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Based on observation, interview, record review, policy reivew, and review of video monitoring, the Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for management of the entire facility including accountability for the effective oversight of the staff to comply with the requirements under the Conditions of Participation (COP) for hospitals. (A-0057)

This resulted in the facility to be out of compliance with 42 CFR 482.12 COP: Governing Body.

Based on observation, interview, record review, policy review and review of video monitoring, the Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for management of the entire facility including accountability for the effective oversight of the staff to comply with the requirements under the Conditions of Participation (COP) for Patient's Rights, Medical Records, Infection Control and Surgical Services. This failure had the potential to affect the quality of care and safety of all patients.

Findings included:

Review of the job description for Staff J, CEO, showed a duty, that under the direction of the Governing Body, he administers, directs, and coordinates all activities and employees of the hospital to carry out its objectives in the provision of health care, furtherance of education and research, and participation in community health programs.

The CEO failed to ensure compliance with the following:

COP: Patient's Rights (A-115)
The facility staff failed to ensure a safe environment when facility staff failed to:
- Provide the Patient Bill of Rights to patients on three units (Obstetrical Unit [OB, a unit that provides care of women in childbirth and during the period before and after delivery], the Intensive Care Unit [ICU] and the Emergency Department [ED]) of four units reviewed when patients were admitted to the hospital. (A-117)
- Ensure that all patients in the ED received their patient's rights notification that contained a phone number and address for lodging a grievance with the State Agency (SA). (A-118)
- Ensure that staff provided privacy to one ED Behavioral Health Patient (#7) of one behavior health patient observed. (A-143)
- Ensure a safe environment for restraint patients and patients who were at risk for harm to self and others. (A-144)
- Use the least restrictive restraint to restrain one patient (#7) of one restraint patient reviewed. (A-165)
- Complete an assessment within one hour after a restraint or seclusion episode for violent behaviors for one patient. (#7) of one patient in restraints reviewed. (A-178)
- Ensure that 18 physicians of 18 physicians reviewed had evidence of competency in restraint (application of mechanical restraining devices or manual restraints which were used to limit the physical mobility of a patient), first aid (techniques used to address common emergencies that can occur from the use of restraint and seclusion) and one hour face to face evaluation. (A-206)

COP: Medical Records (refer to A-431)
The facility failed to:
- Ensure that the Medical Records Department followed policies and procedures that directed staff how medical records were maintained to protect against loss, defacement and tampering for three of three storage areas observed. (A-441)
- Ensure that the Medical Records Department followed policies and had metal cabinets available that protected medical records from fire. (A-441)
- Protect against unauthorized access to patients' protected health information (PHI), when one patient (#1) of one Obstetrical (OB, a unit that provides care of women in childbirth and during the period before and after delivery) Unit patient's medication record was left in the hallway unattended, and when 15 boxes of medical records were left unattended in the outpatient Cardiac Rehabilitation Unit. (A-441)
- Ensure that physician orders were signed prior to the evaluation and treatment for three patients (#16, #17 and #18) of four patients' records reviewed who received outpatient physical therapy. (A-450)

COP: Infection Control (refer to A-747)
The facility failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Ensure that the dietary staff labeled with an acquisition date, and a date to be consumed, ready-to-eat foods that were prepared onsite or commercially prepared and opened for refrigerated, frozen food, and dry storage areas. (A-749)
- Dispose of outdated foods, and label open food containers with the date opened and beyond use dates in patient refrigerators and food storage areas. (A-749)
- Perform temperature checks on patient food trays. (A-749)
- Dispose of outdated supplies in medication and supply rooms on the Medical Surgical Unit. (A-749)
- Dispose of outdated medication in the ICU. (A-749)
- Ensure that blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) quality control (QC) vials (contains a solution used to ensure testing accuracy) and test strips were dated when opened. (A-749)
- Document catheter care on two patients (#5 and #6) of two patients in the ICU. (A-749)

COP: Surgical Services (A-940)
The facility failed to:
- Eliminate the residue and debris in two sterilizers (machines that use high heat and steam to kill harmful organisms) in the operating room (OR) Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacterial] instruments or equipment that were used in procedures) clean room (where sterile instruments and equipment were packaged and/or prepared for use). (A-940)
- Ensure the sterile processing rooms were terminally cleaned (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) daily. (A-940)
- Maintain a sterile environment in the SPD clean room, by allowing multiple paper products (particle shedding products that can cause contamination), a laminate worktable with tape around the edges and exposed wood in the room. (A-940)
- Ensure that an updated examination of the patient was completed and documented on three discharged patient charts (#27, #28 and #29) of three discharged patient charts reviewed that had History and Physical's (H&P) completed prior to the day of surgery. (A-952)

During an interview on 10/23/19 at 4:12 PM, Staff J, CEO, stated that all staff should follow the facility's policies.

Based on observation, interview, record review, policy review and video monitoring review, the facility staff failed to ensure a safe environment when facility staff failed to:
- Provide the Patient Bill of Rights to patients on three units (Obstetrical Unit [OB, a unit that provides care of women in childbirth and during the period before and after delivery], the Intensive Care Unit [ICU] and the Emergency Department [ED]) of four units reviewed when admitted to the hospital. (A-117)
- Ensure that all patients in the ED received their patient's rights notification that contained a phone number and address for lodging a grievance with the State Agency (SA). (A-118)
- Ensure that staff provided privacy to one ED Behavioral Health Patient (#7) of one behavior health patient observed. (A-143)
- Ensure a safe environment for restraint patients and patients who were at risk for harm to self and others. (A-144)
- Use the least restrictive restraint, to restrain one patient (#7) of one restraint patient reviewed. (A-165)
- Complete an assessment within one hour after a restraint or seclusion episode for violent behaviors for one patient (#7) of one patient in restraints reviewed. (A-178)
- Ensure that 18 physicians of 18 physicians reviewed had evidence of competency in restraint (application of mechanical restraining devices or manual restraints which were used to limit the physical mobility of a patient), first aid (techniques used to address common emergencies that can occur from the use of restraint and seclusion) and one hour face to face evaluation. (A-206)

These failed practices prevented patients from understanding their rights, including the right to formulate a grievance with the SA, failed to protect the privacy of the patients and failed to ensure a safe environment as related to restraint and/or seclusion, all of which resulted in the overall non-compliance with 42 CFR 482.13, Condition of Participation: Patient's Rights.

Based on interview, record review and policy review, the facility failed to provide the Patient Bill of Rights to patients on three units (Obstetrical Unit [OB, a unit that provides care of women in childbirth and during the period before and after delivery], the Intensive Care Unit [ICU] and the Emergency Department [ED]) of four units reviewed when patients were admitted to the hospital. This failure had the potential to prevent all patients from understanding their rights as a patient.

Findings included:

1. Review of the facility's policy titled, "Patient Rights and Responsibilities," dated 06/2015, showed that patients should receive a copy of their Patient Rights and Responsibilities upon admission.

Review of the facility's document titled, "Patient Rights and Responsibilities," contained no phone number or address for the patient to lodge a grievance with the State Agency (SA).

Review of the OB Unit's undated document titled, "The Pregnant Patient's Bill of Rights," showed that OB patients were to receive The Pregnant Patient's Bill of Rights in addition to the "Patient Bill of Rights," and should be recognized as having the additional rights because the pregnant patient represents two patients, rather than one. The document contained no phone number or address for the patient to lodge a grievance with the SA.

Review of Patient #1's medical record on 10/22/19 at 11:00 AM, showed that no Patient Rights and Responsibilities were given or explained to the patient, or the patient's representative.

During an interview on 10/22/19 at 9:55 AM, Patient #1 stated that she had received a copy of the Patient Rights and Responsibilities.

After review of Patient #1's medical record, it was determined that the patient responded "yes" that she had received a copy of the Patient Bill of Rights and Responsibilities, but had only received The Pregnant Patient's Bill of Rights that was developed by the facility.

During an interview on 10/22/19 at 11:05 AM, Staff C, Registered Nurse (RN), stated that she was not aware of any basic Patient Bill of Rights and Responsibilities given to any OB patients, only the Pregnant Patient's Bill of Rights were provided at the time of admission.

During an interview on 10/22/19 at 11:10 AM, Staff B, OB Director, stated that the basic Patient Bill of Rights and Responsibilities were not given to any OB patients, and that OB patients only received The Pregnant Patient's Bill of Rights and Responsibilities, which focused more on OB care, rather the right to be involved in their treatment.

2. Review of ICU Patient #5, #6 and #20's medical record, showed that no Patient Rights and Responsibilities were given or explained to the patient or the patient's representative.

During an interview on 10/22/19 at 11:30 AM, Staff G, RN, stated that patients did not receive a copy of their Patient Rights and Responsibilities upon admission to the ICU. They previously provided each patient an admission folder with the patient rights inside, but no longer provided it.

