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Based on observation, interview, record review, and review of facility policy, it was determined the facility failed to ensure the Chief Executive Officer (CEO), appointed by the Governing Body, was effectively managing the facility. The CEO failed to ensure the hospitals policies and procedures were individually reviewed prior to implementation and failed to ensure systems were in place to identify patient care problems in the facility. The deficiencies identified related to Quality Assurance Improvement Plan (QAPI), Pharmacy (outdated medications and supplies), Lab (late diagnostic testing), Radiology (lack of direct physician supervision during a CT Scan with contrast and failure to notify Emergency Department patients of test results), and Emergency Preparedness (lack of risk assessment) had not been identified by the CEO.

Refer to A0057.

Based on observation, interview, record review, and review of facility policy, it was determined the facility failed to ensure the Chief Executive Officer (CEO), appointed by the Governing Body, was effectively managing the facility. The CEO failed to ensure the hospital's policies and procedures were individually reviewed prior to implementation and failed to ensure systems were in place to identify patient care problems in the facility. The deficiencies identified related to Quality Assurance Improvement Plan (QAPI), Pharmacy (outdated medications and supplies), Laboratory (late diagnostic testing), Radiology (lack of direct physician supervision during a CT Scan with contrast and lack of facility policy to notify patients of test results), and Emergency Preparedness (lack of risk assessment) had not been identified by the CEO.

The Findings include:

Review of the facility "Chain of Command" policy dated revised 06/2019 revealed the Chief Executive Officer (CEO) with the medical staff were under the Board of Directors. The policy stated in the absence of the CEO, the On-Site Administrator, Chief Nursing Officer (CNO) would be in charge. In the absence of these individuals command authority was delegated to the respective department head in which the problem occurs.

Review of the facility "Policy and Procedures; Development and Approval" policy dated approved on June 2019 revealed "Procedures: ..... 4. a. Unit Managers and Administration shall review all policies at a minimum of every three years, or at any time changes occur within the organization or when applicable regulatory standards are revised.....".

Review of the facility "Governing Board Responsibilities" policy revised on June 2019 revealed "2. The following items must be reviewed and documented monthly: ....f. Review and evaluation of policies and procedures relating to the conduct of the organization..... j. Review of hospital policies and procedures regarding patient rights and responsible and ensure they are implemented and practiced accordingly..... j. Monthly review of the hospital Quality Improvement Plan..."

1. Review of the policies and procedures for Radiology and Administration revealed most of the policies were documented as reviewed/revised in June 2019.

Interview with the CEO on 07/30/19 at 9:10 AM revealed the process for approval of facility policies and procedures was for any newly developed or revised policy to go to QAPI for approval, then to the Medical Staff, and finally to the Governing Body for approval. The CEO stated each department director had reviewed their own policies, then brought any concerns for the above to review. Some of the former policies were adopted after they were submitted by the department directors. However, the CEO stated that not all policies and procedures had been reviewed prior to being changed/implemented.

Interview with the Chairman of the Board (Governing Body) on 07/26/19 at 10:51 AM revealed he expected the CEO and CNO to ensure the facility's policies and procedures were followed related to care and treatment provided in the facility. Continued interview on 07/30/19 at 9:45 AM revealed policies and procedures were discussed in the Governing Body Board Meeting but the board members did not review each policy and procedure individually.
2. Review of the facility's 2019 Quality Improvement Plan revealed a scope of practice that included performance areas that would be monitored to include Radiology, Pharmacy, Emergency, and Laboratory services, etc. The Department Directors were responsible for submitting areas that would be reviewed in the Quality Improvement Performance Improvement Plan (QAPI). However, the facility failed to conduct the reviews as planned. Further, the facility failed to develop/implement systems (audits, monitors) to identify specific problems in these departments which affected patient care. Concerns with the failure to notify patients of diagnostic test results after a Emergency Department visit, expired medications/supplies, late diagnostic testing, physician supervision during radiology testing, competency evaluations for radiology staff, and failure to review policies and procedures had not been identified in the QAPI program.

Interview with the CEO on 08/05/19 (post survey interview) at 2:50 PM revealed he attended the QAPI weekly meetings and worked with the CNO to ensure measures and indicators per the CMS guidelines were followed. The CEO stated he understood the QAPI program should catch problems areas and address those problems to improve quality of patient care. The CEO stated he was not aware of the problems identified on the initial survey prior to being identified by the survey team.

3. The facility failed to ensure drugs were kept in a secure area, controlled, and distributed in accordance with acceptable standards of practice; and failed to ensure a system was in place to ensure expired medications were not available for patient use. Observations revealed multiple medications were expired and available for patient use in the Surgery Department and Intensive Care Unit.

In addition, observation revealed Diprivan (muscle relaxant used for sedation during surgery) was being stored in a rolling treatment cart in the facility's surgery suites, which was not staffed and was unlocked. In addition, interview with the pharmacist revealed the facility failed to have an effective system for accounting for Diprivan medication and was not aware the medication was in the surgery suites.

Interview with the CEO on 08/05/19 (post survey interview) at 2:50 PM revealed the CEO was not aware of the expired medications, or the storage concern with the Diprivan or of the accountability of this medication.

4. The facility failed to ensure that diagnostic radiologic services were maintained to meet professionally approved standards for safety. The facility failed to ensure radiologic services were available to meet patient needs. No radiology staff were scheduled to provide services from 12:30 AM until 7:30 AM each night, but were "on call"; subsequently, staff were not readily available to conduct "stat" procedures as ordered by Emergency Department physicians. The facility failed to ensure Computed Tomography (CT) scans with contrast were only completed under direct supervision of a physician and only completed by qualified staff. The facility failed to ensure a medical physicist had tested and calibrated radiology equipment within the last year. The facility failed to ensure policies and procedures for the Radiology Department were specifically reviewed by the medical staff and governing body. The facility failed to ensure the emergency medication kit located in the CT scan room contained medications and information per the facility policy. The facility failed to ensure that potential hazards with equipment (portable x-ray machine) were identified and promptly corrected. The facility failed to ensure that competency was assessed for radiology staff who administered intravenous (IV) contrast for Computed Tomography (CT) scans for four (4) of four (4) staff employed by the facility in the radiology department. The facility failed to ensure "STAT" (urgent) ordered radiologic diagnostic testing was completed timely and failed to ensure abnormal results were communicated with the patient.

Interview with the CEO on 08/05/19 (post survey interview) at 2:50 PM revealed he was not aware of the above concerns identified in the Radiology Department expect for the medical physicist evaluation. The CEO stated he was aware that this evaluation had not been completed, but did not ensure the evaluation was completed until the week of the initial survey.

5. The facility failed to meet the emergency needs of patients in accordance with acceptable standards of practice. Interviews with staff and review of facility schedules revealed radiology and laboratory services were not readily available at night at the facility. Staff were "on call" and were required to responds when the facility notified them that services were needed. Review of Patient #13's medical record revealed the facility failed to conduct "stat" radiology testing in accordance with the facility's policy. In addition, the facility failed to conduct "stat" laboratory testing for Patient #8 and #13 in accordance with facility policy.

In addition, interviews with staff revealed the facility failed to ensure policies and procedures were developed/implemented to ensure medications were administered "stat" per policy, to ensure supplies were available in accordance with the facility's identified needs, and to ensure expired medications and supplies were not available for patient use.

Interview with the CEO on 08/05/19 (post survey interview) at 2:50 PM revealed he was not aware of the above concerns identified in Laboratory and Emergency Department. The CEO stated that for a brief period of time, there was only on-call coverage at night for the laboratory, and radiology staff continued to be on call from 12:30 AM to 7:30 AM.

6. The facility failed to develop and maintain a comprehensive emergency preparedness program that met the requirements and had a facility-based and community-based risk assessment, utilizing an all-hazards approach.

Interview with the Risk Manager and the Facility's Emergency Preparedness Coordinator on 07/25/19 at 3:57 PM revealed the facility failed to conduct a facility-based and community-based risk assessment, utilizing an all-hazards approach; failed to develop policies and procedures that addressed the provision of subsistence needs for staff whether they evacuate or shelter in place to include medical and pharmaceutical supplies; failed to have a system to track the location of on-duty staff and sheltered patients in the facility's care during an emergency; failed to have a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records; and failed to have a communication plan that includes the names and contact information for staff, entities providing services under arrangement, patients' physicians, other facilities, or volunteers.

Interview with the CEO on 08/05/19 (post survey interview) at 2:50 PM revealed the facility had a Emergency Preparedness plan, but understood the risk assessment had not been completed.

Based on interview, record review, and review of facility's complaint policy, it was determined the facility failed to ensure grievances were resolved for one (1) unsampled patient (Patient #16). Review of a grievance form for Patient #16 dated 06/20/19 revealed the family alleged Physician #1 was "very rude," and told the family that they were "wasting his time," when they visited the Emergency Room (ER) on 06/19/19. The facility failed to investigate or respond to the patient's grievance as required by the facility's policy.

