2019

– USP 797 – standards for sterile compounding

– USP 800 – standards for hazardous compounding


mailto:[email protected]

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Pharmaceutical Services: Massachusetts Draft Regulations

247 CMR 17.00, 18.00, 19.00

• 17.00 - Sterile Compounding

• 18.00 – Non-sterile Compounding

• 19.00 – Hazardous Drugs

When Board of Pharmacy (BoP) regulations are finalized:

• Scope and authority of the sterile compounding component will shift to the Board of Pharmacy

• Approval Process

Draft Regulations: https://www.mass.gov/lists/draft-regulations-for-the-board-of-registration-in-pharmacy


MRSA Validation: LabID Event Definitions & Testing Algorithm

MRSA bacteremia laboratory result:

https://www.cdc.gov/nhsn/pdfs/training/2017/Leaptrot_March23.pdf

• Any methicillin-resistant Staphylococcus aureus (MRSA) blood specimen obtained for clinical decision making purposes.

• Excludes screening cultures, such as those used for active surveillance testing


https://www.mass.gov/lists/draft-regulations-for-the-board-of-registration-in-pharmacy

https://www.cdc.gov/nhsn/pdfs/training/2017/Leaptrot_March23.pdf

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69 MA facilities reported 2017 MRSA data in NHSN

• 18 facilities targeted for validation

• 2 facilities randomly selected for validation

MRSA Validation: Hospital Selection

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Method 1

Prioritizing Facilities with Highest Likelihood of Event

Occurrence

18Method 2

Cumulative Attributable Difference (CAD) Approach 2

20 FacilitiesSelected

https://www.cdc.gov/nhsn/validation/index.html


n=20Relative Ratio of SIRs = 1.03 (p-value = 0.81; 95% CI = 0.79 – 1.35)

*Data extracted from NHSN on August 16, 2018

^Data extracted from NHSN on August 15, 2019

MRSA Events

Patient Days

Predicted Infections

SIRConfidence

IntervalInterpretation

Pre-Validation*

107 2,483,351 168 0.64 (0.52 - 0.76) Lower

Post-Validation^

109 2,483,351 177 0.61 (0.50 – 0.73) Lower

MRSA Validation: Standardized Infection Ratio Analysis


https://www.cdc.gov/nhsn/validation/index.html

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Primary Stroke Service Validation

Purpose:To ensure compliance with primary stroke service requirements in the hospital regulation found at 105 CMR 130.1400 and foster quality emergency stroke care delivery across the Commonwealth.


Primary Stroke Service Validation Findings

Validated Primary Stroke Service Regulatory Meeting Specific Regulatory Requirements in 2018, N=24 PSS facilities

Up to 10 ischemic or transient ischemic strokes were selected for an onsite chart review.

• 34 submitted data elements being completed with greater than 90% accuracy when compared to the patient chart.

• Facilities have opportunity to improve documenting:

- last known well time (82% with no discrepancy),

- symptom onset time (86% with no discrepancy)

- brain imaging date and time (65% with no discrepancy)

- date and time of alteplase initiation (88%)


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Neonatal Abstinence Syndrome Validation


8th highest rate of drug overdose in 2017

ICD Codes Substances

Mother F11.20, F13.20 opioids and benzodiazepines

Baby P96.1, P04.49

opioids, methamphetamine, benzodiazepines, barbiturate,

cocaine, hallucinogens, or cannabis

NAS incidence 5 times higher than national average in 2015MA

DPH instructed hospitals to file monthly reports on infants

exposed to controlled substances in the month prior

to delivery Drug overdose deaths. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Available at: https://www.cdc.gov/drugoverdose/data/statedeaths.htmlKo JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome — 28 States, 1999–2013. MMWR Morb Mortal Wkly Rep 2016;65:799–802. DOI: http://dx.doi.org/10.15585/mmwr.mm6531a2.


Neonatal Abstinence Syndrome Validation Findings Across 15 Selected Hospitals: Preliminary Results

• Reviewed 1,123 mother-baby dyads

• ICD code information was provided by hospitals

• Substance use or exposure was assigned based on chart review and included the following drugs:

– methadone, buprenorphine, heroin, other opioids, methamphetamine, amphetamines, benzodiazepines, barbiturate, cocaine, hallucinogens, or cannabis

• Findings are not representative of all births in MA because oversampled reported NAS/SEN cases

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Neonatal Abstinence Syndrome Validation:Preliminary Observations and Action Steps• Observation:

There were 339 moms with evidence of opioid use during pregnancy, but only 3.8% of those mothers had documentation of standardized screening tool (n=13)

– Action: Select an appropriate validated screening tool for use in prenatal and L&D settings and implement them

• DPH recommended screening tools (“Guidelines for Community Standard for Maternal/Newborn Screening for Alcohol/Substance Use ”)

• AIM OUD bundle

– Action: Document screening in prenatal charts and send to intended birth hospital


* Findings are not representative of the general population, hospital reported NAS/SEN cases were oversampled for validation purposes

Questions?

Please contact the Hospital Complaint Unit at 617-753-8204 with any follow up questions.

Thank you for your time today and commitment to safe care in our health care facilities.

• Katie Dinges• Katherine Fillo• Lisa Rengucci• John Thayer• Alex Tinios


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