3. Observation on 10/21/19 at 10:00 AM in the ED, showed no posted patient's rights signage within the treatment areas.

During an interview on 10/22/19 at 10:05 AM, Patient #8, in the ED, stated that she had not received a patient's rights notification.

Review of the ED's admission process did not contain a patient's rights notification.

During an interview on 10/22/19 at 10:05 AM, Staff K, ED Registration Clerk, stated that the ED admission process did not contain a patient's rights notification.

During an interview on 10/22/19 at 10:41 AM, Staff M, Patient Accounts Director, stated that:
- The ED did not have patient's rights signage posted.
- Patients that were discharged or transferred from the ED would not receive a patient's rights notification.
- All patients should be informed of their patient's rights.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer, CNO, stated that all patients should have received the Patient Bill of Rights upon admission to any unit, and that OB patients should have been given the basic Patient Bill of Rights and Responsibilities in addition to The Pregnant Patient's Bill of Rights.

The facility failed to ensure that patients were informed of their rights, when their process did not include communicating those rights verbally, or through alternative means, such as posted signage or written material.


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Based on observation, interview, and record review, the facility failed to ensure that all patients in the Emergency Department (ED) received their patient's rights notification that contained a phone number and address for lodging a grievance with the State Agency (SA). This failure had the potential to affect all patients in ED by preventing them from knowing their rights as a patient.

Findings included:

1. Review of the facility's policy titled, "Patient Rights and Responsibilities," revised 06/2015, showed that a patient had a right to become informed of his or her rights as a patient in advance of, and upon discontinuing, the provision of care. This included to be advised of the facility's grievance process, notification of the grievance process, whom to contact to file a grievance, and steps taken on his or her behalf to investigate the grievance.

Review of the facility's document titled, "Patient Rights and Responsibilities," contained no phone number or address for the patient to lodge a grievance with the SA.

Observation on 10/21/19 at 10:00 AM, in the ED, showed no posted patient's rights signage within the treatment areas.

Observation of the ED's admission information, provided to patients, did not contain a patient's rights notification with a phone number and address to lodge a grievance with the SA.

During an interview on 10/22/19 at 10:05 AM, Staff K, ED Registration Clerk, stated that the ED admission process did not contain a patient's rights notification with a phone number or address to lodge a grievance with the SA.

During an interview on 10/22/19 at 10:41 AM, Staff M, Patient Accounts Director, stated that:
- The ED did not have patient's rights signage posted.
- Patients that were discharged or transferred from the ED would not receive a patient's rights notification and therefore would not received a phone number or address to lodge a grievance with the SA.
- All patients should be informed of their patient's rights, and include a phone number and address to lodge a grievance with the SA.

The facility failed to ensure that patients were informed of the right to file a grievance with the SA, when patient's rights information was not provided to patients verbally, or through alternative means, such as posted signage or written material. Additionally, the patient's rights information the facility had available to provide to patients, did not include the phone number or address of the SA, should the patient want to file a grievance.

Based on interview, record review and review of video monitoring, the facility failed to ensure that staff provided privacy to one Emergency Department (ED) Behavioral Health Patient (#7) of one Behavioral Health patient observed who was:
- Placed in four-point restraints (medical cuffs applied to both arms and both legs to prevent someone from causing harm to themselves or others), and a urinary catheter (small flexible tube inserted into the bladder to drain urine) was placed while Law Enforcement (LE) was present in the room (Patient #7 was not in custody of LE).
- Forced to have medical procedures performed in the presence of LE while not in custody of LE.
- Forced to provide a urine sample in the presence of LE while not in custody of LE.
This had the potential to affect all patients who were admitted to the facility by preventing them from having personal privacy.

Findings included:

1. Review of the facility's policy titled, "Patient Rights and Responsibilities," revised 06/2015, showed that the patient had the right to privacy concerning medical care program. Case discussion, consultation, examination, and treatment, were confidential and should be conducted discreetly.

Review of the facility's policy titled, "Security Alert + Combative Patient/Person," revised 08/11/16, showed the following:
- When a combative patient/visitor was recognized within the hospital or grounds, the employee should immediately notify registration/operator security assistance was needed and the location.
- All attempts were to be made to de-escalate the situation.
- Other departments should send a staff member to the location where security assistance was needed.

Review of Patient #7's ED medical record showed that he was a 26 year old male patient, presented to the ED on 10/20/19, for chest pain. The physician's note showed he was anxious, restless, and had not slept in eight to nine days. While in the ED, the patient was noted to be of harm to self and/or others, and staff filed an application for a 96 hour hold (court ordered evaluation by behavioral specialists to determine if a person was safe to themselves and others).

Review of Patient #7's affidavit (a written statement confirmed by oath it is true) in support for the 96 hour hold, dated 10/20/19, signed by Staff Y, Physician, showed that the patient presented as overtly manic (elevated or excited mood or behavior) and did not sleep in eight to nine days. The patient had poor insight to his condition, was paranoid (excessive suspiciousness without adequate cause), and had significantly aggressive behavior to staff and implied he would "blow his head off." The patient remained confused and did not have the capacity to make decisions in his care.

Review of Patient #7's ED nurses' notes from 10/20/19 to 10/21/19 showed that:
- On 10/20/19 at 11:45 PM, the patient was placed in four point restraints per the doctor's order.
- On 10/20/19 at 11:50 PM, an in and out urinary catheter was performed while the patient was in four point restraints. Two LE officers were present in the room (the nurse was unable to obtain urine and the patient was in a non-video monitored room).
- On 10/21/19 at 9:41 AM, a call was made to dispatch for LE assistance for ordered procedures.
- On 10/21/19 at 9:59 AM, LE was at bedside and a urine sample was obtained.
- On 10/21/19 at 5:20 PM, the patient was transferred to computed tomography (CT, a combination of X-rays and a computer to create pictures of your organs, bones, and other tissues, which shows more detail than a regular X-ray) department with facility staff and LE.

At no time during the ordered procedures was Patient #7 under the custody of LE.

Review of the LE officers' daily activity from 10/20/19 to 10/21/19 showed that:
- On 10/20/19 at 11:36 PM, the facility reported a patient fighting with staff. The LE officer arrived and noted facility staff attempting to place Patient #7 in restraints (this was in a non-video monitored room, and approximate time where staff placed the urinary catheter in the presence of LE).
- On 10/21/19 at 9:42 AM, the ED staff requested LE to come and standby while the staff attempted to get a urine sample. Upon arrival, the staff advised LE that they were going to insert a catheter in the patient. LE advised the staff that LE would talk to Patient #7 and the patient agreed to give a urine sample.
- On 10/21/19 at 4:20 PM, LE stood by while staff conducted a CT scan.
- On 10/21/19 at 11:16 PM, LE stood by at the ED room while staff took Patient #7's vital signs.
- On 10/21/19 at 11:53 PM, LE stood by at the ED room while staff took Patient #7's vital signs.
- On 10/22/19 at 2:23 AM, LE stood by at the ED while staff took Patient #7 vital signs.

Review of video monitoring for ED room #4 through camera #11 showed the following:
- CAM 11 20191021-064021: Two LE officers were in the room with no facility staff, the patient was completely nude, and changing into blue paper scrubs.
- CAM 11 20191021-095428: Two LE officers were in the room with no facility staff. Patient #7, in view of the LE officers, urinated into a urinal with his genitalia exposed. LE then handed the urinal to a staff member that had opened the door.
- CAM 11 20191022-22522: Patient #7 was in the room sleeping with the light off. LE opened the door, appeared to talk to Patient #7, and the light turned on. LE entered the room with staff member and vital signs were taken.

During an interview on 10/23/19 at 10:45 AM, Staff Z, ED Director, stated that:
- Patient #7 became aggressive, LE was notified, and the patient was placed in four point restraints.
- An in and out urinary catheter was performed while the patient was in four point restraints, and LE officers were in the room.
- She had directed staff to call LE to standby for procedures.
- She called LE every four hours when vital signs were performed on Patient #7.

During an interview on 10/22/19 at 2:32 PM, Staff V, ED Registered Nurse (RN), stated that:
- She documented that she notified LE for an ordered procedure.
- She needed to obtain a urine sample from Patient #7.
- LE officers obtained the urine sample.

During an interview on 10/23/19 at 9:45 AM, Staff N, Patient Safety Officer, stated that after review of the video monitoring, LE should not have performed procedures on the patient alone.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer (CNO), stated that the facility staff should have maintained oversight of the patient at all times.

