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Tag No.: A0043
Based on interview, record review, and review of facility policies and bylaws, it was determined the facility failed to have an effective governing body to carry out the responsibilities of the hospital. The Governing Body appointed a Chief Executive Officer (CEO) to ensure the facility was managed in a manner that promoted patient safety. The CEO was aware that Preventative Maintenance (PM) was not being conducted as required on equipment throughout the facility, but took no action to address the problem and failed to notify the Governing Body of the concerns.
Interviews with staff revealed the CEO was aware that the operating room environment was not being maintained in a safe manner, that patients were being unnecessarily restrained, and that facility staff were administering sedative/anesthetic medication without adequate monitoring/training. However, the CEO denied being aware of the issues and therefore failed to notify the Governing Body of the concerns. There was no evidence action was taken to address the concerns.
Tag No.: A0115
Based on observation, interview, record review, and review of facility policies, it was determined the facility failed to protect and promote the rights of each patient. The facility failed to obtain informed consent prior to providing treatment for Patients #5, #6, #7 and #8; failed to provide care in a safe setting in the behavioral unit; failed to ensure two Patient #1 and Patient #2 were free from restraints imposed as a means of convenience; failed to modify Patient #1, Patient #2, Patient #3, and Patient #4's plan of care when chemical and physical restraints were implemented; failed to obtain an order to physically restrain Patient #4; and failed to ensure a physical restraint ordered for violent or self-destructive behavior was renewed every four (4) hours for Patient #3.
Tag No.: A0263
Based on interview, record review, and review of the facility's quality assurance program, it was determined that the facility failed to develop and implement and maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement program. The facility identified that preventative maintenance had not been conducted on equipment throughout the facility, identified that the temperature/humidity of the operating rooms were not being maintained within acceptable parameters; and identified that physicians were not ensuring medical records were complete and accurate. However, there was no evidence the facility developed/implemented action plans to address/correct the identified concerns.
Tag No.: A0385
Based on interview, record review, review of Diprivan (sedative/anesthetic medication) medication package insert, and review of facility policy, it was determined the facility failed to ensure nursing services were provided appropriately to patients who required continuous assessment and monitoring.
On 12/20/17 at 3:00 PM, Patient #1's Physician ordered Diprivan medication to be administered for sedation of Patient #1 while mechanically ventilated. Although the facility established a Diprivan protocol for mechanically ventilated patients, the protocol failed to address the frequency of patient monitoring, including blood pressure monitoring as recommended by the manufacturer of the medication. In addition, the facility failed to ensure nursing staff were trained on medication administration/monitoring of Diprivan. The facility failed to monitor the patient's vital signs for approximately three hours and fifteen minutes after Diprivan was initiated. On 12/20/17 at 8:00 PM, the patient's blood pressure dropped to 74/30 (normal blood pressure 120/80) after Diprivan medication was increased. Although Registered Nurse (RN) #7 contacted the resident's physician and obtained an order to administer medication to increase the resident's blood pressure, the RN failed to decrease the Diprivan medication in response to the patient's low blood pressure.
Tag No.: A0431
Based on interviews, record reviews, and review of facility policies, it was determined the facility failed to ensure a legible, complete, and accurate medical record was maintained for each patient evaluated and/or treated at the facility. Review of seven (7) of twenty-eight (28) patient records revealed the facility failed to ensure physician's orders and the physician's progress notes were illegible; failed to ensure that written and/or verbal physician orders for eight (8) of twenty-eight (28) sampled patients were dated, timed, and/or authenticated within the facility's required/established guidelines; failed to ensure a medical history and physical examination was completed timely (within 24 hours of admission) for one (1) of twenty-eight (28) sampled patients; and failed to ensure an accurate discharge summary was completed and authenticated for one (1) of twenty-eight (28) sampled patients.
Tag No.: A0528
Based on interview, record review, and review of the facility's medical equipment inspection and maintenance policy, it was determined the facility failed to ensure that diagnostic radiologic services were maintained to meet professionally approved standards for safety. The facility failed to ensure an inspection of equipment utilized in radiology including x-ray machines, a Computed Tomography (CT) machine, and a Gamma camera (utilized for nuclear medicine studies) received preventative maintenance (PM) as required by the facility's established PM schedule.
Tag No.: A0700
Based on interview, record review, and review of the facility's policy, it was determined the facility failed to ensure it was maintained to ensure the safety of patients. The facility failed to maintain appropriate relative humidity and temperature levels in the OR (operating room). Review of the OR temperature and humidity log for November 2017 through 01/25/18 for Operating Room #1 revealed the relative humidity level and/or temperature was not within acceptable parameters on thirty-one days of forty-seven days that surgeries were performed. In addition, review of the temperature and humidity log for Operating Room #2 from November 2017 through 01/30/18 revealed the humidity/temperature in the OR was not within acceptable parameters on thirty-one of the forty-nine days that surgery was conducted in Operating Room #2.
In addition, the facility failed to maintain equipment in a manner to ensure an acceptable level of safety and quality. The facility failed to ensure Preventative Maintenance (PM) was conducted on 212 pieces of equipment throughout the hospital.
Tag No.: A0940
Based on observations, interviews, record reviews, and review of the facility policy, it was determined the facility failed to ensure surgical services were provided in accordance with acceptable standards of practice. The facility failed to ensure the physicians for six (6) of twenty-eight (28) sampled patients (Patient #21, Patient #22, Patient #23, Patient #24, Patient #25 and Patient #26) completed a history and physical examination prior to having a surgical/invasive procedure.
In addition, the facility failed to ensure major preventative maintenance (PM) was conducted on surgical equipment in accordance with the facility's established PM schedule to ensure sterility of the surgical equipment/instruments.
Tag No.: A0057
Based on interview, record review, and review of a facility policy, it was determined the facility Chief Executive Officer (CEO) failed to ensure the facility was managed in a manner that promoted patient safety. The CEO was aware that Preventative Maintenance (PM) was not being conducted as required on equipment throughout the facility; but, took no action to address the problem. Interviews with staff revealed the CEO was also aware that the operating room environment was not being maintained in safe manner, that patients were being unnecessarily restrained, or that facility staff were administering sedative/anesthetic medications without adequate monitoring/training; however, the CEO denied being aware.
The findings include:
Review of the facility's policy titled "Governing Board Responsibilities," dated June 2017, revealed the Governing Board was responsible for the conduct of the hospital consistent with the objectives of the hospital and established standards of patient care.
Review of the job description titled "Chief Executive Officer," undated, revealed the CEO/Administrator would be the Governing Board's representative in the management of the facility. The CEO would be given the necessary authority and responsibility to operate the hospital in all its activities and departments.
1. The facility failed to ensure major preventative maintenance (PM) was conducted on surgical equipment in accordance with the facility's established PM schedule to ensure sterility of the surgical equipment/instruments; however, the facility continued to utilize the equipment for surgery/invasive procedures and conducted 669 surgeries/procedures from 06/01/17 through 01/24/18.
The facility further failed to ensure an inspection of equipment utilized in radiology including x-ray machines, a Computed Tomography (CT) machine, and a Gamma camera (utilized for nuclear medicine studies) received preventative maintenance (PM) as required by the facility's established PM schedule; however, the facility continued to conduct diagnostic studies. From August 2017 through 01/28/18, the facility conducted 3,411 x-rays, 450 CT scans, and 59 Nuclear Medicine studies.
In addition, the facility failed to ensure Preventative Maintenance (PM) was conducted on 212 pieces of equipment throughout the hospital as established by the facility's Risk Department.
