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Based on interview and document review, the hospital failed to ensure physician orders for restraints were based on assessed need for 3 of 5 patients (P2, P3, P4). In addition, the hospital failed to ensure comprehensive individualized assessments were conducted to ensure least restrictive restraint measures were implemented for 1 of 5 patients (P4). In addition, the hospital also failed to ensure patients were appropriately monitored during restraint use for 1 of 5 patients (P2). In addition, the facility failed to ensure physician order's were obtained for restraint use for 2 of 5 patients (P5, P6).

Findings include:

P2 was admitted to the facility on 11/12/19, with diagnoses of congestive heart failure, weakness, and shortness of breath and was transferred to another hospital on 11/13/19, at 12:30 p.m.

P2's record indicated on 11/12/19, P2 was intubated at 7:44 p.m., nursing documentation indicated at 7:45 p.m. P2 agitated/restless and was pulling at tubes, and at 7:45 p.m. bilateral soft wrist restraints were applied to prevent line/tube removal by P2.

P2's restraint order signed and dated 11/12/19, at 9:40 p.m. directed soft restraints for bilateral ankles and wrists to prevent line and tube removal with medical condition identified as sepsis. P2's record lacked evidence of a comprehensive assessment or behaviors that would justify the physician orders for soft ankle restraint.

P2's restraint documentation indicated P2 was in soft wrist restraints from 7:45 p.m. until time of transfer on 11/13/19, at 12:30 p.m. P2's record lacked evidence of every 2 hour monitoring of circulation, safety, skin, physical needs, range of motion, and behavioral status between 6:00 a.m. and 12:30 p.m. on 11/13/19.

P2's record identified the use of only soft wrist restraints until P2 was transferred to another hospital on 11/13/19, at 12:30 p.m. P2's record lacked evidence of assessment that would justify the physician order for soft ankle restraints.

During an interview on 12/5/19, at 8:45 a.m. registered nurse (RN)-E and RN-F indicated patients were supposed to be monitored every 2 hours for areas on the drop down list and the restraints were released at those two hour intervals. RN-E and RN-F reviewed P2's record and verified the record lacked documentation of every 2 hour monitoring documentation after 6:00 a.m. However, RN-E identified and stated a flowsheet indicated R2 had received range of motion at 8:00 a.m. but there was nothing documented after that. Director of nursing services (DNS) verified the physician order included bilateral ankle restraints. DNS stated ankle restraints would be applied if a patient was kicking; DNS indicated the physician order should not have included the order for bilateral ankle restraints unless they were indicated through assessment.

P3 was admitted to the medical intensive care unit (MICU) on 10/25/19, with diagnosis of pneumonia.

P3's restraint order signed and dated 10/25/19, at 11:58 a.m. directed soft restraints for bilateral ankles and wrists to prevent line/tube with medical condition identified as community acquired pneumonia. P3's record lacked evidence of assessment or behaviors that would justify the physician order for ankle restraints.

P3's record indicated P3 was intubated on 10/25/19, at 12:55 p.m. Nursing documentation indicated at 10/25/19, at 1:15 p.m. P3 was calm, was pulling lines/tubes, and bilateral soft wrist restraints were applied to prevent line/tube removal. P3's record indicated P3 was transferred to another hospital on 10/16/19, at 1:17 p.m., the record did not identify any assessed need for ankle restraints.

During an interview on 12/5/19, at 8:45 a.m. DNS indicated the physician order should not have included the order for bilateral ankle restraints unless they were indicated through assessment.

P4 was admitted to the MICU on 10/14/19, with diagnoses of shortness of breath and congestive heart failure.

P4's restraint order signed and dated 10/15/19 at 8:07 p.m. directed soft restraints for bilateral wrists and ankles. P4's record lacked evidence of assessment that would justify the physician order for soft ankle restraints.