Based on observation, interview, record review, policy review and review of video monitoring, the facility staff failed to ensure a safe environment when facility staff failed to:
- Follow their internal security assistance policy to prevent further escalation for one patient (#7) of one patient observed in the Emergency Department (ED).
- Follow their internal suicide (thoughts of killing self) precautions policy in the ED, by providing constant line-of-sight observation (continuous visual contact of patient) on one current patient (#7) of one current patient observed and one discharged patient (#26) of one discharged patient reviewed on suicide precautions.
- Follow their internal restraint precautions policy by providing constant line-of-sight observation of one current patient (#7) of one current patient in four point restraints (medical cuffs applied to both arms and both legs to prevent someone from causing harm to themselves or others) in the ED.
- Ensure that supply rooms and carts that contained sharps (a term used for devices with sharp points or edges that can puncture or cut the skin) were secured in a manner to prevent unauthorized access for three units (the Intensive Care Unit [ICU], the Obstetric [OB, specialized care of women during pregnancy, childbirth, and after childbirth] Unit , and the Medical Surgical Unit), of four units observed.

Findings included:

1. Review of the facility's policy titled, "Patient Requiring Psychiatric Evaluation," revised 01/2019, showed that if the patient was a danger to self, staff, or others, the patient will be continually observed.

Review of the facility's policy titled, "Security Alert + Combative Patient/Person," revised 08/11/16, showed the following:
- When a combative patient/visitor was recognized within the hospital or grounds, the employee should immediately notify registration/operator security assistance was needed and the location.
- All attempts were to be made to de-escalate the situation.
- Other departments should send a staff member to the location where security assistance was needed.

Observation on 10/22/19 at 10:35 AM, in the ED, showed room #4 with a five foot by three foot hole through the wall that exposed the interior wood, and electrical conduit (a tube or trough for protecting electric wiring). A staff member was repairing the wall as a patient laid on a mattress on the floor.

During an interview on 10/22/19 at 10:41 AM, Staff O, ED Registered Nurse, (RN) stated that:
- The patient in room #4 was Patient #7.
- Patient #7 was in room #4 because he was a harm to self and others.
- Patient #7 did not have a designated person assigned to provide constant line-of-sight.
- Room #4 had video monitoring in the room.
- Staff who were closest to the video monitor at the nurses' station were to have observed the patient.
- There were times when patients, which were monitored by video monitoring, were not observed by staff.
- Patient #7 started hitting the wall, yelling, and broke through the wall.
- The facility had a security alert /security response for a combative person, but assistance was not called.
- He did not enter the room to attempt to de-escalate the situation.
- He, along with three other staff, waited for Law Enforcement (LE) to arrive before they entered the room.

Review of Patient #7's ED medical record showed that he was a 26 year old male patient, presented to the ED on 10/20/19, for chest pain. The physician's note showed he was anxious, restless, and had not slept in eight to nine days. While in the ED, the patient was noted to be of harm to self and/or others, and staff filed an application for a 96 hour hold (court ordered evaluation by behavioral specialists to determine if a person was safe to themselves and others).

Review of Patient #7's affidavit (a written statement confirmed by oath it is true) in support for the 96 hour hold, dated 10/20/19, signed by Staff Y, Physician, showed that the patient presented as overtly manic (elevated or excited mood or behavior) and did not sleep in eight to nine days. The patient had poor insight to his condition, was paranoid (excessive suspiciousness without adequate cause), and had significantly aggressive behavior to staff and implied he would "blow his head off." The patient remained confused and did not have the capacity to make decisions in his care.

Review of Patient #7's ED nurses' notes dated 10/22/19 showed that:
- 7:38 AM, patient was screaming, beating himself-off the walls, screaming "let me out";
- 7:40 AM, LE was at bedside;
- 7:52 AM, the patient busted through the sheet rock wall; and
- 7:79 AM, LE was in room with patient.

Review of video monitoring for ED room #4 through camera #11 showed the following:
Cam 11 20191022-074106: Patient appeared to be sleeping, woke up and walked to the door. The patient appeared to be yelling, hitting the door and walls with his fist and head. No staff entered the room. The patient then began to kick the wall in a forward motion, then turned around and kicked the wall in a backward motion. The patient turned around and appeared to pull insulation from the wall. The patient then sat down on the mattress, on the floor, and appeared to be out of breath. Again, no staff entered the room. The patient then got up and started to kick through the wall. No staff entered the room. The patient laid on his back, kicked the walls with both feet. No staff entered the room. The patient again, appeared out of breath, sat down on mattress, and no staff enter the room. The patient went to the hole in the wall, attempted to climb through the wall, started kicking and removing insulation from wall. The patient sat down, appeared out of breath, no staff entered the room. LE was observed opening the door and entered the room.

The time frame from when Patient #7 started to hit the door and wall, until LE entered the room was approximately 12 minutes. No staff were seen entering the room to prevent further escalation, prevent potential harm to the patient, or prevent further property damage.

Review of Patient #7's ED nurses' notes dated 10/21/19 showed that:
- At 4:20 PM, the patient beat his head on the walls, punched the walls, and was screaming. LE was called and the panic alarm was sounded. The patient was screaming at the top of his lungs.
- At 4:22 PM, LE had arrived.
- At 4:25 PM, the patient became aggressive with LE, and the patient was restrained by LE.

During an interview on 10/22/19 at 2:32 PM, Staff V, RN, stated that:
- Patient #7 was in room #4 and did not have a designated staff member to provide constant-line-of-sight for the patient.
- Room #4 had video monitoring, so oversight was shared between the staff working, whomever was closest to the video monitor would observe the patient.
- When Patient #7 started to hit the wall and yell she had been off the floor to deliver another patient to the inpatient area.
- The other RN was in the triage area of the ED.
- There were times when patient's, which are monitored by video monitoring, were not observed by staff.
- She did not call a security alert /security response for combative patient assistance.
- She did not enter the room to attempt to de-escalate.
- There was another suicidal patient in the ED, Patient #26, who did not have a designated person in constant line-of-sight.
- Patient #26 was in room #3, which did not have video monitoring capabilities.

Review of video monitoring for ED room #4 through camera #11 showed the following:
Cam 11 20191022-16174: Patient #7 appeared to be sleeping on a mattress on the floor. The patient got up and started hitting the walls with his fist and head. No staff entered the room. LE entered the room while staff were positioned behind LE at the doorway with their hands in their pockets. Patient #7 attempted to pull the sheet over his head, and LE restrained the patient.

Review of Patient #26's ED medical record showed that he was a 38 year old male patient presented to the ED on 10/19/19 for suicidal thoughts. The physician's note showed he was agitated, depressed, confused, and was out of psychiatric medication and was using drugs. A 96 hour hold was initiated.

Review of Patient #26's affidavit dated 10/20/19, showed that the patient stated he had been off his psychiatric medication and was abusing drugs. The patient stated that he wanted to hang himself.

Review of Patient #26's ED medical record from 10/19/2019 through 10/21/19 did not demonstrate that he was continually observed.

Even though Patient #7 and Patient #26 were at risk for harm to self and others, the facility failed to ensure they followed the facility's policy that they were continually observed.

2. Review of the facility's policy titled, "Restraints for Behavioral Health," revised 04/2017, showed that patients who were in seclusion and restraints must be continually monitored by face to face monitoring by trained staff or video monitoring by an assigned trained staff member within close proximity of the patient.

Review of Patient #7's ED nurses' notes from 10/20/19 to 10/21/19 showed that:
- On 10/20/19 at 11:45 PM the patient was placed in four-point restraints.
- On 10/21/19 at 5:43 AM, the patient requested for restraints to be released, Staff Z asked the patient if he was not going to be aggressive and could provide a urine sample. The patient rolled over on his side and refused.
- On 10/21/19 at 6:32 AM, the patient started yelling, ripped off the four point restraints, and LE was called.

Review of Patient #7's restraint order/flow sheet signed by Staff Z, ED Director, showed restraints were applied on 10/20/19 at 11:45 PM and the patient removed the restraints (without authorization) on 10/21/19 at 6:32 AM.

During an interview on 10/23/19 at 10:45 AM, Staff Z, ED Director, stated that:
- Patient #7 became aggressive, LE was notified, and the patient was placed in four point restraints.
- There was no video monitoring by an assigned trained staff member within close proximity of the patient.
- She did not call a security alert/security response for combative person assistance because there were no other staff in the facility to assist.
- She brought the broken restraint to Staff A, Chief Nursing Officer (CNO) to ask for more resources and staff to help with Patient #7.

During an interview on 10/23/19 at 4:00 PM, Staff A, CNO, stated that Staff Z brought the broken restraint to her, and asked for more resources. Staff A also stated that she brought the request to Staff J, Chief Executive Officer (CEO) who told her to "do the best that you can."

During an interview on 10/23/19 at 4:12 PM, Staff J, CEO, stated that he did not remember the conversation with Staff A about Patient #7. Staff A also stated that all staff should follow the facility's policies.

