The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CAROLINAS HEALTHCARE SYSTEM UNION 600 HOSPITAL DR MONROE, NC 28112 Nov. 19, 2015
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on administrative staff interviews, policy manual review and Care Event report documentation, the facility's leadership failed to assure oversight and direction by failing to provide a safe environment as evidenced by failure to ensure nursing staff evaluated and supervised the care of patients (#1 and #9), ensure medications requiring a therapeutic level were administered per the physician's order (#7) and failure to ensure expired or discontinued medication were not available for patient use (#5).

Findings include:

The facility's leadership failed to provide a safe environment as evidenced by failure: of nursing staff to evaluate and supervise patient care services; ensure medications requiring a therapeutic level were administered per physician's order and ensure expired or discontinued medications were not available for patient use.

~ Cross Reference 482.25(b)(2)(i) - Pharmaceutical Services - All drugs and biologicals must be kept in a secure area, and locked when appropriate.

~ Cross Reference 482.25(b)(3) - Pharmaceutical Services - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.
VIOLATION: SECURE STORAGE Tag No: A0502
Based on review of the hospital's policy and procedures, observation and staff interview, the hospital failed to ensure medications are maintained in a secure area for 2 of 2 patient care units toured.
The findings include:
Review of on 11/17/2015 of the hospital's "Storage and Security of Medications" policy last reviewed 11/2014 revealed, "Policy: Medication storage and preparation areas within the pharmacy and throughout the facility shall be under the supervision of the Director of Pharmacy Services. Medications must be stored under proper conditions (light, moisture, ventilation), segregated for safety, and secured as determined by official compendia (standard) and/or current regulation..."
Observation on 11/17/2015 at 1340 of the nursing station on Unit B revealed a shelf with various items on it. Observation revealed 2 IVPBs were stored in a basket on top of the shelf, unsecured. Observation revealed the IVPBs were under several pieces of paper. Observation revealed medications stored in that area were not secure and readily available to patients, staff, and visitors. Observation revealed the 2 IVPBs were removed and taken to the nurse responsible. Observation on 11/18/2015 of the same area revealed an IVPB stored in the same location. Observation revealed the Nurse Manager (NM) removed the medication and instructed the nurse to place it in the bottom drawer of the locked medicine cart.
Interview on 11/17/2015 at 1100 with LN (Lead Nurse) #1 on Unit C revealed the medication room has always been unlocked. Interview revealed "typically, someone is here at the nursing station all the time." Interview revealed "I guess it would be possible that the station would be unattended but I haven't experienced that." Interview revealed the hospital's current practice dose not ensure storage of medications in a secure area.
Interview on 11/17/2015 at 1340 with NM #2 revealed, "Someone is in the nursing station at all times." Interview revealed, this (referencing the area outlined with blue tape just outside the nursing station) area is restricted to staff only. Patients are not allowed to come in the nursing station." Interview revealed IVPBs are "typically administered fairly quickly and would not be stored there (basket on top of shelf)." Interview revealed, "It's been busy this morning. We had a Rapid Response Team call (team of health care providers that responds to patients with early signs of clinical deterioration) around 0900 and have been playing catch-up since then." Interview revealed, "Yes, it's possible but highly unlikely. I just don't see it happening." Interview revealed the hospital's current medication security practice presents a possibility of unauthorized access to medications.
Interview on 11/17/2015 at 1400 with NM #1 revealed, "A pilot is being conducted on Unit C focusing on medication delivery and the number of times nurses have to stop patient care duties to perform other tasks, such as having to go to the dumb waiter and obtain the new medication. Interview revealed the the 40 bed unit was spilt into two separate "Pods", one on each end of the unit. Interview revealed when "Pods" were created, the areas selected for use as the medication rooms, key pads locks were placed on the doors at that time. Interview revealed the goal of creating the "Pods" was to have nursing staff at both ends of the unit to better streamline the delivery of care. Interview revealed key lock pads were placed on the doors because the rooms open directly into the hall of the patient care area and because nursing staff would not always be readily available to monitor the security of medications.
Interview on 11/19/2105 at 1430 with PharmD revealed, "No, I was not aware it (door to the medication room on Unit A) wasn't locked." Interview revealed, "I've always heard the nursing station is considered a secure area." Interview revealed, "It's (medication room) probably not secure enough and is a simple fix." Interview revealed the PharmD was also not aware that IVPBs were being stored in the nursing station on a readily accessible shelf. Interview revealed, "My primary focus has been on the Pharmacy and trying to get a handle on things down there. I think I need to work with nursing on trying to improve the overall process." Interview revealed the hospital's current medication security practice presents a possibility of unauthorized access to medications.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on review of the hospital's policy and procedures, medical record review, observation, and interviews, the hospital staff failed to ensure expired and discontinued medications greater than 48 hours were not available for use for 2 of 2 patients.
The findings include:
Review of on 11/17/2015 of the hospital's "Storage and Security of Medications" policy last reviewed 11/2014 revealed, "Policy: Medication storage and preparation areas within the pharmacy and throughout the facility shall be under the supervision of the Director of Pharmacy Services. Medications must be stored under proper conditions (light, moisture, ventilation), segregated for safety, and secured as determined by official compendia (standard) and/or current regulation... 13. Any damaged, expired, discontinued or discharged patient's medications sent from the pharmacy are sent back to the pharmacy via the tube system as soon as identified to avoid mix-up with current/active patient medications...At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy. Non-tubable items and refrigerated items will be placed in designated return baskets for pick-up by pharmacy personnel..."

