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A. Based on document review and interview, it was determined for 1 of 5 (Pt #11) patients records reviewed, who required the use of restraints, the Hospital failed to ensure restraints were ordered by a physician or other licensed practitioner (LP), authorized to order restraints. This has the potential to affect all inpatients and outpatients who require the use of restraints by the Hospital.

Findings include:

1. The Policy titled "Restraints" (revised by the Hospital 09/01/2020) was reviewed on 10/15/2020 at approximately 1:00 PM. On page 4, the policy noted, "V. Procedure: A. Non-violent/Non-Self-Destructive Behavior Restraints... 2.... a. Restraint shall be used only upon written order of a physician or other LP."

2. Pt #11 Date of Admission: 10/09/2020
Diagnosis: Closed Hip Fracture. The record was reviewed on 10/15/2020 at approximately 12:00 PM. The "Anesthesia Preprocedure Eval (Evaluation)" authored by MD #1 noted, "Comments: Combative and confused preoperatively, .... Soft restraints applied for self protection." An "Addendum to H & P (history and physical)" completed by MD #2 noted, "Pt was combative and confused in the preop (preoperative) holding area, requiring restraints." Pt #11's record lacked an order for restraints.

3. During an interview on 10/15/2020 at approximately 12:00 PM, E#7 (Nurse Educator) reviewed Pt #11's record and stated "There is no order for restraints and there should be."

B. Based on document review and interview, it was determined for 2 of 5 (Pt #8 and Pt #11) non-violent restraint patients, which lasted more than 24 hours or one calendar day, the Hospital failed to ensure a LP (Licensed Practitioner) reviewed the patient's status and re-initiated the ongoing non-violent restraint order every 24 hours/ calendar day, in accordance with its' policy. This has the potential to affect all inpatients and outpatients who require the use of non-violent for longer than 24 hours by the Hospital.

Findings include:

1. The Policy titled "Restraints" (revised by the Hospital 09/01/2020) was reviewed on 10/15/2020 at approximately 1:00 PM. On page 6, the policy noted, "5. Successive Orders for Ongoing Restraint for Non-Violent/ Non-Self-Destructive Behavior. a. After the order for restraint expires, or at the end of one calendar day, the patient must be released from restraint unless an LP has reviewed and re-initiated an order for restraint."

2. Pt #8 Date of Admission (DOA): 08/16/2020
Diagnoses: Persistent Hyperactive Sedative Hypnotic or Anxiolytic Withdrawal and Delirium. On 10/14/2020 at approximately 2:00 PM, the record was reviewed. The record noted Pt #8 was placed in an enclosure bed on 08/17/2020 through discharge on 09/02/2020. The Physician Progress Notes lacked documentation which addressed the use of restraint and continued need for the restraint.

3. Pt #11 DOA: 10/9/2020
Diagnosis: Closed Right Hip Fracture. The record was reviewed on 10/15/2020 at approximately 12:00 PM. The record noted Pt #11 was placed in non-violent soft restraints from 10/09/2020 at 5:40 PM to 10/11/2020 at 10:00 AM. The Physician Progress Notes lacked documentation which addressed the use of restraints and continued need for the restraints.

4. During an interview on 10/15/2020 at approximately 2:30 PM, E#7 (Nurse Educator) reviewed Pt #8 and Pt #11's records and verbally agreed the Physician Progress Notes/assessments lacked documentation which addressed the use of restraints and continued need for the restraints. E#7 stated "The physicians should be evaluating the restraints every 24 hours. This should have been completed and was not."

Based on document review and interview, it was determined in 1 of 1 (Pt #11) surgical patient, who required restraints, the Hospital failed to ensure all staff were trained and demonstrated competencies in the application and care of patients in restraints, prior to providing care and services to restrained patients. This has the potential to affect all inpatients and outpatients who require the use of restraints.

Findings include:

1. Pt #11 Date of Surgery: 10/9/2020
Diagnosis: Closed Hip Fracture. The clinical record was reviewed on 10/15/2020 at approximately 12:00 PM. The Anesthesia Preprocedure Evaluation dated 10/9/2020 at 2:07 PM noted, "... Soft restraints applied for self-protection." An amended History and Physical dated 10/9/2020 at 1:00 PM noted "Pt (patient) was combative and confused in the preop (preoperative) holding area, required restraints." The Patient Hand-off form authored by E#18 (Post Anesthesia Care Unit (PACU) Nurse) noted on 10/9/2020 at 5:15 PM, while in the PACU, Pt #11 was in wrist restraints. The record noted 3 nurses (E#18, E#19, E#20) provided direct patient care for Pt #11 pre-operatively, intra-operatively, and post-operatively, while Pt #11 was restrained.