Interview with the Chief Executive Officer (CEO) on 01/30/18 at 10:40 AM revealed he was aware that PM had not been completed on facility equipment, and was aware that the equipment continued to be utilized by the facility during surgical procedures, diagnostic exams, and throughout the hospital. The CEO stated the company that managed the facility would not provide the funds for PM to be performed until the management company purchased the facility.
2. The facility failed to maintain appropriate relative humidity and temperature levels in Operating Rooms (ORs). Review of the OR temperature and humidity log for November 2017 through 01/25/18 for Operating Room #1 revealed the relative humidity level and/or temperature was not within acceptable parameters on thirty-one (31) of forty-seven (47) days that surgeries were performed. In addition, a review of the temperature and humidity log for Operating Room #2 from November 2017 through 01/30/18 revealed the humidity/temperature in the OR was not within acceptable parameters on thirty-one (31) of the forty-nine (49) days that surgery was conducted in Operating Room #2.
Interview with the Infection Control Nurse on 01/29/18 at 1:12 PM, the Operating Room (OR) Nurse on 01/29/18 at 1:10 PM, and the OR Manager on 01/25/18 at 1:50 PM revealed they were aware the temperature/relative humidity was not within acceptable parameters in the operating rooms.
Interview with the Maintenance Supervisor on 01/24/18 at 4:30 PM revealed the boilers and sensors for the heat/air units needed repairs and the temperature/humidity could not be regulated properly. The Maintenance Supervisor stated administrative staff was aware that the equipment had not been inspected, but to his knowledge no action had been taken.
However, interview with the Chief Executive Officer on 01/30/18 at 10:40 AM revealed he was not aware the operating room temperature/humidity was not within acceptable parameters and no one notified him that the conditions in the OR were not safe.
3. Based on interview, record review, and a review of the facility's restraint policy, it was determined the facility failed to ensure two (2) of twenty-eight (28) sampled patients (Patient #1 and Patient #2) were free from restraints imposed as a means of convenience. When Patients #1 and #2 were mechanically ventilated, the facility administered Diprivan (an anesthetic/sedative medication) and physically restrained the patients, even though the patients were sedated.
4. The facility failed to ensure a registered nurse supervised and evaluated the nursing care for Patient #1. On 12/20/17 at 3:00 PM Diprivan (a sedative medication) was initiated for the patient for sedation while mechanically ventilated in absence of patient monitoring and staff training.
Interview with the Certified Registered Nurse Anesthetist (CRNA) on 01/30/18 at 2:30 PM revealed Diprivan was an anesthetic and the administration of the medication required extensive monitoring, including blood pressure, respirations, heart rate, and other pertinent systemic monitoring.
Interviews with Registered Nurse (RN) #1 on 01/24/18 at 11:35 AM, RN #4 on 01/25/18 at 2:05 PM, and RN #5 on 01/29/18 at 4:18 PM revealed they administered Diprivan to patients at the facility, but had not received training related to administration/monitoring of the medication.
Interview with the Chief Executive Officer on 01/30/18 at 10:40 AM, revealed he was not aware staff were administering a medication that they were not adequately trained to administer/monitor.
Interview with Board Member #1 on 01/29/18 at 1:25 PM and Board Member #3 on 01/29/18 at 1:57 PM revealed they were not aware of the gravity of the issues. The Board Members stated they were not aware that the facility did not have a service contract to conduct Performance Maintenance on facility equipment. Continued interviews revealed the Board hired the Management Company who appointed the CEO to provide day to day management of the facility and to ensure regulatory compliance. The Board Members stated the CEO was required to convey issues regarding the facility on a monthly basis; however, the CEO had not reported any issues at the facility.
Tag No.: A0131
Based on interviews, record reviews, and facility policy review, it was determined the facility failed to protect and promote patient rights for four (4) of twenty-eight (28) sampled patients (Patient #5, #6, #7 and #8). The facility failed to obtain informed consent prior to providing treatment.
The findings include:
Review of the facility's policy titled, "Medical Record Content" dated March 2017, revealed the facility's medical record should contain evidence of informed consent in each patient's medical record.
1. Review of the medical record for Patient #5 revealed the facility admitted the patient on 12/29/17 with diagnoses that included Pneumonia, Congestive Heart Failure (CHF), Hypoxemia (abnormally low concentration of oxygen in the blood), and Lung Cancer. Continued review of the medical record revealed no documented evidence the facility obtained informed consent or a consent for treatment.
2. Review of the medical record for Patient #6 revealed the facility admitted the patient on 12/11/17 with diagnoses that included Acute Chronic Respiratory Failure and Chronic Obstructive Pulmonary Disease (COPD). Continued review of the medical record revealed no documented evidence the facility obtained informed consent or a consent for treatment.
3. Review of the medical record for Patient #7 revealed the facility admitted the patient on 11/26/17 with a diagnosis of COPD. Continued review of the medical record revealed no documented evidence the facility obtained informed consent or a consent for treatment.
4. Review of the medical record for Patient #8 revealed the facility admitted the patient on 12/22/17 with diagnoses that included CHF, and Non-alcoholic Cirrhosis. Continued review of the medical record revealed no documented evidence the facility obtained informed consent or a consent for treatment.
Interview with the Chief Nursing Officer (CNO) on 01/25/18 at 2:25 PM, revealed the facility was not aware that informed consent was not obtained for the patients. The CNO stated she did not know if staff failed to obtain consent or if the facility's signature pad was not functioning properly.
Interview with a Medical Records Specialist on 01/24/18 at 9:30 AM revealed she tracked to ensure informed consent/consent to treat was completed, but had not identifed that there was an issue with informed consents not being obtained. The Medical Record Specialist stated that even if the signature pad malfunctioned, there still should have been an informed consent form on the patients' medical record.
Tag No.: A0144
Based on observations, interviews, and review of facility policy, it was determined the facility failed to provide care in a safe setting on the Behavioral Health Unit. Observation of the sixteen beds on unit on 01/24/18, revealed electrical cords and call light cords that created a possible ligature risk.
The findings include:
Review of the facility policy titled, "Patient Rights and Responsibilities," dated February 2017 each patient had the right to have safe care in a safe environment.
Observation on 01/24/18 at 3:43 PM revealed the Behavioral Health Unit had seven (7) semi-private rooms and two (2) private rooms for a total of sixteen beds, with a census of five patients. Observations of patient rooms revealed the power cord for the hospital beds were uncoiled exposing approximately six (6) feet of electrical cord laying in the floor creating a possible ligature risk. Continued observations revealed call light cords were coiled on the wall between the patient beds, creating a possible ligature risk.
Interview with the Manger of the Behavioral Health Unit on 01/24/18 at 4:00 PM, revealed he was unaware of the possible risk the hospital bed cords and call light cords could impose to patients.
Tag No.: A0154
Based on interview, record review, and a review of the facility's restraint policy, it was determined the facility failed to ensure two (2) of twenty-eight (28) sampled patients (Patient #1 and Patient #2) were free from restraints imposed as a means of convenience. When Patient #1 and #2 were mechanically ventilated, the facility administered Diprivan (an anesthetic/sedative medication) and physically restrained the patients, even though the patients were sedated.
The findings include:
Review of the facility policy titled, "Use of Patient Restraints," dated February 2017 revealed that patients had the right to be free from restraint or seclusion of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff. The facility defined a physical restraint as any manual method, physical or mechanical device, or equipment that immobilizes or reduces the ability of a patient to move his/her arms, legs, body, or head freely. The facility defined a chemical restraint as a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. The policy further stated a restraint may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest time.
1. Review of Patient #1's medical record revealed the facility admitted the patient on 12/16/17 with diagnoses that included Urosepsis and Dehydration. Further review of the record revealed Patient #1 was 91 years old and weighed 86.6 pounds.
