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COOLEY DICKINSON HOSPITAL INC,THE 30 LOCUST STREET NORTHAMPTON, MA 01060 Jan. 5, 2016
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on documentation review and interviews the hospital failed to identify opportunities for improvement for 2 patients (Patient #1 and Patient #4) in a sample of 10 patients, after receipt of a complaint regarding Patient #1's care in the Emergency Department (ED), on 9/11/15; and after an event in the Operating Room regarding Patient #4, on 11/19/15.

Findings include:

1. Patient #1's ED record, dated 9/11/15, indicated Patient #1, experienced severe back pain and rated his/her pain level at 10, using a 0-10 pain scale, waited for approximately 5 hours to be treated for his/her pain and waited with a temperature of 102.2 degree Fahrenheit. The ED record indicated that Patient #1's fever was not reassessed after triage or treated while being care for in the ED before Patient #1 was discharged home.

The Surveyor interviewed the Chief Medical Officer (CMO) at 2:00 P.M. on 1/4/16. The CMO said Patient #1's complaint was reviewed according to the Hospital's medical peer review process and 3 areas of concern were identified. The CMO said the areas were, 1) the Patient #1's fever, 2) provider communication and 3) pain management. The CMO did not say 0what opportunities and what corrective actions were implemented based on the peer review when asked by the Surveyor.

The Surveyor interviewed the ED Nurse Manager at 2:15 P.M. on 1/4/16. The Nurse Manager said she was not made aware of Patient #1's complaint prior to 1/4/16, (Survey date 1/4/16) and it was the first time she reviewed Patient #1's 9/11/15 ED record. The ED Nurse Manager said after reviewing Patient #1's ED record, she identified several areas for improvement and planned to move forward with corrective actions.

The policy titled Response to Patient Complaints and Grievances, reviewed on 1/5/16, indicated that the Risk Management Department will refer a complaint/grievance to the appropriate Manager/Director for an investigation and response. The policy did not indicate the Risk Management personnel accountable for notifying department directors or managers for their investigation and response.

The Surveyor interviewed the Risk Manager at 8:50 A.M. on 1/5/16. The Risk Manager said that the Administrative Assistant will review a patient complaint and the Administrative Assistant will decide, with the Risk Manager's review, where the complaint needs to go, to the appropriate staff. The Risk Manager said Patient #1's complaint was reviewed by the medical staff and there was no reason to forward Patient #1's complaint to anyone else. The Risk Manager said she did not review Patient #1's ED record, dated 9/11/15.





2. A Letter of Complaint, dated 12/15/15, indicated Endoscopy Technicians administered medications (lidocaine, epinephrine, saline, Botox, simethicone and contrast) during bronchoscopy and endoscopy procedures and, although the Hospital had stopped the practice, the Hospital went back to the practice of the Endoscopy Technicians administering medications.

On 1/4/16, the Surveyor interviewed the Endoscopy Nurse Manager, at 10:10 A.M., Operating Room Nurse Director (OR Nurse Director), at 10:40 A.M. and 3:50 P.M., the Chief Nurse Officer (CNO, high-ranking Hospital Registered Nurse) at 1:10 P.M. and 4:10 P.M., the Chief Medical Officer (CMO, high-ranking Hospital physician), at 1:45 P.M. and 4:10 P.M., and the Quality & Patient Safety Director, at 2:45 P.M.. They said that they could not identify the date of the occurrence, patient name or date the practice of Endoscopy Technicians administering medications stopped; when asked by the Surveyor, on 1/4/16.

The OR Nurse Director said, on 1/4/16 at 3:50 that RN #5 was the OR Nurse that identified the practice the Endoscopy Technicians administered medications during a bronchoscopy conducted in the OR and the Patient Safety Officer said, on 1/5/16 at 8:00 A.M., that the patient was Patient #4 and the date of the bronchoscopy procedure was 11/19/15.