During an interview on 10/23/19 at 9:12 AM, Staff N, Patient Safety Officer, stated that he had not observed a designated person used for constant line-of-sight of a patient used in the ED, until the surveyors entered the facility.

3. Review of the facility policies showed no policy for the storage and security of supplies.

Observation on 10/23/19 at 10:45 AM, in the ICU, showed an unsecured cart in close proximity to patient rooms with numerous patient supplies which included two boxes of scalpels (a small and extremely sharp bladed instrument used for surgery, dissection, and other procedures). There was also an unlocked drawer by the patient medication area that contained multiple boxes of various sized needles.

During an interview on 10/23/19 at 10:50 AM, Staff G, RN, stated that there was a key to lock the drawer with the needles, but staff were told they didn't have to lock it since the ICU was a secured unit. She had not thought about the scalpels being unsecured and a possible danger to patients and staff.

Observation on 10/22/19 at 10:10 AM showed a door in the hallway of the OB Unit, marked "Authorized Personnel Only", unlocked and unsecured, that contained multiple medical supplies that could have caused harm to anyone unauthorized who gained access. Medical supplies found included:
- Eighteen needles used to start an intravenous catheter (IVC, small flexible tube inserted into a vein through the skin to deliver medications or fluids into the bloodstream);
- Four small bins filled with needles to draw blood;
- One small bin filled with lancets (device with a sharp point used to prick the skin for a small blood sample); and
- An unlocked drawer that contained two full boxes of disposable scalpels.

During an interview on 10/22/19 at 2:20 PM, Staff B, OB Director, stated that the supply room was never locked and that patients' and family members' safety was at risk with an unsecured supply room.

Observation on 10/22/19 at 1:30 PM, in an unlocked supply room, of the Medical Surgical Unit showed:
- Four intravenous (IV, in the vein) trays that contained various types and sizes of needles.
- Two shelves with multiple boxes that contained various sizes of needles.
- Two boxes of scalpels.

During an interview on 10/24/19 at 9:45 AM, Staff D, Infection Control Nurse, stated that she agreed there could have been potential risks for patient safety with stored sharps in unlocked rooms.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer, CNO, stated that:
- She was unaware the supply room on the OB Unit was kept unlocked.
- There was a risk to both patients and families if they had gained access to that area due to the types of supplies that were stored.
- She expected that all supply rooms and carts that contained supplies that could have caused injury to have been kept locked.
- There was no policy directing staff on the security of sharps in the unlocked supply rooms.



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41474

Based on interview, record review and policy review, the facility failed to use the least restrictive restraint to restrain one patient (#7) of one restraint patient reviewed. This had the potential to affect all restrained patients, causing them undue stress and/or harm by restricting their movement any more than necessary. The facility had 44 patients in restraints for 2019.

Findings included:

1. Review of the facility policy titled "Restraints for Behavioral Health" revised 04/2017, showed the following:
- Texas county Memorial Hospital supports the patient's right to be free from restraints that were not medically necessary or used for the purpose other than patient benefit and safety.
- Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, staff members, or other form of harm.
- Physical restraint was any manual method, physical or mechanical device, material, or equipment that immobilizes or reduce the ability of the patient to move his or her arms, legs, body, or head freely and cannot be removed easily by the patient.
- Chemical restraint was any drug or medication used to control behavior or restrict a patient's movement and was not a standard treatment or dosage for the patient's condition. The medication was considered to be a restraint if the overall effect of a drug or medication, was to reduce the patient's ability to effectively or appropriately interact with the world around them.
- Restraints were to be discontinued as soon as possible.

Review of Patient #7's ED medical record showed that he was a 26 year old male patient, presented to the ED on 10/20/19, for chest Pain. The physician's note showed he was anxious, restless, and had not slept in eight to nine days. While in the ED, the patient was noted to be a harm to self and/or others. Staff filed an application for a 96 hour hold (court ordered evaluation by behavioral specialists to determine if a person was safe to themselves and others).

Review of Patient #7's affidavit (a written statement confirmed by oath it is true, serves as evidence for court) dated 10/20/19, signed by Staff Y, Physician, showed that the patient presented as overtly manic (elevated or excited mood or behavior), and had not sleep in eight or nine days. The patient had poor insight to his condition, was paranoid (excessive suspiciousness without adequate cause), and had significantly aggressive behavior to staff and implied he would "blow his head off." The patient remained confused and did not have the capacity to make decisions in his care.

Review of Patient #7's ED nurses' notes from 10/20/19 to 10/21/19 showed that:
- On 10/20/19 at 11:20 PM, the patient was difficult to arouse, would opened his eyes to sternal stimuli (painful pressure on the chest to gain the patient's response) and rolled over. Attempted to arouse the patient again, but the patient did not respond. Sternal stimuli was performed again and the patient was educated about the need for urine sample.
- On 10/20/19 at 11:30 PM, staff attempted to wake the patient with sternal stimuli, the patient started to become more combative to staff. When staff attempted to de-escalate the situation, the patient attempted to swing at staff, and Law Enforcement (LE) was called.
- On 10/20/19 at 11:38 PM, medication was administered (chemical restraint).
- On 10/20/19 at 11:45 PM the patient was placed in four-point restraints (medical cuffs applied to both arms and both legs to prevent someone from causing harm to themselves or others).
- On 10/21/19 at 5:29 AM, the patient would wake to sternal stimuli (the patient was still in four point restraints).
- On 10/21/19 at 5:43 AM, the patient requested for the restraints to be released. Staff Z, asked the patient if he was not going to be aggressive and could provide a urine sample, and the patient rolled over on his side and refused.
- On 10/21/19 at 6:32 AM, the patient started yelling, ripped off the four point restraints, and LE was called.

Review of Patient #7's restraint order/flow sheet signed by Staff Z, ED Director, showed the restraints were applied on 10/20/19 at 11:45 PM, and the patient removed the restraints (without authorization) on 10/21/19 at 6:32 AM.

During an interview on 10/23/19 at 10:45 AM, Staff Z, ED Director, stated that:
- She remembered Patient #7 and the events on 10/20/19.
- Patient #7 had became aggressive, LE was notified, and the patient was placed in four point restraints.
- The patient did receive medication prior to restraints being applied (chemical restraint).
- She did have to use sternal stimuli to awake patient while he was still in four point restraints.
- She did not remove the four point restraints because she was fearful of the patient.

During an interview on 10/23/19 at 11:30 AM, Staff BB, Nurse Educator, stated that if a patient was in four point restraints and needed to have sternal stimuli to awake the patient, the restraints should be discontinued to provide the least restrictive method.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer (CNO), stated that staff should use the least restrictive restraint once the patient became less aggressive.

Based on interview, record review, and policy review, the facility failed to complete an assessment within one hour after a restraint or seclusion episode for violent behaviors for one patient (#7) of one patient in restraints reviewed. This had the potential to affect all patients with episodes of restraint/seclusion. The facility had 44 patients in restraints for 2019.

Findings included:

1. Review of the facility policy titled "Restraints for Behavioral Health" revised 04/2017, showed the following:
- Attending physician or Registered Nurse (RN) must complete comprehensive assessment to determine the safety and protective needs of the patient prior to the application of restraints, medical protective devices.
- A physician or trained RN must see or re-evaluate the patient within one hour after initiation of the restraint to evaluate the patient's immediate situation, reaction to the intervention, medical and behavioral condition and the need to continue or terminate the restraint or seclusion.
- If the face to face evaluation was conducted by the RN, the RN must consult with the attending physician who was responsible for the patient's care soon as possible after completing the one hour face to face evaluation.

Review of Patient #7's ED medical record showed that he was a 26 year old male patient, who presented to the ED on 10/20/19 for chest Pain. The physician's note showed he was anxious, restless, and had not slept in eight to nine days. While in the ED, the patient was noted to be a harm to self and/or others. Staff filed an application for a 96 hour hold (court ordered evaluation by behavioral specialists to determine if a person was safe to themselves and others).

Review of Patient #7's affidavit (a written statement confirmed by oath it is true) support for the 96 hour hold, dated 10/20/19 and signed by Staff Y, Physician, showed that the patient presented as overtly manic (elevated or excited mood or behavior), and did not sleep in eight to nine days. The patient had poor insight to his condition, was paranoid (excessive suspiciousness without adequate cause), and had significantly aggressive behavior to staff and implied he would "blow his head off." The patient remained confused and did not have the capacity to make decisions in his care.

Review of Patient #7's ED nurses' notes from 10/20/19 to 10/21/19 showed that:
- On 10/20/19 at 11:20 PM, the patient was difficult to arouse, the patient would open his eyes to sternal stimuli (painful pressure to the patient's chest to gain patient's response) and rolled over. Attempts were made to arouse the patient again, but the patient did not respond. Sternal stimuli was performed again and the patient was educated about the need for a urine sample.
- On 10/20/19 at 11:30 PM, attempts were made to wake the patient with sternal stimuli, and the patient started to become more combative to staff. Attempts were made to de-escalate the situation, the patient attempted to swing at staff, and Law Enforcement (LE) was called.
- On 10/20/19 at 11:38 PM, medication was administered (chemical restraint).
- On 10/20/19 at 11:45 PM, the patient was placed in four-point restraints (medical cuffs applied to both arms and both legs to prevent someone from causing harm to themselves or others).

