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Based on the systemic nature of the standard level deficiencies related to patient rights, the facility failed to comply with this condition.

The findings were:

(482.13(a)(2) Tag A-0118)
Based on interview and document review, it was determined the patient relation/advocate staff failed to follow the facility's process for grievance resolution for one (1) of two (2) grievances reviewed. (Patient #6)

(482.13(a)(2)(ii) Tag A-0122)
Based on interview and document review, it was determined the patient relations/advocate staff failed to follow the facility's process for notifying a complainant in writing within thirty (30)-days regarding the grievance resolution for one (1) of two (2) grievances reviewed. (Patient #6)

(482.13(e)(4)(i) Tag A-0166)
Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure the plan of care for one (1) of nineteen (19) patients was modified to include the use of restraints (Patient #16).


(482.13(e)(4)(ii) Tag A-0167)
Based on clinical record review, staff interview, and facility document review, it was determined the facility staff failed to ensure restraints were monitored per facility policy for two (2) of nineteen (19) patients (#15 and #17) and that physician's orders were followed for one (1) of nineteen (19) patients (#13) regarding the type of restraint to be used.

(482.13(e)(5) Tag A-0168)
Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure physician's orders were obtained for the use of restraints for three (3) of nineteen (19) patients who had documented use of restraints (Patient #13, #15 and #20).

(482.13(e)(11) Tag A-0176)
Based on employee record review, staff interview and facility document review, it was determined the facility staff failed to ensure four (4) of four (4) facility staff identified as "rotating residents" and one (1) of five (5) facility resident staff, who had written orders for restraints, received training regarding the facility policy on the use of restraints at the facility.

(482.13(e)(12) Tag A-0179)
Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure each patient who had orders for the use of restraints were seen face-to-face by an LIP (Licensed Independent Practitioner) at the initiation of the restraint (every calendar day for non-violent restraints and within one hour for violent restraints) for three (3) of nineteen (19) patients. (Patient #4, 5, and 22)

Based on interview and document review it was determined the patient relation/advocate staff failed to follow the facility's process for grievance resolution for one (1) of two (2) grievances reviewed. (Patient #6)

The findings included:

Review of Patient #6's electronic medical record (EMR) documented the patient's admission date as April 9, 2018. Patient #6's admission diagnoses included an elevated INR level (11.5) and "bilateral infratentorial hyperdensity" "possible SDH [subdural hemorrhage]" after a fall prior to admission.

Staff Member #43 navigated Patient #6's EMR. During the review with the surveyor an entry on April 16, 2018 by Staff Member #31 documented Patient #6's family member verbalized "frustrations at the level of care, coordination and communication given ..." A nursing entry documented the notification of Staff Member #43 and a Patient Relations Representative regarding the concerns voiced by Patient #6's family member.

On September 10, 2018 at approximately 10:39 a.m., the surveyor requested the complaint/grievance information related to Patient #6 and the outcome of the Patient Relations' investigation.

On September 10, 2018 at approximately 1:40 p.m., Staff Member #3 presented the facility's documentation regarding a discussion between a Patient Relations Representative (Staff Member #42) and Patient #6's family member. The document included Patient #6's admission date (April 9, 2018) then proceeded into the patient having a "bad night," "somnolence" the next day, and signs of weakness the following day that staff disregarded. The document did not include information related to an investigation.

On September 10, 2018 at 3:40 p.m., the surveyor conducted an interview with Staff Member #7 (Director of Patient Relations). Staff Member #7 offered the same document for review. Staff Member #7 reported the Clinical Director (Staff Member #43) contacted Patient Relations "on April 19, 2018" regarding Patient #6's family members dissatisfaction. Staff Member #7 reported the complaint information was given to Staff Member #42. Staff Member #7 reported Staff Member #42 met with Patient #6's family member to discuss the concerns. The surveyor requested clarification related to the verbalized dates and the document presented, which did not include the dates when Patient #6's family met with the Patient Representative or the dates for which the family verbalized dissatisfaction. The surveyor requested documentation of the investigation by Patient Relations. Staff Member #7 reported he/she did not have the investigation at present; only the document presented for review. Staff Member #7 and the surveyor agreed to postpone the interview until September 11, 2018 providing Staff Member #7 the opportunity to gather the documents necessary to review the facility's complaint process.