2. During an interview on 10/15/2020 at approximately 11:00 AM, E#10 (Intra-operative Nurse Educator) and E#11 (Pre-operative/Post-operative Nurse Educator) stated "Surgical (pre, intra and post operative staff) staff do not require restraint training because patients are not restrained in the surgical areas." E#10 stated "If we had to go get a patient from the ICU (Intensive Care Unit) or floor, we (surgical staff) would take an OR (Operating Room) bed to the patient and transfer the patient to the bed and go directly to the OR room. The restraints would be removed prior to transfer."

3. During an interview on 10/15/2020 at approximately 12:50 PM, E#7 (Nurse Educator) reviewed Pt #11's clinical record and verbally agreed soft wrist restraints were applied to Pt #11 in the pre-operative holding area on 10/09/2020. E#7 stated, "So, if a patient had a broken hip and was restrained on the floor, we bring the patient down (to the Operating Room) in their own bed. They are sedated before we transfer them to the OR bed because they are in too much pain. We take the restraints off when they are sedated, or obviously as soon as possible... Sometimes patients from the floor are brought to the pre-op holding area. Maybe the room isn't quite ready or the checklist needs reviewed or whatever... I agree. It seems like a patient could wake up violently in the PACU (Post Anesthesia Recovery Unit) and require restraints."

4. During an interview on 10/15/2020 at approximately 2:00 PM, E#3 (Director of Quality and /Safety, Corporate Compliance Officer) stated during a phone conversation with E#17 (Director of Surgery), it was verbally confirmed E#18, E#19 and E#20 had not received restraint training and/or demonstrated competency nor had any of the surgical staff. E#3 verbally agreed restraints, although infrequent, could be utilized in the surgical areas if needed and restraint training and competencies should have been conducted.

Based on document review, observation, and interview, it was determined for 4 of 8 (Pt #33, Pt #34, Pt #35, and Pt #36) patients observed with fall precautions, the Hospital failed to ensure the falls care plan precautions/interventions were implemented, per policy. This has the potential to affect all inpatients and outpatients who require fall precautions by the Hospital.

Findings include:

1. The policy titled "Inpatient and Observation Patient Fall Prevention" (revised by the Hospital 02/13/2020) was reviewed on 10/15/2020 at approximately 12:00 PM. The policy noted, "E. Initiate and document interventions as indicated in the Electronic Medical Record (EMR). The Fall Precaution interventions required, "...Placement close to nurses station; Armband/colored socks..."

2. During a tour of the Medical-Surgical Unit on 10/13/2020 at approximately 11:00 AM to 1:00 PM with the Nurse Educator (E#9), the following fall precaution observations were made:
a. Pt #33, Pt #34, Pt #35, and Pt #36 were observed to be on fall precautions.
b. Pt #33 and Pt #34 lacked the required yellow arm band.
b. Pt #35 and Pt #36 lacked the required colored socks (yellow).

3. During an interview on 10/13/2020 at approximately 12:00 PM, E#9 verbally agreed the required arm bands and colored socks were not on the patient and should have been, as per the care plan precautions/interventions listed in their policy and reflected in the EMR.

Based on document review and interview, it was determined in 2 of 30 (Pt #28 and Pt#2) patients records reviewed, the Hospital failed to ensure documentation was accurate and complete. This has the potential to affect all patients, with a current census of 33 in-patients on the medical surgical unit, 11 in-patients on the geriatric psychiatric unit, Emergency Room patients with an average census of 1473 patients per month.

Findings include:

1. The "Medical Staff Rules and Regulations" (implemented by the Hospital June 1, 2020) noted "3.2 Authentication, All clinical entries in the patient's medical record will accurately dated, timed, and authenticated (signed) with the practitioner's legible signature or by approved electronic means. Authentication identifies the author of the medical record entry and confirms that the contents are what the author intended."

