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900 E BROADWAY

BISMARCK, ND 58501

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on record review, policy and procedure review, and staff interview, the Hospital failed to ensure 1 of 3 inpatient psychiatric patients (Patient #25) records reviewed received care with respect and dignity. Failure to care for a psychiatric patient in a respectful and dignified manner may have resulted in triggering an avoidable behavior.

Findings include:

Review of psychiatric policies occurred on 10/18/17 and included:
* "Precautions," dated 05/01/17, defined the purpose as "To provide guidelines for staff that care for patients on the inpatient psychiatry unit who are on designated acuity precautions." The procedure stated, "All patients admitted to psychiatry are monitored ongoing for aggression . . . boundaries . . . psychosis . . . safety concerns as part of daily assessments and safety rounding. These are all standard precautions taken into consideration on every patient. . . . PSYCHIATRY PRECAUTIONS: A. Aggression 1. Definition: A patient who demonstrates angry or agitated behavior at staff or peers either verbally or physically. This may include posturing towards staff, yelling, or making threatening comments. 2. Interventions: a. Offer less stimulating environment/room if able b. Offer time in QR [quiet room] to calm down as needed c. Separate patient from stressor if able d. Set clear boundaries on respectful and therapeutic communication and and actions with patients and staff . . . g. Evaluate need for . . . Individualized Staffing/1:1 Staffing (this should only be used if all other interventions fail). . . ."
* "TIME-OUT / QUIET ROOM," dated 02/17, stated, "Time-out / Quiet Room may be used as a means to allow the patient to regain control, reflect on their behavior and identify what alternatives could have been more effective. . . . PROCEDURES: . . . 1. A time-out / Quiet Room is not to be utilized for staff convenience, or as a punishment for behaviors. Patient behaviors that are disruptive to the therapeutic environment may include: . . . 2. Staff redirects patient by informing them behavior is disruptive. Staff provides patient with alternative choices. Staff set limits in a clear, simple, reasonable and enforceable manner. 3. If patient fails to respond to redirection in an appropriate manner, a time-out / Quiet Room may be considered to allow the patient to regain control. . . . 4. Areas used for time-out / quiet room may be . . . unlocked quiet room. Patients are monitored closely and time-out is discontinued when behavior is calm or when time limit expires. . . ."

* "Patient Rights and Responsibilities," dated 12/21/16, stated, "We at [the Hospital] stand committed to a mission of healing and hospitality. This commitment is evidenced through the care we provide in accordance with the following patient rights: . . . 3. The right to considerate and respectful care. . . . 26. The right to receive care in a safe, secure, and least restrictive environment . . ."

- Review of Patient #25's medical record occurred on all days of survey. Diagnoses included schizophrenia, suicidal ideation, and closed displaced fracture of the neck of the right fifth metatarsal bone.

The record included a psychiatric intake by a registered nurse on 10/06/17 at 10:14 p.m. The intake lacked indication of the patient having any physical injuries.

The record included a history and physical completed by a child and adolescent psychiatrist on 07/07/17. "Review of Systems" identified no abnormalities.

