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Based on observation, interview and record review, the facility failed to follow professional standards of care and facility policy regarding patient care and assessment for two dialysis patients (#2 and #3) of two patients observed with known risks during treatment. This had the potential to affect all dialysis patients in the facility. The facility census was 752.

Findings included:

1. Record review of the Centers of Medicare and Medicaid Services document titled, "ESRD [End Stage Renal Disease] Basic Technical Surveyor Training Interpretive Guidance, Interim Final Version 1.1" dated October 3, 2008 gives the following guidance:
- Patients must be in view of staff during Hemodialysis treatment to ensure patient safety;
- Each patient, including his/her face, vascular access site, and bloodline connections, must be able to be seen by a staff member throughout the dialysis treatment, (video surveillance will not meet this requirement);
- Allowing patient to cover access sites and line connections provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected which could result in exsanguinations [bleeding out] and death in minutes.

Record review of the facility policy titled, "Clinical Procedures" revised 08/12, gave the following direction to clinical staff in the Dialysis (Hemodialysis) Unit:
- Purpose: Ensure patient safety and extend the use of the patient's vascular access;
- Patients face, vascular access site and bloodline connections will remain in view throughout the dialysis treatment.

Dialysis is a specialized treatment that requires visual contact with the patient and the patient's access site at all times throughout dialysis treatment as a standard of practice. Dialysis access is an entranceway into the patient's bloodstream that lies completely beneath the patient's skin. The access is usually in the arm, but sometimes in the leg, and allows blood to be removed from the patient, circulated through tubing into a machine where unwanted blood components are removed, then returned through tubing back into the patient. This can be done quickly, efficiently, and safely. However, venous pressure alarms that are part of this system are not consistently reliable in detecting venous disconnections before a significant amount of blood is lost. Therefore, the patient should not be placed alone where the access site cannot be seen by staff trained to watch for problems, such as rooms which do not permit ongoing observation of the blood lines. In the majority of these cases, the venous pressure alarm on the dialysis machine fails to detect the event until significant blood loss had occurred. Episodes of blood loss can occur that if not detected or stopped can result in hospital admission or death of the patient.

2. Observation on 09/18/12 at 10:00 AM of Patient #2 in bed four and Patient #3 in bed five showed that the access sites and blood lines were covered by blankets and could not be seen.

Observation showed neither Registered Nurse assigned to the unit to be within site of the patients.

3. During an interview on 09/18/12 at 10:15 AM, Staff B, Registered Nurse, stated that the patient's would continually cover themselves including their access site because they were cold.

4. During an interview on 09/18/12 at 10:20 AM Staff A, Nurse Manager, stated that a new patient was being admitted to the unit for dialysis and both nurses were with that patient. She stated that she was responsible for Patient #2 and #3. She confirmed that the access sites of both patients were not visible and should be. She stated that it was an ongoing problem because the patients were cold and would recover their access sites.






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Based on observation, interview, and policy review, the facility failed to ensure controlled substances (medications that are high risk for abuse) were secured to prevent unauthorized access in two of three anesthesia carts (carts in operating rooms #3 and #18) observed in the main operating room (OR). There were a total of 28 anesthesia carts and 28 OR suites in the main OR. The main OR completes an average of 2400 surgical cases per month. The facility census was 752.

Findings included:

1. Record review of the facility's policy titled "Security of Medications in the Operating Room" revised on 12/01/10, showed direction for controlled substances to be kept under lock in all locations at all times. The sole exception is for controlled substances in the physical presence of and under the direct control of the qualified anesthesia provider.