P4's nursing documentation on 10/15/19, at 8:45 p.m. indicated P4 was confused, agitated/restless, and uncooperative with monitoring, removed equipment, pulling lines/tubes and soft restraints were applied to bilateral wrists to prevent harm to self and line/tube removal. Less alternatives to restraints attempted but ineffective included family presence, promotion of appropriate expression, and offer of medication.

P4's nursing documentation on 10/15/19 from 9:00 p.m. to 12:44 a.m. indicated P4 remained in wrist restraints and lacked assessment for least restrictive measure. At 9:00 p.m. documentation, indicated P4 was confused and did not pull at lines or tubes. Nursing note at 9:29 p.m. included, "patient was swing legs and arms trying to get out of bed and angry at staff. Family members were in room at the time talking all at the same time and upsetting the patient." Nursing note at 9:35 p.m. included "Patient stated, "Where the h. am I?" patient climbing out of bed. MD notified."

P4's nursing documentation on 10/15/19 at 10:00 p.m. indicated P4 was confused and calm, and did not pull at lines/tubes. From 10:00 p.m. to 12:00 a.m. the record lacked evidence of assessment for least restrictive measure. Assessment documentation at 12:00 a.m. indicated P4 was agitated and restless and did not specify the behaviors; record did not reflect assessment to determine reason for agitation/restlessness or indication for ongoing restraint use. At 12:45 a.m. documentation indicated the discontinuation of wrist restraints because behaviors improved. However, nursing note

During an interview on 12/5/19, at 8:45 a.m. DNS reviewed R4's record and indicated the physician order should not have included the order for bilateral ankle restraints unless they were indicated through assessment. DNS verified at 10:00 p.m. R4 was confused and calm, the record did not identify how long the restraints were off, and did not identify that R4 had continued behaviors of pulling at lines or tubes, and the documentation lacked re-assessment for the least restrictive device.






29433

P5 was admitted to the facility emergency department (ED) on 2/12/19, with diagnosis of intentional overdose.

On 2/12/19, at 4:25 p.m. a facility incident report indicated ED staff was attempting to give P5 medications by means of an injection. P5 was agitated, and security staff restrained P5 by holding her ankles, and released the hold once the medication was injected. The facility did not have a physican's order for use of the restraint.

P6 was admitted to the facility on 9/23/19, with diagnosis of prostatectomy.

On 9/26/19, at 2:30 a.m. a facility incident report indicated P6 was out of his room, and had been located by nursing staff in the 1C stairwell. Security staff was contacted, and restrained P6, while nursing staff called for additional staff. The facility did not have a physician's order for use of the restraint.

On 12/4/19, at 3:35 p.m. the supervisor of safety/security (SS)-A, and the DNS were interviewed. SS-A stated security officers are trained to ensure staff security and safety, and are allowed to use force to keep staff safe. The DNS stated security officers are used for staff protection, and use of a hold by security officers was not considered a restraint, and because they were not considered restraints, there was no physician order.

The facility policy Restraints: Non-Violent dated 4/19, defines a restraint as use of any method to involuntary restrain movement of the whole or a portion of a patient's body as a means of modifying a patient's physical activities to protect the patient or others from injury. A registered nurse (RN) may identify the need and initiate the use of a restraint intervention but must obtain an order from a licensed independent practitioner (LIP) within 1 hour of initiation of restraints for violent or self-destructive behavior and within 12 hours on initiation of restraint for non-violent or non-self-destructive behavior. Verbal orders must be authenticated by the responsible LIP.

Based on observation, interview, and document review, the hospital failed to ensure only authorized personnel had access to locked medication rooms and medications that were sent unsecured via pneumatic tube stations in the facility. This practice had the potential to affect all 97 patients in the hospital.

