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Tag No.: A0043
Based on observation, interview and record review the Governing Body failed to:
A. ensure plans to close the ICU unit during time of low census and moving ICU patients to the Medical- surgical unit was reviewed and approved before implementation.
During an observation on 06/5/2018 after 11:00 a.m., the Intensive care unit (ICU) was closed.
Staff #2 reported the unit had been closed since last Thursday(05/31/2018). When the ICU census got to 2 or below they closed the unit. There was two rooms on the Medical Surgical unit which were being used for low level ICU patients (Room #'s 222 and 223).
During confidential interview with nursing staff they revealed the ICU unit was closing prior to 05/31/2018.
Review of a draft policy/procedure named "ICU Closure" prepared by the CNO and dated 05/15/2018 revealed it had not been approved by the Medical Staff or Governing body yet.
During an interview on 06/06/2018 after 1:20 p.m., Staff #2 (CNO) confirmed that the staffing plan concerning closing the ICU for purposes of a low census was still in draft form. The plan had not been shared with nursing staff yet. Staff #2 confirmed they had not taken into account who would be charge nurse when the ICU patients were cared for by the ICU nurses and that had just been added to the plan today.
B. ensure the Director of nurses failed to have a plan of administrative authority and delineation of responsibilities to nursing staff on 2 of 2 units (Intensive care unit (ICU) and Medical-surgical unit).
The Director of nurses failed to in-service nurses on the plan to close the ICU unit during times of low census and to move ICU patients to the Medical- surgical unit.
The Director of nurses failed to have clear instructions on charge nurse assignments, the staffing plan, to whom ICU nurses should report to in emergencies, where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
Refer to tag A0386 for additional information.
C. ensure adequate staffing on 2 of 2 units (Intensive Care unit (ICU) and Medical-surgical unit). The facility failed to ensure there was clear instructions on charge nurse assignments, supervisory assignments, the staffing plan, and to whom ICU nurses should report to in emergencies. They failed to ensure nursing staff delivering patient care knew where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
The facility failed to ensure there were sufficient numbers of ICU nurses caring for patients when they were housed on the Medical -Surgical unit. They failed to ensure the ICU staffing matrix was being used to guide with staffing numbers.
They failed to ensure licensed vocational nurses providing patient care on the Medical-surgical unit received adequate supervision.
Refer to tag A0392 for additional information.
D. ensure registered nurses evaluated and supervised patient care on 5 of 27 sampled patients (Patient #'s 1, 3, 6, 9, and 10).
The facility failed to ensure interventions were initiated timely to address patients with critically low blood sugars. The facility failed to ensure interventions were initiated timely on a patient with an elevated blood sugar.
Patient #1's blood sugar went from 53 to 21 and nursing staff failed to provide timely intervention and timely evaluation after interventions were provided to increase the blood sugar.
Patient #'s 3 and 10 had blood sugars which were out of reference range and nursing staff failed to provide physician ordered interventions and evaluation as needed.
The facility failed to ensure patients classified as needing an Intensive care unit (ICU) bed received one. The facility failed to ensure nursing staff received physicians orders before downgrading a patient from needing an ICU bed to needing a Medical-Surgical bed.
Patient #6 had a physician's order to be transferred to an ICU bed. Patient #6 was downgraded by nursing and transferred to a Medical-Surgical bed which was not equipped or designated as an ICU bed. There was no physician's order downgrading the patient until four days after the admission.
The facility failed to ensure there were a sufficient number of ICU nurses supervising patient care.
Patient #9 had admitted diagnoses which included dyspnea, chronic obstructive pulmonary disease with acute exacerbation, and pleural effusion.. Patient #9 had a change in condition and required being transferred from a Medical- surgical status to ICU status. According to staffing numbers there was only one registered nurse supervising the patient when the facility's staffing matrix called for 2 registered nurses.
Refer to tag A0395 for additional information.
E. ensure 4 of 20 Emergency department (ED) nurses had required specialized qualifications to provide care in the ED (Staff #'s 15, 16, 17 and 19).
The facility failed to ensure a nurse serving in the role of the Intensive Care Unit (ICU) Director had the required special qualifications (Staff #2).
Refer to tag A0397 for additional information.
F. ensure that verbal orders were completed with a date, time, and dosage in 1 of 27 patients (Patient #11). Also, the facility failed to ensure that verbal orders were written clearly and accurately to prevent medication error and safe medication administration, and the facility failed to follow their own policy on verbal orders. Verbal orders for sedation were documented on a sedation flowsheet with no date, time, or dosage.
Refer to tag A0407 for additional information
G. to ensure the infection control officer developed a system that maintained a clean and sanitary environment for two (Intensive Care Unit (ICU) and Medical Surgical floor) of two departments. The facility failed to:
Ensure the ICU equipment room was sanitary, organized, and free from equipment that was broken or damaged. The equipment room had equipment and patient care supplies on the floor. A procedural chair mattress had torn vinyl and a Bi-Pap machine had broken plastic coverings.
Ensure patient rooms in ICU were kept clean, sanitary, and free from broken and damaged equipment and structures. Patient rooms had suction tubing, oxygen tubing, and electrodes hooked up and hanging from equipment. The unit had been closed two weeks. There were open packages of EKG electrodes in a drawer. The walls had missing chips of paint and scrapes. The patient beds had plastic that was cracked and covered in dust. A wall head board was broken and being held up with tape. The head board had broken and missing pieces of the laminate.
Ensure the ICU Medication/Supply room was clean, sanitary and free from broken cabinets. The supply rack had expired and open IV fluid bags stored on it. The bins that stored IV bags and supplies were covered in dust and debris. The cabinets had chips of paint and laminate missing. The cabinets had a yellow substance splattered on the inside and outside walls of the cabinet. The floors were unsanitary. An insect trap was found on the floor next to the Pyxis dispenser (A medication dispensing unit). The temperature and humidity logs for the room and refrigerator were incomplete. Two trash cans were found in medication room with used IV supplies, patient gloves, and medication packages. The unit had been closed two weeks.
Ensure the ICU nursing station was clean and sanitary. The floor had missing chips from the tiles. The floor and cables underneath the desk were covered in dust. A shelf underneath the desk was missing the trim and had exposed wood around the edges.
Ensure the medical and surgical medication supply room was clean, sanitary, and free from expired supplies. The supply bins were covered in dust. Blood tubes were stored in bins that expired 5 days prior to observation.
Ensure patient rooms were clean and sanitary. A ceiling tile in patient room 223 had a water stain on it.
