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Based on interviews and document review the facility failed to have an arrangement for or establish a process for the procurement and transfusion of blood products.

Findings include:

1. The facility failed to establish a process for the procurement, storage, and transfusion of blood products or have an arrangement for blood transfusion.

a. On 12/10/18 at 2:00 p.m., observations were conducted of the facility's emergency room. During the time of the observation, the registered nurse (RN #12) explained the facility had no process to store or transfuse blood products for patients. According to the interview, patients requiring blood products received the transfusion during emergency medical services (EMS) transport or at the next accepting hospital. However, there was no arrangement in place for the process.

b. A review of clinical policies was conducted, and found no evidence the facility had a governing body approved policy or procedure for the procurement, storage, or administration of blood products.

c. On 12/13/18 at 8:41 a.m., an interview was conducted with the facility's chief nursing officer (CNO #1). According to the interview, the facility had no process to store or administer blood products on site. According to CNO #1, any patient that required an emergent or non-emergent blood transfusion was transferred to a higher level of care, therefore the facility had no process in place to store and administer blood on-site. CNO #1 stated patients requiring emergent blood would receive the transfusion with EMS personnel while transporting to another hospital. CNO #1 also stated patients requiring non-emergent blood may receive the transfusion during EMS transport, or at the accepting hospital when they arrived.

CNO #1 stated the facility attempted in the past to access funding in order to develop a process to provide blood products on-site, however the financial grant was denied and the facility was unable to move forward with the plan.

CNO #1 confirmed the facility had not formulated a formal policy and procedure because they had not developed a process to obtain blood products or transfuse blood products emergently and non-emergently. CNO #1 was also unable to provide a contracted agreement with an outside agency regarding the storage or procurement of blood products or other arrangement.

Based on the onsite complaint investigation, completed January 9, 2019, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K211, K222, K232, K324, K353, K363, K711, and K918. See survey event ID #1WZZ21 for full details of the cited deficiencies.

Based on observation, interviews, and document review the facility failed to ensure glucometer quality control testing supplies were labeled and discarded according to manufacturer instructions. The failure was identified in 2 of 2 glucometer quality control testing supplies reviewed.

Findings include:

Facility policy:

The policy, Point of Care Glucose Testing, stated for glucose meter testing the test strips and control solutions must be checked for an expiration date. For point of care testing, the test strips must be checked for expiration before use.

The policy, Use of Glucometer, outlined the procedure for use and included making sure the strips were not outdated.

Reference:

The user instruction guide for the SD Gluco Navii explained the test strips should be discarded after six months from opening. The instructions noted the control solution could be used for three months after opening the container and the opened date should be written on the container for reference.

1. The facility failed to ensure glucometer quality control testing supplies were labeled and discarded according to manufacturer instructions.

a. On 12/10/18 at 1:20 p.m., observations were conducted of the inpatient nursing station which identified two opened bottles of control solutions (high control and low control, used for glucometer quality control testing) without evidence the staff labeled the opened date. The bottle of high solution had a manufacturer's expiration date of 11/17/18 but was still available for use on 12/10/18. This was in contrast to the manufacturer's instructions.

b. On 12/10/18 at 2:04 p.m., observations were conducted of the extended care unit nursing station which identified an open bottle of high control solution and an open container of test strips (strips inserted into the machine to run patient and control tests). Neither of the bottles were labeled the opened date.

c. On 12/11/18 at 10:05 a.m., an interview was conducted with Registered Nurse (RN) #10. RN #10 stated that upon opening the control solutions and test strips, the person doing so, should date them in order to properly identify the discard date.

d. On 12/11/18 at 10:20 a.m., an interview was conducted with the licensed practical nurse (LPN #11). She explained that she would refer to the control solution and test strip bottles for expiration details as needed. LPN #11 confirmed that upon opening the control solutions and test strips, the person doing so should date them for proper expiration identification.

e. On 12/10/18 at 2:28 p.m., an interview was conducted with the director of the extended care unit (Director #9) regarding the requirements for labeling glucometer quality control testing supplies. She explained that if an opening date was not labeled on the control solutions or the test strips, it could note be appropriately determined when the items would expired. Director #9 verified the unlabeled high control solution and container of test strips were not in accordance with the facility's policies.

f. On 12/13/18 at 8:41 a.m., an interview was conducted with the chief nursing officer (CNO #1). She confirmed the expectation of staff was to properly label glucometer control solutions and test strips upon opening.

Based on interviews and document review, the facility failed to ensure a physician order was obtained for patient restraints in one of one restraint medical records reviewed (Patient #1).

Findings include:

Facility policy:

The Non-behavioral Restraint policy read, behavioral restraints were beyond the scope and resources of the hospital. In the event there is a delay in transfer, the sheriff's office will be contacted for additional assistance. Each episode of restraint requires an order by a physician or other licensed independent practitioner primarily responsible for the patient's ongoing care.