The findings include:

Review of the facility policy titled "Receipt/Resolution of Complaints" dated June 2019, revealed to ensure respect for the rights of patients, all complaints from patients and/or significant others should be investigated and resolved in a timely manner. The policy also stated complaints would be investigated as expeditiously as possible, and a response would be submitted verbally or in writing to the patient about the actions taken to resolve the complaint within five (5) business days. If the actions taken to resolve the grievance were not satisfactory to the patient and/or significant other, the complaint would be forwarded to the Administrator for further recommendations to obtain a complaint resolution.

Review of a Grievance/Complaint form for Patient #16, dated 06/20/19, revealed his/her spouse alleged Physician #1 "was very rude" and wanted to treat the patient for seizures, without "any tests done," when they visited the facility ED on 06/19/19. The form also revealed the family member informed the physician that they did not feel that the patient had a seizure, and Physician #16 informed the family member they were "wasting his time." There was no documented evidence the facility investigated the complaint or responded to the patient's spouse with the actions that were taken to resolve the complaint.

Interview with the Facility's Risk Manager (RM) on 07/30/19 at 2:05 PM revealed she was responsible for ensuring grievances were investigated/resolved within seven (7) days from the date the grievance was filed, not five days as stated in the policy. She stated even though she received Patient #16's grievance on 06/20/19, she did not forward the complaint to the ED physician's contract agency until 07/03/19 (13 days after the grievance was received). Further interview with the RM revealed the facility did not investigate the patient's grievance; e.g., interview Physician #1 related to the voiced grievance, other staff who worked with Physician #1, etc., nor had the facility contacted Patient #16 or his/her spouse to ensure resolution of the voiced grievance. The RM stated she reviewed all grievances with the Chief Nursing Officer (CNO), and no concerns had been identified. The interview revealed even though the facility had not followed their policy, she stated they believed forwarding the complaint to the physician's employer was sufficient to resolve the grievance.

Interview with the CNO on 07/30/19 at 2:55 PM and further review of the Patient #16's grievance form, revealed she documented that she had reviewed Patient #16's grievance on 06/21/19, and that the grievance form was complete. She stated she did not identify that the patient's grievance had not been investigated and/or resolved.

Based on observation, interview, record review, and review of facility policies, it was determined that the facility failed to develop, implement, and/or maintain an effective, ongoing, data-driven quality assessment and performance improvement program (QAPI). Review of the facility's 2019 Quality Improvement Plan revealed the plan included performance areas that would be monitored in Radiology, Pharmacy, Emergency, and Laboratory services, etc. The Department Directors were responsible for submitting areas that would be reviewed in the Quality Improvement Performance Improvement Plan (QAPI). However, the facility failed to conduct the reviews as planned. Further, the facility failed to develop/implement systems (audits, monitors) to identify specific problems in these departments which affected patient care, implement action to address the concerns, and evaluate actions to ensure care was improving. During the initial survey, observations revealed expired medications/supplies, late diagnostic testing, physician supervision during radiology testing, competency evaluations for radiology staff, and failure to review policies and procedures had not been identified in the QAPI program.

Refer to A0273.

Based on observation, interview, record review, and review of facility policies, it was determined that the facility failed to identify concerns with care, implement action to address the concerns, and evaluate actions to ensure care was improving. The facility had developed a 2019 Quality Improvement Plan with a scope of practice that included performance areas that would be monitored to include Radiology, Pharmacy, Emergency, and Laboratory services, etc. The Department Directors were responsible for submitting areas that would be reviewed in the Quality Improvement Performance Improvement Plan (QAPI). However, the facility failed to conduct the reviews as planned. Further, the facility failed to develop/implement systems (audits, monitors) to identify specific problems in these departments which affected patient care. Concerns with expired medications/supplies, failure to notify patients of the results of diagnostic tests, late diagnostic testing, physician supervision during radiology testing, competency evaluations for radiology staff, and failure to review policies and procedures had not been identified in the QAPI program.

The findings include:

Review of the facility's 2019 Quality Improvement Plan revealed the facility's plan.... "encompasses all programs, including Acute Care, Laboratory and contracted services...." The Scope of Activities included "B. Performance Areas... Emergency Department...Laboratory,... Radiology..., Pharmacy....... Quality Improvement Committee with the approval of the Board, shall: Establish priorities for Quality Improvement activities; Review and evaluate the pertinent findings; conclusions, recommendations, actions taken and results of actions taken by the Medical Staff Committees; ....Assist committees and teams with implementation of action plans or process changes as needed; Evaluate the results of actions process changes for resolution of issues and improvement in performance or outcomes; Ensure the communication of all relevant findings, conclusions, recommendations, actions taken, and results of actions take to all appropriate committee, services and individuals;...."

1. Observation of the surgery Department on 07/24/19 and the Intensive Care Unit on 07/25/19 revealed multiple medications were expired and available for patient use. Interview with the Pharmacy Director on 07/30/19 at 11:40 AM revealed the facility expired medications were not being monitored in QAPI, and believed the outdated medications had not been identified due to nurses not entering information correctly when reloading medications into the electronic medication storage cabinet.

Further observation revealed Diprivan (muscle relaxant used for sedation during surgery) medication was being stored in a rolling treatment cart in the facility's surgery suites, which was not staffed and was unlocked. An interview with the facility pharmacist on 07/25/19 at 1:40 PM revealed the facility failed to identify that Diprivan (muscle relaxant used for sedation during surgery) was not being stored securely. In addition, interview with the pharmacist revealed the facility failed to have an effective system for accounting for Diprivan medication and was not aware the medication was in carts in the surgery suites.

Review of the Pharmacy Department Performance Improvement Plan for 2019 revealed the pharmacy indicators were as follows: "Number of Medication Errors; Number of Adverse Events; % of times an antibiotic is given within the 1 [hour] window; % times pharmacist recorded the culture results on monitoring sheet; % of times an anticoagulant med is given within the 1 hr window; and % of Meds requested that were not available.

However, review of data documentation and interview with the Pharmacy Director on 07/30/19 at 11:40 AM revealed the facility was not currently monitoring whether medications were not available when requested and was not monitoring culture results (whether an antibiotic is resistant to the bacteria in a patient's wound, blood, etc.)

2. Interview with the Radiology Director on 07/26/19 at 4:12 PM revealed a Radiology Technician was not scheduled to provide services at the facility daily from 12:30 AM until 7:30 AM, but was "on call" to respond to the facility when contacted. The Radiology Director stated even though he was aware that physician's orders in the ED for any type of radiology service was "STAT" and that test was required to be completed within 15 minutes, he stated the technicians got to the facility as quickly as possible to complete the tests.

Review of Patient #13's medical record revealed the patient presented to the Emergency Department (ED) on 07/19/19 after a motor vehicle collision. The patient had Computed Tomography (CT) scans, the preliminary results the patient had "no acute" findings, and the ED physician discharged the patient home. However, on 07/20/19, the Radiologist reviewed the CT scans and determined the results were suspicious for a cervical spine fracture and sternum (breast bone) fracture. The facility did not have a system for contacting patients of test results after discharge and failed to contact Patient #13 regarding the CT scan abnormalities, and there was no evidence the patient was contacted regarding the abnormal findings.

Continued interview with the Radiology Director on 07/23/19 at 1:00 PM revealed radiology equipment should be tested by a physicist annually to ensure adequate functioning; however, review of the last physicist inspection revealed the radiology equipment/X-ray machines were last tested by a physicist on 03/24/17, more than two years ago.

Interview the Radiology Director on 07/23/19 at 1:00 PM and on 07/29/19 at 4:55 PM, and with Emergency Department Physician #4 on 07/24/19 at 3:10 PM revealed Computed Tomography (CT) scans with contrast were not being completed under direct supervision of a physician as required by the facility's policy. Further, interview with the Director of Radiology on 07/29/19 at 4:55 PM and with Physician #6, Vice Chairman of the Medical Executive Committee (MEC), on 07/30/19 at 1:30 PM revealed the content of the Radiology Department's policies had not been reviewed. Physician #6 stated that medical staff approved adopting the old policies and procedures previously used by the hospital, but did not review individual policies and procedures.

In addition, observation of the emergency medication kit located in the CT scan room revealed the kit did not contain medications and information regarding contrast as required by the facility policy.

Review of the Radiology Department Performance Process Aspect of Care Indicator revealed the following areas were being monitored: "Cat Scan Down in February 20 hours, Delay in Service (Due to Lack of Supplies); Stroke Protocols Door to CT. Report Done.; Staff Licensures - 100% for January - March, 2019; and Radiation Badges Being Worn - January - 97 %, February - 95%, March 100%."

