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Tag No.: A0115
Based on interview, record review and policy review, the hospital failed to protect and promote patient's rights when the hospital failed to:
- Follow their policy to keep a log of patient complaints/grievances for one current patient (#12) and one discharged patient (#14) of two patients reviewed;
- Provide a timely written response to patients and patient representatives after submission of a grievance for one current patient (#12) and one discharged patient (#14) of two patients reviewed;
- Investigate multiple medication errors including controlled substances (drugs or medications that are high risk for personal consumption or abuse) for seven patients (#10, #12, #19, #25, #26, #27, and #28) of 12 patients reviewed;
- Recognize, report, and investigate patient complaints of possible injury/incidents for three patients (#1, #10, and #15) of three patients reviewed; and
- Safeguard Protected Health Information (PHI, any information about health status, provision of health care, or payment for health care that can be linked to a specific individual) for five patients (#1, #6, #8, #16, and #22) out of eight patients observed.
This failed practice resulted in a systemic failure and noncompliance with 42 CFR 482.13 Condition of Participation: Patient's Rights.
The severity and cumulative effect of this practice had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ). The hospital submitted a document to abate the IJ on 11/18/24 to provide an acceptable plan of correction to prevent further risk to patients. A second IJ was identified and the hospital submitted a second document to abate the IJ on 11/20/24 to provide an acceptable plan of correction to prevent further risk to patients.
Please refer to A-0122, A-0123, A-0144, A-0145 and A-0146.
Tag No.: A0263
Based on interview, record review and policy review, the hospital failed to adequately analyze the causes, investigate, and implement actions as part of their Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program, to prevent potential patient injury and address multiple medication errors and prevent potential diversion and misuse of controlled substances. These failures had the potential to adversely affect the quality of care, safety, and care outcomes of all patients in the hospital.
The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.21 Condition of Participation: QAPI Program and resulted in the hospital's failure to ensure quality health care and safety.
Please refer to A-0286.
Tag No.: A0385
Based on observation, interview, record review and policy review, the hospital failed to ensure that staff followed the hospital policies when they failed to:
- Provide appropriate hygiene for five current patients (#1, #2, #15, #17, and #18) out of six patients reviewed;
- Appropriately turn and reposition six current patients (#1, #2, #5, #12, #16, and #17) out of 10 patients reviewed;
- Appropriately provide and document pain assessments for two current patients (#12 and #15) and two discharged patients (#25 and #28) out of 11 patients reviewed;
- Appropriately provide and document nursing assessments for two current patients (#12 and #16) and one discharged patient (#25) out of 13 patients reviewed;
- Appropriately date, time and initial all intravenous (IV, in the vein) catheters sites and lines for six current patients (#1, #2, #5, #8, and #11) out of 13 patients reviewed; and
- Ensure two nursing personnel (Staff J and Staff Z) of four nursing personnel records reviewed, completed orientation and education prior to providing patient care.
- Administer and document medications appropriately for seven patients (#10, #12, #19, #25, #26, #27 and #28) of 12 patients reviewed.
The severity and cumulative effects of these failures resulted in the hospitals non-compliance with 42 CFR 482.23 Condition of Participation: Nursing Services and resulted in the hospital's failure to ensure quality healthcare and safety.
Please refer to A-0395, A-0398, and A-0405.
Tag No.: A0489
Based on observation, interview, record review and policy review, the hospital failed to ensure patient medications were properly secured and labeled with a patient identifier.
Due to the potential risk and harm to all patients this resulted in the non-compliance with
ยง42 CFR 482.25 Condition of Participation: Pharmaceutical Services.
Please refer to A-0502.
Tag No.: A0122
Based on interview, document review and policy review, the hospital failed to follow their policy to keep a log of patient complaints/grievances for one current patient (#12) and one discharged patient (#14) of two patients reviewed. These failures had the potential for harm when care or safety concerns from patients or patients' representatives were not addressed after brought to the attention of hospital staff.
Finding included:
Review of hospital policy titled, "Patient Complaints and Grievances," reviewed 02/2023, showed the following:
- The purpose of the policy was to provide a consistent process for addressing patient and/or patient's representatives complaints and grievances.
- A complaint was an expression of dissatisfaction brought to the attention of personnel. A grievance was a formal or informal written or verbal grievance that is made to the hospital by a patient, or the patient's representative regarding the patient's care. A complaint is considered a grievance if received in writing or if the patient's representative requests their complaint handled as a formal grievance.
- All complaints and grievances will be logged for tracking purposes. The hospital keeps and maintains a grievance log and written documentation and all responses and correspondences.
On 11/12/24 the survey team requested items for investigation including a list of all complaints and grievances submitted to the hospital from 11/01/23 through 12/31/23 and from 05/01/24 through 11/12/24. The hospital could not provide a list of complaints and grievances from 2023.
On 11/18/24 the hospital submitted a document titled, "Landmark Hospital 2024 Grievance/Complaint Log,". The log consisted of one hand-written page and one typed page. Patient #12's complaint was listed on both pages of the documents. The typed page showed Patient #12 submitted a verbal complaint on 09/13/24. A hand-written page showed Patient #12 submitted a written grievance on 09/13/24. The hand-written page also showed a verbal grievance submitted by Patient #14 on 06/11/24.
Review of the hospital's document titled, "Quality Assessment and Process Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety)," dated 10/31/24, showed there were no complaints or grievances submitted during the third quarter of 2024.
Review of the hospital's document titled, "QAPI," dated 07/31/24, showed there were no complaints or grievances submitted in June 2024.
During an interview on 11/18/24 at 1:15 PM, Staff C, CEO, stated that he was not able to locate the list of patient grievances/complaints previously recorded.
Tag No.: A0123
Based on interview, document review and policy review, the hospital failed to provide a timely written response to patients and patient representatives after submission of a grievance for one current patient (#12) and one discharged patient (#14) of two patients reviewed. These failures had the potential for Patients and Patients' Representatives perception their concerns were not investigated or fairly evaluated.
Findings included:
Review of hospital policy titled, "Patient Complaints and Grievances," revised 02/2023, showed the following:
- A complaint was an expression of dissatisfaction brought to the attention of personnel. A grievance was a formal or informal written or verbal grievance that is made to the hospital by a patient, or the patient's representative regarding the patient's care. A complaint is considered a grievance if received in writing or if the patient's representative requests their complaint handled as a formal grievance.
- Within seven days of receipt of a grievance, the hospital will review, investigate, and reconcile the issue or provide an acknowledgement letter to the patient or patient's representative. If more than 30 days is needed to investigate the grievance, a letter will be sent notifying the patient or patient's representative of the delay and include an anticipated date of completion. Unless complex issues were involved in investigation of the grievance, patient grievances should be resolved within 30 days of notification to the Risk Management.
- Letters will be sent from the Directory of Quality and Risk Management and will include confirmation of receipt of the grievance; steps taken to investigate; results of the grievance process, date of 30 days completion; or if additional time is needed, an expected timeframe of the next response from the hospital; and the name and contact information for risk management.
On 11/12/24 the survey team provided the hospital with a list of requested items including a list of all complaints and grievances submitted to the hospital from 05/01/24 through 11/12/24. On 11/18/24 the hospital submitted a document titled, "Landmark Hospital 2024 Grievance/Complaint Log,". The log showed Patient #12 submitted a verbal complaint on 09/13/24 with no written response required marked on the form and the complaint was resolved on 09/13/24 after a meeting with Patient #12's spouse. The log also showed Patient #12 submitted a written grievance on 09/13/24 and that a written response was required. The hand-written page also showed a verbal grievance was submitted by Patient #14 on 06/11/24.
Review of the hospital-provided documents associated with a grievance submitted by Patient #12's spouse showed a document marked "Received via Fax 09/13 and meeting occurred on 09/13." The document was a letter with three grievances presented to hospital administration from Patient #12's husband.
A letter on Landmark Hospital Letterhead, dated 11/18/24, showed Staff C, Chief Executive Officer (CEO) wrote a final response to Patient #12's husband summarizing a meeting held on 09/13/24 with the husband; Staff C; Case Management; Staff E, Chief Clinical Officer (CCO); and Staff F in attendance.
Review of a hospital-provided letter on Landmark Hospital Letterhead, dated 11/18/24, showed Staff C, CEO wrote to Patient #14 summarizing a meeting held on 06/11/24 with the patient, his wife, the CEO, and Case Management in attendance regarding the patient's displeasure with being discharged from the hospital on that date.
During an interview on 11/18/24 at 1:15 PM, Staff C, CEO, stated meetings with Patient #12 and #14 had occurred immediately after their grievances were voiced, but written documentation of the investigation or outcome was not mailed to the patients or families until 11/18/24.
