HospitalInspections.org

Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by:

1. Failing to ensure the hospital developed, implemented, and maintained an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program (Refer to A263, A273, and A286).

2. Failing to ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs (Refer to A385, A397, and A405).

3. Failing to ensure pharmaceutical services and operations were provided in a safe and effective manner that would meet the patients' needs. (Refer to A490, A494, and A500).

4. Failing to ensure respiratory services were provided in a safe and effective manner that would meet the patients' needs. (Refer to A1151).

The cumulative effect of these systemic problems resulted in the failure of the Governing Body to ensure patients were receiving quality care in a safe and effective manner.

Based on interview and record review, the facility failed to ensure the "Transfusion Consent," form was completed prior to Patient 105 receiving blood on August 9, 2015. This failure resulted in Patient 105 signing a consent, without the information needed to make an informed decision about receiving a blood transfusion.

Findings:

On August 11, 2015, Patient 105's record was reviewed. The following was noted:

a. Patient 105 was admitted to the facility on August 3, 2015, with a diagnosis of pneumonia;

b. On August 9, 2015, at 2:30 p.m., the patient's physician wrote an order to "Transfuse 1 unit PRBC (packed red blood cells);"

c. The "Transfusion Consent," form in the patient's record was signed and dated by Patient 105 on August 9, 2015, at 2:45 p.m.;

d. The form was not signed or dated by Patient 105's physician; and

e. On August 9, 2015, at 11:40 p.m., the nurse documented: "Started first unit of PRBCs."

Patient 105's "Transfusion Consent," form was reviewed. The form was separated into two sections, one for the "Physician Certification," and the second for the patient's consent. By signing the form, the physician was certifying the patient was given information about the advantages and disadvantages, risks, benefits and alterative therapies and he answered questions and he had "...obtained informed consent..." The section did not have the date, time, or signature of the physician.

On August 11, 2015, at 11:25 a.m., Patient 105's record was reviewed with the Clinical Manager (CM). The CM verified the patient had received a blood transfusion on August 9, 2015, and the physician's area on the "Transfusion Consent," form was not complete. The CM stated the physician should sign the form before the blood was given.

The facility policy titled, "Administration of Blood and Blood Derivatives," revised September 2013, was reviewed. The policy indicated its purpose was to outline nursing management responsibilities to patients receiving blood and blood products. The following was documented: "Ensure physicians discussion of informed consent is documented. Obtain written consent for blood and/or blood derivatives..."

Based on observation, interview, and record review, the facility failed to:

1. Ensure quality data was collected to determine the timeliness of respiratory therapy (RT) initiation, and to identify opportunities for improvement after previous problems were identified and corrective action was taken (A273 and A1151);

2. Ensure a medication error resulting in an adverse event was analyzed in accordance with the standards of practice to which they subscribed (A286);

3. Implement corrective action that included education for nursing staff of changes made to the medication administration record (MAR) (A286);

4. Perform data collection to ensure the corrective actions taken were effective in preventing further medication errors and adverse events (A286); and,

5. Develop and implement medication error reduction strategies that would produce measureable outcomes as a result of review and analysis of its own medication errors, potential and actual, which led to changes to the system or processes (A286).

The cumulative effect of these systemic problems resulted in failure to ensure the facility maintained an effective quality assessment and performance inprovement program.

Based on observation, interview, and record review, the facility failed to ensure quality data was being collected to determine the timeliness of respiratory therapy (RT) initiation, and identify opportunities for improvement after previous problems were identified and corrective action was taken, resulting in continued delays in initiating respiratory therapy, and the potential for deterioration in the patient conditions, respiratory distress, and death.

Findings:

Physician orders were received in the Respiratory Therapy (RT) department in two different ways:

1. When a physician wrote an order and placed the order in the paper medical record, the unit secretary would enter the order into the clinical computer system (IMED), and a notification would print in the RT department to alert the staff of a new or modified order; and,

2. When a physician entered an order using the computerized physician order entry system (CPOE), the order would be sent electronically to the pharmacy. The pharmacist would enter the order onto the medication administration record (MAR), and trigger a notification to the RT department to alert the staff of a new or modified order.

During a tour of the Respiratory Therapy (RT) Department on August 12, 2015, at 9:30 a.m., the RT Coordinator stated there was a previous problem with the department receiving orders that were entered using the CPOE system, but that had been corrected. He stated there was currently a problem with them receiving orders from the unit secretaries, as the orders were not being put into the IMED system in a timely manner.

During an interview with the RT Director on August 12, 2015, at 9:40 a.m., the Director stated he was aware of the current problem, and he had met with the pharmacy and information technology (IT) departments the previous week. He stated he was supposed to meet with the nursing department sometime in the current week. The director stated the unit secretaries were not getting RT orders communicated to them in a timely manner through the IMED system, when the physician wrote them on a physician's order form instead of using the CPOE system. He stated there were, "still," delays in the system. According to the Director, the Chief Operating Officer (COO) and the Director of Quality (DQ) were aware of the problem.

During the tour, a copier/printer was observed in the RT office that was printing papers with lists of patient names periodically. The coordinator stated the lists were generated by IT, and included the names and locations of patients who had RT orders entered using CPOE. The list also contained a list of patient who had orders written by the physician, but the orders had not been acknowledged by the RT staff yet. He stated the lead RT staff checked each patient on the list to make sure therapy had been started.

The facility policy titled, "Medication Administration," was reviewed on August 12, 2015. According to the policy, RT medications, "must," be administered within four hours of being ordered.

a. The record for Patient 209 was reviewed on August 12, 2015. Patient 209, a 70 year old female, was admitted to the facility on August 6, 2015, with diagnoses that included Congestive Heart Failure (CHF), Decreased Oxygen Saturation (low oxygenation), and Respiratory Failure.

The patient's home medications were reviewed on admission using the Medication Reconciliation Process, albuterol and atrovent (respiratory medications) nebulizer (breathing treatment) treatment was ordered to be continued every 2 hours as needed, and the orders were faxed to the pharmacy at 6 p.m.

According to the order history, the information technology (IT) department entered the order into the clinical (IMED) system on August 9, 2015, at 2 a.m. (8 hours after the therapy was ordered).

The order detail indicated the unit secretary entered the order in the computer (IMED) system on August 9, 2015, at 2:25 p.m. (20 hours and 25 minutes after the therapy was ordered).

According to the record, the initial RT assessment to determine whether a treatment was needed, was completed on August 9, 2015, at 4:49 p.m. (22 hours and 49 minutes after therapy was ordered).

b. The record for Patient 210 was reviewed on August 12, 2015. Patient 210, an 82 year old male, was admitted to the facility on August 8, 2015, with diagnoses that included Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, and Hypoxia (lack of oxygen).

The Pre-Printed Emergency Admit orders, written at 8 p.m., included an order for albuterol and atrovent (respiratory medications) to be given via a nebulizer (breathing treatment) every four hours and as needed.

According to the record, the order was entered by the unit secretary at 10:56 p.m. (2 hours and 56 minutes later).

The record indicated the order was acknowledged by the RT staff on August 9, 2015, at 2:51 a.m., (6 hours and 51 minutes after it was written).

The RT Treatment form indicated the first time RT had contact with Patient 210, and administered a breathing treatment, was on August 9, 2015, at 7:20 a.m., (11 hours and 20 minutes after the order was written).

c. On August 11, 2015, at 10:50 a.m., a tour of the second floor was conducted. The Charge Nurse (CN) indicated Patient 105 was admitted for treatment of pneumonia.

The record for Patient 105 was reviewed on August 11, 2015. Patient 105, presented to the facility on August 3, 2015, with complaints of difficulty breathing. Patient 105 was admitted to the facility on August 3, 2015, at 11 p.m., with diagnoses that included pneumonia.

Handwritten physician orders dated August 3, 2015, at 11 p.m., indicated: "Duoneb (albuterol and ipratropium medication combination that relaxes muscles in the airways and increases air flow to the lungs) Neb (nebulizer-breathing treatment) Q (every) 4 (four) hours ATC (around the clock)."

According to the record, the order was entered by the unit secretary on August 3, 2015, at 11:45 p.m.

The record indicated the order was acknowledged by the RT staff on August 4, 2015, at 5:09 a.m., (6 hours after the order was written). The RT documented an initial assessment at this time but did not administer the medication treatment as ordered.

The RT Treatment form indicated the first time RT administered a breathing treatment was on August 4, 2015, at 10:10 a.m., (11 hours after the order was written).

During an interview with the RT Director, on August 12, 2015, at 1 p.m., the Director stated initial assessment and treatment should be done as soon as possible. The Director stated it would have been better if Patient 105 received a treatment at 5:09 a.m., when the RT initially assessed the patient. The RT Director stated they were still having problems with initiating treatments due to delays in receiving the orders.

The policy and procedure for inhalation treatments was requested. The policy and procedure for "Medication Administration," revised March 2014, was reviewed. The policy indicated the purpose was to ensure safe administration of medications to patients. Respiratory Therapy was accountable to this policy. The policy indicated: "Routine medications must be administered within four (4) hours."

During an interview with the Director of Respiratory Therapy (DRT), the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), and the Director of Information Technology (DIT), on August 12, 2015, at 1:10 p.m., the DRT, the DOP, and the DIT stated they were aware problems continued to exist regarding notification of the RT staff when new therapy was ordered.

They stated they had recent problems (lasting approximately two to three months) with the computerized physician order entry (CPOE) system not triggering a notification to RT staff, but they thought they had corrected that problem. They stated they did not do any data collection or follow up to make sure the problem was corrected. They stated they were not monitoring for RT notification and timely order initiation. They stated the problem continued to occur as a result of a different failure, failure of the unit secretaries to enter the orders into the clinical computer (IMED) system that would generate a notification to the RT staff when a written order was received. They stated they had not gathered a multidisciplinary team, initiated a performance improvement project, developed indicators, or performed data collection to ensure they had identified the true cause and frequency of the problem.

The RT director stated he was aware of the ongoing problem, and had communicated it to the pharmacy and the IT department (at different times). He stated he needed to, "get together," with nursing to discuss it.

The DOP stated he was aware of the problem, but he was not responsible for it, as it was failure of the unit secretaries to enter new RT orders.

The DIT stated he was aware of the problem, and monitored the system every four hours to identify orders that were not entered by the unit secretary, so they could be acknowledged and initiated by RT. He stated if he identified such orders, he would enter the order into the clinical system (IMED), and generate a notification to RT. He stated he put Patient 209's orders in, when he realized during his regular four hour check (on August 9, 2015, at 2 a.m.) the RT order had not been entered by the unit secretary and communicated to the RT staff for eight hours. He stated he checked the system every four hours, around the clock, seven days a week, in an effort to catch all of the orders that had not been communicated through the electronic system.

The CNO stated he was just told about the ongoing problem with the unit secretaries not entering orders in a timely manner, approximately two hours earlier.

Although the DRT, the DOP, and the DIT were aware of delays in RT orders being communicated to RT staff, resulting in delays in initiation of therapy, they failed to identify the need for a multidisciplinary, organized, data driven approach to correcting the reoccurring problem.

Based on observation, interview, and record review, the facility failed to:

1. Ensure a medication error resulting in an adverse event was analyzed in accordance with the standards of practice to which they subscribed;

2. Implement corrective action that included education for nursing staff of changes made to the medication administration record (MAR);

3. Perform data collection to determine whether the corrective actions taken were effective in preventing further medication errors and adverse events; and,

4. Develop and implement medication error reduction strategies that would produce measurable outcomes as a result of review and analysis of its own medication errors, potential and actual, which led to changes to the system or processes.

These failed practices resulted in the potential for additional life threatening medication errors, patient harm, and death.

Findings:

[According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dL (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM), on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had a physician order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 214 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m., (in preparation of giving the next scheduled 100 unit dose) and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 214 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1, on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

RN 1 stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his blood sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., and he was lethargic and unresponsive. According to RN 1, a sitter, who was with the patient reported he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 214's physician to report the patient's condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due) and the result was 21. According to the RN 1, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. RN 1 stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the RN 1 nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure). In addition the blood sugar was to be checked before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled", insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive, and the physician was paged;

C. At 11:25 a.m., (the patient) was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40, the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

According to the Novolog dosing guidelines, if the average insulin requirement was 0.5-1.0 units/kilogram/day, Patient 214 would require an average of 41 to 82 units per day (both long acting and short acting insulins combined). Patient 214 received 100 units of insulin medication in one dose.

According to the Institute for Safe Medication Practices (ISMP), an independent double-check of a high-alert medication is a procedure in which two clinicians separately check (alone and apart from each other, then compare results) each component of prescribing, dispensing, and verifying the high-alert medication before administering it to the patient. Manual redundancies such as independent double checks play an important role in error detection (by "about" 95%). Independent double checks assist in preventing serious errors from reaching the patient. They should be done on error prone processes such as the use of high alert medications (including insulin).

