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.

NORTHEASTERN VERMONT REGIONAL HOSPITAL 1315 HOSPITAL DRIVE SAINT JOHNSBURY, VT 05819 Nov. 15, 2016
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and staff interview, the CAH failed to provide Tdap (tetanus, [DIAGNOSES REDACTED], and pertussis) vaccinations in accordance with appropriate written policies in all areas of the hospital for 2 of 8 patients reviewed (Patient #1 and #11). Findings include:

Per medical record review, the Emergency Department (ED) policy for the administration of the Tdap (tetanus, [DIAGNOSES REDACTED], and pertussis) vaccination was not followed for 2 patients who received the vaccine in the ED. Per review of the policy, Tetanus, [DIAGNOSES REDACTED], and Pertussis (rev 1/21/16), under the heading Procedure, staff are directed in Step 1. "Obtain the Patient Information-Informed Consent. Discuss with patient and provide opportunities for questions ... 2. Patient will sign the consent form; keep the information sheet with the patient's chart. 3. Signatures are required prior to administration. 4. Administer medication as per current policy. Consent form must be completed with Vaccine date, manufacturer, lot number and expiration date." Per review of Patient #1 and #11's medical record, there was no evidence that either patient signed an informed consent form prior to receiving the Tdap vaccination. Patient #1 received the Tdap on 2/24/16 and Patient #11 received the Tdap on 10/19/16.

Additionally the Vaccine Administration Policy (revised 5/20/16) which also covers administration of the Tdap as well as other vaccines, states under Supplemental Data, step 3 "Exclusion criteria will be listed in the Vaccine Information Sheet supplied by the CDC. Forms are available on all nursing units or may be obtained at the CDC web site." Per review, the TdapVaccine Information Statement (VIS) forms currently in use by the ED nursing staff were dated 05/09/13; per the CDC website, the current VIS form is dated 2/24/16. Information provided at the CDC website states: "As required under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), all health care providers in the United States who administer, to any child or adult, any of the following vaccines - [DIAGNOSES REDACTED], tetanus, pertussis, [DIAGNOSES REDACTED],[DIAGNOSES REDACTED], [DIAGNOSES REDACTED], polio, hepatitis A, hepatitis B, [DIAGNOSES REDACTED] type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) - shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC)." Per record review, both Patient #1 and Patient #11 received the outdated VIS from 2013 instead of the current statement. (At the time of the survey, a new consent form was developed and the outdated VIS forms were replaced with current ones).

During an interview on 11/15/16 at 9:25 AM, the VP of Quality Management (VPQM) confirmed the above information and that the CAH policies for vaccine administration had not been followed. The VPQM reported that there had been changes in leadership at the hospital and the responsibility for the policies covering Tdap vaccinations were not formally handed off to a designated person. Additionally, on 11/15/16 at 11:59 AM, the Nurse Educator confirmed that there had been no training for nurses in the past year around the administration of vaccinations.
(Refer to C-0277, C-0297, and C-0336)

http://www.cdc.gov/vaccines/hcp/vis/vis-dates.html
http://www.immunize.org/catg.d/p2027.pdf
VIOLATION: POLICIES - MED ERRORS & ADRS Tag No: C0277
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

The CAH's pharmacy service failed to ensure that policies and procedures for the reporting of an alleged adverse drug reaction following the administration of a vaccination were consistently implemented throughout all areas of the hospital for 1 of 8 patients (Patient #1). Findings include:

Per medical record review and staff interview, Emergency Department (ED) medical and nursing staff failed to report to the pharmacy department, per policy, patient and family allegations of an adverse drug reaction following the administration of a Tdap (tetanus, [DIAGNOSES REDACTED], and pertussis) injection in the ED. Per record review, on 2/24/16, Patient #1 was assessed in the ED by Physician #1. The patient was identified as due for a tetanus booster and was administered Boostrix (a Tdap injection) by nursing staff. On 3/19/16, Physician #2 documented that Patient #1 returned to the ED with symptoms of [DIAGNOSES REDACTED][Patient #1] had to pertussis vaccine when [s/he] was a child and [s/he] is quite concerned that [his/her] symptoms today might be part of an allergic reaction to the pertussis vaccine [s/he] received on February 24th." On 3/20/16, Patient #1 returned to the ED. Per Physician #3's notes; Patient #1 had complaints of neck pain with associated twitching, visual changes and headache. A family member voiced concerns that s/he was "having an allergic reaction to the Dtap that s/he should never have received..." Also at the 3/20/16 encounter, Patient #1 and a family member reported to an ED nurse that Patient #1 had "serious neurological issues after a dtap immunization as a child, received Tdap in here about a month ago, [family] wonders if these [symptoms] are [due to] that ...." On 3/21/16, Patient #1 returned to the ED and saw Physician #4 who documented that Patient #1 was "... very angry about the receiving of a Dtap injection on a recent emergency room visit because of severe allergy and believes that this may have harmed [him/her] ...."

