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Based on interview and record review, it was determined the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program that involved all hospital departments and services. Specifically, the hospital failed to appropriately investigate and follow-up on a patient incident/medication error.

Findings include:

The hospital failed to adequately track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.
(Refer to Tag A-0286)

Based on interview and record review, the hospital did not adequately track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. Specifically, for 1 out 10 sampled patients the hospital did not identify a medication error/adverse event, which could negatively impact patients. (Patient identifer: 3)

Findings include:


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1. Patient 3 was admitted to the hospital on 7/2/21, with an admitting diagnosis of metastatic colon cancer.

On 7/12/21 at 10:30 AM, an interview was conducted with patient 3 and his sister. Patient 3 stated he had surgery on 7/2/21 and was supposed to be discharged to home the next day. Something went wrong and his legs quit working and his kidneys shut down, so they had to figure out what was going on. He was admitted to the the intensive care unit, where he was currently. When asked if he had any concerns with his medications patient 3 stated he lost over 50 pounds and was not diabetic anymore. Patient 3 stated he did not take diabetes medications. He stated he thought he may have been given one of the diabetic medications that may have made him sick.

At that time, his sister stated patient 3 was given an oral diabetic medication after surgery. The sister stated patient 3 had not taken the medication for a while since he did not need the medication to control his blood sugars any longer. The sister stated the diabetic medication caused his blood sugar to drop too low and his kidney function decreased. They thought patient 3 may not make it. The sister stated the physician told them the patient may have been in the initial stages of renal failure and surgery may have triggered it. Patient 3 and his sister were asked if anyone reviewed patient 3's medication with him prior to surgery. They both said the anesthesiologist reviewed his medications with him prior to surgery and they told him he was no longer on his diabetic medication. The sister further stated the pharmacist talked with the patient after he had received the dose of diabetic medication after surgery. She stated the medication was discontinued after the conversation.

2. A review of patient 3's medical record was completed on 7/13/21.

A review of the pre operation nursing form, completed during a telephone conversation with the patient on 7/1/21, indicated the following current medications:
a. Lorazepam (Ativan)1 mg (milligrams)
b. morphine sulfate extended release (MS Contin) 60 mg
c. solifenacin (Vesicare) 5 mg
d. ferrous sulfate 325 mg
e. tamsulosin (Flomax) 0.4 mg

There was no documentation of diabetic medications at that time.

A review of the surgeon's admission history and physical revealed the medications listed above along with the following diabetic medications:

aa. glimepiride 1 mg
bb. metformin 500 mg

A review of the of the anesthesia pre operation history and physical completed by the anesthesiologist indicated the patient had "Diabetes mellitus, type 2, non-insulin dependent, well-controlled, no current meds (medications)."The section, prior to admission medications list, contained the glimepiride and metformin along with all other medication the patient was currently taking. The section labeled currently taking was left blank next to the glimepiride and the metformin. All other medications on the list indicated "yes" as currently taking the medications.

A review of the physician orders revealed an order dated 7/2/21 at 6:56 PM, for glimepiride 1 mg to be given daily at breakfast. The glimepiride was given on 7/3/21 at 8:08 AM. The glimepiride was discontinued on 7/3/21 at 3:38 PM, after the medication reconciliation had been started by the pharmacist. The pharmacist documented the patient was no longer taking the glimepiride.

A review of patient 3 labs revealed a blood glucose level of 91 mg/dL (deciliters) prior to surgery on 7/2/21 at 12:26 PM. Normal blood glucose levels are 70-110 mg/dL.

Review of patient 3's lab results revealed a steady decline in the blood glucose levels down to 11 on 7/4/21 at 6:15 AM. At that time a code was called and patient 3 was transferred to the intensive care unit for a higher level of care.

Review of patient 3 records revealed no documented evidence of pre-operative labs drawn prior to patient 3's admission and/or surgery.