Tag No.: A0144
Based on interview, record review and policy review, the hospital failed to investigate multiple medication errors including controlled substances (drugs or medications that are high risk for personal consumption or abuse) for seven patients (#10, #12, #19, #25, #26, #27, and #28) of 12 patients reviewed. These failures had the potential to affect all patients receiving care in the hospital.
Findings included:
Review of the hospital's policy titled "Controlled Drugs Administration," effective 10/2021, showed the following:
- Administration of controlled drugs should be recorded on the MAR.
- The medical record must include the date and time of administration to the patient; quantity of the drug issued, administered, wasted, or returned; signature of the person who administered the drug; and signature of a witness to waste.
- The disposition of the remainder of a controlled drug must be documented as wasted or destroyed and cosigned by a licensed person.
- The pharmacist should reconcile the amount of controlled substance on hand and compare with the patient records.
- The pharmacy should review a daily report of all controlled substance transactions from the automated dispensing machine (ADM) and confirm that all discrepancies have been resolved, overrides approved, and documentation completed.
- The person responsible for the incorrect or incomplete entry of drug administration should be required to make an entry or correction. If necessary, the supervisor-in-charge should make the MAR available to the responsible person.
Review of hospital's document titled, "Incident and Accidents," dated 05/01/24 through 11/12/24, showed from 08/01/24 through 11/12/24 a total of 98 incidents with 84 of the incidents documented as medication errors.
Review of the hospital-provided incident report, dated 11/11/24, showed Staff F, Pharmacy Director, documented a medication error where Tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) 50 mg was removed from the ADM for Patient #10 on 11/09/24 at 4:51 PM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the hospital-provided incident report dated 09/03/24 showed Staff F, Pharmacy Director, documented a medication error where lorazepam (a medication used to treat anxiety or sleep difficulty) one mg tablet was removed for Patient #12 from the ADM on 09/02/24 at 5:19 PM. The medication was not documented as administered on the Patient #12's MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of an incident report dated 11/07/24 showed Staff F, Pharmacy Director, documented a medication error where oxycodone-acetaminophen (synthetic pain medication with a high risk for misuse) 5/325 mg tablet for Patient #12 from the ADM on 11/05/24 at 6:18 PM. The medication was documented as administered at 6:15 PM and the administration signed at 6:35 PM.
Review of the hospital-provided incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error where lorazepam two mg was removed and administered to Patient #19 on 10/19/24 at 7:06 AM. There was not an active order for the medication for Patient #19, however staff were able to remove the medication without an over-ride because a previous one-time order from the previous day was still active.
Review of the hospital-provided incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error where oxycodone five mg was removed from the ADM for Patient #25 on 10/17/24 at 10:29 AM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the hospital-provided incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error where methadone (a medication used to treat moderate to severe pain or to treat narcotic drug addiction) tablets were removed from the ADM for Patient #26 on 10/16/24 at 10:23 AM. The medication was documented as administered in the MAR at 9:25 AM.
Review of the hospital-provided incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error where methadone tablets were removed from the ADM for Patient #26 on 10/17/24 at 11:09 AM. The medication was documented as administered in the MAR at 9:13 AM and signed by the nurse at 11:14 AM. The incident report also showed Patient #26 was given a hydromorphone (a potent opioid analgesic drug) injection at 11:13 AM, the administration was signed at 11:56 AM and the hydromorphone was removed from the ADM at 11:20 AM.
Review of the incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed hydromorphone two mg from the ADM for Patient #26 on 10/18/24 at 12:30 PM. The medication was not documented as administered in the MAR. A waste for one mg of hydromorphone was completed at 1:10 PM, leaving one mg of the hydromorphone unaccounted for.
Review of the incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed morphine 4 mg from the ADM for Patient #27 on 10/16/24 at 2:17 PM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the hospital-provided incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error where lorazepam two mg was removed and administered to Patient #28 on 10/20/24 at 7:48 AM. There was not an active order for the medication for Patient #28.
During an interview on 11/19/24 at 4:05 PM and on 11/21/24 at 8:15 AM, Staff F, Pharmacy Director, stated that she did not believe that the hospital was addressing medication errors. She did not believe that the errors were related to diversion of controlled substances, but a result of negligent documentation by nursing personnel. Medication errors were presented to the Chief Clinical Officer (CCO) in the form of incident reports and for the past month she had also included the Director of Quality Management (DQM) from the hospital's corporate office. Over the previous six months the number of patients, as well as the number of new staff had increased; and the number of medication errors also increased.
During interviews on 11/20/24 at 8:55 AM and 11/21/24 at 11:55 AM, Staff E, CCO, stated that he was aware of the number of medication errors identified and had developed a document to track the reports to identify trends. Staff E stated that some errors showed controlled substances pulled from the ADMs and were never documented as given to the patient. He did not follow-up the investigation of an unaccounted controlled substance with patient interview or review of pain documentation; but did not believe that the medications were being diverted by the nurses. He felt that the number of medication errors would improve because he talked with each nurse face-to-face.
During an interview on 11/20/24 at 10:00 AM, Staff C, Chief Executive Officer (CEO), stated that he was aware of a problem with medication errors, but not the volume of the errors. The corporate office saw and signed off on all incident reports and therefore they were also aware of the number of incident reports identified as medication errors. The medication errors were presented during a weekly meeting of audits by each department because of incident reports and the categorization of the event being identified as medication errors. Staff C was not aware if nursing staff were aware of the number of medication errors identified.
47504
Tag No.: A0145
Based on interview, record review and policy review, the hospital failed to recognize, report, and investigate patient complaints of possible injury/incidents for three patients (#1, #10, and #15) of three patients reviewed. This failure had the potential to affect the safety of all patients in the hospital.
Findings included:
Review of the hospital's policy titled, "Patient Rights and Responsibilities," revised 08/2019, showed the following:
- Patients have the right to receive safe, quality care delivered by skilled staff with high professional standards.
- Patients have the right to receive care in a setting that is safe and free from any form of abuse or neglect.
- Patients have the right to receive proper assessment and management of pain.
- Patients have a right to expect a timely response from the hospital related to any complaint.
Review of hospital policy titled, "Incident Reporting," revised 06/24, showed:
- An incident was defined as an unusual event or circumstance not consistent with quality and safe patient care or hospital standards.
- Situations were included that may potentially or actually result in injury, harm, or loss to any patient.
- Events for incident reporting include a medical treatment problem or complication, an equipment/device problem involving a patient, falls and other patient injuries, and other incidents that are considered unusual or problem prone.
Review of hospital policy titled, "Patient Events," revised on 06/2024, showed upon receipt of an incident report or knowledge of an adverse event, the risk manager would review and investigate the incident to determine if a Root Cause Analysis (RCA, a tool to help study events where patient harm or undesired outcomes occurred in order to find the root cause) is indicated. The gathering of information, data collecting, investigation and interviews should be started within 72-96 hours after notification of the event.
On 11/13/24 at 10:30 AM, incident and investigation reports were requested for Patient #1 and Patient #10 regarding safety concerns reported to hospital staff by the patients and their families. No incident reports were available. On 11/14/24 at 8:15 AM, the survey team was presented with incident reports dated 11/13/24 regarding the reported events.
Review of the medical record for Patient #1, showed:
- She was admitted on 10/15/24 for acute hypoxic respiratory failure (a condition where there is not enough oxygen reaching the tissues of the body caused by a failure of the respiratory system) and acute chronic physical (a condition of the body) debility (physical weakness as a result of illness) requiring therapy for rehabilitation (the action of restoring someone to health or normal life through training and therapy.)
- On 11/09/24 at 11:11 AM the primary care physician documented a progress note. Patient #1 was awake, alert, and oriented times four (A&O x 4, a person is oriented to person, place, time, and situation) with mild pitting edema (swelling caused by fluid building up in the body's tissues and organs, which can leave a temporary dent in the skin when pressure is applied) to extremities and ace wraps on both legs.
- On 11/10/24 at 9:24 a nursing assessment showed Patient #1 reported pain in her left foot and stated that her toe was broken during a transfer the previous day. The nurse reported no bruising, redness or swelling. Her psychosocial assessment showed the patient's memory was intact. Her musculoskeletal assessment showed patient transfers were completed by a patient lift.
- On 11/10/24 at 9:37 AM a primary care physician progress note showed Patient #1 reported pain in her left big toe and she thought she hit the toe against metal while lifted with the patient lift. She did not want to get out of her bed and into the chair because of the pain. The physician documented that he ordered x-rays of the left foot.