Findings include:

On 12/3/19, at 8:15 a.m. a tour of the three medical surgical nursing stations and medications rooms was conducted with the registered nurse manager (RN)-A and director of nursing services (DNS). Each nursing station had a pneumatic tube system used to deliver medications from the pharmacy. The pneumatic tube system was accessible to patients, visitors, and staff. RN-A indicated the only medications that were securely sent were controlled medications. There was a medication room on each nursing station; the rooms were accessible by electronic badge entry. Each medication room had an Omnicell which dispensed medications, and an unsecured medication cart that contained bulk medications and/or medications not available in the Omnicell. On top of the medication cart located in 1B medication room was a one gallon size zip locked bag that contained several bottles of a patient's medication. DNS stated housekeepers had access to the medication rooms, and were not supervised when they cleaned the rooms.

On 12/3/19, at 9:00 a.m. a tour of the medical intensive care unit and medication room was conducted with registered nurse manager (RN)-B and DNS. The nursing station also had a pneumatic tube system for medication delivery that was also accessible to patients, staff, and visitors. The medication room accessible with electronic badge entry had Omnicell, and a cupboard with containers for each patient used for bulk medications and/or medication not available in the Omnicell. RN-B confirmed the cupboard was not locked, and stated nursing assistants and housekeepers had unsupervised access to the room. DNS also confirmed the unrestricted access.

On 12/3/19, at 9:25 a.m. a tour of the birthing center and medication room was conducted with registered nurse manager (RN)-C and DNS. The nursing station had a pneumatic tube system for medication delivery that was accessible to patients, staff, and visitors. The medication room accessible with electronic badge entry had an Omnicell, and an unsecured medication cart with patient medications. On top of the cart was a syringe with Betamethasone. RN-C stated the medication was probably delivered in the pneumatic tube and the health unit coordinator put the medication in the room on top of the cart. RN-C and DNS confirmed health unit coordinators and housekeepers had unrestricted access to the room without supervision.

During an interview on 12/3/19, at 1:30 p.m. director of pharmacy stated all medications should be secured and unauthorized personal should not have access to medications, which included housekeepers.

Based on observation, interview, and record review, the hospital was found to be out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) due to lack of compliance with Life Safety Code requirements. This had the potential to affect any current and future patients.

Findings include:

Refer to Life Safety Code inspection tags: K222, K321, K341, K351, K362, K372 and K920.

The cumulative effect of these systemic problems resulted in the Hospital's inability to ensure safety from fire therefore they were unable to meet this condition.

Based on observation, interview, and document review, the facility failed to provide wound care in a manner that minimized the development of infectious disease for 1 of 1 patients (P1) observed for a dressing change.

Findings include:

During an observation on 12/3/19, at 10:15 a.m. registered nurse (RN)-D was observed to change the surgical wound dressing on P1's lower back. RN-D donned sterile gloves, removed the soiled gauze dressing and the saturated bio-patch dressing from around the drain tubing. While wearing the soiled gloves, RN-D applied the new bio-patch dressing, and secured the clean gauze dressing with tape. RN-D did not change gloves or perform hand hygiene after the removal of the soiled bio-patch dressing.

When interviewed immediately after the dressing change, RN-D confirmed she had not changed her gloves after removal of the soiled bio-patch dressing, and did not perform hand hygiene. RN-D stated she should have removed the soiled gloves, performed hand hygiene and donned clean gloves. DNS was also present during the interview, and DNS confirmed gloves should have removed, and hand hygiene performed after removal of the soiled dressing and prior to the application of the new dressing.

Record review revealed P1 was admitted to the hospital on 12/2/19, and on 12/2/19, underwent L4-5, L5-S1 posterior spinal fusion and instrumentation, L4-5 laminectomy with revision lateral recess decompression, and L5 laminectomy with L5-S1 bilateral partial facetectomy. A physician order dated 12/2/19, directed cover incision with waterproof dressing or sterile barrier, and keep dressings dry, if dressing is damp, change dressing and not reinforce. Use dry gauze and paper tape.

During an interview on 12/5/19, at 11:45 a.m. infection preventionist (IP)-A stated that gloves should be changed after removal of an old dressing, and before the application of a new dressing.