3. On 7/15/21 at 9:00 AM, an interview was conducted with the resident who assisted in surgery and wrote the medication order for glimepiride after surgery. He stated patient 3 was to receive palliative surgery due to his diagnosis and condition. After surgery the resident stated he looked at patient 3 medical record and reviewed the medications to determine which medications needed to be ordered. The resident stated in patient 3's case the patient was on the medication prior to surgery so he felt it was appropriate to give the medication. The surgery team did not find out until after the medication had been given that the patient was no longer taking it. The resident should have been okay to take unless the patient had renal failure, which was diagnosed after the medication had been given.

The resident was asked if this would have been considered an adverse event. He stated it really was not a medication error since it was a patient receiving a medication that had been ordered prior, but had not been taking. He stated this could have been an adverse event. The resident stated he it was unusual for them to go through the RL (report and learn) system to report an adverse event or medication error. The nurses would usually report it.

4. On 7/15/21 at approximately 9:30 AM an interview was conducted with the surgeon. She stated she saw the patient in her office on 7/1/21. It was decided then that the patient needed emergent surgery. She scheduled him for surgery on 7/2/21. The surgeon stated she wrote orders for labs to be drawn on 7/1/21. She stated the patient did not stop at the lab to have them drawn after the appointment. The surgeon stated the lab orders were still in effect and should have been drawn prior to surgery when the patient was admitted. The labs were not drawn at that time. The surgeon stated if they had the labs prior to surgery they would have noticed patient 3 was in acute renal failure. The diabetic medication of glimepiride would not have been ordered since the kidneys would not have been able to clear the medication out of the patient's system.

5. On 7/14/21 at approximately 1:00 PM, an interview was conducted with the director of patient support services (DPSS). She stated there was an incident RL report filed on patient 3, but it was not on medications. The DPSS stated it was related to personnel, it was not classified as a medication error. She further stated they were not looking at is as medication error so no investigation was done looking into the cause.

6. On 7/14/21 at 2:21 PM, the director of executive projects (DEP) was in interviewed. She stated that they were not looking at the investigation that way at all. The DEP stated the medication error was not something they were aware of.

7. On 7/15/21 at 8:56 AM, the DPSS stated the incident should have been reported as a medication error once it was determined the patient should not have been on the medication.

No documented evidence could be provided that the facility identified the incident/medication error. Therefore, no cause was analyzed, and no preventive action was implemented to prevent future incidents.

Based on interview and record review, it was determined that the hospital did not ensure that the medical staff was organized and accountable for the quality of medical care provided to patients. Specifically, the hospital did not ensure medication reconciliation's were done appropriately and per policy for 3 out 10 sampled patients. (Patient identifiers: 1, 3 and 4)

Finding include:

1. Patient 3 was admitted to the hospital on 7/2/21, with an admitting diagnosis of metastatic colon cancer.

A review of patient 3's medical record was completed on 7/13/21.

A review of the pre operation nursing form completed during a telephone conversation with the patient on 7/1/21, indicated the following current medications:
a. Lorazepam (Ativan)1 mg (milligrams)
b. morphine sulfate extended release (MS Contin) 60 mg
c. solifenacin (Vesicare) 5 mg
d. ferrous sulfate 325 mg
e. tamsulosin (Flomax) 0.4 mg

There was no documentation of diabetic medications at that time.

A review of the surgeon's admission history and physical revealed the medications listed above along with the following diabetic medications:

aa. glimepiride 1 mg
bb. metformin 500 mg

A review of the of the anesthesia pre operation history and physical completed by the anesthesiologist indicated the patient had "Diabetes mellitus, type 2, non-insulin dependent, well-controlled, no current meds (medications)."The section, prior to admission medications list, contained the glimepiride and metformin along with all other medication the patient was currently taking. The section labeled currently taking was left blank next to the glimepiride and the metformin. All other medications on the list indicated "yes" as currently taking the medications.

A review of the physician orders revealed an order dated 7/2/21 at 6:56 PM, for glimepiride 1 mg to be given daily at breakfast. The glimepiride was given on 7/3/21 at 8:08 AM. The glimepiride was discontinued on 7/3/21 at 3:38 PM, after the medication reconciliation had been started by the pharmacist. The pharmacist documented the patient was no longer taking the glimepiride.