Review of the QAPI minutes for July 2019 revealed few notes related to department specific reports. On 07/16/19, there was a report from the Radiology Department that stated the CT scan time was overdue due to "Radiology was not notified in the specific time frame."

Interview with the Radiology Director on 07/29/19 at 4:55 PM revealed he had submitted the above indicators/monitors for the Radiology Department. The Director stated the Stroke Protocol and CT Down Time monitors were developed after problems were identified by the survey agency earlier in the year. The Director stated he had not consider putting the Physicist's evaluations of the radiology machines as a monitor in QAPI. The Director stated he had requested this evaluation numerous times from administration/owners and was turned down. He stated there would have been a record if the Physicist checks had been monitored through QAPI. The Director stated the concern with physician availability during CT scans had not been identified. He stated that changes in policies from the current to former owner was discussed in QAPI, but each specific policy was not reviewed and he had not identified that the physician supervision of the department during CT scans directed that the physician covering must be able to perform the procedure. The Director further stated that they had not identified concerns with STAT (urgent) diagnostic tests not being done timely at night nor had the facility identified that there was not an effective system for notifying patients seen in the Emergency Department of abnormal diagnostic test results.

3. Review of the facility's laboratory staffing schedule revealed laboratory technicians were not always scheduled to work at the facility from 7:00 PM until 7:00 AM, but were "on call". Interview with the Laboratory Director 07/26/19 at 3:55 PM revealed the facility did not have enough staff to cover all shifts because of financial constraints. Review of two patient records (Patient #8 and #13) revealed the patients presented to the Emergency Department; however, the facility failed to conduct "stat" labs for the patients in accordance with facility policy.

Further review of the QAPI plan revealed the facility monitors/indicators for Laboratory and Emergency Department (ED) revealed no monitors for timely diagnostic testings and there was no documented evidence the facility identified laboratory and diagnostic testing was not being conducted timely, nor had the facility identified there was no system to ensure patients were notified of abnormal diagnostic tests after discharge from the ED.

Interview with the CNO/QAPI Director on 07/30/19 at 2:55 PM revealed the facility had held a QAPI meeting, with the last meeting being held on the morning of 07/30/19. However, the CNO stated the QAPI Committee had not identified and was unaware of the concerns that had been identified during the facility's initial survey.

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure a Registered Nurse (RN) supervised the nursing care for one (1) of fifteen (15) sampled Patients (Patient #5). Patient #5 had a physician's order for three liters of oxygen; however, staff documented that the patient only received two liters of oxygen on 07/17/19 and 07/18/19.

The findings include:

Review of the facility policy titled "Medical Record Content" last reviewed/revised in June 2019 revealed patient medical records should contain sufficient information to justify patient treatment with accurate documentation.

Review of Patient #5's medical record revealed the patient was admitted on 07/16/19 with diagnoses to include Acute Dyspnea, Chronic Pulmonary Edema, Congestive Heart Failure, and Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

Review of Patient #5's physician orders dated 07/16/19 revealed an order for oxygen per nasal cannula at 3 liters per minute.

However, review of Patient #5's nursing notes revealed on 07/17/19 at 8:22 AM, 07/17/19 at 8:00 PM, and 07/18/19 at 7:45 AM, nursing staff documented the patient was on 2 liters of oxygen.

Interview with Registered Nurse #2 on 07/26/19 at 4:39 PM revealed she was responsible for Patient #1's care on 07/18/19. RN #2 stated she was unable to recall how much oxygen the physician had ordered for the patient or how much the patient received, but stated the patient should have received the physician ordered amount.

An interview with the Chief Nursing Officer (CNO) on 07/30/19 at 2:55 PM revealed she expected patient medical records to be accurate.

Based on interview, record review and review of facility policy it was determined the facility failed to ensure medical records were accurately maintained for one (1) of fifteen (15) sampled Patients (Patient #14). Review of Patient #14's medical record revealed the patient arrived at the facility Emergency Department (ED) on 07/28/19 at 2:57 PM with complaints of shortness of breath. Patient #14's ED Note indicated that Patient #14 received discharge instructions and was transferred back to a nursing home on 07/28/19. However, further review of the medical record revealed Patient #14 was admitted to the facility on 07/28/19 at 5:20 PM and expired at 7:15 AM 07/28/19.

The findings include:

Review of the facility policy titled "Medical Record Content" last reviewed/revised in June 2019 revealed patient medical records should contain sufficient information to identify the patient, support the diagnoses, and justify patient treatment with accurate documentation.

1. Review of Patient #14's ED record revealed he/she arrived to the facility ER on 07/28/19 at 2:57 PM, with complaints of shortness of breath. Continued review of the ER record revealed Physician #5 dictated that Patient #14 was discharged from the ED on 07/28/19 with instructions to continue inhalers at the nursing home, to follow up with his/her primary care physician the next week, and to return to the ED if his/her condition worsened.

However, further review of Patient #14's record revealed he/she was admitted to the medical-surgical unit of the facility from the ED on 07/28/19 at 5:20 PM with diagnoses, which included Congestive Heart Failure and Pneumonia. Continued review of the medical record revealed the patient had physician admission orders that included a do not resuscitate (DNR), which indicated the patient did not wish to receive cardiopulmonary resuscitation (CPR) should he/she be observed to have no signs of life. Patient #14's record revealed he/she had no signs of life on 07/28/19 at 7:10 PM and Physician #5 pronounced the patient deceased on 07/28/19 at 7:15 PM.

An interview was attempted with Physician #5 on 07/29/19; however, the physician was not available for interview.

An interview with the Health Information Management (HIM) Director on 07/30/19 at 4:25 PM revealed the facility had identified concerns with accuracy of medical records related to physician transcription. She stated she had been auditing one-hundred percent of in-patient medical records to ensure accuracy. However, she stated she had not been directed to review ED documentation to ensure the medical records were accurate.

An interview with the Chief Nursing Officer (CNO) on 07/30/19 at 2:55 PM revealed she expected patient medical records to be accurate in the facility. The CNO acknowledged that even though a concern had been identified related to accuracy of patient records, no one had been monitoring documentation in the facility ED.

Based on observation, interview, and review of facility policy, it was determined the facility failed to ensure drugs were kept in a secure area, controlled, and distributed in accordance with acceptable standards of practice; and failed to ensure a system was in place to ensure expired medications were not available for patient use. Observations revealed multiple medications were expired and available for patient use in the Surgery Department and Intensive Care Unit.

In addition, observation revealed Diprivan (muscle relaxant used for sedation during surgery) was being stored in a rolling treatment cart in the facility's surgery suites, which was not staffed and was unlocked. In addition, interview with the pharmacist revealed the facility failed to have an effective system for accounting for Diprivan medication and was not aware the medication was in the surgery suites.

Refer to A500, A502, and A505.

Based on observation, interview, and review of facility policy, it was determined the facility failed to ensure drugs were controlled and distributed in accordance with acceptable standards of practice. Observation revealed Diprivan (muscle relaxant used for sedation during surgery) was being stored in a rolling medication cart in the facility's surgery suites. Interview with the pharmacist revealed the facility failed to have an effective system for accounting for Diprivan medication; subsequently, the facility was not aware the medication was in the surgery suites.

The findings include:

Review of the facility policy titled "Monitoring and Evaluation-Automated Drug Delivery Systems," dated June 2019, revealed "any automated drug delivery system shall have a documented and ongoing Quality Control and Oversight Program that monitors total system performance and includes the requirement for one hundred percent (100%) accuracy in drug and strength delivered." Further review revealed "an automated drug delivery system is defined as unit-based medication distribution cabinets (UBCs) typically located in patient care area". Further review revealed several components of UBCs should be routinely monitored to ensure accurate delivery of medication including medication selection function, medication return bin function, verification of medication location, and verification of medication and strength.

Review of the Drug Enforcement Administration (DEA), Diversion Control Division, Drug and Chemical Evaluation Section, dated July 2019 revealed Propofol (Diprivan) revealed the medication was used in hospital settings for general anesthesia and sedation of ventilated patients. According to the publication, Diprivan is not scheduled under the Controlled Substance Act; however, is " ...abused by health care staff ..." and the DEA has proposed that the medication be placed into a Schedule IV Controlled Substance.

Review of a statement from the American Association of Nurse Anesthetists (AANA) the AANA recommends for facilities to " ...develop and implement methods to reduce the likelihood of propofol diversion...Establish a comprehensive workplace substance use disorder policy, which includes...methods to prevent drug diversion, and reentry ..."

Observation of the Surgery Department on 07/24/19 at 2:55 PM revealed a Medicatio Cabinet was located in the department. Interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed medications were required to be stored in the UBC, removed on an individual patient basis, and returned to the UBC if the medication was not used.

