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.

MCLAREN FLINT 401 S BALLENGER HIGHWAY FLINT, MI 48532 Sept. 4, 2019
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interview and record review the facility failed to ensure safe administration of drugs when they failed to identify an allergy/intolerance to medication for one (#1) of ten patients reviewed for medications, resulting in the potential for adverse drug reactions. Findings include:

Review of patient #1's closed clinical record revealed patient #1 arrived to the facility's emergency department (ED) on 8/8/19 at 1604 via ambulance. The ambulance run sheet noted patient #1 was seated in a wheelchair calm and in no obvious distress when they arrived at the pick up location. Patient #1 was noted to be accompanied by bystanders who identified as the patients guardian. At the time the guardian stated patient #1 was being transferred to a new care facility and had a panic attack upon arrival and his physician requested transfer to the ED. The run sheet documented allergies were obtained from the guardian. An allergy to Ativan (a benzodiazepine used to treat anxiety disorders) was documented on the run sheet and on the the ambulance hand written short form.

The ED documentation noted chief complaint as anxiety. Patient #1 was documented to be oriented to person and place, anxious, requiring assistance with function and forgetful of limitations. The basic information sheet noted his primary physician was contacted via phone and history was obtained which included frequent anxiety, stress, cognitive impairment and chronic obstructive pulmonary disease (COPD). No allergies were listed. Patient was noted as in no acute distress.

Further review of patient #1's clinical records dated 8/8/19 documented no known drug allergies (NKDA). The medication administration sheets documented patient #1 was administered Ativan three times as follows: On 8/8/19 at 1726, 2 mg (milligrams) Ativan per injection. On 8/8/19 at 2222, 0.5 mg Ativan by mouth. And on 8/9/19 at 1452, 0.5 mg Ativan by injection. Review of nursing notes documented patient #1 remained awake, with stable vital signs, but was less agitated and not getting out of bed following Ativan administrations. A copy of the guardianship documents was within the clinical record.

The medication administration sheets documented patient #1 was administered Flumazenil (Romasicon) 0.1 mg on 8/9/19 at 1552, (an antagonist used to reverse the effects of Ativan or other benzodiazepines).

On 9/4/19 at 0840 the accreditation RN staff B stated patient #1's clinical record was reviewed this morning and it was found that the Ativan allergy was only noted on the ambulance run sheet. She stated the RN staff in the ED and on the units were unaware of the the allergy to Ativan.

A case manager (CM) note on 8/9/19 at 1650 documented RN, CM staff O received a call from her manager RN, CM staff R stating patient 1#'s guardian found post discharge placement for patient #1 and would be picking him up. The guardian requested patient #1 be given a sedative to calm patient prior to transfer. An order was obtained and the patient was administered 0.5 mg Ativan by injection (noted above). When the guardian arrived she stated patient #1 appeared below baseline, was sleepy and slurring words. The guardian asked what medication he was given and when informed of the Ativan, the guardian stated patient #1 was allergic to Ativan. CM O reviewed the clinical record and informed the guardian that no allergies were listed. The physician was called immediately and a one time dose of Flumazenil was administered by RN staff N (as noted above). The note documented the patient began to wake up and the guardian stated patient was at baseline and she was comfortable taking the patient with her for discharge. Post op instructions were given by RN staff N and patient #1 was discharged with the guardian.

On 9/4/19 at 1000 RN staff N was interviewed and confirmed the above noted scenario. Staff N stated she was the RN assigned to patient #1 on 8/9/19 and that he was alert, very anxious, wondering and climbing out of bed, was a fall risk and had bed and chair alarms in place. Staff N stated on 8/9/19 she had him in the hall with her seated in a chair and he was coloring so she could supervise him. She received a call from CM, manager O, saying the guardian was picking the patient up and wanted a sedative given prior to discharge. An order for Ativan was recieved and she administered the Ativan per order. Staff N stated when the guardian reported the allergy to Ativan the CM staff O was on the unit at the time and called the physician immediately and received the Flumazenil order and it was administered. Staff N stated following the Flumazinal the guardian said patient #1 was now at baseline and she was comfortable taking him. Staff N stated patient 1#'s clinical record noted he had no known drug allergies (NKDA) and after the guardian informed her of the allergy she added it to his record on 8/9/19. When queried staff N stated following the Ativan patient #1 was a little more confused but still functional with eyes open and she saw very little change. After the Flumazenil she saw no clinical reason he could not be discharged .

