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.

HARRIS REGIONAL HOSPITAL 68 HOSPITAL RD SYLVA, NC 28779 July 28, 2016
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy and procedure review, medical record review, observation, and staff interviews, the hospital failed to ensure informed consent was obtained for the administration of blood for 1 of 2 (Patient #6) blood administration records sampled.

The findings include:

Review on 07/27/2016 of the hospital's policy titled, "Consent for Treatment" revised 11/2015 revealed, "PURPOSE: It is the responsibility of every health care provider to protect the patient's right to know... The documentation of this right is accomplished through the written consent...POLICY: An informed consent is required for all procedures that involve a substantial risk to the patient...PROCEDURE FOR OBTAINING INFORMED CONSENT: ...it must be obtained by the physician or responsible practitioner who will actually provide treatment. -The physician/practitioner is responsible for providing the patient with sufficient information concerning proposed treatment including both its benefits and risks, ... The consent form...will include: ...Signature, date and time of the practitioner obtaining consent.

Review of the hospital's policy titled, "Blood Component Therapy" revised 04/2013 revealed, "...Procedure: 1. Prior to Transfusion: ... D. The Transfusion Consent form must be signed prior to the transfusion..."

1. Medical record review on 07/27/2016 for Patient #6 revealed a [AGE] year-old male was admitted on [DATE] at 1339 with complaints of weakness, black and tarry stools, "appears more pale than usual" per his wife. Review revealed a diagnosis of [DIAGNOSES REDACTED].2 (Reference Range: 13.0 - 17.4) and stool was positive for blood. Review revealed MD #5 ordered two (2) units of packed red blood cells (PRBC) on 07/15/2016 at 1859 and the first unit of blood was initiated at 2300 by RN #8. Review revealed a "Consent for Operation, Treatment, or Procedure" with a check box marked stating, "I understand that I have been ordered a transfusion of BLOOD OR BLOOD PRODUCTS. My practitioner has described the risks, benefits, and alternatives to this therapy." Review revealed the form was signed by the patient and RN #8 but the "Practitioner Signature" line was blank. Review revealed the consent was not "completed in its entirety", including the "Signature, date, and time of the practitioner obtaining consent" per policy.

Interview on 07/27/2016 at 1330 with Quality Manager #1 revealed consents for any type of procedure, including blood administration, should be obtained by the prescribing practitioner. Interview revealed consents are typically signed by the practitioner following explanation of the risk and benefits associated with the indicated procedure. Interview revealed nursing staff are expected to review the consent to ensure it has been completed in its totality prior to administering blood or any other type of therapy requiring a practitioner signature. Interview revealed the blood product should not have been infused until after the consent was signed by the ordering practitioner. Interview revealed the consent for treatment was not completed per policy.
VIOLATION: PATIENT RIGHTS: PRIVACY AND SAFETY Tag No: A0142
Based on review of hospital policy and procedure, observation, and staff interviews, the hospital failed to ensure patient information privacy was protected for 6 of 6 computers (#1, #2, #3, #4, #5, and #6).

The findings include:

Review on 07/27/2016 of the hospital's policy titled, "HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Sanctions" revised 11/2015 revealed, "PURPOSE: (Hospital name) and (County name) Community have a duty to reasonably safeguard protected health information (PHI) from intentional and unintentional misuses...

Observation on 07/26/2016 at 1215 during the tour of Unit A revealed six (6) computers centrally located in the nursing station. Observation revealed the computers were set up back to back so that three (3) employees were able to access them on one side of the table and three (3) on the other, simultaneously. Observation revealed the three (3) staff members were working on the computers facing the front of the nursing station (#1, #2 and #3) and each staff member had patient information pulled up that was easily visible to anyone who walked up to the nursing station. Observation revealed a doorway that led into the nursing station from the right hall that also allowed direct visualization of patient information on computers #4, #5, and #6. Continued observation revealed no privacy screens were present on any of the computers. Observation revealed family members, visitors, and other patients walking past the computers and down the hallway.

Interview on 07/26/2016 at 1215 with Quality Manager #1 revealed the computers located at the nursing station were used by the multidisciplinary team when accessing patient information. Interview revealed information on computer was protected information and that privacy screens should be used. Interview revealed privacy screens were not available and that patient information was not protected.

Interview on 07/26/2016 at 1220 with Nurse Manager #2 revealed at one time, privacy screens were used on the computers to ensure the protection of patient information. Interview revealed staff had removed the privacy screens over time and that they had not been replaced. Interview revealed privacy screens should be on the computers for protection of patient information.

Interview on 07/28/2016 at 1545 with the Chief Nursing Officer (CNO) revealed privacy screens were purchased for use when the computers on Unit A were set up but "must have been taken off." Interview revealed patient information should not be readily visible to the general public or to those not involved in the provision of care for the patient. Interview revealed failure to protect patient information is not acceptable practice.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on review of hospital policy, medical record review and staff interviews, the hospital failed to provide a safe environment for patient care in the emergency department by failing to increase the level of observation for a patient with a threat of suicide and failed to prevent a patient elopement for 1 of 1 (#2) patient that attempted suicide and elopement.

Findings include:

Hospital policy review on 07/28/2016 revealed "Patient Rights and Responsibilities" last revised 12/2015. Review of the policy revealed "[Name of hospital] respects, protects, and promotes patient rights. . . Patients will receive care, treatment, and services demonstrating respect for the patients' dignity . . . Patient rights and responsibilities will be provided and made available to patients and surrogate decision makers. This includes both inpatients and outpatients within the organization. . . RIGHTS OF ALL PATIENTS . . . The right to receive care in a safe setting. . ."

Hospital policy review on 07/28/2016 revealed "Suicide Risk and Safety Interventions" revised 10/2015. Review of the policy revealed "[Name of hospital] provides treatment for patients with diagnoses of substance abuse, and/or mental or emotional illnesses. When such diagnoses are identified, even if unrelated to primary diagnosis or reason for visit, every effort will be made to ensure patient safety. . . INPATIENT/EMERGENCY DEPARTMENT SAFETY INTERVENTIONS . . . In addition to the normal course of treatment for each patient, the following additional interventions should be carried out to ensure patient safety. . . 1:1 Observation Staff must remain within arm's length of the patient at all times, obtaining relief as needed. The patient is at imminent risk and there is imminent danger of suicide, and patient behavior may demonstrate: Verbalizing clear intent for self-harm, Concrete and viable plan, Recent attempts at suicide by lethal method, Attempting to elope . . ."

Closed medical record review on 07/26/2016 for Patient #2 revealed an emergency room admission, via private vehicle on 03/07/2016 at 1457 for suicidal ideation, drug overdose and alcohol intoxication with a history of traumatic brain injury and Bipolar Disorder. The review revealed the patient was admitted under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer to a different facility, until discharge home on 03/19/2016 at 1140.

Review of nursing progress notes revealed documentation for 03/09/2016 at 1845 that stated "Pt [patient] to nurses station and speaking with Pharmacy Technician. Pt states she is having hallucinations and needs to speak to someone. Pt states 'I want to commit suicide and I will just pull his gun.' (Pt referring to [law enforcement] officer overseeing her)." Continued review revealed 03/09/2016 at 1913 "[Law enforcement] Sergeant to nurses station. Pt. had removed IV pole from bed and attempted to tie sheet around it and her neck. All sheets removed from room. Paper sheet placed on pts bed . . ." Continued review revealed the patient had been given paper scrubs to wear on 03/07/2016 at 1716 and suicide precautions had been initiated on 03/07/2016 at 2013 which included "Monitoring of patient in place. Suicide precautions maintained: a safety sweep of the room is ongoing. . . Side rails up x 1. Bed placed in lowest position. Brakes of bed on." Continued review revealed no documention as to when the patient was provided with cloth sheets.

Review of nursing documentation for 03/12/2016 at 0355 revealed "Patient pulled fire alarm as she was fleeing out back door of department. . . Patient seen fleeing from room by [law enforcement] officer, out back exit door, and into the parking lot. [Law enforcement] officer detained patient and returned her to department. . . "

Review of "Every 15 minute safety check for suicidal patients" documentation revealed the nursing assistant staff had documented the patient's activity every 15 minutes starting at 1800 on 03/07/2016 and ending on 03/19/2016 at 1130. There was no evidence the level of observation had been increased to 1:1 Observation for patient safety when the patient communicated the threat of suicide on 03/09/2016 at 1845 or after the patient eloped on 03/12/2016 at 0355.

