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Based on record review and staff interview, the facility failed to ensure safe and effective use of medications when adverse drug reactions were not reported timely in accordance with the facility's policy. Use of rescue agents, which are used to reverse the effects or side effects of specific medications, was not evaluated for detection of potential medication error or adverse drug reactions for three patients: Patients 11, Patient 24, and Patient 25.

Such failure put patients at increased risk of experiencing unidentified adverse consequences and potential for harm.

Findings:

1. On 10/26/17 at 9 a.m., the record for Patient 25 was concurrently reviewed with RN 5. The record showed documentation that Patient 25's family accidentally gave the patient 4 milligrams instead of one milligram of Ativan. Ativan is a muscle relaxant, and it is used to treat seizure disorders among other things. One of the side effects associated with Ativan is drowsiness and sleepiness, and decrease in breathing.

Family brought Patient 25 to the Emergency Department (ED) for loss of consciousness and vomiting. In the ED, Patient 25 was administered Romazicon, also known as flumazenil, which is a rescue medication that is used to reverse the effects of or treat overdose of benzodiazepine type medications such as Ativan or Valium.
The ED record showed that Patient 25 was given three doses of Romazicon 0.4 mg each and responded to treatment, became alert and returned to base line.

On 10/30/17, when asked if an Adverse Drug Reaction (ADR) report was completed for Patient 25's Romazicon use, Licensed Vocational Nurse A (LVN A) provided an ADR report for the incident. The report was completed on 10/30/17, which was more than four months after the incident and only after the issue was brought up by the surveyor..

2. On 10/25/17 at 3:05 p.m., the medical record for Patient 24 was concurrently reviewed with Medical Assistant and Informatics staff, (MAIT). The record had documentation that Narcan was administered to Patient 24, on 6/21/17 at 20:22 (8:22 p.m.) Narcan also known as naloxone, which is a rescue medication used to reverse the effect related to excessive use of opiates/opioid medications (morphine and fentanyl like medications) such are decrease in respiration and sedation.

Patient 24 was brought to the hospital by ambulance. The record include documentation that Patient had a fentanyl patch, possibly 25 microgram in strength, which the paramedics removed.

Patient 24, a 72 year old and had several medications that cause sedation including fentanyl patch and hydrocodone (opioid type medication used for pain). In the Emergency Department (ED), Patient 24 had shortness or breath and altered level of consciousness. Patient 24 was administered 0.4 mg of Narcan to reverse the sedative effects the fentanyl and hydrocodone had, and the "patient became much more aroused."

On 10/30/17, when asked if an Adverse Drug Reaction (ADR) report was completed for Patient 24's naloxone use, Licensed Vocational Nurse A (LVN A) provided an ADR report for the event. The report was completed on 10/30/17, which was more than four months after the incident and only after the issue was brought up by the surveyor.

3. On 10/24/17 at 9 a.m., the record for Patient 11 was concurrently reviewed with Medical Assistant and Informatics staff, (MAIT). Patient 11 had kidney stone and other related conditions. During the hospital stay, Patient 11 developed rash, possibly related to one of the antibiotics (medications used to treat infections) she received. To treat the rash, physician ordered Benadryl (also known as diphenhydramine, a medication used to treat allergies and help sleep) and SlouMedrol (also known as methylprednisolone, a steroid type medication that is used to treat inflammation and severe allergies). Both physician orders were written on 10/21/17, and the order for tobramycin (an antibiotic medication) was discontinued on the same day, 10/21/17 at 17:17.

On 10/24/17 at 7:45 a.m., the nurse stated that the rash was better.

On 10/24/17 at 10:55 a.m., LVN A was asked if and Adverse Drug Reaction report was filed, LVN A stated that ADR was mentioned, but nothing was said about completing the report. As of the morning of 10/26/17, there was no documented evidence that the rash for Patient 11 was reported as adverse drug reaction.

The facility's policy titled "Adverse Drug Reporting" and revised on 2/25/16, was reviewed. Under Definition, the policy included the following:
"ii. Use of any of the following medications may indicated a drug reaction has occurred:
1. Diphenhydramine,
2. Flumazenil
3. Hydrocortisone IV
4. Methlyprednolodolne IV
5. Naloxone ...

iii. When in doubt, report the reaction and have the physician evaluated the likelihood a reaction has occurred."