The CMO said he became aware of the issue in the middle of December 2015. The Quality & Patient Safety Director said she heard about the issue at a morning meeting and did not know the date. The CNO said someone who did not routinely work " there " saw the practice and in October 2015 or November 2015, the practice of Endoscopy Technicians administering medications ceased when discovered.

The OR Nurse Director said RN #5 reported to her that an Endoscopy Technician administered medication (lidocaine and epinephrine) during a bronchoscopy procedure conducted in the OR.

The Surveyor interviewed RN #5 at 10:20 A.M. on 1/5/16. RN #5 said she was the Operating Room Nurse present at Patient #5's bronchoscopy procedure, observed the Endoscopy Technician administer Patient #5 medication. RN #5 said the Endoscopy Nurse present during the procedure and the Endoscopy Nurse Manger told her it was within the scope of practice for the Endoscopy Technicians to administer medications.

The OR Nurse Director said Endoscopy Nurse Manager told her Endoscopy Technicians could administer the medications because the Endoscopy Technicians were Certified, and trained to administer medications. The OR Nurse Director said that the Endoscopy Technicians were not certified and the Society of Gastroenterology Nurses & Associates (SGNA, professional organization) did not offer a Certification for Endoscopy Technicians. The OR Nurse Director said the SGNA offered an online (completed over the Internet) class that did not include information about medication administration. The OR Nurse Director said the Endoscopy Technicians did not have competency (education) or training to administer medications. The OR Nurse Director said that the practice stopped a week ago and did not know the date.

The Endoscopy Nurse Manager said Endoscopy Technicians administered medications, lidocaine, epinephrine, simethicone, saline and Botox in the past.

The CNO said Endoscopy Technicians were not certified or licensed to administer medications and that the Endoscopy Nurse Manager just did not know or understand why the Endoscopy Technicians could not administer medications.

The Surveyor interviewed Endoscopy Technician #1 at 11:45 A.M. on 1/4/16 and Endoscopy Technician #2 at 11:45 on 1/5/16. Endoscopy Technicians #1 and #2 said that Endoscopy Technicians administered medications in the past. Endoscopy Technicians #1 and #2 said that the process for the Endoscopy Technician to administer medications was reviewed during orientation. Endoscopy Technician #1 said that she had the Endoscopy Technician Certification it was an online certification and did not contain content on medication administration.

The Surveyor interviewed RN #6 (Endoscopy Nurse), at 11:45 A.M., Physician #1, a Gastroenterologist (gastro-intestinal specialist), at 12:20 P.M. on 1/4/16, and Physician #3 at 12:30 P.M. on 1/5/16. RN #6 said that Endoscopy Technicians administered medications under the physician request by pushing the medication into the endoscopy scope (tube). Physician #1 said that Endoscopy Technologists administered medication in the past and Physician #3 said Endoscopy Technicians administered medications on his command and as he designated to push the plunger on a syringe because his "hands were full".

Endoscopy Nurse Manager said this practice stopped in the fall, after a directive from the OR Nurse Director and did not know the date; the CMO said he did not know when the practice stopped.

The CMO said that the administration of the medications (epinephrine, lidocaine, Botox, India ink, methylene blue) intra-lumen was a gray area. The CMO said a small group met to collect information about the practice in other Hospitals about Endoscopy Technologists administering medications. The CMO said the physicians probably practiced with the Endoscopy Technicians administering medications for approximately 30 years.

A document (electronic calendar invitation) titled, Endoscopy Technician Role, dated 12/3/15, indicated nurses, physicians and Chief Nurse Officer (CNO) were invited to a meeting to discuss the issue of Endoscopy Technicians pushing medications in the Endoscopy Unit.

The Endoscopy Technician Role Meeting Minutes, dated 12/3/15, indicated medications could not be administered by unlicensed personal, the Endoscopy Technicians.