Ensure hinged surgical equipment was not sterilized in an open position, peel packets of sterilized equipment was dated, and expired sterilized equipment was discarded in the ICU crash cart. A Magill forceps was found in the ICU crash cart that had been sterilized in a closed position. The sterilization date was 12/29/2015, 19 months past the manufacturer guaranteed sterility date.
Refer to tag A0749 for additional information.
Tag No.: A0131
Based on record review and interview, the facility failed to protect patients' right to make an informed decision on their care for 2 (Patient's #11 and #3 ) of 27 patient charts reviewed. The facility failed to ensure that patients receiving medication for sedation were informed of the risks and benefits of receiving sedation as an anesthetic during a procedure. Also, the facility failed to ensure consent for treatment was obtained on admission.
This deficient practice had the likelihood to cause harm to all patients.
Findings include:
A review of the Disclosure and Consent - Anesthesia and/or Perioperative Pain Management form for Patient #11 revealed that Moderate Sedation and sedation (Monitored Anesthesia Care) were marked. The consent was signed by Patient #11 and Staff RN #20. There was not a physician signature on the sedation/anesthesia consent. There were no additional notes in the chart that the physician explained the risks and benefits of moderate sedation to the patient.
Staff #2 confirmed the above findings.
10135
Review of the Emergency Department (ED) record on Patient #3 revealed, he was a 73 year old male who presented on 06/04/2018 at 7:50 p.m. Patient #3 was documented as having diagnoses of elevated white blood cell count, hyperglycemia, anemia, and pressure ulcer of the sacral region.
At 8:08 p.m., the following was documented in an ED nursing assessment:
"Appears in no apparent distress, comfortable, Behavior is cooperative, pleasant. Neuro: Level of Consciousness is awake, alert, obeys commands, Oriented to time, place, person, situation."
Review of the "GENERAL CONSENT FOR TESTS, TREATMENT, PHOTO, VIDEO, AND SERVICES" dated 06/04/2018 and timed at 10:45 p.m. (almost 3 hours after presenting) revealed the following P.U.T.S.(meaning patient unable to sign).
On 06/04/2018 at 11:12 p.m., Patient #3 was admitted to inpatient status to the Med/Surg unit.
There was no documentation that an attempt was made to get consent in the ED later from Patient #3 or a family member.
During an interview on 06/06/2018 after 1:00 p.m., Staff #10 confirmed the the missing signature on the consent.
Review of the facility policy titled , "Informed Consent", last reviewed 10/17 revealed the following:
"POLICY:
Informed consent will be obtained from the patient or their surrogate decision maker for each procedure or operation to be performed. If the patient is a minor or otherwise legally incompetent as defined in the "Consent to Medical Treatment Act" effective September 1, 1993, consent will be obtained from an adult surrogate.
The Medical Staff shall be responsible for obtaining the patient's informed consent prior to procedures requiring such documentation. Nurses shall be responsible for obtaining and witnessing the patient's signature on informed consent documentation. The patient shall be informed of the nature and the risks of the procedure and possible alternatives ...
...TYPES OF CONSENTS:
1. GENERAL CONSENT
Upon admission to the hospital, the patient or adult surrogate shall sign a general consent to treat form which provides a record of consent to routine hospital services, diagnostic procedures, and general medical treatment.
2 This specific form(s) is designed to comply with the requirements promulgated by the Texas Medical Disclosure Panel, List A.
3. SPECIFIC CONSENTS
Specific consent forms may be used in other procedures or situations. Examples of specific required consents are listed, but may not be limited to:
a) Administration of Blood/ Blood Products
b) Anesthesia Consent (if applicable by policy)
c) Consent to Photograph/Video
d) Consent for HIV testing
e) Permission for Disposal of Severed Body Parts
f) Permission for Autopsy"
Review of the facility policy titled, "Moderate Sedation" last reviewed date of 7/16 revealed the following:
"...I. PRE-PROCEDURE CARE:
Physician responsibilities:
Informed Consent: The patient /guardian must be informed by the physician about the risks, possible complications, benefits and alternatives to sedation anesthesia as a component of the planned procedure. Patients or their authorized representative(s) should be informed of and agree to the
administration of moderate sedation before the procedure begins..."
Tag No.: A0385
Based on observation, interview and record review the facility failed to:
A. ensure the Director of nurses developed a plan of administrative authority and delineation of responsibilities to nursing staff on 2 of 2 units (Intensive care unit (ICU) and Medical-surgical unit).
The Director of nurses failed to in-service nurses on the plan to close the ICU unit during times of low census and to move ICU patients to the Medical- surgical unit.
The Director of nurses failed to have clear instructions on charge nurse assignments, the staffing plan, to whom ICU nurses should report to in emergencies, where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
Refer to tag A0386 for additional information.
B. ensure adequate staffing on 2 of 2 units (Intensive Care unit (ICU) and Medical-surgical unit). The facility failed to ensure there was clear instructions on charge nurse assignments, supervisory assignments, the staffing plan, and to whom ICU nurses should report to in emergencies. They failed to ensure nursing staff delivering patient care knew where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
The facility failed to ensure there were sufficient numbers of ICU nurses caring for patients when they were housed on the Medical -Surgical unit. They failed to ensure the ICU staffing matrix was being used to guide with staffing numbers.
They failed to ensure licensed vocational nurses providing patient care on the Medical-surgical unit received adequate supervision.
Refer to tag A0392 for additional information.
C. ensure registered nurses evaluated and supervised patient care on 5 of 27 sampled patients (Patient #'s 1, 3, 6, 9, and 10).
The facility failed to ensure interventions were initiated timely to address patients with critically low blood sugars. The facility failed to ensure interventions were initiated timely on a patient with an elevated blood sugar.
Patient #1's blood sugar went from 53 to 21, and nursing staff failed to provide timely intervention and timely evaluation after interventions were provided to address the citical blood sugar level.
Patient #'s 3 and 10 had blood sugars which wer out of reference range and nursing staff failed to provide physician ordered interventions and necessary evaluation f the patients' condition as needed.
The facility failed to ensure patients classified as needing an Intensive Care Unit (ICU) bed received one. The facility failed to ensure nursing staff received physicians orders before downgrading a patient from needing an ICU bed to needing a Medical-Surgical bed.
Patient #6 had a physician's order to be transferred to an ICU bed. Patient #6 was downgraded by nursing and transferred to a Medical-Surgical bed which was not equipped or designated as an ICU bed. There was no physician's order downgrading the patient until four days after the admission.
The facility failed to ensure there were a sufficient number of ICU nurses supervising patient care.