An interview was conducted on September 11, 2018 at 8:54 a.m., with Staff Member #7 in the presence of Staff Member #12 at Staff Member #7's request. Staff Member #7 verbally presented the dates corresponding to the undated information in the presented document. Staff Member #7 reported Patient Relations forwards a patient's (or family member's) concerns to the departments involved. Staff Member #7 stated, "The investigation should have been conducted by [Staff Member #43's name] and [Staff Member #31]. We don't have an investigation." The surveyor inquired if Patient Relations had a policy or process related to what happens when a department fails to investigate a patient concern. Staff Member #7 reported it was the duty of the Patient Relations Representative to contact the department/Director of the department. Staff Member #7 reported the contact "is generally captured in emails." The surveyor requested proof that Staff Member #42 contacted Staff Member #31 and #43 requesting their investigation into the concerns voiced by Patient #6's family member. Staff Member #7 stated, "I don't have that information." The surveyor inquired regarding Staff Member #7's awareness that Patient #6's family member received a letter from the facility regarding "action plans" and "educational opportunities to prevent similar issues from occurring in the future ..." Staff Member #7 reported he/she became aware of the "lack of follow through." Staff Member #7 verified staff failed to implement the facility's complaint/grievance process.

Review of the facility's policy titled "Patient Complaint / Grievance Process in the Hospital" provided the facility's expectation for implementation of the grievance process. The policy read in part "4. Complaints and grievances will be recorded in the Safety Always database and will include documentation of actions associated with case investigation, resolution and response ... IV. Procedure ... 3. Hospital employees are expected to respond to complaints expressed by a patient or their representative. If the employee is unable to resolve the patient complaint he/she should take initiative to escalate the issue to the appropriate manager and/or Patient Relations Department ... 4. d. As soon as a grievance is received, the Patient Relations Department should be notified to ensure compliance with the grievance policy. The Patient Relations Department will maintain the documentation of the grievance, including the details of the investigation and resolution ..."

Based on interview and document review it was determined the patient relations/advocate staff failed to follow the facility's process for notifying a complainant in writing within thirty (30)-days regarding the grievance resolution for one (1) of two (2) grievances reviewed. (Patient #6)

The findings included:

Review of Patient #6's electronic medical record (EMR) documented the patient's admission date as April 9, 2018. Staff Member #43 navigated Patient #6's EMR. During the review with the surveyor an entry on April 16, 2018 by Staff Member #31 documented Patient #6's family member verbalized "frustrations at the level of care, coordination and communication given ..." A nursing entry documented the notification of Staff Member #43 and a Patient Relations Representative regarding the concerns voiced by Patient #6's family member.

On September 10, 2018 at approximately 10:39 a.m., the surveyor requested the complaint/grievance information related to Patient #6 and the outcome of the Patient Relations' investigation.

On September 10, 2018 at approximately 1:40 p.m., Staff Member #3 presented the facility's documentation regarding a discussion between a Patient Relations Representative (Staff Member #42) and Patient #6's family member. The document included Patient #6's admission date (April 9, 2018) then proceeded into the patient having a "bad night," "somnolence" the next day and signs of weakness the following day that staff disregarded. The document did not include information related to an investigation.

A second interview was conducted on September 11, 2018 at 8:54 a.m., with Staff Member #7 in the presence of Staff Member #12 at Staff Member #7's request. Staff Member #7 reported Patient Relations forwards a patient's (or family member's) concerns to the departments involved for investigation. Staff Member #7 stated, "The investigation should have been conducted by [Staff Member #43's name] and [Staff Member #31]. We don't have an investigation." The surveyor inquired regarding Staff Member #7's awareness that Patient #6's family member received a letter from the facility, dated "June 25, 2018" regarding "action plans" and "educational opportunities to prevent similar issues from occurring in the future ..." Staff Member #7 reported he/she became aware of the "lack of follow through." Staff Member #7 did not provide the date he/she gained awareness regarding the lack of follow through and delay in providing the required response to Patient #6's family member. Staff Member #7 verified staff failed to implement the facility's complaint/grievance process. The surveyor inquired if the facility had additional documentation or a notification sent to Patient #6's family member indicating a delay regarding the investigation. During a third interview, conducted on September 11 at 12:36 p.m., Staff Member #7 stated, "There is no more information."