2. Pt #28 Start of Care (SOC): 10/12/2020
Diagnosis: Gangrene Subacute Osteomyelitis of Left Foot. The record was reviewed on 10/14/2020 at approximately 10:00 AM.
a. The Anesthesia Record dated 10/12/2020 noted MAC (Monitored Anesthesia Care) was administered. The Anesthesia Post Procedure Evaluation dated 10/12/2020 at 5:28 PM noted General anesthesia was administered. The Immediate Post-operative Post-procedure note by MD#3 dated 10/12/2020 5:02 PM noted General anesthesia was administered. It was unable to be determined what type of anesthesia was administered.
b. During an interview on 10/14/2020 at approximately 10:45 AM, E#9 (Nurse Educator) verbally agreed there was a discrepancy to the type of anesthesia used for Pt #28.











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3. Pt #2 Start of Care (SOC): 8/21/2020
Diagnoses: Sepsis and Urinary Tract Infection. The record was reviewed on 10/14/2020 at approximately 2:15 PM. a. The Discharge Summary dated 8/29/2020 noted "... after 20 minutes or so of resuscitation, was pronounced dead..." The record lacked documentation of the resuscitation events.
b. On 10/16/2020 at approximately 8:30 AM, E#3 (Director of Quality and Safety, Corporate Compliance Officer) produced Pt #2 resuscitation record. E#3 stated a copy of it was found with the auditors although the original was not in the record and could not be found.

Based on observation, document review and interview, it was determined for 1 of 1 offsite location toured, the Hospital failed to ensure expired biologicals were not available for patient use. This has the potential to affect all patients who receive care in the ARC (Addiction Recovery Center) with a current census of 16 patients.

Findings include:

1. During a tour of the ARC on 10/14/19 between 10:00 AM and 11:00 AM with the ARC Manager (E#12), the AED (automated external defibrillator) at the nurses station, available for staff and/or patient use, were observed to have an expiration date of February 2020.

2. During the tour with E#12, it was verbally confirmed the AED pads were outdated and should have been removed.

Based on document review, observation and interview, it was determined for 1 of 3 (E#22) X-ray technicians, the Hospital failed to ensure x-ray technicians were wearing a dosimetry badge used to monitor radiation exposure. This has the potential to affect all staff who have exposure to radiation.

Findings include:

1. The policy titled "General Radiation Safety (revised by the Hospital 08/17/2020) was reviewed on 10/13/2020 at approximately 2:00 PM. The policy noted, "IV. Basic Radiation Protection of Personnel.... E. Radiation monitoring badges are always to be worn by radiology staff who may occupationally receive radiation exposure."

2. During a tour of the Emergency Department (ED) x-ray room on 10/13/2020 at approximately 11:30 AM, with E#23 (ED Department Manager), and Xray technician (E #22) was observed taking a patient into the x-ray room. E#22 did not have a dosimetry badge on. An interview was conducted at that time with E #22. E#22 stated "Radiation exposure is monitored through a badge. I forgot to put mine on this morning when I started my shift." The X-ray log noted E#22 had completed 4 x-ray procedures on 10/13/2020 while not wearing a monitoring badge.

3. During an interview on 10/15/2020 at approximately 12:15 PM, E#21 (Radiology Department Manager) reviewed the x-ray record and stated "All radiology personnel should be wearing the badges to be able to appropriately monitor radiation exposure. (E #22) did not wear the badge for those procedures and should have."

A. Based on observation and interview, it was determined the Hospital failed to ensure dietetic services maintained a sanitary environment in the food preparation area, to prevent the potential for cross contamination. This has the potential to affect all patients, staff and visitors who consume food prepared by the Hospital.

Findings include:

1. During a tour of the Food Services Department on 10/13/2020 at approximately 1:00 PM, E#13 (Food Service Manager) a fan was observed to be blowing unfiltered air down on the food preparation area and not in a manner that would minimize the potential for contaminating the food.

2. During an interview on 10/13/2020 at approximately 2:00 PM, E#13 verbally agreed the fan could cause food contamination.


B. Based on document review, observation and interview, it was determined in the cafeteria food area the Hospital failed to ensure dietetic services assured food temperatures were checked before being served to patients and visitors, to prevent the potential for spoilage and bacterial growth. This has the potential to affect all patients, staff and visitors who consume food prepared by the Hospital.

1. The policy "Guideline On Cafeteria Temperature Test" (revised October 2020) was reviewed 10/13/2020 at approximately 3:00 PM. The policy noted "ACTION: 1. Conduct temperature test before each service.... 10:15 AM Lunch."