A "Plan of Care" nursing progress note, dated 10/08/17 at 1:21 a.m., stated, "The pt [patient] was isolative [sic] towards the start of the shift with the covers pulled over his head. The pt was provided 1 to 1 about that time with regard to support and encouragement. The pt was somewhat receptive at that time and provided feedback of his own. The pt stated several times during the 1 to 1 that 'I just don't feel right.' The pt [sic] asked what he meant by this comment and said it was in his head and psych. The pt inquired if the QR [Quiet Room] was still available and referred to it as 'the box' and chuckled. The pt was informed that it was available if he wanted to use it. The pt declined at that time. About one hour later the pt had a blanket over his head and was shaking his head some back and forth. The pt said he was hearing voices telling him to kill others. The pt was encouraged and prompted to use the QR, since it had helped at times during his previous hospital stay. The pt refused at that time with ample prompting and encouragement, but agreed about 15 minutes later. The pt voluntarily walked to the unlocked QR and first stood and the [sic] sat in the corner underneath the camera. The pt refused to move at that time. The pt was also, being monitored per camera, but was unable to be seen. This nurse returned to the QR and the pt was beginning to pull the mattress over him. The mattress was removed from the QR and the pt was again asked to move out of the corner in ordered [sic] to be monitored for safety. The pt continued to refuse and ignore this nurse as he sat in the corner with a blanket over his head. The blanket was removed and the patient continued to ignore this nurse with his head hanging between his legs. The patient was unable to be redirected with numerous prompts and reasons as to why he cannot be under the camera and out of view of the camera. The nurse grabbed hold of the pts [sic] foot and pulled him from the corner. The pt became upset, angry and hostile and wanted to fight. The pt stood in front of this nurse threatening and wanting to fight, as well as, throwing punches towards this nurses face to taunt and entice this nurse into a fight. Psych Tech [first name] then entered the QR and pt was able to stop this behavior. The pt remained in unlocked QR for about 30 more minutes and monitored on the camera. The pt then went to his RM [room] when an adult pt need [sic] the QR. The pt was escorted to his RM by Psych Tech and informed the Tech that he thought he fractured his hand. The pts [sic] was unable to make a fist with the hand as it was painful already turning blackish/bluish to knuckle of his little finger. Ice was applied to the area and Dr. [last name] was called and orders received. Radiology X-rayed the hand per three views on the unit. The X-ray showed a possible boxer fracture to the knuckle of the little finger on the right hand. Dr [last name] was called and further orders were received. The Orthopedic on call PA [physician's assistant] was paged and informed of the incident. Further orders were received. The pt was provided blankets to elevate the hand and encouraged to keep the area iced. . . ."

The attending psychiatric physician progress note, dated 10/08/17 at 7:04 p.m., stated, ". . . the patient is floridly psychotic. The patient was very agitated last evening and responding to voices. He was aggressive and agitated with staff. He punched a door. An x-ray of hand was obtained. He has a fracture of finger. Orthopedic surgery was counseled [sic]. There needs to be surgical correction of it. . . ."

The attending psychiatric physician progress note, dated 10/09/17 at 12:46 p.m. stated, ". . . 17 y.o. [year old] male . . . Orthopedic surgery will follow-up his fractured finger. . . ."

A physician note from the orthopedic surgery service, dated 10/10/17 at 8:41 a.m. stated, "We reviewed patient's xrays. All he needs is a ulnar gutter splint . . . No surgery needed. . . ."

During interview on the morning of 10/17/17, a staff member (#18) stated that when a patient is in the QR and staff cannot monitor them on the camera, staff are expected to observe the patient every 5, 10, or 15 minutes depending on the patient.

The incident between a staff nurse and Patient #25 resulted in a confrontation and an aggressive response from the patient. The nurse failed to follow the Hospital policy regarding "Precautions" for psychiatric patients which included separating the patient from "stressors if able." "Precautions" included treating the patient with "respectful and therapeutic communication" and "Evaluate need for . . . Individualized Staffing/1:1 Staffing."

NURSING CARE PLAN

Tag No.: A0396

Based on observation, record review, policy and procedure review, and staff interview, the Hospital failed to ensure staff developed a Plan of Care and/or reviewed or revised the Plan of Care for 5 of 29 (Patients #1, #7, #20, #25, and #27) active records reviewed. Failure to develop and/or review and revise the Plan of Care limited the Hospital's ability to manage patient needs, communicate treatment approaches, and ensure continuity of care.

Findings include:

Review of the hospital policy titled "Plan of Care" occurred on 10/18/17. This policy, dated August 2017, stated, "PURPOSE: The purpose of this Policy is: To assure that the hospital provided the patient with care, treatment and services according to his or her individualized plan of care. To facilitate consistency and continuity in patient care. To facilitate multidisciplinary communication regarding the needs of the patient . . . Care Plan: an electronic or written plan based on data gathered during assessment that identifies care needs and treatment goals, describes the strategy for meeting those needs and goals, outlines the criteria for terminating any interventions, and documents progress toward meeting the plans objectives. PROCEDURES: . . . D. Planning: Documentation of this phase of the nursing process demonstrated that the clinical status of the patient was recognized and that the nurse developed an appropriate, individualized plan of care. *The purpose of documenting the plan of care is to: 1. Direct the contributions of all care providers towards the achievement of positive patient outcomes. 2. Promote collaborative practice, coordination of care and continuity of care. 3. Strengthen the collaborative nature of patient care through mutually agreed upon outcomes, timelines and processes. *The plan of care must contain the following elements: 1. Patient problem/aspect of care. 2. Expected patient outcome (Standards of Care). 3. Caregiver interventions to achieve patient outcomes (Standards of Practice). *Documentation of the patients' plan of care will show that: 1. It is individualized to the patient. 2. Initiated on admission. 3. Developed by a RN [registered nurse]. 4. Updated regularly to reflect current patient status."