1. Review on 11/17/2015 of patient #5's History and Physical (H&P) dated 10/28/2015 at 1638 revealed an 84 y.o. female was admitted for "UTI (Urinary Tract Infection); Hypovolemic Shock (an emergency condition in which severe blood and fluid loss make the heart unable to pump enough blood to the body); Adrenal Insufficiency (a condition in which the adrenal glands do not produce adequate amounts of steroid hormones); and Anemia."
Review on 11/17/2015 of patient #5's physician orders revealed an order by MD #3 dated 11/13/2015 at 1000 for Ferric Glucon Complex 125 mg (milligrams: unit of measurement) with 100 ml (milliliter: unit of measurement) NS (Normal Saline: solution used to treat fluid and electrolyte imbalance) IVPB (IV Piggy Back: used to administer small volumes of fluids) daily. Review of the MAR revealed the ordered dose was administered on 11/15/2015 at 1010. Continued review revealed an order by MD #3 dated and timed 11/12/2015 at 1300 for Thiamine (a vitamin) 100mg IVPB daily. Review of the Medication Administration Record (MAR) revealed the ordered dose was administered on 11/16/2015 at 1106.
Observation on 11/17/2015 at 1030 of the medication room on Unit A revealed a metal shelf containing baskets labeled with individual patient room numbers. Observation revealed the baskets contained 12 IVPBs in various patient's individual medication baskets. Observation revealed 2 IVPBs in patient #5's basket. Observation revealed an IVPB labeled "Ferric Glucon Complex 125 mg with 100 ml NS" in the basket to be hung on 11/15/15 at 1000. Observation revealed an expiration date of 11/16/2015 written on the label by pharmacy. Observation revealed an IVPB labeled "Thiamine 100mg with 50 ml of NS" in the basket to be hung 11/16/2015 at 1000 in patient #5's basket. Observation revealed an expiration date of 11/17/2015 written on the label by pharmacy.
Interview on 11/17/2015 at 1125 with an RN #11 assigned to Unit A revealed that when scheduled medications are not readily available at the time of administration, nursing calls pharmacy and requests the dose. Interview revealed the dose requested from pharmacy is administered and when the scheduled dose is delivered, either by the pharmacy technician or the dumb waiter, it is placed in the patient's individual medication basket for the next scheduled dose. Interview revealed pharmacy picks expired and discontinued medications up when the Omni cell is filled. Interview revealed RN #11 was not aware expired medications were readily available for use in patient #5's individual medication basket. Interview revealed RN #11 was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed RN #11 was not aware of the hospital's policy or process of returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/17/2015 at 1130 with LN (Lead Nurse) #1 revealed the tube system is not used on Units A and B. Interview revealed damaged, expired, discontinued or discharged patient's medications sent from the pharmacy "are returned to pharmacy via the dummy waiter on Units A and B." Interview revealed LN #1 was not aware expired medications were readily available for use in patient #5's basket. Interview revealed LN #1 was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed LN #1 was not aware of the hospital's policy or process of returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/17/2015 at 1140 with the hospital's PharmD D revealed, "The clinical supervisor goes through patient baskets who are discharged and sends them to pharmacy." Interview revealed "Typically, that (expired and discontinued medications) should be picked up when one of my techs (technician) makes their daily round." Interview revealed "This should be looked at daily, yes there should be process in place where nursing is sending expired or discontinued medications down (to pharmacy) or we're collecting them." Interview revealed, "Certainly, if it's (medication) expired or discontinued, it should be picked up and removed from the patient's individual medication basket." Interview revealed the hospital's PharmD D was not aware expired medications were readily available for use in patient #5's basket. Interview revealed the PharmD D was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed the hospital's PharmD D was not aware of the hospital's policy or process of returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed she was not aware that expired and discontinued medications were not being removed and returned to pharmacy. Interview revealed she was not aware that nursing staff are not familiar with the hospital's process of removing expired or discontinued mediations to avoid a mixing in with current medications. Interview revealed, "I think it's an education issue." Interview revealed, "No, it is not acceptable practice to have discontinued and expired medications mixed in with current medications. Interview revealed the hospital nursing staff did not follow the "Storage and Security of Medications" policy.
1. a. Review on 11/17/2015 of patient #5's H&P dated and timed 10/28/2015 at 1638 revealed an 84 y.o. female was admitted for "UTI (Urinary Tract Infection); Hypovolemic Shock (an emergency condition in which severe blood and fluid loss make the heart unable to pump enough blood to the body); Adrenal Insufficiency (a condition in which the adrenal glands do not produce adequate amounts of steroid hormones); and Anemia."
Review on 11/17/2015 of patient #5's physician orders revealed an order written by MD #3 dated and timed 11/15/2015 at 1930 for Meropenem (used to treat a wide range of bacteria) 500 mg IVPB every 6 hours. Review revealed the order for Meropenem was discontinued on 11/16/2015 at 1339. Review on 11/17/2015 of patient #5's MAR revealed the last dose of Meropenem was administered on 11/16/2015 at 0507.
Observation on 11/17/2015 at 1030 revealed a Meropenem 500mg IVPB in patient #5's individual medication basket. Observation revealed the label directed the medication to be administered 11/16/2015 at 1800. Observation revealed the discontinued IVPB was readily available in patient #5's individual medication basket with no indication or other notation alerting nursing staff that it had been discontinued.
Interview on 11/17/2015 at 1030 with LN #1 revealed the tube system is not used on Units A and B. Interview revealed damaged, expired, discontinued or discharged patient's medications sent from the pharmacy "are returned to pharmacy via the dummy waiter on Units A and B." Interview revealed LN #1 was not aware discontinued medications were readily available for use in patient #5's basket. Interview revealed LN #1 was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed LN #1 was not aware of the hospital's policy or process of returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/17/2015 at 1140 with the hospital's PharmD D revealed, "The clinical supervisor goes through patient's baskets who are discharged and sends them to pharmacy." Interview revealed "Typically, that (expired and discontinued medications) should be picked up when one of my techs (technician) makes their daily round." Interview revealed "This should be looked at daily, yes there should be process in place where nursing is sending expired or discontinued medications down (to pharmacy) or we're collecting them." Interview revealed, "Certainly, if it's (medication) expired or discontinued, it should be picked up and removed from the patient's individual medication basket." Interview revealed the hospital's PharmD D was not aware discontinued medications were readily available for use in patient #5's basket. Interview revealed the PharmD D was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed the hospital's PharmD D was not aware of the hospital's policy or process for returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed she was not aware that expired and discontinued medications were not being removed and returned to pharmacy. Interview revealed she was not aware that nursing staff are not familiar with the hospital's process of removing expired or discontinued mediations to avoid a mixing in with current medications. Interview revealed, "I think it's an education issue." Interview revealed, "No, it is not acceptable practice to have discontinued and expired medications mixed in with current medications. Interview revealed the hospital nursing staff did not follow the "Storage and Security of Medications" policy.
2. Review on 11/17/2015 at 1030 of patient #6's H&P completed by MD (Medical Doctor) #10 11/13/2015 at 2234 was admitted to the hospital's observation unit 11/13/2015 at 1245 with a diagnosis of Community Acquired Pneumonia; Dehydration; Hyponatremia (low sodium: electrolyte that helps regulate water in and around cells in the body: normal range 136-145 mMol/L : millimoles per liter: unit of measurement); Acute Kidney Infection; and Hyperkalemia (high potassium).
Review on 11/17/2015 of patient #6's physician orders revealed an order written by MD #10 on 11/13/2015 at 0102 for Aztreonam (used to treat bacterial infection) 1 gm (gram: unit of measurement) per 50 ml (millimeters: unit of measurement) NS every 8 hours. Review revealed the order was discontinued 11/14/2015 at 1245. Review of patient #6's MAR revealed the last dose administered 11/14/2015 at 0644.
Observation on 11/17/2015 at 1030 revealed an Aztreonam/NS 50 ml 1 gm IVPB in patient #6's individual medication basket. Observation revealed the label directed the medication to be administered 11/14/2015 at 1400. Observation revealed the discontinued IVPB was readily available in patient #6's individual medication basket with no indication or other notation alerting nursing staff that it had been discontinued.
Interview on 11/17/2015 at 1030 with LN #1 revealed the tube system is not used on Units A and B. Interview revealed damaged, expired, discontinued or discharged patient's medications sent from the pharmacy "are returned to pharmacy via the dummy waiter on Units A and B." Interview revealed LN #1 was not aware discontinued medications were readily available for use in patient #6's basket. Interview revealed LN #1 was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed LN #1 was not aware of the hospital's policy or process of returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/17/2015 at 1140 with the hospital's PharmD D revealed, "The clinical supervisor goes through patient's baskets who are discharged and sends them to pharmacy." Interview revealed "Typically, that (expired and discontinued medications) should be picked up when one of my techs (technician) makes their daily round." Interview revealed "This should be looked at daily, yes there should be process in place where nursing is sending expired or discontinued medications down (to pharmacy) or we're collecting them." Interview revealed, "Certainly, if it's (medication) expired or discontinued, it should be picked up and removed from the patient's individual medication basket." Interview revealed the hospital's PharmD D was not aware discontinued medications were readily available for use in patient #6's basket. Interview revealed the PharmD D was not aware that "At the end of each nurses' shift, all discontinued medications, or discharge patients medications are returned to the pharmacy" in accordance with hospital policy. Interview revealed the hospital's PharmD D was not aware of the hospital's policy or process for returning expired or discontinued medications to the pharmacy. Interview revealed the hospital nursing staff did not follow the hospital's "Storage and Security of Medications."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed she was not aware that expired and discontinued medications were not being removed and returned to pharmacy. Interview revealed she was not aware that nursing staff are not familiar with the hospital's process of removing expired or discontinued mediations to avoid a mixing in with current medications. Interview revealed, "I think it's an education issue." Interview revealed, "No, it is not acceptable practice to have discontinued and expired medications mixed in with current medications. Interview revealed the hospital nursing staff did not follow the "Storage and Security of Medications" policy.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on administrative staff interviews, policy manual review, Care Event report documentation and patient interviews, the hospital's governing body failed to assure oversight and direction by failing to provide a safe environment as evidenced by failure to ensure nursing staff evaluated and supervised the care of patients (#1 and #9), ensure medications requiring a therapeutic level were administered per the physician's order (#7) and failure to ensure expired or discontinued medication were not available for patient use (#5).

Findings include:

The hospital leadership staff failed to provide a safe environment as evidenced by failure: of nursing staff to evaluate and supervise patient care services; ensure medications requiring a therapeutic level were administered per physician's order and ensure expired or discontinued medications were not available for patient use.

~ Cross Reference 482.13(a)(2)(iii) Patients Rights - In its resolution of the grievance, the hospital must provide the patient with written notice of its decision . . . the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

~ Cross Reference 482.13(c)(2) Patients Rights - The patient has the right to receive care in a safe setting.
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
Based on hospital policy review, Patient Complaint Form review, and administrative staff interviews, the hospital failed to investigate and resolve one of one grievances sampled (Patient #1).

Findings include:

Policy review on 11/18/2015 revealed "Patient Grievance Management Policy" reviewed/revised 01/2014. The policy review revealed "This policy sets forth the procedure for appropriately identifying and promptly resolving patient grievances . . . 7. Within seven calendar days, the patient or complainant will be sent a follow-up letter by the appropriate administrator; or designee which addresses a resolution or notified the patient that further investigation is required. The patient or complainant will be informed of an expected follow-up time to address the resolution and will be kept informed of the progress on a weekly basis. All grievances will be resolved as soon as possible with a goal of resolution within seven calendar days and the recommendation that it take no longer than 30 days. 8. In the resolution of the grievance, the administrator, or designee will provide the patient or complainant with written notice of the decision, the name of the appropriate contact person, the steps taken to investigate, the results of the grievance process, and the date of completion. The grievance is considered resolved when the patient or complainant is satisfied with the actions taken, or if the patient or complainant is dissatisfied, the grievance is considered resolved when the facility has taken all appropriate and reasonable actions and on behalf of the patient to resolve the grievance . . ."

Review of Patient Complaint Form dated 04/11/2015 revealed a complaint was received by the weekend House Supervisor in regards to Patient #1. The form contained two complaints regarding care received by Patient #1 between 03/25/2015 and 04/11/2015. Number one: "The nurses in [Name of unit] were going to give the patient the wrong meds [medications] many times." Number two: "The physicians gave conflicting information about the patient's medical condition." Review of the complaint form documentation, identified as being conducted by the Chief Medical Officer (CMO), revealed "Details: On April 13, 2015 at 9:16 AM, I spoke by phone with [Name of complainant]. She remains very angry and specifically wants to know what transpired during the CT scan procedure [the patient] underwent. Prior to calling [Name of complainant], I reviewed the patient's medical record to get a better understanding of her course of care. On April 14, 2015 at 3:30 PM I met with a group of our teammates to discuss next steps. On April 15, 2015 I composed a letter to [Name of complainant] offering to meet with her to discuss the events surrounding the CT Scan." Continued review revealed a copy of a letter dated 04/15/2015 and addressed to the complainant. Review of the letter revealed "To help me better understand these issues, before I called you on the phone, I reviewed . . . medical record. . . I gathered together a group of our employees who were directly or indirectly involved . . . They gave me a better understanding of what [Patient #1] experienced during her stay here. . . I would like to offer to personally meet with you to discuss the events . . ." The review revealed no documentation of an investigation of the two complaints or no documentation of a resolution.

Interview on 11/17/2015 at 1415 with the CMO revealed the CMO was unaware of the complaints regarding medication administration or communication with physicians. The interview revealed the "teammates" that attended the meeting were the Director of Patient Support, the Risk Manager, the Director of Adult Inpatient and the Assistant Director of Radiology. The interview revealed the complainant did come in for a meeting with the CMO. The interview revealed there was no documentation of the meeting and the complainant was still upset after the face to face meeting. The interview revealed the CMO referred the complaint to Risk Management after the complainant left the meeting and was still upset.

Interview on 11/18/2015 at 0920 with the Risk Manager revealed the Risk Manager was not aware of any documentation of the investigation of the complaint regarding medication administration or communication with physicians in reference to Patient #1. The interview revealed the Director of Patient Support is responsible for investigation of all grievances.