On September 11, 2018 at approximately 1:08 p.m., Staff Member #3 reviewed the facility's grievance log and identified the complaint filed by Patient #6's family member. The log documented the complaint was received on April 19, 2018, the letter was sent to Patient #6's family member on June 25, 2018 and the case was closed on June 27, 2018. Staff Member #3 verified the letter was sent greater than the thirty (30)-day required timeframe. Staff Member #3 verified the letter included information regarding "action plans" and "educational opportunities to prevent similar issues from occurring in the future ..." Staff Member #3 acknowledged the facility failed to perform an investigation related to the complaints raised by Patient #6's family member. Staff Member #3 verified the Patient Relations Representative failed to follow the facility's policy and procedures.

Review of the facility's policy titled "Patient Complaint / Grievance Process in the Hospital" provided the facility's expectation for implementation of the grievance process. The policy read in part "4. All grievances are responded to in writing. a. If the grievance cannot be resolved within seven [7] days, the hospital will provide a written acknowledgement within that time period. In acknowledgement, the acknowledgement, the hospital will notify the complainant of the expected period of time (in most cases, 30 days) needed to resolve the grievance. b. It is expected that most grievances can be resolved and the resolution communicated in writing within 30 days. c. The written response must include the steps taken to investigate the grievance, the results of the investigation, the date of completion ... d. As soon as a grievance is received, the Patient Relations Department should be notified to ensure compliance with the grievance policy. The Patient Relations Department will maintain the documentation of the grievance, including the details of the investigation and resolution ..."

Based on clinical record review, staff interview and facility document review, the facility staff failed to ensure the plan of care for 1 of 19 patients was modified to include the use of restraints. Patient #16.

Patient #16 had an order for the use of restraints which was not included on the patients plan of care.

The findings included:

On 9/6/18 the clinical record for Patient #16 with the assistance of Staff Member #11 (Navigator and Stroke Unit Clinical Director) was reviewed for the use of restraints. Patient #16 was admitted to the facility on 8/29/18 with diagnoses that included, but were not limited to : multivessel coronary artery disease, ischemic cardiomyopathy and non ST elevated myocardial infarction. The patient underwent an ascending aortic aneurysm repair and was ordered the use of restraints on 9/1/18 in order to prevent the patient from "dislodging necessary medical equipment and interfering with medical care". A review of the plan of care for Patient #16 revealed no inclusion of the use of the restraints. Staff Member #11 stated, "I cannot find it. There is no care plan for the use of the restraints."

The facility policy and procedure Restraints and Restraint Alternatives" was reviewed and evidenced, in part: "...B. Documentation 1. The following must be documented in the EHR (Electronic Health Record):...g. Plan of care and any modifications...2. Documentation on a daily basis must include the following components: ...g. Modifications to the plan of care, as applicable..."

The concerns were discussed with facility Administrative staff on 9/6/18 at approximately 3:30 p.m. (Staff Members #1, #3, #4, #6, #11, #12, and #18).

The concerns were again discussed during a wrap-up meeting with the facility administrative staff (Staff Members #1, #3, #4, #5, #12, and #18 - Quality Improvement director and staff, Assistant Chief Medical Officer and Regulatory Improvement Consultant) on 9/11/18 at 3:00 p.m.

Based on clinical record review, staff interview, and facility document review, the facility staff failed to ensure restraints were monitored per facility policy for 2 of 19 patients (#15 and #17) and that physician's orders were followed for 1 of 19 patients (#13) regarding the type of restraint to be used.

Patient #15 and #17 were not monitored every two hours per the requirements for restraint monitoring.

Patient #13 had orders for the use of restraints, however the restraint type documented, was not the type that was ordered.

The findings included:

1. Patient #15 was admitted to the facility on 8/29/18 with diagnoses that included, but were not limited to: traumatic subdural bleed (bleeding in the brain). Patient #15 had restraints ordered to prevent the dislodgement of life sustaining medical equipment. Review of the clinical record revealed "restraint flow sheet" documentation for the monitoring of the restraints every two hours. There was documentation at 4:00 a.m. on 9/1/18 of the every two hour checks (q2h), however there was not another check documented until 8:00 a.m.