On 7/15/21 at 9:00 AM, an interview was conducted with the resident who assisted in surgery and wrote the medication order for glimepiride after surgery. He stated patient 3 was to receive palliative surgery due to his diagnosis and condition. After surgery the resident stated he looked at patient 3 medical record and reviewed the medications to determine which medications needed to be ordered. The resident stated in patient 3's case the patient was on the medication prior to surgery, so he felt it was appropriate to give the medication. The surgery team did not find out until after the medication had been given that the patient was no longer taking it. The resident stated the patient should have been okay to take the glimepiride unless the patient had renal failure, which was diagnosed after the medication had been given.

2. Patient 4's record review was completed on 7/15/21 and revealed the follow:

Patient 4 was admitted on 7/8/21 at 6:06 AM with a diagnosis of squamous cell carcinoma hypopharynx, and admitted as an inpatient on 7/08/21 at 6:00 PM.

On 7/8/21 at 5:57 PM, patient 4 had an order for Celebrex 200 mg BID (Twice a day).

The pharmacist medication reconciliation with the patient was done on 7/9/21 at 3:32 PM. The pharmacist documented that patient 4 stated they were no longer taking Celebrex.

Patient 4 was given Celebrex on 7/8/21 through 7/13/21.

Note: it was unclear in patient 4's medical record whether the medication should have been discontinued or not after the medication reconciliation was done by the pharmacist.

3. Patient 1's record review was completed on 7/15/21 and revealed the following:

Patient 1 was admitted on 7/11/21 at 7:44 AM with a diagnosis of constipation, and admitted as inpatient on 7/11/21 at 11:22 AM, with a diagnosis of small bowl obstruction.

On 7/11/21 at 8:43 AM, an order was written for cyclosporine 0.05% ophthalmic emulsion 1 drop BID.

A review of Patient 1's medication administration record was completed on 7/15/21 and revealed the following:

On 7/11/21 at 12:00 PM, it was documented as not given, that the patient or family refused the dose.
On 7/11/21 at 8:27 PM, it was documented as given.
On 7/12/21 at 9:00 AM, it was documented as not given, that the patient or family refused the dose.
On 7/12/21 at 9:00 PM, it was documented as not given, that the patient or family refused the dose.
On 7/13/21 at 8:24 AM, it was documented as given.

On 7/11/21 at 5:04 PM, it was documented in an emergency department provider note that the patient had no medications on file, but listed previous medications with cyclosporine on that list. (It is unknown where this medication list came from)

On 7/11/21 at 8:43 AM, a medication list was documented on a provider history and physical note under "Current Outpatient Medications on File Prior to Encounter." Cyclosporine was on this list.

On 7/11/21 at 2:29 PM, patient 1 had a medication reconciliation done with the pharmacist. The pharmacist determined the patient was no longer taking cyclosporine 0.05% ophthalmic emulsion.

There was no documentation in patient 1's medical record as to why the patient was still receiving the medication after the medication reconciliation determined the patient was no longer taking the medication.

4. On 7/15/21, a policy labeled medication reconciliation was reviewed. The policy stated that a, "Licensed Independent Practitioners (e.g., physicians, nurse practitioners, and physician assistants) will perform an initial assessment of patient's home medications to document in the patient's chart. This will include a medication list with the following information from the patient's pre-admission medication list: drug, dose, route, and dosing schedule.

On 7/15/21, a policy labeled mediation ordering was reviewed. The policy stated, "Medication reconciliation shall be performed by the admitting practitioner. The prescriber is responsible for ordering or reconciling the patient's home medications upon admission as needed. This may not be delegated to nursing or pharmacy staff. For example, orders that say "pharmacy to reconcile patient's home med (medication) list and initiate therapy," are not acceptable. Pharmacy and/or Nursing may assist in entering the Prior to Admission (PTA) medication list."

5. On 7/14/21 at 1:00 PM physician 1 was interviewed. Physician 1 stated that her assistant goes over medications with the patient and that she will review medications if she had a concerning medication. She stated the medication lists from the clinic transfers to the facility's electronic medical record and that medication list from the clinic was used to order home medications. Physician 1 further stated she did not do the medication reconciliation, that the pharmacist did that. She would just ask the patient if there had been any changes with their medications.


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