Interview on 11/18/2015 at 0940 with the Director of Patient Support revealed the Director of Patient Support did not attend the meeting with the CMO. The interview revealed the Director of Patient Support was not aware of an investigation of the complaint regarding medication administration or communication with physicians in reference to Patient #1. The interview revealed the Director of Patient Support thought the CMO had resolved the grievance.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hosptial policy review, medical record review, Care Event reporting review and staff interviews, the hospital staff failed to ensure patient care was provided in a safe setting for 3 of 11 patients sampled (#1, #9 and #7)
The findings include:
Review on 11/18/2015 of the hospital's "Care Event Reports" policy reviewed/revised 04/2013 revealed, "(Hospital) provides its employees with a formal risk identification system. The purpose of the system is to identify patient safety issues ... and opportunities for improvement. (Hospital) recognizes the importance of early identification and expects its employees to complete a CARE Event Report for any occurrence which occurs in the facility.... Definitions A. Event: 1) is any expected or unintended incident/accident/occurrence relating to patients, or visitors...Events may include, but are not limited to...6. Near miss...B. Severity/Extent of Injury is defined...Level 0 - Near miss - error did not reach the patient; Level 1 - No apparent harm to patient related to the event... Procedure: ... B. In reporting events care should be taken in completing the form...Document a factual account of the event in the medical record..."
Review on 11/18/2015 of the hospital's "Seizure Precautions" policy last reviewed/revised 05/2012 revealed, "I. Policy Patients with a seizure disorder will be managed according to procedure... D. Absence Seizures (characterized by blank stare and lack of awareness. May include rapid blinking and/or chewing)... 3. Notify MD (Medical Doctor) of seizure activity... V. Documentation...B. MD notified..."
Review on 11/19/2105 of the hospital's "Assessment of Patients" policy last reviewed 04/2015 revealed, "I. Policy: ...Patients will receive care based on documented assessment of their needs/current state. Assessment data is used to determine and prioritize the patient's need...Data received from the patient, as well as the patient's family/significant others are included in the assessment... B. Reassessment... 2. Nursing... d. Patient's will be reassessed by a Registered Nurse...at least every 12 hours, with changes in patient condition and/or diagnosis... Nursing assessments/reassessments will be documented in the electronic medical record (EMR)..."
Policy reivew on 11/19/2015 revealed "Patient Transportation" reviewed/ revised January 2015. The policy stated, "This policy is designed to facilitate the safe and timely movement of patients throughout the facility. Patients will be transported for the purpose of admission, diagnostic test, medical procedure and discharge. . . If continuous telemetry monitoring os the patient is required, an RN and monitor must accompany the patient. II. Patient transports requiring Clinical Staff assistance: . . 2. Patients on continuous telemetry monitoring . . . 5. When clinical condition requires. . . "
1. Closed medical record review for Patient #1 revealed a hospital admssion on 03/25/2015 with diagnoses including Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Pulmonary Edema and Pneumonia with a history of Dementia and Diabetes. Review of Respiratory Therapy (RT) notes for 04/10/2015 revealed oxygen (O2) therapy was administered using medium flow nasal cannula while awake and BiPAP (Bilevel Positive Airway Pressure) while asleep. Review revealed at 1530 the patient received oxygen therapy at 10 liters per minute via nasal cannula with oxygen saturation levels of 88 - 96 % (normal range is greater than 90%), heart rate per minute 116 - 128 (normal range 60-80) and breaths per minute 27 - 31 (normal range 16-20). Oxygen therapy was increased to 15 liters per minute via nasal cannula at approximately 1810 with oxygen saturation level of 96 % and respiratory rate decreased to 25 breaths per minute. Continued review revealed BiPAP was initiated at 2100. Review of RT notes for 04/11/2015 at 1245 revealed the patient received oxygen therapy at 15 liters per minute via nasal cannula with a heart rate of 111 and breaths per minute of 19 breaths.
Review of nursing notes for 04/11/2015 revealed a nursing assessment at 1300 which indicated the patient left the floor for a Chest Angiography CT (imaging study to visualize arteries and veins) with "transport" with portable oxygen at 15 liters per minute via nasal cannula with oxygen saturation level of 99%. Continued review of nursing notes revealed the nurse called the CT imaging staff and notified family the patient was "still off unit." Continued review revealed an entry for1517 which stated the patient expired at 1416. Continued review revealed the patient was recieving continous cardiac monitoring prior to being transported off the floor. Continued review revealed no nursing evaluation or supervision of care after 1300.
Review of three signed statements from Radiology Department staff dated 04/11/2015 revealed "Patient arrived in CT 1255. Injector started to malfunction between 1300 and 1330. . . Patient was taken off table. Patient was put in holding bay fully alert and conscious on 10 ml of oxygen via nasal cannula. . . Pt. [patient] was then brought back in and onto table. Pt. was kept on oxygen at all times while in our dept [department] ad sitting upright except while on scan table. . . 1401 scan started. Scouts taken. Scouts [CT pictures] were taken. After utilizing smart prep [contrast injected into patient's vein for better visualization] we noticed that the bolus was not optimal. We decided to give patient more contrast. . . went out to explain this to patient and noticed that patient was not responding. We then proceeded to pull patient out of the gantry [part of CT machine] to check on her. We then noticed that she was not breathing and had no pulse. . . proceeded to call a Code Blue [hospital wide intercom call for help]. Review of medical record revealed no documentation of evaluation or supervision of oxygen therapy by Radiology Department staff.
Interview on 11/17/2015 at 1400 with the Assistant Director of Radiology revealed there was no documentation in Radiology notes for oxygen therapy. The interview revealed oxygen therapy was administered at 10 liters per minute via nasal cannula, while the patient was in the x-ray department, instead of 15 liters per minute via nasal cannula as documented by nursing staff. The interview revealed Transport staff get patients from their rooms and transport them to the Radiology Department. The interview revealed a "Hall Pass" with patient information was provided to the Transport staff to handoff to Radiology staff. The interview revealed the "Hall Pass" is not part of the medical record.
Review of Care Event, identified as the hospital's system for incident reporting, for Patient #1 dated 04/11/2015 with time of event documented as 1245, revealed "Pt was taken down to ct [CT] on 15 liters oxygen nasal cannula, without the tele monitor [cardiac monitor] and a nurse. Pt coded [Code Blue] in ERCT [Emergency Department CT]. Pt was DNR [Do Not Resusitate]. Code called ER Dr. responded and pronounced death."
Interview on 11/18/2015 at 0950 with Nurse Manager #2 revealed Patient #1 had been on continous cardiac monitoring prior to transport to Radiology. The interview revealed the patient should have been transported with cardiac monitoring and assisted by a RN throughout transport and while in Radiology until the patient was returned to the patient's room per hospital policy.
2. Review of closed medical record for Patient #9 revealed a hospital admission on 07/25/2015 with diagnoses including Chronic Renal Failure, Hypertension and Colon Cancer. Patient #9 underwent abdominal surgery on 07/27/2015 for bowel resection. Review of nursing notes for 08/04/2015 revealed the patient experienced a change in condition on 08/04/2015 at approximately 0807 with a heart rate of 128 beats per minute (normal range 60-90) and an increase in breathing of 28 breaths per minute (normal range 16-20). Nursing staff notified the physician and a chest x-ray was ordered and oxygen was started at 4 liters per minute via nasal cannula. The patient was transported to the radiology department, received a chest x-ray and was transported back to the patient room by radiology staff at approximately 0928. Nursing staff discovered the patient unresponsive and initiated a Code Blue (hospital intercom call for emergency help) at approximately 0930. The patient was pronounced expired 08/04/2015 at 0956. The record review revealed no documentation of evaluation and supervision of the patient's change in condition upon return to the patient's room.

Review of Care Event, identified as the hospital's system for incident reporting, for Patient #9 revealed the report was dated 08/05/2015. The report stated "Pt brought back from radiology by radiology staff at 0928 (change in pt's status wasn't communicated-0930 nurse found pt. unresposive, no pulse. Code Blue called at 0932...0956-pt pronounced dead by MD."

Interview on 11/18/2015 at 1620 with the Patient Safety Coordiator revealed a Root Cause Analysis was conducted for Patient #9. The interview revealed the analysis identified a need for better patient handoff between staff during transport and a need for Guidelines/Parameters to provide nursing with standardized criteria for which patients would be safe to travel alone off the floor.

Interview on 11/19/2015 at 1600 with the Assistant Director of Radiology revealed Patient #9 was "not responding in x-ray. The x-ray staff did not do hand-off with nursing staff" on the floor. The interview revealed there was no documentation of when the patient became unresponsive. The interview revealed the x-ray staff that transported the patient back to the floor should have performed a hand-off report to nursing staff on the floor.

Interview on 11/19/2015 at 0945 with the Chief Nursing Officer revealed there was no documentation the radiology staff had reported a change in Patient #9's condition to the nursing staff. The interview revealed there was no documentation the patient was stable enough for transport to Radiology.The interview revealed there was no documentation the nursing staff evaluated Patient #9's condition upon return to the floor.