Interview on 07/26/2016 at 1550 with RN #6 revealed the nursing assistant (NA) staff perform every 15 minute checks on patients that are placed on suicide precautions. The interview revealed the registered nurse (RN) staff check on the patients "about every hour." The interview revealed the RN checks "should include safety checks, removal of IV poles (pole to hang intravenous fluids), make sure the patient has paper scrubs and paper sheets if the patient is on suicide precautions." The interview revealed the RNs do not document the hourly patient checks. The interview confirmed 1:1 Observation was not implemented for Patient #2 after the patient threatened suicide or after the patient eloped.

Interview on 07/27/2016 at 1350 with NA#2 revealed the emergency department NA staff are responsible for every 15 minute checks for patients on suicide precautions. The interview revealed the checks included documentation of patient activity. The interview revealed a "Safety Sweep" was conducted at least each shift and more frequently, if needed, for patients on suicide precautions. The interview revealed the "Safety Sweep" included ensuring there was a paper trash bag in the trash receptacle, paper sheets on the bed and to ensure there were no plastic emesis bags or SHARPS containers in the patient room.

Interview on 07/26/2016 at 1420 with the Director of Quality and Regulatory revealed the patient should have been placed on 1:1 observation when a suicide threat had been made and after the patient had eloped.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0164
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy and procedure review, medical record review, observation, and staff interview, the hospital nursing staff failed to utilize least restrictive interventions for 3 of 3 ventilated (a machine that moves air in and out of the lungs when a person cannot breathe on their own) patients (Patient #5, #9, and #16) on a Propofol drip; and failed to implement least restrictive intervention for 1 of 2 (Patient #2) patients that received a chemical restraint.

The findings include:

Review on 07/28/2016 of the hospital's policy titled, "Restraint Application and Use" revised 12/2014, revealed, "DEFINITIONS ...Chemical Restraint: Drug or medication used as a restriction to manage the patient's behavior or restrict freedom which is not a standard treatment or dosage for the patient's medical or psychiatric condition...Non-Violent (Medical) Restraint Use: A restraint used to control a behavior in an otherwise non-combative, cooperative patient, to protect the patient from harm, facilitate treatment, and promote recovery. ...POLICY STATEMENT: ....Use the least restrictive method of restraint. Promote the use of non-physical interventions and alternatives to restraints...ALTERNATIVES TO RESTRAINTS Prior to application of restraints, less restrictive alternative measures will be considered and documented. If alternative interventions are ineffective, the patient is assessed for the risk of injury and observed behaviors that indicate imminent patient harm, restraints are applied and the least restrictive restraint is utilized while protecting the patient's rights, dignity and well-being. - Family or significant other involvement in patient care . . . - Encouragement of visitation/companionship by family and friends during hospitalization - Activities such as reading, cards, listening to music - Providing a calm environment and adherence to daily patient routine. . . Calm therapeutic communication techniques - Verbal interventions and reminders - Music, video, photographs to occupy patient. . . - Establish routine for toileting... RESTRAINT APPLICATION AND REMOVAL ...Discontinuation occurs when the patient no longer exhibits risks or behaviors of harm. Behavior will be assessed and documented by a trained registered nurse (RN). ...PATIENT ASSESSMENT AND CARE ...Restraints are removed as soon as the patient is free from risks and observed behaviors that would cause harm to self or others...PATIENT ASSESSMENT AND CARE An RN will assess the patient in restraints every two (2) hours for non-violent (medical) restraint use...

Review on 07/28/2016 of the hospital's policy titled, "Propofol (Diprivan) Protocol For Mechanically Ventilated Patients" revised 07/2016 revealed, 'PURPOSE: Propofol is a Sedative/Hypnotic agent delivered IV (intravenously) for use in the induction and maintenance of anesthesia or sedation... Therapeutic doses produce hypnosis rapidly... PROCEDURE: I. Use of Propofol in an intubated patient...C. Assess adequacy of sedation using the RASS (Richmond Agitation-Sedation Scale) Score. A score of -2 or -3 is recommended..."

1. Medical record review on 07/27/2016 for Patient #5 revealed a [AGE] year old female presented to the hospital's emergency department (ED) on 07/14/2016 at 1551 with a fracture and two day old wound on her 5th toe that developed redness. diagnoses included [DIAGNOSES REDACTED]. Review of the History and Physical (H&P) performed by (Medical Doctor) MD #7 on 07/14/2016 at 2358 indicated the patient was admitted to the Medical/Surgical floor for further evaluation and management by MD #7. Review of physician's order revealed an Orthopedic consult was ordered and perform by MD #8 on 07/14/2016. Review of the consultation recommendation by MD #8 revealed, "IMPRESSION" revealed a recommendation to amputate (remove) the left small toe. The patient underwent surgery for amputation of the left small toe on 07/15/2016 and was transferred from Medical/Surgical floor to the Intensive Care Unit (ICU) following discharge from recovery. Transfer to the ICU at was prearranged prior to surgery in anticipation of possible difficulties getting the patient extubated (removal of a breathing tube). Review revealed the patient arrived to the ICU at 1640.

Review of the Medication Administration Record (MAR) revealed the patient received:
Dilaudid (pain medication) 0.5mg (milligrams) every two hours IV (intravenous) as needed for breakthrough pain on:
- 07/15/2016 at 0914 (one dose);
- 07/16/2016 at 0135, 0338, 0811, and 1621 (four doses);
- 07/17/2016 at 0102, 0714, 1107, 1632, and 2156 (five doses);
- 07/18/2016 at 0707, 0910, 1230, 1458, and 1821 (five doses);
- 07/19/2016 at 0106, 1034, 1317, and 1619 (four doses);
- 07/20/2016 0937, 1406, and 2205 (three doses);
- 07/20/2016 at 0937, 1406, and 2205 (three doses);
- 07/22/2016 at 0028 and 2028 (two doses)

Haldol (antipsychotic) 2 mg IV as needed for agitation on:
- 07/18/2016 1821 and 2255 (two doses);
- 07/19/2016 at 1753 (one dose);
- 07/20/2016 at 1406 and 2205 (two doses);
- 07/21/2016 at 0510 (one dose);
- 07/22/2016 at 2319 (one dose);
- 07/23/2016 at 1650 (one dose);
- 07/24/2016 at 0338 and 1032 (2 doses);
- 07/25/2016 at 1035, 1558, and 2131 (three doses),
- 07/26/2016 at 1607 (one dose)

Propofol 1,000 mg IV titrate (adjust) on:
- 07/20/2016 at 1912 (one dose);
- 07/21/2016 at 0318, 1214, and 2207 (three doses);
- 07/22/2016 at 1642 and 2311 (two doses);
- 07/23/2016 at 0343, 1422, and 1932 (three doses);
- 07/24/2016 at 0010, 0450, 1245, 1707, and 2126 (five doses);
- 07/25/2016 at 0128, 0625, 1020, 1409, 1410, 1750, and 2131 (7 doses);
- 07/26/2016 at 0439, 0829, 1155, 1611, 2333, and 2352 (six doses);
- 07/27/2016 at 0803 (one dose)

Benadryl 25mg every six hours as needed for allergy symptoms on:
- 07/16/2016 at 1517 (one dose),
- 07/17/2016 at 0150, 1212, and 1942 (three doses) for "nonverbal c/o itching in BLE (bilateral lower extremity). Notation: Patient is noticeably rubbing her feet back and forth on the bed... Also increased patient sedation (Propofol) to maintain a Rass (Richmond Agitation-Sedation Scale: Used to assess the level of sedation for patients on ventilators with -2 to 0 recommended. Scores of -3 or less are considered to be "deeply sedated") of -1 per MD orders",
- 07/18/2016 at 0400 (one dose)

Atarax 25 mg four time per day as needed for itching on 07/18/2016 at 1056 (one dose)

Trazadone 100 mg once daily at bedtime via feeding tube on 07/18/2016 at 2255 (one dose) and 07/19/2016 at 2321 (one dose).