On 12/20/17 at 1:55 PM, Patient #1 was placed on a mechanical ventilator due to respiratory arrest. Review of Patient #1's physician orders revealed on 12/20/17 at 3:00 PM, the physician ordered Diprivan (anesthetic medication)and bilateral soft wrist restraints due to the patient interfering with/removing medical devices.
Continued review of Patient #1's progress notes from 12/20/17 at 3:00 PM until 12/21/17 at 11:00 AM, revealed the patient remained physically restrained and staff documented the indication for the use of the physical restraints was due to interference with medical interventions and attempts to remove medical devices; however, documentation revealed the patient continued to be sedated with Diprivan medication and there was no evidence the patient was exhibiting this behavior. On 12/20/17 at 7:31 PM, staff documented that Patient #1 was "sedated" and on 12/21/17 at 7:30 AM, staff documented that the patient's "eyes open, little movement and patient remains in bilateral soft wrist restraints. [Patient #1] is calm, cooperative and emotional support given, sitter remained in room 1:1."
2. Review of Patient #2's medical record revealed the facility admitted the patient on 10/11/17 with diagnosis that included Partial Small Bowel Obstruction. Record review revealed Patient #2 had a hernia repair, was unable to be extubated (could not tolerate removal of mechanical ventilation) after surgery, and was transferred to the medical/surgical floor on a ventilator on 10/13/17 at 11:30 AM. Review of the patient progress notes for Patient #2 revealed the patient was physically restrained when the patient arrived to the floor at 11:30 AM on 10/13/17, and an Intravenous infusion of Diprivan was initiated at 11:31 AM.
Continued review of Patient #2's progress notes from 10/13/17 at 11:31 AM until 10/14/17 at 9:15 AM, revealed the patient remained physically restrained and staff documented the indication for the use of the physical restraints was due to interference with medical interventions and attempts to remove medical devices. However, documentation revealed the patient continued to be sedated with anesthetic/sedative medication (Diprivan) and there was no evidence the patient was exhibiting this behavior. Review of patient progress notes revealed on 10/13/17 at 11:52 AM Patient #1 was "sedated," and Diprivan was infusing. Staff documented Patient #2 was "sedated" until the patient was removed from the ventilator on 10/14/17 at 9:15 AM.
Interview with Registered Nurse (RN) #5 on 01/29/18 at 4:18 PM, RN #1 on 01/24/18 at 11:35 AM, RN #2 on 01/24/18 at 11:50 AM, and RN #4 on 01/25/18 at 2:05 PM revealed when patients were mechanically ventilated on the medical floor, the patients were routinely physically restrained even though they were sedated with Diprivan medication.
Interview with Physician #6 on 01/24/18 at 1:45 PM, revealed it was not his practice to physically restrain patients and had never ordered physical restraints while practicing at the facility because he believed this practice was "archaic"
Interview with Physician #5, the Chief of Staff on 01/24/18 at 12:20 PM, revealed she was unaware nursing staff were not discontinuing physical restraints for patients on ventilators when the patients became calm/cooperative or sedated.
Tag No.: A0166
Based on interviews, record reviews, and review of facility policy, it was determined the facility failed to modify four (4) of twenty-eight (28) patients' (Patient #1, Patient #2, Patient #3, and Patient #4) plan of care when chemical and physical restraints were implemented.
The findings include:
1. Review of Patient #1's medical record revealed the facility admitted the patient on 12/16/17, with diagnoses that included Urosepsis and Dehydration. Review of the physician orders revealed on 12/20/17 at 3:00 PM, the patient's physician ordered bilateral soft wrist restraints because the patient was interfering/removing with medical devices.
Review of Patient #1's plan of care dated 12/20/17 and 12/21/17, following the implementation of restraints revealed no evidence the facility updated the plan of care to include the use of restraints.
2. Review of Patient #2's medical record revealed the facility admitted the patient on 10/11/17, with a diagnosis of Partial Small Bowel Obstruction. Review of the patient's physician orders revealed on 10/13/17 at 11:45 AM, the physician ordered bilateral soft wrist restraints for the patient because the patient was interfering/removing medical devices.
Review of the plan of care dated 10/11/17 and 10/12/17, revealed no evidence the facility revised Patient #2's plan of care to include the use of restraints.
3. Review of Patient #3's medical record revealed the facility admitted the patient on 11/29/17, with diagnoses that included Volume Depletion and Gastrointestinal Bleed. Review of the physician orders revealed on 12/07/17 at 2:00 PM, Patient #3's physician ordered bilateral soft wrist restraints related to the patient interfering/removing medical devices.
Review of the plan of care dated 12/07/17 and 12/08/17, revealed no evidence the facility updated Patient #3's plan of care to include the use of restraints.
4. Review of Patient #4's medical record revealed the facility admitted the patient on 10/10/17 with diagnoses of Altered Conscious, Delirium, and Combativeness. Review of Patient #4's physician orders revealed on 10/10/17 at 5:56 PM, the physician ordered bilateral soft wrist restraints and bilateral ankle restraints related to the patient inferring with medical interventions and the risk of violence.
However, a review of Patient #4's plan of care dated 10/10/17 and 10/11/17, revealed no evidence the facility updated the patient's plan of care to include the use of restraints.
Interview with the Nursing Supervisor on 01/29/18 at 5:00 PM and with the Chief Nursing Officer on 01/29/18 at 4:30 PM, revealed they were not aware a patient's plan of care required revision when restraints were implemented.
Tag No.: A0168
Based on interviews, record reviews, and review of facility policy, it was determined the facility failed to obtain an order to physically restrain one (1) of twenty-eight (28) sampled patients (Patient #4). On 10/10/17, Patient #4 was admitted to the medical floor of the facility, in physical restraints that had been initiated in the Emergency Department (ED). However, the facility failed to ensure a physician's order was obtained to continue the physical restraints on the medical floor. Subsequently, Patient #4 remained in physical restraints for approximately thirty-six hours without a physician's order.
The findings include:
Review of the facility's policy titled, "Use of Patient Restraints," dated February 2017 revealed patients had the right to be free from restraint or seclusion of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. The policy stated restraint could only be imposed to ensure the immediate physical safety of the patient, a staff member, or others, and must be discontinued at the earliest time. Further review of the policy revealed that a physician responsible for the patient's care must order a restraint and the attending physician must be consulted as soon as possible.
Interview with the Medical/Surgical Nursing Supervisor on 01/25/18 at 5:00 PM and the Chief Nursing Officer (CNO) on 01/25/18 at 2:25 PM revealed when a patient was transferred from one unit of the hospital to another, a new order to physically restrain the patient must be obtained.
Review of Patient #4's medical record revealed the patient was admitted to the facility on 10/10/17 at 9:49 PM from the facility's ED physically restrained. However, the patient had no admission orders for physical restraints to be utilized on the unit.
Review of Patient #4's progress note dated 10/10/17 at 10:19 PM revealed Registered Nurse (RN) #9 contacted Physician #6 and requested a physical restraint order for Patient #4; however, the physician did not order a restraint. However, review of Patient #4's medical record revealed RN #8 completed a physician's order form for a physical restraint on 10/10/17 at 9:50 PM.
Review of Patient #4's Patient Progress Notes revealed the patient remained in four point restraints from 10/10/17 at 9:50 PM until 10/12/17 at 9:29 AM, approximately thirty-six hours, without a physician's order for physical restraints.
Interview with Physician #6 on 01/24/18 at 1:45 PM, revealed he did not specifically recall being contacted regarding physically restraining Patient #4, but it was not his practice to physically restrain patients and had never ordered physical restraints while practicing at the facility.
Interview with the CNO on 01/25/18 at 2:25 PM revealed she was not aware that Patient #4 did not have an order for physical restraints and was restrained for approximately thirty-six hours without a physician's order.