However, observations on 07/24/19 at 3:00 PM of Surgical Suite #2 revealed two (2) Diprivan 100 milliliter (mL) vials were being stored in a treatment/supply cart with a small padlock. Further observation on 07/24/19 at 3:30 PM seven (7) vials of Diprivan were in Surgical Suite #1 also located in a cart with a small pad lock.

Continued interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed she was not aware that there was Diprivan in the Surgical Suites. The Pharmacist stated the UBC automatically accounted for all medications when they were signed in and out of the machine. She stated the UBC also generated a report and she utilized the report to account for all medications; however, she stated for an unknown reason, she did not recognize that nine (9) 100 mL vials of Diprivan had not been accounted for in the facility's UBC.

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed he expected the Pharmacist to ensure all medications, including Diprivan, were stored properly and accurately accounted for in the facility.

Based on observation, interview, and review of facility policy, it was determined the facility failed to ensure all drugs were kept in a secure area. Observation during the initial survey revealed Diprivan (muscle relaxant used for sedation during surgery) was being stored in an unsecured surgical suite in a locked rolling cart. Interviews with staff and observation revealed the Surgical Department was not staffed and surgeries were not being scheduled.

The findings include:

Review of the facility policy titled "Monitoring and Evaluation-Automated Drug Delivery Systems," dated June 2019, revealed "any automated drug delivery system shall have a documented and ongoing Quality Control and Oversight Program that monitors total system performance and includes the requirement for one hundred percent (100%) accuracy in drug and strength delivered." Further review revealed, "an automated drug delivery system is defined as unit-based medication distribution cabinets (UBC's) typically located in patient care area". Further review revealed several components of UBC's should be routinely monitored to ensure accurate delivery of medication including medication selection function, medication return bin function, and verification of medication location.

Interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed medications were supposed to be removed from the UBC for each individual patient and if not used, the medication was required to be returned to the medication storage machine.

Interview with the Chief Nursing Officer (CNO) on 07/26/19 at 10:30 AM revealed the facility did not have a policy regarding storage of Diprivan, but stated all drugs should be stored in the facility's medication distribution cabinets.

Review of the Drug Enforcement Administration (DEA), Diversion Control Division, Drug and Chemical Evaluation Section, dated July 2019 revealed Propofol (Diprivan) revealed the medication was used in hospital settings for general anesthesia and sedation of ventilated patients. According to the publication, Diprivan is not scheduled under the Controlled Substance Act; however, is " ...abused by health care staff ..." and the DEA has proposed that the medication be a Schedule IV Controlled Substance.

According to the American Association of Nurse Anesthetists (AANA) "Securing Propofol" Position Statement, Revised April 2017 revealed "Since 2010, it has been the AANA's position that, due to the risk of abuse, propofol warrants, at a minimum, Schedule IV controlled substance classification." The AANA recommends for facilities to " ...develop and implement methods to reduce the likelihood of propofol diversion, such as placing propofol in a secure environment only accessible by those professionals identified in a medication management policy ...Establish a comprehensive workplace substance use disorder policy, which includes propofol, and addresses drug storage, abuse and diversion, methods to prevent drug diversion, and reentry ..."

Observations on 07/24/19 at 3:00 PM of Surgical Suite #2 revealed two (2) Diprivan 100 milliliter (mL) vials were being stored in a rolling medication cart with a small padlock. Further observation on 07/24/19 at 3:30 PM seven (7) vials of Diprivan 100 mL were being stored in a medication cart with a small pad lock in Surgical Suite #1. Observation revealed the Surgery Department was not locked and was accessible.

Interview with the Surgical Manager on 07/24/19 at 3:00 PM revealed the facility had not utilized the Surgery Department and stated the medications located in the surgical suites had stored in the rolling carts since the previous owners of the facility utilized the department. The Surgical Manager stated the medications should not be stored in the cart in the surgery suite and should have been returned to the UBC.

Interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed medications were supposed to be removed from the UBC for each individual patient and if not used, the medication was required to be returned to the medication storage machine (UBC). Further interview revealed she was aware that surgical staff routinely "pull extra" Diprivan, but had not addressed this practice and stated she had no way to track the medication.

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed he expected medications, including Diprivan, to be stored in a secure manner.

Based on observation, interview, and review of facility policy it was determined the facility failed to ensure a system was in place to ensure expired medications were not available for patient use. Observations conducted during the initial survey revealed multiple medications were expired and available for patient use.

The findings include:

Review of the facility policy titled "Expired and Destroyed Drugs," last revised July 2019, revealed the facility "pharmacy will assure that out-dated or unusable drugs are properly removed from active stock and either returned to a reversal management company for credit or face destruction in a proper manner". Further review revealed, "expired medications will include those medications whose expiration date has passed".

Review of the facility policy titled "Monitoring and Evaluation-Automated Drug Delivery Systems," dated June 2019, revealed, "any automated drug delivery system shall have a documented and ongoing Quality Control and Oversight Program that monitors total system performance and includes the requirement for one hundred percent (100%) accuracy in drug and strength delivered." Further, review revealed, "an automated drug delivery system is defined as unit-based medication distribution cabinets (UBC's) typically located in patient care area". Further review revealed several components of UBC's should be routinely monitored to ensure accurate delivery of medication including medication selection function, medication return bin function, verification of medication location, and verification of medication and strength. The policy stated the medications in each UBC should be verified for expiration dating on a monthly basis.

Observations conducted on 07/24/19 at 3:00 PM in Surgical Suite #2 revealed the following medications had expired, but were available for use: Lidocaine (injectable numbing agent) 20 milliliter (mL) vial was opened on 05/15/19 and had an expiration of 06/13/19; Famotidine (stomach acid reducer) 20 milligrams (mg)/2 mL via with an expiration of April 2019; and Famotidine 20 mg/2 mL via with an expiration of June 2019.

Observations conducted on 07/24/19 at 3:30 PM in Surgical Suite #1 revealed the following medications had expired, but were available for use: two (2) Rocuronium Bromide (injectable muscle relaxant) 100 mg/10 mL vials with an expiration date of 05/29/19; Lidocaine 400 mg/20 mL vial with expiration of 06/06/19; Labetalol Hydrochloride (blood pressure medication) 100 mg/20 mL vial with expiration of 07/01/19; and Epinephrine (used to treat cardiac arrest) 1 mg/1mL vial with an expiration of January 2019.

Observations conducted on 07/24/19 at 5:00 PM in the Recovery Room UBC medication cabinet revealed two tubes of Lidocaine jelly (topical numbing agent) with an expiration of May 2016; Gentamicin (antibiotic) 80 mg/100 mL with an expiration of January 2017; four (4) vials Epinephrine 1mg/1mL with an expiration date of October 2018 and six (6) vials with an expiration of November 2018; two (2) Xylocaine 2% (numbing agent) 400 mg/20 mL with expiration date of February 2017 and one (1) vial with an expiration of April 2018; and Cyclopentolate Hydrochloride Ophthalmic Solution (eye drops) 15 mL with an expiration date of January 2018.

Observations conducted on 07/25/19 at 11:30 AM of the UBC in the Intensive Care Unit (ICU) revealed three (3) tablets of Ondansetron (nausea medication) 4 mg with expiration of June 2019; four (4) Armour Thyroid (thyroid medication) 60 mg tablets with expiration of 06/30/17; and Advair Diskus (inhaler) 100 mg/50 mL with an expiration of April 2019.

Interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed she was responsible for ensuring expired medications were removed and not available for patient use. She stated she depended on reports generated by the medication storage machines (UBCs) to know when medications expired, but had not ensured that all information regarding medications, including expiration dates, had been entered into the UBCs.

Interview with the Lead Respiratory Therapist on 07/30/19 at 2:30 PM revealed he was responsible to ensure all respiratory equipment was removed from patient use prior to the expiration date. He stated he had not identified any concerns with expired supplies; however, acknowledged that some respiratory supply packaging made it difficult to determine when it expired. He also stated, "We always remove the respiratory supplies from patient use when the packages turn yellow."

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed he expected the facility Pharmacist to ensure expired medications were removed from the facility's UBCs. The CEO also stated he expected the appropriate departments to ensure all supplies were removed from patient use when they had expired.

