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45 ST LAWRENCE DRIVE

TIFFIN, OH 44883

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

Based on medical record review, complaint/grievance log review, patient interview, staff interview, and hospital policy review the hospital failed to ensure one (Patient #2) of ten patients reviewed had their grievance responded to within a reasonable time frame. The sample size was ten medical records reviewed. At the time of the survey, the census of the Outpatient Cancer Care unit was 66 patients and the inpatient hospital census was 21 patients.

Findings Included:

The review of the medical record for Patient #2 was completed on 10/02/13 at 9:50 AM. Patient #2 was admitted to the Outpatient Cancer Care Unit on 10/29/10, with a diagnosis of myelodysplastic syndrome (cancer of the blood and bone marrow). The medical record revealed that Patient #2 received subcutaneous injections of the medication Aranesp (red blood cell stimulator) 300 micrograms (mcg) every other Friday for the past year at the outpatient cancer center.

In an interview with Patient #2 on 09/30/13 at 9:20 AM, Patient #2 stated that around the middle of April 2013, he/she received the wrong medication at the outpatient cancer center. Patient #2 stated that approximately 30 minutes after he/she left the cancer center that day, Staff C called him/her to come back to the cancer center because they realized Patient #2 received the wrong medication injection. Patient #2 stated he/she then returned to the cancer center and received the correct medication injection. Patient #2 stated he/she had ongoing problems after that day. The first week of May 2013, he/she had severe bronchitis, the flu, and then had bronchitis again. He/she also had "bone pain, like arthritis" in the wrists, back, and neck and continues to have this pain. Patient #2 stated he/she spoke with "a CEO" from the hospital a couple of times in September 2013, and was told, "someone would get back with me." Patient #2 stated he/she never heard back from anyone and never received anything in writing. Patient #2 stated he/she has accumulated multiple medical bills from the extra doctor visits and testing because of the problems that occurred after receiving the wrong medication and stated, "I just want it to be fair."

The review of the hospital's complaint/grievance log was completed on 09/30/13 at 3:00 PM. The complaint/grievance log revealed Patient #2 called the hospital on 07/12/12 "regarding receiving wrong medication and believes [he/she] has had bronchitis, the flu, hives, and pains. Believes it is due to receiving the wrong medication." The Result/Comments section of the log revealed, "CNO [Chief Nursing Officer] spoke to patient and pharmacist. Ordering physician told pt [patient] symptoms not from medication. Referred to CHP [Catholic Health Partners]." The log had this complaint marked as "Open."

In an interview with Staff A and Staff B on 10/01/13 at 3:30 PM, Staff B confirmed Patient #2 was administered the wrong medication, Neulasta (a white blood cell stimulator), instead of the ordered Aranesp (a red blood cell stimulator) on 04/12/13, in the outpatient cancer center.

Staff B stated that he/she spoke to Patient #2 on 07/12/13 and again on 07/26/13 regarding Patient #2's complaint. The complaint was then forwarded on to the person who handles patient satisfaction at CHP [their corporate owners]. Staff B stated that he/she spoke with the person who handles patient satisfaction at CHP again on 08/22/13 and asked him/her to call Patient #2 to discuss Patient #2's request. Staff B stated he/she did not know if anyone contacted Patient #2 since 07/26/13. Staff B stated that he/she never sent Patient #2 anything in writing concerning the patient's complaint.

The review of the hospital's policy entitled Patient Grievance Process authored by Staff B and last reviewed in March, 2013, revealed "If a verbal patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purposes of these requirements. A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf." Additionally, the procedure section of the policy stated, "After research of the grievance, the Quality Management Analyst or designee shall notify the patient in writing within seven (7) working days. In its resolution of the grievance, the hospital must provide the patient with written notice of its decisions. The letter to the patient shall include the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of the completion of the process. If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the hospital should inform the patient or the patient's representative that the hospital is still working to resolve the grievance and that the hospital will follow up with a written response within a stated number of days."

In the interview with Staff A and Staff B on 10/01/13 at 3:30 PM, Staff B confirmed this finding.

PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING

Tag No.: A0130

Based on medical record review, staff interview, and hospital policy review the hospital failed to ensure five(Patients #2, #5, #6, #7, and #8) of ten patients whose medical records were reviewed in the Outpatient Cancer Care unit participated in the development and implementation of their plan of care. This had the potential to affect all of the patients treated in the Outpatient Cancer Care. At the time of the survey, the census of the Outpatient Cancer Care unit was 66 patients and the inpatient census of the hospital was 21 patients.

Findings Included:

The review of the medical record for Patient #2 was completed on 10/02/13 at 9:50 AM. Patient #2 was admitted to the Outpatient Cancer Care Unit on 10/29/10 with a diagnosis of myelodysplastic syndrome (cancer of the blood and bone marrow). The medical record lacked documentation of a care plan for Patient #2, indicating Patient #2 did not participate in the development and implementation of their plan of care.

The review of the medical record for Patient #5 was completed on 10/02/13 at 10:00 AM. Patient #5 was admitted to the Outpatient Cancer Care Unit on 11/26/10 with a diagnosis of mantle cell non-Hodgkin's lymphoma. The medical record lacked documentation of a care plan for Patient #5, indicating Patient #5 did not participate in the development and implementation of their plan of care.

The review of the medical record for Patient #6 was completed on 10/02/13 at 10:15 AM. Patient #6 was admitted to the Outpatient Cancer Care Unit on 03/08/13 with a diagnosis of non-Hodgkin ' s lymphoma. The medical record lacked documentation of a care plan for Patient #6, indicating Patient #6 did not participate in the development and implementation of their plan of care.

The review of the medical record for Patient #7 was completed on 10/02/13 at 10:30 AM. Patient #7 was admitted to the Outpatient Cancer Care Unit on 03/19/13 with a diagnosis of breast cancer. The medical record lacked documentation of a care plan for Patient #7, indicating Patient #7 did not participate in the development and implementation of their plan of care.

The review of the medical record for Patient #8 was completed on 10/02/13 at 10:45 AM. Patient #8 was admitted to the Outpatient Cancer Care Unit on 03/09/00 with a diagnosis of breast cancer and anemia (low hemoglobin). The medical record lacked documentation of a care plan for Patient #8, indicating Patient #8 did not participate in the development and implementation of their plan of care.

The review of the hospital's policy authored by Staff A and entitled Charting, Using the PIE [problem, intervention, evaluation] Documentation System was completed on 10/02/13 at 1:30 PM. The policy stated, "All RN's and LPN's will maintain a record of the patient's progress using the PIE documentation system. "

The review of the hospital's policy #T-NAURU-ADN-0002 authored by Staff A and entitled Nursing Standards of Care was completed on 10/02/13 at 1:50 PM. The policy stated, "Standards of Care describe a competent level of nursing care, as demonstrated by the nursing process, involving assessment, diagnosis, outcome identification, planning, implementation and evaluation . . . The nursing staff will be responsible for knowing their content and following the guidelines for implementation."

In an interview with Staff A and Staff D on 10/02/13 at 3:30 PM, Staff A and Staff D confirmed that although teaching was being provided to the cancer center patients, care plans were not being done.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on medical record review, staff interview, employee file review, and hospital policy review the hospital failed to ensure one (Patient #2) of five patients whose medical records were reviewed and who received care in the Outpatient Cancer Care Unit and one (Patient #9) of five patients whose medical records were reviewed and who received care as an inpatient. The sample size was ten medical records reviewed. At the time of the survey, the census of the Outpatient Cancer Care unit was 66 patients and the inpatient census of the hospital was 21 patients.

Findings Included:

The review of the hospital's policy #T-NUR-MED-0030 entitled Medication Errors was reviewed on 10/01/13 at 12:00 PM. The policy stated,
"Analysis of medication errors is performed to determine the need for educational offerings and/or review and changes the medication administration process.
A. When a medication error is noted, the following should be notified:
1. Unit Manager/Shift Manager
2. Physician
B. Follow the physician's order.
C. Document on the patient's chart the medication given, time it was given, and the patient's response to the medication, if applicable.
D. Complete the "SafeCARE" event report documenting only what occurred."