Tag No.: A0171
Based on interviews, record reviews, and facility policy review, it was determined the facility failed to ensure physical restraint orders for violent or self-destructive behavior were renewed every four (4) hours for one (1) of twenty-eight (28) sampled patients (Patient #3). Patient #3 was physically restrained on 12/07/17 at 2:00 PM, due to self destructive behavior; however, the facility staff failed to ensure that the order was renewed every four (4) hours as per facility policy and regulation.
The findings include:
Review of the facility policy titled, "Use of Patient Restraints," dated February 2017 revealed patients had the right to be free from restraint or seclusion of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. The policy stated restraint could only be imposed to ensure the immediate physical safety of the patient, a staff member, or others, and must be discontinued at the earliest time. Further review of the policy revealed restraint orders for self-destructive behavior must be renewed every four (4) hours and not exceed twenty-four (24) hours.
Review of Patient #3's medical record revealed the facility admitted the patient on 11/29/17, with diagnoses of Volume Depletion and Gastrointestinal Bleed. Review of Patient Progress Notes revealed on 12/07/17 at 2:00 PM, Patient #3 was "pulling off dressings and pulled stitches loosed." Review of the patient's physician orders revealed on 12/07/17 at 2:00 PM, Patient #3 was placed in bilateral soft wrist restraints due to interfering with medical devices.
Continued review of the Patient Progress Notes for Patient #3 revealed the patient continued to be physically restrained until 12/08/17 at 9:00 AM, approximately nineteen hours with no renewal order every four (4) hours. Review of patient progress notes revealed on 12/07/17 at 8:30 PM, while the patient continued to be physically restrained, Patient #3 was "jeopardizing safety of self, destructive behavior." Nursing Progress Notes dated from 12/07/17 at 8:30 PM until 12/08/17 at 6:00 AM revealed the behavioral indications for restraints was "jeopardizing safety of self and destructive behavior."
Interview with Registered Nurse (RN) # 1 on 01/24/18 at 11:35 AM revealed believed a restraint order was "good" for twenty-four (24) hours and was unaware a restraint was ordered for a behavioral reason had to be renewed every four (4) hours.
Interview with the Chief Nursing Officer (CNO) on 01/25/18 at 2:25 PM revealed she was not aware that restraints utilized for behavioral reasons had to be renewed every four (4) hours. She further stated that she was unaware that Patient #3 was restrained and did not have an order for restraints renewed every four (4) hours.
Tag No.: A0273
Based on interview, record review, and review of the facility's quality assurance program, it was determined that the facility failed to utilize data collected in quality assurance reporting to develop/implement action plans to address identified concerns. The facility identified that preventative maintenance had not been conducted on equipment throughout the facility, identified that the temperature/humidity of the operating rooms were not being maintained within acceptable parameters; and identified that physicians were not ensuring medical records were complete and accurate. However, there was no evidence the facility developed/implemented action plans to address/correct the identified concerns.
The findings include:
Review of the facility Performance Improvement Plan dated February 2017 revealed the purpose of the plan was to focus on outcomes of care, treatment, and services to ensure that the facility recognized and acknowledged risks and unanticipated adverse events and ensure action was taken to address the risks/adverse events. The plan stated that the data collected was utilized to identify areas requiring improvement and identified desired changes. The data was also analyzed to identify areas in need of improvement and collected at a frequency appropriate to the identified concerns.
1. The facility failed to ensure major preventative maintenance (PM) was conducted on medical equipment throughout the facility in accordance with the facility's established PM schedule (Refer to A0724).
2. The facility failed to ensure that proper ventilation and temperature controls were maintained within acceptable standards in the operating room (OR) to prevent bacterial growth and compromise of sterile equipment and supplies. The facility failed to develop a policy related to humidity in the OR that met mandated regulatory requirements and failed to maintain acceptable humidity and temperature parameters from November 2017 through January 2018, on 31 (thirty-one) of the 47 (forty-seven) days in Operating Room #1 and on 31 (thirty-one) of the 49 (forty-nine) days that surgery was conducted in the Operating Room #2 (Refer to A0951).
3. The facility failed to modify Patient #1, Patient #2, Patient #3, and Patient #4's plan of care after the use of a restraint (Refer to A0166).
4. The facility failed to ensure the physicians for Patient #21, Patient #22, Patient #23, Patient #24, Patient #25, and Patient #26 completed a history and physical examination prior to conducting surgical/invasive procedures on the patients. (Refer to A0952).
5. The facility failed to ensure a medical history and physical examination was completed timely (within 24 hours of admission) for Patient #17. Patient #17 was admitted on 12/21/17; however, a history and physical was not completed until 12/25/17, four days after admission (Refer to A0458).
6. The facility failed to ensure that written and/or verbal physician orders for Patient #5, Patient #6, Patient #7, Patient #8, Patient #14, Patient #15, Patient #16, and Patient #17 were dated, timed, and/or authenticated within the facility's required/established guidelines (Refer to A0454).
Review of the facility's Quality Performance Indicators for 2017 revealed the facility identified patient care plans were not being individualized to address specific patient needs and care plans were not being reviewed each shift and revised as necessary; patient history and physical examinations were not legible, signed timely, or updated prior to a procedure being performed; and verbal orders were not counter signed, dated, or timed as required.
Review of the facility's 2017, fourth quarter Physical Environment Committee minutes dated 01/09/18, revealed the contracted vender who completed Preventative Maintenance at the facility had placed the contract on hold due to nonpayment. Further review of the minutes revealed PM was required to be conducted based on the equipment manufacturers' recommendations. The minutes stated "objective not met due to financial issues causing the facility to not have a bio-medical company." The facility's action/follow-up was to have an internal audit of the biomedical process completed when a new contract for biomedical services was obtained. There was no evidence the facility implemented an action plan to address the facility's utilization of equipment that was known to require preventative maintenance.
Interview with Physician #6 on 01/29/18 at 3:36 PM revealed during the last meeting, the committee discussed the concerns with abnormal humidity/temperatures in the operating rooms. The physician stated he asked the committee what the plan of action should be to address the humidity/temperature; however, the committee director went on to the next topic and did not address the concern.
Interview with the Quality Assurance Director on 01/25/18 at 4:30 PM revealed the facility had identified the above concerns; however, there was no evidence corrective action had been taken to address the identified concerns.
Tag No.: A0395
Based on interview, record review, review of Diprivan medication package insert, and review of facility policy, it was determined the facility failed to ensure a registered nurse supervised and evaluated the nursing care for one (1) of twenty-eight (28) patients. Patient #1 was admitted to the medical floor of the facility and on 12/20/17 at 3:00 PM. Diprivan (a sedative/anesthetic medication) was initiated for sedation while mechanically ventilated. Although the facility established a Diprivan protocol for mechanically ventilated patients, the protocol failed to address the frequency of patient monitoring, including blood pressure monitoring as recommended by the manufacturer of the medication. In addition, the facility failed to ensure nursing staff were trained on medication administration/monitoring of Diprivan. The facility failed to monitor the patient's vital signs for approximately three hours and fifteen minutes after Diprivan was initiated. On 12/20/17 at 8:00 PM, the patient's blood pressure dropped to 74/30 (normal blood pressure 120/80) after the Diprivan medication was increased. Although Registered Nurse (RN) #7 contacted the patient's physician and obtained an order to administer medication to increase the patient's blood pressure, the RN failed to decrease the Diprivan medication in response to the patient's low blood pressure.