Patient #17 was admitted to the facility on 8/2/18 with diagnoses that included, but was not limited to, bilateral pneumonia. Patient #17 had orders for the use of restraints to prevent interference with medical treatment. On 8/13/18 the clinical record revealed restraint monitoring was not completed at the q2h intervals from 2:00 a.m. through 8:00 a.m. and from 2:00 p.m. through 8:00 p.m. There was also no q2h monitoring on 8/14/18 from 2:00 a.m. until 8:00 a.m. and not again until 11:00 a.m. Monitoring was again not documented from 12:00 p.m. through 4:00 p.m. On 8/15/18 at 10:00 p.m. monitoring was documented, but was not done again until 2:00 a.m. on 8/16/18.

Review of the facility policy and procedure "Restraints and Restraint Alternatives" evidenced the following: "...V. Medical Restraint: Non-Violent and/or Non-Self Destructive Behavior C. Assessment and Monitoring- Patients restrained for medical/surgical reasons are assessed by the RN (Registered Nurse) and monitored by a qualified clinician (i.e RN, Clinical Technician) at a minimum, every 2 (two) hours, or more frequently based on clinical judgement, and according to the patient's need..."

2. Patient #13 was admitted to the facility on 8/26/18 with diagnoses that included but were not limited to, closed head injury and traumatic subarachnoid bleed. Patient #13 had orders for the use of restraints to prevent interference with medical treatment. On 8/27/18 at 10:35 a.m.,the patient had a physician's order for the use of : "Restraint type: soft limb restraint, Restraint location: Left wrist, Right wrist". According to documentation on the restraint flow record, the type of restraint documented was : "mitt R (right) and mitt L (left). " The application and documentation of the use of the right and left mitts continued from 8/27/18 at 10:30 a.m. through 8/30/18 at 2:23 a.m., even though new orders were written on 8/28/18 at 4:52 a.m. for the use of the soft limb restraint on the left and right wrist, and another order on 8/29/18 at 5:10 a.m. for the use of the soft wrist restraints bilaterally. The order for the use of the mitts: "Restraint type- Mitt, Restraint location- right wrist, left wrist" was not received until 8/30/18 at 2:32 a.m.

Review of the facility policy and procedure "Restraint and Restraint Alternatives" evidenced, "...V. Medical Restraint: Non-Violent and/or Non-Self Destructive Behavior C. Assessment and Monitoring...1. The assessment and documentation includes, as appropriate the type of restraint and/or seclusion, the following: a. correct application...e. whether the restraint has been appropriately applied..."

During the review of the clinical records on 9/5/18 and 9/6/18 for the above patients, Staff Member #11 assisted the surveyor to navigate the clinical record. The findings were discussed with Staff Member #11 upon discovery. Staff Member #12 was also present during the review and was aware of the issues identified.

The concerns were discussed with facility Administrative staff on 9/6/18 at approximately 3:30 p.m. (Staff Members # 1, #3, #4, #6, #11, #12, and #18).

The concerns were again discussed during a wrap-up meeting with the facility administrative staff (Staff Members # 1, #3, #4, #5, #12, and #18 - Quality Improvement director and staff, Assistant Chief Medical Officer and Regulatory Improvement Consultant) on 9/11/18 at 3:00 p.m.

Based on clinical record review, staff interview and facility document review, the facility staff failed to ensure physicians orders were obtained for the use of restraints for 3 of 19 patients who had documented use of restraints. Patient #13, #15 and #20.

The findings included:

1. Patient #13 was admitted to the facility on 8/26/18 with diagnoses that included but were not limited to: closed head injury and traumatic subarachnoid bleed. Review of the clinical record for Patient #13 revealed restraint flowsheet documentation for the use/monitoring of restraints on 8/26/18 at 10:00 a.m. through 8/27/18 at 10:35 a.m.. The documentation evidenced the use of "type pf restraint- mitt, right and left". On 9/6/18 during a review of the clinical record with Staff Member #11 at approximately 9:00 a.m., no order for the use of the restraint could be found. Staff Member #11 stated, "It appears the patient was in the ED (Emergency Department) and went to the ICU (intensive care unit) trauma unit at ten (10:00 a.m.), and I cannot find that an order was written until the next day." The surveyor discussed the concern that Patient #13 had been restrained without an order from the physician for twenty-four hours.