The facility policy titled, "High Alert Drugs," was reviewed on July 23, 2015. According to the policy for insulin safety, "... 6.3.1- Any time a nurse prepared a dose of insulin, a second nurse was to double check the accuracy of the dose prepared. The second nurse was to review the actual container from which the dose was taken, and verify the type of insulin and actual amount of the dose to determine accuracy."

During a Quality Department interview on August 13, 2015, at 10 a.m., the Chief Nursing Officer (CNO) stated when he spoke to RN 2 about double-checking the insulin dose, she told him she did not check it correctly. The CNO stated RN 2 told him that she was aware 100 units of insulin was, "way too much," and she would have stopped RN 1 if she knew that was how much she was getting ready to administer.

During an interview with the Director of Pharmacy (DOP) on July 23, 2015, at 11:10 a.m., the director stated he was aware of the medication error, and had reviewed the record. He stated he identified, "multiple failure points," including:

a. Order entry, the dose of insulin was incorrect as entered by the pharmacist;

b. Order entry, the insulin was entered as a scheduled medication instead of a sliding scale dose by the pharmacist;

c. Nursing accepted the order when they noted it;

d. The nurse did not question the dose before giving the insulin; and,

e. The "whole EMR (electronic medical record) set up," and the inability to have the MAR reflect the physician's orders accurately.

The DOP stated the pharmacist used, "bad judgement," when she entered the order as, "scheduled." He stated at one point the patient was getting accuchecks every two hours, before meals, and at bedtime. He stated it was confusing, and the, "scheduled," dose was the only way the pharmacist could think of to make sure accuchecks were done every two hours, before meals, and at bedtime (as required according to the orders).

According to the DOP, the EMR had no way to change the information that was being put in for insulin dosing. He stated every entry under concentration and dose must be assigned a value, so they could not enter, "sliding scale," or anything similar for the dose, they had to pick a value. He stated the value they picked was the concentration available for the staff to give, 100 units/ml, so that is why it showed that way in the, "dose," area for Patient 214.

The DOP stated they were in the process of changing all of the MARs with sliding scale orders to have the dose section read, "1 unit/0.01 ml. He stated then the nurses would have to use their judgement and, "medicate according to the sliding scale." The DOP stated he was aware by making the change on the MARs, all sliding scale doses would be incorrect , "on paper," but if a patient received the amount of insulin shown in the, "dose," section (1 unit/0.01 ml), they would receive an underdose, not an overdose, which was much safer.

The failure of RN 1 to verify the physician's order and question the insulin dose of 100 units prior to administering it; of RN 2 to double-check the insulin dose according to hospital policy and standards of practice; and, of the pharmacy to ensure the MAR was accurate and reflected the physician's orders, resulted in administration of a potentially fatal dose of insulin, life threatening hypoglycemia, and transfer to the ICU on a ventilator.

1. During an interview with the Director of Quality and Risk Management (DQRM) on August 13, 2015, at 10 a.m., the director stated the facility convened a team to investigate the medication error/adverse event.

The DQRM stated the team consisted of members from the departments of nursing, quality, risk, and pharmacy. He presented the sign in sheet that included nursing leaders/managers and representatives from the other departments. The pharmacist who was involved in development of the MAR was present. There was no evidence that RN 1 or RN 2 were present for the meeting or involved in the investigative process.

The DQRM stated the Risk Manager (RM), (a non-clinical person) interviewed the nurses, but the nurses were not invited to participate in the investigative process due to recommendations by the National Patient Safety Foundation (NPSF), the organization that developed the investigative process the facility subscribed to and followed.

According to the DQRM, the team convened on one occasion, and determined the medication error/adverse event was due to the pharmacy developing the MAR that included an insulin dose of 100 units in 1 ml. The DQRM stated, in addition, the team identified the double check done by RN 2 was not done correctly, and the physician's orders for the accuchecks and insulin administration were, "ambiguous." The DQRM stated the team did not identify RN 1's experience, orientation, or training as a potential cause of the error.

The DQRM stated the pharmacy MAR process was the cause of the error, and RN 1 was terminated as the corrective action.

The National Patient Safety Foundation (NPSF) paper, published June 2015, was provided by the DQRM on August 13, 2015. The DQRM stated the standards recommended in the paper were the standards the facility followed when investigating adverse events.

According to the NPSF:

a. It is vital that individuals who were involved in the event (staff) are interviewed by the team;

b. Front line staff who work in the area where the adverse event occurred should be represented on the team, and should be interviewed by the team to provide insight into how people can be set up to fail by improperly designed systems;

c. The process was not to be used to focus on or address individual health care worker performance as the primary cause of an adverse event, but instead to look for the underlying system's level causations that were manifest in personnel-related performance issues. Findings from the investigation must not be used to discipline, shame, or punish staff; and,

d. In order to improve patient safety, corrective actions must be implemented and their effectiveness measured. Each action requires one measure, which may be either a process measure or an outcome measure.

In contrast, the following actions were taken by the facility:

aa. The nurses involved in the medication error/adverse event were not interviewed by the team so they could explain what happened from their perspective;

bb. Managers, not front line staff who worked in the area and within the current systems, were included on the team;

cc. The findings from the investigation were used to discipline (terminate) a nurse; and,

dd. No measures were put into place to measure the action(s) taken to prevent reoccurrence of a life threatening medication error/adverse event related to insulin administration.

None of these actions represented the recommendations made by the NPSF. The facility did not follow the process they subscribed to to investigate the adverse event and determine corrective actions.

2. During an interview with the Director of Pharmacy (DOP) on July 23, 2015, at 11:10 a.m., the DOP stated the electronic medical record (EMR) had no way to change the information that was being put in for insulin dosing. He stated every entry under concentration and dose must be assigned a value, so they could not enter, "sliding scale," or anything similar for the dose, they had to pick a value. He stated the value they picked was the concentration available for the staff to give, 100 units/ml, so that is why it showed that way in the, "dose," area for Patient 214.

The DOP stated they were in the process of changing all of the MARs with sliding scale orders to have the dose section read, "1 unit/0.01 ml. He stated then the nurses would have to use their judgement and, "medicate according to the sliding scale." The DOP stated he was aware by making the change on the MARs, all sliding scale doses would be incorrect, "on paper," but if a patient received the amount of insulin shown in the, "dose," section (1 unit/0.01 ml), they would receive an underdose and not an overdose, which was much safer. The DOP stated the nursing staff had not yet been educated on the changes being made on all of the MARs that contained insulin sliding scale orders.

During an interview with the Director of Quality and Risk Management (DQRM) on August 13, 2015, at 10 a.m., the director stated the facility convened a team to investigate the medication error/adverse event.

According to the DQRM, the team convened on one occasion, and determined the cause of the medication error/adverse event was the MAR developed by pharmacy that included an insulin dose of 100 units/1 ml. The DQRM stated, in addition, the team identified the double check done by RN 2 was not done correctly, and the physician's orders for the accuchecks and insulin administration were, "ambiguous."

The DQRM stated there was no education or training for the nurses done to date on the correct process for double checking insulin, the new insulin dosage entry on the MAR, or the process for clarifying ambiguous orders. He stated the training/education had not been scheduled yet.

3. During an interview with the Director of Quality and Risk Management (DQRM) on August 13, 2015, at 10 a.m., the director stated the facility convened a team to investigate the medication error/adverse event.

According to the DQRM, the team convened on one occasion, and determined the cause of the medication error/adverse event was the MAR developed by pharmacy that included an insulin dose of 100 units/1 ml. The DQRM stated, in addition, the team identified the double check done by RN 2 was not done correctly, and the physician's orders for the accuchecks and insulin administration were, "ambiguous."

The DQRM stated there were no quality indicators developed and no data collection had been done to determine the scope and severity of the problem, and whether the changes made had been effective in preventing further adverse events.


25281

4. During an interview on August 12, 2015, at 2 p.m., the Director of Pharmacy (DOP), stated there was a significant amount of medication errors that were not being captured and currently the medication errors were, "vastly," underreported. The DOP also stated one of the problems was the recent change in reporting from a manual error reporting system to an electronic error reporting system, that made it cumbersome for the staff to use.

The DOP acknowledged because of underreporting there was not enough data to identify the trends and patterns that would point out problem prone areas and changes that would lead to measurable reduction in medication errors.

During an interview, on August 13, 2015, at 10 a.m., the Director of Quality Risk Management (DQRM), acknowledged that the medication errors were underreported.

Review of the facility's policy and procedure titled, "Medication Event," stipulated:

"The Medication Safety Team and P&T (Pharmacy and Therapeutics) Committee evaluates the reports to include the appropriateness of action taken by staff including action taken by personnel, observation of patients for signs of an adverse effect, appropriateness and chronological history of supportive treatment if needed, availability of emergency drugs antidotes and observations after treatment.

Patterns and trends are identified, as are changes in frequency, types of events and personnel involved. Reviews of patterns and trends cover 12-month period.

Reports of the findings of Performance Improvement (PI) activities were intended to prompt actions to improve the processes identified above. The effect of the action was assessed and, when those actions were determined to be successful, the improvements were maintained by continued surveillance. When initial actions were not effective, new actions were designed and implemented and the effectiveness of those actions is assessed."

Based on observation, interview and record review, the facility failed to ensure organized nursing service was provided to all patients by failing to ensure:

1. Nurses demonstrated competency prior to being assigned to care for:

a. One patient with complex insulin orders (Patient 214) , resulting in a life threatening medication error and transfer to the Intensive Care Unit (ICU) (A397); and

b. Four patients undergoing procedure related sedation (Patients 201, 111, 112, and 113), resulting in the potential for respiratory depression, respiratory arrest, and death (A397);

2. Insulin was administered in accordance with the physician's order and accepted standards of practice, when a registered nurse (RN 1) administered 100 units of Novolog (fast acting) insulin (a potentially fatal dose) to lower the blood sugar of one patient (Patient 214), and a second RN (RN 2) incorrectly double-checked and signed off on the dose, resulting in life threatening hypoglycemia (low blood sugar), a transfer to the Intensive Care Unit (ICU) on a ventilator (breathing machine), and the potential for death (A405);

3. The insulin sliding scale (administration of insulin doses according to the blood sugar level) was adjusted in accordance with pre-printed physician's orders for three patients (Patients 204, 106, and 108), resulting in prolonged elevation of blood sugars and the potential for infection and dehydration (A405); and,

4. Four patients (Patients 201, 111, 112, and 113) who received procedural sedation (medication administered to sedate a patient during a painful or uncomfortable procedure) were monitored every five minutes during the procedure according to the facility procedure on sedation care and accepted standards of practice, resulting in the potential for respiratory depression (slow, ineffective respirations) or arrest and death (A405).

The cumulative effects of these systemic problems resulted in failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on observation, interview, and record review, the facility failed to ensure nurses demonstrated competency prior to being assigned to care for:

1. One patient with complex insulin orders (Patient 214) , resulting in a life threatening medication error and transfer to the Intensive Care Unit (ICU); and,

2. Four patients undergoing procedure related sedation (Patients 201, 111, 112, and 113), resulting in the potential for respiratory depression, respiratory arrest, and death.

Findings:

1.[According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had an order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 1 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 1 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1 on July 23, 2015, at 10:45 a.m., RN 1 stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

RN 1 stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 214 at 10 a.m., he was lethargic and unresponsive. According to the RN, a sitter, who was with the patient reported the patient fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 1's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m. when the next scheduled dose of insulin was due, and the result was 21. According to the nurse, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. The nurse stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did RN 1 indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure). In addition the blood sugar was to be checked before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive. The physician was paged;

C. At 11:25 a.m., (the patient) was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40, the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

Review of the MAR for Patient 214 indicated the MAR looked the same as RN 1 described.

According to the Novolog dosing guidelines, if the average insulin requirement was 0.5-1.0 units/kilogram/day, Patient 214 would require an average of 41 to 82 units per day (both long acting and short acting insulins combined). Patient 214 received 100 units of insulin medication in one dose.

In an interview with RN 1 on July 23, 2015, at 10:45 a.m., RN 1 stated she received three weeks of orientation to the facility (the first week being general and classroom nursing orientation, then two weeks on the floor). She stated she requested additional orientation time because she was, "new grad status," and she was given one additional week.

According to the RN 1, she had diabetic patients during her orientation period, and learned that the medication administration record (MAR) had areas to document accucheck results on the first page, scheduled insulin a few pages later, then sliding scale insulin at the end. The nurse stated she was taught that scheduled insulin was to be given at the scheduled times, and sliding scale insulin was to be given in addition to the scheduled insulin, if needed, based on the blood sugar levels.

