HospitalInspections.org

Based on policy review, staff interview, observations and medical record review, the facility failed to ensure patients or patients' representatives were provided with the phone number and address for lodging a grievance with the State agency and failed to ensure the facility informed patients a grievance could be filed directly with the State(A0118). The facility failed to ensure informed consent was obtained for a blood transfusion (A0131). The facility failed to provide Advance Directive information when requested (A0132). The facility failed to ensure the personal privacy of all patients was protected (A 0143), care plans were updated to include restraint usage (A0166), physician orders were obtained and hospital policy was followed for restraint usage (A0173). The cumulative effect of these systemic practices resulted in the facility's inability to ensure patients rights were protected.

Based on policy review, staff interview, observations and medical record review, the facility failed to ensure patients cardiac monitor alarms were addressed by clinical personnel (A0392). The facility failed to ensure nursing staff functioned within their scope of practice and referred to the attending physician for the pronouncement of a patient's death (A0395). The facility failed to ensure nurses reassessed patient responses to nursing interventions (A0396). The facility failed to ensure drugs were administered in accordance with physician orders (A0405). The facility failed to administer blood transfusions according to facility policy (A0409). The cumulative effect of these systemic practices resulted in the facility's inability to ensure patients' safety.

Based on interview, policy review and observation of posting, the facility failed to ensure patients or representatives were provided with the phone number and address for lodging a grievance with the State agency and failed to ensure the facility informed patients of their right to lodge a grievance with the State directly, regardless of whether they had first used the facility's grievance process for one (Campus #1) of one campus visited. This deficient practice has the potential to affect all 21 patients who may wish to file a grievance hospitalized at Campus #1. The facility operates a total of four distinct campus locations and the census at the time of the survey was 62.

Findings included:

1) On 1/16/14 at 11:33 AM, the facility's admission folder was reviewed. The folder did not contain information on how to lodge a grievance with the Ohio Department of Health.

2) Observation of the Ohio Department of Health posting on 1/16/14 at 1:45 PM, revealed the Ohio Department of Health complaint phone number was hanging on a wall next to an elevator. The posting did not contain the address for lodging a grievance with the Ohio Department of Health. The posting instructed to notify the facility of complaints prior to contacting the Ohio Department of Health. Immobile patients are not able to view the posting next to the elevator.

3) On 1/16/14 at 11:33 AM, Staff D and G confirmed the admission folder did not contain information regarding how to lodge a grievance with the Ohio Department of Health.

4) On 1/21/14 at 2:27 PM, the facility's Complaint and Grievance Process policy was reviewed. The policy stated during the admission process, the patient is notified of his/her right to make a complaint or file a grievance. Every patient should receive an admission education packet which includes an Important Telephone Number information sheet. These numbers identify who to contact with questions, concerns and/or complaints at the facility. The policy stated contact numbers and address for the State survey agency and a hospital contact name and number are posted in a public area.

Based on medical record review, interviews and policy review, the facility failed to obtain informed consent for blood transfusions according to facility policy for two (Patient #3 and Patient #1) of two medical records reviewed of patients who received blood transfusions out of a total of 10 patient medical records reviewed. The census at the time of the survey was 62.

Findings included:


1) The medical record for Patient #3 was reviewed on 01/17/14. A hospital "Consent to Blood Transfusion" form was reviewed and appeared to have been completed on 01/11/13. Further review of the form revealed two separate registered nurses appeared to have obtained telephone consent from Patient 3's spouse for a blood transfusion. The same form contained no documentation by the physician indicating he/she "explained the benefits, alternatives and risks of" the blood transfusion to either Patient #3 or his/her spouse. The physician also failed to sign and date the form.

A progress note completed by the renal physician on 01/11/13 read "anemia transfuse 2 units." The note lacked any evidence of communication between the physician and Patient #3 or Patient #3's spouse regarding the need for a blood transfusion.

Four hospital "Blood Transfusion Time Out Procedure" forms were also reviewed in Patient 3's medical record. These forms revealed Patient #3 received two units of blood product on 01/11/13 and two units on 02/04/13.

Staff D (Chief Nursing Officer) was made aware and confirmed the above findings during an interview on 01/17/14 at approximately 2:56 PM. At that time, Staff D also stated that if the physician did not fill out the "Consent to Blood Transfusion" form in its entirety, he/she should document that risks and benefits were explained to the patient and/or the patient's representative in the progress notes.