2. Record review of the Anesthesia Narcotic (controlled substance) Log showed the following controlled substances were dispensed in the controlled substance box used by the anesthesia staff in the OR:
-One ampule (glass container) of Hydromorphone (narcotic pain medication) 2 milligrams (mgs - unit of measurement);
-One ampule of Meperidine (narcotic pain medication) 100 mgs;
-Five vials (glass container) of Midazolam (used for sedation and to create memory loss during procedures) 2 mgs;
-One vial of Ketamine (maintains anesthesia) 500 mgs;
-Five vials of Morphine (narcotic pain medication) 10 mgs;
-Five vials of Fentanyl (narcotic pain medication) 250 micrograms (mcgs - unit of measurement);
-Five vials of Fentanyl 100 mcg;
-Three ampules of Ephedrine (stimulant) 50 mgs.

3. Observation on 09/18/12 at 10:50 AM showed a controlled substance box located in the top drawer of an anesthesia cart located in OR #3. The anesthesia cart was not locked and was not attended by anesthesia staff. The controlled substance box contained all of the controlled substances listed on the Anesthesia Narcotic Log except only three of five of the Midazolam 2 mg vials, and only three of five of the Fentanyl 100 mcgs vials remained in the controlled substance box (due to use during procedures).

4. Observation on 09/18/12 at 11:00 AM showed a controlled substance box located in the third drawer of an anesthesia cart located in OR #18. The anesthesia cart was not locked and was not attended by anesthesia staff. The controlled substance box contained all of the controlled substances listed on the Anesthesia Narcotic Log.

5. During an interview on 09/18/12 at 11:10 AM, Staff R, Certified Registered Nurse Anesthetists (who was responsible for the controlled substance box found unsecured in OR #18), stated that controlled substances should be locked in the top drawer of the cart (which has a double-locking mechanism) but she hadn't taken the time to place the controlled substance in the top drawer of the anesthesia cart to secure the medications.

6. During an interview on 09/18/12 at 2:35 PM, Staff U, Director of Pharmacy, stated that controlled substances are to be locked and secure in the OR when the medications are not attended by the anesthesia staff.

7. During an interview on 09/18/12 at 3:40 PM, Staff V, OR Pharmacist, stated that he had no concerns about diversion (when a controlled substance is used for personal use) of controlled substances in the OR, but that occasionally the Anesthesia Narcotic Log is returned to pharmacy with a discrepancy (when returned medication amounts do not equal expected medication amounts). Staff V stated that when this happens, he contacts the anesthesia staff member and asks him or her to correct the Narcotic Log discrepancy. Staff V stated that the anesthesia staff member may or may not verify the remaining controlled substance amounts with the documented amounts of the controlled substance administered, but corrects the log, and the discrepancy is not further investigated.

Based on observation, interview and record review the facility failed to apply personal protective equipment (PPE-gowns, used to ensure infection control) appropriately when they provided care for two patients (#14 and #15) of four patients observed for infection control measures. The facility census was 752.

Findings included:

1. Review of facility policy titled, "Infectious Diseases & types of Precautions," reviewed 10/11showed the following:
-Hand hygiene must be used when caring for a patient in contact isolation and all persons entering the room must wear gown and gloves.

2. Review of Patient #14's History and Physical (H&P) dated 08/07/12 showed the patient had burns on 30.5 percent of his body.

The patient was in strict contact isolation in the burn unit.

3. Observation on 09/18/12 at 10:35 AM in the burn unit showed Staff X, Registered Nurse (RN) and Staff Y, Burn Technician, providing care to Patient #14. Both staff wore gowns which they failed to tie at the waist allowing the ties to dangle on the bed and on the bed frame.

4. Review of Patient #15's Resident admission note dated 08/20/12 showed the patient was admitted on 08/20/12 with burns to 58 percent of her body.

The patient was in strict contact isolation in the burn unit.

5. Observation on 09/18/12 at 10:30 AM in the burn unit showed Staff W, Physical Therapist and Staff X, RN, providing care to Patient #15. Both staff wore gowns which they failed to tie at the waist allowing the ties to dangle on the bed and on the bed frame.

6. During an interview on 09/18/12 at 10:45 AM Staff Z, Nurse Manager, stated that she saw the gowns were not tied at the waist and they were required to be tied and she would be speaking to the staff about it.



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