A review of the resume and application for RN 1 indicated she was issued a nursing license in 2010, but did not begin working as a nurse. She returned to school and received a bachelor's degree in 2014. According to the documents, her position at the facility was her first experience with responsibility for her own patients in an acute care setting.

A review of the Nursing Orientation Agenda indicated Medication Safety/Medication Reconciliation (verification)/Glycemic (blood sugar) control topics were combined, and a total of 15 minutes was spent on them.

The facility was unable to provide evidence of competency verification for MAR use, insulin administration, or knowledge of medications/dosages/calculations for RN 1.

During an interview with the Senior Human Resources Generalist (SHRG) on July 23, 2015, at 10 a.m., the SHRG stated there was no medication test in place to determine a baseline understanding and knowledge of the medication administration process. She stated the facility began to administer a pre-employment test in April of 2015, so RN 1, "just missed it."

2. According to the American Society of Anesthesiology, "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists", vital signs should be monitored every 3-5 minutes once a stable level of sedation has been established.

a. During a tour of the Interventional Radiology (IR) section of the Radiology Department on August 11, 2015, at 10:10 a.m., accompanied by IR registered nurse (RN) 1, the RN stated she performed procedure related sedation on patients who were undergoing painful or uncomfortable invasive procedures. The RN stated she gave fentanyl (narcotic medication) and versed (sedative/relaxant) medication regularly for sedation. She stated during the procedure she monitored the patient's heart rate and rhythm, blood pressure, respiratory rate, oxygenation, level of consciousness, and pain level every 15 minutes.

The record for Patient 201 was reviewed on August 11, 2015. Patient 201, a 69 year old male, presented to the facility on August 11, 2015, to undergo a biopsy of a mediastinal (mid chest) mass, using computerized tomography (CT) assistance, in the radiology department.

The monitoring section of the radiology procedure notes included a pre-printed message that read, "Monitor pt (patient) at every 5 min (minute) during procedure if sedation used."

According to the record, the patient was taken into the procedure room at 9 a.m., the procedure started at 9:45 a.m., at which time IR RN 2 administered fentanyl 50 mcg (micrograms) intravenous (IV) for sedation, and the procedure was completed at 10:20 a.m.

The monitoring section of the notes indicated IR RN 2 documented the patient's heart rhythm, blood pressure, heart rate, respiratory rate, oxygenation, level of consciousness, and pain every 15 minutes (at 9:25 a.m., 9:40 a.m., 9:55 a.m., 10:10 a.m., and 10:25 a.m.).

There was no evidence in the record Patient 201 was monitored every five minutes during the procedure.

b. The record for Patient 111 was reviewed on August 13, 2015. Patient 111, presented to the facility on June 8, 2015, to undergo an ultrasound guided liver biopsy, in the radiology department.

The monitoring section of the radiology procedure notes included a pre-printed message that read, "Monitor pt (patient) at every 5 min (minute) during procedure if sedation used."

According to Patient 111's "Special Procedures Form," dated June 8, 2015, completed by IR RN 3, the patient presented to the room at 8:35 a.m. and the procedure started at 9 a.m. Patient 111 received fentanyl 25 mcg at 9:04 a.m., and 50 mcg at 9:10 a.m. Patient 111's procedure was completed at 9:20 a.m.

The monitoring section of the notes indicated IR RN 3 documented the patient's heart rhythm, blood pressure, heart rate, respiratory rate, oxygenation, level of consciousness, and pain level, at 8:40 a.m., 8:45 a.m. (before sedation given) and at 9:15 a.m., and fifteen minutes later at 9:30 a.m.

There was no evidence in the record that Patient 111 was monitored every five minutes between 9 a.m. and 9:20 a.m.

c. The record for Patient 112 was reviewed on August 13, 2015. Patient 112, presented to the facility on July 9, 2015, to undergo a computerized tomography (CT) guided lymph node biopsy, in the radiology department.

The monitoring section of the radiology procedure notes included a pre-printed message that read, "Monitor pt (patient) at every 5 min (minute) during procedure if sedation used."

According to Patient 112's "Special Procedures Form," dated July 9, 2015, completed by IR RN 2, the patient presented to the procedure room at 9:05 a.m. and the procedure started at 9:20 a.m. Patient 112 received fentanyl 50 mcg at 9:31 a.m., and 50 mcg at 10:05 a.m. Patient 112's procedure was completed at 10:20 a.m.

The monitoring section of the notes indicated IR RN 2 monitored the patient's heart rhythm, blood pressure, heart rate, respiratory rate, oxygenation, level of consciousness, and pain level, at 9:20 a.m., 9:35 a.m., 9:50 a.m., 10:05 and 10:20 a.m.

There was no evidence in the record that Patient 112 was monitored every five minutes between 9:20 a.m. and 10:20 a.m., on July 9, 2015.

d. The record for Patient 113 was reviewed on August 13, 2015. Patient 113, presented to the facility on June 12, 2015, to undergo a computerized tomography (CT) guided lung biopsy, in the radiology department.

The monitoring section of the radiology procedure notes included a pre-printed message that read, "Monitor pt (patient) at every 5 min (minute) during procedure if sedation used."

According to Patient 113's "Special Procedures Form," dated June 12, 2015, completed by IR RN 2, the patient presented to the procedure room at 8:45 a.m., and the procedure started at 9:05 a.m. Patient 113 received fentanyl 50 mcg at 9:08 a.m., and 50 mcg at 9:19 a.m. There was no "end time" documented in Patient 113's record.

The monitoring section of the notes indicated IR RN 2 monitored the patient's heart rhythm, blood pressure, heart rate, respiratory rate, oxygenation, level of consciousness, and pain level, at 8:45 a.m., (before sedation given), 9:15 a.m., 9:30 a.m., and 9:45 a.m.

There was no documentation in the record that Patient 113 was monitored every five minutes between 9:08 a.m. and the end of his procedure on June 12, 2015.

During an interview with the Radiology Supervisor (RS) on August 13, 2015, at 1 p.m., the RS stated she was unaware information needed to be documented every five minutes. The RS stated the patient was under continuous monitoring, but she could see the information was not documented every five minutes.

The facility policy and procedure titled "Adult Sedation Care," revised November 2013, was reviewed. The policy indicated its purpose was to establish appropriate and consistent standards for administering and monitoring sedation during diagnostic, therapeutic and invasive procedures in the facility. The policy indicated, "Document vital signs, pain level and level of consciousness every five minutes."

The employee files for IR RN 1, 2, and 3, were reviewed on August 13, 2015. There was no evidence in the files the nurses had been trained or had demonstrated competency in administration of procedure related sedation.

During an interview with the Senior Human Resources Generalist (SHRG) on August 13, 2015, at 2 p.m., the SHRG stated she had not received any evidence of competency verification/demonstration in administration of procedure related sedation for any of the IR nurses.

Based on observation, interview, and record review, the facility failed to ensure:

1. Insulin was administered in accordance with the physician's order and accepted standards of practice when a registered nurse (RN 1) administered 100 units of Novolog (fast acting) insulin (a potentially fatal dose) to lower the blood sugar of one patient (Patient 214), and a second RN (RN 2) incorrectly double-checked and signed off on the dose, resulting in life threatening hypoglycemia (low blood sugar), a transfer to the Intensive Care Unit (ICU) on a ventilator (breathing machine), and the potential for death;

2. The insulin sliding scale (administration of insulin doses according to the blood sugar level) was adjusted in accordance with pre-printed physician's orders for three patients (Patients 204, 106, and 108), resulting in prolonged elevation of blood sugars and the potential for infection and dehydration.

Findings:

1. [According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had a physician order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 214 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 214 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1, on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

The RN stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., he was lethargic and unresponsive. According to the nurse, a sitter who was with the patient reported that he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 214's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due), and the result was 21. According to the RN 1, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. RN 1 stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure), in addition to checking it before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive, and his physician was paged;

C. At 11:25 a.m., he was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40 a.m., the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

According to the Novolog dosing guidelines, if the average insulin requirement was 0.5-1.0 units/kilogram/day, Patient 214 would require an average of 41 to 82 units per day (both long acting and short acting insulins combined). Patient 214 received 100 units of insulin medication in one dose.

According to the Institute for Safe Medication Practices (ISMP), an independent double-check of a high-alert medication is a procedure in which two clinicians separately check (alone and apart from each other, then compare results) each component of prescribing, dispensing, and verifying the high-alert medication before administering it to the patient. Manual redundancies such as independent double checks play an important role in error detection (by "about" 95%). Independent double checks assist in preventing serious errors from reaching the patient. They should be done on error prone processes such as the use of high alert medications (including insulin).

The facility policy titled, "High Alert Drugs," was reviewed on July 23, 2015. According to the policy for insulin safety, "...6.3.1 - Any time a nurse prepared a dose of insulin, a second nurse was to double check the accuracy of the dose prepared. The second nurse was to review the actual container from which the dose was taken, and verify the type of insulin and actual amount of the dose to determine accuracy."

During a Quality Department interview on August 13, 2015, at 10 a.m., the Chief Nursing Officer (CNO) stated when he spoke to RN 2 about double-checking the insulin dose, she told him she did not check it correctly. According to the CNO, RN 2 was aware that 100 units of insulin was, "way too much," and she would have stopped RN 1 if she knew that was how much she was getting ready to administer.

The facility policy titled, "Medication Administration," was reviewed on July 23, 2015. According to the policy:

aa. The nurse should observe the six rights of medication administration, including right dose;

bb. The nurse should check the MAR against the original physician's order; and,

cc. High alert medications, including insulin, would be checked by two licensed nurses before it was administered.

The failure of RN 1 to verify the physician's order and question the insulin dose of 100 units prior to administering it, and of RN 2 to double-check the insulin dose according to hospital policy and standards of practice resulted in administration of a potentially fatal dose of insulin to Patient 214, life threatening hypoglycemia, and transfer of the patient to the ICU on a ventilator.

2. The facility approved pre-printed Insulin Sliding Scale (ISS) Orders were reviewed on August 11, 2015. The orders indicated for patients on an insulin sliding scale, the nurse was to use Novolog (fast acting) insulin subcutaneously (into the fatty tissue just under the skin) in addition to any scheduled insulin, depending on the patient's blood sugar level.

A patient was to receive their regularly scheduled insulin dose(s) throughout the day (if ordered), and blood sugar levels would be checked at regular intervals. Depending on their blood sugar levels, additional insulin was to be given according to the pre-printed sliding scale.

The pre-printed supplemental insulin order indicated the following:

- Patients were placed on a low dose sliding scale, a standard dose sliding scale, or a high dose sliding scale according to their physician's order;

- If their blood sugar levels were greater than 200 for two consecutive readings, the nurse was to move them to the next level of the scale as described below;

- If a patient on a low dose sliding scale had two consecutive blood sugar readings greater than 200, the patient was to be placed on a standard dose sliding scale;

- If a patient on a standard dose sliding scale had two consecutive blood sugar readings greater than 200, the patient was to be placed on the high dose sliding scale; and,

- If a patient on a high dose sliding scale had two consecutive blood sugar readings greater than 200, the nurse was to contact the physician for further instructions.

2a. During a tour of the ICU on August 12, 2015, at 2 p.m., accompanied by the ICU charge nurse (CN), the CN stated they used the pre-printed sliding scale orders when a patient's physician ordered insulin to be given according to a sliding scale.

The record for Patient 204 was reviewed. Patient 204, a 39 year old female, was admitted to the facility on August 5, 2015, with diagnoses that included Renal (kidney) Failure and Diabetes.

The record contained a physician's order dated August 6, 2015, for accuchecks (blood sugar test) every four hours to be covered with a standard dose insulin sliding scale.

A review of the accuchecks indicated the following:

August 10, 2015:

A. At 1 p.m., the accucheck was 211, and the nurse gave 4 units of insulin according to the standard dose ISS;

B. At 5 p.m., the accucheck was 275 (two consecutive accuchecks above 200), and the nurse gave 6 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders;

C. At 9 p.m., the accucheck was 284, (the third consecutive accucheck above 200), and the nurse gave 6 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders;

August 11, 2015:

D. At 1 a.m., the accucheck was 232, (the fourth consecutive accucheck above 200), and the nurse gave 4 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders;

E. At 5 a.m., the accucheck was 224, (the fifth consecutive accucheck above 200), and the nurse gave 4 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders;

F. At 9 a.m., the accucheck was 292, (the sixth consecutive accucheck above 200), and the nurse gave 6 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders; and,

G. At 1 p.m., the accucheck was 299, (the seventh consecutive accucheck above 200), and the nurse gave 6 units of insulin according to the standard dose ISS. The nurse did not advance the patient to the high dose ISS according to the physician's orders.

Patient 204 had seven consecutive blood sugar values over 200, and the nursing staff did not adjust her insulin to the high dose scale, so her blood sugar levels continued to be high.