Review of the hospital policy titled "GUIDELINES FOR THE COORDINATION OF CARE OF A DIALYSIS PATIENT" occurred on 10/18/17. This policy, dated July 2016, stated, "PURPOSE: To provide other care providers with information on care of a dialysis patient for continuity of care and achievement of patient's expected outcomes. RESPONSIBILITY: Unit where dialysis patient is admitted. PROCEDURE: A. The guidelines for dialysis patients are to be integrated into the patient's care plan to enhance continuity of care. . . ."

- Review of Patient #7's medical record occurred on 10/17/17. Patient #7's diagnoses included end stage renal disease on peritoneal dialysis. Patient #7's medical record identified an admission date of 10/13/17 with orders to receive peritoneal dialysis over a 10 hour period each night. Review of Patient #7's current Plan of Care identified Physiological Instability as a problem/aspect of care, but failed to develop, identify, or individualize the care plan with any expected patient outcomes or interventions/evaluations regarding peritoneal dialysis. An administrative nurse (#14) and a staff nurse (#6) both confirmed staff had not developed or included peritoneal dialysis in Patient #7's Plan of Care.


17256


- Review of Patient #25's medical record occurred on all days of survey. Diagnoses included a fracture of the fifth right finger on 10/08/17.
A progress note, dated 10/08/17, stated the patient ". . . informed the Tech that he thought he fractured his hand. The pts [sic] [patient] was unable to make a fist with the hand as it was painful already turning blackish/bluish to knuckle of his little finger. Ice was applied to the area and Dr. [last name] was called and orders received. Radiology X-rayed the hand per three views on the unit. The X-ray showed a possible boxer fracture to the knuckle of the little finger on the right hand. Dr [last name] was called and further orders were received. The Orthopedic on call PA [physician's assistant] was paged and informed of the incident. Further orders were received. The pt was provided blankets to elevate the hand and encouraged to keep the area iced. . . ."

Following the finger injury, the record lacked a plan of care to address the injury. Notes reviewed included:
* 10/09/17 at 5:26 p.m., a progress note identified the patient having pain in the hand but the patient didn't complain about it
* 10/11/17 at 12:22 p.m., Addressed the problem of PSYCHOSIS: ". . . Rt. [right] Hand swollen. Able to move fingers. Reminded to keep hand elevated . . . Rt hand swollen."
* 10/12/17 at 11:11 p.m.: "Problem: RISK FOR SUICIDE. . . . The pt was also, medicated with PRN [as needed] tylenol at HS [bedtime] for right hand pain. . . ."
* 10/13/17 at 3:28 p.m. "Patient fit for hand-based Ulnar Gutter splint for distal 5th metacarpal neck fracture. Splinting session completed with psych nurse providing supervision . . . OT [occupational therapy] provides education on current hand injury. Patient instructed on wearing schedule to wear at all times except off for hand hygiene. . . . Nursing encouraged to contact this therapist directly should any splint issues arise."
* 10/13/17 at 4:58 p.m.: "Problem: SUBSTANCE USE/ABUSE . . . He was seen by hand OT & a splint was applied on his right hand. Ice pack was also placed to reduce swelling."

The record showed nursing staff assessed the injury once daily and not on all shifts. Review of Patient #25's plan of care failed to identify the fracture as a problem.

During an interview on the afternoon of 10/16/17, a psychiatric clinical supervisor (#9) stated the plan of care should have included the specific problem of the fracture.

- Review of Patient #27's record occurred on all days of survey. Admission occurred on 10/14/17 with diagnoses of pneumonia and sepsis.

Progress notes entered by a respiratory therapy staff member included:
* 10/14/17 at 7:14 p.m., "Pt educated on IH [inhalation/incentive spirometry - deep breathing technique], encouraged to use per self, pt stated that he liked using IH because it helps him a lot. Will continue to monitor . . . Encouraged DB&C [deep breathing and coughing]."
* 10/15/17 at 4:03 p.m., ". . . instructed on flutter valve purpose and use. He will use that as well as incentive spirometry per self. . . ."