3. Review on 11/18/2015 of patient #7 "Admission History and Physical (H&P) performed by MD #1 on 11/12/2015 at 1305 revealed a [AGE] year old man with a "history of severe developmental delay secondary to CP ([DIAGNOSES REDACTED]: an inherited disorder that causes severe damage to the lungs), history of epileptic seizures (abnormal activity in the brain varying from uncontrolled jerking movement to subtle temporary loss of awareness) since the age of 6 months ... recently hospitalized at .... (Family member) told the doctor that she dosed him (patient #7) based on 'how he looked and acted' ... He (the doctor) changed his medications to ...Valporic Acid 1000mg (milligrams: unit of measurement) BID (twice daily) ... " Review revealed patient #7 had follow up appointments with two physicians in August; however the (Family member) cancelled the appointments. Review revealed patient #7 was seen by his primary care physician (PCP) on 10/12/2015 for a checkup and new coughing symptom. The patient's primary caregiver refused a recommended speech therapy evaluation following the physician's concerns of the patient #7's swallowing abilities. Review revealed patient #7's Phenytoin (also known as Dilantin: used to treat seizures) was changed from pill form to liquid due to concerns related to his swallowing ability. Review revealed patient #7 "Dilantin level was therapeutic (10-20 ug/ml: micrograms per milliliter - unit of measurement) at 15.2, today it is <2.5 ...transported to the ED (emergency department) this morning in [DIAGNOSES REDACTED] (a dangerous condition in which epileptic seizures follow one another without recovery of consciousness between them) ... (Family member) is a poor historian ... he 'had a few spells yesterday (11/16/2015) ... when she went in this morning around 7 AM he ws [sic] 'really getting to it'. He received 4mg IV (intravenous: indicates mode in which liquid medications or fluids are administered into the vein) Ativan (used to produce a calming effect) and 5mg IV Versed (used to produce a calming effect on the brain and nervous system) by EMS (Emergency Medical Services) and had episodes of his O2 (oxygen) saturation (level of O2 available for the brain's use: normal 95-100) dropping into the 60's briefly ...Upon arrivalot [sic] ... it wsa [sic] felt he could not protect his airway, therefore he was intubated ..." Continued review revealed patient #7 also has a history of Anemia (condition that results due to low red blood cells), "diagnosed ,d+[DATE]. (Family member) refused any further workup ...Malnutrition with Albumin 3.3 (a protein found in the blood. Normal values 3.5-5.5) 07/2015 ..."
Review on 11/19/2015 revealed a "CT (computed tomography: an imaging procedure that uses special x-ray equipment to create detailed pictures, or scans, of areas inside the body) Head without Contrast" (solution used to highlight specific structures of the body) was performed on 11/12/2015 at 0913. Review revealed "Impression and Plan: 1. [DIAGNOSES REDACTED] related to medication noncompliance as evidence by subtherapeutic (below normal range) Dilantin level; 2. [DIAGNOSES REDACTED]/Mental Retardation; 3. [DIAGNOSES REDACTED] related to #1 ([DIAGNOSES REDACTED]); and 4. Acute Respiratory Failure related to #1." Review revealed "...mechanical ventilation (technique used to move oxygen to and from the lungs) protocol, EEG (electroencephalogram: test that traces electrical activity of the brain), neurology consult (provider specialized in disorders of the nerves and nervous system) ...NPO (nothing by mouth) until extubated" as the plan for continued treatment and stabilization.
Review on 11/18/2015 of patient #7 nursing assessments revealed no nursing assessment on 11/15/2015 during 1900-0700 hours. Review revealed no evidence of a full neurological assessment on 11/16/2015 at 1918. Review of progress note written by RN (registered nurse) #1 (work schedule 0700-1900) dated and timed 11/17/2015 at 0800 revealed a nursing assessment documented with abnormalities indicated. Review revealed identified abnormal findings includes "No response ...Lethargic (slow or sluggish) ...Spastic, Stiff gait (manner of walking) ...Glasgow Coma Score (system used to describe the level of consciousness) of 5 (scale scored between 3 and 15, with 3 being the worst, and 15 the best) ....Behavior: Clam, Despondent (loss of hope), Does not follow commands, Fatigued ..." Continued review of progress notes written by RN #1 revealed a note entry at 0830 stating "Family/Visitors present ... Other: pt (patient) (Family member) in rm (room) with pt states pt having sz (seizure), unwitnessed by staff will cont (continue) to monitor." Continued review revealed a note by RN #1 at 1300 stating "Family/Visitors present, IV Site Check, infusing without complication, IV site, no complications, Patient in bed, Reassessment, no change" Review revealed another note by RN #1 at 1500 with the same verbiage as that entered at 1300. Review revealed the last progress note by RN #1 at 1600 states "Family/Visitors present, IV Site Check, infusing without complication, IV site, no complications. Other: pt (Family member) states pt had another sz, will cont to monitor activity not witness [sic] ..." Continued review of nursing progress notes revealed no further RN assessment documentation until 11/17/2015 at 1953 by RN #2 (work schedule 1900-0700). Review revealed no evidence of documented physician notification following the family's reported seizure activity at 0830 or again at 1600. Review revealed no evidence of other neurological assessments following the one completed at 0800 until 1953 by RN #2.
Review on 11/19/2105 of the progress note by MD #2 dated and timed 11/17/2015 at 1121 revealed "Patient Summary ...11/13/2015: Patient continues to be intubated to be weaned as tolerated ... Dilantin and valporic acid levels are therapeutic (within normal limits) ... EEG (electroencephalogram: test used to trace electrial activity of the brain) showed diffuse epileptiform activity (symptoms of [DIAGNOSES REDACTED]" Review revealed patient #7 was extubated (removal of a breathing tube) on 11/14/2015. Continued review revealed "Subjective: Seen and examined by the bedside with his mom in the room. His mom reports questionable seizure-like activities this morning with staring and rolling his eyes backwards ..." Review revealed a Dilantin level of 3.0 on 11/17/2015 and Magnesium (used for immediate control of life-threatening sudden, violent irregular movement of a limb of the body caused by muscle contractions related to seizures) level of 1.4 mg/dl (Normal level 1.7-2.6 mg/dl). Review revealed patient #7 "Impression and Plan/Dx (diagnosis [identification of an illness) and Plan: 1. [DIAGNOSES REDACTED] resolving cont [sic] with antiepileptic meds; ... 6. Hypokalemia (low potassium), [DIAGNOSES REDACTED] (low magnesium) ... " Review revealed "Active Inpatient Medications: Depakote Sprinkles (used to treat seizures that requires maintenance of consistent therapeutic drug levels) 375 mg by mouth every 8 hours (standard administration times for every 8 hours are listed as 0600, 1400, and 2200 in the hospitals "Medication Administration Record: Standard Administration Times" policy referenced above.
Review on 11/18/2015 of the hospital's "Patient Care Leadership" meeting minutes dated May 26, 2015 revealed four (4) identified trends (patterns) in nursing documentation. Review revealed RN #3 presented the "topic" identified as "Nursing Professional Review Report" identifying the following documentation concerns: "1. Lack of event charting (risk, real or potential, identification) with Rapid Response team (RRT) calls (a team of health care providers that responds to hospitalized patients with early signs of clinical deterioration to prevent respiratory or cardiac arrest); 2. Lack of event charting with change in condition requiring MD notification; 3. Lack of review (of data entry in the EMR) to assure CNA (certified nursing assistant) vital sign documentation; 4. Lack of understanding regarding flow over of bedside monitor vital signs. When signing off, it indicates nurse agrees they are accurate. 4. Lack of documentation at beginning of shift..." Review revealed the chief nursing officer (CNO) stated, "This is very concerning...as the CNO is ultimately responsible to ensure documentation is accurate and complete." Continued review revealed, "She (CNO) charged leaders to randomly audit charts daily to ensure documentation is as it should be...Documentation must tell the true story of what is going on with the patient. (CNO) said inaccurate documentation is a patient safety issue...Leaders must own this and ensure documentation improves." Further review revealed the "topic" identified as "(Regulatory Body) Survey Follow-up" stated, "As a follow-up to our survey, (CNO) stressed the importance of documentation. She stated documentation is proof of the care we provide the patient."
Interview on 11/19/2015 at 0950 with the CNO revealed, "I'm very disappointed in what you are seeing...The documentation is sloppy...I think there's a lot of verbal communication but we struggle getting information in the chart." Interview revealed, "A nursing assessment have been completed and documented after the family reported seizure activity. It is a nursing responsibility to conduct an assessment" following a suspected or actual change in the any patient's condition. We are struggling with documentation." Interview revealed, "I'm disappointed. I've never experienced this during a survey. We have to show evidence of care and remind nurses that documentation is basic. Not because we say that's what we do but because it's the right thing to do. This is not my expectation." Interview revealed the hospital nursing staff did not follow hospital policy and failed to document an assessment following reported seizure activity and notification of a physician.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on administrative staff interviews, policy manual review, Care Event report documentation and patient interviews, the hospital's governing body failed to assure oversight and direction by failing to provide a safe environment as evidenced by failure to ensure nursing staff evaluated and supervised the care of patients (#1 and #9), ensure medications requiring a therapeutic level were administered per the physician's order (#7) and failure to ensure expired or discontinued medication were not available for patient use (#5).

Findings include:

The hospital's leadership staff failed to provide a safe environment as evidenced by failure: of nursing staff to evaluate and supervise patient care services; ensure medications requiring a therapeutic level were administered per physician's order and ensure expired or discontinued medications were not available for patient use.

~ Cross Reference 482.23(b)(3) Nursing Services - A nurse must supervise and evaluate the nursing care for each patient.