The findings include:
Review of Diprivan package insert revealed the medication may be utilized for sedation during intensive care. The infusion rate should be determined based on the desired depth of sedation. The reduction should take into account the physical status and age of the patient, and in elderly patients the dose requirement is reduced. The medication should be administered at a slower rate and titrated in correlation with the response in the elderly. The medication should be given by those trained in anesthesia or where appropriate, doctors trained in the care of patients in intensive care. Patients receiving Diprivan should be continually monitored for hypotension and oxygen desaturation. In the event a patient experienced an adverse reaction such as hypotension, decreasing the dosage of the medication should be considered.
Review of the facility's Diprivan protocol for medically ventilated patients (no date) revealed Diprivan would be administered in the Intensive Care Unit (ICU) and the dosage would be titrated to ensure the desired level of sedation ordered by the physician was achieved. The protocol also stated neurological and respiratory function should be evaluated to ensure the minimal dose of Diprivan was administered. The protocol failed to address monitoring of patient's vital signs, including the patient's blood pressure.
Observation 01/24/18 at 3:00 PM revealed the facility did not have an Intensive Care Unit (ICU).
Review of Patient #1's medical record revealed the facility admitted the patient on 12/16/17 with diagnoses that included Urosepsis and Dehydration. Review of a Patient Progress Note dated 12/20/17, at 1:55 PM, revealed Patient #1 was in respiratory distress and was intubated with mechanical ventilation. Continued review of the Patient Progress Notes dated 12/20/17 at 3:00 PM, revealed Diprivan was initiated at 5 micrograms (mcg) because the patient was pulling at the intubation tubing and medical equipment.
Review of the Physician's Orders for Patient #1 revealed an order for propofol (Diprivan) drip, per protocol. However, there was no order for the desired level of sedation as required by the Diprivan protocol.
Further review of Patient Progress Notes dated 12/20/17 at 9:57 AM revealed Patient #1's blood pressure was 107/59. On 12/20/17 at 4:00 PM, Diprivan was increased to 10 micrograms (mcg) because the patient was "moving around a lot". However, the facility failed to document the patient's blood pressure to ensure the patient was able to tolerate the increased dosage. According to the Notes, at 5:00 PM, Diprivan was decreased to 5 mcg because the patient was "calming down." At 6:15 PM, Diprivan was again increased to 10 mcg due to the patient "moving a lot." At this time the patient's blood pressure was 91/40, the first blood pressure obtained since the medication was initiated approximately three hours prior.
Continued review of the Patient Progress Notes revealed on 12/20/17 at 8:00 PM, the patient's blood pressure continued to drop and was 74/33. At 8:25 PM, staff contacted the physician regarding the patient's blood pressure and a new order was received for Dopamine (medication to raise blood pressure).
Further review of Patient #1's Progress Notes revealed from 8:30 PM on 12/20/17 to 12:30 AM on 12/21/17 revealed the patient's blood pressure ranged from 84-107 systolic (top number) to 37-54 diastolic (bottom number) and the facility continued to administer Diprivan at 10 mcg until the patient was transferred to another hospital on 12/21/17 at 12:35 PM.
Review of yearly nursing skills proficiency for facility staff revealed no evidence nurses received training regarding administration of Diprivan medication to patients. In addition, interviews with Registered Nurse (RN) #1 on 01/24/18 at 11:35 AM, RN #4 on 01/25/18 at 2:05 PM and RN #5 on 01/29/18 at 4:18 PM revealed they administered Diprivan to patients at the facility; however, they had not received training related to the administration of Diprivan medication/monitoring patients while receiving Diprivan.
Interview with the Certified Registered Nurse Anesthetist (CRNA) on 01/30/18 at 2:30 PM revealed Diprivan was an anesthetic and the administration of the medication required extensive monitoring, including blood pressure, respirations, heart rate, and other pertinent systemic monitoring. The CRNA stated if a patient exhibited a decrease in blood pressure, the primary action should be to decrease the dosage of Diprivan. The CRNA went on to say that the addition of Dopamine mediation to treat a low pressure should only occur when Diprivan was being utilized in the operating room as anesthesia.
Tag No.: A0450
Based on interviews, record reviews, and review of facility policies, it was determined the facility failed to ensure all patient medical record entries were legible for seven (7) of twenty-eight (28) sampled patients (Patient #1, Patient #3, Patient #5, Patient #8, Patient #15, Patient #16, and Patient #21). Review of records for Patient #1, Patient #3, Patient #5, Patient #8, Patient #15, Patient #16, and Patient #21 revealed the physician's orders and the physician's progress notes were illegible.
The findings include:
Review of the Medial Staff Rules and Regulations, undated, revealed practitioners were responsible for ensuring that all medical records were complete and legible.
1. Review of the medical record for Patient #1 revealed the facility admitted the patient on 12/16/17 with diagnoses that included Urosepsis and Dehydration. Continued review of the record revealed the progress notes and physician's orders written by Physician #4 on 12/20/17 were illegible.
2. Review of the medical record for Patient #3 revealed the facility admitted the patient on 11/29/17 with diagnoses that included Volume Depletion and Gastrointestinal Bleed. Continued review of the record revealed the progress notes and physician's orders written by Physician #3 on 12/03/17, 12/04/17, 12/05/17, and 12/08/17 were illegible. Further review of the record revealed the progress notes and physician's orders written by Physician #5 on 12/11/17 and 12/12/17 were illegible.
3. Review of the medical record for Patient #5 revealed the facility admitted the patient on 12/29/17 with diagnoses that included Pneumonia, Congestive Heart Failure (CHF), Hypoxemia (abnormally low concentration of oxygen in the blood), and Lung Cancer. Continued review of the record revealed the progress notes and physician's orders documented on 12/29/17 were illegible.
4. Review of medical record for Patient #8 revealed the facility admitted the patient on 12/22/17 with diagnoses that included CHF, and Non-Alcoholic Cirrhosis. Continued review of the record revealed the progress notes and physician's orders written by Physician #5 on 12/24/17 were illegible. Further review of the record revealed physician's orders and progress notes written on 12/25/17 were illegible.
5. Review of the medical record for Patient #15 revealed the facility admitted the patient on 11/08/17 with a diagnosis of Metastatic Cancer of the breast and colon. Continued review of the record revealed the progress notes and physician's orders written by Physician #3 on 11/08/17 were illegible.
6. Review of the medical record for Patient #16 revealed the facility admitted the patient on 10/12/17 with a diagnosis of Acute and Chronic Cholecystitis. Continued review of the record revealed the progress notes and physician's orders written by Physician #3 on 10/12/17 were illegible.
7. Review of the medical record for Patient #21 revealed the facility admitted the patient on 01/25/18 with no diagnosis listed. Continued review of the record revealed the progress notes written by Physician #2 were illegible.
Interview RN #1 on 01/24/18 at 11:35 AM, RN #2 on 01/24/18 at 11:50 AM, and RN #4 on 01/25/18 at 2:05 PM revealed they all worked on the medical floor and had a difficult time reading Physician #2, Physician #3, Physician #4 and Physician #5's written orders and progress notes.
Interview with the Quality Manager on 01/24/18 at 4:30 PM revealed she was aware the entries made by specific physicians were illegible and had been working with the physicians to rectify the situation. However, she indicated she had not been successful.
Tag No.: A0454
Based on interviews, medical record review, review of Rules and Regulations of the Medical Staff Bylaws, and review of a facility policy, it was determined that the facility failed to ensure that written and/or verbal physician orders for eight (8) of twenty-eight (28) sampled patients (Patient #5, Patient #6, Patient #7, Patient #8, Patient #14, Patient #15, Patient #16, and Patient #17) were dated, timed, and/or authenticated within the facility's required/established guidelines.
The findings include:
Review of the facility's policy titled, "Physician Orders," dated February 2017 revealed all verbal and telephone orders were required to be dated, timed, and signed/authenticated in the Electronic Health Record (EHR) by the ordering physician within 48 hours.
