QA Investigation Results

Pennsylvania Department of Health
Health Inspection Results
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Initial Comments:

This report is the result of an unannounced onsite complaint investigation at the Chambersburg Hospital conducted on December 10, 2018, and completed on March 1, 2019, at Chambersburg Hospital. It was determined that the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 482-Conditions of Participation for Hospitals.

Plan of Correction:

117.41 (a) LICENSURE

Name - Component - 00
117.41 Emergency patient care
(a) Emergency patient care shall be
guided by written policies and
procedures which delineate the proper
administrative and medical procedures
and methods to be followed in
providing emergency care. These
policies and procedures shall be clear
and explicit; approved by the medical
staff and hospital governing body;
reviewed annually, revised as
necessary; and dated to indicate the
date of the latest review or revision,
or both.


Based on a review of medical records (MR) and facility documentation, and staff interviews (EMP), it was determined that the facility failed to follow adopted policies to ensure that a patient's allergies were reviewed and verified prior to being ordered and administered medication, in one of one medical record (MR1).

Chambersburg Hospital -Standard Policy Title: Patient's Bill of Rights and Responsibilities, policy and procedure dated September 26, 2018. "Purpose: To delineate the Patients Rights and Responsibilities. ... Policy: It is the poilicy of the Chambersburg Hospital to provide each patient, family member, or guardian of a newborn, adolescent, or geriatric patient, rights and responsibilities as identified by the PA Department of Health. ... Content: 1. You Can Expect" a. You, or your legally responsible representative, can expect the Hospital to: ... treat you with dignity and respect; provide quality care by skilled staff who maintain professional standards; ... request to refuse any drugs or treatments, and to be told what to expect (your doctor must determine whether your request is necessary and appropriate in your care); ... medical and nursing care no matter what your age, race sex, religion, or beliefs, color sexual preference, country of birth, or how your bill is being paid. ... tell us what medication you are taking; answer questions about your health honestly and completely; ... help the doctor and staff take care of you by following their orders; take only the drugs offered and given by the hospital staff. ... ."

Chambersburg Hospital -Standard Policy Title: Emergency Department Standards of Care, policy and procedure dated August 8, 2018. "Standard I: Assessment. The assessment of the Emergency Department patient, from neonate through geriatrics, is initiated on admission and continues throughout the length of stay in the Emergency Department (ED). A Registered Nurse performs all assessments. Assessment Factors I. An RN will assess the patient during triage. The RN will perform an initial triage to determine the patient's chief complaint, vital signs, and a brief history relating to the chief complaint. Past medical history, current medications with dosages, allergies, height/weight, and further pertinent related medical history will be determined by either the RN in triage, by the RN assessing the patient as the bedside, or by ED staff providing care. ... Standard V: Implementation ... Assessment Factors ... III. The patient will be administered medications and treatments according to established polices, procedures, and protocols of the Chambersburg Hospital. ... VIII. The patient will experience adequate provision for safety based on age-specific needs following established hospital policies and procedures in the emergency care setting. ... ."

Chambersburg Hospital -Standard Policy Title: Medication/Distribution, policy and procedure dated April 9, 2018. "Purpose: To provide patients with medications necessary for their treatment. Policy: It is the policy of the Chambersburg Hospital Emergency Department that the physician is responsible for ordering medications. ... ."

Chambersburg Hospital -Standard Policy Title: Medications: Administration of: policy and procedure dated October 17, 2018. "Purpose: To provide for safe and efficient administrations of medications. Policy: It is the policy of the Chambersburg Hospital to maintain a foundation for patient safety by outlining processes for medication management and administration. Content: ... 2. Steps: a. Observe the six (6) rights: 1) Right Health Care Provider: a) Health Care Provider will confirm all allergies prior to administering medications. (1) If any new allergies develop hospital stay, place medication and reaction into the patient's medical record ... e) Preparation: ... (5) The health care provider verifies that there are no contraindications for administering the medication: (a) Confirms and reviews the patient and their allergy information i. Verifies with the patient (if patient stable) ii. Reviews the Medication Administration Record for a list of allergies iii. Reviews the Enterprise Medical Record for allergy information ... (8) If concerns are noted, the health care provider will contact the Pharmacy and/or physician for further direction. ... 6) Right Patient ... b) The health care provider will discuss the purpose of the medication(s) with the patient at their level of understanding and advise the patient and, or if appropriate, the patient's family about any potential clinically significant adverse reactions, or other concerns before administering to the patient. c) The health care provider will remain at the bedside until the medication has been taken. d) Medications will not be left at the bedside. e) If the patient refuses to or is unable to take the medication, notify the physician and document the reason on the Medication Administration Record or on appropriate departmental form. ... 3. Documentation: ... f. Allergies will be confirmed and documented in the patient care record. ... ."

Findings Include:

1. MR1 History and Physical dated November 29, 2018, revealed, "... Allergies: red dye (Verified Allergy, Unknown, Other-see comments, 11/29/18) rash/behavior ... ."