- On 11/10/24 at 12:42 PM a nursing note showed the patient reported that her pain was in her right foot and not in her left foot and that there was obvious injury to her right foot. The nurse documented that both feet were swollen, red and that the left toe looked worse than the right.
- On 11/10/24 at 9:28 AM the primary care physician entered an order for x-rays of the left foot but then changed the order to the right foot on 11/10/24 at 1:50 PM.
- A radiology report showed an x-ray was completed of Patient #1's left foot on 11/10/24 at 9:45 AM, but the findings were documented for the right foot and showed degenerative changes of the first toe, demineralization of bones and degenerative changes of the midfoot. No fracture was identified.
- On 11/10/24 at 1:30 PM, a pain scale assessment was documented for right foot pain rated at seven on a pain scale of zero to 10.
- On 11/11/24 at 12:29 AM, a nursing assessment showed Patient #1 reported pain in her right toe following a patient lift transfer two days prior. Assessment of the toe did not show redness or bruising but was tender to the touch. An x-ray had been ordered and completed and the patient was started on pain medication.
- On 11/11/24 at 10:37 PM, a pain scale assessment was documented for right foot pain rated at eight on a pain scale of zero to 10.
- There was no other documentation in nursing notes regarding an incident involving a patient lift.
- There was no incident report or investigation that occurred until identified by the survey team.
Review of the incident report for Patient #1, dated 11/13/24, showed a complaint regarding an event that occurred on 11/09/24 at approximately 12:00 PM. The incident description showed Patient #1 told the nurse that she thought she broke a toe on her left foot, and later reported the injury occurred to her right foot, the previous day while being transferred using a patient lift. The patient care technician (PCT) who cared for the patient on 11/09/24 reported that the patient was not transferred using the patient lift during that shift. The incident report showed that the physician ordered x-rays (a test that creates pictures of the structures inside the body-particularly bones) of the foot following the patient's reported injury and no injury was identified.
During an interview on 11/12/24 at 3:30 PM, Patient #1, stated that on 11/09/24, the PCTs were using the patient lift to transfer her and did not have her correctly in the sling. Her feet were swinging around when her right foot hit the metal piece of the patient lift. She complained of pain and reported it to the nurse. The following day she reported it to the physician. She stated that her pain scale assessment (pain rating on a scale of zero to ten, zero means no pain and a ten means worst pain possible) had been at an eight to nine on a pain scale of zero to ten consistently since it happened. An x-ray was done on her foot with no findings. No one from hospital administration came to discuss the incident with her.
Record review of Patient #10's medical record, showed:
- She was a 78-year-old admitted on 11/07/24 for methicillin-susceptible staphylococcus aureus, (MSSA, a type of bacterial infection caused by staph bacteria.) bacteremia (bacteria in the bloodstream) with multi valve endocarditis (infection to the heart's inner lining) requiring intravenous (IV, in the vein) antibiotic therapy.
- On 11/08/24 at 10:00 AM, a nursing assessment showed Patient #10 was alert, awake, and oriented times three (A&O x 3, refers to being alert and oriented to person, place and time), complained of sternal pain and back pain. The patient had mild intermittent confusion at times. She was incontinent with use of an external urinary suction catheter. Her mobility was limited and was chairfast.
- On 11/10/24 at 8:30 PM, a nursing assessment by Staff HH, Registered Nurse (RN), showed Patient #10 was A&Ox3 and her behavior was appropriate to situation. She was incontinent with use of external urinary suction catheter and requested to use the bed pan only to void.
- On 11/10/24 at 10:00 PM, Staff HH documented Patient #10 was A&Ox3, and needed assistance with toileting.
- On 11/11/24 at 2:34 PM, documentation showed that Staff NN, Physician, documented Patient #10 had a bad experience last night when she was on the bedpan and had suctioning from the external urinary suction catheter which irritated her buttocks/perianal region. She thought the nurse did not listen to her complaints. She was awake, alert, and cooperative with examination and answered questions appropriately.
- There was no documentation on 11/10/24 of a problem with the external urinary suction catheter.
Review of the incident report for Patient #10, dated 11/13/24, showed a complaint regarding an event that occurred on 11/10/24 at 11:00 PM. The incident description showed Patient #10 complained of irritation caused by an external urinary suction catheter. Staff K, Advanced Practice Registered Nurse (APRN, a nurse with advanced clinical education and training), met with the patient on 11/13/24. Patient #10 stated that she needed to urinate and did not want to use the bedside commode due to pain from her recent surgeries. She stated that the nurse placed a "suction tube" in her perianal region and that she was also placed on the bedpan. She stated that it felt like the bedpan formed a suction seal to her buttocks but realized that she could feel the suction tube applying suction to her perianal area while she was urinating. She stated this caused her irritation. Per nursing documentation, the patient did not have any perianal wounds and did not complain of pain in the area since that incident. It was unknown if the nurse in question placed the external urinary suction catheter incorrectly. Education of proper external urinary suction catheter would be provided to the nurse.
During an interview on 11/13/24 at 10:30 AM, Staff A, Quality Management Director (DQM), stated she did not have an incident report for Patient #10 regarding an external urinary suction catheter.
During an interview on 11/13/24 at 10:50 AM, Staff E, Chief Clinical Officer (CCO), stated that he was not aware of any incident regarding the use of an external urinary suction catheter with Patient #10.
During an interview on 11/13/24 at 11:40 AM, Staff K, APRN, was not aware of any incident and asked for details regarding the external urinary suction catheter incident that was reported to the survey team.
During an interview on 11/13/24 at 12:30 PM, Staff C, Chief Executive Officer (CEO), stated that he was not aware of any incident regarding an external urinary suction catheter.
During an interview on 11/25/24 at 7:00 PM, Staff HH, RN, stated she did not put an external urinary suction catheter on Patient #10. She stated "That is not my job, that is the tech's job. I have no idea how to even put one on." She stated that Patient #10 never made any complaint to her regarding the use of the external urinary suction catheter. She stated that Patient #10 was confused most of the time. Staff HH stated that she had not received any education regarding the use of the external urinary suction catheter. She was not aware of the incident reporting policy. She stated that the PCT had to be the one to put the external urinary suction catheter on Patient #10. She stated that she had an assigned PCT that night but did not recall who it was.
Review of Patient #15's medical record showed the following:
- He was admitted on 10/21/24 for hypoxic respiratory failure, tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter the lungs) care/weaning and oxygen titration, and underlying tetraplegia (a medical condition that causes partial or total loss of function in the torso and all four limbs).
- On 10/26/24 at 8:44 AM, documentation showed the tracheostomy was secured in place.
- On 10/26/24 at 10:16 AM, nursing documentation showed a respiratory therapist (RT) responded to Patient #15's room around 9:15 AM due to oxygen saturation (measure of how much oxygen is in blood. A normal is between 95% and 100%) alarms showing a low value. RT called out for assistance because the patient had been decannulated (the process by which a tracheostomy tube is removed).
- Staff GG, RN, responded to Patient #15's room. His eyes were open, but he was not responding to voice or pain stimulation. His pupils appeared to be unequal with sluggish response and he was not following commands, tracking, or speaking. Vital signs were normal. The charge nurse (CN) was notified. The on-call APRN ordered Patient #15 transferred to Hospital B (nearby acute care hospital) for evaluation. RT notified family that he was being sent to Hospital B. The CN called Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) and report was called to Hospital B's Emergency Department (ED).
- Patient returned to Landmark Hospital on 11/05/24 for continued care.
Review of Patient #15's medical record from Hospital B, dated 10/26/24, showed he was a 33-year-old who presented to the ED on 10/26/24 after being found unresponsive at Landmark Hospital. He was reportedly found on the ground, decannulated, and his oxygen saturation was in the 80s. The trach was put back in place and he was transported to the ED. He was admitted to the Medical Intensive Care Unit (MICU) for further care.
On 11/18/24 at 11:30 AM, incident and investigation reports were requested for Patient #15 regarding a safety concern reported to hospital staff by his family on 10/27/24. No incident report was available.
During an interview on 11/14/24 at 9:50 AM, Patient #15's family stated that when he was transferred to Hospital B, the documentation showed he was found on the floor at Landmark Hospital. She returned to Landmark Hospital the day after Patient #15 was transferred to get some of his belongings. She spoke with a nurse and made a complaint that she was not notified that her brother had fell and was found on the floor. She stated that the nurse told her that he was not found on the floor and that the documentation from Hospital B's ED was incorrect. She asked if the survey team could investigate the fall. She stated that no one from Landmark had contacted her regarding the incident after she told the nurse her concern.