In an interview with Staff C and Staff D on 10/01/13 at 10:00 AM, Staff C and Staff D confirmed Patient #2 was administered the wrong medication, Neulasta (a white blood cell stimulator) instead of Aranesp (a red blood cell stimulator) on 04/12/13, in the outpatient cancer center. Staff C confirmed she gave the wrong medication. Staff C said after the patient left, she realized she gave the wrong medication so she called the patient on the telephone and asked the patient to come back and explained why. The patient came back and she gave the patient the correct medication. Staff C said she notified Staff D and Staff E of the medication error. Staff C said she knew what she did was wrong and that Staff D did talk to her about it, but she did not receive any education or review any policies.

During an observation of the medication refrigerator in the outpatient cancer center on 10/01/13 at 10:30 AM, it was noted the Aranesp (in a blue box) was stored right next to the Neulasta (in a yellow box) in the medication refrigerator, this refrigerator was locked and only opened with a key stored in a locked drawer which only opened when prompted by the electronic medication dispensing computer (Accudose).

The review of the medical record for Patient #2 was completed on 10/02/13 at 9:50 AM. Patient #2 was admitted to the Outpatient Cancer Care unit 10/29/10 with a diagnosis of myelodysplastic syndrome (cancer of the blood and bone marrow). The medical record revealed an ongoing physician's order for the past year for Patient #2 to receive subcutaneous injections of the medication Aranesp (red blood cell stimulator) 300 micrograms (mcg) every other Friday if his/her hemoglobin result was less than 10 grams per deciliter (g/dl).

The medical record did not contain the following required documentation (according to the hospital's policy): The medical record did not include documentation that Patient #2 had been administered the wrong medication on 04/12/13, documentation the Unit Manager and the physician were notified, documentation the patient was reassessed, monitored, and/or educated after he/she had received the wrong medication.

The review of the hospital's policy #T-NUR-ADM-0002 authorized by Staff A and entitled Nursing Standards of Care was completed on 10/02/13 at 1:50 PM. The policy stated, "Standards of Care describe a competent level of nursing care, as demonstrated by the nursing process, involving assessment, diagnosis, outcome identification, planning, implementation and evaluation . . . The nursing staff will be responsible for knowing their content and following the guidelines for implementation."

The review of the employee file for Staff C was completed on 10/01/13 at 1:30 PM. The employee file revealed that Staff C was hired on 07/21/82, and that Staff C had completed patient safety and infection control training on 04/10/13. The employee file did not include documentation that Staff C had been counseled, or educated/re-educated following the medication administration error that occurred on 04/12/13.

This finding regarding Patient #2 was confirmed by Staff D on 10/02/13 at 9:40 AM.

Review of the medical record for Patient #9 was completed on 10/02/13 at 1:40 PM with Staff A. Patient #9 was admitted to the hospital on 07/17/13 with a diagnosis of feeling ill and sepsis. Patient #9 was discharged on 07/23/13. The medical record revealed and Patient #9 was administered a dose of Lovenox (a blood thinner) 40 milligrams (mg) on 07/17/13 at 4:45 PM, and a second dose of Lovenox 40 mg by a different nurse, Staff G, on 07/17/13 at 8:40 PM.

No documentation was found regarding notification of the Shift Manager and/or the patient's physician by Staff G after he/she was made aware he/head administered a second unauthorized dose of Lovenox 40 mg to Patient #9 the same day Patient #9 received the first one.

The medical record did not include and the hospital staff were unable to provide, when requested documentation of the re-education of the nurse (Staff G) after the medication error occurred. These findings were confirmed with Staff A during the medical record review on 10/02/13 at 1:40 PM and during an interview on 10/02/13 at 3:20 PM.

This deficiency substantiates Substantial Allegation Number OH00071697.