Review of nursing "Daily Focus Assessment Report" revealed notation of patient 's behavior on: 07/17/2016 at 0800 "becomes restless with stimulation adn [sic] spontaniously [sic] ...RASS +1 Restless. Level of Consciousness (LOC): Sedated; 07/18/2016 at 1056 "rubbing legs on bed, skin ruddy, possible itchy, 1100 "intermittently agitated, 1150 "not rubbing legs on bed now", 1200 "restless when disturbed and intermittently. RASS +1 restless, alert and calm, 1500 IVs were dislodged while pt was restless earlier...1800 bilateral wrist restraints (BWR) initated for "Attempting to remove invasive lines", 1821 "walking in the bed" very restless and grimacing...; 07/19/2016 at 1951, "pt agitated" restraint assessment for continued need not documented; 07/20/2016 at 2205, "Pt became anxious and agitated..." restraint assessment for continued need not documented; 07/21/2016 at 0500 "Marked anxiety noted at this time..." behaviors requiring restraints, "Attempting to remove invasive lines"; 07/20/2016 restraint assessment for continued need not documented; 07/22/2016 restraint assessment for continued need not documented; 07/23/2016 at 1600 "moving legs continually and pulling on flexiseal (is a temporary containment device for incontinent patients), attempting to mouth words, moving head back and forth...LOC: Sedated", restraint assessment for continued need not documented; 1700 moving legs and scooting buttocks...1750 "follow up 1750, appears more calmer but still moving legs, restraint assessment for continued need not documented; 07/24/2016 2100 "Pt restless, biting on EET (endotracheal tube)..Propofol drip increased to obtain a RASS of -2, restraint assessment for continued need not documented; 07/25/2016 at 0900 "Vent wean/sedation vacation in progress. Pt is alert and agitated..., 1600 RASS -2 Light Sedation, LOC Sedated", 2130 "Pt became anxious during change of propofol infusion ...bags, restraint assessment for continued need not documented. Review revealed every two hour assessments of the patient in restraints was not documented.

Interview on 07/26/2016 at 1400 Nurse Manager (NM) #1 revealed the patient's transfer to the ICU post operatively, if needed, was arranged prior to surgery in anticipation of possible difficulties getting her extubated (removal of breathing tube). Interview with NM #1 revealed BWR were initated on 07/18/2016 after the patient dislodged her IV lines. Interview with NM #1 indicated patients who are not able to tolerate being on the ventilator and attempt to or remove invasive lines are placed in BWRs to "prevent possible removal of the endotracheal tube (ET)." Interview with NM #1 revealed the patient "remains sedated" until they are able to breathe without the use of the ventilation and the use of the "Propofol not only helps, "Prevent possible removal", it also helps the patient to remain calm because, "Being in the ICU is frightening for most people to begin with." Interview with NM #1 indicated there was no documentation of every two hour assessments of the patient while in restraint and "There should have been." Interview with NM #1 revealed patients "remain in the current sedated state" until the ventilator is not longer required. Interview with NM #1 indicated "they have always been used and we've never treated them as a restraint." Interview with NM #1 revealed a Propofol drip is used for most patients placed on a ventilator. Interview with NM #1 revealed a "drop down list" is used to describe the "Behaviors Requiring Restraints" in the electronic medical record (EMR) and that "Attempting to remove invasive lines is typically used". Interview with NM #1 revealed less restrictive interventions are not consistently documented and "It looks as though we have a learning opportunity here."

Interview on 07/27/2016 at 0930 with Quality Manager #1 revealed, "We've had many discussions about the use of restraints in the ICU but we are met with resistance from the doctors and Nurse Manager." Interview revealed restraints should never be used to prevent "possible removal of lines". Interview with Quality Manager #1 revealed, "Patients should not be maintained in restraints if Propofol is keeping them sedated and they are asleep most of the time." Interview with Quality Manager #1 indicated least restrictive interventions should be attempted prior to initiation of restraints and throughout the course of their use.

2. Medical record review on 07/27/2016 for Patient #9 revealed a [AGE] year old female patient presented to the hospital's emergency department (ED) on 07/19/2016 at 1735 via emergency medical services (EMS) after being found in her home unresponsive. Review of the History and Physical (H&P) performed by MD #10 dated 07/19/2016 at 2016 revealed the patient was intubated upon arrival to the ED secondary to respiratory failure, hypoxia (poor oxygenation), and hypotension (low blood pressure). Review revealed diagnoses include, Altered mental status, (AMS)/[DIAGNOSES REDACTED] (infection affecting the brain), Sepsis (infection), septic shock (critically low blood pressure and alteration in metabolism), acute kidney injury, hyperkalemia (high potassium level), hyponatremia (low sodium level) and a urinary tract infection (UTI). Review revealed the patient was transferred to the Intensive Care Unit (ICU) for further treatment and evaluation. Review of physican orders revealed an order on 07/19/2016 at 2026 by MD #10 for Propofol (used to slow brain activity and nervous system) 1,000 mg (milligram) IV with instructions to "Titrate to RASS (Richmond Agitation-Sedation Scale: Used to assess the level of sedation for patients on ventilators with -2 to 0 recommended. Scores of -3 or less are considered to be "deeply sedated") score as indicated by physician "Start drip at 5 mcg(micrograms/kg (kilogram)/min. (minute). Titrate (adjust) to RASS score as indicated by physician. Increase by 5 mcg/kg/min every 5 minutes to goal sedation. Decrease by 5mcg/kg/min every 5 minutes to goal sedation. ...Monitor sedation level and perform sedation holiday (attempt to discontinue Propofol daily to determine whether the patient can tolerate the breathing tube without it's use) daily."Review revealed a Propofol drip was initiated on 07/19/2016 at 2026 and was discontinued 07/21/2016 at 1403. Review revealed the patient was transferred to the ICU on 07/19/2016 at 2016 and placed in bilateral wrist restraints (BWR) at 2300 for "Attempting to remove invasive lines." Review revealed staff "Positioned Tubes / Drains out of Patients Reach" as "Alternatives to Restraints Attempted" at 2300. Review revealed "Attempt to remove invasive lines" as justification for the need for restraint use while on the Propofol drip was documented every two (2) hours until the restraints were discontinued on 07/20/2016 at 0800.

Interview on 07/26/2016 at 1400 with Nurse Manager (NM) #1 revealed patients who are not able to tolerate being on the ventilator and attempt to remove invasive lines are placed in BWRs to "prevent possible removal of the endotracheal tube (ET)." Interview with NM #1 indicated the patient "remains sedated" until they are able to breathe without the use of the ventilation and the use of the "Propofol not only helps, "Prevent possible removal", it also helps the patient to remain calm because, "Being in the ICU is frightening for most people to begin with." Interview with NM #1 revealed patients "remain in the current sedated state" until the ventilator is not longer required. Interview with NM #1 indicated "they have always been used and we've never treated them as a restraint." Interview revealed a Propofol drip is used for most patients on a ventilator. Interview with NM #1 revealed a "drop down menu" is used to select a description of the "Behaviors Requiring Restraints" in the electronic medical record (EMR) and that "Attempting to remove invasive lines is typically used". Interview with NM #1 indicated less restrictive interventions are not consistently documented and "It looks as though we have a learning opportunity here." Interview with NM #1 revealed "Attempting to remove invasive line" was documented every two (2) hours 24/7 until the patient was removed from the ventilator, indicating she was constantly "Attempting to remove invasive lines."

Interview on 07/27/2016 at 0930 with Quality Manager #1 revealed, "We've had many discussions about the use of restraints in the ICU but we are met with resistance from the doctors and Nurse Manager." Interview revealed restraints should never be used to prevent "possible removal of lines". Interview with Quality Manager #1 revealed, "Patients should not be maintained in restraints if Propofol is keeping them sedated and they are asleep most of the time." Interview with Quality Manager #1 indicated least restrictive interventions should be attempted prior to initiation of restraints and throughout the course of their use.