Review of Patient #7's restraint order/flow sheet signed by Staff Z, ED Director, showed restraints were applied on 10/20/19 at 11:45 PM and the patient removed the restraints (without authorization) on 10/21/19 at 6:32 AM. The restraint order/flow sheet also did not indicated that the one hour face to face was performed or whether the physician was notified after the restraints were applied.

During an interview on 10/23/19 at 10:45 AM, Staff Z, ED Director, stated that:
- Patient #7 became aggressive, LE was notified, and the patient was placed in four point restraints.
- The patient did receive medication prior to restraints being applied (chemical restraint).
- She acknowledged that the restraint order/flow sheet was not signed to indicate that the one hour face to face was performed and/or that the attending physician was notified after the restraints were applied.
- She thought that the one hour face to face was performed on documented observations of the patient every 15 minutes.
- Staff Z had not received any special training to perform one hour face to face assessments.

During a telephone interview on 10/23/19 at 10:40 AM, Staff Y, Physician, stated that he was not sure if the facility provided him any restraint training that included one-hour face to face evaluation and restraint first aid. Staff Y also stated that if the restraint order/flow sheet was not signed to indicate that the one hour face to face was performed and/or that the attending physician was notified after the one hour face to face, it was not done.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer (CNO), stated that staff should follow facility policies as indicated.

Based on interview, record review, and policy review, the facility failed to ensure that 18 physicians of 18 physicians reviewed, had evidence of competency in restraint (application of mechanical restraining devices or manual restraints which were used to limit the physical mobility of a patient) first aid (techniques used to address common emergencies that can occur from the use of restraint and seclusion) and one hour face to face evaluation. The lack of this training before hire and periodically had the potential to affect the care and safety of all patients in this facility.

Findings included:

Review of the facility's policy titled, "Restraints or Seclusion," Revised 04/2017, showed that physicians who were authorized to order restraint or seclusion must have a working knowledge of the hospital policy regarding the use of restraint and seclusion. The restraint policy to be reviewed annually with physicians who order restraint and seclusion.

Review of the facility's "Rules and Regulations of the Medical Staff", revised 2015, showed that training at a minimum:
- Physicians and other licensed independent practitioners authorized to order restraint or seclusion, must have a working knowledge of hospital policy regarding the use of restraint and seclusion.
- Staff must be trained and able to demonstrate competency in the application of restraints.
- This training shall include monitoring the physical and psychological well-being of the patient, respiratory and circulatory status, skin integrity, vital signs, and any other special requirements pursuant to the one-hour face to face evaluation.
- This training shall also include the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, with periodic recertification.

Record review and concurrent interview on 10/23/19 at 11:55 AM, showed a facility provided list of 18 Emergency Department (ED) physicians. Staff BB, Nurse Educator, stated that the 18 physicians did not receive any restraint training from the facility.

During a telephone interview on 10/23/19 at 10:40 AM, Staff Y, Physician, stated that he was not sure if the facility provided him any restraint training that included one-hour face to face evaluation or restraint first aid.

During a telephone interview on 10/23/19 at 10:55 AM, Staff CC, Physician, stated that he was unfamiliar with the term one-hour face to face. Staff CC also stated that the facility did not provide him with any restraint training including one-hour face to face evaluation and restraint first aid.

During an interview on 10/24/19 at 10:10 AM, Staff AAA, Chief of Staff, stated that she had never heard of the term one-hour face to face until the surveyors arrived. She had not had any restraint training from the facility.

During an interview on 10/22/19 at 10:41 AM, Staff U, Medical Director of the ED, stated that she did not receive any restraint training from the facility. The facility did not have any restraint training for any of the physicians.

During an interview on 10/23/19 at 11:30 AM, Staff BB, Nurse Educator, stated that she was unaware of any first aid training related to restraint use ever having been provided to the medical staff.

Based on observation, interview, and policy review, the facility failed to:
- Ensure that the Medical Records Department followed policies and procedures that directed staff how medical records were to have been maintained to protect against loss, defacement and tampering for three of three storage areas observed. (A441)
- Ensure that the Medical Records Department followed policies and had metal cabinets available that protected medical records from fire. (A441)
- Protect against unauthorized access to patients' protected health information (PHI), when one patient (#1) of one Obstetrical Unit (OB, a unit that provides care of women in childbirth and during the period before and after delivery) patient's medication record was left in the hallway unattended and when 15 boxes of medical records were left unattended in the outpatient Cardiac Rehabilitation Unit. (A441)
- Ensure that physician orders were signed prior to the evaluation and treatment for three patients (#16, #17, and #18) of four patients' records reviewed that received outpatient physical therapy. (A450)
These failed practices by the facility placed all patients' PHI at risk for unauthorized access and at risk for potential damage or destruction with unacceptable storage practices.

The cumulative effects of these systemic practices resulted in the facility's inability to ensure the safety and confidentiality of all patients medical records/PHI and resulted in the facility being out of compliance with 42 CFR 482.24 Conditions of Participation (CoP): Medical Record Services.

Based on observation, interview and record review, the facility failed to ensure that patients' paper medical records were:
- Protected against potential damage or destruction by water damage, flooding or fire, when three of three medical records storage areas had cardboard boxes that contained paper medical records, which were found stored directly on the floor and on shelves that were not metal and could not be closed to prevent damage.
- Protected against potential water damage or destruction when one of three medical records storage areas had cardboard boxes stored on the floors and on shelves located under the main water sprinkler system pipes.
- Secured from unauthorized access (by individuals who were not providing care for those patients) when one of three storage areas that had three doors to gain access and one door had two large windows that could have been broken.
- Protected against unauthorized access in outpatient Cardiac Rehabilitation, when 15 boxes of medical records were left unattended in patient care areas.
- Protected against unauthorized access to a patient's protected health information (PHI), when one patient (#1) of one Obstetrical Unit (OB, a unit that provides care of women in childbirth and during the period before and after delivery) patient's medication record was left on the medication cart, in the hallway unattended.

These deficient practices had the potential for unauthorized individuals to access, review, and/or possibly alter the documented health information in patients' paper medical records located in the medical record department areas, on the OB Unit, and in the Cardiac Rehab Unit.This also had the potential for patients' medical records to be at risk for damage and destruction through water or fire due to unacceptable storage methods.

Findings included:

1. Review of the facility's undated policy titled, "(D) Medical Records.0216," showed that the patient's medical records shall be maintained to safeguard against loss, defacement and tampering and to prevent damage from fire and water.

Review of the facility's policy, "Health Information Management Department Fire Plan," dated 05/2009, showed that once a fire has been discovered, staff are to be sure that all records are secure inside metal filing cabinets.

Observation on 10/23/19 at 9:10 AM in the Medical Records Department showed four cardboard boxes that contained patients' medical records stored directly on the carpeted floor under a folding table and 16 cardboard boxes that contained patients' medical records stacked in the middle of the department.

During an interview on 10/23/19 at 9:15 AM, Staff LL, Medical Records Department Director, stated that the records were stored on the floor due to lack of available space, and that the medical records were at risk of damage if the department would flood.

2. Observation on 10/23/19 at 9:25 AM, in the basement Medical Records Department storage area showed:
- Three cardboard boxes that contained patients' medical records stored directly on the concrete floor.
- Two stacks of cardboard boxes on a three-fourths inch thick piece of plywood approximately 50 feet from a water softer tank.
- Five shelves that held cardboard boxes that contained patients' medical records positioned directly under the main sprinkler system pipes.
- No metal cabinets that stored medical records safely from fire.

During an interview on 10/23/19 at 9:30 AM, Staff LL, Medical Records Department Director, stated that:
- She agreed that the medical records found on the floor would be at high risk of damage if there was a flood.
- The majority of the medical records were off the floor related to the water softer that had leaked in the past and had damaged some of the medical records.
- If a pipe burst, the medical records would have been ultimately damaged or destroyed.
- There were no metal cabinets to store medical records in the basement.

3. Observation on 10/23/19 at 9:35 AM, in a shed, located in the back of the hospital where patients' medical records were stored, showed:
- Sixteen total boxes piled four high, with four of those boxes stored directly on the concrete floor next to a door that had two large glass windows.
- Eleven boxes directly on the concrete floor that were next to shelves that held boxes of other medical records.
- Seven total boxes, with four of those stored directly on the concrete that were piled up along the back wall in front of shelves that held other medical records.
- No metal cabinets that stored medical records safely from fire.