Hospital procedure Dressing: Transparent dated 8/19, directed staff 16) Perform hand hygiene and don gloves. 19) Remove the existing dressing following manufacturer's instructions for use. 20) Place the soiled dressing in the waste container or a waterproof bag. 21) Remove gloves, perform hand hygiene, and don clean gloves. Don sterile gloves if performing a sterile dressing change.

Based on observation, interview, and document review, the acute care hospital (ACH) failed to develop policies to define when Immediate Use Steam Sterilization (IUSS) should be utilized for sterilization of instruments used in surgery. This had the potential to affect all patients who had surgery in which the surgical instruments were sterilized with Immediate Use Steam Sterilization. In addition, the hospital failed to ensure safe operation of the electrocautery device as indicated by hospital policy and manufacturer's recommendations for 2 of 3 patients (P31, P32) observed during a surgical procedure in which a Valleylab FT10 cautery was utilized.

Findings include:

On 12/4/19, at 1:00 p.m. a tour of the surgical department was done with the clinical manager of surgical services (CMSS). Four autoclaves were located near the surgical suites. Review of the IUSS logs from 8/1/19, to 11/30/19, included documentation of all surgical instruments that were sterilized with IUSS. The logs identified the instrument processed as well as the reason for the use of IUSS. Interview with the CMSS at this time indicated the IUSS logs had not been thoroughly monitored and that there were many times when IUSS had been utilized when not emergent and could have been prevented. The CMSS further confirmed IUSS use in the surgical department had been higher than their standards, but had not thoroughly investigated the high rate of use to implement preventive interventions, other than ordering some extra instruments in the past month. The CMSS also included there were no parameters to guide the staff to when IUSS was appropriate. The staff were unable to provide IUSS logs for months prior to 8/1/19, in the past year.

Review of the IUSS logs included multiple back to back cases, instruments brought in by a representative, unknown and instrument shortage
-August 2019: 30 (back to back cases/instrument shortage), 15 (rep/vendor brought in late) 2 (unknown) 10 (instrument shortage/no reason) (67 total IUSS completed)
-September 2019: 35 (back to back cases/instrument shortage) 11 (rep/vendor brought in late) 3 (unknown) 5 ( instrument shortage/no reason) (91 total IUSS completed)
-October 2019: 41 (back to back cases/instrument shortage) 2 (rep/vendor brought in late) 1 (unknown) 5 ( instrument shortage/no reason) (67 total IUSS completed)
-November 2019: September 2019: 38 (back to back cases/instrument shortage) 7 ( instrument shortage/no reason) (54 total IUSS completed)

Review of the most current Infection Prevention and Control Committee meeting minutes dated 2/14/19, included reasons for the highest use of IUSS. The reasons for use included high demand/ too many like cases on the same day and instruments not cleaned. Interventions were to continue to monitor with no other interventions implemented to reduce the use. Review of the quarterly Infection and control meeting minutes for the past year did not address the high use of IUSS. Interview with the facility Infection Preventionist (IP) at this time, stated she was aware of the increased us of IUSS and staff had discussed concerns informally. The IP further included the staff had not been monitoring the use appropriately when the high use had been identified over the past several months and did not have a quality improvement program in place (QIP) for the reduction of the IUSS use, other than ordering a couple extra instruments in the past month.

Interview on 12/5/19, at 11:15 a.m. instrument reprocessing technician (IRT)-A indicated she was not aware of the high usage of IUSS in the surgical department over the past year. IRT-A stated there were no specific guidelines related to the appropriate use of IUSS, but that it should be utilized for emergent situations only.

Review of the facility Policy/Procedure for IUSS dated 4/17, indicated IUSS is not recommended and employed only in emergent situations. The policy lacked specific direction for appropriate use of IUSS.

