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Based on document review and interview, it was determined that the Hospital failed to protect and promote each patient's rights related to restraint use and patient care. Therefore, the Condition of Participation, 42 CFR 482.13 Patient Rights was not met.

Findings include:


1. The Hospital failed to ensure the patient/representative was informed of changes in patient condition and participated in the the plan of care. See A-0130

2. The Hospital failed to provide goods and services necessary to avoid physical harm by failing to follow the nursing care plan in order to prevent skin breakdown, See A-0145

3. The Hospital failed to provide goods and services necessary to avoid physical harm by failing to follow the nutritional plan of care recommended by the dietitian. See A-0145

4. The Hospital failed to provide assessments and interventions prior to administering medications used to restrict and manage patient's movement. (chemical restraint) See A-0160

Based on document review and staff interview it was determined for 1 of 10 (Pt #1) patient medical records reviewed, the Hospital failed to ensure the patient/representative was informed of changes in patient condition and participated in the the plan of care. This has the potential to effect all patients receiving services.-average daily census-110.

Findings include:

1. The hospital policy, revision date 9/8/20, titled, "Patient Rights and Responsibilities" was reviewed on 11/29/21 at 1:00 PM. The policy under "PROCESS: I. As key members of the Health Care Team, patients have the right to:...G. Have a family member, support person, or other individual involved in treatment decisions or make health care decisions for them, to the extent permitted by law.

2. On 11/29/21-12/2/21, the medical record of Pt #1 was reviewed. Pt #1 was admitted on 9/27/21 via the emergency department (ED) for altered mental status. On 9/27/21 at 7:08 PM, Pt #1 was admitted to the intensive care unit (ICU) with diagnoses of altered mental status, diabetic ketoacidosis, hyperglycemia and hyperkalemia. Pt #1 also had bilateral foot ulcers and was on intravenous (IV) antibiotics at home via a peripherally inserted central catheter (PICC) for bone infection. On 9/28/21 at 3:48 PM, Pt #1 was transferred to the medical surgical unit (MSU). On 9/29/21 at 7:33 AM, Pt #1 had a debridement of left heel and bilateral integra grafts placed under monitored anesthesia care (MAC). Documentation indicated Pt #1 had confusion and attempts to get out of bed after procedure. On 9/28/21 at 9:38 PM, according to the medication administration record (MAR), Pt #1 received first dose of Geodon (antipyschotic) 10 mg intramuscularly (IM) per verbal order of nurse practitioner (E#3) for attempting to get out of bed. On 9/29/21 at 12:21 AM, Pt #1 received a second dose of Geodon 10 mg IM per verbal order of E#3 for attempting to get out of bed. There was no documentation that patient or family representative was notified of changes in behavior, plan of care, or administration of Geodon.

3. On 12/1/21, an interview was conducted with the regional regulatory specialist (E#1). E#1 reviewed the medical record of Pt #1 and confirmed the lack of documentation of patient or family involvement with the changes in patient behavior or the plan of care.

A. Based on document review and staff interview, it was determined for 1 of 10 (Pt #1) patient, the nursing staff failed to provide goods and services necessary to avoid physical harm by failing to follow the nursing care plan and skin care policy, to prevent skin breakdown, This failure has the potential to affect all patients, an average of 110 inpatients.

Findings include:

1. The hospital policy titled "Skin Care for Adults (last revision 8/5/2019). The policy indicates on page 2 under III Planning/Intervention, A. For patients with Braden score of 18 or less, consider initiating preventative measures and the preventative portion of the SSM Health Systems Inpatient Skin Care Guidelines and Specialty Mattress-Surface Algorithm attachment. The attachment, page 1 under "Pressure Redistribution 1. Initiate individual turn schedule. Turn and/or reposition frequently with goal of at least every 2 hours and at least every 1 hour for sitting with small weight changes every 15 minutes.

2. A review of the medical record of Pt #1 was conducted on 11/30/21 to 12/1/21. Pt #1 was admitted to the hospital on 9/27/21, with diagnoses of of osteomyelitis of the calcaneous bone, history of cellulitis, diabetes mellitus with diabetic ketoacidosis and metabolic encephalopathy. Pt #1 also had bilateral foot ulcers and was on intravenous (IV) antibiotics at home via a peripherally inserted central catheter (PICC) for bone infection. Pt #1 received an initial skin assessment on 9/27/21 at 3:15 PM, with a Braden score of 16, indicating Pt #1 was at moderate risk for skin breakdown. The daily flowsheets and care plan throughout the hospital stay from 9/27/21 thorough 10/29/21 indicated Pt #1 was to be turned and/or repositioned every 2 hours, as well as, additional measures for pressure redistribution. Documentation failed to indicate Pt #1 was turned and/or repositioned every 2 hours, and at least every 1 hour for sitting. During admission, Pt #1 developed a wound on the coccyx documented by a photo taken on 10/23/21 (no time documented). There was no documentation of wound description or measurements in the medical record. The last documentation of coccyx wound care was a "protective dressing" on 10/27/21. Pt #1 was discharged on 10/29/21.