During a concurrent interview with the ICU CN, the CN stated the nurses should have changed Patient 204 to the high dose ISS after the second blood sugar value over 200.

2b. On August 11, 2015, at 11:30 a.m., Licensed Vocational Nurse (LVN) 1 stated she needed to administer insulin coverage to Patient 106. LVN 1 stated she had completed a finger stick blood sugar test on Patient 106 and he was due to receive 3 (three) units of Novolog insulin.

LVN 1 brought Patient 106's Medication Administration Record (MAR), the bottle of insulin and the syringe, to a second nurse who verified the type of insulin, the dose and the order. According to both nurses, Patient 106 had a finger stick blood sugar reading of 256 mg (milligrams)/dL (deciliter) and he was to receive 3 (three) units of Novolog insulin. LVN 1 administered the dose of insulin at 11:30 a.m.

On August 11, 2015, Patient 106's record was reviewed. Patient 106 was admitted to the facility on August 6, 2015, for treatment of acute pancreatitis (inflammation of the pancreas-the pancreas produces enzymes that assist digestion and hormones that help regulate the way the body processes sugar [glucose]). Patient 106 had a history of diabetes, prior to this hospitalization.

Patient 106's paper chart contained a form titled: "Insulin Sliding Scale Orders-Adult-Target Range 90-120 mg/dl (ISS)." The form indicated: "Finger stick glucose before each meal (AC) and at bedtime (HS)." Additional orders included "Supplemental Insulin-Use in Addition to Scheduled insulin Aspart/Lispro (Novolog) Insulin Sub-Q (subcutaneous)..." Patient 106's orders indicated supplemental insulin was to start with the "Low Dose," scale. The form also contained a "Standard Dose" scale, a "High Dose Scale," and an area for the physician to customize doses.

Additional instructions indicated the following:

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "Low Dose," on the second consecutive reading move to the "Standard Dose."

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "Standard Dose," on the second consecutive reading move to the "High Dose."

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "High Dose," on the second consecutive reading contact physician for further instruction.

According to Patient 106's MAR, dated August 11, 2015, from 7 a.m., through August 12, 2015, at 7 a.m., the patient was to receive Novolog insulin per the following special instructions:

151-200=0 units
201-250=2 units
251-300=3 units
301-350=4 units
351-400=5 units
401-449=6 units
>450=7 units call MD (physician).

Patient 106's MAR was reviewed with the Clinical Manager (CM) on August 11, 2015, at 11:35 a.m. Patient 106 was receiving sliding scale insulin coverage from the "Low Dose," scale. Documentation on the MAR indicated Patient 106's finger stick blood sugar was 224 mg/dL, on August 11, 2015, at 8:30 a.m. The patient received two units of Novolog insulin. At 11:30 a.m., Patient 106's finger stick blood sugar was 256 mg/dL (second consecutive test above 200 mg/dL) and the patient received three units of Novolog insulin. The CM verified that three units was the low dose coverage for this blood sugar level, and the nurse should have given six units of insulin, the dose from the "Standard Dose," schedule.

During a concurrent interview with the CM, the CM stated the instructions to increase the dose of coverage for finger sticks over 200 mg/dL, was part of the insulin protocol and the nurse should "bump" up to the next level on the second consecutive reading of 200 mg/dL.

During an interview with LVN 1, on August 11, 2015, at 11:35 a.m., LVN 1 stated she would notify Patient 106's physician about the finger stick results, but she would not increase to the "Standard Dose," with the second consecutive reading over 200.

2c. On August 11, 2015, at 2:10 p.m., Registered Nurse (RN) 3 was interviewed. RN 3 stated she was monitoring Patient 108's finger stick blood sugars. RN 3 stated Patient 108 was on a "sliding scale" for insulin coverage based on the patient's finger stick results. RN 3 stated the patient's physician ordered either a "Low, Standard, or High Dose," scale and insulin was given according to the finger stick result. RN 3 stated if the patient had two consecutive readings above 200 mg/dL, she would give the ordered dose, then call the patient's physician. RN 3 stated she would not give the higher dose.

Patient 108's record was reviewed with the Definitive Observation Unit (DOU), Charge Nurse (CN), on August 11, 2015, at 2:15 p.m. A pre printed order form, dated July 13, 2015, indicated the physician ordered finger stick blood sugar checks every six hours. The "Standard Dose," scale was ordered.

The "Standard Dose," sliding scale insulin coverage was documented as follows:

120-150=0 units
151-200=2 units
201-250=4 units
251-300=6 units
301-350=8 units
351-400=10 units
401-449=12 units
>450=14 units and call MD (physician).

Additional instructions indicated the following:

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "Low Dose," on the second consecutive reading move to the "Standard Dose."

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "Standard Dose," on the second consecutive reading move to the "High Dose."

-If blood glucose was greater than 200 mg/dL for two consecutive readings and the patient was on the "High Dose," on the second consecutive reading contact the physician for further instruction.

A review of the MAR dated August 5, 2015, at 6 a.m., indicated Patient 108's blood sugar was 201 mg/dL and he received four units of Novolog insulin. The patient's next finger stick blood sugar result, on August 5, 2015, at 12 p.m., was documented as 216 mg/dL. Patient 108 was given four units of Novolog insulin. There was no evidence in the record that the nurse moved up to the high dose scale when the patient had two consecutive finger stick blood sugar readings over 200 mg/dL.

During an interview with RN 3, on August 11, 2015, at 2:15 p.m., RN 3 stated she would not increase the sliding scale dose with the second consecutive reading over 200 mg/dL. RN 3 stated she would call the physician if the patient had two consecutive readings over 200, but she would still give the insulin dose based on the "Standard," scale.

During an interview with the CM, on August 11, 2015, at 2:30 p.m., the CM stated the instructions to increase the dose of coverage for finger sticks over 200 mg/dL, was part of the insulin protocol and the nurse should "bump" up to the next level on the second consecutive reading of 200 mg/dL. The CM stated staff were instructed about this process.

Based on interview and record review, the facility failed to ensure the Medication Administration Record (MAR) correctly reflected the physician's orders for one of 34 sampled patients (Patient 301). This placed Patient 301 at risk for blood sugars not being monitored, and insulin not being given according to a sliding scale and physician's orders.

Findings:

The record for Patient 301 was reviewed. Patient 301 was admitted to the facility on August 4, 2015. A hand written physician's order, dated August 4, 2015, (unknown time) indicated the following:

a. Accuchecks (a test used to monitor blood sugar) before meals and at bedtime; and
b. Novolog (a fast acting insulin) per sliding scale "low dose", (dosage varied, dependant on the blood sugar results).

The order was acknowledged by the licensed nurse on August 5, 2015, at 4 a.m.

The MAR for Patient 301, dated August 5, 2015 was reviewed. The hand written transcribed entry indicated the following:
a. Accu check before each meal and at bedtime; and
b. Sliding scale.

The transcribed entry on the MAR did not include:
a. Scheduled times when the accucheck should be done;
b. Results of the accucheck;
c. Insulin type (Novolog) and dosage to administer; and
d. What the exact parameters were for "low dose" sliding scale.

On August 11, 2015, the medical record for Patient 301, was reviewed with Charge Nurse (CN) 1. CN 1 stated Patient 301's MAR was incomplete. She stated the MAR should have included the scheduled times to do the accucheck, the blood sugar results from the accuchecks performed, the type of insulin to be administered, and a complete sliding scale dosage for the amount of insulin to administer dependant upon the results of the accucheck. CN 1 stated when there was a new admission, and/or a new physician order, the licensed nurse transcribed the orders onto the MAR. CN 1 stated the accucheck orders, as well as the insulin low dose sliding scale order, should be completely written out onto the patient's MAR.

The policy and procedure titled, "Medication Administration Record (MAR), dated March 2014, was reviewed. The policy indicated, "The nurse is responsible for the transcription of medication orders to the MAR and shall include the start/stop times (if applicable), medication, strength, dose, route, frequency, indication for use if necessary and any clarifying notes... Accucheck blood sugars must be documented on the MAR to coincide with the administration of insulin sliding scale doses..."

Based on observation, interview, and record review, the facility failed to ensure:

1. Medications were given as ordered, when a physician's order for one patient (Patient 214) indicated he should be medicated with insulin based on a sliding scale (giving varied amounts of insulin when the blood sugar was high to bring it down to normal levels), but the medication administration record (MAR) included a scheduled insulin dose to be given three times a day (regardless of his blood sugar). This failed practice resulted in the patient receiving 100 units of insulin for a blood sugar of 124 (normal with no insulin needed), life threatening hypoglycemia (low blood sugar), a transfer to the Intensive Care Unit (ICU) on a ventilator (breathing machine), and the potential for death;

2. Medication administration records (MARs) were accurate and reflected physician's orders when insulin sliding scale doses (giving varied amounts of insulin when the blood sugar was high to bring it down to normal levels) were listed on the MAR as 100 units/1 ml (milliliter), and 1 unit/0.01 ml regardless of the amount to be given. These failed practices resulted in the potential to overdose with insulin leading to life threatening hypoglycemia and death, or to underdose with insulin leading to unsafe increase in blood sugars, dehydration, and infection;

3. Respiratory therapy (RT) was initiated timely when RT medication orders were not communicated to the RT staff, and three patients (Patients 209, 210, and 105) experienced delays lasting several hours, resulting in the potential for decompensation in the patients' conditions, respiratory distress, and death;

4. Accounting procedures for controlled substance use throughout the facility were developed and implemented to accurately capture the movement of the controlled drugs, resulting in the potential for delays in identifying drug diversion (A494);

5. Implement, and recommend to physicians, drug dosing adjustments for specified medications ( low molecular weight heparin and histamine 2 antagonists) for patients with reduced kidney function, in accordance with the facility's policy and procedure, resulting in the potential for further kidney damage, under medicating, or over medicating patients. (A500);

6. Process orders accurately and without omission in the electronic medical record (EMR) and include complete instructions from the preprinted order form for Insulin Sliding Scale (ISS), resulting in the potential for medication errors in patients being treated with an ISS (A500); and,

7. Process medication orders under the right patient, resulting in the potential for medication errors as a result of staff administering medications to the wrong patient (A500).

The cumulative effect of these systemic problems resulted in failure to ensure pharmacy services met the needs of the patients and patients were receiving medications in a safe and effective manner.

Findings:

1. [According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had an order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 1 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 1 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1 on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 1 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

The RN stated when she checked Patient 1's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., he was lethargic and unresponsive. According to the nurse, a sitter who was with the patient reported that he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 1's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due) and the result was 21. According to the nurse, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. The nurse stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 1 was reviewed on July 23, 2015. Patient 1, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure), in addition to checking it before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive, and his physician was paged;

C. At 11:25 a.m., he was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40, the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

According to the Novolog dosing guidelines, if the average insulin requirement was 0.5-1.0 units/kilogram/day, Patient 214 would require an average of 41 to 82 units per day (both long acting and short acting insulins combined). Patient 214 100 units of insulin medication in one dose.

During an interview with the Director of Pharmacy (DOP) on July 23, 2015, at 11:10 a.m., the director stated he was aware of the medication error, and had reviewed the record. He stated he identified, "multiple failure points," including:

a. Order entry, the dose of insulin was incorrect as entered by the pharmacist;

b. Order entry, the insulin was entered as a scheduled medication instead of a sliding scale dose by the pharmacist;

c. Nursing accepted the order when they noted it;

d. The nurse did not question the (potentially fatal) dose before giving the insulin; and,

e. The "whole EMR (electronic medical record) set up," and the inability to have the MAR reflect the physician's orders accurately.

The DOP stated the pharmacist used, "bad judgement," when she entered the order as, "scheduled." He stated at one point the patient was getting accuchecks every two hours, before meals, and at bedtime. He stated it was confusing, and the, "scheduled," dose was the only way the pharmacist could think of to make sure accuchecks were done every two hours, before meals, and at bedtime (as required according to the orders).

According to the DOP, the EMR had no way to change the information that was being put in for insulin dosing. He stated every entry under concentration and dose must be assigned a value, so they could not enter, "sliding scale," or anything similar for the dose, they had to pick a value. He stated the value they picked was the concentration available for the staff to give, 100 units/ml (a potentially fatal dose), so that is why it showed that way in the, "dose," area for Patient 214.

The DOP stated they were in the process of changing all of the MARs with sliding scale orders to have the dose section read, "1 unit/0.01 ml. He stated then the nurses would have to use their judgement and, "medicate according to the sliding scale." The DOP stated he was aware by making the change on the MARs, all sliding scale doses would be incorrect , "on paper," but if a patient received the amount of insulin shown in the, "dose," section (1 unit/0.01 ml), they would receive an underdose and not an overdose, which was much safer.