During an interview on 11/19/24 at 2:00 PM, Staff GG, RN, stated that Patient #15 was not found on the floor. He was found unresponsive, it happened very fast, he decannulated. RT responded to an alarm and called for the nurse. She went in to assist. She notified the physician of the incident and then called EMS to transfer the patient to the ED at Hospital B for an evaluation. She did call the ED and gave report but did not report he was found on the floor. She stated Patient #15's sister approached her the day following his transfer and asked her how he ended up on the floor. She told her that it was not a true statement, and that Patient #15 could not move himself out of a bed. She did call the hospital and attempted to get the note taken out of the medical record. She did not fill out an incident report as she thought she had taken care of the problem. "If I can take care of a complaint, I will just take care of it. If I can't, I would call the CN to come to speak with the patient."
During an interview on 11/19/24 at 2:30 PM, Staff EE, RT, responded to an alarm for Patient #15. She stated his oxygen level was 88-89% and that his tracheostomy was laying on his chest. He was unresponsive and she called the nurse. He was found laying in his bed on his back. The CN called Staff K, APRN, and a decision was made to send him to the ED at Hospital B for an evaluation. She stated that Staff K did come and ask if he was found on the floor, and she told her that he was found in the bed.
During an interview on 11/19/24 at 3:30 PM, Staff K, APRN, stated she was on-call the night Patient #15 was sent to the ED at Hospital B. He was not on the floor, there was no way he could get there on his own. She had heard that his sister asked if he fell out of the bed so she reviewed his chart and asked the staff that was on duty that night if he was found on the floor. She stated that the information Hospital B documented was incorrect.
During an interview on 11/19/24 at 2:35 PM, Staff CC, CN, stated that over the previous six months there had been several new clinical staff added and new leadership. Nursing had received recent training regarding the process of patient and family complaints and incident reports.
During interviews on 11/20/24 at 8:55 AM and on 11/21/24 at 11:55 AM, Staff E, CCO, stated his expectation from staff was to follow the policy for patient complaints and it was the nurse's responsibility to ensure that an incident report was entered. He stated that it was his expectation that staff forwarded patient and family complaints and all incidents to administration.
Tag No.: A0146
Based upon observation, interview and policy review, the hospital failed to safeguard Protected Health Information (PHI, any information about health status, provision of health care, or payment for health care that can be linked to a specific individual) for five patients (#1, #6, #8, #16, and #22) out of eight patients observed. This failure had the potential to affect the confidentiality of all patients in the hospital.
Findings included:
Review of the hospital's policy titled, "Patient Rights and Responsibilities," revised 08/2019, showed patients have a right to every consideration of privacy, including personal needs. This also means that care discussion, consultation, examination, and treatment will be conducted to protect the patient's privacy. Patients have a right to expect all written communications and records about treatment be treated as strictly confidential except in certain cases permitted or required by law (i.e. suspected abuse, public health hazards). This includes written notices that explains how personal health information will be used and shared with other health care professionals involved in the patients care.
Review of the hospital's policy titled, "Confidentiality of Patient Information," revised 11/2022, showed patient specific medical information should not appear anywhere that can be accessed by other patients or visitors. Patients have the right to have their medical record read only by individuals directly involved in their treatment or the monitoring of quality and by other individuals only on their written authorization.
Observation on 11/13/24 at 11:43 AM, showed Staff R, Patient Care Technician (PCT), left a computer monitor unattended outside of Patient #1's room. The computer monitor faced the hallway and left patient information (names, medications, diagnosis) visible to staff and visitors not involved in the patient's care.
Observation on 11/13/24 at 12:05 PM, showed Staff MM, Registered Nurse (RN), left a computer monitor unattended outside of Patient #1's room. The computer monitor faced the hallway and left patient information visible to staff and visitors not involved in the patient's care.
Observation on 11/14/24 at 9:15 AM, showed Staff L, RN, left a computer monitor unattended outside of Patient #6's room. The computer monitor faced the hallway and left patient information visible to staff and visitors not involved in the patient's care.
Observation on 11/13/24 at 9:10 AM, showed Staff M, RN, left a computer monitor unattended in the hallway outside of Patient #8's room. The computer monitor faced the hallway and left patient information visible to staff and visitors not involved in the patient's care.
Observation on 11/14/24 at 9:28 AM, showed Staff Y, RN, left a computer monitor unattended outside of Patient #16's room. The computer monitor faced the hallway and left patient information visible to staff and visitors not involved in the patient's care.
Observation on 11/14/24 at 08:15 AM, showed Staff W, RN, left a computer monitor unattended outside of Patient #22's room. The computer monitor faced the hallway and left patient information visible to staff and visitors not involved in the patient's care.
During an interview on 11/20/24 at 8:55 AM, Staff E, Chief of Clinical Operations (CCO) stated that computer monitors should not be open and left in the hall with patient information visible. All medical records should be kept confidential at all times.
Tag No.: A0286
Based on interview, record review and policy review, the hospital failed to adequately analyze the causes and implement actions to prevent potential medication errors and prevent potential diversion and misuse of controlled substances for seven incident reports of medication errors with seven patients (#10, #12, #19, #25, #26, #27 and #28) of 12 patients reviewed involving controlled substances (drugs or medications that are high risk for personal consumption or abuse). These failures had the potential to put all patients at risk for sub-standard quality of health care and adverse outcomes.
Findings included:
Review of the hospital's policy titled, "Patient Safety Risk Management Plan," reviewed 01/2024, showed that the patient safety risk management goals are to continuously improve patient safety and minimize and/or prevent the occurrence of errors, events and system breakdowns leading to harm to patients, staff and visitors through proactive risk management and patient safety activities. The patient safety and risk management functional responsibilities included the following:
- Developing systems for and overseeing the reporting of adverse events, near misses and potentially unsafe conditions.
- Ensuring the collection and analysis of data to monitor the performance of processes that involve risk or that may result in serious safety events (SSE).
- Overseeing the organizational incident reporting process for data collection and processing, information analysis and generation of statistical trend reports for the identification and monitoring of SSE's.
-Analyzing data collected on SSE, near misses and potentially unsafe conditions. Providing feedback to providers and staff and using this data to facilitate system improvements to reduce the probability of future occurrence.
- Facilitating and ensuring the implementation of patient safety initiatives and provider and staff participation in education programs on patient safety and risk management.
Review of the hospital's policy titled, "Quality Assessment Performance Improvement Plan (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety)," reviewed 01/2024, showed the following:
- QAPI provided continuous process improvement, education, and training to achieve excellent clinical outcomes and patient safety.
- Pharmacy and Therapeutics review provided ongoing monitoring and evaluation of selected medications of high risk, high volume, or problem prone activities, and was designed to improve processes including medication administration.
Review of the hospital's policy titled, "Incident Reporting," revised 04/06/21, showed the following:
- The objective of incident reporting was to ensure immediate management of an incident when required and that every incident is appropriately prioritized, investigated and managed, and to mitigate risk and prevent future incidents through development of appropriate action plans, recommendations and ongoing review.
- Quarterly reports are provided to the Risk Management Committee, QAPI Committee, Medical Executive Committee and Governing Body that show trended data by category of events. Trends are reviewed and ad hoc process improvement and patient safety initiatives implemented as indicated with follow-up through the QAPI committee. If trends are identified or increases in incidents are noted, leadership should have monthly Risk Management meetings until the trends decrease. Incidents, complaints, grievances, employee injuries, and safety events are all brought through Risk Management for open discussion and problem solving.
Review of the hospital's policy titled, "Controlled Drugs (drugs or medications that are high risk for personal consumption or abuse) Drug Diversion Prevention, Detection and Response," effective 10/2021, showed the following:
- The prevention, detection, and reporting of drug diversion should be interdisciplinary and the responsibility of all personnel.
- The hospital should routinely audit relevant data and ensure trends and variances are acted on in a timely manner and that corrective action plans are implemented.
- Pharmacy audits could include full tracing audits on opioids routinely; audit nursing removal, administration, and wasting records; audit pain medication administered to patient response documentation, review reports of high-volume users from the automated dispensing machine (ADM) and tracking trends of poor documentation practices.
- A quality improvement review should be initiated by the pharmacy director, including a Root Cause Analysis (RCA, a tool to help study events where patient harm or undesired outcomes occurred to find the root cause) to prevent future occurrences.
Review of the document titled, "Landmark Hospital - The Governing Board (Body) Bylaws," reviewed 09/2024, showed responsibilities of the Board included the review, approval, and periodic reassessment of improving performance; maintaining quality patient care; and assuring continuous performance improvement by regularly receiving and acting on reports and requests from the administrative staff and clinical staff.
Review of hospital's document titled, "Incident and Accidents," dated 05/01/24 through 11/12/24, showed a total of 98 incidents from 08/01/24 through 11/12/24 with 84 of the incidents documented as medication errors.