During an interview on 10/23/19 at 9:40 AM, Staff LL, Medical Records Department Director, stated that:
- It was possible for an unauthorized person to have seen the medical records through the glass window and could have broken in and tampered with or stolen PHI.
- Medical records stored on the concrete floor would put the medical records at risk of damage if the building would have flooded or had a fire.
- There were no metal cabinets that stored medical records in the shed area.

4. Review of the facility's policy, "Providing Notice of Privacy Practices," dated 04/2003, showed that it is the policy of facility to protect the privacy of individually identifiable health information in compliance with federal and state laws governing the use and disclosure of PHI.

Observation on 10/23/19 at 10:55 AM, in the Cardiac Rehabilitation Department Secretary's office, on the floor, just inside the office door, showed 15 boxes full of patient medical records that contained protected patient information.

During an interview on 10/23/19 at 10:55 AM, Staff JJ, Director of Cardiac and Pulmonary Rehab Secretary, stated that she did not lock the door to her office during the day, just in the evenings when she left for the day. Housekeeping, patients and visitors had access during the day to the area where the boxes were stored that contained medical records.

5. Observation on 10/22/19 at 10:30 AM, in the hallway of the OB Unit, showed Patient #1's medication records that were dated 10/21/19 and 10/22/19, were left unattended and face up on the medication cart. The patient's name, room number, and the name of the medication and dosage administered was visible for any unauthorized person see.

During an interview on 10/22/19 at 11:05 AM, Staff C, Registered Nurse (RN), stated that the medication record should have been turned over to protect the patient's PHI.

During an interview on 10/22/19 at 2:20 PM, Staff B, OB Director, stated that she had expected staff to have turned the medication sheet over face down or removed the medication sheet from the medication cart that was left unattended.

During an interview on 10/24/19 at 10:35 AM, Staff A, Chief Medical Officer (CMO), stated that:
- She agreed that patients' medical records stored on the floor or too close to the ceiling would have been at higher risk of damage.
- Medical records should not have been stored in boxes in unlocked areas.
- She expected staff to have turned any medical record face down if unattended, or take the medical record with them when they left the area.




41474

Based on interview, record review and policy review, the facility failed to ensure physician orders were signed prior to evaluation and treatment for three patients (#16, #17 and #18) of four patients' records reviewed that received outpatient physical therapy. This had the potential to affect all patients in outpatient physical therapy.

Findings included:

1. Review of the facility's policy titled, "Outpatient Procedure Orders Policy," dated 10/25/10, showed that an order for outpatient procedures, which included a physician signature, must be completed prior to the patient obtaining the outpatient services.

Review of the facility's policy titled, "Department of Physical Therapy," dated 05/2006, showed the directive for staff for outpatient referrals was that a signed prescription must be received by the physical therapy department before initiating evaluation or treatment.

Review of Patient #16's medical record showed an outpatient verbal order, dated 09/04/19, for physical therapy to evaluate and treat that was not signed by the physician. There was a Physician's visit note, dated 09/04/19, that was not signed by the physician.

Review of Patient #17's medical record showed an outpatient verbal order, dated 10/18/19, for physical therapy to evaluate and treat, which was not signed by the physician. Review of the Physician's Visit Note, dated 10/15/19, was also not signed by the physician.

Review of Patient #18's medical record showed a verbal order for Physical therapy, dated 10/15/19, to evaluate and treat, was not signed by the physician. The Physician's visit note, dated 10/14/19, does not mention physical therapy, and it also was not signed by a physician.

During an interview on 10/23/19 at 10:35 AM, Staff II, Physical Therapy Secretary, stated:
- There were no signed orders for physical therapy to evaluate and treat Patients #16, #17 and #18.
- A signed order to evaluate and treat a patient was needed prior to the evaluation and treatment.
- She could pull up the signed Physician's note and that would be equivalent to the signed order.
- The Physician's notes were also not signed on three of four orders for physical therapy to evaluate and treat.

During an interview on 10/24/19 at 10:00 AM, Staff AAA, Medical Doctor, Chief of Staff and Chief of Surgery, stated that she had 24 hours to sign outpatient verbal orders. She expected Medical Staff would do the same for all verbal outpatient orders.

During an interview on 10/24/19 at 10:35 AM, Staff A, Chief Medical Officer (CMO), stated that Doctors had 24 hours to sign outpatient verbal orders.


41474

Based on observation, interview and policy review, the facility failed ensure that schedule IV drugs (substances or chemicals rated based on their potential for abuse and dependence, schedule I had the greatest risk and schedule V the lowest risk) were kept secure from unauthorized staff access for six crash carts of six crash carts reviewed. This had the potential to allow unauthorized staff access to controlled substances (drugs or medications that are high risk for personal consumption or abuse).

Findings included:

1. Review of the facility's undated policy titled, "Emergency Medications List," showed Diazepam (Valium, a schedule IV prescription drug used to treat anxiety and seizure disorders) listed as one of the medications on the emergency crash cart.

Review of the facility's policy titled, "Storage/Security of Controlled Medications," revised 08/2010, showed that all schedule II, III, IV and V controlled medication shall be stored in locked cabinets separate from all other medications.

Review of the facility's policy titled, "Emergency Crash Cart Security and Accountability," revised 11/2019, showed that if necessary, the Pharmacy Department will insert another sealed medication tray into the crash cart medication drawer after Central Services has replenished any missing non-medication stock.

Review of the facility's policy titled, "Emergency Crash Carts," renewed 11/2019, showed that:
- The seals will be broken only when an emergency situation arises.
- After an emergency and after Central Service has completed the restocking of all non-medication items, the Pharmacy department will restock all the medications and lock the cart.
- The emergency drug supply shall be stored in a sealed tray on each crash cart.
- The crash carts emergency drugs will remain inside the cart, sealed at all times, when not in use.

Observation on 10/22/19 at 10:55 AM, in the Emergency Department (ED), showed an adult crash cart with two red pull away locks that secured the top and bottom drawers. After removing the pull away lock, the drawer was opened, and in the top drawer was one vial of Diazepam, unsecured, in the drawer.

During an interview on 10/22/19 at 11:12 AM, Staff R, Purchasing Director, stated that:
- Staff S, Receiving Clerk, and Staff T, Control Clerk, (unlicensed personnel) had access to the crash carts to check for expired supplies.
- She was unaware that the crash carts contained scheduled controlled medications.
- Her staff should not have access to scheduled controlled medications.

Review of the facility's documentation titled, "Code Cart Check Flow Sheet September," showed that unlicensed personnel restocked the top drawer of the crash cart, having unauthorized access to Diazepam on the following dates:
- 09/03/19;
- 09/09/19;
- 09/13/19;
- 09/16/19;
- 09/20/19;
- 09/24/19;
- 09/26/19; and
- 09/30/19.

During an interview on 10/23/19 at 9:25 AM, Staff EE, Director of Pharmacy, stated that it was the full responsibility of the Pharmacy and Central supply staff to stock the crash carts, and that Diazepam was kept in the top drawer of all six crash carts.

During an interview on 10/24/19 at 10:30 AM, Staff A, Chief Nursing Officer (CNO), stated that unlicensed employees should not have access to schedule IV drugs stored on the crash carts.

By having the Diazepam in sealed, not locked containers, unlicensed staff who had access to the top drawer of the crash cart also had access to the schedule IV drugs stored in the top drawer.



37921

Based on observation, interview, record review, policy review and reviews of the United States Department of Agriculture (USDA), ServSafe and Food and Drug Administration (FDA) guidelines, the facility failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Ensure that the dietary staff labeled with an acquisition date, and a date to be consumed, ready-to-eat foods that have been prepared onsite or commercially prepared and opened for refrigerated, frozen food, and dry storage areas. (A-0749)
- Dispose of outdated foods and label open food containers with date opened and beyond use dates in patient refrigerators and food storage areas. (A-0749)
- Perform temperature checks on patient food trays. (A-0749)
- Dispose of outdated supplies in medication and supply rooms on the Medical Surgical Unit. (A-0749)
- Dispose of outdated medication in the Intensive Care Unit (ICU). (A-0749)
- Ensure that blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) quality control (QC) vials (contains a solution used to ensure testing accuracy) and test strips were dated when opened. (A-0749)
- Document catheter care on two patients (#5 and #6) of two patients in the ICU. (A-0749)

These failed practices had the potential to expose all patients, visitors and staff to cross contamination (germs that are spread from one person or surface to another), and increased the risk of infection and foodborne illness.

The cumulative effects of these systemic failures resulted in the facility's non-compliance with §42 CFR 482.42 Condition of Participation: Infection Control and resulted in the facility's failure to ensure safe infection control practices to prevent infections and communicable disease.