2. Patient #15 was admitted to the facility on 8/29/18 with diagnoses that included, but were not limited to: traumatic subdural bleed (bleeding in the brain). Review of the clinical record on 9/6/18 with Staff Member #11 revealed Patient #15 had a physicians order for the use of restraints initially written on 8/29/18. The orders were renewed on 8/30/18 and again on 8/31/18 at 10:26 a.m. through 9/1/18 at 10:27 a.m. The order expired on 9/1/18 at 10:27 a.m., and was documented "discontinued at 11:00 a.m.", however at 1:15 p.m. the restraint flow sheet in the clinical record evidenced documentation of the use of the restraints which continued until a new order was received at 4:40 p.m. Staff Member #1 stated on 9/6/18 at 9:30 a.m., "I can't find a note about this and can't tell if a verbal order was obtained and it was just not entered into the system until four p.m." The surveyor discussed the concern that the patient had been restrained without an physician's order for over three hours.

3. Patient #20 was admitted to the facility on 9/3/18 with hypertension and type A Aortic dissection. Review of the clinical record with Staff Member #11 on 9/6/18 at 1:30 p.m. revealed restraint flowsheet documentation indicating Patient #20 had the application of restraints "soft limb restraint right wrist, soft limb restraint left wrist" on 9/4/18 at 8:00 a.m. until 2:00 p.m. with no corresponding physician's order for the use of the restraints. At 1:40 p.m., Staff Member #11 stated, "I do not see an order or any other documentation for the restraints."

The facility policy and procedure "Restraints and Restraint Application" evidenced, in part: "...B. Orders- The use of restraints must be ordered by a Licensed Independent Practitioner (LIP), unless the patient's RN (Registered Nurse) determines that the need to restrain the patient is clinically justified and an LIP is not immediately available, in which case restraint procedures may be initiated. Note: In this instance the LIP must be notified and a telephone order or written order must be obtained within four hours...4. A new order must be rewritten by the LIP every calendar day after completing an in-person evaluation of the patient. No telephone orders are accepted for renewal..."

The concerns were discussed with facility Administrative staff on 9/6/18 at approximately 3:30 p.m. (Staff Members #1, #3, #4, #6, #11, #12, and #18).

The concerns were again discussed during a wrap-up meeting with the facility administrative staff (Staff Members #1, #3, #4, #5, #12, and #18 - Quality Improvement director and staff, Assistant Chief Medical Officer and Regulatory Improvement Consultant) on 9/11/18 at 3:00 p.m.


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4. On September 5, 2018 Staff Member #43 and the surveyor reviewed Patient #5's electronic medical record (EMR). Patient #5's EMR indicated the patient's admission as March 15, 2018. Patient #5's admitting diagnosis included a frontal brain mass, Brain edema with compression and encephalopathy. Patient #5's EMR documented nursing staff placed the patient in a soft limb left wrist restraint at 11:03 p.m. on March 19, 2018. Nursing staff obtained the next order for Patient #5's soft limb left wrist restraints at 00:03 a.m. on March 21, 2018. Nursing staff changed the soft limb left wrist restraint to a left mitt at 00:05 a.m. on March 21, 2018.

Staff Member #43 reviewed Patient #5's EMR for documentation of the required every two (2) hour assessment in accordance with the facility's policy. Staff Member #43 reviewed Patient #5's restraint flowsheet with the surveyor. The EMR restraint flowsheet documented the nursing staff assessed Patient #5's restraints every two-(2) hours on March 20, 2018. The surveyor inquired regarding the physician's order for restraints for Patient #5 on March 201, 2018.

Staff Member #43 reviewed the restraint orders within Patient #5's EMR. Staff Member #43 reported Patient #5 had six (6) restraint orders, but "No order dated March 20, 2018. There are three (3) orders for March 21, 2018." Staff Member #43 acknowledged the facility's policy for non-violent/ medical restraints required a physician's order for every "calendar day." Staff Member #43 verified Patient #5 was in non-violent restraints on March 20, 2018 without a physician's order.

Based on employee record review, staff interview and facility document review, the facility staff failed to ensure 4 (four) of 4 (four) facility staff identified as "rotating residents" and 1 (one) of 5 (five) facility resident staff, who had written orders for restraints, received training regarding the facility policy on the use of restraints at the facility.