3. Medical record review on 07/27/2016 for Patient #16 revealed a [AGE] year old male patient presented to another hospital's emergency department (ED) on 06/07/2016 with Respiratory Distress and Failure. He was intubated (breathing tube) and transferred to (Hospital name) for higher level of care. Upon presentation to (Named hospital) his blood pressure was stable but then started dropping. A central line was placed and he was admitted to the Intensive Care Unit (ICU) on 06/07/2016 at 1230. Diagnoses include Sepsis with septic shock, Pneumonia, and Respiratory Failure. Review of physician orders revealed an order on 06/10/2016 at 1807 by MD #9 for Propofol (used to slow brain activity and nervous system) 1,000 mg (milligram) IV. Titrate per protocol to RASS (Richmond Agitation-Sedation Scale: Used to assess the level of sedation for patients on ventilators with -2 to 0 recommended. Scores of -3 or less are considered to be "deeply sedated") -3. "Start drip at 5 mcg(micrograms/kg (kilogram)/min. (minute). Titrate (adjust) to RASS score as indicated by physician. Increase by 5 mcg/kg/min every 5 minutes to goal sedation. Decrease by 5mcg/kg/min every 5 minutes to goal sedation. ...Monitor sedation level and perform sedation holiday (attempt to discontinue Propofol daily to determine whether the patient can tolerate the breathing tube without it's use) daily."Review revealed the need for the Propofol drip was not required until 06/10/2016 at 1815 with 1,000 mg administered. Review revealed the patient remained on the Propofol drip until 06/14/2016 at 1522. Review of the "Flowsheet Inquiry Report" revealed the patient was placed in bilateral wrist restraints (BWR) on 06/08/2016 at 0800 with "Attempting to remove invasive lines" as justification for the continued need of restraints noted as the "Behaviors Requiring Restraints" noted every two (2) hours until they were discontinued 06/14/2016 at 0940. Review revealed, "Positioned Tubes/Drains Out of Patients Reach" noted on 06/07/2016 at 1400, 1600, and 1800 and again on 06/09/2016 at 1600 and 1800 while the patient was in restraints with no documentation to indicate removal of the restraint. Interview revealed no other documentation of least restrictive interventions attempted prior to the patient being placed in BWRs or throughout the duration of use.

Interview on 07/26/2016 at 1400 with Nurse Manager (NM) #1 revealed patients who are not able to tolerate being on the ventilator and attempt to remove invasive lines are placed in BWRs to "prevent possible removal of the endotracheal tube (ET)." Interview with NM #1 indicated the patient "remains sedated" until they are able to breathe without the use of the ventilation and the use of the "Propofol not only helps, "Prevent possible removal", it also helps the patient to remain calm because, "Being in the ICU is frightening for most people to begin with." Interview with NM #1 revealed patients "remain in the current sedated state" until the ventilator is not longer required. Interview revealed "they have always been used and we've never treated them as a restraint." Interview with NM #1 indicated a Propofol drip is used for most patients on a ventilator. Interview revealed a "drop down menu" is used to select a description of the "Behaviors Requiring Restraints" in the electronic medical record (EMR) and that "Attempting to remove invasive lines is typically used". Interview revealed less restrictive interventions are not consistently documented and "It looks as though we have a learning opportunity here." Interview revealed "Attempting to remove invasive line" was documented every two (2) hours 24/7 until the patient was removed from the ventilator, indicating she was constantly "Attempting to remove invasive lines."

Interview on 07/27/2016 at 0930 with Quality Manager #1 revealed, "We've had many discussions about the use of restraints in the ICU but we are met with resistance from the doctors and Nurse Manager." Interview revealed restraints should never be used to prevent "possible removal of lines". Interview with Quality Manager #1 revealed, "Patients should not be maintained in restraints if Propofol is keeping them sedated and they are asleep most of the time." Interview with Quality Manager #1 indicated least restrictive interventions should be attempted prior to initiation of restraints and throughout the course of their use.




4. Closed medical record review on 07/26/2016 for Patient #2 revealed an emergency room admission, via private vehicle, on 03/07/2016 at 1457 for suicidal ideation, drug overdose and alcohol intoxication with a history of traumatic brain injury and Bipolar Disorder (illness that affects mood). The review revealed the patient was admitted , under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer to a different facility, until discharge home on 03/19/2016 at 1140.

Review of nursing progress notes revealed documentation for 03/09/2016 at 1845 that stated "Pt [patient] to nurses station and speaking with Pharmacy Technician. Pt states she is having hallucinations and needs to speak to someone. Pt states 'I want to commit suicide and I will just pull his gun.' (Pt referring to [law enforcement] officer overseeing her)." Continued review revealed 03/09/2016 at 1913 "[Law enforcement] Sergeant to nurses station. Pt. had removed IV pole from bed and attempted to tie sheet around it and her neck. All sheets removed from room. Paper sheet placed on pts bed . . . 20:22 Ativan (Lorazepam) [medication for anxiety] IM [intramuscular] 2 mg [milligram] given. . . Haldol [medication used for severe behavioral problems to reduce aggression] IM 5 mg given . . . 21:01 Patient agreed to behave without any violent outbursts anymore. Restraints that were placed by [law enforcement] was removed by [law enforcement]. . . 22:30 Haldol IM 5 mg given. . . . " Continued review of the closed medical record revealed nursing documentation for 03/11/2016 at 2218 " Pt locked herself in restroom and would not open door. This nurse retrieved restroom key and entered restroom, at which point pt was talking about things and people that were not present. . ." Continued review revealed the patient struck the nurse and was escorted to her room by law enforcement. "22:19 . . . Haldol IM 5 mg given. . . Ativan IM 2 mg given. . . (Pt yelling continuously from room at this time) 23:34. . . Geodon [medication to treat the manic phase of Bipolar Disorder] IM 20 mg given . . . Benadryl [medication used for allergic reactions and also has a sedative effect] IM 50 mg . . . " Further review revealed nursing documentation for 03/12/2016 at 1033 "patient requesting to use the phone [law enforcement officer] patient denied phone priveleges at this time [12 hours after the patient exhibited aggressive behavior]. . . 11:11 Ativan IM 2 mg given. . . " Continued review of nursing progress notes revealed documentation for 03/17/2016 at 1354 "per [law enforcement] patient not allowed visitors" (five days after the patient had exhibited aggressive behavior). Continued review of nursing progress note documentation revealed least restrictive interventions were not used as an alternative to chemical restraint in 5 of 5 instances where chemical restraint was used to calm Patient #2.

Review of the Medication Administration Record revealed Ativan IM, Haldol IM, Geodon IM or Benadryl IM were not routinely scheduled medications.

Interview on 07/27/2016 at 0910 with the Emergency Department Nursing Director revealed Patient #2's family member had talked with the director on 03/17/2016 regarding the law enforcement refusal to allow the patient to have a visitor. The interview revealed the director had given permission for the family member to visit and the law enforcement officer had refused to allow the patient to have a visitor. The interview confirmed the use of least restrictive interventions had not been utilized prior to chemical restraint for Patient #2.

Interview on 07/27/2016 at 1550 with the Director of Quality and Regulatory, Patient Safety Officer and Risk Management revealed the psychiatric holding area in the Emergency Department did not have a television or radio in March of 2016. The interview revealed the patients did have access to books and magazines. The interview revealed the nursing staff did not restrict visitors or telephone calls, however a law enforcement officer did restrict Patient #2 from having telephone privileges with a family member on 03/12/2016 at 1033 and refused to allow a family member to visit the patient on 03/17/2016 at 1354. The interview confirmed least restrictive interventions had not been utilized prior to chemical restraint for Patient #2.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
Based on review of hospital policy, medical record review and staff interviews, the provider failed to conduct a face to face assessment after the initiation of a restrictive intervention for 2 of 2 (#2 and #18) patients that received a restrictive intervention.

Findings include:

Policy review on 07/28/2016 revealed "Restraint Application and Use" last approved 12/2014. Review of the policy revealed "Chemical Restraint: Drug or medication used as a restriction to manage the patient's behavior or restrict freedom which is not a standard treatment or dosage for the patient's medical or psychiatric condition. . . A provider must perform a face-to-face assessment of the patient within one (1) hour of application of Violent (behavioral) restraints and 12 hours for Non-Violent (medical) restraints. The in-person evaluation, conducted within one hour of the initiation of restraint for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes evaluation of the patient's immediate situation, reaction to intervention(s), and medical/behavioral condition. . . "

1. Closed medical record review on 07/26/2016 for Patient #2 revealed an emergency room admission, via private vehicle, on 03/07/2016 at 1457 for suicidal ideation, drug overdose and alcohol intoxication with a history of traumatic brain injury and Bipolar Disorder. The review revealed the patient was admitted , under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer to a different facility, until discharge home on 03/19/2016 at 1140.