The failure of RN 1 to verify the physician's order and question the insulin dose of 100 units (a potentially fatal dose) prior to administering it, and of the pharmacy to ensure the MAR was accurate and reflected the physician's orders, resulted in administration of a potentially fatal dose of insulin, life threatening hypoglycemia, and transfer to the ICU on a ventilator.

2. On August 11, 2015, at 2:10 p.m., Registered Nurse (RN) 3 was interviewed. RN 3 stated she was monitoring Patient 108's finger stick blood sugars. RN 3 stated Patient 108 was on a "sliding scale" for insulin coverage based on the patient's finger stick results.

Patient 108's record was reviewed with the Definitive Observation Unit (DOU), Charge Nurse (CN), on August 11, 2015, at 2:15 p.m. Patient 108 was admitted to the facility on June 30, 2015, with diagnoses that included Diabetes Mellitus. A pre printed order form, dated July 13, 2015, indicated the physician ordered finger stick blood sugar checks every six hours. The "Standard Dose," insulin sliding scale was ordered.

The "Standard Dose," sliding scale insulin coverage was documented as follows:

120-150=0 units
151-200=2 units
201-250=4 units
251-300=6 units
301-350=8 units
351-400=10 units
401-449=12 units
>450=14 units and call MD (physician).

According to the MAR, dated August 11, 2015, 7 a.m., through August 12, 2015, 7 a.m., Patient 108's finger stick was checked every six hours and sliding scale insulin coverage was given "PRN-(as needed)," to cover the blood sugar result. The MAR instructions included the following:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 units/1 ml (a potentially fatal dose); and,

d. PRN: See Special Instruction.

During an interview with the Clinical Manager on August 11, 2015, at 2:30 p.m., the CM verified the instructions for the dose on the MAR as 100 units/ml.

On August 11, 2015, at 4 p.m., during an interview with the Director of Pharmacy (DOP), the DOP stated the instructions on the MAR were to be changed to 1 unit/0.01 ml, following the incident on July 23, 2015.

Patient 108's MAR contained instructions, that if followed, would provide a dose of regular insulin (100 units) seven times the highest ordered dose (14 units), and would be potentially fatal.

3. In the Respiratory Therapy (RT) department, orders were received in two different ways:

a. When a physician wrote an order and placed it in the paper medical record, the unit secretary would enter the order into the clinical computer system (IMED), and a notification printed in the RT department to alert the staff of a new or modified order; and,

b. When a physician entered an order using the computerized physician order entry system (CPOE), the order would be sent electronically to the pharmacy. The pharmacist would enter the order onto the medication administration record (MAR), and trigger a notification to the RT department would alert the staff of a new or modified order.

During a tour of the Respiratory Therapy (RT) Department on August 12, 2015, at 9:30 a.m., the RT Coordinator stated there was a previous problem with the department receiving orders that were entered using the CPOE system, but that had been corrected. He stated there was currently a problem with them receiving orders from the unit secretaries, as they were not being put into the IMED system in a timely manner.

During an interview with the RT Director on August 12, 2015, at 9:40 a.m., the director stated he was aware of the current problem and had met with the pharmacy and information technology (IT) departments the previous week. He stated he was supposed to be meeting with the nursing department sometime in the current week. The director stated the unit secretaries were not getting RT orders communicated to them in a timely manner through the IMED system, when the physician wrote them on a physician's order form instead of using the CPOE system. He stated there were, "still," delays in the system. According to the director, the Chief Operating Officer (COO) and the Director of Quality (DQ) were aware of the problem.

During the tour, a copier/printer was observed in the RT office that was printing papers with lists of patient names periodically. The coordinator stated the lists were generated by IT, and included names and locations of patients who had RT orders entered using CPOE, or written by the physician, but the orders had not been acknowledged by the RT staff yet. He stated the lead RT staff was to check each patient on the list to make sure therapy had been started.

The facility policy titled, "Medication Administration," was reviewed on August 12, 2015. According to the policy, RT medications, "must," be administered within four hours of being ordered.

a. The record for Patient 209 was reviewed on August 12, 2015. Patient 209, a 70 year old female, was admitted to the facility on August 6, 2015, with diagnoses that included Congestive Heart Failure (CHF), Decreased Oxygen Saturation (low oxygenation), and Respiratory Failure.

The patient's home medications were reviewed on admission using the Medication Reconciliation Process, the albuterol and atrovent (respiratory medications) nebulizer (breathing treatment) was ordered to be continued every 2 hours as needed, and the orders were faxed to the pharmacy at 6 p.m.

According to the order history, the information technology (IT) department entered the order into the clinical (IMED) system on August 9, 2015, at 2 a.m. (8 hours after the therapy was ordered).

The order detail indicated the unit secretary entered the order in the computer (IMED) system on August 9, 2015, at 2:25 p.m. (20 hours and 25 minutes after the therapy was ordered).

According to the record, the initial RT assessment to determine whether a treatment was needed was completed on August 9, 2015, at 4:49 p.m. (22 hours and 49 minutes after therapy was ordered).

b. The record for Patient 210 was reviewed on August 12, 2015. Patient 210, an 82 year old male, was admitted to the facility on August 8, 2015, with diagnoses that included Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, and Hypoxia (lack of oxygen).

The Pre-Printed Emergency Admit orders, written at 8 p.m., included an order for albuterol and atrovent (respiratory medications) to be given via a nebulizer (breathing treatment) every four hours and as needed.

According to the record, the order was entered by the unit secretary at 10:56 p.m. (2 hours and 56 minutes later).

The record indicated the order was acknowledged by the RT staff on August 9, 2015, at 2:51 a.m. (6 hours and 51 minutes after it was written).

The RT Treatment form indicated the first time RT had contact with Patient 210, and administered a breathing treatment, was on August 9, 2015, at 7:20 a.m. (11 hours and 20 minutes after the order was written).

During an interview with the Director of Respiratory Therapy (DRT), the Director of Pharmacy (DOP), and the Director of Information Technology (DIT) present, on August 12, 2015, at 1:10 p.m., the DRT, the DOP, and the DIT stated they were aware that problems continued to exist regarding notification of the RT staff when new therapy was ordered.

They stated they had recent problems (lasting approximately two to three months) with the computerized physician order entry (CPOE) system not triggering a notification to RT staff, but they thought they had corrected that problem. They stated the problem continued to occur as a result of a different failure, failure of the unit secretaries to enter the orders into the clinical computer (IMED) system that would generate a notification to the RT staff when a written order was received.

The RT director stated he was aware of the ongoing problem, and had communicated it to the pharmacy and the IT department (at different times).

The DOP stated he was aware of the problem, but he was not responsible for it, as it was failure of the unit secretaries to enter new RT orders.

Although the DRT and the DOP were aware of delays in RT orders being communicated to RT staff, resulting in delays in initiation of therapy, they failed to identify a corrective action to prevent the delays in administration of respiratory medications.

c. On August 11, 2015, at 10:50 a.m., a tour of the second floor was conducted. The Charge Nurse (CN) indicated Patient 105 was admitted for treatment of pneumonia.

The record for Patient 105 was reviewed on August 11, 2015. Patient 105, presented to the facility on August 3, 2015, with complaints of difficulty breathing. Patient 105 was admitted to the facility on August 3, 2015, at 11 p.m., with diagnoses that included Pneumonia.

Handwritten physician orders dated August 3, 2015, at 11 p.m., indicated "Duoneb (albuterol and ipratropium medication combination that relaxes muscles in the airways and increases air flow to the lungs) Neb (nebulizer-breathing treatment) Q (every) 4 (four) hours ATC (around the clock)."

According to the record, the order was entered by the unit secretary on August 3, 2015, at 11:45 p.m.

The record indicated the order was acknowledged by the RT staff on August 4, 2015, at 5:09 a.m., (6 hours after the order was written). The RT documented an initial assessment at this time but did not administer the medication treatment as ordered.

The RT Treatment form indicated the first time RT administered a breathing treatment was on August 4, 2015, at 10:10 a.m., (11 hours after the order was written).

During an interview with the RT Director on August 12, 2015, at 1 p.m., the Director stated initial assessment and treatment should be done as soon as possible. The Director stated it would have been better if Patient 105 received a treatment at 5:09 a.m., when the RT assessed the patient. The RT Director stated they were still having problems with initiating treatment due to delays in receiving the orders.

The policy and procedure for inhalation treatments was requested. The policy and procedure for "Medication Administration," revised March 2014, was reviewed. The policy indicated the purpose was to ensure safe administration of medications to patients. Respiratory Therapy was accountable to this policy. The policy indicated "Routine medications must be administered within four (4) hours."

Based on interview and document review, the facility failed to ensure accounting procedures for controlled substance use throughout the facility were developed and implemented to accurately capture the movement of the controlled drugs, resulting in the potential for unidentified drug diversion.

Findings:

During an interview on August 12, 2015, at 3:30 p.m., Radiology Supervisor (RXS) and the Director of Pharmacy (DOP), stated that all controlled substance (CS) access/use from the Pyxis MedStations (an automated dispensing cabinet for medications) available in Emergency Department (ED), Recovery, Radiology, Surgery, and Gastrointestinal (GI) Laboratory (Lab) were reviewed daily for appropriateness. They stated the review included ensuring there was a physician's order for each dose of CS accessed and all wastage was documented with another staff member.

Observation of these areas revealed they had Pyxis MedStations that were non-profiled, which meant the users were be able to withdraw CS and non-CS medications without waiting for the pharmacist to verify and unlock the medications to make them available.

RXS also stated that the Pharmacy reviewed all override medications (medications accessed prior to order verification by a pharmacist) with the corresponding physician's orders.

The DOP stated forms were sent to department managers/directors to assist in resolving medication discrepancies.

The form contained the following instruction for the directors:

"The following medication(s) and/or supply item(s) have an open (unresolved) discrepancy pending. The medication noted below has been removed from Pyxis and the patient does not have a current order in Pyxis to support the Nurse obtaining the Medication. Please review the attached report and reply back to Pharmacy within 24 hours as to the resolution of the discrepancy. Attach copies of the requested medication order(s) if requested/appropriate."

A review of one of the completed "Override Notification Form," dated July 15, 2015, that was returned to the Pharmacy had this explanation written on the form:

"Stat (Definition: now or immediately) Med (Medication). MD (a physician) was to input order into computer."

It was noted that the returned date was missing and the person that provided the explanation did not sign the form.

During a concurrent interview, RXS stated there was no follow-up investigation to ensure there was a corresponding physician order entered in the computer system.

During a concurrent interview, DOP stated that the explanation was not an acceptable response.

During an interview on August 13, 2015, at 11:30 a.m., Pharmacy Technician (PT) 1, a pharmacy technician, stated he reviewed the Pyxis generated report that listed all CS use in the non-profiled areas, daily, and entered the information on the Excel spreadsheet as a way of tracking any unexplainable discrepancies. After comparing the list with the clinical records, a "Discrepancy Reconciliation Form" would be filled out and sent to the Unit Director for explanation.

A review of the Excel spreadsheet indicated there were 1364 individual entries for CS that were accessed from Pyxis located in ED for the month of June 2015. There were 39 discrepancies as indicated on the spreadsheet by red colored entries. There were only 11 returned "completed" forms returned to the pharmacy.

All 11 forms were missing the signature and date they were completed by the Unit Director.

During a concurrent interview, PT 1 stated he did not communicate with RXS of the status of the resolution of the discrepancy forms and stated he was not able to find the discrepancy forms for the month of July because some of the boxes kept in the Pharmacy were moved to a different location.

During a concurrent interview, RXS stated she did not keep track of resolved and unresolved discrepancies and did not look to ensure the resolution was complete and satisfactory. RXS stated this oversight was also consistent with previous months as well.

During an interview on August 13, 2015, at 2:30 p.m., the DOP stated that the facility policy on CS accountability did not specifically state the currently implemented procedure, and it was necessary that the policy be revised to reflect the current procedure for CS accountability and CS diversion.

Based on observation, interview, and document review, the facility failed to effectively control drugs and biologicals for patient safety by failing to:

1. Implement, and recommend to physicians, drug dosing adjustments for specified medications (low molecular weight heparin and histamine 2 antagonists) for patients with reduced kidney function, in accordance with the facility's policy and procedure.

2. Process orders without omission in the hospital wide electronic medical record system by the pharmacists and include complete instructions from the preprinted order form for Insulin Sliding Scale(ISS).

3. Process medication orders under the right patient, to prevent medication errors as a result of staff administering medications to the wrong patient.

Findings:

1. On August 11, 2015, at 10:30 a.m., a review of the Pharmacy clinical monitoring program revealed the Pharmacy managed antibiotic (anti-microbial) drug therapy for patients with poor kidney function, by adjusting the dose down to prevent overdosing and unwanted adverse effects.