Patient #27's plan of care lacked an entry to identify the problem of alteration of respiratory status and measures implemented.

During an interview on 10/16/17 at 5:30 p.m., a supervisory staff nurse (#7) stated she would expect the plan of care to reflect the respiratory problem and use of the respiratory devices, and she would expect staff to individualize the care plan for pertinent problems.



22495

- Review of Patient #20's medical record occurred on October 16-17, 2017 and showed an admission date of 10/07/17. The patient had coronary artery bypass grafting (CABG) on 10/12/17, went to the intensive care unit after the procedure, and transferred to the progressive care unit on 10/16/17.

Observation on 10/16/17 at 11:20 a.m. showed Patient #20 laying on the bed with a pillow hugged to his chest, oxygen in place via nasal cannula, and an incentive spirometer (a device used to measure how deep an individual can breathe in and to prevent lung problems, such as pneumonia) on the bedside table. Observation showed a nurse (#16) instructed the patient how to utilize the incentive spirometer, how often, and the importance of deep breathing and coughing.

Review of Patient #20's care plan showed the respiratory care goal met on 10/15/17 and failed to show the current problem/aspect of care, patient outcome, and interventions/evaluations for Patient #20's respiratory care related to oxygen use, the incentive spirometer, and deep breathing and coughing.

During an interview on the morning of 10/17/17, a nurse supervisor (#17) agreed Patient #20's care plan should include the respiratory care/interventions.


32641


- Review of Patient #1's medical record occurred on October 16-17, 2017 and showed an admission date of 10/11/17. Diagnoses included bleeding from hemodialysis shunt, urinary tract infection (UTI), sepsis, nephrostomy tube, Multi-Drug Resistant Organisms (MRDO), Stenotrophomonas, Vancomycin-Resistant Enterococci (VRE).

Observation on 10/16/17 at 1:15 p.m. showed a staff nurse (#8) completed a dressing change on Patient #1's nephrostomy tube.

The record showed the following:
* 10/11/17 - Bedside procedure for shunt clot removal
* 10/11/17 - Nephrostogram with tube exchange and left thoracentesis
* 10/12/17 - Antibiotic ordered after positive urinary analysis
* 10/13/17 - Hospitalist note stated "fever . . . sepsis related to UTI due to nephrostomy tube
* 10/14/17 - Blood transfusion of two units

Review of Patient #1's current care plan showed no problem/aspect of care, patient outcome, and interventions/evaluations for the patient's infection process or nephrostomy tube which required dressing changes.

During an interview on the morning of 10/17/17, a supervisory nurse (#13) agreed the care plan lacked the problem for infection, nephrostomy tube, and/or skin.

ADMINISTRATION OF DRUGS

Tag No.: A0405

PRN MEDICATIONS

1. Based on record review, professional literature review, and staff interview, the Hospital failed to assess and/or document in a timely manner the effectiveness of medications given to patients on an as needed (PRN) basis for 9 of 29 active patient (Patients #1, #2, #4, #18, #19, #20, #27, #28, and #29) records reviewed. Failure to assess the patient prior to PRN medication administration and evaluate the patients' responses limited the nursing staff's ability to determine whether the medication achieved the desired effect or if the patients experienced any side effects or adverse reactions from the medication.

Findings include:

Berman and Snyder, "Kozier & Erb's Fundamentals of Nursing: Concepts, Process, and Practice," 10th ed., Pearson Education, Inc., New Jersey, 2016, page 771, 773, 774, 778, and 1109 stated, ". . . Process of Administering Medications: When administering any drug . . . the nurse must do the following: . . . 6. Evaluate the client's response to the drug. . . . In all nursing activities, nurses need to be aware of the medications that a client is taking and record their effectiveness as assessed by the client and the nurse on the client's chart. . . . Right Assessment - Some medications require specific assessments prior to administration . . . Right Evaluation - Conduct appropriate follow-up (e.g. [for example], was the desired effect achieved or not? Did the client experience any side effects or adverse reactions?). . . . Narcotic Analgesic [e.g. oxycodone, Percocet, Percodan] . . . Assess pain prior to and 60 minutes after administration. . . ."

- Review of Patient #1's active medical record occurred on all days of survey. Diagnoses included bleeding from hemodialysis shunt, diabetes, and coronary artery disease. The record identified a physician's order for Tylenol 650 milligrams (mg) PRN for pain.