Review of the hospital's document titled, "QAPI," dated 09/30/24, showed the QAPI committee discussed an increase in unaccounted for narcotics. There was no documentation of medication error trending, analysis, investigation or determination of root causes. The document showed audits and education were planned.
Review of the incident report dated 11/11/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff KK, RN, removed Tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) 50 mg from the automated dispenser machine (ADM) for Patient #10 on 11/09/24 at 4:51 PM. The medication was not documented as administered in the medication administration record (MAR), nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the incident report dated 09/03/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, Registered Nurse (RN) (a nurse employed by a business that provides nursing staff to hospitals and other health care institutions), removed lorazepam (a medication used to treat anxiety or sleep difficulty) one mg for Patient #12 from the ADM on 09/02/24 at 5:19 PM. The medication was not documented as administered on Patient #12's MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of an incident report dated 11/07/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff Y, RN, removed oxycodone-acetaminophen (synthetic pain medication with a high risk for misuse) 5/325 mg tablet for Patient #12 from the ADM on 11/05/24 at 6:18 PM. The medication was documented as administered at 6:15 PM and the administration signed at 6:35 PM.
Review of the incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff LL, APRN, removed and administered lorazepam two mg to Patient #19 on 10/19/24 at 7:06 AM. There was not an active order for the medication at that time; however, staff were able to remove the medication from the ADM without an over-ride because a previous one-time order from the previous day was still active.
Review of the incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed Oxycodone five mg from the ADM for Patient #25 on 10/17/24 at 10:29 AM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed methadone (a medication used to treat moderate to severe pain or to treat narcotic drug addiction) 10 mg from the ADM for Patient #26 on 10/16/24 at 10:23 AM. The medication was documented as administered in the MAR at 9:25 AM.
Review of the incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed methadone tablets from the ADM for Patient #26 on 10/17/24 at 11:09 AM. The medication was documented as administered in the MAR at 9:13 AM and signed by the nurse at 11:14 AM. The incident report also showed Staff J documented Patient #26 was given a hydromorphone (a potent opioid analgesic drug) injection at 11:13 AM, signed the medication administration at 11:56 AM and withdrew the hydromorphone from the ADM at 11:20 AM.
Review of the incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed hydromorphone two mg from the ADM for Patient #26 on 10/18/24 at 12:30 PM. The medication was not documented as administered in the MAR. A waste for one mg of hydromorphone was completed at 1:10 PM, leaving one mg of the hydromorphone unaccounted for.
Review of the incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff J, RN, removed morphine (opioid pain medication) 4 mg from the ADM for Patient #27 on 10/16/24 at 2:17 PM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff Z, Agency RN, removed and administered lorazepam two mg to Patient #28 on 10/20/24 at 7:48 AM. There was not an active order for the medication.
During interviews on 11/19/24 at 4:05 PM and 11/21/24 at 8:15 AM, Staff F, Pharmacy Director, stated that she did not believe the hospital was addressing medication errors. Medication errors were presented to the CCO in the form of incident reports and for the past month she had also included the DQM. She completed an incident report for medication "unaccounted for" when the medication was not reconciled as given or wasted or when the time withdrawn from the ADM did not coincide with documented administration. Every medication error involving controlled substances or critically timed medications was presented during an administration meeting held monthly reviewing departmental audits. The medication errors were reported to QAPI by way of the incident reports completed. Some physicians were aware of the errors due to incident reports reviewed during the Pharmacy and Therapeutics meeting.
During an interview on 11/20/24 at 8:55 AM, Staff E, CCO, stated that he was aware of the number of medication errors identified and had developed a document to track the reports to identify trends. He followed through and talked with each nurse involved in a medication error. He had not identified specific trends or worked on a solution. Staff E stated that some errors showed controlled substances pulled from the ADMs and were never documented as given to the patient. His investigation involved asking the nurse who pulled the medication if the medicine was given to the patient. When the nurse reported they had given the medication and neglected to document, the incident was resolved. He did not follow-up the investigation with patient interview, review of medical record or pain documentation.
During an interview on 11/19/24 at 2:35 PM, Staff CC, Charge Nurse, stated that the hospital had a problem with medication errors last year. They developed and implemented extensive training and the number of medication errors decreased. Over the previous six months there had been changes with several new clinical staff and new leadership. Some of the progress with medication errors was lost. Nursing had not had recent education on reducing medication errors.
During an interview on 11/20/24 at 10:00 AM, Staff C, Chief Executive Officer (CEO), stated that he was aware of a problem with medication errors, but not the volume of the errors.
Tag No.: A0395
Based on observation, interview, policy review and record review, the hospital failed to ensure that staff:
- Provided appropriate hygiene for five current patients (#1, #2, #15, #17, and #18) out of six patients reviewed;
- Appropriately turned and repositioned six current patients (#1, #2, #5, #12, #16, and #17) out of 10 patients reviewed;
- Appropriately provide and document pain assessments for two current patients (#12 and #15) and two discharged patients (#25 and #28) out of 11 patients reviewed;
- Appropriately provide and document nursing assessments for two current patients (#12 and #16) and one discharged patient (#25) out of 13 patients reviewed; and
- Appropriately date, time and initial all IV sites, PICC lines, and central lines for six current patients (#1, #2, #5, #8, and #11) out of 13 patients reviewed.
These failures had the potential to result in increased infections, impaired skin integrity, and overall increase the risk of deterioration in health status.
Findings included:
Review of the medical record for Patient #1, showed she was admitted on 10/15/24. She received five baths during 28 days of hospitalization.
Review of the medical record for Patient #2, showed he was admitted on 10/22/24. He received four baths during 21 days of hospitalization.
Review of the medical record for Patient #15, showed he was admitted on 11/05/24. He received one bath during eight days of hospitalization.
Review of the medical record for Patient #17, showed she was admitted on 10/24/24. She received five baths during 23 days of hospitalization.
Review of the medical record for Patient #18, showed he was admitted on 11/07/24. He received one bath during six days of hospitalization.
During an interview on 11/12/24 at 3:30 PM, Patient #1, stated the staff was very inconsistent in bathing and she has only received a few baths since her admission date of 10/15/24. When she asked the staff for a bath, she was told they were too busy or did not have enough staff.
During an interview on 11/12/24 at 4:00 PM, Patient #2, stated that he had not received regular bathing due to not enough staff.
During an interview on 11/13/24 at 12:00 PM, Staff N, Patient Care Tech (PCT), stated that management reduced staffing and that she was typically assigned 10 patients during her shift. All of the patients required a high level of assistance and she was unable to bathe patients regularly.
During an interview on 11/20/24 at 11:52 AM, Staff E, Chief of Clinical Operations (CCO), stated his expectation was for all patients to receive daily hygiene and offered a bath or shower. Bathing should be documented daily; and if the patient refused, the PCT should document the refusal and report it to the nurse. The nurse was responsible to ensure that all hygiene needs are met.
Review of the medical record for Patient #1 showed she was admitted on 10/15/24. She was to be turned and/or repositioned in bed or chair every two hours. Repositioning or Patient #1's refusal to be turned were not documented:
- From 6:19 PM on 10/15/24 through 7:27 AM on 10/16/24;
- From 4:48 PM on 10/16/24 through 9:16 AM on 10/17/24;
- From 4:27 PM on 10/17/24 through 9:58AM on 10/18/24;
- From 4:25 PM on 10/18/24 through 3:05 PM on 10/19/24;
- From 5:03 PM on 10/19/24 through 6:33 AM on 10/20/24;
- From 2:19 PM on 10/20/24 through 8:00 AM on 10/21/24;
- From 4:58 AM on 10/22/24 through 10:48 PM on 10/22/24;
- From 10:48 PM on 10/22/24 through 6:35 AM on 10/23/24;
- From 8:43 PM on 10/23/24 through 6:11 AM on 10/24/24;
- From 1:55 PM on 10/27/24 through 7:16 PM on 10/29/24; and
- From 3:39 PM on 10/31/24 through 3:16 AM on 11/01/24.
Review of the medical record for Patient #2 showed he was admitted on 10/22/24. He was to be turned and/or repositioned in the bed or chair every two hours. Repositioning or Patient #2's refusal to be turned were not documented:
- From 12:55 AM through 6:15 AM on 10/24/24;
- From 7:27 PM on 10/24/24 through 5:24 AM on 10/25/24;
- From 7:12 PM on 10/27/24 through 7:12 PM on 10/29/24;
- From 7:12 PM on 10/29/24 through 4:58 AM on 10/30/24;
- From 8:45 PM on 10/30/24 through 2:13 AM on 10/31/24;
- From 5:39 PM on 10/31/24 through 12:00 AM on 11/01/24;
- From 4:10 PM on 11/01/24 through 6:00 AM on 11/02/24;
- From 2:20 PM on 11/03/24 through 6:00 AM on 11/04/24.