A review of the dosing adjustments made by the Pharmacy indicated medication doses for Lovenox (low molecular weight heparin an injectable blood thinner-not an antimicrobial) and famotidine (an injectable stomach acid reducer histamine 2 antagonist-not an antimicrobial), were adjusted based on the Pharmacy protocol that allowed the pharmacist to change the dosing.

The "Renal Dosing Screening/Interventions," binder was reviewed. There was no evidence physician authorizations for the changes were obtained "Per Protocol," for the Lovenox and famotidine orders.

During an interview on August 11, 2015, at 10:30 a.m., Registered Pharmacist (RPH) 1 stated she did not include documentation of her communication with, and her recommendation to the physicians, when receiving dose change orders from the physicians. RPH 1 indicated the new dosage change orders, from the physicians, were communicated via phone texting.

During an interview on August 11, 2015, at 1:15 p.m., the Director of Pharmacy (DOP) stated text messaging was not an acceptable form of communication and changes to the orders should have been written as a telephone order.

A review of the facility's policy and procedure titled, "Renal dosing monitoring," indicated:

"This physician directed, pharmacist managed Renal Dosage Adjustment policy will allow pharmacist to automatically adjust dosing for renal function if warranted for medication listed on Renal Dosage Adjustment Guidelines without physician contact...

...Pharmacist will monitor patient renal function on the following drugs and make recommendations to prescriber if necessary: Low Molecular Heparin, Histamine 2 blocker and Metformin.

...The pharmacist will write a new order on the physician orders "Per Renal Dosing Protocol..."

2. On August 11, 2015, the facility's preprinted order set titled, "Insulin Sliding Scale Orders - Adult (ISS)," was reviewed and the following was noted:

"... Supplemental Insulin-Use in Addition to Scheduled insulin Aspart/Lispro (Novolog) Insulin Sub-Q (Fast-Acting)

-If blood glucose is greater than 200 mg/dL for two consecutive readings and the patient is on the "Low Dose," on the second consecutive reading move to the "Standard Dose."

-If blood glucose is greater than 200 mg/dL for two consecutive readings and the patient is on the "Standard Dose," on the second consecutive reading move to the "High Dose."

-If blood glucose is greater than 200 mg/dL for two consecutive readings and the patient is on the "High Dose," on the second consecutive reading contact physician for further instruction."

The dosing of insulin per blood sugar level was higher for the "High Dose" column compared to "Standard Dose" column which was higher than the "Low Dose" column. For instance, dosing for a blood sugar reading between 251 and 300 mg/dL would be 3 units on the "Low Dose" column, 6 units on the "Standard Dose," and 8 units for the "High Dose," scale.

During an interview on August 11, 2015, at 1:15 p.m., the Director of Pharmacy (DOP) stated there was an issue with the insulin sliding scale protocol. The DOP also stated reported incidences of medication errors was significantly higher for insulin administration. The DOP acknowledged there were instructions for increasing the dose (moving up a column), but there were no instructions, on the protocol, to adjust the dose "down" a column. The DOP stated the pharmacy did not process the insulin sliding scale order completely, as the entered only the dose (column) originally ordered by the physician.

During an interview on August 11, 2015, at 2:30 p.m., Registered Pharmacist (RPH) 2, a pharmacist familiar with the computer system, stated the instructions from the ISS order would not be entered by the pharmacist in the computer system and the instructions would not be included on the medication administration record (MAR) for nurses to follow.

During an interview on August 11, 2015, at 3 p.m., registered nurse (RN) 5 was unaware ISS doses should be adjusted. RN 5 did not indicate she knew ISS dose should move up to a higher dose. RN 5 stated she would continue to cover with doses on the originally ordered ISS dose (column) if the blood sugar was between 200 and 300 mg/dL. RN 5 stated if a patient's blood sugar was more than 400 mg/dL two times she should move to the next column and call the physician.

During an interview on August 11, 2015, at 3:10 p.m., RN 6 stated after the third blood sugar above 200 mg/dL she would move to the next column. RN 6 stated after reading the instructions on the ISS order form, she was confused by the instructions. RN 6 stated she was not sure whether to move to the next column on the second or third consecutive reading.

3. On August 12, 2015, at 9:50 a.m. a medication pass observation was conducted with registered nurse (RN) 7. Patient 100's medication administration record (MAR) contained a profiled medication, Atripla (an antiviral) that read "Patient's Own Medication." Patient 100 did not receive this medication during the medication med pass observation with RN 7.

A review of Patient 100's record was conducted. There was no order for Atripla for Patient 100.

During an interview on August 12, 2015, at 11:30 a.m., RN 7 stated he called the Pharmacy requesting the medication. RN 7 stated Pharmacy informed him they did not have the medication and they did not know about the order.

During an interview on August 12, 2015, at 12 p.m., the Pharmacy Supervisor (RXS), stated the physician order for Atripla was for a different patient and the pharmacist that processed the order entered it under the wrong patient. The RXS stated the mistake was corrected, but the pharmacist who entered the order into the system, forgot to discontinue/cancel the order.

Based on observation, interview, and record review, the facility failed to ensure:

1. Respiratory therapy was initiated within four hours of being ordered in accordance with the facility policy on Medication Administration, for three patients (Patients 209, 210, and 105), resulting in the potential for decompensation in the patients' conditions, respiratory distress, and death; and,

2. Quality data was being collected to determine the timeliness of therapy initiation and identify opportunities for improvement after previous problems were identified and corrective action was taken, resulting in continued delays in initiating respiratory therapy, and the potential for deterioration in the patient conditions, respiratory distress, and death.

The cumulative effect of these systemic and ongoing problems resulted in failure to ensure respiratory services were provided in a safe and effective manner and met the needs of the patients.

Findings:

Physician orders were received by the Respiratory Department (RT) in two different ways:

a. When a physician wrote an order and placed the order in the paper medical record, the unit secretary would enter the order into the clinical computer system (IMED), and a notification would print in the RT department to alert the staff of a new or modified order; and,

b. When a physician entered an order using the computerized physician order entry system (CPOE), the order would be sent electronically to the pharmacy. The pharmacist would enter the order onto the medication administration record (MAR), and trigger a notification to the RT department to alert the staff of a new or modified order.

During a tour of the Respiratory Therapy (RT) Department on August 12, 2015, at 9:30 a.m., the RT Coordinator stated there was a previous problem with the department receiving orders that were entered using the CPOE system, but that had been corrected. He stated there was currently a problem with them receiving orders from the unit secretaries, as they were not being put into the IMED system in a timely manner.

During an interview with the RT Director on August 12, 2015, at 9:40 a.m., the Director stated he was aware of the current problem, and he had met with the pharmacy and information technology (IT) departments the previous week. He stated he was supposed to meet with the nursing department sometime in the current week. The director stated the unit secretaries were not getting RT orders communicated to them in a timely manner through the IMED system, when the physician wrote them on a physician's order form instead of using the CPOE system. He stated there were, "still," delays in the system. According to the Director, the Chief Operating Officer (COO) and the Director of Quality (DQ) were aware of the problem.

During the tour, a copier/printer was observed in the RT office that was printing papers with lists of patient names periodically. The coordinator stated the lists were generated by IT, and included names and locations of patients who had RT orders entered using CPOE, or written by the physician, but the orders had not been acknowledged by the RT staff yet. He stated the lead RT staff was to check each patient on the list to make sure therapy had been started.

1. The facility policy titled, "Medication Administration," was reviewed on August 12, 2015. According to the policy, RT medications, "must," be administered within four hours of being ordered.

a. The record for Patient 209 was reviewed on August 12, 2015. Patient 209, a 70 year old female, was admitted to the facility on August 6, 2015, with diagnoses that included Congestive Heart Failure (CHF), Decreased Oxygen Saturation (low oxygenation), and Respiratory Failure.

The patient's home medications were reviewed on admission using the Medication Reconciliation Process, the albuterol and atrovent (respiratory medications) nebulizer (breathing treatment) was ordered to be continued every 2 hours as needed, and the orders were faxed to the pharmacy at 6 p.m.

According to the order history, the information technology (IT) department entered the order into the clinical (IMED) system on August 9, 2015, at 2 a.m. (8 hours after the therapy was ordered).

The order detail indicated the unit secretary entered the order in the computer (IMED) system on August 9, 2015, at 2:25 p.m. (20 hours and 25 minutes after the therapy was ordered).

According to the record, the initial RT assessment to determine whether a treatment was needed was completed on August 9, 2015, at 4:49 p.m. (22 hours and 49 minutes after therapy was ordered).

b. The record for Patient 210 was reviewed on August 12, 2015. Patient 210, an 82 year old male, was admitted to the facility on August 8, 2015, with diagnoses that included Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, and Hypoxia (lack of oxygen).

The Pre-Printed Emergency Admit orders, written at 8 p.m., included an order for albuterol and atrovent (respiratory medications) to be given via a nebulizer (breathing treatment) every four hours and as needed.

According to the record, the order was entered by the unit secretary at 10:56 p.m. (2 hours and 56 minutes later).

The record indicated the order was acknowledged by the RT staff on August 9, 2015, at 2:51 a.m. (6 hours and 51 minutes after it was written).

The RT Treatment form indicated the first time RT had contact with Patient 210, and administered a breathing treatment, was on August 9, 2015, at 7:20 a.m. (11 hours and 20 minutes after the order was written).

c. On August 11, 2015, at 10:50 a.m., a tour of the second floor was conducted. The Charge Nurse (CN) indicated Patient 105 was admitted for treatment of pneumonia.

The record for Patient 105 was reviewed on August 11, 2015. Patient 105, presented to the facility on August 3, 2015, with complaints of difficulty breathing. Patient 105 was admitted to the facility on August 3, 2015, at 11 p.m., with diagnoses that included pneumonia.

Handwritten physician orders dated August 3, 2015, at 11 p.m., indicated "Duoneb (albuterol and ipratropium medication combination that relaxes muscles in the airways and increases air flow to the lungs) Neb (nebulizer-breathing treatment) Q (every) 4 (four) hours ATC (around the clock)."

According to the record, the order was entered by the unit secretary on August 3, 2015, at 11:45 p.m.

The record indicated the order was acknowledged by the RT staff on August 4, 2015, at 5:09 a.m., (6 hours after the order was written). The RT documented an initial assessment at this time but did not administer the medication treatment as ordered.

The RT Treatment form indicated the first time RT administered a breathing treatment was on August 4, 2015, at 10:10 a.m., (11 hours after the order was written).

During an interview with the RT Director on August 12, 2015, at 1 p.m., the Director stated the initial assessment and treatment should be done as soon as possible. The Director stated it would have been better if Patient 105 received a treatment at 5:09 a.m., when the RT assessed the patient. The RT Director stated they were still having problems with initiating treatment due to delays in receiving the orders.

The policy and procedure for inhalation treatments was requested. The policy and procedure for "Medication Administration," revised March 2014, was reviewed. The policy indicated the purpose was to ensure safe administration of medications to patients. Respiratory Therapy was accountable to this policy. The policy indicated "Routine medications must be administered within four (4) hours."

2. During an interview with the Director of Respiratory Therapy (DRT), the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), and the Director of Information Technology (DIT) on August 12, 2015, at 1:10 p.m., the DRT, the DOP, and the DIT stated they were aware that problems continued to exist regarding notification of the RT staff when new therapy was ordered.

They stated they had recent problems (lasting approximately two to three months) with the computerized physician order entry (CPOE) system not triggering a notification to RT staff, but they thought they had corrected that problem. They stated they did not do any data collection or follow up to make sure the problem was corrected, and that RT staff was being notified and therapy was being initiated timely. They stated the problem continued to occur as a result of a different failure, failure of the unit secretaries to enter the orders into the clinical computer (IMED) system that would generate a notification to the RT staff when a written order was received. They stated they had not gathered a multidisciplinary team, initiated a performance improvement project, developed indicators, or performed data collection to ensure they had identified the true cause and frequency of the problem.

The RT director stated he was aware of the ongoing problem, and had communicated it to the pharmacy and the IT department (at different times). He stated he needed to, "get together," with nursing to discuss it.

The DOP stated he was aware of the problem, but he was not responsible for it, as it was failure of the unit secretaries to enter new RT orders.

The DIT stated he was aware of the problem, and monitored the system every four hours to identify orders that were not entered by the unit secretary so they could be acknowledged and initiated by RT. He stated if he identified such orders, he would enter the order into the clinical system (IMED), and generate a notification to RT. He stated he did that with Patient 209 when he realized during his regular four hour check (on August 9, 2015, at 2 a.m.) that the RT order had not been entered by the unit secretary and communicated to the RT staff for eight hours. He stated he checked the system every four hours, around the clock, seven days a week in an effort to catch all of the orders that had not been communicated through the electronic system.

The CNO stated he was just told about the ongoing problem and the unit secretaries not entering orders in a timely manner approximately two hours earlier.