~ Cross Reference 482.23(c) Nursing Services - Standard: Preparation and Administration of Drugs
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hosptial policy review, medical record review, Care Event reporting review and staff interviews, the hospital's nursing staff failed to ensure patients with a change in condition were evaluated and supervised for 3 of 3 patients with a change in condtion (#1, #9 and #7)
The findings include:
Review on 11/18/2015 of the hospital's "Seizure Precautions" policy reviewed/revised 5/2012 revealed, "I. Policy Patients with a seizure disorder will be managed according to procedure... D. Absence Seizures (characterized by blank stare and lack of awareness. May include rapid blinking and/or chewing)... 3. Notify MD (Medical Doctor) of seizure activity... V. Documentation...B. MD notified..."
Review on 11/19/2105 of the hospital's "Assessment of Patients" policy reviewed 04/2015 revealed, "I. Policy: ...Patients will receive care based on documented assessment of their needs/current state. Assessment data is used to determine and prioritize the patient's need...Data received from the patient, as well as the patient's family/significant others are included in the assessment... B. Reassessment... 2. Nursing... d. Patient's will be reassessed by a Registered Nurse...at least every 12 hours, with changes in patient condition and/or diagnosis... Nursing assessments/reassessments will be documented in the electronic medical record (EMR)..."
Policy reivew on 11/19/2015 revealed "Patient Transportation" reviewed/ revised January 2015. The policy stated, "This policy is designed to facilitate the safe and timely movement of patients throughout the facility. Patients will be transported for the purpose of admission, diagnostic test, medical procedure and discharge. . . If continuous telemetry monitoring os the patient is required, an RN and monitor must accompany the patient. II. Patient transports requiring Clinical Staff assistance: . . 2. Patients on continuous telemetry monitoring . . . 5. When clinical condition requires. . . "
1. Closed medical record review for Patient #1 revealed a hospital admssion on 03/25/2015 with diagnoses including Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Pulmonary Edema and Pneumonia with a history of Dementia and Diabetes. Review of Respiratory Therapy (RT) notes for 04/10/2015 revealed oxygen (O2) therapy was administered using medium flow nasal cannula while awake and BiPAP (Bilevel Positive Airway Pressure) while asleep. Review revealed at 1530 the patient received oxygen therapy at 10 liters per minute via nasal cannula with oxygen saturation levels of 88 - 96 % (normal range is greater than 90%), heart rate per minute 116 - 128 (normal range 60-80) and breaths per minute 27 - 31 (normal range 16-20). Oxygen therapy was increased to 15 liters per minute via nasal cannula at approximately 1810 with oxygen saturation level of 96 % and respiratory rate decreased to 25 breaths per minute. Continued review revealed BiPAP was initiated at 2100. Review of RT notes for 04/11/2015 at 1245 revealed the patient received oxygen therapy at 15 liters per minute via nasal cannula with a heart rate of 111 and breaths per minute of 19 breaths.
Review of nursing notes for 04/11/2015 revealed a nursing assessment at 1300 which indicated the patient left the floor for a Chest Angiography CT (imaging study to visualize arteries and veins) with "transport" with portable oxygen at 15 liters per minute via nasal cannula with oxygen saturation level of 99%. Continued review of nursing notes revealed the nurse called the CT imaging staff and notified family the patient was "still off unit" at 1400. Continued review revealed an entry for1517 which stated the patient expired at 1416. Continued review revealed the patient was receiving continous cardiac monitoring prior to being transported off the floor. Continued review revealed no nursing evaluation or supervision of care after 1300.
Review of three signed statements from Radiology Department staff dated 04/11/2015 revealed "Patient arrived in CT 1255. Injector started to malfunction between 1300 and 1330. . . Patient was taken off table. Patient was put in holding bay fully alert and conscious on 10 l of oxygen via nasal cannula. . . Pt. [patient] was then brought back in and onto table. Pt. was kept on oxygen at all times while in our dept [department] and sitting upright except while on scan table. . . 1401 scan started. Scouts taken. Scouts [CT pictures] were taken. After utilizing smart prep [contrast injected into patient's vein for better visualization] we noticed that the bolus was not optimal. We decided to give patient more contrast. . . went out to explain this to patient and noticed that patient was not responding. We then proceeded to pull patient out of the gantry [part of CT machine] to check on her. We then noticed that she was not breathing and had no pulse. . . proceeded to call a Code Blue [hospital wide intercom call for help]. Review of medical record revealed no documentation of evaluation or supervision of oxygen therapy by Radiology Department staff.
Interview on 11/17/2015 at 1400 with the Assistant Director of Radiology revealed there was no documentation in Radiology notes for oxygen therapy. The interview revealed oxygen therapy was administered at 10 liters per minute via nasal cannula, while the patient was in the x-ray department, instead of 15 liters per minute via nasal cannula as documented by nursing staff. The interview revealed Transport staff get patients from their rooms and transport them to the Radiology Department. The interview revealed a "Hall Pass" with patient information was provided to the Transport staff to handoff to Radiology staff. The interview revealed the "Hall Pass" is not part of the medical record.
Review of Care Event, identified as the hospital's system for incident reporting, for Patient #1 dated 04/11/2015 with time of event documented as 1245, revealed "Pt was taken down to ct [CT] on 15 liters oxygen nasal cannula, without the tele monitor [cardiac monitor] and a nurse. Pt coded [Code Blue] in ERCT [Emergency Department CT]. Pt was DNR [Do Not Resusitate]. Code called ER Dr. responded and pronounced death."
Interview on 11/18/2015 at 0950 with Nurse Manager #2 revealed Patient #1 had been on continous cardiac monitoring prior to transport to Radiology. The interview revealed the patient should have been transported with cardiac monitoring and assisted by a RN throughout transport and while in Radiology until the patient was returned to the patient's room per hospital policy.
2. Review of closed medical record for Patient #9 revealed a hospital admission on 07/25/2015 with diagnoses including Chronic Renal Failure, Hypertension and Colon Cancer. Patient #9 underwent abdominal surgery on 07/27/2015 for bowel resection. Review of nursing notes for 08/04/2015 revealed the patient experienced a change in condition on 08/04/2015 at approximately 0807 with a heart rate of 128 beats per minute (normal range 60-80) and an increase in breathing of 28 breaths per minute (normal range 16-20). The patient was transported to the radiology department, received a chest x-ray and was transported back to the patient room by radiology staff at approximately 0928. Nursing staff discovered the patient unresponsive and initiated a Code Blue (hospital intercom call for emergency help) at approximately 0930. The patient was pronounced expired 08/04/2015 at 0956. The record review revealed no documentation of evaluation and supervision of the patient's change in condition upon return to the patient's room.

Review of Care Event, identified as the hospital's system for incident reporting, for Patient #9 revealed the report was dated 08/05/2015. The report stated "Pt brought back from radiology by radiology staff at 0928 (change in pt's status wasn't communicated-0930 nurse found pt. unresposive, no pulse. Code Blue called at 0932...0956-pt pronounced dead by MD."

Interview on 11/19/2015 at 1600 with the Assistant Director of Radiology revealed Patient #9 was "not responding in x-ray. The x-ray staff did not do hand-off with nursing staff" on the floor. The interview revealed there was no documentation of when the patient became unresponsive. The interview revealed the x-ray staff that transported the patient back to the floor should have performed a hand-off report to nursing staff on the floor.

Interview on 11/19/2015 at 0945 with the Chief Nursing Officer revealed there was no documentation the radiology staff had reported a change in Patient #9's condition to the nursing staff. The interview revealed there was no documentation the patient was stable enough for transport to Radiology.The interview revealed there was no documentation the nursing staff evaluated Patient #9's condition upon return to the floor.