Review of the medical record for Patient #5 showed they were admitted on 10/25/24. He was to be turned and/or repositioned in the bed or chair every two hours. Repositioning or Patient #5's refusal to be turned were not documented:
- From 4:44 AM on 10/26/24 through 12:37 AM on 10/27/24;
- From 4:19 AM on 10/27/24 through 12:00 AM on 10/29/24;
- From 4:00 AM on 10/30/24 through 7:10 AM on 11/03/24;
- From 6:44 PM om 11/03/24 through 6:43 PM on 11/04/24;
- From 6:43 PM on 11/04/24 through 2:00 PM on 11/05/24;
- From 5:47 AM on 11/10/24 through 8:32 AM on 11/12/24.
Review of the medical record for Patient #12, showed they were admitted on 06/28/24. She was to be turned and/or repositioned in the bed or chair every two hours. Repositioning or Patient #12's refusal to be turned were not documented:
- From 8:22 AM 09/02/24 through 7:23 AM on 09/04/24.
- From 9:40 AM on 09/04/24 through 8:00 PM on 09/05/24.
- From 2:25 AM on 09/07/24 through 9:05 AM on 09/09/24.
- From 9:05 AM through 6:56 PM on 09/09/24.
- From 4:37 AM through 7:00 PM on 09/10/24.
- From 7:00 PM 09/10/24 through 3:16 AM on 09/11/24.
- From 4:46 AM through 6:26 PM on 09/11/24.
- From 4:41 AM through 8:30 PM on 09/12/24.
- From 10:00 AM through 7:00 PM on 09/13/24.
- From 5:42 AM through 6:00 PM on 09/14/24.
- From 6:00 PM on 09/14/24 through 8:22 AM on 09/16/24.
- From 8:22 AM on 09/16/24 through 8:19 AM on 09/18/24.
- From 11:30 AM 09/20/24 through 9:19 AM on 09/23/24.
- From 9:19 AM 09/23/24 through 10:46 PM on 09/24/24.
- From 10:46 PM on 09/24/24 through 6:54 PM on 09/26/24.
- From 4:30 AM on 10/01/24 through 6:39 AM on 10/02/24.
- From 5:58 PM on 10/02/24 through 3:04 PM on 10/04/24.
- From 7:00 PM on 10/04/24 through 6:30 PM on 10/06/24.
- From 4:06 PM on 10/07/24 through 6:30 PM on 10/13/24.
Review of the medical record for Patient #16, showed she was admitted on 10/31/24. She was to be turned and/or repositioned in the bed or chair every two hours. Repositioning or Patient #16's refusal to be turned were not documented:
- From 5:30 AM on 11/04/24 through 12:23 PM on 11/05/24;
- From 6:21 PM on 11/05/24 through 7:532 AM on 11/06/24;
- From 6:17 PM on 11/06/24 through 12:23 AM on 11/07/24;
- From 3:38 AM on 11/07/24 through 6:36 PM on 11/08/24;
- From 4:29 AM on 11/09/24 through 12:30 AM on 11/10/24;
- From 10:00 PM on 11/10/24 through 6:48 PM on 11/11/24;
- From 4:00 AM on 11/12/24 through 7:06 PM on 11/12/24.
Review of the medical record for Patient #17, showed she was admitted 10/21/24. She was to be turned and/or repositioned in the bed or chair every two hours. Repositioning or Patient #17's refusal to be turned were not documented:
From 10:43 PM on 10/21/24 through 6:30 PM on 10/22/24;
From 8:30 PM on 10/22/24 through 12:30 AM on 10/23/24;
From 12:31 AM on 10/23/24 through 10:18 AM on 10/23/24;
From 10:18 AM on 10/23/24 through 12:32 PM on 10/25/24;
From 4:50 PM 10/26/24 through 8:51 AM on 10/27/24, Patient #17 was documented on back;
From 8:51 AM on 10/27/24 through 12:32 PM on 10/27/24, Patient #17 was documented on left side;
From 12:32 PM on 10/27/24 through 4:58 PM on 10/27/24, Patient #17 was documented in bed on right side;
From 8:30 PM on 10/27/24 through 12:19 PM on 10/28/24;
From 12:30 AM on 10/29/24 through 6:30 PM on 10/29/24; and
From 4:49 PM on 11/11/24 through 6:00 AM on 11/12/24.
During an interview on 11/12/24 at 3:30 PM, Patient #1, stated she did not get repositioned at night.
During an interview on 11/12/24 at 4:00 PM, Patient #2, stated he did not get repositioned every two hours at night.
During an interview on 11/14/24 at 9:30 AM, Patient #15's family stated that staff did not come in on a regular basis and turn the patient.
During an interview on 11/13/24 at 11:30 AM, Staff N, PCT, stated that she was not able to turn patients every two hours. They have a minimum of 10-12 patients to care for, the patients had a lot of needs, and she did not have time to turn them.
During an interview on 11/19/24 at 1:35 PM, Staff CC, Charge Nurse (CN), stated that every patient should be turned at a minimum of every two hours. It was part of the care plan, as well as part of wound care.
During an interview on 11/19/24 at 10:05 AM, Staff K, Advanced Practice Nurse (APRN, a nurse with advanced clinical education and training), stated that it was considered the standard of care to turn patients every two hours. The physician does not order repositioning but it was expected on every patient and was part of their care plan and wound assessments. She stated that the PCT's should have no excuse for not turning patients and that it was the responsibility of the nurse to ensure that their patients were being turned. If a patient refused to turn, the PCT should notify the nurse.
During an interview on 11/20/24 at 11:00 AM, Staff I, Wound Care Nurse (WCN), stated that turning does not occur every two hours anywhere in the country. Turning was important to wound healing, deterioration of the wound could occur if a patient was not turned every two hours.
Review of the medical record for Patient #12 showed pain assessments were not completed during the following dates of her admission:
- 09/06/24 evening shift;
- 09/07/24 evening shift;
- 09/08/24 morning and night shift;
- 09/10/24 morning shift;
- 09/12/24 morning shift;
- 09/14/24 morning and night shift;
- 09/15/24 morning shift;
- No pain assessments were completed on the evening shift of 09/18/24 until the morning shift of 09/22/24;
- 09/23/24 morning shift;
- No pain assessments were completed on 09/24/24 through the evening shift of 09/26/24;
- No pain assessments were completed from 09/27/24 evening shift through 09/29/24;
- No pain assessments were completed from evening shift 09/30/24 through 10/03/24;
- No pain assessments were completed on 10/05/24 through the evening shift of 10/06/24;
- No pain assessments were completed from 10/08/24 evening shift through 10/15/24;
- No pain assessments were completed from 10/15/24 evening shift through 10/17/24 evening shift;
- No pain assessments were completed on 10/18/24 through 10/19/24 evening shift; and
- No pain assessments were completed 10/30/24 evening shift through 11/01/24.
Review of the medical record for Patient #15 showed that pain assessments were not completed during the following dates of his admission:
- 11/09/24 morning and night shift;
- 11/12/24 morning and night shift; and
- 11/13/24 morning shift.
Review of the medical record for Patient #25 showed pain assessments were not completed on 10/17/24 during the day shift or 10/18/24 during the evening shift.
Review of the medical record for Patient #28 showed that pain assessments were not completed from 10/15/24 at 1:06 AM through 10/25/24 at 11:47 AM and 10/25/24 at 12:46 PM through 10/28/24 at 10:26 PM during his admission.
Review of hospital policy titled, "Clinical Practice Guidelines," revised 11/2023, showed every patient would have a nursing history and comprehensive assessment completed within the first 24 hours of admission, before the end of the RN's shift. A complete shift assessment would be done towards the first part of the shift and documented in the patient's medical record. Any significant change in the patient's condition would result in a focused re-assessment.
Review of the medical record for Patient #12 showed nursing assessments were not completed for the evening/night shift of 09/30/24 or the morning/day shift of 10/01/24.
Review of the medical record for Patient #16 showed nursing assessments were not completed for the following dates of admission:
- No assessment on 11/02/24;
- No assessment on night shift on 11/04/24;
- No assessment on night shift on 11/06/24; and
- No assessment on night shift on 11/12/24.
Review of the medical record for Patient #25 showed nursing assessments were not completed on 10/16/24 during the day shift and on 10/18/24 during the evening shift.