Patient #9 had admitted diagnoses which included dyspnea, chronic obstructive pulmonary disease with acute exacerbation, and pleural effusion.. Patient #9 had a change in condition and required being transferred from a Medical- surgical status to ICU status. According to staffing numbers there was only one registered nurse supervising the patient when the facility's staffing matrix called for 2 registered nurses.
Refer to tag A0395 for additional information.
D. ensure 4 of 20 Emergency department (ED) nurses had required specialized qualifications to provide care in the ED (Staff #'s 15, 16, 17 and 19).
The facility failed to ensure a nurse serving in the role of the Intensive Care Unit (ICU) Director had the required special qualifications (Staff #2).
Refer to tag A0397 for additional information.
E. ensure that verbal orders were completed with a date, time, and dosage in 1 of 27 patients (Patient #11). Also, the facility failed to ensure that verbal orders were written clearly and accurately to prevent medication error and safe medication administration, and the facility failed to follow their own policy on verbal orders. Verbal orders for sedation were documented on a sedation flowsheet with no date, time, or dosage.
Refer to tag A0407 for additional information
Tag No.: A0386
Based on observation, interview, and record review, the Director of nurses failed to have a plan of administrative oversight and delineation of responsibilities to nursing staff on 2 of 2 units (Intensive care unit (ICU) and Medical-surgical unit).
A. The Director of nurses failed to in-service nurses on the plan to close the ICU unit during times of low census and to move ICU patients to the Medical- surgical unit.
B. The Director of nurses failed to have clear instructions on charge nurse assignments, the staffing plan, to whom ICU nurses should report to in emergencies, where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
This deficient practice had the likelihood to cause harm to all patients on the ICU unit and the Medical-surgical unit.
Findings include:
During an observation on 06/5/2018 after 11:00 a.m., the Intensive care unit (ICU) was closed.
Staff #2 reported the unit had been closed since last Thursday(05/31/2018). When the ICU census got to 2 or below they closed the unit. There was two rooms on the Medical Surgical unit which were being used for low level ICU patients (Room #'s 222 and 223).
During confidential interviews with ICU and medical surgical staff they reported the following:
Knowing about the ICU patients being transferred to the Medical/surgical, but not being told by Administration about what to do. This had been going on since about the first of this year.
Working sometimes as the only ICU nurse and there was no charge nurse for them. The staff member reported that the rapid induction kit (emergency paralytic medications used for intubation) was not on the Medical Surgical unit if they needed it.
Having to take care of ICU patients on the Medical surgical unit a few weeks ago. Being assigned to take care of a patient here and discovered that the telemetry was not working. There was no way to monitor the patient at the main desk. The nurse had to stay at the bedside with the patient (1:1).
It was difficult to take care of their patients, the layout made it hard. Feeling isolated down there (in the corner where the 2 designated ICU rooms were) . We don't know who is in charge of us, who we turn to for help, emergencies, lunches, or anything else. The nurses have not been included in this decision. We have concerns. All of the medical supplies are in closet, so if you go into the closet you cannot see your patients directly or hear them. You cannot leave to go get any supplies you need. There is not a house supervisor until 4:00 PM so we are unclear who to go to until then. Also, we don't have some of the emergency medications down here that we have in ICU.
The Medical Surgical director was supposed to be responsible for the ICU staff and they report to her. There was no staffing plan made out and shared with staff about taking care of ICU patients on the Medical -Surgical unit. The house supervisors were ICU competent and were only in the building on Monday-Fridays from 4:30 p.m.-8;30 p.m. and 24 hours on the weekends.
The CNO was supposed to be responsible for the ICU staff and they report to her. They were not included in the Medical/Surgical staffing. ICU staff were not using their staffing matrix when they took care of ICU patients on the Medical surgical unit. There was no knowledge of the Medical surgical Director being responsible for the ICU staff.
During an interview on 06/06/2018 after 1:20 p.m., Staff #2 (CNO) confirmed that the staffing plan concerning closing the ICU for purposes of a low census was still in draft form. The plan had not been shared with nursing staff yet. Staff #2 confirmed they had not taken into account who would be charge nurse when the ICU patients were cared for the ICU nurses. and that had just been added to the plan today.
Tag No.: A0392
Based on observation, interview, and record review, the facility failed to ensure adequate staffing on 2 of 2 units (Intensive Care unit (ICU) and Medical-surgical unit). The facility failed to:
A. ensure there was clear instructions on charge nurse assignments, supervisory assignments, the staffing plan, and to whom ICU nurses should report to in emergencies. They failed to ensure nursing staff delivering patient care knew where and how emergency medications and supplies would be handled when ICU patients were housed on the Medical-surgical unit.
B. ensure there were sufficient numbers of ICU nurses caring for patients when they were housed on the Medical -Surgical unit. They failed to ensure the ICU staffing matrix was being used to guide with staffing numbers.
C. ensure licensed vocational nurses providing patient care on the Medical-surgical unit received adequate supervision.
This deficient practice had the likelihood to cause harm to all patients on the ICU unit and Medical-Surgical unit.
Findings include:
During an observation on 06/5/2018 after 11:00 a.m., the Intensive care unit (ICU) was closed.
Staff #2 reported the unit had been closed since last Thursday(05/31/2018). When the ICU census got to 2 or below they closed the unit. There was two rooms on the Medical Surgical unit which were being used for low level ICU patients (Room #'s 222 and 223).
During confidential interviews with ICU and medical surgical staff they reported the following:
Knowing about the ICU patients being transferred to the Medical/surgical, but not being told by Administration about what to do. This had been going on since about the first of this year.
Working sometimes as the only ICU nurse and there was no charge nurse for them. The staff member reported that the rapid induction kit (emergency paralytic medications used for intubation) was not on the Medical Surgical unit if they needed it.
Having to take care of ICU patients on the Medical surgical unit a few weeks ago. Being assigned to take care of a patient here and discovered that the telemetry was not working. There was no way to monitor the patient at the main desk. The nurse had to stay at the bedside with the patient (1:1).
It was difficult to take care of their patients, the layout made it hard. Feeling isolated down there (in the corner where the 2 designated ICU rooms were) . We don't know who is in charge of us, who we turn to for help, emergencies, lunches, or anything else. The nurses have not been included in this decision. We have concerns. All of the medical supplies are in closet, so if you go into the closet you cannot see your patients directly or hear them. You cannot leave to go get any supplies you need. There is not a house supervisor until 4:00 PM so we are unclear who to go to until then. Also, we don't have some of the emergency medications down here that we have in ICU.
The Medical Surgical director was supposed to be responsible for the ICU staff and they report to her. There was no staffing plan made out and shared with staff about taking care of ICU patients on the Medical -Surgical unit. The house supervisors were ICU competent and were only in the building on Monday-Fridays from 4:30 p.m.-8;30 p.m. and 24 hours on the weekends.