Patient #1's medication administration record (MAR) from 10/11/17 to 10/16/17 showed the nursing staff administered Tylenol 650 mg on five occasions.
* On one occasion staff failed to document the patient's response to the medication
* On two occasions staff failed to document an assessment before and a response after the medication.

- Review of Patient #2's active medical record occurred on all days of survey. Diagnoses included acute appendicitis (perforation) and infection with antibiotic treatment. The record identified a physician's order for oxycodone 1-2 tablets every four hours PRN for moderate pain.

Patient #2's MAR from 10/11/17 to 10/15/17 showed the nursing staff administered oxycodone on four occasions and failed to document the patient's response to the medication.

During an interview on 10/16/17 at 2:00 p.m., a nurse supervisor (#6) agreed documentation showed no follow-up assessments for Patient #2's administered oxycodone doses and expected nursing staff to complete a follow-up assessment for PRN medications within one hour.

- Review of Patient #4's active medical record occurred on all days of survey. Diagnoses included contusion of both lungs. The record identified a physician's order for oxycodone 5-10 mg every four hours PRN for moderate pain.

Patient #4's MAR from 10/15/17 to 10/16/17 showed nursing staff administered oxycodone on six occasions and on two occasions failed to document the patient's response to the medication.

During an interview on 10/18/17 at 10:30 a.m., a nurse manager (#7) stated the follow-up assessment time for PRN medications depended on the pharmacological action of the medication and the route administered (by mouth, IV [intravenous], etc. [et cetera]).


22495


- Review of Patient #18's active medical record occurred on October 16-17, 2017. Diagnoses included a bowel obstruction. Physician's orders included Fentanyl every two hours PRN and Dilaudid every four hours PRN for pain.

Patient #18's MAR, dated 10/13/17, showed the following:
* The nurse administered fentanyl at 1:52 a.m. and failed to document the patient's response until 4:29 a.m., approximately two and a half hours later. Patient #18 complained of pain at that time (4:29 a.m.) and the nurse administered Dilaudid. The nurse failed to assess and document the patient's response to the Dilaudid until 6:14 a.m. approximately one hour and 45 minutes later. Patient #18 complained of pain at that time (6:14 a.m.), and the nurse administered fentanyl. The nurse failed to reassess and document the patient's response to the fentanyl until 9:09 a.m., approximately three hours later.
* The nurse administered Dilaudid at 1:37 p.m. The nurse failed to document the source of the pain and failed to reassess and document the patient's response to the medication.
* The nurse administered Dilaudid at 5:56 p.m.. The nurse failed to document the source of the pain and failed to reassess and document the patient's response to the medication.
* At 10:22 p.m., Patient #18 complained of pain and stated he would wait and take the pain medication later. At 11:40 p.m., the nurse administered Dilaudid and failed to assess the patient's pain. The nurse failed to reassess and document the patient's response to the pain medication.

- Review of Patient #19's active medical record occurred on October 16, 2017. Diagnoses included memory loss and decreased alertness. Physician's orders included morphine one to two mg PRN for pain.

Patient #19's MAR, dated 10/16/17, showed the administration of Morphine one mg at 8:45 a.m. Nursing staff failed to reassess and document the patient's response to the medication.

- Review of Patient #20's active medical record occurred on October 16-17, 2017. Diagnoses included chest pain. Physician's orders included Morphine PRN for pain.

Patient #20's MAR, dated 10/14/17, showed the following:
*Administration of Morphine at 4:00 a.m. for pain and no reassessment or documentation of the patient's response to the medication until 8:00 a.m., four hours later.
* Administration of Morphine at 12:04 p.m. for pain and no reassessment or documentation of the patient's response to the medication until 2:24 p.m., approximately two and one half hours later.
* Administration of Morphine at 5:31 p.m. for pain and no reassessment or documentation of the patient's response to the medication until 8:39 p.m., approximately three hours later.

During an interview on the afternoon of 10/17/17, a nurse supervisor (#17) stated she expected nurses to conduct a follow up assessment after administering pain medications to patients.


17256


- Review of Patient #27's record occurred on all days of survey. Diagnoses included pneumonia and sepsis. The record identified a physician's order for Dilaudid (administered for moderate to severe pain) intravenously 0.5 mg every four hours PRN for severe pain.