Case Managers, staff O and Staff R were interviewed on 9/4/19 at 1100 and 1150 respectively, and confirmed the above noted scenario regarding patient #1. Staff O stated the guardian had called earlier on 8/9/19 and requested to speak with the CM, manager staff R regarding discharge and she put her in touch with staff R. When the guardian arrived to pick patient #1 up for discharge and informed them the patient was drowsy, and asked what he was given and informed them of the Ativan allergy, she informed the guardian that drowsiness was a normal reaction to Ativan. The guardian informed her that patient #1's reaction to Ativan was hyperactivity. Staff O said after patient #1 received the Flumazenil he did perk up a little, he was able to stand and transfer to a wheelchair. Staff R confirmed she had spoken with the guardian and provided information for two post discharge placements. On 8/9/19 she received a call from the guardian stating she had placement and needed to have patient #1 there as soon as possible and requested the sedative to avoid a panic attack reoccurrence when he arrived at the new facility.

On 9/4/19 at 1120 emergency department RN staff Q was interviewed and stated when patient #1 arrived by ambulance he (staff Q) was informed patient #1 had a panic attack during transfer from one facility to another. He stated his understanding was the patients primary care physician office requested he (patient #1) be taken to the ED to be given a sedative and sent back. He stated the patient was alert to person and place, very anxious, climbing out of bed. Staff Q stated he did ask patient #1 about allergies and didn't recall any listed in the chart. Staff Q said the order was for Ativan and he gave it and the patient remained alert, was less anxious and was not attempting to climb out of bed, he was sitting up in bed alert eating a sandwich and watching TV. When queried about the notations on the ambulance run sheet of the allergy to Ativan, staff Q stated the run sheets are usually faxed to the hospital at a later date (noted on sheet as faxed on 8/9/19 at 0944). When shown the hand written ambulance short form dated 8/8/19 (no time notation) with Ativan noted under allergies, staff Q stated this form is usually left in the ED with the nurse or in one of the baskets. He stated he did not recall seeing the form. Staff Q stated he did receive verbal report from the ambulance staff regarding patient #1, but did not recall being informed of the allergy to Ativan.

A policy regarding patient medication allergies was requested but not provided prior to survey exit.

Review of the facility policy MM-7A titled "Administering and Charting Medications to Patients" effective 2/2018 documented the following: ". . .For a medication regimen to be most effective, medications must be administered appropriately. . .8. Nursing should advise the patient or, if appropriate, the patient's family or representative about any potentially clinically significant side effects or adverse reactions or other concerns prior to administering any new medication for the first time. . .9. To ensure continuity of care/safe medication administration, it is essential to communicate all relevant information regarding patients' medication risk factors and monitoring when handing off the patient to other clinical staff, as when patients are transferred internally from one unlit to another during shift report are at shift change. . ."
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review the facility failed to follow facility policies related to reporting medication administration errors, when one patient (#1) was administered a medication to which he had a documented allergy, from a total of 10 patients reviewed for medications, resulting in the potential for adverse drug reactions. Findings include:

Patient #1 was admitted on [DATE] at 1604. Review of the ambulance run sheet documented that at the time of pick up bystanders identified themselves as patient #1's guardian and informed ambulance staff of an allergy to Ativan (a benzodiazepine used to treat anxiety disorders). Review of the ambulance run sheet and hand written ambulance short form documented patient #1 had an allergy to Ativan.

During patient #1's time at the facility on 8/8/19 and 8/9/19 the medication administration sheets documented patient #1 was administered Ativan three times as follows: On 8/8/19 at 1726, 2 mg (milligrams) Ativan per injection. On 8/8/19 at 2222, 0.5 mg Ativan by mouth. And on 8/9/19 at 1452, 0.5 mg Ativan by injection. The medication administration sheets documented patient #1 was administered Flumazenil (Romasicon) 0.1 mg on 8/9/19 at 1552, (an antagonist used to reverse the effects of Ativan or other benzodiazepines).

Review of patient #1's clinical record revealed the information related to the Ativan allergy was not transferred from the ambulance forms to patient #1's hospital documents.

Further review of the clinical record documented a case manager (CM) note on 8/9/19 at 1650 documented RN, CM staff O received a call from her manager RN, CM staff R stating patient 1#'s guardian found post discharge placement for patient #1 and would be picking him up. The guardian requested patient #1 be given a sedative to calm patient prior to transfer. An order was obtained and the patient was administered 0.5 mg Ativan by injection (noted above). When the guardian arrived she was concerned the patient was sleepy and was informed the patient was given Ativan. The guardian stated patient #1 was allergic to Ativan. CM O reviewed the clinical record and informed the guardian that no allergies were listed. The physician was called immediately and a one time dose of Flumazenil was administered by RN staff N (as noted above).