3. Review on 11/18/2015 of patient #7 "Admission History and Physical (H&P) performed by MD #1 on 11/12/2015 at 1305 revealed a [AGE] year old man with a "history of severe developmental delay secondary to CP ([DIAGNOSES REDACTED]: an inherited disorder that causes severe damage to the lungs), history of epileptic seizures (abnormal activity in the brain varying from uncontrolled jerking movement to subtle temporary loss of awareness) since the age of 6 months ... recently hospitalized at .... (Family member) told the doctor that the patient is dosed based on 'how he looked and acted' ... He (the doctor) changed his medications to ...Valporic Acid 1000mg (milligrams: unit of measurement) BID (twice daily) ... " Review revealed patient #7 had follow up appointments with two physicians in August; however the (Family member) cancelled the appointments. Review revealed patient #7 was seen by his primary care physician (PCP) on 10/12/2015 for a checkup and new coughing symptom. The patient's primary caregiver refused a recommended speech therapy evaluation following the physician's concerns of the patient #7's swallowing abilities. Review revealed patient #7's Phenytoin (also known as Dilantin: used to treat seizures) was changed from pill form to liquid due to concerns related to his swallowing ability. Review revealed patient #7 "Dilantin level was therapeutic (10-20 ug/ml: micrograms per milliliter - unit of measurement) at 15.2, today it is <2.5 ...transported to the ED (emergency department) this morning in [DIAGNOSES REDACTED] (a dangerous condition in which epileptic seizures follow one another without recovery of consciousness between them) ... (Family member) is a poor historian ... he 'had a few spells yesterday (11/16/2015) ... when she went in this morning around 7 AM he ws [sic] 'really getting to it'. He received 4mg IV (intravenous: indicates mode in which liquid medications or fluids are administered into the vein) Ativan (used to produce a calming effect) and 5mg IV Versed (used to produce a calming effect on the brain and nervous system) by EMS (Emergency Medical Services) and had episodes of his O2 (oxygen) saturation (level of O2 available for the brain's use: normal 95-100) dropping into the 60's briefly ...Upon arrivalot [sic] ... it wsa [sic] felt he could not protect his airway, therefore he was intubated ..." Continued review revealed patient #7 also has a history of Anemia (condition that results due to low red blood cells), "diagnosed ,d+[DATE]. (Family member) refused any further workup ... Malnutrition with Albumin 3.3 (a protein found in the blood. Normal values 3.5-5.5) 07/2015 ..."
Review on 11/19/2015 revealed a "CT (computed tomography: an imaging procedure that uses special x-ray equipment to create detailed pictures, or scans, of areas inside the body) Head without Contrast" (solution used to highlight specific structures of the body) was performed on 11/12/2015 at 0913. Review revealed "Impression and Plan: 1. [DIAGNOSES REDACTED] related to medication noncompliance as evidence by subtherapeutic (below normal range) Dilantin level; 2. [DIAGNOSES REDACTED]/Mental Retardation; 3. [DIAGNOSES REDACTED] related to #1 ([DIAGNOSES REDACTED]); and 4. Acute Respiratory Failure related to #1." Review revealed "...mechanical ventilation (technique used to move oxygen to and from the lungs) protocol, EEG (electroencephalogram: test that traces electrical activity of the brain), neurology consult (provider specialized in disorders of the nerves and nervous system) ...NPO (nothing by mouth) until extubated" as the plan for continued treatment and stabilization.
Review on 11/18/2015 of patient #7 nursing assessments revealed no nursing assessment on 11/15/2015 during 1900-0700 hours. Review revealed no evidence of a full neurological assessment on 11/16/2015 at 1918. Review of progress note written by RN (registered nurse) #1 (work schedule 0700-1900) dated and timed 11/17/2015 at 0800 revealed a nursing assessment documented with abnormalities indicated. Review revealed identified abnormal findings includes "No response ...Lethargic (slow or sluggish) ...Spastic, Stiff gait (manner of walking) ...Glasgow Coma Score (system used to describe the level of consciousness) of 5 (scale scored between 3 and 15, with 3 being the worst, and 15 the best) ....Behavior: Clam, Despondent (loss of hope), Does not follow commands, Fatigued ..." Continued review of progress notes written by RN #1 revealed a note entry at 0830 stating "Family/Visitors present ... Other: pt (patient) (Family member) in rm (room) with pt states pt having sz (seizure), unwitnessed by staff will cont (continue) to monitor." Continued review revealed a note by RN #1 at 1300 stating "Family/Visitors present, IV Site Check, infusing without complication, IV site, no complications, Patient in bed, Reassessment, no change" Review revealed another note by RN #1 at 1500 with the same verbiage as that entered at 1300. Review revealed the last progress note by RN #1 at 1600 states "Family/Visitors present, IV Site Check, infusing without complication, IV site, no complications. Other: pt (Family member) states pt had another sz, will cont to monitor activity not witness [sic] ..." Continued review of nursing progress notes revealed no further RN assessment documentation until 11/17/2015 at 1953 by RN #2 (work schedule 1900-0700). Review revealed no evidence of documented physician notification following the family's reported seizure activity at 0830 or again at 1600. Review revealed no evidence of other neurological assessments following the one completed at 0800 until 1953 by RN #2.
Review on 11/19/2105 of the progress note by MD #2 dated and timed 11/17/2015 at 1121 revealed "Patient Summary ...11/13/2015: Patient continues to be intubated to be weaned as tolerated ... Dilantin and valporic acid levels are therapeutic (within normal limits) ... EEG (electroencephalogram: test used to trace electrical activity of the brain) showed diffuse epileptiform activity (symptoms of [DIAGNOSES REDACTED]" Review revealed patient #7 was extubated (removal of a breathing tube) on 11/14/2015. Continued review revealed "Subjective: Seen and examined by the bedside with his mom in the room. His mom reports questionable seizure-like activities this morning with staring and rolling his eyes backwards ..." Review revealed a Dilantin level of 3.0 on 11/17/2015 and Magnesium (used for immediate control of life-threatening sudden, violent irregular movement of a limb of the body caused by muscle contractions related to seizures) level of 1.4 mg/dl (Normal level 1.7-2.6 mg/dl). Review revealed patient #7 "Impression and Plan/Dx (diagnosis [identification of an illness) and Plan: 1. [DIAGNOSES REDACTED] resolving cont [sic] with antiepileptic meds; ... 6. Hypokalemia (low potassium), [DIAGNOSES REDACTED] (low magnesium) ... " Review revealed "Active Inpatient Medications: Depakote Sprinkles (used to treat seizures that requires maintenance of consistent therapeutic drug levels) 375 mg by mouth every 8 hours (standard administration times for every 8 hours are listed as 0600, 1400, and 2200 in the hospitals "Medication Administration Record: Standard Administration Times" policy referenced above.
Review on 11/18/2015 of the hospital's "Patient Care Leadership" meeting minutes dated May 26, 2015 revealed four (4) identified trends (patterns) in nursing documentation. Review revealed RN #3 presented the "topic" identified as "Nursing Professional Review Report" identifying the following documentation concerns: "1. Lack of event charting (risk, real or potential, identification) with Rapid Response team (RRT) calls (a team of health care providers that responds to hospitalized patients with early signs of clinical deterioration to prevent respiratory or cardiac arrest); 2. Lack of event charting with change in condition requiring MD notification; 3. Lack of review (of data entry in the EMR) to assure CNA (certified nursing assistant) vital sign documentation; 4. Lack of understanding regarding flow over of bedside monitor vital signs. When signing off, it indicates nurse agrees they are accurate. 4. Lack of documentation at beginning of shift..." Review revealed the chief nursing officer (CNO) stated, "This is very concerning...as the CNO is ultimately responsible to ensure documentation is accurate and complete." Continued review revealed, "She (CNO) charged leaders to randomly audit charts daily to ensure documentation is as it should be...Documentation must tell the true story of what is going on with the patient. (CNO) said inaccurate documentation is a patient safety issue...Leaders must own this and ensure documentation improves." Further review revealed the "topic" identified as "(Regulatory Body) Survey Follow-up" stated, "As a follow-up to our survey, (CNO) stressed the importance of documentation. She stated documentation is proof of the care we provide the patient."
Interview on 11/19/2015 at 0950 with the CNO revealed, "I'm very disappointed in what you are seeing...The documentation is sloppy...I think there's a lot of verbal communication but we struggle getting information in the chart." Interview revealed, "A nursing assessment have been completed and documented after the family reported seizure activity. It is a nursing responsibility to conduct an assessment" following a suspected or actual change in the any patient's condition. We are struggling with documentation." Interview revealed, "I'm disappointed. I've never experienced this during a survey. We have to show evidence of care and remind nurses that documentation is basic. Not because we say that's what we do but because it's the right thing to do. This is not my expectation." Interview revealed the hospital nursing staff did not follow hospital policy and failed to document an assessment following reported seizure activity and notification of a physician.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of the hospital's policy and procedures, Quality Assurance Performance Improvement (QAPI) data, medical records, observation, and interviews, the hospital failed to ensure medications were administered per the physician's order for 8 of 11 patients sampled (#3, 4, 5, 6, 7, 8, 11 and 1).
The findings include:
Review on 11/17/2015 of the hospital's "Medication Administration Record: Standard Administration Times" policy last reviewed/revised 06/2015 revealed, "I. Policy: All medications administered to patients shall be administered according to established procedures. Standard administration times shall be utilized as approved by the medical staff. II. Summary: This policy establishes standard administration times of medications for patients. III. Intervention: A. Standard Administration Times: Daily qam 0900...; Q12H 0900, 2100; Q12H A (alternate)1200, 2400; Q8H 0600, 1400, 2200; Q6H 0600, 1200, 1800, 2400; ... Q2H ...0800, 1000, 1200; ... B. All doses should be given as soon as the first dose arrives a subsequent doses are given on the standard schedule. If the first dose is given more than halfway through the original dose interval, it counts as the next dose due. If the first dose is less than halfway through the original dose interval, both the first dose and next scheduled doses are administered (Daily medications will be the only exception and may be given until 2100; after 2100, the medication should not be given until 0900 the next day... C. Doses are considered on time if administered within 30 minutes before or 30 minutes after the scheduled times. If this one-hour window is not met, the nurse administering medication(s) must put a line through the time on the MAR and record the exact time of administration. D. Doses missed will be administered as soon as possible. If the make-up dose is given more than halfway through the original dose interval, the make-up dose counts as the next dose due. If the make-up dose is less than halfway through the original dose interval, both the make-up dose and the next scheduled dose will be administered..."
Review on 11/17/2015 of the hospital's "Medication Administration" policy reviewed/revised 07/2015 revealed, "I. Policy: Medication Administration will be performed in accordance with hospital policies and procedures. II. Summary: This policy provides guidelines for medication administration in a safe manner following established policies and procedures with the right ... time and documentation...IV. Medication Order... G. ... Time frame for administration of scheduled medications is within 30 minutes of scheduled administration time, either before or after scheduled dose..."
Review on 11/17/2015 of the hospital's "YTD (Year-to-Date) Summary Medication System Errors Category - 2015" revealed the following "Type of Error" being monitor and trended are prescribing error; omission error; wrong time error; unauthorized drug; improper dose; wrong dosage form; wrong drug preparation; wrong administration technique..." Review revealed a Severity Score listed on the data form indicating Category A types of medication errors are those that "The circumstance or event had the capacity to cause error; Category B - An error occurred, but the error did not reach the patient; Category C - An error occurred that reached the patient, but did not cause harm..." Review revealed the following "Wrong Time Error" data as January-No occurrences; February-1 occurrence; No occurrences identified in March and April; May-2 occurrences; No occurrences identified June or July; August 1-occurrence; September 1 occurrence; and October 2 occurrences. Review revealed "Near Misses" are not monitored or captured in the hospital's Medication Administration QAPI.
1. Review on 11/18/2015 of patient #3's History and Physical (H&P) performed by MD #6 revealed a [AGE] year-old (y.o.) female (MDS) dated [DATE] at 2335 (emergency department) "after being given 45 units (unit of measurement) of insulin (a hormone that regulates the amount of sugar in the blood) by accident instead of her usual dose of 18 units...EMS (Emergency Medical Services) reports her lowest blood glucose was 44 (normal range is 70-100 mg/dl [milligrams per deciliter]: unit of measurement)...Review revealed, "She was incidentally found to have a Hgb (hemoglobin: chemical in red blood cells that transports oxygenated blood and carbon dioxide to and from the lungs) of 6.3 (normal range for women is 12.0-15.5 grams per deciliter: unit of measurement) in the ED. Continued review revealed a potassium (a chemical [electrolyte] that is critical to the proper functioning of nerve and muscles cells, particularly heart muscle cells: normal range 3.5-5.0 mEqL (milliequivalents per liter: unit of measurement) level of 3.0 on 11/16/2015 and 3.1 on 11/17/2015. Continued review revealed the "Plan" for treatment was "Seizure precautions; Aspiration (choking) precautions...KCL 40 mEq po (by mouth)...transfuse 2 units of blood for symptomatic (current symptoms) anemia (low red blood cells)..."