Patient #27's MAR from October 15-16, 2017, showed the nursing staff administered the Dilaudid for headache or tooth pain on six occasions. The record showed on these six occasions nursing staff did not follow-up on the medication effectiveness until administration of the next dose.

During interview on 10/16/17 at 4:20 p.m., a supervisory staff nurse (#7) stated staff should re-assess the effectiveness of PRN medication based on the actions of the drug.

- Review of Patient #28's medical record occurred on all days of survey. Diagnoses included alcoholic cirrhosis of the liver with ascites. The record identified a physician's order for Morphine Sulfate (potent pain medication) IV one to two mg every four hours as needed.

Patient #28's MAR from October 12-17, 2017 showed nursing staff administered 12 doses of two mg Morphine Sulfate and failed to assess the effectiveness of the medication on six occasions.

- Review of Patient #29's medical record occurred on all days of survey. Diagnoses included B-cell lymphoma and respiratory insufficiency. The record identified medication orders for Zofran (an anti-emetic) IV or by mouth every six hours PRN. The MAR identified two IV doses and one oral dose administered during the patient's hospitalization. The record lacked evidence of the reason for the medication administrations and an assessment for the medication effectiveness.

INSULIN PENS

2. Based on observation and policy and procedure review, the Hospital failed to follow professional standards of practice for 1 of 1 patient (Patient #6) observed receiving insulin medication administration. Failure to properly clean the hub and prime the insulin pen may result in contamination and/or an incorrect dose of insulin.

Findings include:

Review of the Hospital policy "Nursing Guidelines For Insulin Pen Use" occurred on 10/17/17. This policy, amended July 2017, stated, ". . . D. Administration: 1. Swab hub of pen with alcohol and allow to dry . . . 3. Prime safety needle a. Turn dose selector to select 2 units. b. Hold pen with needle pointing up. Tap cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge. c. Keep the needle pointing upwards; press the push button all the way in until the dose selector returns to 0. A drop of insulin should be visible at top of needle. . . ."

Observation on 10/17/17 at 8:45 a.m. showed a nurse (#1) prepared an insulin Flex Pen prior to injecting Novolog insulin to Patient #6. The nurse (#1) failed to swab the hub of the pen with alcohol and failed to hold the Flex Pen in an upright position while priming with two units of insulin.

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on record review, policy and procedure review, professional reference review, and staff interview, the Hospital failed to ensure hospital staff signed, dated, and timed the unit tag when receiving blood products from the blood bank or laboratory for 1 of 3 active patient (Patient #21) records reviewed who received blood/blood product transfusions. Failure to sign, date, and time the unit tag had the potential for patients to receive compromised blood/blood products.

Findings include:

Review of the policy titled "Transfusions - Blood and Blood Products" occurred on 10/18/17. This policy, reviewed January 2016, stated, PURPOSE: Provide safe administration of blood products. . . . POLICY: . . . G. STORAGE OF BLOOD PRODUCTS: . . . If blood cannot be infused when it arrives on the floor, it should be returned immediately to the Blood Bank. It can be accepted back for re-issue provided the time between release of the blood and its return does not exceed 30 minutes. . . . ESSENTIAL STEPS IN PROCEDURE/KEY POINTS: . . . 6. Obtain the blood or blood products from the pneumatic tube system or Laboratory. Staff member retrieving the blood must perform the following steps: . . . If all elements match, sign, date, and time the blood unit tag, as the receiving staff member. . . ."

Berman, Snyder, and Frandsen, "Kozier & Erb's Fundamentals of Nursing, Concepts, Process, and Practice", 10th edition, Pearson Education, Inc., New Jersey, page 1362 stated, "Clinical Alert! . . . Make sure that the blood is left at room temperature for no more than 30 minutes before starting the transfusion. . . . Rationale: As blood components warm, the risk of bacterial growth also increases. If the start of the transfusion is unexpectedly delayed, return the blood to the blood bank after 30 minutes. . . ."

Review of a blood unit tag (attached to the blood/blood product bag by the blood bank) included the statement, "I have verified patient name, MR# [medical record number], blood product received with blood product request form," and an area for the staff member who obtained the blood product from the blood bank or laboratory to sign, date, and time the tag.

Review of Patient #21's active medical record occurred on October 17-18, 2017. The patient's record showed hospital staff administered blood/blood products 31 times from October 03-05, 2017. The staff member who obtained the blood/blood product failed to sign, date, and time the tag eleven times.