Per review of the Hospital's current Adverse Drug Events policy, ..."Adverse Drug Reactions (ADR) are additional effects that are not primarily sought which may have harmful or potentially harmful effects. ADRs which will be considered for review are those that occur during the patient stay and those which result in an outpatient or inpatient admission ....ADRs ... will be documented using the incident report form .... Copies of incident report forms documenting ADRs and medication errors will be forwarded to the pharmacy. The pharmacist will review and document as either a medication error or an ADR ....A summary of all preventable medication events ....and ADRs will be presented to the Pharmacy and Therapeutics Committee quarterly. The committee will review .... using a process which identifies a basic cause or causal factor, and focuses on systems and processes. The results will be sent to the Quality Council for inclusion in performance improvement efforts."

On 11/15/15 at approximately 9:44 AM, the hospital Pharmacy Director (PD) reported that if a patient alleges an adverse reaction to a medication that we did not administer, we would enter it in the patient's allergy list; if an event was related to something we did [including the administration of a Tdap vaccination], s/he would expect staff to complete an incident report. The PD confirmed that the policy was not followed and no incident report had been completed by staff regarding Patient #1's allegation of an ADR following a Tdap injection.
(Refer to C-0271, C-0297, and C-0336)
VIOLATION: NURSING SERVICES - DRUG ADMINISTRATION Tag No: C0297
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review and staff interview, the CAH failed to ensure that all drugs and biologicals were administered by or under the supervision of a registered nurse in accordance with accepted standards of practice and Federal laws for 2 of 8 patients (Patient #1 and Patient #11). Findings include:

Per medical record review, the Emergency Department (ED) nursing staff failed to adhere to written policies for the administration of the Tdap (tetanus, [DIAGNOSES REDACTED], and pertussis) vaccination for 2 patients in the sample who received the vaccine in the ED. Per review of the policy, Tetanus, [DIAGNOSES REDACTED], and Pertussis (rev 1/21/16), under the heading Procedure, staff are directed in Step 1. "Obtain the Patient Information-Informed Consent. Discuss with patient and provide opportunities for questions ... 2. Patient will sign the consent form; keep the information sheet with the patient's chart. 3. Signatures are required prior to administration. 4. Administer medication as per current policy. Consent form must be completed with Vaccine date, manufacturer, lot number and expiration date." Per review of Patient #1 and #11's medical record, there was no evidence that either patient signed an informed consent form prior to being administered the Tdap vaccination. Patient #1 received the Tdap on 2/24/16 and Patient #11 received the Tdap on 10/19/16.

Additionally the Vaccine Administration Policy (revised 5/20/16) which also covers administration of the Tdap as well as other vaccines, states under Supplemental Data, step 3 "Exclusion criteria will be listed in the Vaccine Information Sheet supplied by the CDC. Forms are available on all nursing units or may be obtained at the CDC web site." Per review, the Tdap Vaccine Information Statement (VIS) forms currently in use by the ED nursing staff were dated 05/09/13; per the CDC website, the current VIS form is dated 2/24/16. Information provided at the CDC website states: "As required under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), all health care providers in the United States who administer, to any child or adult, any of the following vaccines - [DIAGNOSES REDACTED], tetanus, pertussis, [DIAGNOSES REDACTED],[DIAGNOSES REDACTED], [DIAGNOSES REDACTED], polio, hepatitis A, hepatitis B, [DIAGNOSES REDACTED] type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) - shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC)." Per record review, both Patient #1 and Patient #11 received the outdated VIS from 2013 from ED nurses instead of the current statement. (At the time of the survey, a new consent form was developed and the outdated VIS forms were replaced with current ones).