Although the DRT, the DOP, and the DIT were aware of delays in RT orders being communicated to RT staff, resulting in delays in initiation of therapy, they failed to identify the need for a multidisciplinary, organized, data driven approach to correcting the reoccurring problem.

Based on observation, interview, and record review, the facility failed to ensure quality data was being collected to determine the timeliness of respiratory therapy (RT) initiation, and identify opportunities for improvement after previous problems were identified and corrective action was taken, resulting in continued delays in initiating respiratory therapy, and the potential for deterioration in the patient conditions, respiratory distress, and death.

Findings:

Physician orders were received in the Respiratory Therapy (RT) department in two different ways:

1. When a physician wrote an order and placed the order in the paper medical record, the unit secretary would enter the order into the clinical computer system (IMED), and a notification would print in the RT department to alert the staff of a new or modified order; and,

2. When a physician entered an order using the computerized physician order entry system (CPOE), the order would be sent electronically to the pharmacy. The pharmacist would enter the order onto the medication administration record (MAR), and trigger a notification to the RT department to alert the staff of a new or modified order.

During a tour of the Respiratory Therapy (RT) Department on August 12, 2015, at 9:30 a.m., the RT Coordinator stated there was a previous problem with the department receiving orders that were entered using the CPOE system, but that had been corrected. He stated there was currently a problem with them receiving orders from the unit secretaries, as the orders were not being put into the IMED system in a timely manner.

During an interview with the RT Director on August 12, 2015, at 9:40 a.m., the Director stated he was aware of the current problem, and he had met with the pharmacy and information technology (IT) departments the previous week. He stated he was supposed to meet with the nursing department sometime in the current week. The director stated the unit secretaries were not getting RT orders communicated to them in a timely manner through the IMED system, when the physician wrote them on a physician's order form instead of using the CPOE system. He stated there were, "still," delays in the system. According to the Director, the Chief Operating Officer (COO) and the Director of Quality (DQ) were aware of the problem.

During the tour, a copier/printer was observed in the RT office that was printing papers with lists of patient names periodically. The coordinator stated the lists were generated by IT, and included the names and locations of patients who had RT orders entered using CPOE. The list also contained a list of patient who had orders written by the physician, but the orders had not been acknowledged by the RT staff yet. He stated the lead RT staff checked each patient on the list to make sure therapy had been started.

The facility policy titled, "Medication Administration," was reviewed on August 12, 2015. According to the policy, RT medications, "must," be administered within four hours of being ordered.

a. The record for Patient 209 was reviewed on August 12, 2015. Patient 209, a 70 year old female, was admitted to the facility on August 6, 2015, with diagnoses that included Congestive Heart Failure (CHF), Decreased Oxygen Saturation (low oxygenation), and Respiratory Failure.

The patient's home medications were reviewed on admission using the Medication Reconciliation Process, albuterol and atrovent (respiratory medications) nebulizer (breathing treatment) treatment was ordered to be continued every 2 hours as needed, and the orders were faxed to the pharmacy at 6 p.m.

According to the order history, the information technology (IT) department entered the order into the clinical (IMED) system on August 9, 2015, at 2 a.m. (8 hours after the therapy was ordered).

The order detail indicated the unit secretary entered the order in the computer (IMED) system on August 9, 2015, at 2:25 p.m. (20 hours and 25 minutes after the therapy was ordered).

According to the record, the initial RT assessment to determine whether a treatment was needed, was completed on August 9, 2015, at 4:49 p.m. (22 hours and 49 minutes after therapy was ordered).

b. The record for Patient 210 was reviewed on August 12, 2015. Patient 210, an 82 year old male, was admitted to the facility on August 8, 2015, with diagnoses that included Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, and Hypoxia (lack of oxygen).

The Pre-Printed Emergency Admit orders, written at 8 p.m., included an order for albuterol and atrovent (respiratory medications) to be given via a nebulizer (breathing treatment) every four hours and as needed.

According to the record, the order was entered by the unit secretary at 10:56 p.m. (2 hours and 56 minutes later).

The record indicated the order was acknowledged by the RT staff on August 9, 2015, at 2:51 a.m., (6 hours and 51 minutes after it was written).

The RT Treatment form indicated the first time RT had contact with Patient 210, and administered a breathing treatment, was on August 9, 2015, at 7:20 a.m., (11 hours and 20 minutes after the order was written).

c. On August 11, 2015, at 10:50 a.m., a tour of the second floor was conducted. The Charge Nurse (CN) indicated Patient 105 was admitted for treatment of pneumonia.

The record for Patient 105 was reviewed on August 11, 2015. Patient 105, presented to the facility on August 3, 2015, with complaints of difficulty breathing. Patient 105 was admitted to the facility on August 3, 2015, at 11 p.m., with diagnoses that included pneumonia.

Handwritten physician orders dated August 3, 2015, at 11 p.m., indicated: "Duoneb (albuterol and ipratropium medication combination that relaxes muscles in the airways and increases air flow to the lungs) Neb (nebulizer-breathing treatment) Q (every) 4 (four) hours ATC (around the clock)."

According to the record, the order was entered by the unit secretary on August 3, 2015, at 11:45 p.m.

The record indicated the order was acknowledged by the RT staff on August 4, 2015, at 5:09 a.m., (6 hours after the order was written). The RT documented an initial assessment at this time but did not administer the medication treatment as ordered.

The RT Treatment form indicated the first time RT administered a breathing treatment was on August 4, 2015, at 10:10 a.m., (11 hours after the order was written).

During an interview with the RT Director, on August 12, 2015, at 1 p.m., the Director stated initial assessment and treatment should be done as soon as possible. The Director stated it would have been better if Patient 105 received a treatment at 5:09 a.m., when the RT initially assessed the patient. The RT Director stated they were still having problems with initiating treatments due to delays in receiving the orders.

The policy and procedure for inhalation treatments was requested. The policy and procedure for "Medication Administration," revised March 2014, was reviewed. The policy indicated the purpose was to ensure safe administration of medications to patients. Respiratory Therapy was accountable to this policy. The policy indicated: "Routine medications must be administered within four (4) hours."

During an interview with the Director of Respiratory Therapy (DRT), the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), and the Director of Information Technology (DIT), on August 12, 2015, at 1:10 p.m., the DRT, the DOP, and the DIT stated they were aware problems continued to exist regarding notification of the RT staff when new therapy was ordered.

They stated they had recent problems (lasting approximately two to three months) with the computerized physician order entry (CPOE) system not triggering a notification to RT staff, but they thought they had corrected that problem. They stated they did not do any data collection or follow up to make sure the problem was corrected. They stated they were not monitoring for RT notification and timely order initiation. They stated the problem continued to occur as a result of a different failure, failure of the unit secretaries to enter the orders into the clinical computer (IMED) sy

Based on observation, interview, and record review, the facility failed to:

1. Ensure a medication error resulting in an adverse event was analyzed in accordance with the standards of practice to which they subscribed;

2. Implement corrective action that included education for nursing staff of changes made to the medication administration record (MAR);

3. Perform data collection to determine whether the corrective actions taken were effective in preventing further medication errors and adverse events; and,

4. Develop and implement medication error reduction strategies that would produce measurable outcomes as a result of review and analysis of its own medication errors, potential and actual, which led to changes to the system or processes.

These failed practices resulted in the potential for additional life threatening medication errors, patient harm, and death.

Findings:

[According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dL (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM), on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had a physician order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 214 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m., (in preparation of giving the next scheduled 100 unit dose) and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 214 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1, on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

RN 1 stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his blood sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., and he was lethargic and unresponsive. According to RN 1, a sitter, who was with the patient reported he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 214's physician to report the patient's condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due) and the result was 21. According to the RN 1, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. RN 1 stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the RN 1 nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure). In addition the blood sugar was to be checked before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled", insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive, and the physician was paged;

C. At 11:25 a.m., (the patient) was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40, the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

According to the Novolog dosing guidelines,

Based on observation, interview, and record review, the facility failed to ensure nurses demonstrated competency prior to being assigned to care for:

1. One patient with complex insulin orders (Patient 214) , resulting in a life threatening medication error and transfer to the Intensive Care Unit (ICU); and,

2. Four patients undergoing procedure related sedation (Patients 201, 111, 112, and 113), resulting in the potential for respiratory depression, respiratory arrest, and death.

Findings:

1.[According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had an order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 1 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 1 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1 on July 23, 2015, at 10:45 a.m., RN 1 stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

RN 1 stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 214 at 10 a.m., he was lethargic and unresponsive. According to the RN, a sitter, who was with the patient reported the patient fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 1's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m. when the next scheduled dose of insulin was due, and the result was 21. According to the nurse, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. The nurse stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did RN 1 indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure). In addition the blood sugar was to be checked before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive. The physician was paged;

C. At 11:25 a.m., (the patient) was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40, the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

Review of the MAR for Patient 214 indicated the MAR looked the same as RN 1 described.

According to the Novolog dosing guidelines, if the average insulin requirement was 0.5-1.0 units/kilogram/day, Patient 214 would require an average of 41 to 82 units per day (both long acting and short acting insulins combined). Patient 214 received 100 units of insulin medication in one dose.

In an interview with RN 1 on July 23, 2015, at 10:45 a.m., RN 1 stated she received t

Based on observation, interview, and record review, the facility failed to ensure:

1. Insulin was administered in accordance with the physician's order and accepted standards of practice when a registered nurse (RN 1) administered 100 units of Novolog (fast acting) insulin (a potentially fatal dose) to lower the blood sugar of one patient (Patient 214), and a second RN (RN 2) incorrectly double-checked and signed off on the dose, resulting in life threatening hypoglycemia (low blood sugar), a transfer to the Intensive Care Unit (ICU) on a ventilator (breathing machine), and the potential for death;

2. The insulin sliding scale (administration of insulin doses according to the blood sugar level) was adjusted in accordance with pre-printed physician's orders for three patients (Patients 204, 106, and 108), resulting in prolonged elevation of blood sugars and the potential for infection and dehydration.

Findings:

1. [According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had a physician order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 214 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 214 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1, on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 214 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

The RN stated when she checked Patient 214's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., he was lethargic and unresponsive. According to the nurse, a sitter who was with the patient reported that he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 214's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due), and the result was 21. According to the RN 1, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. RN 1 stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 214 was reviewed on July 23, 2015. Patient 214, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure), in addition to checking it before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending on the glucose level when it was checked every four hours. The scheduled insulin was documented on the MAR as follows:

a. Medication available - Novolog 1 unit/0.01 ml (milliliter);

b. Generic name - Insulin Aspart;

c. Dose - 100 unit/1 ml; and,

Frequency - Every four hours.

The MAR indicated RN 1 and RN 2 both signed off on administration of 100 units of Novolog insulin on July 21, 2015, at 7 a.m., and the 11 a.m. dose was held because Patient 214 had a blood sugar of 21 (normal 80-100).

The nurse's notes indicated the following:

A. At 7:50 a.m., the patient was lying in his bed, alert and oriented, with no signs of distress or pain;

B. At 10 a.m., the patient was lethargic and unresponsive, and his physician was paged;

C. At 11:25 a.m., he was using accessory muscles to breathe (difficulty breathing), he was not responding to touch or stimulation, and his blood sugar had dropped to 21. RN 1 gave 25 grams of dextrose (to increase his blood sugar);

D. At 11:40 a.m., the patient's blood sugar had increased to 103, but he remained unresponsive to stimulation; and,

E. Upon rechecking the blood sugar, it had dropped to 59, additional nurses were called for assistance, a rapid response team (emergency response team) was called, the patient was intubated (a breathing tube was inserted), and he was transferred to the ICU.

The physician responding to the emergency call documented he found the patient unresponsive with decerebrate posturing (involuntary extension of the arms and legs indicating severe brain injury), so he intubated him and transferred him to the ICU.

A neurology consult, completed July 22, 2015, indicated an electroencephalogram (EEG - brain wave test) showed slowing of the brain and seizure-like activity. The problems identified by the neurologist included transient coma, hypoglycemic encephalopathy (damage to or malfunction of the brain caused by hypoglycemia), and seizures due to the encephalopathy.