The CNO was supposed to be responsible for the ICU staff and they report to her. They were not included in the Medical/Surgical staffing. ICU staff were not using their staffing matrix when they took care of ICU patients on the Medical surgical unit. There was no knowledge of the Medical surgical Director being responsible for the ICU staff.
Review of "daily staffing" sheets and facility's "Matrix Guidelines for Staffing" the following was found:
MEDICAL- SURGICAL UNIT
On 05/28/2018, 7:00 p.m.-7:00 a.m., there was a patient census of 13. The staffing numbers was 1 charge nurse and 2 registered nurses.
According to the "Medical Surgical Matrix-(Guidelines for Staffing) the facility was short .50 a nurse.
On 05/26/2018, 7:00 a.m.-7:00 p.m., there was a patient census of 6. The staffing numbers was 1 charge nurse (RN), 1 licensed vocational nurse (LVN) and a monitor tech who was a RN.
The RN charge and the LVN was identified as taking patients. The RN monitor tech was not able to leave her post for watching telemetry patients.
There was no RN to supervise the LVN in the event the RN had an emergency with her patients.
On 05/25/2018, 7:00 a.m.-7:00 p.m., there was a patient census of 5. The staffing numbers was 1 charge nurse (RN), 1 licensed vocational nurse (LVN) and a monitor tech was a Certified nurses aide (CNA).
The RN charge and the LVN was identified as taking patients. The CNA monitor tech was not able to leave her post for watching telemetry patients.
There was no RN to supervise the LVN in the event the RN had an emergency with her patients.
During an interview on 06/06/2018 after 8:30 a.m., Staff #5 confirmed the staffing numbers.
ICU UNIT
Review of the "daily staffing" sheets for 05/22/2018 revealed there was an ICU patient cared for in Room #208.
During a confidential interview it was reported that ICU nurses took care of a patient in Room #208 on 05/22/2018. It was reported that the nurse had to remain in the room with the patient (1:1) because the room was not set up for the telemetry patient to monitored from the nurses station. The patient was put on a portable telemetry monitor. If needed, the staff reported there was no rapid induction kit (emergency paralytic medications used for intubation) on the Medical Surgical unit. The staff member reported that someone would have to go to the ICU unit and get the kit if they needed it.
During an observation on 06/06/2018 after 9: 40 a.m., induction kits were found in the medication rooms on the Medical-surgical unit and on ICU unit.
Staff #8 confirmed the observation and reported the emergency medications had been in the medication rooms.
The nurses had not been informed of where the emergency medications were and who would obtain them in the event of an emergency.
Review of the "daily staffing" sheets for 05/26/2018, 7:00 p.m.-7:00 a.m. revealed there was 3 patients on the ICU unit and there was 1 RN. The other 2 nurses on the unit were orientees.
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN.
Review of the "daily staffing" sheets for 05/28/2018, 7:00 p.m.-7:00 a.m. revealed there was 1 ICU patient cared for on the Medical -surgical unit and there was 1 ICU RN designated for the patient.
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN.
Review of the "daily staffing" sheets for 05/29/2018, 7:00 p.m.-7:00 a.m. revealed there was 1 ICU patient cared for on the Medical -surgical unit. From the time frame of 7:00 p.m.-10:30 p.m. and from 2:00 a.m. -7:00 a.m. there was 1 RN .
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN.
Review of the "daily staffing" sheets for 05/30/2018, 7:00 a.m.-7:00 p.m. revealed there was 1 ICU patient cared for on the Medical -surgical unit and there was 1 ICU nurse designated for the patient.
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN.
Review of the "daily staffing" sheets for 06/04/2018, 7:00 a.m.-7:00 p.m. and 7:00 p.m.-7:00 a.m. revealed there was 1 ICU patient cared for on the Medical -surgical unit and there was 1 ICU nurse designated for the patient.
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN on both shifts.
During an interview on 06/06/2018 after 8:30 a.m., Staff #5 confirmed the staffing numbers. Staff #5 reported that the ICU nurses were not utilizing the staffing matrix when they cared for their patients on the Medical surgical unit and they were not counted in her numbers for staffing for the Medical surgical unit.
During an interview on 06/06/2018 after 1:20 p..m.,Staff #2 (CNO) confirmed that the staffing plan concerning closing the ICU for purposes of a low census was still in draft form. The plan had not been shared with nursing staff yet. Staff #2 confirmed they had not taken into account who would be charge nurse when the ICU patients were cared for the ICU nurses and that had just been added to the plan today.
Tag No.: A0395
Based on interview and record review, the facility failed to ensure registered nurses evaluated and supervised the patient care on 5 of 27 sampled patients (Patient #'s 1, 3, 6, 9, and 10). The facility failed to:
A. ensure interventions were initiated timely to address patients with critically low blood sugars. The facility failed to ensure interventions were initiated timely on a patient with an elevated blood sugar.
Patient #1's blood sugar went from 53 to 21 and nursing staff failed to provide timely intervention and timely evaluation after interventions were provided to address the critical blood sugar level.
Patient #'s 3 and 10 had blood sugars which were out of reference range and nursing staff failed to provide physician ordered interventions and necessary evaluation of the patients' condition as needed.
B. The facility failed to ensure patients classified as needing an Intensive care unit (ICU) bed received one. The facility failed to ensure nursing staff received physicians orders before downgrading a patient from needing an ICU bed to needing a Medical-Surgical bed.
Patient #6 had a physician's order to be transferred to an ICU bed. Patient #6 was downgraded by nursing and transferred to a Medical-Surgical bed which was not equipped or designated as an ICU bed. There was no physician's order downgrading the patient until four days after the admission.
C. The facility failed to ensure there were a sufficient number of ICU nurses supervising patient care.
Patient #9 had admitted diagnoses which included dyspnea, chronic obstructive pulmonary disease with acute exacerbation, and pleural effusion.. Patient #9 had a change in condition and required being transferred from a Medical- surgical status to ICU status. According to staffing numbers there was only one registered nurse supervising the patient when the facility's staffing matrix called for 2 registered nurses.
This deficient practice had the likelihood to cause harm to all patients.
Findings include:
Review of the Emergency department (ED) record on Patient #6 revealed, she was a 72 year old patient who presented to the on 05/22/2018 at 1:30 p.m. Patient #6 presented with diagnoses which included unspecified atrial fibrillation, pneumonia, acute respiratory failure with hypoxia, hypokalemia, acute pulmonary edema, and hyperglycemia.
At 2:26 p.m., "Physician consultation. (Physician #23) was contacted at (2:45), regarding admission, to the ICU, patient's condition and will see patient in the inpatient room."