The findings included:

During a review of the employee/staff training records for physicians/residents who had written orders for the use of restraints at the facility on 9/11/18 at approximately 11:00 a.m., the following was evidenced:

Four Residents, who were identified as "rotating" staff did not have evidence of training on the facility policy regarding the use of restraints. One Resident, identified as an employee, did not have the training documented as well.

The facility policy and procedure "Restraints and Restraint Alternatives" was reviewed and documented the following: "...F. Competency and Training Requirements...C. Physicians and other licensed independent practitioners (LIPs) or designee- 1. LIPs authorized to order restraints or seclusion must have a working knowledge regarding the appropriate use of restraint or seclusion. 2. In order to be authorized to order restraints and seclusion, physicians and licensed independent practitioners will be required to attest the restraint standards during their credentialing process, and again whenever significant changes are made to the restraint policy that could affect their ordering of restraints and seclusion."

On 9/11/18 at 11:00 a.m., Staff Member # 19 (Vice Chair Department of Medicine) assisted the surveyor with the review of the records. Staff Member #19 stated, " These were rotating residents. I do not know if they are fully aware of (our) policy. I know they have training in their own home institution, but I can't say they were trained on this company's policy. It's something we need to initiate...the other is a new employee and I am sure this was gone over during their "boot camp" training, but there is no documentation that shows this..."

The concerns were discussed during a wrap-up meeting with the facility administrative staff (Staff Members # 1, 3, 4, 5, 12, and 18 - Quality Improvement director and staff, Assistant Chief Medical Officer and Regulatory Improvement Consultant) on 9/11/18 at 3:00 p.m.

Based on clinical record review, staff interview and facility document review, the facility staff failed to ensure each patient who had orders for the use of restraints was seen face-to-face by an LIP (Licensed Independent Practitioner) at the initiation of the restraint (every calendar day for non-violent restraints and within one hour for violent restraints). This involved 3 (three) of 19 (nineteen) patients, Patient #4, 5, and 22.

The findings included:

Patient #4 was admitted to the facility on 7/20/18 for colorectal surgery. On 7/30/18 at 9:05 p.m. an order was written for the use of restraints to prevent the patient from "interfering with medical treatment" (non-violent restraint). According to documentation on the physicians order: "Was a face-to-face performed? No- telephone order for initial placement." There was no documentation in the clinical record that a face-to-face assessment was performed by the LIP.

On 9/5/18 at 3:15 p.m. with the assistance of Staff Member #11, the clinical record was reviewed for evidence of the face-to-face assessment. Staff Member #11 stated, "There's no documentation." Staff Member #12 was also present and assisting to locate the information, which could not be found.

Patient #22 was admitted 8/28/18 with a diagnoses that included but was not limited to: Traumatic subdural hemorrhage. Orders for the use of restraints were reviewed and revealed an order written on 8/29/18 and 8/30/18 for the use of "soft limb restraints- left wrist and right wrist- to prevent the patient from removing life sustaining equipment". On the physician's order was documented: "Question- Face-to-face performed? No telephone order for initial placement".

On 9/6/18 at 2:50 p.m., with the assistance of Staff Member #11 the clinical record was reviewed for evidence of a face-to-face assessment by the LIP. Staff Member #11 stated, "There's no face-to-face note that I can find."

Review of the facility policy and procedure "Restraints and Restraint Alternatives" evidenced, in part, "...V. Medical Restraint: Non-violent and/or Non-Self Destructive Behavior...B.1. An LIP must complete an in person evaluation of the patient and write an order within one calendar day of the initiation of restraints. 2. If a patient is medically restrained and is released before the LIP arrives to perform the assessment, the LIP must still perform a a face-to-face assessment and write an order for the time period that the patient was restrained...4. A new order must be written by the LIP every calendar day after completing an in-person evaluation of the patient. No telephone orders are accepted for renewal..."

The concerns were discussed with facility Administrative staff on 9/6/18 at approximately 3:30 p.m. (Staff Members # 1, 3, 4, 6, 11, 12, and #18).