During an interview on the afternoon of 10/17/17, a nurse supervisor (#5) stated she would expect staff members to sign the unit tag attached to the blood/blood product when they receive the product from the blood bank or laboratory.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on record review, policy and procedure review, professional reference review, and staff interview, the Hospital failed to ensure patients received informed consent from the health care practitioner responsible for conducting the medical procedures and/or anesthesia for 3 of 30 patient (Patients #8, #21, and #22) records reviewed. Failure to ensure health care practitioners obtained written and signed informed consent limited the patients' rights to fully consent to the medical procedure and/or anesthesia.

Findings included:

Review of the policy titled "CONSENT FOR OPERATION OR OTHER PROCEDURE" occurred on 10/18/17. This policy, dated July 2016, stated, "A consent form is a written authorization by the patient or legal representative which indicates his/her permission and knowledge of the procedure to be performed. Consents must be signed and witnessed before each surgical procedure, specified treatment, or diagnostic test. . . ."

Berman, Snyder, and Frandsen, "Kozier & Erb's Fundamentals of Nursing, Concepts, Process, and Practice", 10th edition, Pearson Education, Inc., New Jersey, page 53-55, stated, ". . . Informed consent is an agreement by a client to accept a course of treatment or a procedure after being provided complete information, including the benefits and risks of treatment, . . . Nurses are often asked to obtain a signed consent form. The nurse is not responsible for explaining the procedure but for witnessing the client's signature on the form. The nurse's signature confirms three things: *The client gave consent voluntarily. *The signature is authentic. *The client appears competent to give consent."

- Review of Patient #21's medical record, on 10/17/17, showed two staff members signed a surgery consent form on 10/05/17, but failed to obtain the patient or the legal representative's signature. The patient's medical record also showed an anesthesia consent form, signed by the anesthesiologist on 10/13/17, which staff had failed to enter the patient's name and date of the surgery/procedure. Staff entered "covered by the procedure consent from family" on the patient or legal representative signature line.

- Review of Patient #22's medical record on 10/17/17 showed an anesthesia consent form, signed by the patient's representative and anesthesiologist on 10/05/17. Hospital staff failed to enter the patient's name and the date of surgery/procedure.

- Review of Patient #8's medical record on 10/18/17 showed an anesthesia consent form, signed by the patient's representative and anesthesiologist on 10/12/17. Hospital staff failed to enter the patient's name and the date of surgery/procedure.

During an interview on the afternoon of 10/17/17, a nurse supervisor (#5) confirmed nursing staff should ensure completion of consent forms.





19410

SECURE STORAGE

Tag No.: A0502

Based on observation, policy review, and staff interview, the Hospital failed to ensure the security of medications on 4 of 4 patient care areas (medical, neuro/surgical, ortho/surgical, and oncology nursing units) observed with unlocked medication storage. Failure to store medications in a secure area limited the hospital's ability to prevent unauthorized personnel, visitors, and/or patients access to medications.

Findings include:

Review of the "MEDICATION STORAGE AREAS" policy occurred on 10/16/17. The policy, dated 07/17, stated, "The Pharmacy Department is responsible for assuring medications are . . . accounted for throughout the hospital. The proper storage and accountability are . . . to prevent access to medications by unauthorized persons, and to prevent diversion of medications to unintended persons. PROCEDURES: A. Pharmacy medication storage systems include the central pharmacy, med rooms, automated dispensing unit machines, medication carts . . . and refrigeration units. B. Drugs shall be stored under the proper conditions of . . . security. C. All medication storage areas located throughout the hospital shall be locked and/or under the direct supervision of personnel approved to handle the medications at all times. When it is impossible to impractical to lock a medication storage unit, as in the case of some refrigerators, those storage units must be located in a secure area which is not accessible to unauthorized personnel. D. All medication carts shall remain locked at all times when not in use. . . ."

Review of the "SECURITY - PHARMACY" policy occurred on 10/17/17. The policy, dated 07/17, stated, "POLICY: All Pharmacy personnel must strictly adhere to all security systems and controls within the hospital and to those security measures that apply to the Pharmacy. PROCEDURE: . . . Security of Medication Areas: A. All drug storage areas will be locked when not in use. B. Medications in patient care areas shall be accessible only to individuals responsible for administering medications to patients. . . . D. All medication rooms and carts shall be locked when not in use. . . . E. When impossible/impractical to lock a medication storage unit, such as refrigerators, those storage units must be located in a secure area which is not accessible to unauthorized personnel. . . ."