At 2:28 p.m., the physician documented some of the following:
"Differential diagnosis:Bronchitiis, CHF exacerbation, pneumonia, pulmonary edema."
"Data interpreted: Cardiac monitor :rate is 150 beats/min, rhythm is atrial fibrillation ..."
"ED course: Improved with BIPAP, Speaks in full sentences, Normotensive, CXR consistent with pneumonia and CHF, Abx given, cultures. Replace potassium. Amiodarone for rate control, Lovenox x 1. Admit to ICU."
Review of ED documentation at 2:45 p.m. revealed "CALLED (Staff #11), RN ON SECOND MEDICAL FOR ROOM ASSIGNMENT. ICU NOT OPEN AT THIS TIME. CONTINUE TO HOLD PT. AND WILL CALL BACK WITH ASSIGNMENT."
At 3:04 p.m., "CONTINUE TO HOLD PT IN ER AWAITING ROOM ASSIGNMENT.:
Review of a physician's order dated 05/22/2018 that was signed off by the physician at 3:12 p.m. ( first written at 2:37 p.m.), revealed the following;
"ADMIT TO INPATIENT -ICU ADMIT TO INPATIENT (FROM ED) TO ICU,"
At 3:25 p.m., "Awaiting bed assignment. Awaiting delay in bed assignment for rearrangement of staff."
At 3:32 p.m., " PT WAS DOWN GRADED TO TELE PT PER (Staff #5) RN.RECD ROOM ASSIGNMENT.
There was no written physicians order on the chart to change the patient's status.
Review of therapy notes revealed that Patient #6 arrived to the medical surgical bed Room #208 at 3:50 p.m., on 05/22/2018.
Review of physician orders dated 05/26/2018 (four days later) at 11:38 a.m., revealed an order for the following:
"INPATIENT TRANSFER TO TELEMETRY"
During an interview on 06/5/2018 after 11:00 a.m., Staff #2 reported the unit had been closed since last Thursday(05/31/2018). When the ICU census got to 2 or below they closed the unit. There was two rooms on the Medical Surgical unit which were being used for low level ICU patients (Room #'s 222 and 223).
Staff #6 reported that Room #222 and 223 had the monitors that communicated to the telemetry system at the nurses station.
Room #208 was not a room designated for ICU patients.
During an interview on 06/06/2018 after 1:00 p.m., Staff #10 confirmed the physician orders and the documentation in the chart.
Review of the ED record of Patient #1 revealed she was a 86 year old female who presented on 05/24/2018 at 2:12 a.m.. Patient #1 had diagnoses which included respiratory failure, hypoxia, hypercapnia, pneumonia, sepsis, and hypoglycemia.
At 2:15 a.m.," NH ( nursing home) report that pt has had low blood glucose despite three doses of glucagon. And has recently been diagnosed with pneumonia and has had spo2 in 80s all day. Care prior to arrival: See EMS report. Saline lock initiated. 20g to left antecubital area."
At 2:40 a.m., a physician's order was written for "D10W 500ml IV at 80ml/hr continuous."
At 2:41 a.m., lab results revealed that Patient #1 had a low glucose level of 53 (reference ranges being 70-110).
At 4:39 a.m., a physician's order was written for "D50W 50 ml IVP (intravenous push) once.(1amp)
At 4:34 a.m., Patient #1 was intubated and placed on a ventilator.
At 4:40 a.m., there was documentation that the D10W 500ml IV at 80ml/hr was administered (2 hours after ordered).
At 5:10 a.m., there was documentation that D50W 50 ml IVP ordered at 4:39 a.m.was administered. There was no documentation of a follow- up blood glucose level.
At 5:42 am., Patient was resting quietly, sleeping. Awatiing a.m., ICU staff to arrive and open ICU unit.
At 6:01 a.m. the following physician orders were written:
Dextrose 50 %..IVP (intravenous push)..PRN Reason:HYPOGLYCEMIA..
"Comments: FOR BLOOD GLUCOSE LESS THAN 75 GIVE 25 ML D50W.REPEAT GLUCOSE IN 15 MIN. IF REPEAT BLOOD GLUCOSE LESS THAN 90 GIVE A REPEAT DOSE OF 25ML D50w."
"ADMIT TO INPATIENT (FROM ED)TO ICU"
At 6:03 a.m. and 6:16 a.m., was the first documentation of another glucose level taken. Patient #1 had a glucometer reading of 21.
At 6:30 a.m., there was documentation that D50W 50 ml IVP was administered.
At 6:34 a.m., there was documentation that the blood glucose was at 119.
At 6:52 a.m., Patient #1 was admitted to inpatient status to ICU.
During an interview on 06/06/2018 after 1:00 p.m., Staff #10 confirmed the physician orders and the documentation in the chart.
Review of the ED record of Patient #9 revealed he was a 64 year old male who presented on 05/28/2018 at 6:51 p. m.. Patient #9 presented with diagnoses of dyspnea, chronic obstructive pulmonary disease with acute exacerbation, and pleural effusion.
Some of the following lab results were recorded on the physician's medical screening dated 05/28/2018:
At 8:20 p.m. a Troponin level of 0.071 (reference ranges being 0.000-0.055); (Troponin level is a type of blood test used to check for damage to the heart)
At 8:20 p.m. a Pro BNP level of 10538071 (reference ranges being 5-125 ); Pro-BNP (B-type natriuretic peptide (BNP) and amino-terminal pro-BNP (NT-proBNP) plasma levels are commonly high at the early phase of septic shock and have been suggested to be prognostic markers for this condition)
At 9:42 p.m. a D-Dimer level of 7.89 071 (reference ranges being 0.19-0.50; D dimer is a protein fragment that is found in the blood after someone has had a blood clot
On 05/29/2018 at 1:42 a.m., a physician orders was written to "PLACE IN OBSERVATION (FROM ED) ....UNIT TELEMETRY"
On 05/29/2018 at 2:24 a.m., Patient #9 was placed in observation to telemetry on the second floor.
On 05/29/2018 at 5:14 p.m. a physician's order was written for a Heparin drip (anti-coagulant) to be started.
On 05/29/2019 at 5:19 p.m. a physician's order was written for "INPATIENT TRANSFER TO ICU."
On 05/29/2019 at 5:54 p.m., there was documentation in "Patient Care Notes" that Patient #9 was received from the second floor Med Surg via wheelchair to ICU to room #222. Patient anxious and agitated upon arrival. Patient was restless and moving from side to side in bed ...Patient coughing and expectorating brown sputum ...Prepping for heparin drip.