The concerns were again discussed during a wrap-up meeting with the facility administrative staff (Staff Members # 1, 3, 4, 5, 12, and 18 - Quality Improvement director and staff, Assistant Chief Medical Officer and Regulatory Improvement Consultant) on 9/11/18 at 3:00 p.m.

Based on staff interviews and medical record reviews, facility staff failed to ensure that the nursing care plan for two (2) patients (Patient #18 and Patient #29) included all identified needs.

Findings include:

A review of the medical record for Patient #18 revealed an order for patient supplied non formulary eye drops to be left at the patient's bedside. The nursing care plan did not include self administration of medication/medications brought from home.

A review of the medical record for Patient #29 revealed that his/her primary language was Punjabi and required an interpreter.

Staff Member (SM) #44 was interviewed on 9/11/18 at 11:30 a.m. and stated "All the elements of documentation of the language barrier are not on the care plan. The information in the "Language assistance" area of the assessment collected at the time of admission remains relevant during the entire admission. The patient did not choose to use a family member as an interpreter, this documentation is showing on admission to the unit and the patient states (he/she) wants an interpreter".

The facility policy entitled "Assessment/Reassessment of Patients by Nursing Staff" was reviewed and revealed the following information: "I. Purpose: To delineate the assessment process in order to form the patient's individualized plan of care. II. Policy: ...d. Social/cultural status...9. The patient's learning needs, abilities, preferences, preferred language, and readiness to learn will be assessed and the patient education adapted accordingly. Multiple factors are to be considered, including: ...3. Language barriers...12. Needs for effective communication will be met and documented at all times according to the Language Services for Individuals with Limited English Proficiency 9-18-1...".
Addendum A Assessment/Reassessment Parameters states in part that "the need for an interpreter or communication aids, including that of the patient care companion and the patient's preferred language must be documented in the electronic health record within 24 hours of the patient's arrival to the unit", and that "Reassessment generally includes the need for interpreter or communication aids".
The facility's guidelines related to the timeframe for reassessment on Medical Surgical, Behavioral Health, Telemetry, Maternal/Child, and Family Centered care units states that a reassessment is "To be completed, at a minimum, once per shift, with no more than 12 hours between assessments. Increased frequency with change in patient status...".

Concerns were discussed with SM #44 as noted above on 9/11/18 at 11:30 a.m.

Based on a review of thirty (30) patient records, facility staff failed to ensure that a physician order for medication was complete for one (1) patient (Patient #18).

Findings include:

At 3:20 p.m. on 9/4/18 while touring the physical plant, the surveyor observed a bottle of Genteal eye drops on the bedside table in room 601, Patient #18's room. The bottle lacked a hospital pharmacy label. Patient #18, admitted 9/1/18, was interviewed and asked about the bottle of eye drops, and stated "I brought those from home and I use them when my eyes are dry".

A review of the record for Patient #18 on 9/6/18 revealed a physician order written by Staff Member (SM) #29 dated 9/5/18 at 8:30 a.m. for "Patient supplied non formulary 2 drop; Sig-Route: Place 2 drops into both eyes every 6 (six) hours as needed (dry eyes), Administration instructions: May leave at patient's bedside"; the order did not specify the name of the medication to be administered, only "patient supplied non formulary".

The eye drop order was entered on 9/5/18, the day after the bottle of eye drops was observed by the surveyor sitting on the bedside table.

The order was discontinued on 9/6/18 at 7:43 a.m. by the pharmacist, and an order was entered for "Carboxymethylcellulose (PF) (Refresh Plus) 0.5% ophthalmic solution 2 drop both eyes 3 times daily PRN for dry eyes".