2. During a tour of the cafeteria (area where staff and visitors are served) on 10/13/2020 at approximately 1:30 PM with E#13, the "Cafeteria Food Temp Logs" were observed to be incomplete.

3. During an interview on 10/13/2020 at approximately 2:00 PM, E #13 verbally agreed the logs lacked documentation the temperatures were completed prior to serving guest and staff and should have been.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on October 13-14, 2020, the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Full Survey Due to a Complaint conducted on October 13-14, 2020, the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

A. Based on document review and interview, it was determined the Hospital failed to ensure active, accurate surveillance was conducted for the immediate use sterilizers, to prevent the potential for cross contamination. This has the potential to affect all patients who receive surgical services with an average monthly census of 650 surgeries.

Findings include:

1. The policy titled "Positive Sterilizer Biological Monitor Process " (dated 9/13/2020) was reviewed on 10/16/2020. The policy noted "V. Procedure A. Monitoring sterilizers... 4. Two 3-hour Rapid Read biologicals are run in the SaniPak (waste steam sterilizer) every seven days."

2. The Immediate Use Sterilizer Cycle Monitor Records for sterilizers #1, #3, #5, #7 and #9 dated August 3, 2020 to September 28, 2020 were reviewed on 10/14/2020 at 2:40 PM. 11 out of 33 records reviewed, the records lacked documentation of a sterilizer number, 2 sterilizer numbers were illegible, 1 sterilizer was numbered as 1st (first floor) and it was unable to be determined if all the immediate use sterilizers were accurately monitored.

3. During an interview on 10/14/2020 at approximately 2:40 PM observed by E#1 (Manager Accreditation Patient Safety Officer), E#5 (Certified Surgical Technician, Sterile Processing Department Lead) and E#6 (Nurse Manager Surgical Services) reviewed the Immediate Use Sterilizer Cycle Monitor Records. E#5 and #6 were unable to determine where sterilizers #1, #3, #5, #7 and #9 were located and which record went with which sterilizer. E#5 and E#6 returned on 10/14/2020 at approximately 3:30 PM with 53 Immediate Use Sterilizer Cycle Monitor Records. The records now noted sterilizer #1 as located in the eye room and an additional sterilizer monitoring records, identified with a heart-shape, was identified as the sterilizer located on the first floor open heart or orthopedic room. The record were observed to be edited and now each record was identified with a sterilizer number or a heart shape. The Immediate Use Sterilization Biological Log Book dated 8/3/2020 thru 9/29/2020 was also produced at 3:30 PM by E#5 and E#6. The Biological Log Book noted on 8/3/2020 a sterilizer #2, 6 sterilizer numbers were changed from a #2 to a heart shape, 1 sterilizer number was changed from "1st" to a heart shape and 1 sterilizer number was changed from a 2 to note eye room.






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B. Based on document review, observation and interview, it was determined the Radiology/Nuclear Medicine Department, failed to maintain a safe and sanitary department in order to prevent/control infections and communicable diseases. This has the potential to affect all patients served in the Radiology/Nuclear Medicine Department.

Findings include:

1. The Policy titled, "Inspection of Lead Protective Devices for Radiation Protection (revised 07/22/2020) was reviewed on 10/14/2020 at approximately 9:00 AM. The policy stated "B... 2... a. Visual Inspection: 1) Each lead protective device should be visually inspected for any tears or cracks in the external covering of the lead protective devices. This should include any tears inside or shoulder seams or any missing ties. 2) Any defects noted should be documented and evaluated as to whether the device needs to be repaired or replaced or just monitored."

2. During a tour of the Radiology/Nuclear Medicine Department on 10/13/2020 at approximately 12:00 PM with E#21 (Radiology Department Manager), in x-ray room 6 a full length lead apron was lying on the x-ray table and was observed to have a 4 inch rip along the seam of the apron.

3. During an interview on 10/13/2020, E#21 verbally agreed the apron was ripped and stated "This cannot be appropriately cleaned to prevent cross contamination. The apron should have been removed from service and a work order placed. This has not been completed and should have been."

Based on document review and interview, it was determined the Hospital failed to ensure active, accurate surveillance was conducted for the immediate use sterilizers, to assure the quality and safety of the surgical services provided, in accordance with its' policy. This has the potential to affect all patients who receive surgical services with an average of 650 surgical cases per month.