Based on observation, interview, record review, and policy review, the facility failed to ensure that diagnostic radiologic services were maintained to meet professionally approved standards for safety. The facility failed to ensure radiologic services were available to meet patient needs. No radiology staff were scheduled to provide services from 12:30 AM until 7:30 AM each night, but were "on call"; subsequently, staff were not readily available to conduct "stat" procedures as ordered by Emergency Department physicians. The facility failed to ensure Computed Tomography (CT) scans with contrast were only completed under direct supervision of a physician and only completed by qualified staff. The facility failed to ensure a medical physicist had tested and calibrated radiology equipment within the last year. The facility failed to ensure policies and procedures for the Radiology Department were specifically reviewed by the medical staff and governing body. The facility failed to ensure the emergency medication kit located in the CT scan room contained medications and information per the facility policy. The facility failed to ensure that potential hazards with equipment (portable x-ray machine) were identified and promptly corrected. The facility failed to ensure that competency was assessed for radiology staff who administered intravenous (IV) contrast for Computed Tomography (CT) scans for four (4) of four (4) staff employed by the facility in the radiology department. The facility failed to ensure "STAT" (urgent) ordered radiologic diagnostic testing was completed timely and failed to ensure abnormal results were communicated with the patient.

Refer to A529, A535, A537, A547

Based on interview, record review, and review of facility policy, it was determined the facility failed to maintain radiologic services according to the needs of patients. Interviews with staff revealed radiology staff are on call each night from 12:30 AM until 7:30 AM, and are not readily available to conduct radiological testing. Patient #13 presented to the Emergency Department (ED) on 07/19/19 after a motor vehicle collision. The patient had Computed Tomography (CT) scans, the preliminary results the patient had "no acute" findings, and the ED physician discharged the patient home. However, on 07/20/19, the Radiologist reviewed the CT scans and determined the results were suspicious for a cervical spine fracture and sternum (breast bone) fracture. However, the facility did not have a system for contacting patients of test results after discharge and failed to contact Patient #13 regarding the CT scan abnormalities.

The findings include:

Interview with the Radiology Director on 07/26/19 at 4:12 PM revealed CT scans were reviewed by a contracted Radiology service at night, then the Radiologist reviewed the scans the next day and documented a final report. The Director stated when the Radiologist's interpretation of the scans differed from the contracted Radiology service, a form was required to be completed and taken to the ED physician so the patient could be contacted regarding the results.

Review of the medical record for Patient #13 revealed the facility admitted the patient on 07/19/19 at 11:49 PM via Emergency Medical Services (EMS) with a chief complaint of a "motor vehicle collision". The ED physician ordered a stat CT of the head, chest, and cervical spine without contrast on 07/19/19 at 11:55 PM.

Further review of Patient #13's medical record revealed the facility completed the patient's first CT scan, the CT scan of the Cervical Spine at 12:26 AM, 31 minutes after the scans were ordered, and all CT scans were completed and authenticated by 1:16 AM on 07/20/19.

Review of Patient #13's Medical Screening Exam dated 07/19/19 a 11:47 PM revealed the ED physician documented that the patient's CT of the C-spine, head, and chest revealed "no acute disease" and Patient #13 was discharged from the ED on 07/20/19 at 5:20 AM with instructions to "take over the counter medications."

However, review Patient #13's Radiology Report of the CT of the Cervical Spine dated 07/20/19 at 9:51 AM, after the patient had been discharged home, revealed "Suboptimal study due to some movement. Apparent suspicious fracture of C2 (cervical spine fracture)...may be due to movement artifact. However, if clinically indicated, repeat CT without movement and/or MRI of cervical spine will be useful for further evaluation."

Review of Patient #13's CT of the Chest Preliminary Radiology Report dated 07/20/19 revealed "Severe liver steatosis" (fatty liver). In addition, review of the CT of the Chest dated 07/20/19 at 10:15 AM revealed, "Suspicious fractures of sternum (breast bone) ...these may be due to movement artifacts. If patient has persistent symptoms, a repeat study without movement artifact will be useful."

There was no documented evidence the facility contacted Patient #13 to inform the patient of the possible sternum fracture or a possible fracture of the cervical spine.

Interview with the Radiology Director on 07/26/19 at 4:12 PM revealed he had no documentation that the ED physician was notified of Patient #13's final reports, nor that the patient was notified that fractures may be present. The Radiology Director further stated that he had no system to monitor when tests were interpreted differently or to ensure the ED physician/patient was contacted when the Radiologist identified concerns.

Continued interview with the Radiology Director on 07/26/19 at 4:12 PM revealed a Radiology Technician was not scheduled to provide services at the facility daily from 12:30 AM until 7:30 AM, but was "on call" to respond to the facility when they were contacted. The Radiology Director stated even though he was aware that physician's orders in the ED for any type of radiology service was "STAT" and that test was required to be completed within 15 minutes, he stated the technicians got to the facility as quickly as possible to complete the tests.

Interview with the Assistant Chief Nursing Officer (CNO) on 07/29/19 at 5:05 PM revealed the facility did not have a system to ensure patients were notified when the radiologist identified concerns after the patient had left the ED.

Based on observation, interview, record review, and review of facility policy, it was determined that the facility failed to ensure Computed Tomography (CT) scans with contrast were only completed under direct supervision of a physician and only completed by qualified staff. The facility failed to ensure a medical physicist had tested and calibrated radiology equipment within the last year. The facility failed to ensure policies and procedures for the Radiology Department were specifically reviewed by the medical staff and governing body. In addition, the facility failed to ensure the emergency medication kit located in the CT scan room contained medications and information per the facility policy.

The findings include:

1. Review of the facility policy "Medical Director of Imaging Services and Supervising Physician Coverage" dated revised June 2019 revealed "Supervising Requirements: The Medical Director of Imaging Services shall designate proper supervision of the imaging center in their absences. Diagnostic tests must be performed under the supervision of a physician, as identified in 42 CFR 410.32(b)(3). Definitions of Supervision for Diagnostic Tests are as follows: General Supervision - under the physician's overall direction and control, but the physician's presence is not required.....Direct Supervision - physician must be present on the premises and "immediately available" to furnish assistance and direction throughout the performance of the procedure. They do not have to be in the procedure room during the procedure. Immediately available is not defined but CMS 2010 OPPS clarify that a physician is NOT immediately available if they cannot be interrupted during another procedure or if they are so physically far away that he or she could not intervene right away. Direct supervision is required for but not limited to: procedures where contrast materials are given (CT's with contrast materials, MRI's with contrast materials)..... Qualifications of the Supervision Physician are: Must have, within his/her scope of practice and hospital privileges, the knowledge, ability and hospital privileges to perform the service being supervised. Must be prepared to step in and perform the services, not just respond to an emergency...."

Observation of the Radiology Department revealed the room containing the CT scanner was located across the hallway from the Emergency Department (ED).

Interview with the Radiologist, Physician #5, on 07/24/19 at 12:20 PM revealed the ED physician covered when CT scans with contrast were being completed and that he covered when direct supervision was required.

However, interview with the ED Physician #4 on 07/24/19 at 3:10 PM revealed that the only CT scans he knew about were the ones he ordered. Physician #4 stated he was not aware when other CT scans were being completed and did not cover radiology. The Physician stated at times he would be unavailable if he was completing another procedure in the ED. Per the Physician, he did not know how to complete a CT Scan.

Interview with the Radiology Director on 07/23/19 at 1:00 PM and on 07/29/19 at 4:55 PM revealed all four (4) radiology technologists complete patient CT scans and some of the scans for outpatients. The Director stated the physician in the ED covered/supplied direct physician supervision. Per the Director, there was not a schedule given to the ED physicians letting them know when a CT scan was being completed. The Director stated he was not aware the policy directed that the physician covering was required to be able to perform the procedure and stated he understood the ED physician might not always be immediately available.

Interview with the Chief Nursing Officer (CNO) on 07/30/19 at 2:55 PM revealed during the Performance Improvement Meeting the facility had on the morning of 07/30/19, they had discussed physician coverage for patients receiving CT scans. The CNO stated she had spoken with two (2) of the four (4) of the physicians who provided services at the hospital. According to the CNO, Physician #2 said she was available in the hospital if she ordered a CT scan with contrast. Even though Physician #4 did not cover the radiology department, the CNO stated Physician #4 was in the building (one floor above the ED) and could respond to problems in radiology, Monday - Friday from 9:00 AM to 5:00 PM.

2. Review of the facility policy "Physicist Services in the Imaging Center" dated revised 06/2019 revealed the services of a Radiation Physicist shall be available for Imaging Services Department for the following: Consultation, Periodic safety checks, supervision of radiation safety procedures, participation in educational programs...."

Review of the last Physicist inspection revealed the radiology equipment/X-ray machines were last tested by a physicist on 03/24/17.

Interview with the Radiology Director on 07/23/19 at 1:00 PM revealed he became the Director of the Radiology Department in 2017 and the last Physicist check of the department's machines was before he became Director. The Director stated he had attempted to get the prior owner to consult with a physicist, but was unsuccessful in getting the owner to pay for the quality check of the equipment by a physicist. The Director stated he was aware a physicist check should be done annually.

3. Review of the Radiology Department Policies and Procedures revealed most of the policies were dated as reviewed/revised in June 2019 by the Director of the Radiology Department.