P31 was observed on 12/3/19, from 12:25 a.m. to 2:30 p.m. during a total thyroidectomy and central neck dissection surgical procedure (removal of the thyroid). P31 was observed to utilize oxygen during the surgical procedure. During the procedure, it was noted the use of a Electrocautery Generator (a cautery pencil device) was utilized by medical doctor (MD)-B. At 1:46 p.m. After utilizing the cautery pencil, MD-B placed the cautery pencil on the patients drape that was located over the patients upper chest. The tip of the pencil was resting on the drape for 2 seconds before MD-B picked the pencil up. At 1:55 p.m. after utilizing the cautery pencil, MD-B placed the cautery pencil on the patients drape that was located on the patients upper chest. The tip of the pencil was resting on the drape for 2 seconds before MD-B picked the pencil up. At 2:03 p.m. after utilizing the cautery pencil, MD-B placed the cautery pencil on the patients drape that was located on the patients upper chest. The tip of the pencil was resting on the drape for 30 seconds before scrub tech (ST)-A picked the pencil up at 2:33 p.m. and placed it in the holster. At 2:16 a.m. after utilizing the cautery pencil, MD-B placed the cautery pencil on the patients drape that was located on the patients upper chest. The tip of the pencil was resting on the drape for 1 1/2 minutes before ST-A picked the pencil up and placed it in the holster. At 2:18 p.m. after utilizing the cautery pencil, MD-B placed the cautery pencil on the patients drape that was located on the patients upper chest. The tip of the cautery pencil was resting on the drape for 5 seconds before ST-A picked the pencil up at 2:23 p.m. and placed it in the holster.

Interview on 12/5/19, at 10:30 a.m. circulating registered nurse (RN)-R, indicated she did not observe the cautery pencil resting on the draped patient during the above times. RN-R further included it was the responsibility of the ST, MD and RN to make sure the cautery pencil was holstered after each use as facility policy directed.

Interview on 12/5/19, at 10:45 a.m. CMSS indicated he observed the tip of the cautery pencil resting on the patients drape twice during the surgical procedure, but could not recall the times. CMSS further indicated all surgical team members are responsible for holstering the cautery pencil when not in use and should not have been placed on the patients drape per facility policy.

A phone call was placed to MD-A and MD-B, for interview on 12/5/19, at 1:00 p.m. with no return call.

A phone call was placed to ST-A for interview on 12/9/19, at 2:00 p.m. with no return call.

P32 was observed on 12/3/19, from 9:34 a.m. to 10:45 a.m. during an open repair of a umbilical hernia
P32 was observed to utilize oxygen during the surgical procedure. During the procedure, it was noted the use of a Electrocautery Generator (a cautery pencil device) was utilized by medical doctor MD-A. At 10:34 a.m., after utilizing the cautery pencil, MD-A placed the cautery pencil on the patients drape that was located on the patients upper abdominal area. The tip of the pencil was resting on the drape for 30 seconds before ST-A picked the pencil up and holstered it.

Interview on 12/5/19, at 10:30 a.m. circulating registered nurse (RN)-R, indicated she did not observe the cautery pencil resting on the draped patient during the above time. RN-R further included it was the responsibility of the ST, MD and RN to make sure the cautery pencil was holstered after each use as facility policy directed.

Interview on 12/5/19, at 10:45 a.m. CMSS indicated he did not observe the tip of the cautery pencil resting on the patients drape during the surgical procedure. CMSS further indicated all surgical team members are responsible for holstering the cautery pencil when not in use and should not have been placed on the patients drape per facility policy.

A phone call was placed to MD-A, for interview on 12/5/19, at 1:00 p.m. with no return call.

A phone call was placed to ST-A for interview on 12/9/19, at 2:00 p.m. with no return call.

A review of the hospital's incident/accident reports for the past year revealed no incidents of fire/injury had occurred related to the use of electrocautery devices.

Review of the hospital's policy, Fire Prevention in the OR dated 2019, included fire plan precautions for surgical cases. The policy directed operating room (OR) staff to monitor the location of the cautery pencil at all times and return it to the holster when not in use, to prevent unintentional activation.

Review of the manufactures instructions for Valleylab Cautery included; Warning: Fire hazard: Do not place active instruments near or in contact with flammable materials (such as gauze or surgical drapes), flammable gases, or high levels of oxygen. Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from the patient and flammable material.