Review of the facility's Medical Staff Rules and Regulations, undated, revealed verbal orders were required to be authenticated (signed, dated, and timed) by the practitioner within fifteen (15) days, not forty-eight (48) hours as required by the federal regulation. The bylaws further stated the responsible physician must countersign all orders given by a APRN.
1. Review of the medical record for Patient #5 revealed the facility admitted the patient on 12/29/17 with diagnoses that included Pneumonia, Congestive Heart Failure (CHF), Hypoxemia and Lung Cancer.
Review of Patient #5's physician orders revealed the physician gave a verbal order on 12/29/17 at 5:47 PM; however, the physician had not authenticated the order. Further, Physician #5 wrote an order for Patient #5, but did not document a date or time on the order.
2. Review of the medical record for Patient #6 revealed the facility admitted the patient on 12/11/17 with diagnoses that included Acute Chronic Respiratory Failure and Chronic Obstructive Pulmonary (COPD).
Review of Patient #6's physicians orders revealed Physician #1 gave verbal orders on 12/13/17 at 5:57 PM, 12/15/17 at 10:42, 12/12/17 at 5:07 AM, 12/12/17 at 11:15 AM, 12/13/17 at 5:56 PM, and 12/15/17 at 11:12 AM, but failed to authenticate the orders within 48 hours.
3. Review of the medical record for Patient #7 revealed the facility admitted the patient on 11/26/17 with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
Review of Patient #7's physician orders revealed on 11/26/17 at 12:40 PM, APRN #2 wrote orders for the patient; however, the orders had not been counter signed by a supervising physician as of 01/29/18. In addition, APRN #2 gave a verbal order on 11/26/17 at 11:54 AM and the order was not counter signed by a supervising physician within 48 hours.
4. Review of the medical record for Patient #8 revealed the facility admitted the patient on 12/22/17 with diagnoses that included CHF and Non-Alcoholic Cirrhosis.
Review of Patient #8's physician orders revealed Physician #1 gave verbal orders on 12/26/17 at 10:42 AM and on 12/29/17 at 9:05 AM; however, the orders were not authenticated within 48 hours. Further review of the physician orders revealed Physician #5 gave verbal orders on 12/23/17 at 9:30 AM, which had not been authenticated as of 01/29/18.
5. Review of medical record for Patient #14 revealed the facility admitted the patient on 11/20/17 with diagnoses that included Anemia and Myelodysplastic Syndrome.
Review of the physician orders for Patient #4 revealed Physician #8 wrote orders on 11/20/17; however, the time of the order was not documented.
6. Review of the medical record for Patient #15 revealed the facility admitted the patient on 11/08/17 with a diagnosis of Metastatic Cancer of the breast and colon.
Review of Patient #15's physician orders revealed Physician #3 wrote orders on 11/08/17; however, the physician failed to document the time the order was written.
7. Review of the medical record for Patient #16 revealed the facility admitted the patient on 10/12/17 with a diagnosis of Cholecystitis.
Review of Patient #16's physician orders revealed Physician #3 wrote pre-operative orders; however, the orders were not dated and timed. In addition, the physician wrote post-operative orders, but did not document the time the orders were written.
8. Review of the medical record for Patient #17 revealed the facility admitted the patient on 12/21/17 with a diagnosis of Sepsis.
Review of Patient #17's physician orders revealed Physician #1 gave verbal orders on 12/22/17 at 4:38 PM and 12/22/17 at 10:15 PM; however, the orders were not authenticated within 48 hours. In addition, Physician #5 gave verbal orders on 12/23/17 at 2:00 AM and on 12/23/17 at 6:21 AM that were not authenticated within 48 hours.
Interview with the Quality Director on 01/24/18 at 1:00 PM revealed it was the facility's expectation that physicians sign verbal orders as soon as possible, but no later than 48 hours after the order was given. She stated she was aware physicians were not signing verbal orders and the facility was tracking physician documentation.
Tag No.: A0458
Based on interviews, record review and review of facility policy it was determined the facility failed to ensure a medical history and physical examination was completed timely (within 24 hours of admission) for one (1) of twenty-eight (28) sampled patients reviewed (Patient # 17). The facility admitted Patient #17 on 12/21/17; however, a history and physical was not completed until 12/25/17, four days after admission.
The findings include:
Review of the facility policy titled, "History and Physical-Medical Staff," dated March 2017 revealed a comprehensive history and physical (H&P) examination was required to be completed within 24 hours of admission to the facility. The H&P was required to be completed by the appropriate practitioner privileged to perform history and physicals.
Review of the medical record for Patient #17 revealed the facility admitted the patient on 12/21/17 with a diagnosis of Sepsis. Continued review of the medical record revealed Physician #1 did not complete the history and physical until 12/25/17 (96 hours after admission).
Interview with the Quality Director on 1/24/18 at 1:00 PM revealed it was the expectation of the facility that all history and physicals be completed within 24 hours of the patients' admission to the facility.
Interview with Physician #6, a physician who participates on the Quality Assurance Committe on 01/24/18 at 1:45 PM, revealed he monitored for the timely completion of H&P's and was aware that physicians were not completing H&Ps timely, but was unable to change the physician's practice.
Tag No.: A0468
Based on interviews, record review and review of facility policy it was determined the facility failed to ensure an accurate discharge summary was completed and authenticated for one (1) of twenty-eight (28) sampled patients (Patient #1). Patient #1 was discharged from the facility on 12/21/17 to the care of another acute care facility; however, review of the discharge summary revealed the summary was inaccurate and stated the patient was discharged on 12/19/17 to a nursing home.
The findings include:
Review of the facility policy titled, "Medical Record Content," dated March 2017 revealed each facility record would document treatment and results of the treatment accurately. Continued review of the policy revealed a discharge summary would be completed and it would include an admitting diagnosis, a final diagnosis, consults, history, pertinent physical findings, clinical laboratory findings, all procedures performed, the hospital course, discharge medications, the condition of the patient on discharge, and discharge instructions.
Review of the medical record for Patient #1 revealed the facility admitted the patient on 12/16/17 with diagnoses that included Urosepsis and Dehydration. Continued review of the medical record revealed a discharge summary written by Physician #4 on 12/19/17 that stated Patient #1 was treated for "urinary tract infection and rehabilitated as an inpatient, found a bed for a nursing home, to go back to the nursing home." Further review of the medical record revealed nursing documentation that stated on 12/20/17 at 1:55 PM Patient #1 was in respiratory distress and a code was called. Patient #1 was intubated and placed on a ventilator. On 12/21/17 at 11:00 AM Physician #3 contacted another acute care facility and arranged for a transfer. Emergency Medical Services arrived at the facility and Patient #1 was transferred to another acute care facility at 2:07 PM on 12/21/17.
Interview with Physician #6, a physician who participated on the Quality Committe, revealed if a physician was going to dictate a discharge summary prior to discharge, the physician was required to ensure the hospital course did not change and the discharge summary accurately reflected the hospital course.
Interview with the Chief of Staff (Physician #5) on 01/24/18 at 12:20 PM revealed it was the expectation of the medical staff of the facility that each physician ensure their documentation was accurate and up to the standard of practice. Continued interview revealed that in the past, the facility had a difficult time ensuring their physicians complied with regulatory guidelines.
Tag No.: A0537
Based on interview, record review, and review of the facility's medical equipment inspection and maintenance policy, it was determined the facility failed to ensure a periodic inspection of equipment was performed and hazards that were identified were properly corrected. Review of the facility's preventative maintenance (PM) schedule for diagnostic equipment revealed the facility failed to complete PM as required.