Interview with the Director of Radiology on 07/29/19 at 4:55 PM revealed his review of the department's policies and procedures in June 2019 consisted of changing the policies from the previous owner/name to the facility's new name. The Director stated he did not review each individual policy for content.

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed each department director was responsible for reviewing their own policies and procedures. However, the CEO stated some of the policies were replaced by policies from the old company and had not been individually reviewed.

Interview with Physician #6, Vice Chairman of the Medical Executive Committee (MEC), on 07/30/19 at 1:30 PM revealed the facility policies and procedures were discussed in a recent MEC meeting by medical staff. Physician #6 stated that medical staff approved adopting the old policies and procedures previously used by the hospital, but did not review individual policies and procedures.

4. Review of the facility policy "Emergency Medication Kits in the Imaging Center" revised June 2019, revealed the following medications should be in the emergency kit: Ammonia Inhalants (used to arouse someone who has fainted/lost consciousness); Epinephrine IM auto-injector for children (injects 0.15 mg or 0.3 ml of 1:2,000 - EPI PEN JR) (treats allergic reactions); Epinephrine IM auto-injector for adults (injects 0.3 mg or 0.3 ml of 1:1,00 - EPI Pen); Nitroglycerin Spray (treats chest pain); Oral Glucose Gel (treats low blood sugar); Aspirin 325 mg; Epinephrine 1:10,000-10 ml preloaded syringe (for IV injection to treat cardiac arrest), and ; Atropine 1 ml in 10 ml preloaded syringe (treats cardiac arrest). A copy of the ACR's contrast media guide should also be attached to the emergency medication kit.

However, observation of the Emergency Medication Kit located in the CT scan room on 07/23/19 at 1:30 PM revealed the medication kit was locked with a plastic breakaway lock. The kit did not contain adult and children auto injectors of epinephrine (EPI PENS); Ammonia Inhalants, Nitroglycerin Spray, Oral Glucose Gel, or Aspirin. The kit contained ampules of Atropine and Epinephrine, but did not contain preloaded syringes of these medications as required by the facility's policy. In addition, the contrast guide was not attached or beside the Emergency Medication Kit.

Interview with the Radiology Director on 07/23/19 at 5:50 PM revealed he was not aware the medications that were required by the facility policy were not available in the facility's Emergency Medication Kit.

Based on observation, interview, and policy review, it was determined that the facility failed to ensure potential hazards with equipment (portable x-ray machine) were identified and promptly corrected.

The findings include:

Review of the facility policy "Imaging Equipment Care and Service" revised June 2019 revealed "Purpose: To ensure that all imaging equipment is of the highest possible quality....General Equipment Care: .....It is the technologist's reasonability to maintain this equipment in the state of peak efficiency.....Do not run over equipment electrical orders with heavy equipment. Do not unplug portable equipment by pulling on the cord."

Observation on 07/24/19 at 11:40 AM revealed the exterior cover of a portable X-ray machine electrical cord was missing an approximate three (3) inch area just above the plug. Electrical tape had been applied to the cord, but did not cover the entire missing portion and interior wires were visible.

Interview with Radiology Technologist #1 on 07/24/19 at 12:47 PM revealed the exterior cover of the electrical cord had pulled loose and staff had put tape on the cord to ensure the interior wires stayed covered. The Technologist stated he could not remember how long the cord had been in this condition, but had been frayed for at least a few days.

Interview with the Radiology Director on 07/24/19 at 11:40 AM revealed the electrical cord should have been covered.

Based on interview, record review, and policy review, it was determined that the facility failed to ensure that competency was assessed for radiology staff who administered intravenous (IV) contrast for Computed Tomography (CT) scans for four (4) of four (4) staff employed by the facility in the radiology department.

The findings include:

Review of the policy "Radiology Scope of Service" dated February 2019 revealed .... "All individuals who provide technical diagnostic services are licensed or registered (according to applicable state law and regulation) and have the appropriate training and competence..."

Review of competency checklist, performance evaluation age-related competency reports, and new hire competency assessments revealed the competency of the four (4) radiology staff (including the Director) had been completed in June and/or July 2019. However, further review of the competencies revealed none of the radiology staff were assessed for competency with starting an IV (accessing a patient's vein) to administered CT contrast (dye used during CT scans).

Interview with the Radiology Director on 07/23/19 at 1:00 PM and 5:50 PM revealed all Radiology staff performed CT scans of patients as ordered by the physician and started IV lines for administration of contrast. The Director stated when conducting a CT scan, the radiology technologist starts a patient's IV and administers the contrast via a contrast injector (medical device that pushes the medication into the patient's vein). The Radiology Director stated the competencies completed for staff did not currently cover starting patient IV's.

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure laboratory services were available 24 hours per day to meet the needs of its patients. Review of two patient records (Patient #8 and #13) revealed the facility failed to conduct "stat" labs in accordance with facility policy. Review of the facility's laboratory schedule revealed laboratory technicians were not always scheduled to work at the facility from 7:00 PM until 7:00 AM, but were "on call"; subsequently, staff were not readily available to conduct "stat" labs as required by the facility policy. Interview with the Laboratory Director revealed the facility did not have enough staff to cover all shifts due to not being able to employ enough staff because of financial constraints. Review of the laboratory staffing schedule for July 2019, revealed staff were on call for the following 7:00 PM to 7:00 AM shifts for July: 07/01-03/19, 07/08/19, 07/11/19, 07/12/19, 07/17/19, 07/18/19, 07/20/19, 07/23/19, 07/24/19, 07/27/19, and 07/27/19.

Refer to A0583.

29809

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure laboratory services were available 24 hours per day. Review of the facility's laboratory schedule and interview with staff revealed there were no laboratory technicians readily available at the facility to conduct laboratory testing from 7:00 PM until 7:00 AM every night. Interviews revealed staff were "on call" for the nights that no one was scheduled; however, stated it was "probably impossible" to timely complete "stat" laboratory testing ordered in the facility Emergency Department (ED). The facility failed to conduct "stat" laboratory testing for Patient #8 and #13 in a timely manner in accordance with facility policy/procedure.

The findings include:

Interview with the facility Chief Nursing Officer (CNO) on 07/26/19 at 4:43 PM, revealed the facility defined "STAT" as within 15 minutes and that the facility followed the "Medication Administration" policy for time frames for all medications and diagnostic tests. The CNO stated all orders in the Emergency Department were considered "STAT" and should be completed within 15 minutes.

Review of the facility policy titled "Medication Administration" last revised in June 2019, revealed staff were required to provide care, treatment, and services using the most current patient orders. All orders for medication and treatment should be documented in the patient's medical record, signed by the patients licensed independent practitioner, and should be legible. The facility's policy defined "Stat" as should be conducted within fifteen (15) minutes.

Review of the laboratory staffing schedule for July 2019, revealed staff were "on call" and not readily available for the following 7:00 PM to 7:00 AM shifts for July: 07/01-03/19, 07/08/19, 07/11/19, 07/12/19, 07/17/19, 07/18/19, 07/20/19, 07/23/19, 07/24/19, 07/27/19, and 07/27/19.

1. Review of the medical record of Patient #8 revealed the patient presented to the ED on 07/22/19 at 10:33 AM with a chief complaint of "gradually worsening of [shortness of air]."

Review of the ED orders revealed the physician ordered laboratory studies on 07/22/19 at 10:38 AM which included: blood cultures (tests for bacteria in the blood), proBNP (tests for congestive heart failure), D-Dimer (tests for blood clots), Comprehensive Metabolic Panel (tests for dehydration, blood sugar, etc.), Troponin T Quantitative (tests for heart attack), Lactic Acid (tests the amount of acid in the bloodstream), CBC with Auto Diff, and ProThrobim Time (tests the blood clotting ability of the blood). However, further review of Patient #8's medical record revealed a blood specimen to obtain the tests was not collected until 07/22/19 at 11:10 AM, 32 minutes after the tests were ordered by the patient's physician.

Continued review of patient #8's physician orders revealed the physician ordered a urinalysis on 07/22/19 at 10:43 AM; however, the urine specimen for the test was not collected until 07/22/19 at 12:44 PM, approximately three hours after it was ordered.

2. Review of the medical record for Patient #13 revealed the patient arrived at the facility ED via Emergency Medical Services (EMS) on 07/19/19 at 11:49 PM with a chief complaint of a "motor vehicle collision".

Review of the physician orders for Patient #13 revealed the ED Physician ordered laboratory studies (urine drug screen and Ethanol level) on 07/19/19 at 11:55 PM. However, further review revealed the Ethanol level was not obtained until 12:25 AM on 07/20/19, thirty minutes later, and the Urine Drug Screen was not collected until 12:51 AM on 07/20/19, approximately one hour later.