1. Nursing staff did not obtain a physician order for restraints.

a. Review of Patient #1's medical record revealed, the patient presented to the emergency department (ED), on 12/1/18 at 11:40 p.m., for alcohol intoxication and an overdose of Baclofen (a medication to treat muscle spasms).

Review of Physician #6's hospital course documentation in the discharge summary, showed Patient #1 required medical monitoring because of the Baclofen overdose.

b. Review of Patient #1's nursing notes revealed, on 12/2/18 at 12:07 a.m., Registered Nurse (RN) #4, documented Patient #1 became combative and verbally abusive. The local sheriff department was notified and an officer responded. RN #4 then documented Patient #1 began hitting himself in the face and both the officer and the certified nursing assistant (CNA) attempted to restrain the patient.

At 12:27 a.m., RN #4 documented, another officer arrived at the facility to assist with Patient #1 who was belligerent. RN #4, documented soft restraints had been initially applied but the patient was able to break through the restraints. She also noted, the patient refused being placed on monitors and other interventions. RN #4 documented both officers and the CNA were able to handcuff the patient and put him on the stretcher.

According to the physician's documentation in the discharge summary hospital course, Patient #1 was handcuffed to the gurney. Physician #6 also documented in is note, medical staff recommended restraint.

At 1:00 a.m., RN #4 documented the patient insisted to be released, but remained restrained.

At 1:48 a.m., RN #4 documented the patient was quiet but thrashing around at times. The patient remained restrained. The sheriff remained in attendance.

At 2:40 a.m., the nursing notes showed, medical transport team arrived to transfer the patient to another hospital.

On review of Patient #1's entire medical record, there was no evidence of a physician order for Patient #1 to be restrained. This was in contrast to policy.

c. On 12/14/18 at 9:41 a.m., an interview was conducted with the chief nursing officer (CNO #1) who stated a restraint was anything chemical or physical which would restrict a patient's movement.

CNO #1 provided the nursing note timeline from Patient #1's medical record. She stated there was no order in the medical record. CNO #1 stated Patient #1 was extremely violent and staff were not able to calm him down. She stated the patient was only in soft restraints for a couple of minutes before he broke loose from the soft restraints.

CNO #1 confirmed the patient was placed in handcuffs by the sheriff's department. She said the sheriff's department assisted with hospital security and made the decision to restrain the patient with handcuffs to the stretcher. However, according to the physician's documentation in the discharge summary hospital course, when the patient was punching himself and screaming at the sheriff, the physician documented medical staff recommended restraint.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.638 Clinical Records was out of compliance.

C-0303- Records Systems: A designated member of the professional staff is responsible for maintaining the records and for ensuring that they are completely and accurately documented, readily accessible, and systematically organized. The facility failed to have a single unified, systematically organized medical record for inpatients, including acute inpatients and swing bed patients. Medical record review showed a separate electronic medical record was utilized for 3 of 16 medical records (Patients #15, #16 and #17).

Based on interviews and document reviews, the facility failed to have a single unified, systematically organized medical record for inpatients, including acute inpatients and swing bed patients. Medical record review showed a separate electronic medical record was utilized for 3 of 16 medical records (Patients #15, #16 and #17).

Findings include:

References:

According to the AthenaHealth electronic medical record (EMR) service proposal, the agreement between the facility and AthenaHealth was executed on 1/2/18.

According to the Point Care Click electronic medical record product subscription and service agreement,
Point Care Click product subscription was agreed upon by facility staff and the Point Care Click representative on 11/28/12.

1. The facility did not have one unified medical record system. Specifically, the facility had two separate EMR systems in place. The facility had one EMR for acute patients (Athena) and another EMR for long term patients (Point Click Care).

a. Review of the admission's lists provided, revealed two different EMR reports.

On 12/10/18 at 3:08 p.m., an interview was conducted with the chief nursing officer (CNO #1). She stated "Athena" was the EMR used for the acute patients and the "Point Click Care" medical record system was used for the long term swing patients. CNO #1 stated acute patients included emergency department patients, acute swing patients and inpatients.

b. Review of 16 inpatient records revealed four patients were swing bed patients. Of the four swing bed patients, three patient medical records were provided through Point Click Care. The fourth swing bed patient (Patient #2) was documented in the Athena EMR.

c. Comparison of the two different EMRs revealed a different format for care plans. As example, Patient #15's care plan which was documented in Point Click Care, revealed five separate columns for staff documentation. The columns were labeled: Focus, Goal, Interventions/Task, Position and Frequency/Resolved. Review of Patient #15's entire care plan showed, multiple disciplines (nursing, activities, physical therapy), documented throughout each of the labeled columns. Patients #16 and #17 had the same format.