The findings include:
Review of the facility's policy titled "Medical Equipment and Inspections, Testing and Maintenance" date unknown, revealed biomedical equipment would have inspections, testing, and maintenance performed for all equipment according to preventative maintenance schedules established by the facility's risk department.
Review of the service reports for the radiological equipment revealed the portable X-ray machine and the Gamma camera (utilized for nuclear medicine studies) had not had preventative maintenance since July 2016. Review of the facility's PM schedule revealed the equipment required PM yearly.
Review of the facility's PM schedule revealed X-ray machine #2 required PM every six months. However, review of service reports for x-ray # 2 revealed the facility had not conducted PM since August 2016.
Further review of service reports revealed X-ray machine #3 had not had preventative maintenance since March 2016. However, according to the facility's PM schedule, the machine required yearly PM.
Continued review of the facility's PM schedule revealed the facility's Computed Tomography (CT) machine required PM every four (4) months. However, there was no documented evidence the facility had completed PM since March 2017, approximately ten (10) months.
Review of the facility's recapitulation of radiology examinations performed by the facility from August 2017 through January 28, 2018 revealed the facility had conducted 3,411 X-rays, 450 CT scans, and 59 Nuclear Medicine studies.
Interview with the Director of Radiology on 01/30/18 at 11:05 AM, revealed he was aware that preventative maintenance had not been conducted on the facility's radiology equipment. However, the Director stated the facility continued to conduct radiology tests. He stated failure to ensure preventative maintenance could result in an unclear image; and, subsequently the study could not be interpreted correctly. The Radiologist stated when this occurred, he had the test repeated until he obtained a clear study.
Interview with the Radiology Manager on 01/29/18 at 3:17 PM, revealed the facility normally contracted an outside agency to conduct the facility's PM. However, the facility did not have the funds to pay the vendor to complete the PM; therefore, the outside agency had not completed PM on the facility's equipment.
Interview with the Chief Executive Officer (CEO) on 01/30/18 at 10:40 AM revealed he was also aware that PM had not been completed on the facility's radiology equipment. The CEO stated he was also aware that the equipment continued to be utilized by the facility to conduct diagnostic examinations. During further interview with the CEO, he stated the company that managed the facility would not provide the funds for PM to be performed until the management company purchased the facility.
Tag No.: A0724
Based on interview, record review, and review of the facility's Medical Equipment policy, it was determined the facility failed to maintain equipment in a manner to ensure an acceptable level of safety and quality. The facility failed to ensure Preventative Maintenance (PM) was conducted on equipment throughout the hospital as established by the facility's risk department.
The findings include:
Review of the facility's Medical Equipment and Inspections, Testing and Maintenance (patient care) revealed biomedical equipment would have inspections, testing, and maintenance performed for all equipment according to preventative maintenance schedules established by the facility's risk department.
Review of the facility's PM schedule revealed the following equipment required PM in 2017; however, there was no documented evidence PM was conducted: two Patient Lifts; eighteen vital sign monitors; one weight scale; one defibrillator; thirty-one suction pumps, one ultra sound cleaner; three hypo/hyperthermia units; eighty-five intravenous infusion pumps; one low air loss mattress; sixteen tube feeding pumps; six patient controlled analgesic pumps; two pulse oximeters; eight physiological monitors; one infant radiant warmer; three cast saws; one plasma water bath; ten centrifuges; three gas analyzers; one battery charger; one compression tourniquet pump; one whirlpool bath; one treadmill; two hydrocollators; three physical therapy ultra sound machines; one compressor; one Continuous Positive Air Pressure (CPAP)/Bilevel Positive Airway Pressure (Bipap) machine; two electrocardiograms; one heated humidifier; and, three ventilators.
Further review of the facility's PM schedule revealed the facility had two anesthesia machines that had not had yearly PM. One of the anesthesia machines was due for PM on 06/07/17 and one was due on 06/30/17. The facility had three anesthesia vaporizers that were due for major PM on 07/01/17; two surgical tables that were due for PM on 08/05/17 and 08/12/17; and two electrosurgical units that were due for PM on 08/28/17.
Observation on 01/25/18 at 1:00 PM of the facility's three ventilators revealed one ventilator was out of order and the other two required PM in July 2017.
Observation on 01/25/17 at 12:10 PM in the Emergency Department revealed one of the facility's two EKG machines required PM in July 2017.
Interview with a Certified Registered Nurse Anesthetist on 01/30/18 at 2:30 PM, revealed she was not aware the facility had not conducted PM of the anesthesia equipment that she utilized in the Operating Room. She stated that although she visually inspected the equipment prior to use, PM should be conducted as required to ensure the equipment operated properly.
Interview with the Maintenance Supervisor on 01/24/18 at 4:30 PM revealed he was aware PM had not been completed. He stated the facility contracted an outside vendor to complete PM for the hospital. However, the facility was unable to pay the vender and the vender stopped providing the service; subsequently, PM had not been completed. The Maintenance Director stated administration was aware that PM was past due on facility equipment and was no action had been taken to ensure PM was completed.
Interview with the Chief Executive Officer (CEO) on 01/30/18 at 10:40 AM revealed he aware that PM had not been completed on the equipment, and was aware that the equipment continued to be utilized by the facility during surgical procedures and throughout the hospital. The CEO stated the company that managed the facility would not provide the funds for PM to be performed until the management company purchased the facility.
Tag No.: A0726
Based on interview, record review, and review of the facility's policy, it was determined the facility failed to ensure that proper ventilation and temperature controls were maintained within acceptable standards in the operating room (OR) to prevent bacterial growth and compromise of sterile equipment and supplies. The facility failed to develop a policy related to humidity in the OR that met mandated regulatory requirements and failed to maintain acceptable humidity and temperature parameters from November 2017 through January 2018, on thirty-one of the forty-seven days in Operating Room #1; and, on thirty-one of the forty-nine days that surgery was conducted in Operating Room #2.
The findings include:
Review of the facility's Anesthesia Safety Program policy dated June 2017 revealed the relative humidity and temperature of the operating room would be monitored daily. The policy stated the humidity would be maintained between thirty and sixty percent at all times. However, the facility's temperature/humidity monitoring sheet revealed twenty to sixty percent humidity was acceptable. The policy further stated the temperature of the OR would be maintained at sixty-five degrees Fahrenheit plus or minus five degrees. Review of the facility's temperature/humidity monitoring sheet revealed the acceptable temperature range was sixty-eight to seventy-five degrees Fahrenheit. Further review of the policy revealed if any problems with temperature or humidity occurred, the Facilities Management Department would immediately notify the OR manager.
Review of the OR temperature and humidity log for November 2017 through 01/25/18 for Operating Room #1 revealed the humidity level was not within acceptable parameters for 25 of 47 days that surgeries were conducted. Review of the log revealed the humidity was low and on eighteen days was too low to be measured. Further review of the log revealed the temperature of OR #1 was not within acceptable parameters for 15 of 47 days that surgeries were conducted from November 2017 through 01/25/18. The temperature was below acceptable parameters one day, and was above acceptable parameters for fourteen days. According to the log, no corrective action was taken related to the unacceptable parameters in November 2017. Staff documented on three days in December 2017, that maintenance staff was notified of the abnormal temperatures/humidity. In January 2018, staff documented that maintenance staff was aware each time it was documented that the temperature/humidity was out of acceptable range. Further review of the log revealed results of the temperature/humidity monitoring logs were sent to the Infection Control Department monthly.