The Surveyor interviewed the Patient Safety Officer at 8:00 A.M. on 1/5/15. The Patient Safety Officer said a member of the Quality Department was not invited to the meeting because Nurse Managers and Directors were trained to start a Root Cause Analysis (RCA).

The CNO, OR Nurse Director, and Quality & Patient Safety Officer said physicians were upset, and "pushed back" because this was the way they always practiced.

The OR Nurse Director said the practice resumed after an email from the Chief Medical Officer (CMO, high ranking Hospital physician) directed to go back to the past practice for 1-2 months until things were sorted out. Operating Room Nurse Director said she did not know what the present practice was on 1/4/16 (Survey date 1/4/16) and Endoscopy Technicians were administering medications.

The Electronic Mail (email), dated 12/15/15 and sent by the CMO, indicated the only immediate change in practice was only nursing and physicians could administer IV medications, and Endoscopy Technologists could not. Determination to what could be administered intra-luminal (into a lumen), either via endoscopy or bronchoscopy, would be determined later. A committee of physicians, nurses and Endoscopy Technicians would make recommendations to Hospital senior management in the next 1-2 months.

RCA Hospital policy titled, Event Reporting of Patient or Visitor Incidents and Occurrences, dated July 2003, indicated all serious, major events will have a Root Cause Analysis (RCA, an investigation that focuses on systems and processes) conducted.

The patient Safety Officer said that Endoscopy Technicians administering medications was a serious event.

The CNO said at 4:10 P.M. on 1/4/16, the OR Nurse Director and the Patient Safety Officer said the Hospital failed to generate an event report, and an event report should have been generated. The Quality & Patient Safety Director said she would have investigated if an incident report was generated.

Hospital policy titled Event Reporting of Patient or Visitor Incidents and Occurrences, dated July 2003, indicated all health care providers have the duty to report events (incidents or occurrences that were not consistent with the routine or desired care of the patient or may have an adverse or potential adverse patient effect) in writing within 24 hours.

The CMO, CNO and RN #6 said all medications were on hold until the Hospital figured out what Endoscopy Technicians could administer and what the Hospital needed to do. The Quality & Patient Safety Director said the issue was under analysis for what and how to administer medications.

RN #5 however, said that she received no communication that the Endoscopy Technicians were directed not to administer medications.

Endoscopy Technicians #1 and #2, Physician #1, and RN #6 said the Endoscopy Technicians were not administering medications now. The CNO and CMO, at 4:10 P.M. on 1/4/16, said they assured only RNs and physicians were now administering medications.

The Surveyor interviewed the Pharmacy Director at 11:00 A.M. on 1/5/16. The Pharmacy Director said that un-licensed Hospital personal should not administer medications regardless of the route administered and Normal Saline also should not be administered by un-licensed Hospital personal because Normal Saline requires a prescription and only Registered Nurses process prescriptions in the Hospital.

Endoscopy Technician #1, Endoscopy Nurse Manager, and the CNO said the Hospital was in the process of equipping all the endoscopy rooms with pump equipment for the physician to administer simethicone to the patient.

Endoscopy Technicians #1 and #2 said that they did not record the administration of the medication in the patient's medical record and RN #6 said physicians documented medications administered during the procedure in their notes.

The Pharmacy Director said only Registered Nurses, Pharmacists and Pharmacy Technicians had access to stock medications in the locked cabinet on the Endoscopy Unit.

The Surveyor interviewed Endoscopy Technician #2 at 11:45 on 1/5/16. Endoscopy Technician #2 said she obtained the medication, Simethicone, from the locked stockroom, was given a key.

The Surveyor observed, at 2:00 P.M. on 1/516, a locked storage room with a locked cabinet in the locked storage room, contained Simethicone (medication).

The Surveyor interviewed RN #3 at 2:00 P.M. on 1/5/16. RN #3 said that the Endoscopy Technicians have access to the locked cabinet and the RNs unlock the cabinet for the Endoscopy Technicians.