Review of hospital policy titled, "Clinical Practice Guidelines," revised 11/2023, showed all central lines, PICC and peripheral IV sites will be labeled with date and time when changed along with the nurse's initial. Peripheral IV sites are to be changed on a PRN basis but must be assessed per shift for signs and symptoms of infection and any inflammation. If the site is not changed, there should be documentation to why and the reasonably vigilant in changed the dressing labeling with the date, time, and the nurse initials for when it was changed. Peripheral IV's started at another facility should be changed within 24 hours of admission. This should be documented in the patient's medical record. The IV dressing should be dated, time and initialed for when they are to be changed next. Transparent semipermeable dressing should be changed minimally every seven days. The dressing should be date, timed and initialed for when the dressing is to be changed next. Central line and PICC line dressings should be changed within 24 hours of admission for any non-visible dressing or for those that do not have a date on them. Following the initial dressing change, the dressings should be changed every seven days and as needed. The dressing must be dated, timed, and initialed when they are to be changed.
Observation on 11/12/24 at 3:30 PM, showed that Patient #1's central line dressing was dated 11/02/24, did not have a time, and was not initialed.
Observation on 11/12/24 at 4:00 PM, showed that Patient #2's IV dressing was not dated, did not have a time, and was not initialed.
Observation on 11/13/24 at 9:50 AM, showed that Patient #5's IV dressing was not dated, did not have a time, and was not initialed.
Observation on 11/13/24 at 9:10 AM, showed that Patient # 8's central line dressing was not dated, did not have a time, and was not initialed.
Observation on 11/13/24 at 11:45 AM, showed that Patient #11's IV dressing was not dated, did not have a time, and was not initialed.
During an interview on 11/19/24 at 11:52 AM, Staff E, Chief Clinical Officer (CCO), stated that all IV's, Ports, and Central lines should be dated and initialed. They should be inspected every shift. If they are not clean, dry and intact the nurse should change that dressing.
During an interview on 11/19/24 at 1:35 PM, Staff CC, CN, stated that all dressings should have a date, time and initials.
47504
Tag No.: A0398
Based on interview, record review and policy review, the hospital failed to ensure two nursing personnel (Staff J and Staff Z) of four nursing personnel records reviewed, completed orientation and education prior to providing patient care. This failure had the potential to cause harm to all patients in the hospital.
Findings included:
Review of the hospital's policy titled, "Contract Personnel Orientation," dated 11/2022, showed all clinical contract service personnel will receive orientation to the facility, roles and responsibilities, and they meet all provisions outlined. This includes Infection Prevention and Control and job specific orientation.
Review of the personnel record for Staff J, Agency Registered Nurse (RN), showed no job specific orientation checklist, Infection Control training or restraint (any manual method, physical or mechanical device that limits the ability of free movement of arms, legs, body, or head) training.
Review of the personnel record for Staff Z, Charge RN, showed no job specific orientation checklist, Infection Control training or restraint training.
During an interview and concurrent personnel records review on 11/21/24 at 10:00 AM, Staff JJ, Human Resources Manager, stated that she could not find orientation, competency skills check-off, or restraint training for two contracted staff. She stated that the nurses were on their second assignment with the hospital.
During an interview on 11/21/24 at 11:55 AM, Staff E, Chief Clinical Officer, stated that he was not aware that Staff J and Staff Z had not completed orientation. He was responsible to ensure they received a proper orientation.
47504
Tag No.: A0405
Based on interview, record review and policy review, the hospital failed to ensure that staff follow the medication administration policies for seven patients (#10, #12, #19, #25, #26, #27, and #28) of 12 patients reviewed. These failures had the potential to affect all patients with negative outcomes.
Findings included:
Review of hospital policy titled, "Clinical Practice Guidelines," revised 11/2023, showed patient administration of medication to patients were documented with the appropriate time, route, dose, and injection site in the patient's medical administration record (MAR). When the medication was not given, the nurse noted a brief explanation or documented in the MAR. When administering narcotic medications and the amount available exceeds the dose ordered, the partial dose must be wasted immediately and witnessed by a second nurse. Any full dose narcotic errors were returned directly to the pharmacy with a full explanation.
Review of the hospital policy titled, "Drug Administration General," effective 06/2022, showed:
- Drugs should be administered to patients only upon the receipt of the order from a practitioner who has clinical privileges and is legally authorized to prescribe/order drugs. This includes protocols and pre-printed forms.
Review of the hospital's policy titled "Controlled Drugs (drugs or medications that are high risk for personal consumption or abuse) Storage, Distribution and Accountability," effective 09/2014, showed the following:
- The Director of the Pharmacy should ensure that the use and accountability of controlled drugs are legal and accurate; documentation satisfies all statutes; controlled substances are administered; and all records are properly documented and filed.
- The Director of Pharmacy should ensure the distribution and administration of controlled drugs are documented adequately by nursing.
Review of the hospital's policy titled "Controlled Drugs Administration," effective 10/2021, showed the following:
- Administration of controlled drugs should be recorded on the MAR.
- The medical record must include the date and time of administration to the patient; quantity of the drug issued, administered, wasted, or returned; signature of the person who administered the drug; and signature of a witness to waste.
- The disposition of the remainder of a controlled drug must be documented as wasted or destroyed and cosigned by a licensed person.
- The person responsible for the incorrect or incomplete entry of drug administration should be required to make an entry or correction. If necessary, the supervisor-in-charge should make the MAR available to the responsible person.
Review of hospital's document titled, "Incident and Accidents," dated 05/01/24 through 11/12/24, showed from 08/01/24 through 11/12/24 a total of 98 incidents with 84 documented as medication errors.
Review of the hospital-provided incident report dated 11/11/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff KK, Registered Nurse (RN), removed Tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) 50 mg from the ADM for Patient #10 on 11/09/24 at 4:51 PM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of Patient #10's orders showed an order for oral Tramadol 50 mg every six hours as needed for pain was entered on 11/07/24.
Review of Patient #10's MAR showed tramadol was administered on 11/09/24 at 10:26 AM only. No other doses were documented as administered on 11/09/24.
Review of Patient #10's pain assessment on 11/09/24 showed an assessment and reassessment both documented at 6:21 PM by Staff KK, RN, for an encounter at 11:21 AM. Patient #10 rated her pain level at 8/10 and 0/10.
Review of the hospital-provided incident report dated 09/03/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed lorazepam (a medication used to treat anxiety or sleep difficulty) one mg tablet for Patient #12 from the ADM on 09/02/24 at 5:19 PM. The medication was not documented as administered on the Patient #12's MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of the hospital-provided incident report dated 11/07/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff Y, RN, removed oxycodone-acetaminophen (synthetic pain medication with a high risk for misuse) 5/325 mg tablet for Patient #12 from the ADM on 11/05/24 at 6:18 PM. The medication was documented as administered at 6:15 PM and the administration signed at 6:35 PM.
Review of Patient #12's physician orders showed an order for lorazepam one mg tablet as needed for anxiety entered on 07/02/24 and an order for oxycodone-acetaminophen 5/325 mg as needed for pain every six hours entered on 09/17/24.
Review of Patient #12's MAR for 09/02/24 showed she was administered lorazepam one mg tablet at 5:54 AM. No other doses were administered. Her MAR for 11/05/24 showed the dose was administered at 6:15 PM.
Review of the hospital-provided incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff LL, APRN, removed and administered lorazepam two mg to Patient #19 on 10/19/24 at 7:06 AM. There was not an active order for the medication for Patient #19, however staff were able to remove the medication without an over-ride because a previous one-time order from the previous day was still active. Staff F located a note in the patient's medical record documenting the patient was agitated and pulled his trach out.
Review of Patient #19's physician orders showed a one-time order for lorazepam one mg IV ASAP entered by Staff LL, APRN, on 10/19/24 at 3:58 PM.
Review of the hospital-provided incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed oxycodone five mg from the ADM for Patient #25 on 10/17/24 at 10:29 AM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of Patient #25's physician orders showed an order for oral oxycodone five mg administered as needed for pain levels reported between seven and ten was entered on 10/03/24 at 9:16 PM.
Review of Patient #25's MAR showed the patient was administered oxycodone five mg at 8:34 PM by Staff II, Licensed Practical Nurse (LPN). There was no documentation that oxycodone was administered to Patient #25 at any other time on 10/17/24.
Review of Patient #25's pain scale assessment (pain rating on a scale of zero to ten, zero means no pain and a ten means worst pain possible) showed no pain level assessment from 10/16/24 at 9:33 PM until 10/17/24 at 8:34 PM.
Review of the hospital-provided incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed methadone (a medication used to treat moderate to severe pain or to treat narcotic drug addiction) 10 mg from the ADM for Patient #26 on 10/16/24 at 10:23 AM. The medication was documented as administered in the MAR at 9:25 AM.