- On the afternoon of 10/16/17, observation of the oncology nursing unit occurred. On a counter under a medication refrigerator sat an open bin marked "discharge meds." The bin contained individual packages of medications. An unlocked medication refrigerator contained individual bags of medication and syringes of lidocaine (a local anesthetic).

During interview on the afternoon of 10/16/17, a supervisory staff member (#7) stated staff utilized the bin to place patient medications not used during patients' hospital stays. The staff member stated staff put the medications in the bin and pharmacy picked up the medications daily.

An interview occurred with two pharmacists (#12 and #19) on the morning of 10/17/17. The pharmacist (#12) stated pharmacy staff picked up the discharged patients' medications in the bins twice daily. The pharmacist confirmed non-nursing staff should not have access to medications.


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- Observation on the afternoon of 10/16/17 and the morning of 10/17/17 showed an open plastic bin placed on the counter of the nurses' station/medication area of the medical, neuro/surgical, and ortho/surgical units containing discharged patients' medication for pharmacy return. Each unit contained an unlocked refrigerator containing patients' intravenous antibiotics and syringes of lidocaine.

During an interview on the morning of 10/17/17, an administrative nurse (#15) stated the bins contained non-narcotic, non-controlled medications of discharged patients; the pharmacy picked up these medications twice daily; and prior to discharge, staff stored the patients' medications in a locked medication cart. The nurse verified the unlocked refrigerators contained patient intravenous medications and a locked container for any controlled medications.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, policy and procedure review, and staff interview, the Hospital failed to store, prepare, distribute, and serve food under sanitary conditions in 1 of 1 kitchen. Failure to ensure a clean environment, proper storage of raw meat, and correct sanitizer solution concentrations had the potential to place patients, staff, and visitors consuming food items from the kitchen at risk for food borne illness.

Findings include:

Review of the policy, "Food Protection and Maintenance of Temperature" occurred on 10/18/17. This undated policy stated, "POLICY: All food while being store, prepared, displayed or served from St. Alexius Food and Nutrition Services Department will be protected from contamination . . . PURPOSE: To eliminate the contamination of food from any source within the Food and Nutrition Services Department. To prevent the growth of disease-producing organisms and the production of bacterial toxins. GUIDELINES: 1. All food, while being stored, prepared, displayed or served . . . will be protected as much as possible from contamination by dust and vermin . . . 2. . . . Food shall be stored on shelves from top to bottom in order of those requiring the most time in cooking being stored at the bottom. . . . All food shall be covered as much as possible to protect it from contamination during transportation . . . or in storage. . . . All food contact surfaces must be sanitized with solutions at proper dilutions . . ."

Review of the policy, "Cleaning and Handling of Dishes, Utensils, Equipment and Work Surfaces" occurred on 10/18/17. This undated policy stated, ". . . PURPOSE: To minimize chances for contamination of food during preparation, storage and serving and thus, the transmission of disease organisms to patients and employees. . . ."

Observation of the hospital kitchen occurred on 10/18/17 at 9:00 a.m. with an administrative dietary staff member (#3) and a dietary supervisor (#4) and included the following:

- A reach-in cooler with a shallow pan of raw chicken breasts stored above a pan of raw ground beef and raw beef steaks.

- Red sanitation buckets in food preparation areas. The administrative dietary staff member (#3) stated the buckets contained "Quat" (quaternary ammonium) sanitizer solution used for sanitizing work surfaces and the concentation should be between 150-400 ppm (parts per million). The staff member (#3) tested the solution in two buckets with test strips and both showed less than 150 ppm.

- The walk-in cooler had a fan with an accumulation of dust particles blowing over a cart with uncovered containers of vegetables.

- The dishwashing room had a large fan with an accumulation of dust/debris on the blade and wire cage, blowing in the direction of a rack of clean dishware.

During interviews the morning of 10/18/17, staff members #3 and #4 confirmed staff should store the raw chicken below the raw beef; staff member #3 confirmed the sanitizing solution should be greater than 150 ppm; and staff member #4 confirmed staff should keep the fans clean of dust/debris.