Review of the temperature and humidity log for November 2017 through 01/30/18 for Operating Room #2 revealed the humidity level was not within acceptable parameters (below thirty-five percent) for 25 of 49 days that surgeries were conducted. Further review of the log revealed the temperature of OR #2 was not within acceptable parameters for 16 of 49 days that surgeries were conducted from November 2017 through 01/25/18. The temperature was below acceptable parameters on three days, and was above acceptable parameters for thirteen days. According to the log, no corrective action was taken related to the unacceptable parameters in November 2017. Staff documented on two days in December 2017 and four days in January 2018, that maintenance staff was aware of the abnormal temperatures/humidity.
Interview with the Infection Control Nurse on 01/29/18 at 1:12 PM, revealed she was aware the temperature/relative humidity was not within acceptable parameters. However, she stated no action was taken.
Interview with the OR Nurse on 01/29/18 at 1:10 PM, revealed she was aware the relative humidity/temperature of the OR was not within acceptable range and had notified Maintenance staff
Interview with the OR Manager on 01/25/18 at 1:50 PM revealed the temperature of the OR needed to be less than seventy-two degrees, and preferred it to be sixty-eight degrees. The OR Manager stated 20-35 percent was the standard of practice for relative humidity, which was in conflict with the facility's policy. The OR Manager stated she was aware the temperatures/humidity of the OR was out of range, but she had never been told not to conduct surgeries. She stated she believed the issue was because the system was old and funds were not available to have the system repaired/replaced. The OR Manager stated she was not sure if the temperature/humidity affected the sterility, but stated the facility should not conduct surgery if it was out of acceptable range.
Interview with the Maintenance Supervisor on 01/24/18 at 4:30 PM revealed the boilers and sensors for the heat/air units needed repairs and could not regulate the temperature/humidity properly. The Maintenance Supervisor stated administrative staff was aware that the equipment had not been inspected, but to his knowledge, no action had been taken.
Interview with the Chief Executive Officer on 01/30/18 at 10:40 AM revealed he was not aware the operating room temperature/humidity was not within acceptable parameters and no one notified him that the conditions in the OR were not safe.
Tag No.: A0951
Based on observation, interview, record review, and review of the facility's medical equipment inspection and maintenance policy, it was determined the facility failed to ensure surgical services were consistently maintained according to needs and resources to achieve and maintain medical standards of practice in patient care. The facility failed to ensure major preventative maintenance (PM) was conducted in accordance with the facility's established PM schedule for surgical sterilization equipment.
The findings include:
Review of the facility's Medical Equipment and Inspections, Testing and Maintenance (patient care) revealed biomedical equipment would have inspections, testing, and maintenance performed for all equipment according to preventative maintenance schedules established by the facility's risk department.
Review of the facility's PM schedule revealed the facility's two sterilizers (used to sterilize surgical instruments/tools) were due to have PM conducted on 10/01/17. In addition, two Steris machines (utilized to sterilize endoscopes) were due for PM on 06/01/17; and, the hydrogen peroxide sterilizer was due for PM on 10/01/17.
Review of the facility's surgical log revealed the facility conducted 669 surgeries from 06/01/17 through 01/24/18.
Review of the facility's Infection Control Committee meeting minutes dated 01/16/18 revealed the Surgery Manager discussed several challenges with the facility's sterilizer, stating PM had not been completed or the annual cleaning for the sterilizer and autoclave. The minutes revealed the action/follow up to address the concerns were that no contracted services were available; therefore the PM would remain on hold due to financial constraints.
Interviews with the Surgery Manager on 01/25/18 at 1:50 PM and the Operating Room Nurse on 01/29/18 at 1:10 PM revealed they were aware the surgical equipment had not been maintained as required and continued to utilize the equipment for surgical procedures and sterilization of surgical instruments.
Interview with the staff member who worked in central sterilization processing on 01/29/18 at 12:45 PM revealed she was concerned about PM not being performed as required and feared the surgical equipment would break down or stop working properly.
Interview with the Chief Executive Officer (CEO) on 01/30/18 at 10:40 AM revealed the facility did not have the funds to ensure PM was completed on the facility's surgical equipment, and he was aware that the equipment continued to be utilized by the facility during surgical procedures. The CEO stated the company that managed the facility would not provide the funds for PM to be performed until the management company purchased the facility.
Tag No.: A0952
Based on observations, interviews, record reviews, and review of the facility policy, it was determined the facility failed to ensure that history and physicals were completed and in the medical record prior to having a surgical/invasive procedure for six (6) of twenty-eight (28) sampled patients (Patient #21, Patient #22, Patient #23, Patient #24, Patient #25 and Patient #26.)
The findings include:
Review of the facility's policy titled, "Medical Record Content," dated March 2017 revealed each medical record would include a history and physical that included chief complaint, history of present illness, relevant past medical history, family and social history, allergies to medications and food, review of systems, a report of a physical examination, statement of the physician's impression, treatment plan, and signature of the physician.
Review of the facility's Medical Staff History and Physical policy dated March 2017 revealed a comprehensive history and physical examination would be completed by the appropriate practitioner prior to any operative or invasive procedure being performed.
Review of Medical Staff Rules and Regulations (undated) revealed when a History and Physical Examination is not recorded before an operation or any potentially hazardous diagnostic procedure, the procedure would be canceled unless it was an emergency. The document further stated a preoperative diagnosis must be recorded prior to any operative procedure.
Observations in the pre-operative area of the surgical unit on 01/25/18 at 11:40 AM, revealed Patient #25 and Patient #26 were prepped and ready for procedures. Patient #26 did not have a History and Physical in his/her medical record, and the surgery board revealed that Patient #26 was scheduled for a colonoscopy at 10:15 AM with Physician #2.
Review of the medical record for Patient #25 revealed the facility admitted the patient of 01/25/18 with no diagnosis listed. Continued review of the medical record revealed Physician #2 signed a History and Physical on 01/25/18 (untimed) that did not include a diagnosis, history of present illness, relevant past medical history, family and social history, allergies to medications or foods, or the physician's impression and treatment plan.
Review of the medical record for Patient #21 revealed the facility admitted the patient on 01/25/18 with no diagnosis listed. Continued review of the medical record revealed Physician #2 signed a History & Physical (H&P) document on 01/25/18 (untimed). However, the H&P did not list a diagnosis, history of present illness, relevant past medical history, family or social history, allergies to medication or foods, or statement of impression with a treatment plan.
Review of the medical record for Patient #22 revealed the facility admitted the patient on 01/25/18 with no diagnosis listed. Continued review of the medical record revealed Physician #2 signed a History & Physical conducted on 01/25/18 (untimed); however, the H&P did not include a diagnosis, history of present illness, family or social history, allergies to medication or foods, or statement of impression with treatment plan.
Review of the medical record for Patient #23 revealed the facility admitted the patient on 01/25/18 with no diagnosis listed. Continued review of the medical record revealed Physician #3 signed a History & Physical on 01/25/18 (illegible time) that did not list a diagnosis, history of present illness, relevant past medical history, family or social history, allergies to medication or foods, or statement of impression with treatment plan.
Review of the medical record for Patient #24 revealed the facility admitted the patient on 01/25/18 with no diagnosis listed. Continued review of the medical record revealed Physician #2 signed a History & Physical on 01/25/18 (untimed) that did not include a diagnosis, history of present illness, past family medical history, allergies to medication/food, or statement of impression with treatment plan.
Interview with Operating Room Nurse on 01/29/18 at 1:10 PM, revealed patient History and Physical examinations were required to be in the patient's medical record prior to surgery; however, the facility's surgeons often did not complete the patient's H&P or the H&P was incomplete. She stated it had been an ongoing problem that she had shared with administrative staff.
Interview with Physician #6 on 01/29/18 at 3:36 PM, revealed he was aware of the issues surrounding incomplete or inadequate History and Physicals. Physician #6 stated they had posted a template of a History and Physical in the doctor's lounge so the doctors would understand all components necessary/expected in the History and Physical.