Interview with the Laboratory Manager on 07/26/19 at 3:55 PM revealed that she was aware that all orders in the ED were ordered "STAT" and had to be completed within 15 minutes of being ordered. However, the Manager stated that on some nights there was not a laboratory technician scheduled for night shift because there was not enough staff to cover all shifts. The Manager stated when a laboratory technician was not scheduled, a staff member was on call to come to the facility when notified. The Manager stated the laboratory technicians lived close to the facility; however, stated it was "probably impossible" to get to the facility and complete physician ordered laboratory tests within 15 minutes. The Lab Manager stated, "We get here when we get here."

Based on observation, interview, and review of facility policy it was determined the facility failed to ensure surgical services were designed to assure the achievement and maintenance of high standards of patient care. Observations conducted during the initial survey revealed multiple medications and supplies were expired and available for patient use.

The findings include:

1. Review of the facility policy titled "Expired and Destroyed Drugs," last revised July 2019, revealed the facility "pharmacy will assure that out-dated or unusable drugs are properly removed from active stock and either returned to a reversal management company for credit or face destruction in a proper manner". Further review revealed, "expired medications will include those medications whose expiration date has passed".

Review of the facility policy titled "Monitoring and Evaluation-Automated Drug Delivery Systems," dated June 2019, revealed, "any automated drug delivery system shall have a documented and ongoing Quality Control and Oversight Program that monitors total system performance and includes the requirement for one hundred percent (100%) accuracy in drug and strength delivered." Further, review revealed, "an automated drug delivery system is defined as unit-based medication distribution cabinets (UBC's) typically located in patient care area". Further review revealed several components of UBC's should be routinely monitored to ensure accurate delivery of medication including medication selection function, medication return bin function, verification of medication location, and verification of medication and strength. The policy stated the medications in each UBC should be verified for expiration dating on a monthly basis.

Observations conducted on 07/24/19 at 3:00 PM in Surgical Suite #2 revealed the following medications had expired, but were available for use: Lidocaine (injectable numbing agent) 20 milliliter (mL) vial was opened on 05/15/19 and had an expiration of 06/13/19; Famotidine (stomach acid reducer) 20 milligrams (mg)/2 mL via with an expiration of April 2019; and Famotidine 20 mg/2 mL via with an expiration of June 2019.

Observations conducted on 07/24/19 at 3:30 PM in Surgical Suite #1 revealed the following medications had expired, but were available for use: two (2) Rocuronium Bromide (injectable muscle relaxant) 100 mg/10 mL vials with an expiration date of 05/29/19; Lidocaine 400 mg/20 mL vial with expiration of 06/06/19; Labetalol Hydrochloride (blood pressure medication) 100 mg/20 mL vial with expiration of 07/01/19; and Epinephrine (used to treat cardiac arrest) 1 mg/1mL vial with an expiration of January 2019.

Continued observations of the Surgical Suite #2 on 07/24/19 revealed two (2) retractor covers (a surgical instrument used to separate the edges of a surgical incision or wound, and also used to hold back underlying organs and tissues during a surgical procedure) available for patient use, had expired. One retractor cover had expired in July 2018, and the other one expired in August 2018.

Observations conducted on 07/24/19 at 5:00 PM in the Recovery Room UBC medication cabinet revealed two tubes Lidocaine jelly (topical numbing agent) with expiration of May 2016; Gentamicin (antibiotic) 80 mg/100 mL with an expiration of January 2017; four (4) vials Epinephrine 1 mg/1 mL with an expiration date of October 2018 and six (6) vials with an expiration of November 2018; two (2) Xylocaine 2% (numbing agent) 400 mg/20 mL with expiration date of February 2017 and one (1) vial with an expiration of April 2018; and Cyclopentolate Hydrochloride Ophthalmic Solution (eye drops) 15 mL with an expiration date of January 2018.

Interview with the facility Pharmacist on 07/25/19 at 1:40 PM revealed she was responsible for ensuring expired medications were removed and not available patient use. She stated she depended on reports generated by the medication storage machines (UBCs) to know when medications expired, but had not ensured that all information regarding medications, including expiration dates, had been entered into the UBCs.

2. Continued observations conducted on 07/24/19 at 3:30 PM of Surgical Suite #1 revealed a sterile non-adherent oil emulsion dressing (used to allow free drainage away from surgical wounds) available for patient use that had expired in May 2019.

Observations of the storage room of facility' Surgery Department on 07/24/19 at 4:00 PM revealed six (6) adult laryngeal masks (a device to keep a patient's airway open during anesthesia) had expired in December 2018. Continued observations revealed thirteen (13) pediatric laryngeal masks had expired in October 2018. The storage room also had four (4) Endotracheal tube cuffs (creates a seal to prevent gases from leaking and allows positive pressure ventilation) available for patient use that had expired in December 2018.

Interview with the Lead Respiratory Therapist on 07/30/19 at 2:30 PM revealed he was responsible to ensure all respiratory equipment was removed from patient use prior to the expiration date. He stated he had not identified any concerns with expired supplies; however, acknowledged that some respiratory supply packaging made it difficult to determine when it expired. He also stated, "We always remove the respiratory supplies from patient use when the packages turn yellow."

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed he expected the facility Pharmacist to ensure expired medications were removed from the facility's Omnicells. The CEO also stated he expected the appropriate departments to ensure all supplies were removed from patient use when they had expired.

Based on observation, interview and a review of the facility policy, it was determined the facility failed to ensure emergency equipment in the Surgery Department (SD) functioned properly. Observations conducted of the SD on 07/24/19 revealed staff had not verified the defibrillator (a device used to control heart fibrillation by applying an electric current to the chest wall or heart) had been tested for proper functioning.

The findings include:

Review of the policy titled "Crash Carts" dated June 2019, revealed Emergency drugs and supplies, for use in medical emergencies only, should be immediately available at each patient care unit or service area. The policy also stated the integrity of all equipment on top of the crash cart, which included the defibrillator, should be tested for proper functioning daily.

Observations conducted of the facility Surgery Department (SD) on 07/24/19 at 3:00 PM revealed the defibrillator, located in the Preoperative area of the SD had not been checked to ensure it functioned properly.

Interview with the Surgery Department Manager on 07/24/19 at 3:00 PM revealed the facility had not conducted tested surgical equipment since the facility had new ownership.

Interview with the Chief Executive Officer (CEO) on 07/30/19 at 9:10 AM revealed he expected emergency equipment in the facility to be verified by staff to function properly, as outlined in the facility policy.

Based on interview, record review, and review of facility policy it was determined the facility failed to meet the emergency needs of patients in accordance with acceptable standards of practice. Interviews with staff and review of facility schedules revealed radiology and laboratory services were not readily available at night at the facility. Staff were "on call" and were required to responds when the facility notified them that services were needed. Review of Patient #13's medical record revealed the facility failed to conduct "stat" radiology testing in accordance with the facility's policy. In addition, the facility failed to conduct "stat" laboratory testing for Patient #8 and #13 in accordance with facility policy.

In addition, interviews with staff revealed the facility failed to ensure policies and procedures were developed/implemented to ensure medications were administered "stat" per policy, to ensure supplies were available in accordance with the facility's identified needs, and to ensure expired medications and supplies were not available for patient use


Refer to A1103 and A1104.

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure emergency services was intergrated with laboratory and diagnostic services to assess and render appropriate care for an emergency patient. Interviews with staff revealed radiology staff are "on call" and services are not readily available each night from 12:30 AM until 7:30 AM. In addition, interviews and record review revealed laboratory staff are "on call" and not readily available at times on third shift because there are not enough individuals to staff the department.

The findings include:

Interview with the facility Chief Nursing Officer (CNO) on 07/26/19 at 4:43 PM, revealed the facility followed the "Medication Administration" policy for time frames for all medications and diagnostic tests. The CNO stated all orders in the Emergency Department were considered "STAT" and should be completed within 15 minutes.

Review of the facility policy titled "Medication Administration" last revised in June 2019, revealed staff were required to provide care, treatment, and services using the most current patient orders and defined "Stat" as within fifteen (15) minutes.

1. Interview with the Radiology Director on 07/26/19 at 4:12 PM revealed a Radiology Technician was not scheduled to provide services at the facility daily from 12:30 AM until 7:30 AM, but was "on call" to respond to the facility when they were contacted. The Radiology Director stated even though he was aware that physician's orders in the ED for any type of radiology service was "STAT" and that the test was required to be completed within 15 minutes, he stated the technicians got to the facility as quickly as possible to complete the tests.

Review of the medical record for Patient #13 revealed the facility admitted the patient on 07/19/19 at 11:49 PM via Emergency Medical Services (EMS) with a chief complaint of a "motor vehicle collision". The ED physician ordered a stat CT of the head, chest, and cervical spine without contrast on 07/19/19 at 11:55 PM.