MR1 Medication Discharge Summary dated November 29, 2018 revealed, "... Allergies FD an C red no. 40-rash/behavior, red dye-Other-see comments ... ."

2. MR2 History and Physical dated December 3, 2018, revealed, "... Allergies: red dye (Verified Allergy, Unknown, Other-See Comments, 11/29/18 rash/behavior ... ."

MR2 Medication Discharge Summary dated December 3, 2018, revealed, "... Motrin (children) (Ibuprofen) (Children) Suspension 100/mg 5 ML CUP) 290 mg PO time/one ... 2115 ... Given changed from: Y to: No ... 2116 Refused ... MediWaste-Medicare Waste ... Description: IBUPUDL Drug Waste ... ."

MR2 Nursing documentation revealed, "... 12/03/18 ... 2115 ... attempt to admin ibuprofen per protocol, pt's parent refuses stating patient is allergic to dyes. Will await physician to assess for further medication order. ... 2257 ... physician updated on patient status and parent request for dye free medication. Spoke with Pharmacy and dye free tylenol or motrin not available, physician made aware. ... ."

3. Interview with EMP2 December 10, 2018, at 12:15 PM revealed, "Parent calls in and feels child's rights were violated, feels the child was not well treated because we didn't have any dye free Tylenol and almost gave the child something they were allergic to. ... Talked with Pharmacy and we do not have an allergy free tylenol."

4. Facility electronic documentation revealed, "... [Parent] was going to hold the medication that may have had dye until [parent] talked with the doctor. ... ."

5. Facility electronic documentation revealed, "... Pharmacy was called and verified dye free medication was not available and physician was made aware. ... ."

6. Interview with EMP3 December 10, 2018, at 12:30 PM revealed, "The majority of staff were aware of the child's allergy in the record. The parent and the child were trained to identify it quickly. None of the nurses called Pharmacy to see if it was 'dye free.' The child was given a Tylenol suppository. The ordering physician has a choice between a liquid or tablet."

Plan of Correction:

Representative leaders from ED and Pharmacy reviewed the policies, Patient's Bill of Rights and Responsibilities, policy and procedure dated September 26, 2018 Medication/Distribution, policy and procedure dated April 9, 2018, Medications : Administration of: policy and procedure dated October 17, 2018, and these policies were found to need no revisions.

Revisions to the Emergency Department Standards of Care, policy and procedure dated August 8, 2018 were made to include language that states: a. For pediatric patients, assessment data, including chief complaint, brief history of present illness, past medical history, current medications with dosages, route ( If PO note Tablet or Liquid) , and allergies, will be collected in collaboration with a parent or guardian when able. This change was made on 3/8/2019.

Revisions to policy Medication Reconciliation dated 7/20/18, were made to indicate that the route for oral meds includes determining if liquid or tablets are used. Pharmacy completed this 3/20/19. ED staff were educated through Daily Huddles beginning 3/20/19, held twice a day, that ED staff would then question patient/family which form of PO medication the child takes and note this in the intake note.

Ed staff and Physicians were educated on the Food/Dye allergy awareness and the revisions to the Emergency Department Standards of Care policy through the CH ED Newsletter that was sent to all staff on March 8, 2019. Changes to the ED standards of Care policy and steps to verify a food/drug allergy, including parent in medication review, and assuring hand off report of any drug allergies if care handed to another provider were discussed at Daily huddles, held twice a day. This will be reinforced in huddles for 14 days.

Physician Leadership has educated their staff by posting the CH ED Newsletter in MD office on March 8, 2018 and will be included in the March Department of Emergency Medicine meeting March 20, 2019.

Education on changes in the Policy -Emergency Department Standards of Care and Food/Dye allergy awareness will be included and reinforced in the mandatory ED RN Skills day being held April 10, 2019.

RN leaders will monitor 30 pediatric charts per month for 3 months to assure compliance with documentation of parental/guardian involvement. Results will be posted on the People Link board and discussed at staff meetings. Auditing will begin March 25, 2019. Staff noted to have noncompliance with documentation will be reeducated using the Just Culture algorithm. Auditing will continue until compliance of 100% is noted for a total of 3 months. Results of audits will be forwarded to the QM Department and then forwarded to the SH Quality and Safety Committee meeting for review.

Leadership for the Pharmacy department was notified of concern on 12/4/2018 and began corrective action to assure dye free medication was available for Liquid Motrin and Tylenol in the organization. Dye free medication was secured and available for use on 12/10/18. ED nursing staff was made aware of dye free medication through the March CH ED Newsletter. This information was also sent to the Patient Services Council to share in their daily huddles on 3/16/19.

Pharmacy also added "Red Dye" as an ingredient associated with the above-mentioned meds which will flag the user-RN & MD- if a red dye allergy is noted on the medication profile. This information was shared with nursing and physician members of the Emergency Room on 12/10/2018 and was taken to the Department of Pediatrics for endorsement of adding the dye free medications to the formulary on 12/17/18.