During an interview on 11/15/16 at 9:25 AM, the VP of Quality Management (VPQM) confirmed the above information and that the CAH policies for vaccine administration and directives from the CDC regarding VIS forms had not been followed by nursing staff. The VPQM reported that there had been changes in leadership at the hospital and the responsibility for the policies covering Tdap vaccinations were not formally handed off to a designated person. Additionally, on 11/15/16 at 11:59 AM, the Nurse Educator confirmed that there had been no training for nurses in the past year around the administration of vaccinations.
(Refer to C-0271, C-0277, and C-0336)


http://www.cdc.gov/vaccines/hcp/vis/vis-dates.html
http://www.immunize.org/catg.d/p2027.pdf
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and staff interview, the facility failed to ensure that an effective quality assurance program was in place to evaluate the quality and appropriateness of treatments furnished in the CAH and of the treatment outcomes for 1 of 8 patients (Patient #1). Findings include:

Per medical record review and staff interview, Emergency Department (ED) medical and nursing staff failed use the established Risk Management System to report patient and family allegations of an adverse drug reaction following the administration of a Tdap (tetanus, [DIAGNOSES REDACTED], and pertussis) injection in the ED. The failure to report the alleged adverse reaction created a missed opportunity for the facility to identify areas for improvement in the administration of the vaccine.

Per record review, on 2/24/16, Patient #1 was assessed in the ED by Physician #1. The patient was identified as due for a tetanus booster and was administered a Boostrix (Tdap) injection by nursing staff. On 3/19/16, Physician #2 documented that Patient #1 returned to the ED with symptoms of [DIAGNOSES REDACTED][Patient #1] had to pertussis vaccine when [s/he] was a child and [s/he] is quite concerned that [his/her] symptoms today might be part of an allergic reaction to the pertussis vaccine [s/he] received on February 24th." On 3/20/16, Patient #1 returned to the ED. Per Physician #3's notes; Patient #1 had complaints of neck pain with associated twitching, visual changes and headache. A family member voiced concerns that s/he was "having an allergic reaction to the Dtap that s/he should never have received..." Also at the 3/20/16 encounter, Patient #1 and a family member reported to an ED nurse that Patient #1 had "serious neurological issues after a dtap immunization as a child, received Tdap in here about a month ago, [family] wonders if these [symptoms] are [due to] that ...." On 3/21/16, Patient #1 returned to the ED and saw Physician #4 who documented that Patient #1 was "... very angry about the receiving of a Dtap injection on a recent emergency room visit because of severe allergy and believes that this may have harmed [him/her] ...."

Per review of the facility Adverse Event and Near Miss Reporting (Incident Reports) (reviewed 10/20/16); under the heading Procedure, the policy states that "Any staff member who is aware of an unusual occurrence shall be responsible for notifying his/her immediate supervisor of any medication error, fall, loss or theft, injury or significant patient or visitor complaint." Under the heading, Reporting an Adverse Event or Near-Miss, the policy states, "As soon as an adverse event occurs or a non-medication near-miss is discovered, it should be reported in the Meditech Risk Management system. Reporting adverse events helps us to improve safety in patient care and to create a safe work environment for employees, patients, and visitors alike."

Per interviews with the VP of Quality Management (VPQM) over the morning of 11/15/16, the VPQM confirmed that there was no evidence that medical or nursing staff reported Patient #1 and his/her family's allegations of an adverse drug reaction (ADR) from the Tdap administration to the pharmacy department or to the Quality/Risk Management system for review. The VPQM confirmed that s/he was unaware of the allegations until the time of the survey. During the survey process it was also identified that ED nursing staff failed to obtain signed consents from patients prior to administering Tdap injections as per the ED's Tetanus, [DIAGNOSES REDACTED] and Pertussis policy (reviewed 1/21/16). There was also evidence that the ED nurses failed to provide the most current VIS (Vaccine Information Statement) to patients prior to administering the Tdap vaccination; it was confirmed that staff were giving the VIS form dated 05/09/13 instead of the current form dated 2/24/16. Per review, the Vaccine Information Statement (VIS) forms currently in use in the ED for the Tdap were dated 05/09/13; per the CDC website, the current VIS form is dated 2/24/16. Information provided at the CDC website states: "As required under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), all health care providers in the United States who administer, to any child or adult, any of the following vaccines - [DIAGNOSES REDACTED], tetanus, pertussis, [DIAGNOSES REDACTED],[DIAGNOSES REDACTED], [DIAGNOSES REDACTED], polio, hepatitis A, hepatitis B, [DIAGNOSES REDACTED] type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) - shall, prior to administration of each dose of the vaccine, provide a copy to keep of the relevant current edition vaccine information materials that have been produced by the Centers for Disease Control and Prevention (CDC)." The VPQM confirmed the above information and that the failure of staff to report the alleged ADR created a missed opportunity to investigate the allegations and identify areas for improvement in the administration of the Tdap vaccine.
(Refer to C-0271, C-0277, and C-0297)
http://www.cdc.gov/vaccines/hcp/vis/vis-dates.html
http://www.immunize.org/catg.d/p2027.pdf