On 05/29/2018 at 9:05 p.m., Patient transferred out to another hospital.
On 05/29/2018 at 9:43 p.m.(late entry documentation for 7:45 p.m.) revealed Patient #9 was "intermittently wakes up abruptly screaming help and wanting to leave. Troponins are elevated, just vomited 200 ml of brown liquid (8:10 p.m.) noted to be in SVT with a rate 2013 wide complex ...PA.. made aware. Pt then tried to jump out of the bed" saying wanted to leave.' ....Ambulance at bedside to take pt to Baylor."
Supraventricular tachycardia (SVT) is a series of rapid heartbeats that begin in or involve the upper chambers (atria) of the heart. SVT can cause the heart to beat very rapidly or erratically. As a result, the heart may beat inefficiently, and the body may receive an inadequate blood supply
Review of the "daily staffing " sheets for 05/29/2018, 7:00 p.m.-7:00 a.m. revealed there was 1 ICU patient cared for on the Medical -surgical unit. From the time frame of 7:00 p.m.-10:30 p.m. and from 2:00 a.m. -7:00a.m. there was 1 RN .
According to the "ICU Matrix Guidelines for Staffing" revealed they were short 1 RN.
The facility failed to ensure sufficient numbers of ICU nurseswere supervising care.
Review of the ED record on Patient #3 revealed he was a 73 year old male who presented on 06/04/2018 at 7:50 p.m. Patient #3 was documented as having diagnoses of elevated white blood cell count, hyperglycemia, anemia, and pressure ulcer of the sacral region.
Review of lab revealed at 8:04 p.m., Patient #3 had a glucose level of 204 (reference range was 70-110).
Review of physician orders dated 06/04/2018 at 10:30 p.m. revealed the following:
"Insulin (Humulin R) 100 UNIT/ML SOLN Dose:SLIDING SCALE
SLIDING SCALE= For Blood Glucose below 151, give 0 UNT
From 151-200, give 2 UNT
From 210 to 250, give 4 UNT..
Route:SUBCUTEANOUSLY Frequency: BEFORE MEALS AND AT BEDTIME"
On 06/04/2018 at 11:12 p.m., Patient #3 was admitted to inpatient status to the Med/Surg unit.
Review of ED notes and medication administration records revealed no documentation of any insulin being given in the ED.
Review of glucose readings revealed the first glucometer check was performed on 06/05/2018 at 5:48 a.m.,and it was 216.
According to the Medication administration record revealed the first dose of insulin (4 units) was given at 6:30 a.m. on 06/05/2018 (8 hours after receiving the sliding scale order).
During an interview on 06/06/2018 after 1:00 p.m., Staff #10 confirmed the physician orders and the documentation in the chart.
39801
Review of the medial record for Patient #10 provided during the investigation revealed the following:
Patient #10 is an 83-year-old female who presented to the Emergency Department (ED) on 4-23-2018 at 10:16 PM. Her presenting complaint was vertigo, and high blood pressure and also has nausea. Her Acuity Level was 3. Patient was medically screened at 10:43 PM. The first set of vital signs noted were at 10:32 PM and were documented as; Blood Pressure 192/88, Pulse 78, Respiratory 20, Pulse Ox 98%, Temperature 96.5. Patient #10 had a medical history of hypertension, Diabetes, Arthritis, and Fibromyalgia. The disposition noted on ED physician record shows, "Hospitalization ordered by ___________for observation. Preliminary diagnosis is Urinary Tract Infection, Dizziness, and giddiness, volume depletion, essential hypertension. Patient #10 left the ED at 0747 AM on 4/24/2018.
Patient #10 had multiple glucometer reading on 4/25/2018 at 1059 PM of 49 mg/dl.
A entry was noted on 4/26/2018 at 12:00 AM, " Cool and Clammy. Glucose 49. Snack provided."
A repeat blood glucose done was at 12:31 AM, 15 minutes late per protocol. There was a result of 79 mg/dl.
The next recorded blood glucose done was 4/26/2018 at 05:08 AM.
There was no documentation in the patient chart noting any interventions provided after results of the blood glucose on 4/26/2018 at 12:31 AM .
Review of the facility protocol "Sliding scale algorithm for blood glucose less than 75" revealed the following:
" ...FOR BLOOD GLUCOSE LESS THAN 75 GIVE 4 OUNCES OF ORANGE JUICE OR 25 ML D50W
REPEAT BLOOD GLUCOSE IN 15 MINUTES
REPEAT 25 ML D50W OR 4 OZ ORANGE JUICE IF LESS THAN 90"
Staff # 9 confirmed the observation.
Tag No.: A0397
Based on interview and record review, the facility failed to:
A. ensure 4 of 20 Emergency department (ED) nurses had required specialized qualifications to provide care in the ED (Staff #'s 15, 16, 17 and 19).
B. ensure a nurse serving in the role of the Intensive Care Unit (ICU) Director had the required special qualifications (Staff #2).
This deficient practice had the likelihood to cause harm to all patients presenting to the ED and admitted to ICU.
Findings include:
Review of the facility's "Position Description/Competency Based Evaluation" revealed Emergency department nurses must maintain the following required certifications:
"..ACLS within 6 months of employment
PALS within 6 months of employment
TNCC within 6 months of employment.."
Review of personnel information revealed the following Emergency department nurses were missing the Trauma Nurse Core Course:
Staff #15 had a hire date of 10/2/2017;
Staff #16 had a hire date of 10/3/2017;
Staff #17 had a hire date of 09/6/2016;
Staff #19 had a hire date of 11/27/2016.
During an interview on 06/06/2018 after 8:30 a.m., Staff #2 confirmed the missing training.
Review of the facility's "Position Description/Competency Based Evaluation" revealed the Director of Critical Care Services was required to have the following certifications:
".. ACLS within 6 months of employment, PALS within 6 months of employment. Current CPR certification required."
During an interview on 06/05/2018 after 12:00 p.m., Staff #2 reported that they had been without an ICU Director for 2.5 months. Herself and the Medical surgical Director were tag teaming with the role. Staff #2 reported that her work background was working as an ICU nurse.
During an interview on 06/06/2018 after 8:30 a.m., Staff #2 confirmed she did not have any of the certifications.
Tag No.: A0407
Based on record review and interview, the facility failed to ensure that verbal orders were completed with a date, time, and dosage in 1 of 27 patients (Patient #11). Also, the facility failed to ensure that verbal orders were written clearly and accurately to prevent medication error and safe medication administration, and the facility failed to follow their own policy on verbal orders. Verbal orders for sedation were documented on a sedation flowsheet with no date, time, or dosage.