Review of patient #3's Medication Administration Record (MAR) revealed an order by MD #7 on 11/17/2015 at 0400 for Potassium Chloride 40 mEq by mouth once, routine. Review revealed the ordered dose was administered at 0556 (1 hour, 56 minutes after order entry). Continue review revealed an order by MD #7 on 11/17/2015 at 1400 for Potassium Chloride 40 mEq by mouth, once routine. Review revealed the ordered dose was administered at 1721 (3 hours, 21 minutes after ordered dose). Review revealed "nursing judgement" was documented as the reason for the late medication administration by LPN (Licensed Practical Nurse) #1.
Interview on 11/18/2015 at 1340 with the hospital's CIC (Clinical Informatics Consultant) revealed the administration times "do not align with the policy." Interview revealed documentation of "nursing judgement" as the reason for late administration of medications is "too vague" and "open to interpretation". Interview revealed, "We plan to add more selections to the system to provide more information other than "nursing judgement." Interview revealed hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record and Medication Event Reporting policies or provide medications in a manner such that a therapeutic drug level would be maintained.
Interview on 11/19/2015 at 0920 with MD (Medical Doctor) #2 revealed "It would've been nice to know (inconsistent medication administration of a drug requiring a therapeutic level) and someone should have been notified." Interview revealed it is "rare that nurses report late administration of medication." Interview revealed medications requiring maintenance of a therapeutic drug level "should be administered as consistently as possible." Interview revealed medications requiring maintenance of a therapeutic drug level, including antibiotics, "Need to be administered on time. There may be a few minutes difference, but definitely within a 30 minute timeframe." Interview revealed there are concerns that physicians are not being notified of late administration of medications, specifically those requiring maintenance of a therapeutic drug level, and "definitely in this case." Interview revealed the hospital nursing staff did not follow the hospital's "Medication Administration" and Medication Administration Record: Standard Administration Times or provide medications in a manner to ensure that a therapeutic drug level would be maintained over the course of treatment."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed, "No, it is not acceptable but I wonder if we've created a culture for failure with medication administration times." Interview revealed, "We are working with Pharmacy to identify certain medications you have to be more precise with. There's a lot of work arounds that have become the process." Interview revealed, "I am extremely distressed by your findings. I thought we had it (medication administration) under control. We took our eye off the ball. I am already working on a Plan of Correction (POC) to make sure this doesn't slip through the cracks again." Interview revealed "nursing judgement" as reasons for variations in medication administration times is "too vague and what does it really mean." Interview revealed early and late medication administration is not part of the hospital's Quality Assurance Performance Improvement (QAPI) program. Interview revealed medications requiring maintenance of therapeutic drugs levels should not be administered late on a consistent basis, understanding there may be times late administration of same may not be avoidable. Interview revealed consistent administration of medications outside the specified timeframe this is "not acceptable practice." Interview revealed the hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record, or Medication Event Reporting policies.
2. Review on 11/18/2015 of patient #4's H&P revealed an 88 y.o. male was admitted following "2-3 weeks of gradually worsening hematuria (blood in the urine) noted in foley catheter bag." Review revealed the foley (tube used to drain urine)" was placed in March." Review revealed "He has had to have it changed multiple times due to clots (thick accumulation of blood) preventing urine flow. He has also had multiple bladder irrigations (process of flushing the bladder with liquid) done." Review revealed patient #4 was seen at a neighboring hospital ED 3 days prior to this admission where a bladder irrigation was done and he was given Ciprofloacin (used to fight bacteria) and Doxycyline for a urinary tract infection (UTI) and returned back to the nursing home where he resides. Review revealed a urine culture (test used to identify bacteria) was done while in the ED (emergency department) which was positive for the presence of enterobacter cloacae (type of bacteria). Review revealed patient #4 was scheduled for a TURP (Transurethral Resection of the Prostate: done to relieve severe urinary symptoms cause by an enlarged prostate) procedure on 11/16/2015. Review revealed that while in ED patient #4's "Creatinine (test to determine kidney function) 2.54 (normal levels are 0.7 - 1.2 mg/dl) and showed elevated RBC (red blood cell: transports oxygen to the lungs: normal range is 4.16 - 5.83 cells/uL (cells per microliter of blood) >3640; WBC (white blood cell: cells that fight infection: normal levels are 4,000-11,000 cells/uL) 1,482, moderate presence of Leukocyte Esterase (a urine test for the presence of white blood cells and other abnormalities associated with infection), many bacteria, trace ketones (substances made when the body breaks down fat for energy), and large Hgb (is a protein in red blood cells that carries oxygen throughout the body). Started on Meropenem 500 mg IV q8h due to recent urine cultures positive for MDR (multidrug resistant) organism." Review revealed patient #4 was admitted " for persistent (ongoing) severe UTI with MDR organism and acute symptomatic (current) blood loss anemia likely secondary to hematuria." Review revealed patient #4 received 2 unit of packed RBC's "for severe profound symptomatic anemia."
Review on 11/18/2015 of patient #4's physician orders written by MD #9 for Pipercillin-Tazobactam (antibiotic used to treat presence of multiple bacteria) 3.375 gm per 100 ml IVPB every 12 hours (0900 and 2100), Routine. Review on 11/18/2015 of the MAR revealed patient #4 received Pipercillin-Tazobactam 11/15/2015 at 1041 (1 hour, 11 minutes outside the 30 minute window for medication administration). Review revealed no evidence of a nursing note indicating why the dose was late or notification of the physician.
Review on 11/18/2015 of patient #4's physician's orders revealed an order by MD #8 11/14/2015 at 2100 for Ceftazidime-Avibactam (used to treat the presence complicated bacteria) 0.94 gm, 4.5 ml IVPB every 24 hours. Review revealed the medication was scheduled to be administered at 1400 daily. Review patient #4's MAR (Medication Administration Record) revealed he received Ceftazidime-Avibactam on 11/17/2015 at 1727 (exceeding the 30 minute window for medication administration by 2 hours, 57 minutes). Review revealed a nursing note by RN #10 indicating the reason for the variance as "nursing judgement." Continued review revealed patient #4 received Ceftazidime-Avibactam on 11/18/2015 at 1523 (exceeding the 30 minute medication administration window by 53 minutes). Review revealed a nursing note by RN #9 indicating the reason for the variance as "Patient Not Available/Off Unit." Further review revealed no evidence of documentation indicating the patient was off the unit or notification of the physician.
Interview on 11/19/2015 at 0920 with MD #2 revealed "It would've been nice to know (inconsistent medication administration of a drug requiring a therapeutic level) and someone should have been notified." Interview revealed it is "rare that nurses report late administration of medication." Interview revealed medications requiring maintenance of a therapeutic drug level "should be administered as consistently as possible." Interview revealed medications requiring maintenance of a therapeutic drug level, including antibiotics, "Need to be administered on time. There may be a few minutes difference, but definitely within a 30 minute timeframe." Interview revealed there are concerns that physicians are not being notified of late administration of medications, specifically those requiring maintenance of a therapeutic drug level, and "definitely in this case." Interview revealed the hospital nursing staff did not follow the hospital's "Medication Administration" and Medication Administration Record: Standard Administration Times or provide medications in a manner to ensure that a therapeutic drug level would be maintained over the course of treatment."
Interview on 11/18/2015 at 1340 with the hospital's CIC (Clinical Informatics Consultant) revealed, "No, that does not align with our policy (Medication Administration)." Interview revealed, "It looks like we are all over the place and need to work on this." Interview revealed the medications "should be given consistently." Interview revealed the hospital's nursing staff did not follow the hospital's Medication Administration Record and Medication Administration policies or provide medications in a manner such that a therapeutic drug level would be maintained.
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed, "No, it is not acceptable but I wonder if we've created a culture for failure with medication administration times." Interview revealed, "We are working with Pharmacy to identify certain medications you have to be more precise with. There's a lot of work arounds that have become the process." Interview revealed, "I am extremely distressed by your findings. I thought we had it (medication administration) under control. We took our eye off the ball. I am already working on a Plan of Correction (POC) to make sure this doesn't slip through the cracks again." Interview revealed "nursing judgement" as reasons for variations in medication administration times is "too vague and what does it really mean." Interview revealed early and late medication administration is not part of the hospital's Quality Assurance Performance Improvement (QAPI) program. Interview revealed medications requiring maintenance of therapeutic drugs levels should not be administered late on a consistent basis, understanding there may be times late administration of same may not be avoidable. Interview revealed consistent administration of medications outside the specified timeframe this is "not acceptable practice." Interview revealed the hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record, or Medication Event Reporting policies.
3. Review on 11/17/2015 of patient #5's H&P 10/28/2015 at 1638 revealed an 84 y.o. female was admitted for "UTI (Urinary Tract Infection); Hypovolemic Shock (an emergency condition in which severe blood and fluid loss make the heart unable to pump enough blood to the body); Adrenal Insufficiency (a condition in which the adrenal glands do not produce adequate amounts of steroid hormones); and Anemia."
Review on 11/18/2105 of physician orders for patient #5 revealed an order on 11/15/2015 at 1552 by MD #3 for Meropenem (used to treat bacteria) 500mg IVPB once and then every 6 hours (0600, 1200, 1800, 2400) to start at 1930. Review of the MAR revealed patient #5 received the one time dose at 1719. Review revealed subsequent doses at 11/15/2015 at 1930 (1 hour, 11 minutes between doses); 11/15/2015 at 2023 (49 minutes between doses); 11/15/2015 at 2342 (3 hours, 7 minutes between doses); 11/16/2015 at 0507 (exceeds 30 minute medication window by 3 hours, 7 minutes). Review revealed "nursing judgement" was documented for each late or early medication administration. Review of the CER log revealed no evidence of a Care Event for early or late administration of Meropenem on the corresponding dates.
Interview on 11/19/2015 at 0920 with MD #2 revealed "It would've been nice to know (inconsistent medication administration of a drug requiring a therapeutic level) and someone should have been notified." Interview revealed it is "rare that nurses report late administration of medication." Interview revealed medications requiring maintenance of a therapeutic drug level "should be administered as consistently as possible." Interview revealed medications requiring maintenance of a therapeutic drug level, including antibiotics, "Need to be administered on time. There may be a few minutes difference, but definitely within a 30 minute timeframe." Interview revealed there are concerns that physicians are not being notified of late administration of medications, specifically those requiring maintenance of a therapeutic drug level, and "definitely in this case." Interview revealed the hospital nursing staff did not follow the hospital's "Medication Administration" and Medication Administration Record: Standard Administration Times or provide medications in a manner to ensure that a therapeutic drug level would be maintained over the course of treatment."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed, "No, it is not acceptable but I wonder if we've created a culture for failure with medication administration times." Interview revealed, "We are working with Pharmacy to identify certain medications you have to be more precise with. There's a lot of work arounds that have become the process." Interview revealed, "I am extremely distressed by your findings. I thought we had it (medication administration) under control. We took our eye off the ball. I am already working on a Plan of Correction (POC) to make sure this doesn't slip through the cracks again." Interview revealed "nursing judgement" as reasons for variations in medication administration times is "too vague and what does it really mean." Interview revealed early and late medication administration is not part of the hospital's Quality Assurance Performance Improvement (QAPI) program. Interview revealed medications requiring maintenance of therapeutic drugs levels should not be administered late on a consistent basis, understanding there may be times late administration of same may not be avoidable. Interview revealed consistent administration of medications outside the specified timeframe this is "not acceptable practice." Interview revealed the hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record, or Medication Event Reporting policies.