On 9/4/19 at 0840 the accreditation RN staff B stated patient #1's clinical record was reviewed this AM and it was found that the Ativan allergy was only noted on the ambulance run sheet. She stated the RN staff in the ED and on the units were unaware of the the allergy to Ativan at the time of administrations. She stated the ED staff do not always see the ambulance run sheet, however, they do receive report from the ambulance staff. The ED RN staff Q does not recall getting that information. The CM staff O said she should have probably reported it. We have started a mitigation plan and I entered an adverse event this morning.

On 9/4/19 between 1000 and 1150 hospital staff registered (RN) nurse N, emergency department RN, staff Q, case manager (CM) RN's staff O and R were interviewed. All of the staff noted they were unaware of patient #1's allergy to Ativan at times the Ativan was given.

On 9/4/19 at 1000 RN staff N stated she was made aware of the allergy to Ativan by patient #1's guardian at the time of discharge on 8/9/19 and added it to the clinical record. Staff N stated it should have been reported in Safety First. "I didn't report it."

On 9/4/19 at 1100 CM staff O stated she was made aware of the allergy to Ativan by patient # 1's guardian at the time of discharge on 8/9/19. When queried about reporting the medication event, staff O stated, Any of us, the RN's or myself should have done a Safety First report. I reported it to the physician immediately and to my manager CM staff R, that is what I have been directed to do. I am not sure if she did a report.

On 9/4/19 at 1120 ED RN staff Q said he did not see the information on the ambulance forms or recall being given the information by the ambulance staff of patient #1's allergy to Ativan. Staff Q stated he was just made aware the patient was given Ativan and had an allergy to it.

On 9/4/19 at 1150 the CM manager staff R stated I reviewed patient #1's chart and it was not documented that he had an allergy to Ativan, under allergy it read NKDA (no known drug allergy). We should have put it into Safety First once it was discovered. It is used to do a root cause analysis to prevent reoccurrence.

Review of the facility adverse event logs and grievance logs from 6/2019 to current did not reveal documentation of an event related to patient #1.

Review of the facility policy MM-14-A titled "Adverse Drug Reporting Program" dated effective 4/2018 documented the following: "Adverse consequences to medication therapy can result in morbidity, mortality and increased cost of care. Some drug reactions are predictable and sometimes preventable. It is the goal of the Adverse Drug Reaction (ADR) Reporting Program to identify, analyze, trend and reduce the number of adverse reactions to medications. . .Consistent with the definition, an allergic reaction (an immunologic hypersensitivity occurring as the result of unusual sensitivity to a drug) and an idiosyncratic reaction (an abnormal susceptibility to a drug that is peculiar to the individual) are also considered ADR. . .1. All ADR's that have harmed, have the potential to harm the patient, or the outcome is unknown must be brought to the immediate attention of the attending or covering physician and documented in the medical record. . .6. Regardless of the method of reporting, all adverse drug events should be entered into an electronic reporting system (e.g., My safety First) for uniformity and historical comparison. 7. A summary report is presented to the P & T committee (or equivalent) for its review. Root cause analysis will also be reported to the committee. The ADR are analyzed to determine whether trends or patterns exist. The committee will then determine whether action may be taken to reduce the incidence of reactions."

Review of facility policy MHC-SE001 titled "Safety Event Reporting Policy" effective 5/1/2016 documented the following: 1.1. To provide a systematic multidisciplinary approach in reporting and investigating patient safety events and other safety risks in order to achieve and maintain a safe environment for patients. . .4.1. (Facility name) employees are required to report any and all safety events including but not limited to sentinel events, serious adverse events, near misses, human errors, existence of hazardous conditions and related areas for improvement. It is the responsibility of all employees to report such events in the electronic safety event reporting tool. . .within 24 hours following the occurrence of the event."








During interviews with the Pharmacy Director on 09/03/19 at 1140 and 09/04/19 at 1205, the Pharmacy Director indicated clinical staff were expected to report medication errors, adverse drug reactions and incompatibilities to clinical leadership for internal quality review. The Pharmacy Director indicated they were aware that Flumazenil (an antidote to counteract the sedative effects of Ativan) was administered to a patient in August 2019, however no incident report or quality review had been completed regarding the event.