The deficient practice had the likelihood to harm all patients receiving procedural sedation.
Findings include:
Review of the Moderate Sedation flow sheet for Patient #11 revealed the following:
Orders:
"Midazolam IV, VORB Dr. Updegrove." There was no date, time, or dosage written. Two (2) mg of midazolam were given at 1224 PM by Staff #20.
"Morphine IV, VORB Dr. Updegrove." There was no date, time, or dosage written. One (1) mg of morphine was given at 1224 PM by Staff #20.
The physician signed the Moderate Sedation flow sheet on 5/30/2018 at 1250 and did not make any clarification of the order. There was no order in the CPOE (Computer Physician Order Entry) system for the sedation medications.
Staff #9 confirmed the observation.
Review of the facility policy titled, "Verbal and Telephone Orders-Clinical Process" last reviewed 1/2018 revealed the following:
"..PROCEDURE:
1. Telephone and verbal orders shall be entered into MedHost/HMS via the order entry icon.
2. For outpatients, telephone or verbal orders may be written rather than electronic.
3 Verbal and telephone orders shall be "read back and verified" to the ordering practitioner by the person receiving the order in a non-abbreviated format ...
4. The person reading the outpatient order back will make a notation under the order, "VORBV" (verbal order read back and verify) or "TORBV" (telephone order read back and verify) and initial, date and time the entry.
5. For inpatient verbal or telephone orders, the nurse will enter the order(s) into the EMR system, indicate that the orders were verbal or written, also indicate that the orders were read back in order to verify, and identify the ordering physician..."
Tag No.: A0441
Based on observation and interview, the facility failed to ensure confidentiality of patient information on 1 of 2 medical units ( Intensive care unit).
Patient information which included diagnoses and treatment was stored on top of a desk in the Intensive care unit. The information was not locked and was accessible to anyone who came into the unit.
This deficient practice had the likelihood to affect all patients admitted to the Intensive Care Unit (ICU).
Findings include:
During an observation on 06/5/2018 after 11:00 a.m., the ICU was closed. There was an ICU register which included patient names, date of birth, condition and diagnoses which was on top of the desk at the nurses station. There was also a patient's chart on the desk which belonged to Patient #1 who was admitted on 05/24/2018. The information in the chart included patient diagnoses, Emergency department treatment notes, medications, consents, phone numbers, address and social security information.
Staff #2 confirmed the documents and reported the unit had been closed since last Thursday(05/31/2018).
Review of a facility's policy named "Confidentially Policy" dated 02/01/2006 revealed the following:
"..To ensure compliance with federal and state privacy laws and regulations, PHI (Protected Health Information) collected and /or generated within the facility will be maintained in a manner which restricts access to those with a need-to-know. Need-to-know will be defined by the facility. The use and disclosure of PHI will be restricted in accordance with state and federal requirements.."
Tag No.: A0747
Based on observation, interview, and record review the facility failed to ensure the infection control officer developed a system that maintained a clean and sanitary environment for two (Intensive Care Unit (ICU) and Medical Surgical floor) of two departments. This deficient practice was found in two of the hospital departments, Intensive Care Unit (ICU) and Medical Surgical floor.
The facility failed to:
a. Ensure the ICU equipment room was sanitary, organized, and free from equipment that was broken or damaged. The equipment room had equipment and patient care supplies on the floor. A procedural chair mattress had torn vinyl and a Bi-Pap machine had broken plastic coverings.
b. Ensure patient rooms in ICU are kept clean, sanitary, and free from broken and damaged equipment and structures. Patient rooms had suction tubing, oxygen tubing, and electrodes hooked up and hanging from equipment. The unit had been closed two weeks. There were open packages of EKG electrodes in a drawer. The walls had missing chips of paint and scrapes. The patient beds had plastic that was cracked and covered in dust. A wall head board was broken and being held up with tape. The head board had broken and missing pieces of the laminate.
c. Ensure the ICU Medication/Supply room was clean, sanitary and free from broken cabinets. The supply rack had expired and open IV fluid bags stored on it. The bins that stored IV bags and supplies were covered in dust and debris. The cabinets had chips of paint and laminate missing. The cabinets had a yellow substance splattered on the inside and outside walls of the cabinet. The floors were unsanitary. An insect trap was found on the floor next to the Pyxis dispenser (A medication dispensing unit). The temperature and humidity logs for the room and refrigerator were incomplete. Two trash cans were found in medication room with used IV supplies, patient gloves, and medication packages. The unit had been closed two weeks.
d. Ensure the ICU nursing station was clean and sanitary. The floor had missing chips from the tiles. The floor and cables underneath the desk were covered in dust. A shelf underneath the desk was missing the trim and had exposed wood around the edges.
e. Ensure the medical and surgical medication supply room was clean, sanitary, and free from expired supplies. The supply bins were covered in dust. Blood tubes were stored in bins that expired 5 days prior to observation.
f. Ensure patient rooms were clean and sanitary. A ceiling tile in patient room 223 had a water stain on it.
g. Ensure hinged surgical equipment was sterilized in an open position, peel packets of sterilized equipment was dated, and expired sterilized equipment was discarded in the ICU crash cart. A Magill forceps was found in the ICU crash cart that had been sterilized in a closed position. The sterilization date was 12/29/2015, 19 months past the manufacturer guaranteed sterility date.
Tag No.: A0749
Based on observation, interview, and record review, the facility failed to ensure the infection control officer developed a system that maintained a clean and sanitary environment for two (Intensive Care Unit (ICU) and Medical Surgical floor) of two departments. The facility failed to ensure that ICU patient rooms C, D, and E,and H, ICU supply/medication room, ICU nurse desk, Medical-Surgical supply/medication room (Room 224), ICU Crash cart on medical floor, and patient room 223 were clean, sanitary and free from expired Intravenous (IV) fluids and supplies.
This deficient practice had the likelihood to cause harm in all patients.
Findings include:
During an observation tour on 6/5/2018 after 11:15 AM, the following observations were made:
ICU EQUIPMENT STORAGE ROOM
A fan was sitting on the floor uncovered. An isolation cart that contained patient care gloves, mask, and Sani-wipes was sitting on the floor. On the bottom of a Bi-Pap machine a jug of fluids was stored on a rack. There was no label indicating what the fluid was or the beyond use date. The Bi-Pap machine had broken plastic piece on the side covering a vent. There was a procedural chair mattress that had a tear in the vinyl covering, approximately three inches in length.
ICU PATIENT ROOM C
There was a trash can in the room that had used patient care gloves, empty supply boxes, and outer plastic wrap packages in it. Staff #2 confirmed the ICU unit had been closed for two weeks. Oxygen tubing was still hooked up and hanging over suction canister. Electrode pads were attached to Electrocardiogram cables, hanging freely and uncovered.