37921

Based on observation, interview, record review, policy review and reviews of the United States Department of Agriculture (USDA), ServSafe and Food and Drug Administration (FDA) guidelines, the facility failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Ensure that the dietary staff labeled with an acquisition date, and a date to be consumed, ready-to-eat foods that have been prepared onsite or commercially prepared and opened for refrigerated, frozen food, and dry storage areas.
- Dispose of outdated foods, and label open food containers with the date opened and beyond use dates in patient refrigerators and food storage areas.
- Perform temperature checks on patient food trays.
- Dispose of outdated supplies in medication and supply rooms on the Medical Surgical (Med Surg) Unit.
- Dispose of outdated medication in the Intensive Care Unit (ICU).
- Ensure that blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) quality control (QC) vials (contains a solution used to ensure testing accuracy) and test strips were dated when opened.
- Document catheter care on two patients (#5 and #6) of two patients in the ICU.

These failed practices had the potential to expose all patients, visitors and staff to cross contamination (germs that are spread from one person or surface to another), and increased the risk of infection and foodborne illness. The facility census was nine.

Findings included:

1. Review of the "USDA Food Code," updated on 09/09/16, stated that food shall be discarded if the food was not consumed before the expiration date, and if it was in a container or package which does not bear a date.

Review of the "ServSafe essentials," 7th edition, showed that:
- Ready-to-eat foods that have been prepared onsite or commercially prepared and opened must be labeled with used by date to be consumed.
- All food will be labeled with received by dates and used by dates from manufacturer if in the original container.
- If foods were removed from original containers or open, the product will be appropriately labeled and dated.

Review of the facility's policy titled, "Food Storage," revised 09/04/15, showed the following:
- Dated foods will be monitored for proper rotation and discarded on the expiration date.
- The Certified Dietary Manager, or their designee, will check food storage routinely to monitor dated foods for expiration dates.
- Foods on or after expiration date will be discarded.
- All foods must be covered, labeled and dated in the refrigerator.

Review of the facility's document titled, "QAPI Report to the Governing Body," dated 10/22/19, for the monitoring period of 2019 Third Quarter, showed dietary staff monitoring of dry storage and refrigerator units in the dietary department found one item to be outdated and 35 items not dated. Dietary staff monitoring Med Surg, ICU and Obstetric (OB) refrigerator units eliminated one item not dated and 41 items outdated.

Observation on 10/23/19 at 1:30 PM in the kitchen salad cooler, showed the following:
- Containers of salad dressing, olives, pickles and pudding with no opened date or used by dates.
- A container of maraschino cherries with an opened date of 09/04/19, and no used by date.
- A container of poppy seed dressing with an opened date of 09/29/19, and no used by date.
- A container of honey mustard dressing with an opened date of 10/07/19, and no used by date.
- A metal container of chocolate pudding covered in plastic wrap with a date of 10/18/19, and no used by date.
- A large box of tomatoes with no used by date.

Observation on 10/23/19 at 1:40 PM in the kitchen ice cream freezer, showed several boxes of ice cream with no received by date or used by dates. Individual ice cream bars were laying in the freezer with no expiration date.

Observation on 10/23/19 at 1:45 PM in the food prep area of the kitchen were covered plastic containers that contained the following:
- A plastic bag that contained chocolate chips with a label that read open 10/17, with no year, received by date or used by date.
- A plastic bag labeled cinnamon sugar with a date of 4/6, with no year, received by date or used by date.
- An opened bag of cheesecake mix with an opened date of 10/07/19 and no used by date.
- An opened bag of pinto beans with no received by date or used by date.
- An opened bag of cornmeal that expired in 2018.
- An opened bag of flour dated 8/3, with no year, received by date or used by date.
- Three large bags of egg noodles with no received by date or used by date.
- A box of lentil pasta with no received by date or used by date.

Observation on 10/23/19 at 2:00 PM, in the kitchen dry storage area, showed the following:
- 13 cans of pudding, with no received by date or used by date.
- Eight large plastic containers of vegetable oil, with no received by date or used by date.
- Bags of cornbread stuffing, with no received by date or used by date.

Observation on 10/23/19 at 2:15 PM, in the walk in refrigerator, located in the kitchen, showed boxes of potatoes and other vegetables with no used by dates, and a container of coleslaw with an opened date of 10/18/19 and no used by date.

Observation on 10/23/19 at 2:30 PM, in the walk in the kitchen freezer, showed the following:
- A bag of potato skins dated 12/12/18, with no received by date or used by date.
- A container of salami with an expiration date of 02/18/19.
- A bag labeled five inch looped pretzels with no received by date or used by date.
- An unlabeled bag of biscuit dough with no received by date or used by date.

Observation on 10/22/19 at 9:30 AM, in the patient food storage area of the ICU, showed two containers of thickened water with an expiration date of 10/02/19. Numerous packets of lemon juice, mustard, coffee creamer, seasoning, salt, pepper, butter spread, crackers and bouillon laying in trays or plastic bags without expiration dates.

Observation on 10/22/19 at 1:40 PM, in the patient kitchen of the Med Surg unit showed:
- Eight gelatin containers in the patient refrigerator with expiration dates of 09/2019.
- Two pudding containers with expiration dates of 07/2019.
- One pudding container with an expiration date of 09/2019.
- One ziplock bag that contained coffee creamer singles with no expiration date.

During interviews on 10/23/19 at 2:35 PM, Staff VV, acknowledged the unlabeled foods, and stated that the kitchen staff were to follow Safe Serve guidelines and label and date all foods that were stored in the dry storage area, kitchen, refrigerators and freezers. She was unaware that all foods were to be labeled with a used by date.

2. Even though requested, the facility failed to provide a patient food tray temperature check policy.

Review of the Food and Drug Administration (FDA) guidelines showed that an important duty of the person in charge is to make sure that any required temperatures are achieved or maintained when foods are cooked, cooled or held in a food establishment. By making it a duty of the person in charge to ensure that employees are monitoring food temperatures to verify the critical temperature limits, the likelihood of temperature abuse is reduced. This includes oversight of temperature monitoring to ensure foods that require temperature control for safety are being held at temperatures that adequately prevent pathogen growth and toxin production.

During an interview on 10/23/19 at 11:30 AM, Staff VV, Food Service Manager, stated that she started working at the facility six months ago and had not performed a patient test tray. She could not find documentation of when the last time it was performed and she did not know how often patient trays should be tested.

During an interview on 10/23/19 at 2:40 PM, Staff QQ, Dietician, stated that patient test trays should ideally be done every week but at least once a month and documented.

3. Even though requested, the facility failed to provide a policy on outdated supplies.

Observation on 10/22/19 at 1:20 PM, in the medication room, of the Medical Surgical unit showed:
- Two opened containers of QC control solution vials to be discarded after 01/20/19.
- One box of lubricating jelly packets with an expiration date of 01/2018.
- One insulin Pen (medication that regulates the amount of sugar in the blood), with a current patient label, with no date to discard (should be marked when its first used so it can be discarded after 30 days).
- Four filtered extension sets (tubing used with an intravenous medication) with an expiration date of 04/2018.

Observation on 10/22/19 at 1:30 PM, in the unlocked supply room, of the Medical Surgical unit showed three lotion bottles with expiration dates of 03/2014, 09/2017, and 04/05/2019.

During an interview on 10/22/19 at 1:50 PM, Staff E, Medical Surgical Unit Director, stated that the items in the refrigerator and the supply room were outdated and should have been removed so that patients and staff did not have access to them.

4. Review of the facility's policy titled, "Unusable and Outdated Drugs," dated 11/2018, showed that all drug storage areas of the hospital will be inspected for outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels. The Pharmacy staff member conducting the inspection will remove all of these types of drugs from the area.

Observation on 10/22/19 at 9:35 AM in the patient medication storage area of the ICU, showed four 50 milliliter (a measurement of liquid) bottles of Sodium Bicarbonate (a medication used to treat severe metabolic acidosis, a condition in which too much acid accumulates in the body) with an expiration date of 09/2019.

During an interview on 10/22/19 at 10:00 AM, Staff E, ICU and Med Surg Unit Director, stated that there should be no expired medications in the ICU, and that expired medications should be removed from potential patient use.

During an interview on 10/24/19 at 9:45 AM, Staff D, Infection Control Nurse, stated that:
- She expected no expired food in the refrigerators.
- Supplies should be removed from supply rooms when they were expired.
- She expected foods to be marked with a date made and a discard date.

5. Review of the facility's policy titled, "Blood Glucose Testing," dated 04/2018, showed no directives for staff to date the new QC control solution vials and test strips when opened.

Review of the manufacturer's document provided by the facility, showed that once opened, the test strips were stable when stored as indicated for up to 180 days and the control solution was stable for three months after it was opened.