There was no evidence that the facility tracked or evaluated the use of rescue medications. Evaluating use of rescue medications is important for identifying adverse drug reactions (ADR), possible medication errors or overdoses. Such information can help the facility identify causes for medication errors and ADRs, which, in turn, can be incorporated into processes to prevent future errors.

Based on interview and record review, the hospital failed to ensure that Medical Staff Rules were followed for timely completion of medical records by physicians, delinquent physician documentation, and incomplete patient medical records. This had the potential for problems with physician documentation to continue and not be corrected, a lack of continuity of care (physician led team cooperative of ongoing health care management to achieve quality medical care between providers and nursing staff) due to the patient's history not being available, lack of information on treatments, and the potential for pertinent information to be left out of the medical record or incorrect.

Findings:

On 10/25/17 at 4 pm, Patient 12's record was reviewed with Medical Assistant Informatics (MAIT) and showed she was admitted to the facility on 8/1/17 with diagnoses that included painful frequent urination. Patient 12's History and Physical (H&P, concise information about patient's history and exam findings at the time of admission and means of communicating information to all providers involved in their care) was dated 8/1/17, but had not been signed by the physician MD 2. MAIT confirmed that Patient 12's H&P was not signed by MD 2 as required by the hospital.

On 10/26/17, Patient 13's record was reviewed and included a physician's Progress Note (written record of patient's clinical status and treatment response following each patient encounter) for 8/2/17, dated 8/24/17. It showed it had been dictated and transcribed by MD 1 on 8/23/17 and signed on 8/24/17. Patient 13's Discharge Summary (summary of problems at admission, assessment results, treatments and response, overview of the discharge plan and referrals) for 8/3/17 showed it had been dictated and transcribed by MD 1 on 8/23/17, then signed on 8/24/17 (21 days after discharge).

On 10/26/17 at 9:27 am, the hospital's Health Information Management Manager (HIM) was interviewed about Patient 13's delinquent Physician Progress Notes and Discharge Summary that were completed 21 days late. HIM stated progress notes were to be done daily on the floor and physicians' Discharge Summaries were to be done prior to discharge. HIM stated they did daily audits and documentation was considered delinquent/late 14 days after the date of service. HIM stated that the hospital's Administrator, Chief of Staff (COS) and Medical Staff Coordinator were all notified of delinquent documentation. HIM stated there was a process in place to enforce the Medical Staff Rules. She stated that the physician with delinquent records could be placed on suspension after the records were 14 days late.

On 10/25/17 at 3:20 pm. Patient 14's record was reviewed with MAIT and she concurrently confirmed there was no physician's H&P present, five days after admission. MAIT confirmed Patient 14's H&P should have been completed by MD 2.

On 10/25/17 at 3:30 pm, Chief Nursing Officer (CNO) stated that the hospital wanted the H&P done within 24 hours of Patient 14's admission.

On 10/31/17 at 9:15 am, HIM was interviewed and stated that all incomplete charts were put on a list. She stated that the physicians were notified seven days following the patient's discharge with a memo that informed them their charts were delinquent and that they could be suspended from practice if they were not completed within the 14 days. HIM stated they were not tracking the delinquent medical records issue until 10/1/17.

The hospital's 2016 Medical Staff Rules showed that a complete H&P was to be done within "24 hours after admission", Progress Notes "shall be recorded at the time of observation sufficient to permit continuity of care and transferability ... and done at least daily on all patients" and Discharge Summaries were to be complete at the time of discharge.

Based on interview and record review, the hospital failed to ensure one of 27 sampled patient's History and Physical (H&P - concise information about patient's history and exam findings at the time of admission and means of communicating information to all providers involved in their care), dated 8/1/17, was signed by the physician. This created the potential for patients' medical records to remain incomplete. (Patient 12)

Findings:

On 10/25/17 at 4 pm, Patient 12's record was reviewed with Medical Assistant Informatics (MAIT) and showed she was admitted to the facility on 8/1/17 with diagnoses that included painful frequent urination. Patient 12's H&P was dated 8/1/17 but had not been signed by the physician. During a concurrent interview, MAIT confirmed that Patient 12's H&P was not signed by the physician as required by the hospital.