3. An interview was conducted with registered nurse (E#5), who provided care for Pt #1 on 10/27/21 to 10/29/21. E#5 stated, " I recall the area on the patients buttocks was slightly pink. The night shift takes pictures and changes the dressing, so we don't remove it to check. We did try to turn the patient but the patient didn't understand and wouldn't stay when turned. We had so many pillows in the bed to support Pt #1. We did get Pt #1 a special mattress." E#5 did not offer a reason why documentation was not completed on the new coccyx wound, when asked.

4. An interview was conducted with registered nurse (E#11) who provided care to Pt #1 during the first day and again the last week of Pt #1's stay. E#11 was asked if E #11 recalled the area of skin breakdown on Pt #1's coccyx and reported E #11 did not.

5. An interview was conducted with the Regional Regulatory Specialist (E#1) on 11/30/21 at 4:00 PM. E# 1 reviewed the electronic record and reported the documentation was lacking regarding the turning and/or repositioning of Pt #1. E#1 reviewed the photos of the skin breakdown of Pt #1's coccyx and confirmed the skin breakdown.
E#1 agreed the preventative measures including turning and repositioning should be completed and documented.




B. Based on document review and staff interview it was determined for 1 of 10 (Pt #1) patient, the nursing staff failed to provide goods and services necessary to avoid physical harm by failing to follow the nutritional plan of care recommended by the dietitian. This failure has the potential to affect all with compromised nutritional conditions.

Findings include:

1. A review of the hospital policy titled Patient Care (last revision date 5/26/2021) was completed on 12/2/21. The policy indicates under "Process II . Care plan process: A. Nursing staff develops and maintains a current care plan for each patient. B. Needs to be consistent with the nursing assessment. C. Needs to be consistent with the provider's plan of care."

2. A review of the medical record of Pt #1 was conducted on 11/30/21 to 12/1/21. Pt #1 was admitted to the hospital on 9/27/21 with diagnosis of of osteomyelitis of the calcaneous bone, history of cellulitis, diabetes mellitus with diabetic ketoacidosis and metabolic encephalopathy. Pt #1 also had bilateral foot ulcers and was on intravenous (IV) antibiotics at home via a peripherally inserted central catheter (PICC) for bone infection. Documentation in the nurse flowsheets indicate Pt #1 had intermittent confusion which became increased throughout the first two weeks (9/27 through 10/16/21). The initial nutritional assessment dated 9/28/21 indicates "nutritional needs are increased to aid in wound healing". Several changes were made to Pt #1's nutritional plan from 10/5 through 10/18/21 including the addition of supplements and increased protein at meals. "The patient is receiving 60g(gram) CCHO (consistent carbohydrate diet) 1oz extra protein at lunch and dinner... Mighty Shake (extra protein and calories) 1 x daily to help increase intake." The follow up nutritional note on 10/15/21 indicates "Staff to feed diet with Juven and Prostat (both supplements) bid (2 x daily)." An order was written by the dietician on 10/22/21 for "pureed diet with nectar thick liquids via a teaspoon only, crush medications and nursing to feed". In addition, "One to one assist with moderate verbal cues on all PO (by mouth) is necessary". Pt #1's record lacked documentation of assistance with meals, assistance provided with the supplements, and Pt #1's intake of the supplements or meals. Pt #1's care plan lacked documentation of; changes in nutritional needs, feeding assistance nor nutrition orders of the Pt #1 was to be fed by a nurse, "one to one." The dietician note of 10/19/21 indicates "noted weight loss of 18.9% (50 lb) x 3 months-Severe ...therefore the patient (Pt #1) has met the criteria for severe malnutrition." Pt #1 was in the hospital from 9/27/21 to 10/29/2021.

3. Pt #1's record indicates on the clinical data weight flowsheet the following weights: 9/27/21- 128 kg, 10/02/21 -124.5 kg ( loss of 3.5 kg), 10/16/21-118 kg (loss of 5.5 kg), 10/17/21-123.5 kg (gain of 5.5), 10/18/21-120 kg (loss of 3.5 kg), 10/20/21-119 kg (loss of 1.0 kg), 10/21-119 kg (unchanged).