Review of nursing progress notes revealed documentation for 03/09/2016 at 1845 stated "Pt [patient] to nurses station and speaking with Pharmacy Tech. Pt states she is having hallucinations and needs to speak to someone. Pt states 'I want to commit suicide and I will just pull his gun.' (Pt referring to [law enforcement] officer overseeing her)." Continued review revealed 03/09/2016 at 1913 "[Law enforcement] Sergeant to nurses station. Pt. had removed IV pole from bed and attempted to tie sheet around it and her neck. All sheets removed from room. Paper sheet placed on pts bed . . . 20:22 Ativan (Lorazepam) [medication for anxiety] IM [intramuscular] 2 mg [milligram] given. Given in the left deltoid. [muscle that provides contour form of shoulder located at the upper arm and top of shoulder]. . . Haldol [medication used for severe behavioral problems to reduce aggression] IM 5 mg given in the right deltoid. . . 21:01 Patient agreed to behave without any violent outbursts anymore. Restraints that were placed by [law enforcement] was removed by [law enforcement]. . . 22:30 Haldol IM 5 mg given. Given in the right deltoid. . . " Continued review of the closed medical record revealed nursing documentation for 03/11/2016 at 2218 " Pt locked herself in restroom and would not open door. This nurse retrieved restroom key and entered restroom, at which point pt was talking about things and people that were not present. . ." Continued review revealed the patient struck the nurse and was escorted to her room by law enforcement. "22:19 . . . Haldol IM 5 mg given. . . Ativan IM 2 mg given. . . (Pt yelling continuously from room at this time) 23:34. . . Geodon [medication to treat the manic phase of Bipolar Disorder] IM 20 mg given . . . Benadryl [medication used for allergic reactions and also has a sedative effect] IM 50 mg . . . " Further review revealed nursing documentation for 03/12/2016 at 1033 "patient requesting to use the phone [law enforcement officer] patient denied phone priveleges at this time . . . 11:11 Ativan IM 2 mg given. . . " Review of the Medication Administration Record revealed Ativan IM, Haldol IM, Geodon IM or Benadryl IM were not regularly scheduled medications.

Review of the physician progress notes revealed no evidence a provider performed a face to face evaluation of the patient within one hour after the initiation of 5 of 5 chemical restraint restrictive interventions.

Interview on 07/27/2016 at 1550 with the Director of Quality and Regulatory, Patient Safety Officer and Risk Management revealed patients that receive a chemical restraint should be assessed by nursing and evaluated by a provider the same as a violent behavior restraint. The interview revealed Patient #2 received a chemical restraint on 03/9/2016 at 2022 and 2230, 03/11/2016 at 2219 and 03/12/2016 at 1111. The interview revealed there was no evidence a provider had performed a face to face evaluation of the patient one hour after the restrictive interventions.

Interview on 07/27/2016 at 1530 with MD #2 revealed the physician had not ordered a restrictive intervention since he had been at his current job for "about a month." The interview revealed the physician would assess a patient prior to ordering a physical or chemical restrictive intervention and again in 30 minutes after the intervention to assess for "breathing problems."

2. Closed medical record review on 07/28/2016 for Patient #18 revealed an emergency room admission on 07/04/2016 at 0138, via law enforcement, for chief complaint of being anxious, depressed and behavior changes. The review revealed the patient was admitted , under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer to a different facility, until discharge home on 07/07/2016 at 1105.

Review of nursing progress notes revealed Suicide Precautions with every 15 minute checks by the nursing assistant staff were initiated at time of admission. Continued review revealed nursing documentation for 07/04/2016 at 1000 that stated the patient was aggressive and yelling. The patient was placed in ankle shackles by local law enforcement and at 1001 Geodon (medication to treat the manic phase of Bipolar Disorder) IM (intramuscular) 10 mg given. Continued review revealed at 1614 the patient went to the nurse's station and was yelling and aggressive toward staff. The patient was administered Geodon IM 10 mg. Review of the Medication Administration Record revealed Geodon IM was not a regularly scheduled medication.

Review of the physician progress notes revealed no evidence a provider preformed a face to face evaluation of the patient within one hour after the initiation of 2 of 2 chemical restraint restrictive interventions.

Interview on 07/27/2016 at 1550 with the Director of Quality and Regulatory, Patient Safety Officer and Risk Management revealed patients that receive a chemical restraint should be assessed by nursing and evaluated by a provider the same as a violent behavior restraint. The interview revealed Patient #2 received a chemical restraint on 03/9/2016 at 2022 and 2230, 03/11/2016 at 2219 and 03/12/2016 at 1111. The interview revealed there was no evidence a provider had performed a face to face evaluation of the patient one hour after the restrictive interventions.

Interview on 07/27/2016 at 1530 with the MD #2 revealed the physician had not ordered a restrictive intervention since he had been at his current job for "about a month." The interview revealed the physician would assess a patient prior to ordering a physical or chemical restrictive intervention and again in 30 minutes after the intervention to assess for "breathing problems."
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, policy review and staff interview, the hospital nursing staff failed to supervise and assess nursing care provided to 3 of 3 (#2, 18 and 5) patients with a change in condition.

Findings include:

Policy review on 07/28/2016 revealed "Emergency Department Patient Assessment and Reassessment" revised 07/2014 which stated "After the triage evaluation, a more thorough initial assessment based on the visit reason will be performed. This evaluation of the patient includes physical, psychosocial, nutritional and functional assessment. Assessments are individualized and age-specific. Reassessments are based on the patient's visit reason, interventions and category assigned and is performed and documented on the Medical Record as condition warrants. . . Patients with a psychiatric provisional diagnosis including patients presenting with potential harm to self or others will be reassessed and monitored according to severity of findings. . ."

Review on 07/28/2016 of the hospital's policy titled, "Adult Inpatient Assessment" revised 04/2013 revealed, "...All nursing assessment are made based on a patient's condition. At (Hospital name), the nursing assessment includes the physical, ...status of the patient. ...Daily Assessment: A daily nursing assessment and reassessments are performed for all inpatients each shift, or with patient's change in status..."

Review on 07/28/2016 of the hospital's policy titled, "Pain Assessment and Management" revised 04/2013 revealed, "...ASSESSMENT AND REASSESSMENT ... 2. Reassessment a. Each patient will be reassessed at regular intervals for the presence or absence of pain. ...3. Monitoring Effectiveness of Interventions a. Pain intensity is evaluated within one hour of pain management intervention..."

Review on 07/28/2016 of the hospital's policy titled, "Scope of Services ICU" revealed, "...PURPOSE: ...2. To care for and provide continuous observation and monitoring of patients with acute medical and surgical illnesses...Physiological criteria for admission to the ICU include...2. Vital signs changes that are acute/sudden onset: ... d. Systolic B/P < 90 ... e. Diastolic B/P >120 ... 7. Monitoring vital signs every hour or more frequently as needed. ...Physical Assessment ...patients will be reassessed every four hours or more often as needed..."

1. Closed medical record review on 07/26/2016 for Patient #2 revealed an emergency room admission, via private vehicle, on 03/07/2016 at 1457 for suicidal ideation, drug overdose and alcohol intoxication with a history of traumatic brain injury and Bipolar Disorder. The review revealed the patient was admitted , under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer, to a different facility, until discharge home on 03/19/2016 at 1140. Review of the nursing progress notes for 03/07/2016 through 03/19/2016 revealed there was no documentation of a nursing assessment for 03/09 evening shift, 03/11 evening shift, 03/13 morning shift, 03/16 morning or evening shift, 03/17 morning or evening shift and 03/18/2016 evening shift. There was no evidence a nursing assessment had been conducted every shift or every 12 hours.

Continued review of the nursing progress notes revealed restrictive interventions of chemical restraint were administered due to a change in the patient's behavior on 03/09/2016 at 2022 and 2230, 03/11/2016 at 2219 and 2334 and 03/12/2016 at 1111. Continued review revealed no evidence of a nursing assessment for 5 of 5 changes in the patient's condition. Continued review of nursing documentation for 03/09/2016 at 1913 revealed the patient attempted to hang self with a sheet and IV pole. There was no documentation of an assessment to determine patient harm.

Interview on 07/27/2016 at 0910 with the Emergency Department Nursing Director revealed the expectation was for nursing assessments to be conducted every shift or every 12 hours. The interview confirmed a nursing assessment had not been conducted every shift, every 12 hours or when there was a change in behavior for Patient #2.