Further review of Patient #13's medical record revealed the facility completed the patient's first CT scan, the CT scan of the Cervical Spine at 12:26 AM, 31 minutes after the scans were ordered, and all CT scans were not completed and authenticated until 1:16 AM on 07/20/19.

2. a. Review of the medical record of Patient #8 revealed the patient presented to the ED on 07/22/19 at 10:33 AM with a chief complaint of "gradually worsening of [shortness of air]."

Review of the ED orders revealed the physician ordered laboratory studies on 07/22/19 at 10:38 AM which included: blood cultures (tests for bacteria in the blood), proBNP (tests for congestive heart failure), D-Dimer (tests for blood clots), Comprehensive Metabolic Panel (tests for dehydration, blood sugar, etc.), Troponin T Quantitative (tests for heart attack), Lactic Acid (tests the amount of acid in the bloodstream), CBC with Auto Diff, and ProThrobim Time (tests the blood clotting ability of the blood). However, further review of Patient #8's medical record revealed a blood specimen to obtain the tests was not collected until 07/22/19 at 11:10 AM, 32 minutes after the tests were ordered by the patient's physician.

Continued review of patient #8's physician orders revealed the physician ordered a urinalysis on 07/22/19 at 10:43 AM; however, the urine specimen for the test was not collected until 07/22/19 at 12:44 PM, approximately three (3) hours after it was ordered.

2. b. Review of the medical record for Patient #13 revealed the patient arrived at the facility ED via Emergency Medical Services (EMS) on 07/19/19 at 11:49 PM with a chief complaint of a "motor vehicle collision".

Review of the physician orders for Patient #13 revealed the ED Physician ordered laboratory studies (urine drug screen and Ethanol level) on 07/19/19 at 11:55 PM. However, further review revealed the Ethanol level was not obtained until 12:25 AM on 07/20/19, thirty minutes later, and the Urine Drug Screen was not collected until 12:51 AM on 07/20/19, approximately one hour later.

Interview with the Lab Manager on 07/26/19 at 3:55 PM revealed she was aware that all orders in the ED were ordered "STAT" and had to be completed within 15 minutes of being ordered. However, the Manager stated that on some nights there was not a laboratory technician scheduled for third shift because there was not enough staff to cover all shifts. The Manager stated when a laboratory technician was not scheduled, a staff member was "on call" and required to come to the facility when notified. The Manager stated the laboratory technicians lived close to the facility; however, stated it was "probably impossible" to get to the facility and complete physician ordered laboratory tests within 15 minutes. The Lab Manager stated, "We get here when we get here."

Based on observation, interview, and record review, it was determined that the facility failed to ensure policies and procedures were developed/implemented to ensure medications were administered "stat" per policy, to ensure supplies were available in accordance with the facility's identified needs, and to ensure expired medications and supplies were not available for patient use

The findings include:

1. Review of the facility policy titled "Medication Administration" last revised in June 2019, revealed staff were required to provide care, treatment, and services using the most current patient orders. All orders for medication and treatment should be documented in the patient's medical record, signed by the patient's licensed independent practitioner, and should be legible. According to the policy, "Stat" meant a medication/treatment should be administered within fifteen (15) minutes.

Review of Patient #6's ED record revealed he/she arrived to the ED at 9:06 AM on 07/16/19 with complaints of abdominal pain. Review of Patient #6's medical record revealed the physician ordered Toradol 15 mg (a nonsteroidal anti-inflammatory pain medicine) to be given Intravenous (IV) stat at 12:04 PM. However, the patient's pain medication was not administered until 12:30 PM, 26 minutes after the order.

2. Interview with the Chief Nursing Officer (CNO) on 07/26/19 at 10:30 AM revealed the facility had no policy regarding facility supplies. However, she stated she expected each department manager to ensure expired supplies were removed from patient use.

However, observations the adult crash cart located in the facility Emergency Department (ED) on 07/23/19 at 1:35 PM revealed an Intravenous (IV) solution bag of Lidocaine (2 gms/500 ml) had expired in June 2019. Observations also revealed the IV start kit located in the adult crash cart had expired on 07/07/19.

Observations conducted of the pediatric crash cart located in the facility ED on 07/23/19 at 2:00 PM revealed two (2) pediatric uncuffed tracheal tubes had expired in February 2001.

Further review of the pediatric crash cart revealed the crash cart was required to have pediatric IV tubing and IV start kits. However, no IV tubing or crash carts were available in the cart.

Based on interview and review of the facility's Emergency Preparedness Plan, it was determined the facility failed to develop and maintain a comprehensive emergency preparedness program that met the requirements and had a facility-based and community-based risk assessment, utilizing an all-hazards approach.

Interview with the Risk Manager and the Facility's Emergency Preparedness Coordinator on 07/25/19 at 3:57 PM revealed the facility failed to conduct a facility-based and community-based risk assessment, utilizing an all-hazards approach; failed to develop policies and procedures that addressed the provision of subsistence needs for staff whether they evacuate or shelter in place to include medical and pharmaceutical supplies; failed to have a system to track the location of on-duty staff and sheltered patients in the facility's care during an emergency; failed to have a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records; and failed to have a communication plan that includes the names and contact information for staff, entities providing services under arrangement, patients' physicians, other facilities, or volunteers.


Refer to 006, 007, 0015, 0018, 0023, and 0030.

Based on interview and review of the facility's Emergency Preparedness Plan, it was determined the facility failed to conduct a facility-based and community-based risk assessment, utilizing an all-hazards approach.

The findings include:

Review of the facility's Emergency Preparedness Plan, undated, revealed there was no documented evidence that the facility had completed a facility-based and community-based risk assessment to include strategies for addressing emergency events identified by the risk assessment.

Interview with the Risk Manager and the Facility's Emergency Preparedness Coordinator on 07/25/19 at 3:57 PM confirmed that they had not completed a facility-based and community-based risk assessment utilizing an all-hazards approach.

Based on interview and review of the facility's Emergency Preparedness Plan, it was determined the facility failed to have an Emergency Preparedness Plan that addressed patient population, including, but not limited to, persons at-risk; the type of services the facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

The findings include:

Review of the facility's "Emergency Preparedness Plan, undated, revealed there was no documented evidence the plan addressed the patient population, persons at-risk, or services the facility has the ability to provide in an emergency.

Interview with the Risk Manager and the Facility's Coordinator on 07/25/19 at 3:57 PM confirmed the plan did not address the patient population, persons at-risk, or services the facility has the ability to provide in an emergency. They stated they were not aware it was a requirement.

Based on interview and review of the Emergency Preparedness Plan, it was determined that the facility failed to have policies and procedures that addressed the provision of subsistence needs for staff whether they evacuate or shelter in place to include: food, water, medical and pharmaceutical supplies.

The findings include:

Review of the facility's Emergency Preparedness Plan, undated, revealed it was the responsibility of the purchasing, housekeeping, and dietary departments of the facility to ensure there was enough Critical Supplies (materials and equipment) during an emergency, but did not instruct staff how to ensure there were enough supplies.

Interview with the Risk Manager and the Facility's Emergency Management Coordinator on 07/25/19 at 3:57 PM revealed the Dietary staff had not inventoried medical supplies or equipment to determine what the facility had on hand in working order, or whether they had enough supplies should an emergency occur.

Based on interview and review of the Emergency Preparedness Plan, it was determined the facility failed to have a system to track the location of on-duty staff and sheltered patients in the facility's care during an emergency.

The findings include:

Review of the facility's Emergency Preparedness Plan, undated, revealed there was no documented evidence the facility had a system to track the location of on-duty staff and sheltered patients in the facility's care during an emergency.

Interview with the Risk Manager and the Facility's Coordinator on 07/25/19 at 3:57 PM confirmed the facility did not have a system to track patients or staff during an emergency.

Based on interview and review of the Emergency Preparedness Plan the facility failed to have a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records.

The findings include:

Review of the facility's Emergency Preparedness Plan, undated, revealed there was no documented plan/system to address medical documentation in the event of an emergency.

Interview with the Risk Manager and the Facility's Emergency Managment Coordinator on 07/25/19 at 3:57 PM confirmed the facility did not have a system to address the preservation of medical documentation in the event of an emergency.

Based on interview and review of the Emergency Preparedness Plan, it was determined that the facility failed to have a communication plan that includes the names and contact information for staff, entities providing services under arrangement, patients' physicians, other facilities, or volunteers.

The findings include:

Review of the facility's Emergency Preparedness Plan, undated, revealed there was no documented communication plan.

Interview with the Risk Manager and the Facility's Emergency Preparedness Coordinator on 07/25/19 at 3:57 PM revealed the facility had numbers for staff and physicians, but had not included those in the Emergency Preparedness Plan. Continued interview revealed they were not aware whether the facility had any volunteers, nor did they know all the entities that provided services to the facility or if/how those services would continue if there was an emergency.