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Based on record review and staff interviews, it was determined the hospital failed to ensure manufacturer's instructions for three portable hemodialysis machines were followed and documented. This deficient practice poses a risk to the health and safety of patients if dialysis machines are not cleaned and maintained to accurately monitor and alert when there is a blood leak.

Findings include:

Policy titled, "Dialysis Program, Acute," revealed: " ...Purpose: ...Cobre Valley Regional Medical Center provides dialysis treatment, using the NxStage machine, for both acute renal failure patients and those end stage disease (ESRD) patients needing a hospital stay ...."

Document titled, "NxStage System One User Guide ...For Cycler Models ...NX1000-5-A," revealed: " ...Chapter 6 Maintenance ...Monthly Maintenance ...1. Clean the Blood Leak Detector once a month, or more frequently if necessary. It is located inside the cycler ...."

Documentation of the three portable hemodialysis machines blood leak detector monthly maintenance for the past three months was requested. None was provided.

Employee #35 confirmed during an interview conducted on 03/06/2025 that the hospital has three NxStage cycler model NX1000-5-A portable hemodialysis machines. Employee #9 confirmed the dialysis staff cleans the blood leak detector once a week but does not document the cleaning. Employee #9 confirmed there was no documentation to indicate the monthly maintenance of the blood leak detector was performed on the three portable hemodialysis machines.

Based on review of policies and procedures, medical staff rules and regulations, medical record, and staff interviews, it was determined the Governing Body failed to ensure the physician documented a face-to-face assessment after the initial application of behavioral restraints for 3 out of 3 patients. The deficient practice of not assessing patients while in restraints poses a risk to the health and safety of patients by not identifying and preventing potential or actual injuries sustained while in restraints or the need to continue the restraint of the patient when it is not necessary.

Findings Include:

Policy titled "Restraint Policy" dated 02/2022 revealed: " ...When restraints are used for the management of violent behavior or self-destructive behavior that jeopardizes the immediate physician safety of the patient, staff or others the patient must be seen face to face with in 1 hour after the initiation of the restraints by a physician, other LIP, Registered Nurse or Physician Assistant, for evaluation of the patients immediate situation, the patients reaction to the intervention, the patients' medical and behavioral condition, and need to continue or terminate the restraint ...."

Document titled "Medical Staff Rules and Regulations" revealed: " ...5.6 RESTRAINTS AND SECLUSION. Cobre Valley Regional Medical Center Restraint Policy governs the use of restraints within the institution. Practitioners must abide by the restraint policy whenever restraints are to be used ...."

A review of the patient's medical records on 03/04/2025.
Patient # 26's medical record dated 04/15/2024 at 0850 revealed: " ...Order Restraint-Violent Adult ...." No documentation of a face-to-face meeting was completed following the application of behavioral restraints.
Patient # 27's medical record dated: 09/12/2024, at 19:32 revealed: " ...Order Restraint Violent Adult ...." No documentation of a face-to-face meeting was completed following the application of behavioral restraints.
Patient # 28's medical record dated 12/29/2024, 0845 revealed: .... Order Restraint Violent Adult ..." No documentation of a face-to-face meeting was completed following the application of behavioral restraints.

Employee #10 confirmed during an interview conducted on 03/05/2025 that patient # 26, Patient # 27, and patient # 28's medical records did not reveal documentation of a physician face to face following the application of Behavioral Restraints.




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Based on record reviews and staff interviews, it was determined the hospital failed to ensure medical staff member pronounced and documented time of death, and completed the death certificate for a patient (Patient #9). This deficient practice poses a potential risk of unclear time of death leading to delaying suitability of organs for transplantation.

Findings include:

Policy titled, "Determination of Cardiac Death: Role of the RN," revealed: " ...V. Additional Information: ...Certification of death: Physician documentation regarding patient details of death including but not limited to date, time and cause of death. This can only be filled out by the physician ...."