The facility's policy entitled "Patient's Own Medication (POM) was reviewed, and revealed the following in part: "...1. Use of patient's own medications is discouraged and limited to medically necessary circumstances. The hospital will be the primary source of medications, unless the medication is non-formulary and has no acceptable alternative. 2. Patient's own medications shall not be administered unless the prescriber orders that the patient may use their own medication under the following circumstances; a. The medication is not stocked by the pharmacy department and cannot be procured in a reasonable time frame. b. There is no therapeutic alternative medication that can be recommended....3. A physician or licensed independent practitioner (LIP) must enter the order in the patient's electronic health record (EHR) to authorize the patient to take his/her own medication from home, specifying the medication name, dose, route, and frequency...4. A pharmacist (or physician/LIP in specific cases in which the care would be substantially delayed in areas such as the ED) is responsible for identifying the patient's medication and verifying the integrity of the product prior to administration. a. The medication must be in the original prescription container and properly labeled by the manufacturer or external pharmacy. b. The product in the container must match the medication on the label. Medications may be verified using drug identification references (e.g. Lexi-Comp, Micromedex). c. The pharmacist must complete and attach a "Patient's Own Medication" label to the container after the medication has been verified. d. The medication order must be entered into the EHR to screen for drug-drug interactions and to provide means for nursing to document administration...f. If the pharmacist cannot verify the identity and integrity of the medications, the pharmacist will contact the physician to discuss these findings and to obtain alternative medication orders. The patient will be informed that the medication(s) cannot be used...5. The nurse/respiratory therapist must store the patient's own medication(s) in the patient's assigned medication bin in a locked medication room or in the refrigerator when appropriate, and administer the medication(s) directly to the patient...".

At 1:50 p.m. on 9/6/18 SM #44, an RN (registered nurse) Clinical Director, stated "Any time a medication is brought in by a patient, it is verified by a pharmacist and it is labeled".

SM #15, a pharmacist, was interviewed on 9/6/18 at 3:25 p.m. and stated "We shouldn't have self administration in the hospital as long as we have a similar medication in the pharmacy. The pharmacist inspects/verifies and tags the medication if the patient's home medication is used. The nurse stores medications and takes it to the patient and administers. It is the same process for over the counter or prescription drugs. The day we looked at the eye drop order, the medication hadn't been given. When a patient starts on a medication I think it self feeds into the medication administration record, and it doesn't look like they documented on that. There is a red stop sign that pops up when a medication is unverified, and the nurse knows to call the pharmacist".

Concerns were discussed as noted above with SM's #44 and 15 on 9/6/18, and with members of administration on 9/12/18 between 2:45 p.m. and 3:10 p.m.

Based on observations, patient interview, and medical record review, facility staff failed to ensure that an assessment of the capacity to self administer medications was documented for one (1) patient, (Patient #18), and that the facility's policy for labeling medications brought from home was followed for one (1) patient,(Patient #18).

Findings include:

At 3:20 p.m. on 9/4/18 during a tour of the facility, the surveyor observed a bottle of Genteal eye drops on the bedside table in room 601, Patient #18's room. The bottle lacked a hospital pharmacy label. Patient #18, admitted 9/1/18, was interviewed and asked about the bottle of eye drops, and stated "I brought those from home and I use them when my eyes are dry".

The facility's policy entitled "Patient's Own Medication (POM) was reviewed, and revealed the following in part: "...4. A pharmacist (or physician/LIP in specific cases in which the care would be substantially delayed in areas such as the ED) is responsible for identifying the patient's medication and verifying the integrity of the product prior to administration. a. The medication must be in the original prescription container and properly labeled by the manufacturer or external pharmacy. b. The product in the container must match the medication on the label. Medications may be verified using drug identification references (e.g. Lexi-Comp, Micromedex). c. The pharmacist must complete and attach a "Patient's Own Medication" label to the container after the medication has been verified. d. The medication order must be entered into the EHR to screen for drug-drug interactions and to provide means for nursing to document administration...f. If the pharmacist cannot verify the identity and integrity of the medications, the pharmacist will contact the physician to discuss these findings and to obtain alternative medication orders. The patient will be informed that the medication(s) cannot be used...5. The nurse/respiratory therapist must store the patient's own medication(s) in the patient's assigned medication bin in a locked medication room or in the refrigerator when appropriate, and administer the medication(s) directly to the patient...".

Patient #18's medical record was reviewed with the assistance of a navigator, Staff Member #44. An assessment of Patient #18's capacity to self administer medications could not be located in the medical record. Patient #18 was admitted to the facility as a transfer from another medical facility on 9/1/18 with a diagnosis of large IVH (intraventricular hemorrhage). Patient complaints of headache and memory problems were documented in the record.

Concerns were discussed on 9/6/18 with Staff Member #44 at approximately 2:00 p.m., he/she stated "a nursing assessment was done on admission. It is updated with changes in the patient's condition, and per the unit's policy. There isn't a specific assessment about administering medications".