4. Review on 11/17/2015 at 1030 of patient #6's H&P completed by MD #10 11/13/2015 at 2234 was admitted to the hospital's observation unit 11/13/2015 at 1245 with a diagnosis of [DIAGNOSES REDACTED].
Review on 11/17/2015 of patient #6's physician orders revealed an order written by MD #10 on 11/13/2015 at 0102 for Aztreonam (used to treat bacterial infection) 1 gm (gram: unit of measurement) per 50 ml (millimeters: unit of measurement) NS every 8 hours (0600, 1200, 1800, 2400). Review of patient #6's MAR revealed she received Aztreonam 1 gm on 11/13/2015 at 1441 (exceeded the 30 minute medication administration window by 2 hours, 11 minutes) with "nursing judgement" documented as the reason for late administration. Review revealed the next dose was administered at 2023 (6 hours after last dose) and the last dose was administered 11/14/2015 at 0644 (10 hours, 21 minutes after last dose) with no evidence of nursing documentation addressing late medication administration.
Review on 11/17/2015 of patient #6's physician orders revealed an order by NP #1 on 11/13/2015 at 1657 for Benzonatate (used to relieve a cough) 100mg three time per day (0900, 1300, 1700). Review reveal patient #6 received Benzonatate 100 mg on 11/14/2015 at 0644 (exceeding the 30 minute widow for medication administration by 1 hour, 46 minutes with "nursing judgement" documented as the reason for early administration). Review revealed another was administered 11/14/2015 at 2224 (exceeding the 30 minute medication administration window by 4 hours, 54 minutes with "nursing judgement" documented as the reason for late administration). Continued review revealed no dose was administered 11/15/2015 at 0600 with "Not Done: Not Appropriate at this Time" documented as the reason for omission of the scheduled dose with no evidence of why the scheduled dose was "Not Appropriate". Further review revealed the last dose was administered 11/15/2015 at 2223 (exceeding the 30 minute medication administration window by 4 hours, 53 minutes with "nursing judgement" documented as the reason for late administration).
Interview on 11/19/2015 at 0920 with MD #2 revealed "It would've been nice to know (inconsistent medication administration of a drug requiring a therapeutic level) and someone should have been notified." Interview revealed it is "rare that nurses report late administration of medication." Interview revealed medications requiring maintenance of a therapeutic drug level "should be administered as consistently as possible." Interview revealed medications requiring maintenance of a therapeutic drug level, including antibiotics, "Need to be administered on time. There may be a few minutes difference, but definitely within a 30 minute timeframe." Interview revealed there are concerns that physicians are not being notified of late administration of medications, specifically those requiring maintenance of a therapeutic drug level, and "definitely in this case." Interview revealed the hospital nursing staff did not follow the hospital's "Medication Administration" and Medication Administration Record: Standard Administration Times or provide medications in a manner to ensure that a therapeutic drug level would be maintained over the course of treatment."
Interview on 11/19/2015 at 0950 with the CNO (Chief Nursing Officer) revealed, "No, it is not acceptable but I wonder if we've created a culture for failure with medication administration times." Interview revealed, "We are working with Pharmacy to identify certain medications you have to be more precise with. There's a lot of work arounds that have become the process." Interview revealed, "I am extremely distressed by your findings. I thought we had it (medication administration) under control. We took our eye off the ball. I am already working on a Plan of Correction (POC) to make sure this doesn't slip through the cracks again." Interview revealed "nursing judgement" as reasons for variations in medication administration times is "too vague and what does it really mean." Interview revealed early and late medication administration is not part of the hospital's Quality Assurance Performance Improvement (QAPI) program. Interview revealed medications requiring maintenance of therapeutic drugs levels should not be administered late on a consistent basis, understanding there may be times late administration of same may not be avoidable. Interview revealed consistent administration of medications outside the specified timeframe this is "not acceptable practice." Interview revealed the hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record, or Medication Event Reporting policies.
5. Review on 11/18/2015 of patient #7's History and Physical (H&P) performed by MD #1 on 11/12/2015 at 1305 revealed a [AGE] year-old y.o. male presented to the hospital's ED with a "history of severe developmental delay secondary to CP ([DIAGNOSES REDACTED]: an inherited disorder that causes severe damage to the lungs), history of epileptic seizures (abnormal activity in the brain varying from uncontrolled jerking movement to subtle temporary loss of awareness) since the age of 6 months ...primary caregiver is his sister since 1989 ...recently hospitalized at ....She told the doctor that she dosed him (the patient) based on 'how he looked and acted'...He (the doctor) changed his medications to ...Valporic Acid 1000mg (milligrams: unit of measurement) BID (twice daily) ... "Review revealed patient #7 had follow up appointments with two physicians in August; however the sister cancelled the appointments. Review revealed patient #7 was seen by his primary care physician (PCP) on 10/12/2015 for a checkup and new coughing symptom. The patient's primary caregiver refused a recommended speech therapy evaluation following the physician's concerns of the patient #7 swallowing abilities. Review revealed patient #7 Phenytoin (also known as Dilantin: used to treat seizures) was changed from pill form to liquid due to concerns related to his swallowing ability. Review revealed patient #7 "Dilantin level was therapeutic (10-20 ug/ml: micrograms per milliliter - unit of measurement) at 15.2, today it is < 2.5 ...transported to the ED (emergency department) this morning in [DIAGNOSES REDACTED] (a dangerous condition in which epileptic seizures follow one another without recovery of consciousness between them) ...Sister is a poor historian ...he 'had a few spells yesterday" (11/16/2015) ...when she went in this morning around 7 AM he was [sic] 'really getting to it'. He received 4mg IV (intravenous: indicates mode in which liquid medications or fluids are administered into the vein) Ativan (used to produce a calming effect) and 5mg IV Versed (used to produce a calming effect on the brain and nervous system) by EMS and had episodes of his O2 (oxygen) saturation (level of O2 available for the brain ' s use: normal 95-100) dropping into the 60's briefly ...Upon arrivalot [sic] ... it wsa [sic] felt he could not protect his airway, therefore he was intubated ... " Continued review revealed patient #7 also has a history of Anemia (condition that results due to low red blood cells), "diagnosed ,d+[DATE]. Sister refused any further workup ... Malnutrition with Albumin 3.3 (a protein found in the blood. Normal values 3.5-5.5) 07/2015 ..."
Review on 11/19/2015 revealed a "CT (computed tomography: an imaging procedure that uses special x-ray equipment to create detailed pictures, or scans, of areas inside the body) Head without Contrast" (solution used to highlight specific structures of the body) was performed on 11/12/2015 at 0913. Review revealed "Impression and Plan: 1. [DIAGNOSES REDACTED] related to medication noncompliance as evidence by subtherapeutic (below normal range) Dilantin level; 2. [DIAGNOSES REDACTED]/Mental Retardation; 3. [DIAGNOSES REDACTED] related to #1 ([DIAGNOSES REDACTED]); and 4. Acute Respiratory Failure related to #1." Review revealed "...mechanical ventilation (technique used to move oxygen to and from the lungs) protocol, EEG (electroencephalogram: test that traces electrical activity of the brain), neurology consult (provider specialized in disorders of the nerves and nervous system) ... NPO (nothing by mouth) until extubated" as the plan for continued treatment and stabilization.
Review on 11/18/2105 of physician orders for patient #7 revealed an order on 11/16/2015 at 1926 for Divalproex Sodium (Depakote Sprinkles) 375 mg by mouth every 8 hours (0600, 1200, 1800, 2000) for 14 days. Continued review revealed an order written 11/17/2015 at 1130 for Magnesium Sulfate 2 gm (grams: unit of measurement) per 50 ml IV piggy back (IVPB) Once, Routine 11/17/2015 1130, "Stop date 11/17/2105 1130."
Review of the Medication Administration Record (MAR) for patient #7 revealed Depakote Sprinkles 375 mg doses exceeded the 30 minute medication administration window as follows: 11/16/2015 at 2120 (exceeded by 50 minutes) by RN #4; 11/17/2015 at 1448 (exceeded 18 minutes) by RN #1; 11/17/2015 at 2143 (exceeded by 1 hour, 18 minutes) by RN #2; 11/18/2015 at 0519 (exceeded by 19 minutes) by RN #6; 11/18/2015 at 1538 (exceeded 1 hour, 8 minutes) by RN #7 (6 of 7 possible doses exceeded 30 minute timeframe) Review revealed "nursing judgement" was documented for each late or early medication administration. Further review of the MAR revealed an order by MD #1 on 11/17/2015 at 1130 for Magnesium Sulfate 1 gm with Dextrose (fluids containing sugars: used to add sugar to the body depleted by poor intake) IVPB (IV piggy back: hung with a primary solution) once, routine. Review revealed the ordered dose of Magnesium Sulfate was administered at 1406 (2 hours, 36 minutes post physician orders) with a note stating "medication not available" by RN #1 as the reason for late administration of the medication). Review revealed no evidence of physician notification of early or late medication administration. Review of the "Care Event Report (CER)" log revealed no evidence of a Care Event for missed, early, or late administration of Depakote Sprinkles over the course of 3 days or the Magnesium Sulfate.
Observation during the tour on 11/17/2015 at 1400 on unit A revealed RN #1 documenting in the electronic medical record (EMR) in the medication room. Observation of patient #7's individual medication drawer revealed a Magnesium Sulfate 1 gm with Dextrose IVPB. Observation revealed the label on the IVPB read, "Hang at 1130." Observation revealed the pharmacy received the order at 1123.
Interview on 11/17/2015 at 1400 with RN#1 revealed" I wasn't aware it had been brought up." Interview revealed, "(Patient #7) has been having seizures today and I've been working with him throughout the day." Interview revealed, "Sometimes you just have to juggle things and you do the best you can. Can I have it and I'll go administer it now."
Interview on 11/17/ at 1400 with the Nurse Manager revealed, "We are piloting a new process that involves pharmacy delivery directly to the unit." Review revealed, "The unit still uses the dumb-waiter (a small elevator designated to carrying medications between the floors of the hospital) when medications are ordered and need to be administered before pharmacy rounds." Interview revealed, "It is possible the medication came up and someone pulled it (out of the dumb waiter) without notifying the assigned nurse." Interview revealed it is not a "routine practice and the nurse should have been notified. Interview revealed the hospital nursing staff did not follow the hospital's Medication Administration, Medication Administration Record, or Medication Event Reporting policies.
Interview on 11/18/2015 at 1340 with the hospital's CIC revealed, "I don't know what the policy says but every 8 hours for medication administration are 0600, 1400, 2000 for nursing." Interview revealed, "That policy (Medication Administration Record) is confusing and I'm not surprised the staff get confused. The halfway dosing confuses me and I was part of the committee that work on the policy." Interview revealed, "The only reason I understand it is because I was part of the development of the policy." Interview revealed the hospital's nursing staff did not follow the hospital's Medication Administration Record and Medication Administration policies or provide medications in a manner such that a therapeutic drug level would be maintained.
Interview on 11/19/2015 at 0920 with MD #2 revealed that he ordered Magnesium Sulfate 2 gm IVPB 11/17/2015 at 1130 following the family's report of seizure activity, "
VIOLATION: GOVERNING BODY Tag No: A0043
Based on administrative staff interviews, policy manual review, Care Event report documentation and patient interviews, the hospital's governing body failed to assure oversight and direction by failing to provide a safe environment as evidenced by failure to ensure nursing staff evaluated and supervised the care of patients (#1 and #9), ensure medications requiring a therapeutic level were administered per the physician's order (#7) and failure to ensure expired or discontinued medication were not available for patient use (#5)

Findings include:

The governing body failed to provide a safe environment as evidenced by failure: of nursing staff to evaluate and supervise patient care services; ensure medications requiring a therapeutic level were administered per physician's order and ensure expired or discontinued medications were not available for patient use.

~ Cross Reference 482.13(c)(2) Patients Rights - The patient has the right to receive care in a safe setting.

~ Cross Reference 482.23(b)(3) Nursing Services - A nurse must supervise and evaluate the nursing care for each patient.

~ Cross Reference 482.25 Pharmaceutical Services - The hospital must have pharmaceutical services that meet the needs of the patients.