2. Closed medical record review on 07/28/2016 for Patient #18 revealed an emergency room admission on 07/04/2016 at 0138 via police escort for anxiousness, depression and behavior changes. The review revealed the patient was admitted , under involuntary commitment, in the emergency room awaiting a behavioral health bed transfer, to a different facility, until discharge home on 07/07/2016 at 1105. Review of nursing progress notes for 07/04 through 07/07/2016 revealed nursing assessments on 07/04/2016 at 0714 and 07/05/2016 at 0135 (18 hours after last assessment). There was no evidence a nursing assessment had been conducted every shift or every 12 hours for the patient's first 24 hours in the Emergency Department.

Interview on 07/27/2016 at 0910 with the Emergency Department Nursing Director revealed the expectation was for nursing assessments to be conducted every shift or every 12 hours. The interview confirmed a nursing assessment had not been conducted every shift or every 12 hours for Patient #18.











3. Medical record on 07/27/2016 for Patient #5 revealed a [AGE] year old female presented to the hospital's emergency department (ED) on 07/14/2016 at 1551 with a fracture and two day old wound on her 5th toe that developed redness. Review of the "Clinical Report - Nurses" assessment by Nurse Practitioner (NP) #1 at 1554 revealed the left fourth toe was tender, swollen, and deformed "consistent with a fracture." Review revealed a laceration to the web space between the 4th and 5th toes. The 5th toe was noted with redness, swelling and deformity consistent with fracture and dislocation of the DIP (distal interphalangeal: between the last two toes) joint. Review of the ED record revealed that the patient's Blood pressure (BP) at 1558 was 125/92 with a reported a pain level of 8/10 (0 no pain - 10 worst pain). Review of the "Clinical Impression" by NP #1 on 07/14/2016 at 1744 revealed BP: 149/107 HR (heart rate): 100 ...Vital Signs: have been reviewed. Hypertensive. Tachycardic (elevated heart rate) ...Essential hypertension. ...INSTRUCTIONS: Follow up: Screening today revealed the patient's blood pressure to be in the hypertensive range. The patient was admitted and blood pressure will be managed during admission. Review of the "Clinical Report - Nurse" by RN #9 revealed Dilaudid (used for pain) 0.5 mg IVP (intravenous push) was administered at 1715 for a reported 10/10 pain level. Review revealed a BP of 149/107 at 1744 with no intervention, reassessment of the BP, or of pain documented. Review revealed the patient was transferred to the Medical/Surgical unit at 1849 "improved and stable" BP 163/107 (1 hour, 34 minutes later). Review of the nursing progress note dated 07/14/2016 at 2000 by RN #10 revealed the patient's BP was 138/92 (1 hour, 11 minutes later). Review revealed nursing staff did not perform reassessments per policy.

History and Physical (H&P) by Medical Doctor (MD) #7 dated and timed 07/14/2016 at 2358 review revealed the patient was admitted to the Medical/Surgical floor for further evaluation and management by MD #7 on 07/14/2016 at 1854. Review of physician's order revealed an Orthopedic consult was ordered and performed by MD #8 on 07/14/2016. Review of the consultation recommendation by MD #8 revealed, "IMPRESSION" revealed a recommendation to amputate (remove) the left small toe. The patient underwent surgery on 07/15/2016 and was transferred from Medical/Surgical floor to the Intensive Care Unit (ICU) following discharge from recovery. Review revealed transfer to the ICU was arranged prior to surgery in anticipation of possible difficulties getting the patient extubated (removal of a breathing tube). Review revealed the patient arrived to the ICU at 1640 with diagnoses to include, Deep left 5th toe laceration and pain; Bilateral foot and leg cellulitis, Open fracture of the left 4th toe, Dislocation of the joint of the 5th toe (with tendon injury), Diabetes, Poor circulation, High blood pressure, Obesity, and Chronic Obstructive Pulmonary Disease (COPD).

Review of the "Medication Administration History Report" revealed an order by MD #3 for Lisinopril 5 mg once daily on 07/15/2016 at 1000. Review revealed Lisinopril was discontinued on 07/15/2016 at 1632. Continued review revealed an order by MD #5 on 07/17/2016 at 0743 for Lopressor (used for high BP) 2.5 mg IV every six hours as needed for hypertension: For SBP (systolic BP) greater than 180 or DBP (diastolic BP) greater than 100. Review revealed an order by MD #5 on 07/17/2016 at 1000 Lisinopril (used for high BP) 5 mg once daily.

Review of the "Clinical Notes-Nurse"on 07/14/2016 revealed elevated BPs on:
- 07/17/2016 at 0100 BP 137/89, 0200 BP 151/105 (MD or midlevel practitioner not notified);
- 07/17/2016 at at 0600 118/72, 0700 BP 150/100 (reassessment not performed), 0800 BP 160/103;
- 07/22/2016 at 2300 BP 143/95, 0000 BP 165/108, 1200 BP 164/102, 0100 BP 159/104. Review revealed no documentaion of physician or midlevel practioner notification of the elevated BPs or administration of Lopressor for BPs that fell outside the ordered parameter.

Interview on 07/27/2016 at 1545 with the Chief Nursing Officer (CNO) revealed failure to notify the physician of a patient's change in condition (BPs exceeding set parameters) is not acceptable practice. Interview revealed the expectation is that nurses are aware of the patient's BP regardless of whether it is obtained manually or automatically. Interview revealed the expectation is that nursing follows BP parameters ordered by the physician, if applicable, and if it falls outside those parameters, the physician should be notified. Interview revealed when the BP is outside established parameters, it should be retaken to determine accuracy of the initial assessment.

Interview on 07/28/2016 at 1114 with RN #4 revealed she was the patient's assigned nurse on 07/22/2016 7 am-7 pm. Interview revealed, "If I see this (BP 190/102 on 07/22/2016 at 1000), I would recheck the BP and notify the doctor." Interview revealed, "No, the doctor was not notified and should have been." Interview revealed the certified nursing assistant (CNA) enters vital signs into the electronic medical record following RN verification and typically alerts the nurse when vital signs are not within normal limits for the patient. Interview revealed the CNA staff are, "Not so good at recognizing their (patient) diastolic. They only recognize it when it's low." Interview revealed the physician was not notified of the patient's status change.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, observation, and staff interviews, the hospital staff failed to ensure personal protective equipment (PPE) was removed per hospital policy for 1 of 2 patients on transmission based precautions (Patient #13); failed to ensure hand hygiene was performed per hospital policy for 4 of 5 observations of patient care (Patient #7, #8, #13, and #14); failed to ensure 4 of 6 point of care blood glucose monitors (#1, #2, #3, and #4) were cleaned prior to being returned to the docking station; failed to ensure 1 of 5 sampled holter monitors (#1) were cleaned prior to being returned to the clean equipment area; failed ensure blood glucose monitor HiLo controls were not used beyond expiration date for 2 of 5 sampled bottles; and failed to ensure HiLo control solutions were labeled with the open date.

The findings include:

Review on 07/27/2016 of the hospital's policy titled, "Standard Precautions Policy" revised 09/2015 revealed, "Policy Statement: ... It is the policy of (Hospital name) and (County name) that all healthcare workers will practice Standard Precautions with all patients ... Personal Protective Equipment (PPE) ... 1. Gloves - Gloves shall be worn when hand contamination by blood or body substances is anticipated ... "

Review on 07/27/2016 of the hospital's "(Hospital name) AND (County name) COMMUNITY HOSPITLAS [sic] PPE (personal protective equipment) DONNING (putting on) AND DOFFING (removing) " guidelines revealed, "...Doffing (Removing): ...4. A. Gown front and sleeves are contaminated. B. Unfasten ties. C. Pull away from neck and shoulders, touching inside of gown only... "

1. Medical record review on 07/27/2016 for Patient #13 revealed a [AGE] year-old female was admitted on [DATE] with a diagnosis including Sepsis (infection), Cellulitis (skin infection), Erythema (red rash), and a draining abscess versus other systemic (body-wide) inflammatory disease. Review revealed the patient was placed on Contact Precautions on admission secondary to a history of MRSA within the past 12 months.