Based on interview and record review, the hospital failed to ensure their Quality Assurance Program (QAP) functioned effectively when they did not evaluate the quality, timeliness and appropriateness of diagnosis and treatment of patients in their Emergency Room (ER) according to their Medical Staff Rules and Medical Staff Bylaws when:

1. The cases identified by the quality department as needing peer review were not evaluated or processed for the past two quarters (4/1/17 to 10/24/17).

2. Cases between 1/1/2017 and 10/24/17 that were identified in 8/2017 as delay in physician assessment after contact time, had not been through the QAP or Medical Staff Committee Review as of 10/24/17.

These failures had the potential to result in a lower standard of patient care and poor patient outcomes when the processes the identify and fix issues were not carried out in a timely manner.

Findings:

1. During an interview on 10/25/17 at 6:57 pm with the ERD, he stated that he had recently designed a computer program for the ER log. The ERD stated he had run the different data points from 1/2017-8/2017 which included door to doctor time, transfers, deaths, and other quality measures. This information was given to the Medical Staff Coordinator (MSC) to present at the next quality meeting. RN 4, ERD, and EMR concurrently confirmed the cases should have been identified during review of the the July 2017 ER log and been sent to peer review.

During an interview on 10/26/17 at 9:34 am with the MSC she stated that she received the ER log report from the ERD and that the information was presented to the hospital's CEO, the quality meeting, and the cases identified as "fall out" (re-admits, transfers, ER door to doctor time, etc) would go to peer review. The MSC stated that she gave those cases to the Health information manager (HIM) to give to the MDs for peer review.

During an interview on 10/26/17 at 9:50 am, the HIM stated the cases were pulled, and placed in the physician boxes for review. When the HIM was asked if they had a tracking system to know which doctor reviewed which cases, and when they where completed she stated "no". The HIM stated that the peer review process had only been completed for the first quarter of 2017(Jan, Feb, March) and all the subsequent cases where not done.



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2. On 10/26/17, Medical Staff Peer Review Sheets for "MD contact to MD assessment" were reviewed and indicated there were cases that had been shown during audits to not meet hospital guidelines. Three of the cases were identified as needing the higher level of Medical Staff Quality Assurance Committee peer review to determine if the care was appropriate and met standards or care or deviated with "missed diagnoses, major delay in care." Two of the cases had dates of service on 1/2/17 and the third was for 1/9/17. The Medical Staff Peer Review Sheets showed these three cases were put into the Peer Process on 8/18/17 and after being reviewed by the ERD on 9/1/17, recommended for the higher level of Medical Staff Quality Assurance Committee peer review.

On 10/25/17 at 12:14 pm, the hospital's MSC stated that their Medical Staff Quality Assurance process was not up to date and that cases since March 2017 had not been reviewed. She confirmed that these cases were not put into the peer review process until 8/17 and were reviewed in 9/17. MSC stated these cases should have been reviewed right away. She stated that during the Medical Staff Committee Meeting on 10/12/17, it was determined that there was no documentation these patients were seen on time. MSC stated it was felt that this was a "process error."

On 10/26/18 at 11:04 am, MSC was asked about the Medical Staff Committee Review process. She stated five physicians made up the Medical Staff Quality Assurance Committee that reviewed cases that had been identified as possibly not meeting standard of care guidelines. These were cases that had already gone through the initial peer review evaluation by another physician and were identified as needing further review by the full committee.

On 10/30/17 at 3:10 pm, the hospital's CEO stated that their expectation was the physician was to assess a patient within 30 minutes after arriving to the ER.

On 10/30/17 at 5 pm, the COS stated that she was not aware of the late ER "MD contact to MD Assess" problem.

On 10/30/17 at 5:20 pm, CNO concurrently confirmed that the hospital's QAP was not identifying all of the issues and was not timely.