4. Interviews were conducted on 11/30/2021 and 12/1/2021 with E#5 and E#11, who provided care for Pt #1 during his hospital stay. E#5 or E#11 could not answer why the care plan was not updated and followed regarding the changes in Pt #1 nutritional needs.

5. An interview with the Regional Regulatory Specialist (E#1) on 12/1/21 at 3:00 PM. E#1 agreed there were no changes to Pt #1's care plan to show the needs related to nutrition, in both types of diet and the need for attention by staff to feeding. E#1 agreed there was no documentation to show the amounts of food or oral nutritional supplements or if/how Pt #1 was assisted with or provided the nutrition ordered.

Based on document review and staff interview it was determined for 1 of 10 (Pt #1) patient medical records reviewed, the Hospital failed to provide assessments and interventions, prior to administering medications used to restrict and manage patient's movement. (chemical restraint) This has the potential to effect all patients receiving psychiatric medications.

Findings include:

1. The hospital policy, revision date 2/22/21, titled, "Non-Violent Restraints and Restraint Alternatives" was reviewed on 11/29/21 at 1:15 PM. The policy under "PROCESS: II. Assessment: Assess patient to determine the need for restraint or restraint alternatives. A. Assess cognitive deficits...B. Assess medical reasons..C. Assess the patient environment. D. Assess Patient: 1. Patient/family/significant others concepts and feelings about restraints..."Under III. Prior to the use of restraints, the following intervention, as appropriate, should be considered, including but not limited to: A. Offering companionship...B. Control the environment...C Provide orientation to reality...D. Medication Evaluations 1. Consider pharmacy consultation. E. Diversional Activity...",

2. On 11/29/21-12/2/21, the medical record of Pt #1 was reviewed. Pt #1 was admitted on 9/27/21 via the emergency department (ED) for altered mental status. Pt #1 did not have a history of mental illness or being on antipsychotic medications. On 9/27/21 at 7:08 PM, Pt #1 was admitted to the intensive care unit (ICU) with diagnoses of altered mental status, diabetic ketoacidosis, hypergylcemia, hyperkalemia and bilateral foot ulcers with bone infection. According to the medication administration record (MAR) on 9/28/21 at 9:38 PM, Pt #1 received first dose of Geodon (antipyschotic) 10 mg intramusular (IM) per verbal order of nurse practitioner (E#3) for attempts to get out of bed. On 9/29/21 at 12:21 AM, Pt #1 received a second dose of Geodon 10 mg IM per verbal order of E#3 for attempts to get out of bed. On 9/29/21 at 5:25 PM, Geodon 10 mg IM given per order of hospitalist (E#4) for attempts to get out of bed. On 9/29/21 at 10:28 PM, Geodon 20 mg given IM per order of E#3 for Pt #1's attempt to get our of bed. On 9/30/21 at 9:25 PM, Geodon 10 mg given IM and Ativan (anti-anxiety)1 mg IV given for attempts to get out of bed. On 9/30/21 at 12:24 PM, documentation in the "Hospitlist Progress Note" indicated "Patient's encephalopathy again intermittent following surgery. This remains a barrier to discharge. Requires PRN (as needed) chemical restraint since verbal redirection did not achieve goal to keep patient in bed and removing medical lines/devices/wound vac." On 10/1/21 at 11:28 AM, the "Hospitlist Progress Note" indicated "Patient's acute metabolic encephalopathy persistent. Requires PRN chemical restraint when verbal redirection did not achieve goal to keep patient in bed and removing medical lines/devices/wound vac." The medical record lacked documentation to indicate patient assessments were completed prior to administering any restrictive medications. The medical record lacked documentation of attempted use of other least restrictive interventions or pharmacy consultation, prior to the use of chemical restraints.

3. On 11/29/21 at 1:30 PM, the "Restraint log" was reviewed for 9/1/21-present. Pt #1 was not listed on the log.

4. On 12/2/21 at 2:30 PM, an interview was conducted with the regional regulatory specialist (E#1). E#1 reviewed the medical record of Pt #1 and confirmed E#4 did document the medications as chemical restraint. E#1 also confirmed Pt #1 was not entered into the "Patient with Restraints" log. E#1 confirmed there were no assessments completed or pharmacy consultations prior to restrictive medication administrations for Pt #1.