Document titled, "Medical Staff Rules and Regulations," revealed: " ...4.7 Death in Hospital ...4.7.1 Pronouncing and Certifying the Cause of Death ...In the event of a hospital death, the deceased will be pronounced by the attending physician or his/her designee within a reasonable time. The body will not be released until an entry has been made and signed in the medical record of the deceased by the attending physician or another physician designated by the attending physician. The attending physician or his/her designee is responsible for certifying the cause of death, and completing the Death Certificate in a timely manner ...."

Patient #9's medical record dated 01/03/2025 identified a note titled, "ED - General Adult Hybrid," and it revealed: " ...terminally ill patient presenting to the ED with vomiting blood ....Physical Exam ...Patient is not responding to us ...appears to be very ill and is hypotensive bradycardic and appears to be passing away, patient is very pale and cachectic in appearance ...family wishes for comfort care. While examined (sic) the patient with ...family here the patient did pass away ....Patient Disposition: EXPIRED ...."

Patient #9's medical record dated 01/04/2025 identified a nursing note, and it revealed: " ...Deceased picked up by ...funeral service chosen by family ...."

Further review of Patient #9's medical record revealed no documentation of time of death, or death certificate.

Employee #3 and Employee #4 confirmed during an interview conducted on 03/04/2025 that there was no time of death documented in Patient #9's medical record. Employee #3 and Employee #4 also confirmed there was no death certificate in Patient #9's medical record.

Based on a review of Hospital records and staff interviews, it was determined that the Hospital failed to ensure that the assessment and re-assessment of patient status was documented at least every 15 minutes while one (1) patient while the patient was in behavioral restraints. The deficient practice of not assessing patients while in restraints poses a risk to the health and safety of patients by not identifying and preventing potential or actual injuries sustained while in restraints or possible death in a timely manner.

Findings Include:

Policy titled "Restraint Policy" dated 02/2022 revealed: " ...II. DEFINITIONS: Restraint includes either a physical restraint or a drug that is being used as a restraint. Non-behavioral (Medical) Restraint is defined as temporary immobilization in relation to a medical condition or post-surgical procedure to ensure the patient does not compromise healing process ...Behavioral Restraints are those restraints used only in emergent situations when there is an imminent risk of a patient harming themselves, staff, others, or property; when non-physical interventions are not viable; and when safety issues require and immediate physical response ...V. APPLICATION OF BEHAVIORAL RESTRAINTS ...B. A written or verbal order is obtained and documented on the Behavioral Restraint Order. The ordering physician completes and electronically signs the order for restraint on the Behavioral Restraint Order ...D. Documentation: Every 15 minutes, the patient's physical and behavioral status and needs for care are assessed and documented in the Electronic Medical Record by a competent, trained staff member. The patient's condition and needs the type of restraint used, the staff's clinical judgement will determine specific items will be assessed at any point in time ...."

Patient # 27's medical record dated: 09/12/2024, at 19:32 revealed: " ...Order Restraint Violent Adult ...." No documentation of patient assessment every 15 minutes.

Employee # 10 confirmed in an interview dated 03/04/2025 that patient # 27's medical record revealed that the nurse assessed the patient every 2 hours and not the required every 15 minutes.

Based on observation, review of hospital records, Center for Disease Prevention and Control (CDC) guidelines, and staff interviews, the Department determined the Hospital failed to ensure single-use solutions and multi-dose solutions and ointments were utilized and stored as to be free from contamination. This deficient practice poses a health and safety risk to patients and staff by possibly exposing them to contaminated wound care products.

Findings Include:

Policy titled "Medication Storage Area Inspection" revealed: "I. POLICY: All drug storage areas will be inspected at least monthly by the pharmacist or pharmacy technician. The purpose is to ensure medications are stored properly and to remove outdated, adulterated, or otherwise unusable medications from stock ...."