The Athena care plan format for Patient #2, who was also a swing bed patient, showed care plan documentation was found throughout the medical record review. This was different from the other swing bed patients' all encompassing documentation. For example, nursing care plans in Athena were documented in the Nursing Assessment section. The physical therapy plan of care was documented in the Therapy Notes section.

d. On 12/11/18 at 8:42 a.m., CNO #1 stated when the facility went live with Athena in August, the company did not recommend the new system to be used for the long term patients. She stated the long term patient's information would drop off after 30 days, and the patient would have to then be readmitted into the system.

e. On 12/11/18 at 12:00 p.m., Chief Executive Officer (CEO) #2 was interviewed. She stated the reason the facility kept Point Click Care EMR, was the volume of documentation. She stated both the new EMR, Athena and the old inpatient EMR were not designed to store the volume of notes required by the long term patients. She stated if the facility used Athena for the long term patients, staff would be required to discharge and readmit the patient. CEO #2 stated the facility did not identify this issue until the early implementation stages of Athena.

f. Review of facility contracts provided by the CEO upon exit of the survey, showed two contracts in place for electronic medical record systems. One service agreement was for Point Click Care Product Subscription and the other was for AthenaHealth.

Based on document review and interviews the facility failed to provide evidence that every resident (patient) received a comprehensive care plan which involved the resident's attending physician. The failure was identified in 3 of 4 swing-bed patient medical records reviewed (Patients #15, #16, and #17).

Findings include:

Facility policy:

The policy, Comprehensive Care Plan, stated a comprehensive care plan will be developed for each resident using the results of the comprehensive assessment. Resident care plans shall be reviewed at least quarterly by the interdisciplinary team. Each resident's care plan shall include measurable objectives and timetables to meet all resident needs identified in the comprehensive assessment. Each resident's plan of care shall be developed within seven days after completion of the comprehensive assessment. The interdisciplinary team would include the residents attending physician, or provider.

a. A medical record review was conducted for Patient #15 who was admitted for swing-bed services on 7/1/13. Review of the medical record from the dates of July 2018-December 2018 found no documented evidence of the attending physician's participation in interdisciplinary care plan meetings which formulated the resident's (patient's) comprehensive care plan.

Review of the comprehensive care plan identified the "focus [of the resident's identified needs or deficits]", the goal of the treatment plan for each focus identified, and the planned interventions to achieve each of the goals. Further review of the care plan identified documentation from the following clinical roles: certified nurse assistant (CNA), the registered nurse, the resident activities staff, and social worker. However, no documented evidence identified the attending physician's role in assessing the comprehensive assessments with the interdisciplinary team and formulating a comprehensive care plan.

b. A medical record review was conducted for Patient #16 who was admitted on 8/9/16 for swing-bed services. Review of the record for the dates of July 2018-December 2018 identified similar findings where the interdisciplinary care plan found no documented evidence of the attending physician's involvement in developing the comprehensive care plan.

Similar to Patient #15, the comprehensive care plan identified the focus, goals of the treatment plan, and the planned interventions to help achieve those goals. The comprehensive care plan included documentation from the following departments: nursing staff, therapy, resident activities, dietary, and social work. Review of the comprehensive care plan found no documented evidence of the attending physician's involvement with the interdisciplinary team in reviewing the comprehensive assessments and formulating a comprehensive care plan.

c. A medical record review was conducted for Patient #17 who was admitted on 7/1/13 for swing-bed services. Review of the medical record for the dates of July 2018 - December 2018 also found a lack of physician involvement in reviewing the interdisciplinary comprehensive assessments and formulating a comprehensive care plan with the resident's interdisciplinary team.

Documented evidence of those involved in formulating the comprehensive care plan was identified with the nursing staff, resident activities staff, social services, dietary, and therapy staff. However, review of the comprehensive care plan found no documentation of the physician's involvement in reviewing comprehensive assessments and formulating the comprehensive care plan with the patient's interdisciplinary team.

d. On 12/13/18 at 3:16 p.m., an interview was conducted with the director (Director #9) of the long term swing bed unit. According to the interview, the resident's comprehensive assessment was updated quarterly and used to create the comprehensive care plan. Director #9 stated the facility conducted interdisciplinary care plan meetings (care plan meeting) at least quarterly in order to develop the comprehensive care plan. Director #9 stated the care plan meeting always included the attending physician, but stated the physicians conducted a verbal discussion with the interdisciplinary team and did not document the process into the medical record.

According to Director #9, the facility documented in two different electronic medical records (EMR), and had been working on improving physician documentation in the EMR system utilized for Patients #15, #16 and, #17. Director #9 reviewed the medical records for Patients #15, #16 and, #17 and confirmed there was no documentation the attending physician participated in the interdisciplinary care plan meetings. Director #9 stated there wasn't documented "attestation by the attending physician" they attended the care plan meeting and participated in the process to develop the comprehensive care plan for either of the three patients reviewed during the interview.

Based on interviews and document reviews, the facility failed to identify in their written emergency plan, which facility patient populations would be at risk during an emergency event.

Facility findings:

1. The facility's written emergency plan did not include which facility patients would be at risk during an emergency event. There was no documentation the facility identified which patient populations were at risk during an emergent event.

a. On 12/14/18 at 10:42 a.m., an interview was conducted with the director of quality (Director #3) and the chief executive officer (CEO #2). Both stated all their patients would be at risk during an emergency event. However, neither employee could find evidence of this decision in the written plan reviewed during the interview.