Observation on 07/26/2016 at 1545 during the unit tour revealed a Contact Precaution sign posted on Patient #13's door. Observation revealed Registered Nurse (RN) #1 donning personal protective equipment (PPE). Observation revealed RN #1 did not perform hand hygiene prior to donning gloves. Observation revealed after patient care, RN #1 removed her gloves, untied the top string of the gown, grabbed the outside of the gown, and pulled it forward with non gloved hands.

Interview on 07/26/2016 at 1545 with Quality Manager #1 revealed RN #1 grabbed the outside of the gown and pulled it away from her with nongloved hands. Interview revealed removing a gown used for the care of a patient on contact precautions by grabbing it on the outside was not acceptable practice. Interview revealed RN #1 did not remove PPE according to policy.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) revealed that when staff wear PPE and the gown is removed, the expectation is that should be pulled away from the neck and shoulders, without touching the outside of the gown. Interview revealed nursing staff are trained to remove a gown by pulling it forward, away from the neck and shoulders, and rolling it into a bundle, touching the inside only, and then disposing it into the appropriate trash receptacle. Interview revealed it is not acceptable practice to touch the outside of the gown when removing it. Interview revealed RN #1 did not follow removal of PPE guidelines per policy.

2. Medical record review on 07/27/2016 for Patient #7 revealed a [AGE] year-old female was admitted on [DATE] with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD: lung disease) exacerbation (flare up); Chronic Respiratory Failure; Pneumonia, and Cellulitis (skin infection). Review revealed CBC results on 07/22/2016 indicated a Hemoglobin (Hgb) level of 9.7 (reference range: 11/5 - 15.0) and Hematocrit (HCT) level of 29 (reference range: 34 - 44). Review revealed the patient was diagnosed with an "Active Bleed" on 07/26/2016 at 0521 by MD #3 and an order for one unit of packed red blood cells (PRBC) was given. Review revealed the unit of PRBCs was started at 1145 and ended at 1428.

Observation on 07/26/2016 at 1445 during tour of the ICU revealed Registered Nurse (RN) #3 entered the patient's room, did not perform hand hygiene or don gloves, squeezed the blood bag, and traced the IV (intravenous) line to the patient's arm. Observation revealed RN #3 exited the patient's room, did not perform hand hygiene, walked to the nursing station, and reviewed a chart. Observation revealed RN #3 returned to the patient's room and entered, without performing hand hygiene.

Interview on 07/26/2016 at 1445 with Nurse Manager #1 during observation revealed, she could "not believe the nurse did not performed any type of hand hygiene. She knows better." prior to, during, or following patient contact. Interview revealed hand hygiene compliance was an ongoing issue for the unit, as well as the hospital in general. Interview revealed each unit is required to perform 25 hand hygiene audits per quarter hospital wide. Interview revealed, "Looks like I have some more work to do." Interview revealed failure to perform hand hygiene prior to or following patient care was not acceptable practice. Interview revealed RN #3 did not perform hand hygiene per policy.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) revealed nursing staff should perform hand hygiene, either with an approved hand gel or with soap and water, prior to donning (putting on) gloves and immediately following removal. Interview revealed nursing staff are expected to wear personal protective equipment (PPE) anytime the potential for contact with blood or body fluids exists. Interview revealed all direct care staff, regardless of discipline, are expected to follow hospital policy.

Interview on 07/28/2016 at 1545 with the Chief Nursing Officer (CNO) revealed the expectation is that nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed "My expectation is that staff follow the policy (hand hygiene) and I certainly would not expect anyone to handle blood products and go to a desk without performing hand hygiene." Interview revealed failure to perform hand hygiene prior to entering the patient's room and upon exit was not acceptable. Interview revealed RN #3 did not perform hand hygiene per policy.

3. Medical record review on 07/27/2016 for Patient #8 revealed an [AGE] year-old female was admitted [DATE] with a diagnosis of a Right Hip Fracture. Review revealed CBC results on 07/25/2016 indicated a Hemoglobin (Hgb) level of 10.7 (reference range: 11.5 - 15.0) and Hematocrit (HCT) level of 33 (reference range: 34 - 44). Review revealed the patient underwent surgical repair of the hip fracture on 07/25/2016. Review revealed the patient and was ordered a type and cross match by MD #4 on 07/26/2016 at 0753 and received 2 units of packed red blood cells (PRBC) on 07/26/2016. Review revealed the first unit of blood was started at 1315 and ended at 1600.

Observation on 07/26/2016 at 1630 revealed Registered Nurse (RN) #7 entered the patient's room without performing hand hygiene. Observation revealed RN #7 disconnected the IV (intravenous) blood tubing from the patient, removed the blood product bag from the IV pole, and discarded both. Observation revealed remnants of blood product in the IV tubing as well as the bag. Observation revealed RN #7 did not don gloves prior to disconnecting the tubing from the patient or prior to removing the blood product bag from the IV pole.

Interview on 07/26/2016 at 1615 with the Quality Manager #1 revealed RN #7 did not have gloves on during the observation.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) revealed nursing staff should perform hand hygiene, either with an approved hand gel or with soap and water, prior to donning (putting on) gloves and immediately following removal. Interview revealed nursing staff are expected to wear personal protective equipment (PPE) anytime the potential for contact with blood or body fluids exists. Interview revealed all direct care staff, regardless of discipline, are expected to follow hospital policy.

Interview on 07/26/2016 at 1630 with Nurse Manager #2 revealed nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed nursing staff are expected to wear gloves anytime there is potential for exposure to blood or body fluids. Interview reviewed revealed RN #7 did not have gloves on when handling the IV tubing used to infuse blood products to Patient #8. Interview revealed RN #7 did not perform hand hygiene or don gloves per policy.

Interview on 07/28/2016 at 1545 with the Chief Nursing Officer (CNO) revealed the expectation is that nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed "My expectation is that staff follow the policy (hand hygiene) and I certainly would not expect anyone to handle blood products and go to a desk without performing hand hygiene." Interview revealed failure to perform hand hygiene prior to entering the patient's room and upon exit was not acceptable. Interview revealed RN #3 did not perform hand hygiene per policy.

4. Medical record review on 07/27/2016 for Patient #13 revealed a [AGE] year-old female was admitted on [DATE] with a diagnosis including Sepsis (infection), Cellulitis (skin infection), Erythema (red rash), and a draining abscess versus other systemic (body-wide) inflammatory disease. Review revealed the patient was placed on Contact Precautions on admission secondary to a history of MRSA within the past 12 months.

Observation on 07/26/2016 at 1545 during the unit tour revealed a Contact Precaution sign posted on the patient's door. Observation revealed Registered Nurse (RN) #1 did not perform hand hygiene prior to donning gloves.

Interview on 07/26/2016 at 1545 with the Quality Manager #1 revealed RN #1 did not perform hand hygiene prior to donning gloves.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) revealed nursing staff should perform hand hygiene, either with an approved hand gel or with soap and water, prior to donning (putting on) gloves and immediately following removal. Interview revealed nursing staff are expected to wear personal protective equipment (PPE) anytime the potential for contact with blood or body fluids exists. Interview revealed all direct care staff, regardless of discipline, are expected to follow hospital policy.

Interview on 07/28/2016 at 1545 with the Chief Nursing Officer (CNO) revealed the expectation is that nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed, "My expectation is that staff follow the policy (hand hygiene) and I certainly would not expect anyone to handle blood products and go to a desk without performing hand hygiene." Interview revealed failure to perform hand hygiene prior to entering the patient's room and upon exit was not acceptable. Interview revealed RN #3 did not perform hand hygiene per policy.

5. Medical record review on 07/27/2016 for Patient #14 revealed a [AGE] year-old male was admitted on [DATE] with a diagnosis of Alcohol withdrawal induced seizures, mild Rhabdomyolysis (muscle damage), and Chest Pain. Review revealed the patient was admitted to the hospital's Intensive Care Unit (ICU) for "careful cardiac monitoring" and CIWA (Clinical Institute Withdrawal Assessment: used to assist with alcohol withdrawal) protocol."

Observation on 07/26/2016 at 1500 revealed Registered Nurse (RN) #5 entered the patient's room and touched the bed rail during conversation with an non gloved hand. Observation revealed RN #5 did not perform hand hygiene upon exit from patient room. Observation revealed RN #5 walked out of the room and over to the nursing station, reentered the patient room and touched his armband with non gloved hands. Observation revealed RN #5 did not perform hand hygiene upon exit from the patient's room.