Review of Patient #26's MAR showed a scheduled dose of methadone (a medication used to treat moderate to severe pain or to treat narcotic drug addiction) 95 mg at 9:00 AM, the dose was recorded as administered by Staff J, RN, on 10/16/24 at 9:25 AM and signed at 10:26 AM. Patient #26's pain scale assessment was documented on the MAR as eight at 9:25 AM and was documented as reassessed at 10:25 AM without a pain level identified.
Review of the hospital-provided incident report dated 10/18/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed methadone tablets from the ADM for Patient #26 on 10/17/24 at 11:09 AM. The medication was documented as administered in the MAR at 9:13 AM and signed by the nurse at 11:14 AM. The incident report also showed Staff J documented Patient #26 was given a hydromorphone (a potent opioid analgesic drug) injection at 11:13 AM, signed the administration at 11:56 AM and withdrew the hydromorphone from the ADM at 11:20 AM.
Review of the hospital-provided incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed hydromorphone two mg from the ADM for Patient #26 on 10/18/24 at 12:30 PM. The medication was not documented as administered in the MAR. A waste for one mg of hydromorphone was completed at 1:10 PM, leaving one mg of the hydromorphone unaccounted for.
Review of Patient #26's physician orders showed an order for oral methadone 95 mg in 10 mg tablets administered once per day was entered on 10/09/24 at 4:50 PM and an order for hydromorphone two mg injection every four hours as needed for pain was entered on 10/09/24 at 6:44 PM.
Review of Patient #26's MAR showed hydromorphone was administered on 10/18/24 at 3:36 AM and 5:07 PM.
Review of the hospital-provided incident report dated 10/17/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff J, RN, removed morphine (an opioid pain medication) four mg from the ADM for Patient #27 on 10/16/24 at 2:17 PM. The medication was not documented as administered in the MAR, nor was it returned to the ADM or wasted. The medication was unaccounted for.
Review of Patient #27's physician orders showed an order for intravenous (IV, to manually administer a dose of medication through a tube into a vein) morphine administered prior to wound dressing changes was entered on 10/01/24 at 3:05 PM.
Review of Patient #27's MAR showed she was not administered IV morphine between 10/14/24 and 10/20/24.
Review of the hospital-provided incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error and showed Staff Z, RN, removed and administered lorazepam two mg to Patient #28 on 10/20/24 at 7:48 AM. There was not an active order for the medication for Patient #28. Staff F located a note in the patient's medical record documenting the patient was having a seizure.
Review of the incident report dated 10/22/24 showed Staff F, Pharmacy Director, documented a medication error which showed Staff Z, RN, removed and administered lorazepam two mg to Patient #28 on 10/20/24 at 7:48 AM. There was not an active order for the medication.
Review of Patient #28's medication orders showed a one-time order for lorazepam one mg IV for seizure activity entered by Staff LL, Advanced Practice Registered Nurse (APRN, a nurse with advanced clinical education and training), on 10/29/24 at 7:00 AM. Additional directions for the order showed "Order should have been for 10/20/24 at around 7:20. Not allowing me to back date the order given on 10/20/24."
During an interview on 11/19/24 at 4:05 PM and on 11/21/24 at 8:15 AM, Staff F, Pharmacy Director, stated that she did not believe that the hospital was addressing medication errors. She did not believe that the errors were related to diversion of controlled substances, but a result of negligent documentation by nursing personnel. Medication errors were presented to the Chief Clinical Officer (CCO) in the form of incident reports and for the past month she had also included the Director of Quality Management (DQM) from the hospital's corporate office. Medication errors were a problem for the hospital last year, but the hospital provided education and the number of errors improved significantly. Over the previous six months the number of patients, as well as the number of new staff had increased; and the number of medication errors also increased.
During interviews on 11/20/24 at 8:55 AM and 11/21/24 at 11:55 AM, Staff E, CCO, stated that he was aware of the number of medication errors identified and had developed a document to track the reports to identify trends. Staff E stated that some errors showed controlled substances pulled from the ADMs and were never documented as given to the patient. His resolution was to speak directly with the nurse who pulled the medication and ask if the medicine was given to the patient. He did not follow-up the investigation of an unaccounted controlled substance with patient interview or review of pain documentation; but did not believe that the medications were being diverted by the nurses. He felt that the number of medication errors would improve because he talked with each nurse face-to-face. All staff were aware of the importance of reducing the incidents of medication errors and repeated negligence could result in disciplinary action.
During an interview on 11/21/24 at 10:25 AM, Staff Z, RN, stated that the hospital held a meeting with charge nurses on 11/20/24 and informed them of the concern with medication errors. Nursing staff were informed to adjust times to make consistent with the time the medication was administered to the patient.
During an interview on 11/20/24 at 10:00 AM, Staff C, Chief Executive Officer (CEO), stated that he was aware of a problem with medication errors, but not the volume of the errors. The corporate office saw and signed off on all incident reports and therefore they were also aware of the number of incident reports identified as medication errors. The medication errors were presented during a weekly meeting of audits by each department because of incident reports and the categorization of the event being identified as medication errors. Staff C was not aware if nursing staff were aware of the number of medication errors identified.
Tag No.: A0502
Based on observation, interview, and policy review, the hospital failed to ensure patient medications were properly secured and labeled with a patient identifier for six patients (Pt #1, #2, #3, #6, #8, and #16) out of 12 patient rooms observed. These failed practices had the potential to cause harm for all patients receiving medications in the hospital.
Findings included:
Review of hospital policy titled, "Drug Storage General," dated 04/2020, showed drugs will be stored with appropriate safeguards, so that unauthorized individuals do not have access to them.
Review of hospital policy titled, "Drug Storage Floor Stock," dated 08/2022, showed floor stock medications will be secured and/or locked as to prevent unauthorized access.
Observation on 11/12/24 at 3:30 PM, showed three normal saline (solution made of salt and water) 10 cc syringes in an unlocked drawer of Patient #1's room. The syringes were not labeled with a patient identifier and were not secured in the dedicated medication lock box.
Observation on 11/12/24 at 4:00 PM, showed three normal saline 10 cc syringes and three heparin (a medication used as a blood thinner or to prevent blood clots from forming) 50u/3ml syringes in an unlocked drawer of Patient #2's room. The syringes were not labeled with a patient identifier and were not secured in the dedicated medication lock box.
Observation on 11/12/24 at 4:10 PM, showed one normal saline 10 cc syringe laying on the bedside table of Patient #3's room. It was not labeled with a patient identifier and was not secured in the dedicated medication lock box.
Observation on 11/13/24 at 9:10 AM, showed three normal saline 10 cc syringes and three heparin 50u/3ml syringes laying on the counter of Patient #8's room. The syringes were not labeled with a patient identifier and were not secured in the dedicated medication lock box.
Observation on 11/13/24 at 11:43 AM, showed a multi-dose insulin vial laying in the medication lock box of Patient #1's room. The medication lock box was unlocked and not secure.
Observation on 11/14/24 at 9:15 AM, showed Staff L, Registered Nurse (RN), left Patient #6's medication unsecured and unattended on the top of a workstation on wheels (WOW, a computer or supply and medication storage on a wheeled stand, that can be moved from patient to patient).
Observation on 11/14/24 at 9:28 AM, showed that Staff Y, Registered Nurse (RN), left Patient #16's medications unsecured and unattended on the top of a WOW.
During an interview on 11/12/24 at 3:30 PM, Patient #1 stated that staff leave normal saline filled syringes in the drawer in her room all the time to have them readily available when they need them. She stated, "I could do it myself with them just lying in there."
During an interview on 11/12/24 at 4:00 PM, Patient #2 stated that medication filled syringes were kept in the top drawer. Staff always keep a supply in the drawer of her room.
During an interview on 11/13/24 at 10:15 AM, Patient #2 stated that the previous night someone came and removed all of the medication filled syringes out of the drawer and told him that "State was here", and they "had to put them away."
During an interview on 11/12/24 at 4:10 PM, Patient #3 stated that the nurses always keep extra syringes of normal saline flush in the room. The syringes were usually kept in a drawer or on the countertop by the sink.
During an interview on 11/19/24 at 1:00 PM, Staff I, Director of Pharmacy, stated that patient medications were not to be kept in patient room drawers or on bedside tables. Each patient room had a lock box available for the storage of medications.
During an interview on 11/20/24 at 8:55 AM, Staff E, Chief of Clinical Operations (CCO) stated that all patient medications should be properly secured and not kept in patient drawers or on bedside tables. They should be labeled with a patient identifier.