ICU PATIENT ROOM D
The pullout commode had a brown and yellowish urine color buildup of debris and dirt on commode behind the lid and on the back of the commode around the level/handle release bar. There was scrapes and chips of paint missing on walls. Two open packages of EKG electrodes were found in a drawer next to the bed. The expiration dates had been torn into when the package was opened.
ICU PATIENT ROOM E
Suction tubing was still attached and hanging down from the suction canister. The cabinet door had broken and missing pieces exposing wood.
ICU PATIENT ROOM H
Suction tubing was still attached and hanging down from the suction canister. The bed frame had chips of paint missing and rust on it. The headboard on the wall was broken and being held up with tape. The patient bed had cracked plastic pieces on frame that were covered with dust.
ICU MEDIATION/SUPPLY ROOM
Styrofoam cups were in a bin stored on top of a crate. The crate was on the floor next to a metal supply cart. There were two trash cans noted. One trash can had used IV tubing and an empty IV fluid bag in it. The trash can was stored next to a shelf with IV fluids and sterile supplies. The other trash can contained empty medication boxes, packages and blunt needles in it.
Bins on a storage shelf that stored IV fluid bags and bottles of fluids were covered with dust build up in the bottom and sides of the bins. An IV bag of 10% Dextrose was found in a bin stored with other IV bags that expired October 2017. An IV bag of 5% Dextrose was left on shelf that had been open and did not have outer packaging. A saline syringe was laying partially on a wall rail that was covered in dust.
There was a package of wipes on the counter that was open and left unsealed. A wipe was hanging out of the package.
A pill crusher was on the counter that had a black and yellow debris in the crevices and flat surfaces.
There was a cabinet above the counter that had missing pieces of paint and laminate exposing wood. The cabinet had a yellow colored substance splattered on the inside walls and outside door. Inside the cabinets there was a white plastic rack that was splattered with yellow colored substance and covered in dust. The bins inside the cabinet that stored medications and supplies were covered in dust on the bases and sides of the bins.
On the side of the Pyxis (A medication dispensing system) an insect sticky trap was on the floor at the back of the machine. On the other side of the Pyxis machine the floor had black colored build up on the floor door stopper and multiple medication top tabs were found at the back of the machine covered in dust.
The temperature/humidity room log on the wall was missing entries on May 29, 30, and 31, June 1,3,4, and 5. The last entry was 6 days prior.
The refrigerator log was missing entries on June 2,3,4,5. The last entry was 4 days prior.
ICU NURSING STATION
Underneath the desk the floor and cables were covered in dust. The floor had missing chips from the tiles. The was a wood shelf that had an electrical outlet stored on it. The shelf was missing the trim and showed exposed wood. The electrical outlet was covered in dust. The walls underneath the desk had a black substance smeared on the walls.
MEDICAL/SURGICAL MEDICATION SUPPLY ROOM (224)
Bins storing patient supplies were covered in dust in the base and on the sides of the bin. Blood tubes that expired 5-31-2018, 5 days prior were found in bins.
PATIENT ROOM 223
On the ceiling in the bathroom, a ceiling tile had a water stain on it.
MEDICAL SURGICAL FLOOR/ ICU AREA CRASH CART
A McGill forcep was found on the crash cart in a sterilization pouch that had been sterilized in a closed position. The sterilization date was 12-29-2015, 19 months past the manufacturer guaranteed sterility date.
Staff #2 confirmed the above findings.
Review of the manufacturer insert named "STERILIZATION PACKAGING: SHELF-LIFE STUDY" revealed the following information about the sterilization packs the facility were using:
"The 100% success in maintaining sterility over a 52-week period demonstrates that, with the proper use of Vital Care Reps., Inc. and Vital Care Industries, Inc.* packaging, all of the various formats i.e. tubing, heat-seal and self-seal pouches are effective means of storing sterile supplies for a minimum of 52 weeks."
During an interview on 12/11/2017 after 4:29 p.m., customer service representative reported that they only validated sterilization for one year.
A review of the ANSI/AAMI ST 79 2O17 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Preparation and assembly of instruments revealed the following:
" ...i) Ratcheted instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the unlatched position."
Tag No.: A0955
Based on record review and interview, the facility failed to ensure that patients or their representatives were provided with risks and benefits of a surgical procedure in 1 (Patient #11) of 27 charts reviewed. The facility failed to ensure that the physician provided all necessary information, including risks and benefits of the proposed procedure prior to surgery in 1 patient reviewed.
This deficient practice had the likelihood to cause harm to all patients.
Findings include:
Review of the Disclosure and Consent - Medical and Surgical Procedures form for Patient #11 revealed the following findings:
The Disclosure and Consent form was noted for a Bronchoscopy with Fluoroscopy procedure to be performed by Staff #22. The consent was signed on 5/30/2018 at 0025 by Patient #11 and witnessed on 5/30/2018 at 0025 by Staff #21. The physician signed the consent on 5/30/2018 at 1250, twelve hours after the patient signed the consent, and 5 minutes after the procedure was completed. The time on the consent mirrored the time on the postoperative note indicating the two forms were completed after the procedure.
Review of physician progress notes and history and physicals for Patient #11 did not reveal any documentation of discussion of risks and benefits for a bronchoscopy prior to the start of the procedure.
Staff #9 confirmed the above findings.
Review of the facility Medical Staff Rules and Regulations dated March 7, 2013 revealed the following:
" .....3. Consent
a. Written consent of the patient is required for release of medical information to persons not otherwise authorized to receive this information.
b. The Medical Staff shall be responsible for obtaining the patient's written and signed informed consent from the patient or any person to whom the patient has properly delegated representative authority prior to those procedures outlined in the universal Patient Rights policy and procedure on consent. The patient or any person the patient has properly delegated representative authority, shall be informed of the nature and risks of the procedure, possible alternatives, his or her current health status and the details of his or her plan of care ...."
Review of the facility policy, "Informed Consent", last reviewed October 2017 revealed the following:
"POLICY:
Informed consent will be obtained from the patient or their surrogate decision maker for each procedure or operation to be performed. If the patient is a minor or otherwise legally incompetent as defined in the "Consent to Medical Treatment Act" effective September 1, 1993, consent will be obtained from an adult surrogate.
The Medical Staff shall be responsible for obtaining the patient's informed consent prior to procedures requiring such documentation. Nurses shall be responsible for obtaining and witnessing the patient's signature on informed consent documentation. The patient shall be informed of the nature and the risks of the procedure and possible alternatives ..."