Interview on 07/26/2016 at 1500 with Nurse Manager #1 during observation revealed nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed nursing staff are expected to wear gloves anytime there is potential for exposure to blood or body fluids. Interview revealed RN #5 did not perform hand hygiene or don gloves per policy.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) revealed nursing staff should perform hand hygiene, either with an approved hand gel or with soap and water, prior to donning (putting on) gloves and immediately following removal. Interview revealed nursing staff are expected to wear personal protective equipment (PPE) anytime the potential for contact with blood or body fluids exists. Interview revealed all direct care staff, regardless of discipline, are expected to follow hospital policy.

Interview on 07/28/2016 at 1545 with the Chief Nursing Officer (CNO) revealed the expectation is that nursing staff should perform hand hygiene prior to entering a patient's room and upon exit. Interview revealed "My expectation is that staff follow the policy (hand hygiene) and I certainly would not expect anyone to handle blood products and go to a desk without performing hand hygiene." Interview revealed failure to perform hand hygiene prior to entering the patient's room and upon exit was not acceptable. Interview revealed RN #3 did not perform hand hygiene per policy.

Review on 07/26/2016 of the hospital's policy titled, "Cleaning and Disinfection: Patient Shared Equipment" revised 10/2015, "POLICY: This policy sets forth general guidelines for cleaning of equipment used in the clinical areas in order to prevent the transmission of infectious agents by contaminated equipment ... GENERAL GUIDELINES: ...C. Non-critical items are those that come in contact with intact skin ... 1. Frequency of cleaning and disinfection required by departmental staff ...c. Patient shared equipment should be cleaned and disinfected between patients ..."

Review on 07/27/2016 of the hospital's policy titled, "Standard Precautions Policy" revised 09/2015 revealed, "Policy Statement: Standard Precautions provide a series of methods that have been proven to reduce the spread of microorganisms (germs) ... Patient Care Equipment/Supplies ... 1. Patient Care Equipment - Clean and disinfect reusable equipment after each use... "

6. Observation on 07/26/2016 at 1200 during the unit tour revealed approximately 12 holter monitors hanging on the wall inside the nursing station. Observation revealed one of five montiors (holter monitor #1-TTX8756) sampled had a brownish-red substance on the side. Observation revealed Quality Manager #1 donned gloves, obtained a disinfectant cloth, and the substance was readily wiped away.

Interview on 07/26/2016 at 1200 with Quality Manager #1 revealed the holter monitors hanging on the wall were clean and ready for patient use. Interview revealed there was a brownish-red substance on the holter monitor that was easily wiped away with the disinfectant wipe. Interview revealed the holter monitor was not clean and should not be hanging in the designated clean area.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) shared patient equipment should be cleaned with a hospital approved disinfectant after each use. Interview revealed holter monitors are considered "shared equipment" and the expectation is that each monitor would be cleaned as described above prior to being placed in the clean equipment storage space. Interview revealed it was not acceptable practice to have a holter monitor with a brownish-red substance hanging with clean equipment.

7. Observation on 07/26/2016 at 1330 during unit tour of the Medical/Surgical floor revealed blood glucose monitor #1 ( 79), sitting in the docking station at the medication room. Observation revealed a 1.5-in L x .5-in W brownish-red substance smeared along the battery pack cover (back) of the monitor. Observation revealed a brownish-red substance on the monitor at the test strip port and another on the barcode scanner (laser). Observation revealed Quality Manager #1 donned gloves, obtained a disinfectant cloth, and the substance was easily wiped away.

Interview on 07/26/2016 at 1330 with Quality Manager #1 revealed the blood glucose monitor (#1) was clean and ready for patient use. Interview revealed the brownish-red substance that appeared to be "blood" and that the monitor was not ready for patient use. Interview revealed blood glucose monitors should be cleaned after each patient use. Interview revealed the blood glucose monitor (#1) was not clean and was not cleaned after patient, "It couldn't have been cleaned." Interview revealed the brownish-red smear on the bottle of test strips appeared to be "blood" and that the test strips were acceptable for patient use. Interview revealed both bottles of control solutions were "expired, should have been thrown away, and replaced."

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) shared patient equipment should be cleaned with a hospital approved disinfectant after each use. Interview revealed blood glucose monitors are considered "shared equipment" and the expectation is that each monitor would be cleaned as described above prior to being placed on the docking station. Interview revealed routine audits are not performed to determine staff compliance with cleaning the monitors between patients. Interview revealed it is not acceptable practice to have blood glucose monitors with brownish-red spots or smears in the docking station ready for patient use. Interview revealed staff did not follow hospital policy.

8. Observation on 07/26/2016 at 1345 during the unit tour of the Orthopedic floor revealed blood glucose monitor #2 ( 963) sitting in the docking station at the nursing station. Observation revealed a red substance on the card label (located on the back of the monitor). Observation revealed Quality Manager #1 donned gloves, obtained a disinfectant cloth, and the substance was easily wiped away.

Interview on 07/26/2016 at 1345 with Quality Manager #1 revealed the blood glucose monitor (#2) was clean and ready for patient use. Interview revealed the brownish-red substance appeared "more brown", and that the monitor was not ready for patient use. Interview revealed blood glucose monitors should be cleaned after each patient use. Interview revealed the blood glucose monitor (#2) was not clean.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) shared patient equipment should be cleaned with a hospital approved disinfectant after each use. Interview revealed blood glucose monitors are considered "shared equipment" and the expectation is that each monitor would be cleaned as described above prior to being placed on the docking station. Interview revealed routine audits are not performed to determine staff compliance with cleaning the monitors between patients. Interview revealed it is not acceptable practice to have blood glucose monitors with brownish-red spots or smears in the docking station ready for patient use. Interview revealed staff did not follow hospital policy.

9. Observation on 07/26/2016 at 1400 during tour of the Intensive Care Unit (ICU) revealed blood glucose monitor #3 ( 889) and #4 ( 5254) sitting in the docking station at the nursing station. Observation revealed a red substance smeared across the barcode scanner (laser) and on the test strip port of monitor #4 ( 5254). Observation revealed Nurse Manager #1 donned gloves, obtained a disinfectant cloth, and the substance was easily wiped away.

Interview on 07/26/2016 at 1400 with Nurse Manager #1 revealed the blood glucose monitors (#3 and #4) were clean and ready for patient use. Interview revealed the neither of the two monitors were clean or ready for patient use. Interview revealed blood glucose monitors are not returned to the docking station until after they have been thoroughly cleaned with a disinfectant wipe and are ready to be used on the next patient. Interview revealed the blood glucose monitors were not clean and were not ready for patient use. Interview revealed findings of the observation indicated an educational opportunity for improvement.

Interview on 07/26/2016 at 1410 with Quality Manager #1 revealed blood glucose monitor #3 and #4 were not clean and were not ready for patient use. Interview revealed combined observations of nursing units toured indicated a need for more education and monitoring of the cleaning of medical equipment.

Interview on 07/26/2016 at 1620 with the hospital's Infection Control Preventionist (ICP) shared patient equipment should be cleaned with a hospital approved disinfectant after each use. Interview revealed blood glucose monitors are considered "shared equipment" and the expectation is that each monitor would be cleaned as described above prior to being placed on the docking station. Interview revealed routine audits are not performed to determine staff compliance with cleaning the monitors between patients. Interview revealed it is not acceptable practice to have blood glucose monitors with brownish-red spots or smears in the docking station ready for patient use. Interview revealed staff did not follow hospital policy.

10. Observations during unit tour of Unit A on 07/26/2016 at 1330 revealed two (2) HiLo solution bottles labeled with an expiration date of 07/21/2016 (5 days). Observations during tour of Unit B on 07/26/2016 at 1345 revealed three (3) HiLo solutions with no label indicating the date of opening.

Interview on 07/26/2016 at 1330 with Quality Manager #1 revealed when the control solution bottle is opened, the date of opening should be written on the bottle ' s label. Interview revealed the control solution is good for three (3) months from that date or until the expiration date on the bottle, whichever comes first. Interview revealed HiLo solutions on Unit A were out of date and should not be available for use. Interview revealed use of expired HiLo solutions and failure to label same with the date of opening was not acceptable practice.

NC 417