Policy titled "Expiration Dates for Multi Dose Vials" revealed: II. DEFINITIONS: Single Dose Vial: A vial that is free of preservatives and usually contains the labeling: "Single Dose." ...Multidose Vial A vial that contains a preservative and contains the labeling such as "Multiple Dose" or "Multiple Dose Vial." ...."

Hospital Document titled "Infection Prevention and Control Plan, dated 12/2024, revealed: " ...III.Procedure/Interventions (s) ...2. CVRMC's IP&C program shall be conducted in accordance with applicable federal and state rules and regulations. Nationally recognized IP&C practices and guidelines are available as a reference, including but not limited to: a. Centers for Disease Control (CDC) b. Association for Professional in Infection Control and Epidemiology (APIC) c. Society for Healthcare Epidemiology of America (SHES) d. Association of perioperative Registered Nurses (AORN) e. Occupational Health and Safety Administration (OSHA) F. Centers for Medicare and Medicaid Services (CMS) g. Institute for Healthcare Improvement (IHI) ...."

Document titled "CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings" revealed: " ...5. Standard Precautions Use Standard Precautions to care for all patients in all settings. Standard Precautions include: 5c. Injection and medication safety ...5c. Injection and Medication Safety References and resources: 7, 11, 16-20 ...Prepare medications in a designated clean medication preparation area that is separated from potential sources of contamination, including sinks or other water sources ...Ensure single-dose or single-use vials, ampules, and bags or bottles of parenteral solution are used for one patient only ...Dedicate multidose vials to a single patient whenever possible. If multidose vials are used for more than one patient, restrict the medication vials to a centralized medication area and do not bring them into the immediate patient treatment area (e.g., operating room, patient room/cubicle) ...."

An observation of 3 patient cubicles located in the wound care unit on 03/04/2025 revealed:
2 open and dated 4-oz bottles of betadine solution labeled for single use
2 bottles of Medline READY PREP opened and dated 10/16/2024 and 12/20/2024,
Hydrogen Peroxide Solution 3%, opened and dated 10/09/2023
Aquaphor ointment opened and dated 01/30/2024 and10/21/2024

Employees # 1 and Empoyee # 22 both confirmed during an interview conducted on 03/04/2025 that these items were being used on multiple patients after opening.

Based on record reviews and staff interview, it was determined the hospital failed to ensure the facility's leaving against medical advice (AMA) policy was followed, and one of three patients (Patient #5) was encouraged to stay and risks of leaving AMA was explained. This deficient practice poses a risk to the health and safety of patients if all pertinent information was not presented to make an informed decision about leaving AMA.

Findings include:

Policy titled, "Leaving Against Medical Advice (AMA)," revealed: " ...III. Procedure ...A. Every effort should be made to encourage the patient to remain under the care of the physician ....C. The physician should document in the chart that the patient has left against medical advice, noting the date and time, disclosure as to the risks of leaving, a determination that the patient understands and accepts the risks of leaving against medical advice, and documentation concerning the recommended treatment to which the patient refuses to consent ...."

Patient #5's medical record dated 01/31/2025 identified a section labeled "SBAR," and it revealed: " ...Fri Jan 31 16:14 ...This RN notified MD that the patient is requesting to leave the facility. MD advised that the patient can leave AMA ...Fri Jan 31 16:55 ...This RN notified MD that the patient is leaving AMA ...."

Review of Patient #5's medical record revealed they left AMA on 01/31/2025 at 1715.

Review of Patient #5's medical record revealed no documentation that Patient #5 was encouraged to remain in the hospital for medical evaluation and treatment. Further review of Patient #5's medical record revealed no documentation in the physician notes that risks of leaving AMA were explained to the Patient #5.

Employee #3 confirmed during an interview conducted on 03/04/2025 that Patient #5 left AMA. Employee #3 also confirmed there was no documentation Patient #5 was encouraged to stay for medical treatment or risks of leaving AMA were explained. Employee #3 confirmed the facility's AMA policy was not followed.