Observation on 10/22/19 at 11:00 AM in the ICU showed an opened, undated test strip container and two opened QC control solution vials that were undated.

During an interview on 10/22/19 at 11:05 AM, Staff F, RN, stated that the vials should be dated when opened and did not know how long the strips and QC vials would be good for after they were opened.

6. Review of the facility's policy titled, "Indwelling Urinary Catheter (a small flexible tube inserted into the body through an opening of the urinary tract to drain urine) Insertion and Maintenance," showed the goal was to prevent the transmission of infection. There were no directives for staff related to how often catheter care should be provided or documented.

Review of Patient #5's medical record in the ICU on 10/22/19 showed that she had a urinary catheter inserted on 10/20/19. There was no documentation in the medical record that showed catheter care had been given since the urinary catheter was inserted.

Review of Patient #6's medical record in the ICU on 10/22/19 showed that he had a urinary catheter inserted on 10/15/19. There was no documentation in the medical record that showed catheter care had been given since the urinary catheter was inserted.

During an interview on 10/22/19 at 11:10 AM, Staff F, RN, stated that she took care of Patient #5 and she performed catheter care during the patient's bath. She never thought to document catheter care in the ICU. The patient care technicians charted catheter care for patients on the medical surgical floor. Catheter care should be done at a minimum daily, and with each bowel movement.

During an interview on 10/24/19 at 9:52 AM, Staff A, Chief Nursing Officer (CNO), stated that:
- Staff should follow the policies of the facility.
- Food should not have been available to patients if it was expired, or if the expiration date was unknown.
- Opened vials and controls should have been dated.
- Catheter care should have been documented.


39562

Based on observation, interview, record review, policy review, review of the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI), the facility failed to:
- Eliminate the residue and debris in two sterilizers (machines that use high heat and steam to kill harmful organisms) in the operating room (OR) Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacterial] instruments or equipment that are used in procedures) clean room (where sterile instruments and equipment are packaged and/or prepared for use).
- Ensure the sterile processing rooms were terminally cleaned (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) daily.
- Maintain a sterile environment in the SPD clean room by allowing multiple paper products (particle shedding products that can cause contamination), a laminate worktable with tape around the edges and exposed wood in the room.
- Ensure that an updated History and Physical (H&P) examination of the patient was completed and documented prior to the day of surgery for three discharged patients (#27, #28 and #29) of three discharged patient records reviewed. (A-0952)

These failed practices had the potential to compromise the safety and health of all patients undergoing procedures at the facility. The facility performed approximately 107 procedures per month.

The cumulative effect of these failures resulted in non-compliance with 42CFR 482.51 COP: Surgical Services.

Findings included:

1. During an interview on 10/23/19 at 9:25 AM, Staff RR, Surgery Director, stated that the department followed the AORN and the AAMI guidelines.

Review of the 2017 AAMI Guidelines showed the following:
- Sterilizers should be inspected and cleaned daily to include door gaskets (rubber seal), the chamber drain screen (screen to trap debris when water exits through the drain), the internal chamber (inside of the sterilizer), and external surfaces.
- Weekly or other prescribed inspection and cleaning should be performed as specified by the manufacturer.
- Inspection and cleaning reduce the frequency of equipment malfunction and the risk of accidental contamination of sterile items.

Even though requested the facility failed to provide a sterilizer cleaning policy or the sterilizer manufacturer's manual.

Observation on 10/23/19 at 9:45 AM, in an area next to the OR suites, was a small sterilizer used for immediate use steam sterilization. The inside of the chamber had rust colored stains on the bottom and sides of the sterilizer.

Observation on 10/23/19 at 10:00 AM, in the SPD clean room, showed one large sterilizer. The inside chamber of the sterilizer had black stains on the bottom and rust colored stains on the sides of the sterilizer. There was white hard water deposits on the inside of the door. Visible dust and dirt was seen on the outside doorframe of the sterilizer.

During an interview on 10/23/19 at 10:05 AM, Staff SS and TT, Certified Surgical Technologists, stated that neither of them had cleaned inside the sterilizer.

During an interview on 10/23/19 at 10:10 AM, Staff RR, Surgical Director, stated that she did not know when the last time the inside of the sterilizers were cleaned. It had been over a year.

During an interview on 10/23/19 at 11:00 AM, Staff UU, Housekeeper, stated that she had cleaned the operating rooms and the sterile processing department. She was not required to clean the sterilizers, because the surgery department staff took care of that.

During an interview on 10/24/19 at 8:45 AM, Staff BBB, Housekeeping Director, stated that the housekeeping department was not responsible for cleaning the sterilizers. She did not keep a log of any cleaning that was done in the surgery area.

During an interview on 10/24/19 at 9:45 AM, Staff D, Infection Control RN, stated that her expectation of staff was to clean the sterilizers following recommended AAMI guidelines and to document when the cleaning was completed.

2. Review of the facility's policy titled, "Housekeeping Procedures Surgical Services," revised 02/2019, showed the following directives for OR staff and housekeeping to perform terminal cleaning at the end of the day:
- Clean and disinfect tables, all mobile and fixed equipment, cabinets, doors, handles.
- Walls are cleaned daily and as necessary.
- Entire floor space is mopped with detergent germicide.
- Scrub sinks, faucets, soap dispensers and surrounding walls are cleaned.

Review of the 2018 AORN guidelines showed that sterile processing areas should be terminally cleaned. Sterile processing personnel conduct critical processes, such as decontaminating, assembling, and sterilizing surgical instrumentation, in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical and other invasive procedures are performed.

. Review of the 2017 AAMI guidelines showed the following:
- All surfaces (floors, walls, ceilings and cabinets) should be durable, smooth and cleanable.
- Surfaces that are durable, smooth and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices.
- The clean work area/room is used for the preparation and assembly of instruments and other items to be sterilized.
- The clean work area/room should include space for a processing table, which should be made of nonporous materials (for example, stainless steel).
- Lint and airborne particles can carry microorganisms.
- Web edged (corrugated) boxes can collect dust and debris.

Observation on 10/23/19 at 9:25 AM, in the clean work area/room of the sterile processing department, showed the following:
- Black colored marks and handprints on the walls.
- A laminate countertop that was held down with tape (porous material).
- A portion of the laminate countertop was missing, exposing wood (porous material).
- Corrugated boxes on the shelves.
- A calendar and paper (particle shedding) hanging on the wall.

During an interview on 10/23/19 at 9:30 AM, Staff RR, Surgery Director, stated the following:
- It was difficult to keep painted walls clean.
- Her expectation of staff was to clean the walls if noticeably dirty.
- Housekeeping mopped the floors daily in the sterile processing department.
- Surgery staff cleaned the counters daily.
- Paper products and boxes should not be in the clean work area.

During an interview on 10/24/19 at 8:45 AM, Staff BBB, Housekeeping director, stated that the sterile processing department was terminally cleaned monthly. On a daily basis, housekeeping cleaned the counters, floors and removed trash. She did not keep a log of any terminal cleaning that was done in surgery or SPD.

During an interview on 10/24/19 at 9:45 AM, Staff D, Infection Control Registered Nurse, stated that the Surgery Department and SPD should follow AORN and AAMI guidelines to prevent cross contamination and infection.

Based on interview, record review and policy review, the facility failed to ensure that an updated History and Physical (H&P) examination of the patient was completed and documented prior to the day of surgery for three discharged patients (#27, #28 and #29) of three discharged patient records reviewed. This failure had the potential to cause all surgical patients who had H&P's completed prior to surgery harm or injury related to patient needs and/or risks unidentified by the physician on the day of surgery.

Findings included:

1. Review of the facility's policy titled, "History and Physical Surgical Services," revised 02/2012 and review of the "Medical Staff Bylaws," showed no directive for physicians performing surgical procedures to update a patient's H&P prior to surgery.

Review of Patient #27's medical record showed the following:
- An H&P dated 07/05/19;
- She had a scheduled surgery on 07/29/19; and
- No documentation of an updated examination of the patient by the physician prior to surgery.

Review of Patient #28's medical record showed the following:
- An H&P dated 10/11/19;
- She had a scheduled surgery on 10/18/19; and
- No documentation of an updated examination of the patient by the physician prior to surgery.

Review of Patient #29's medical record showed the following:
- An H&P dated 08/21/19;
- She had a scheduled surgery on 08/23/19; and
- No documentation of an updated examination of the patient by the physician prior to surgery.

During an interview on 10/23/19 at 2:00 PM, Staff RR, Surgery Director, stated that she was unaware that the physicians needed to document an updated examination of the patient prior to the procedure if the H&P was completed within 30 days before admission.

During an interview on 10/24/19 at 10:10 AM, Staff AAA, Chief of Surgery, stated that she knew she should update every H&P, but was not consistent at doing this. She saw every patient preoperatively and only documented if there were any changes in the H&P.