According to the Novolog dosing guidelines, i

Based on observation, interview, and record review, the facility failed to ensure:

1. Medications were given as ordered, when a physician's order for one patient (Patient 214) indicated he should be medicated with insulin based on a sliding scale (giving varied amounts of insulin when the blood sugar was high to bring it down to normal levels), but the medication administration record (MAR) included a scheduled insulin dose to be given three times a day (regardless of his blood sugar). This failed practice resulted in the patient receiving 100 units of insulin for a blood sugar of 124 (normal with no insulin needed), life threatening hypoglycemia (low blood sugar), a transfer to the Intensive Care Unit (ICU) on a ventilator (breathing machine), and the potential for death;

2. Medication administration records (MARs) were accurate and reflected physician's orders when insulin sliding scale doses (giving varied amounts of insulin when the blood sugar was high to bring it down to normal levels) were listed on the MAR as 100 units/1 ml (milliliter), and 1 unit/0.01 ml regardless of the amount to be given. These failed practices resulted in the potential to overdose with insulin leading to life threatening hypoglycemia and death, or to underdose with insulin leading to unsafe increase in blood sugars, dehydration, and infection;

3. Respiratory therapy (RT) was initiated timely when RT medication orders were not communicated to the RT staff, and three patients (Patients 209, 210, and 105) experienced delays lasting several hours, resulting in the potential for decompensation in the patients' conditions, respiratory distress, and death;

4. Accounting procedures for controlled substance use throughout the facility were developed and implemented to accurately capture the movement of the controlled drugs, resulting in the potential for delays in identifying drug diversion (A494);

5. Implement, and recommend to physicians, drug dosing adjustments for specified medications ( low molecular weight heparin and histamine 2 antagonists) for patients with reduced kidney function, in accordance with the facility's policy and procedure, resulting in the potential for further kidney damage, under medicating, or over medicating patients. (A500);

6. Process orders accurately and without omission in the electronic medical record (EMR) and include complete instructions from the preprinted order form for Insulin Sliding Scale (ISS), resulting in the potential for medication errors in patients being treated with an ISS (A500); and,

7. Process medication orders under the right patient, resulting in the potential for medication errors as a result of staff administering medications to the wrong patient (A500).

The cumulative effect of these systemic problems resulted in failure to ensure pharmacy services met the needs of the patients and patients were receiving medications in a safe and effective manner.

Findings:

1. [According to Novolog insulin prescribing information, revised February 2015, Novolog is a fast acting insulin given;

a) Prior to meals to prevent the blood sugar from getting too high due to carbohydrate intake; and/or,

b) To decrease a high blood sugar level.

It begins to work in 15 minutes, peaks in one hour, and lasts four to five hours.

One unit of Novolog insulin will lower the blood sugar approximately 50 mg (milligrams)/dl (deciliter) (points).

The total insulin daily requirement is calculated based on a patient's weight, usually between 0.5 to 1.0 units/kilogram/day.

Hypoglycemia is the most common adverse effect of Novolog therapy. Severe hypoglycemia may lead to unconsciousness and/or convulsions, and may result in temporary or permanent brain damage or death].

During an interview with the facility Risk Manager (RM) on July 23, 2015, at 9:45 a.m., the RM stated Patient 214 had an order for insulin to be given, if needed, according to an insulin sliding scale (based on the value of his blood sugar).

According to the RM, Patient 1 had a blood sugar of 124 (requiring no insulin coverage) the morning of July 21, 2015, and the registered nurse (RN 1) administered, "what she called a routine dose," of 100 units of Novolog insulin. The RM stated RN 1 rechecked the blood sugar at 11 a.m. (in preparation of giving the next scheduled 100 unit dose), and the patient's blood sugar had dropped to 21 (a life threatening low). She stated the nurse gave intravenous (IV) dextrose (to increase the blood sugar), and called a rapid response (summoning a physician and critical care nurse) to assist in treating the patient. According to the RM, Patient 1 was intubated (a breathing tube was inserted) and taken to the intensive care unit (ICU).

The RM stated she interviewed RN 1 and RN 1 demonstrated how she administered the insulin and how she had it checked by a second RN . The RM reenacted the demonstration. The RM stated during her interview with RN 1 on July 21, 2015, RN 1 demonstrated her actions. The RM stated she had observed RN 1 holding an insulin syringe, and pulling the plunger all the way down to the bottom of the syringe (withdrawing one ml [milliliter]). She was holding a vial with Novolog insulin that contained 100 units per ml. The observation verified 1 ml of the insulin would yield 100 units.

According to the RM, when she spoke to RN 2 (who double checked the insulin dose and signed off on it), RN 2 repeatedly stated she did not remember details, but, "it matched," referring to the insulin double check. The RM stated when RN 2 realized 100 units of Novolog had been given to the patient, RN 2 told the RM that was not an appropriate dose to give.

During a telephone interview with RN 1 on July 23, 2015, at 10:45 a.m., the RN stated she took care of Patient 1 early in his admission, and his blood sugars were, "out of control." She stated they were up into the 400's, so when she saw the scheduled insulin dose of 100 units to be given three times a day, she, "figured," that was the solution they came up with to control his blood sugars.

The RN stated when she checked Patient 1's blood sugar the morning of July 21, 2015, his sugar was 124, and no sliding scale coverage was needed, so she didn't give any extra insulin. She stated she only gave what was scheduled at 7 a.m. (100 units, according to the medication administration record [MAR]), and she had a second nurse (RN 2) double-check the dose before administering it.

RN 1 stated she checked Patient 1 at 10 a.m., he was lethargic and unresponsive. According to the nurse, a sitter who was with the patient reported that he fell asleep at approximately 8:30 a.m. RN 1 stated she called Patient 1's physician to report his condition. She stated she did not speak to the physician before she rechecked his blood sugar at 11 a.m., (when the next scheduled dose of insulin was due) and the result was 21. According to the nurse, she gave IV dextrose and summoned a colleague to assist in assessing the patient, then called a rapid response. The nurse stated she thought the 100 unit dose was, "kind of a big dose," but she thought she was giving Lantus (a long acting insulin) and it was the solution to his previously high blood sugars.

At no time during the interview did the nurse indicate she knew 100 units of Novolog insulin was not appropriate to give to a patient with a blood sugar of 124.

The record for Patient 1 was reviewed on July 23, 2015. Patient 1, an 80 year old male, was admitted to the facility on July 13, 2015, with diagnoses that included anemia and diabetes.

A physician's order, dated July 20, 2015, indicated the patient was to have his blood sugar checked every two hours (until he was alert following a surgical procedure), in addition to checking it before meals and at bedtime. The order indicated the blood sugar was to be treated with Novolog insulin sliding scale doses, if needed, every four hours. There was no order for a, "scheduled," insulin dose in addition to the sliding scale.

According to the MAR, the patient had a scheduled insulin dose to be given at 7 a.m., 11 a.m., and 3 p.m., in addition to sliding scale coverage depending

Based on observation, interview, and record review, the facility failed to ensure:

1. Respiratory therapy was initiated within four hours of being ordered in accordance with the facility policy on Medication Administration, for three patients (Patients 209, 210, and 105), resulting in the potential for decompensation in the patients' conditions, respiratory distress, and death; and,

2. Quality data was being collected to determine the timeliness of therapy initiation and identify opportunities for improvement after previous problems were identified and corrective action was taken, resulting in continued delays in initiating respiratory therapy, and the potential for deterioration in the patient conditions, respiratory distress, and death.

The cumulative effect of these systemic and ongoing problems resulted in failure to ensure respiratory services were provided in a safe and effective manner and met the needs of the patients.

Findings:

Physician orders were received by the Respiratory Department (RT) in two different ways:

a. When a physician wrote an order and placed the order in the paper medical record, the unit secretary would enter the order into the clinical computer system (IMED), and a notification would print in the RT department to alert the staff of a new or modified order; and,

b. When a physician entered an order using the computerized physician order entry system (CPOE), the order would be sent electronically to the pharmacy. The pharmacist would enter the order onto the medication administration record (MAR), and trigger a notification to the RT department to alert the staff of a new or modified order.

During a tour of the Respiratory Therapy (RT) Department on August 12, 2015, at 9:30 a.m., the RT Coordinator stated there was a previous problem with the department receiving orders that were entered using the CPOE system, but that had been corrected. He stated there was currently a problem with them receiving orders from the unit secretaries, as they were not being put into the IMED system in a timely manner.

During an interview with the RT Director on August 12, 2015, at 9:40 a.m., the Director stated he was aware of the current problem, and he had met with the pharmacy and information technology (IT) departments the previous week. He stated he was supposed to meet with the nursing department sometime in the current week. The director stated the unit secretaries were not getting RT orders communicated to them in a timely manner through the IMED system, when the physician wrote them on a physician's order form instead of using the CPOE system. He stated there were, "still," delays in the system. According to the Director, the Chief Operating Officer (COO) and the Director of Quality (DQ) were aware of the problem.

During the tour, a copier/printer was observed in the RT office that was printing papers with lists of patient names periodically. The coordinator stated the lists were generated by IT, and included names and locations of patients who had RT orders entered using CPOE, or written by the physician, but the orders had not been acknowledged by the RT staff yet. He stated the lead RT staff was to check each patient on the list to make sure therapy had been started.

1. The facility policy titled, "Medication Administration," was reviewed on August 12, 2015. According to the policy, RT medications, "must," be administered within four hours of being ordered.

a. The record for Patient 209 was reviewed on August 12, 2015. Patient 209, a 70 year old female, was admitted to the facility on August 6, 2015, with diagnoses that included Congestive Heart Failure (CHF), Decreased Oxygen Saturation (low oxygenation), and Respiratory Failure.

The patient's home medications were reviewed on admission using the Medication Reconciliation Process, the albuterol and atrovent (respiratory medications) nebulizer (breathing treatment) was ordered to be continued every 2 hours as needed, and the orders were faxed to the pharmacy at 6 p.m.

According to the order history, the information technology (IT) department entered the order into the clinical (IMED) system on August 9, 2015, at 2 a.m. (8 hours after the therapy was ordered).

The order detail indicated the unit secretary entered the order in the computer (IMED) system on August 9, 2015, at 2:25 p.m. (20 hours and 25 minutes after the therapy was ordered).

According to the record, the initial RT assessment to determine whether a treatment was needed was completed on August 9, 2015, at 4:49 p.m. (22 hours and 49 minutes after therapy was ordered).

b. The record for Patient 210 was reviewed on August 12, 2015. Patient 210, an 82 year old male, was admitted to the facility on August 8, 2015, with diagnoses that included Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, and Hypoxia (lack of oxygen).

The Pre-Printed Emergency Admit orders, written at 8 p.m., included an order for albuterol and atrovent (respiratory medications) to be given via a nebulizer (breathing treatment) every four hours and as needed.

According to the record, the order was entered by the unit secretary at 10:56 p.m. (2 hours and 56 minutes later).

The record indicated the order was acknowledged by the RT staff on August 9, 2015, at 2:51 a.m. (6 hours and 51 minutes after it was written).

The RT Treatment form indicated the first time RT had contact with Patient 210, and administered a breathing treatment, was on August 9, 2015, at 7:20 a.m. (11 hours and 20 minutes after the order was written).

c. On August 11, 2015, at 10:50 a.m., a tour of the second floor was conducted. The Charge Nurse (CN) indicated Patient 105 was admitted for treatment of pneumonia.

The record for Patient 105 was reviewed on August 11, 2015. Patient 105, presented to the facility on August 3, 2015, with complaints of difficulty breathing. Patient 105 was admitted to the facility on August 3, 2015, at 11 p.m., with diagnoses that included pneumonia.

Handwritten physician orders dated August 3, 2015, at 11 p.m., indicated "Duoneb (albuterol and ipratropium medication combination that relaxes muscles in the airways and increases air flow to the lungs) Neb (nebulizer-breathing treatment) Q (every) 4 (four) hours ATC (around the clock)."

According to the record, the order was entered by the unit secretary on August 3, 2015, at 11:45 p.m.

The record indicated the order was acknowledged by the RT staff on August 4, 2015, at 5:09 a.m., (6 hours after the order was written). The RT documented an initial assessment at this time but did not administer the medication treatment as ordered.

The RT Treatment form indicated the first time RT administered a breathing treatment was on August 4, 2015, at 10:10 a.m., (11 hours after the order was written).

During an interview with the RT Director on August 12, 2015, at 1 p.m., the Director stated the initial assessment and treatment should be done as soon as possible. The Director stated it would have been better if Patient 105 received a treatment at 5:09 a.m., when the RT assessed the patient. The RT Director stated they were still having problems with initiating treatment due to delays in receiving the orders.

The policy and procedure for inhalation treatments was requested. The policy and procedure for "Medication Administration," revised March 2014, was reviewed. The policy indicated the purpose was to ensure safe administration of medications to patients. Respiratory Therapy was accountable to this policy. The policy indicated "Routine medications must be administered within four (4) hours."

2. During an interview with the Director of Respiratory Therapy (DRT), the Director of Pharmacy (DOP), the Chief Nursing Officer (CNO), and the Director of Information Technology (DIT) on August 12, 2015, at 1:10 p.m., the DRT, the DOP, and the DIT stated they were aware that problems continued to exist regarding notification of the RT staff when new therapy was ordered.

They stated they had recent problems (lasting approximately two to three months) with the computerized physician order entry (CPOE) system not triggering a notification to RT staff, b