Findings include:

1. The policy titled "Positive Sterilizer Biological Monitor Process" (revised 9/13/2020) was reviewed on 10/16/2020. The policy noted, "V. Procedure A. Monitoring sterilizers 1. A 1-hour Rapid Read bio (biological) is run in all in-house gravity displacement sterilizers every 24 hours... 4. Two 3-hour Rapid Read biologicals are run in the SaniPak... every seven days."

2. The Immediate Use Sterilizer Cycle Monitor Records for sterilizers #1, #3, #5, #7 and #9, dated August 3, 2020 to September 28, 2020, were reviewed on 10/14/2020.
a. 11 out of 33 records reviewed lacked documentation of a sterilizer number.
b. 2 sterilizer numbers were illegible.
c. It was unable to be determined if all the immediate use sterilizers were monitored.

3. During an interview on 10/14/2020 at approximately 2:40 PM, observed by E#1 (Manager Accreditation Patient Safety Officer), E#5 (Certified Surgical Technician, Sterile Processing Department Lead) and E#6 (Nurse Manager Surgical Services) reviewed the Immediate Use Sterilizer Cycle Monitor Records.
a. E#5 and #6 were unable to determine where sterilizers #1, #3, #5, #7 and #9 were located and which record went with which sterilizer.
b. E#5 and E#6 returned on 10/14/2020 at approximately 3:30 PM with the Immediate Use Sterilizer Cycle Monitor Records. The records now noted sterilizer #1 as located in the eye room and an additional sterilizer monitoring records, identified with a heart-shape, were identified as the sterilizer located on the first floor open heart or orthopedic room. The records were observed to be edited and now each record was identified with a sterilizer number or a heart shape.
c. The Immediate Use Sterilization Biological Log Book, dated 8/3/2020 thru 9/29/2020, was also produced on 10/14/2020 at 3:30 PM by E#5 and E#6. The Biological Log Book noted on 8/3/2020 a sterilizer #2, 6 sterilizer numbers were changed from a #2 to a heart shape, 1 sterilizer number was changed from "1st" to a heart shape and 1 sterilizer number was changed from a 2 to note eye room.

4. During an interview on 10/14/2020 at approximately 3:45 PM, E#1 verbally agreed the immediate use monitoring records lacked sterilizer numbers, some were illegible, some had the wrong numbers documented, and the records and logs had been edited without appropriate identifying documentation of the edits. E#1 further verbally agreed E#5 and E#6 were unable to identify the appropriate numbers and locations of the sterilizers, therefore were unable to ensure all sterilizers were monitored. E#1 verbally agreed the Hospital failed to ensure sterilized equipment was safe for patient use. E#1 further verbally

Based on document review and interview, it was determined in 2 of 5 (Pt #25 and Pt #26) surgical patients records reviewed, the Hospital failed to ensure operative reports were completed per policy. This has the potential to affect all patients who receive surgical services with an average of 650 surgical cases per month.

Findings include:

1. The hospital "Medical Staff Rules and Regulations" (amended by the Hospital 8/2/13) required, "Operative reports shall be documented or dictated immediately after the surgery/procedure is finished, and in no case later than twenty-four (24) hours after the procedure...If the operative/procedure report is not immediately available in the record, an interval operative/procedure note is recorded in the medical record, prior to transfer to the next level of care, outlining the procedure performed."

2. The clinical record of Pt #25 was reviewed on 10/14/2020 at approximately 2:00 PM. On 10/13/2020 at 5:34 AM, Pt #25 was admitted and underwent a lipodystropy of the abdomen and bilateral breast ptosis. Pt #25 was admitted to observation status and discharged home on 10/14/2020. The clinical record lacked the interval operative/procedure note. The operative note was dictated on 10/14/2020 at 3:06 PM, beyond the required 24 hour timeframe.

3. The clinical record of Pt #26 was reviewed on 10/14/2020 at approximately 3:30 PM. Pt #26 was admitted to the Hospital on 10/07/2020 with the diagnosis of bilateral proximal humeral fractures and underwent bilateral insertion of nail/rod intramedullary proximal humerus intertrochanteric surgery. The record lacked an operative report.

4. During an interview on 10/14/2020 at approximately 4:00 PM, E#7 (Nurse Educator) verbally agreed the records lacked the required immediate operative report for Pt #25 and lacked the operative report within the required 24 hour timeframe for Pt #25 and Pt #26.