2) The medical record review for Patient #1 was completed on 1/17/14. The record showed the patient received one unit of packed red blood cells on 1/15/14 at 3:00 PM. The medical record did not contain evidence of informed consent from the patient or patient representative to receive the blood product.

On 1/16/14 at 12:14 PM, Staff C reported the facility probably did not have a signed consent for the blood products due to her/his assignment changed and she/he did not inform the newly assigned nurse of the need to obtain consent for the blood transfusion. The physician's progress note from 1/15/14 did not contain evidence of the patient's consent for blood.

The facility's Blood Administration policy was reviewed on 1/16/14 at 12:03 PM. The policy revealed the physician or designee must obtain a consent for blood use prior to the initiation of therapy. Documentation of informed consent for transfusion of blood/blood components will be obtained on form, Consent to Blood Transfusion (NR-16).

On 1/21/14 at 8:34 AM, the facility's Patient Rights/Informed Consent policy was reviewed. The policy revealed the consent is recommended for blood and blood products.

This finding substantiates the allegation(s) contained in Substantial Allegation #OH00070358.












31597

Based on medical record review, policy review and interview, the facility failed to provide Advance Directive information to a patient's representative who requested Advance Directive information for one (Patient #4) of 10 patient medical records reviewed. The census at the time of the survey was 62.

Findings included:

1) The medical record review for Patient #4 was completed on 1/16/14. The record contained an Acknowledgement of Advance Directive Information form stating the patient's representative requested information regarding Advance Directives on 12/30/13. The medical record did not contain evidence information was provided to the patient's representative as of 1/16/14 at 3:00 PM.

2) On 1/16/14 at 3:20 PM, Staff E was interviewed. Staff E reported the patient's representative had not been given additional information regarding Advance Directives. Staff E reported she/he had not received the form showing the patient's representative had requested information regarding Advance Directives. Staff E reported speaking to the patient's representative on 1/2/14 and the patient's representative did not mention Advance Directives.

3) The facility's Advance Directives policy was reviewed on 1/17/14 at PM. The policy stated if a patient requests additional assistance about executing an Advance Directive, the case management department will provide the necessary resources.

Based on random observations and staff interview, the facility failed to ensure the patients nursing needs were not announced over the loud speaker. This affected two of 21 patients hospitalized at Campus #1. (Patient located in Room 5 and Room 609) The census at the time of the survey was 62.

Findings included:

1) On 01/15/14 at 2:04 PM the following announcement was heard via the loud speaker system "pain management needed in 5."

At 2:09 PM on the same day this announcement was heard via the loud speaker "IV assistance to 5 for pain management please." At 2:49 PM "pain management in 5" was again announced over the loud speaker.

2) On 01/17/14 "alarm 609 tube feeding" was heard being announced over the loud speaker.

3) Staff D was made aware of and confirmed the above findings during an interview on 01/17/14 at 2:56 PM.

Based on medical record review and staff interviews the facility failed to ensure care plans were updated to include restraint usage for one of two medical records reviewed with restraint usage (Patient #3). A total of 10 medical records were reviewed and the census at the time of the survey was 62.

Findings included:

1) The medical record for Patient #3 was reviewed beginning on 01/17/14. Review of the DDR's (daily data records), progress notes, restraint flow sheets and physician orders revealed Patient #3 was restrained from the date of admission on 12/28/12 until discharge on 02/06/13. The medical record lacked evidence of the nursing care plan identifying and addressing the use of restraints.

2) Staff D and and Staff G were made aware of and confirmed this finding during an interview on 01/21/14 at 1:30 PM.

Based on medical record review, policy review, and staff interview, the facility failed to ensure physician orders were obtained and hospital policy was followed for restraint usage for one of two patient medical records reviewed for restraint usage (Patient #3). A total of 10 medical records were reviewed and the census at the time of the survey was 62.

Findings included:

1) Facility policy entitled "Restraint" (#R2) was reviewed on 01/15/14 beginning at 2:45 PM. Per said policy, restraint orders were valid for a "calendar day for non-violent/non self-destructive behaviors." The physician was to "conduct a face-to-face assessment and write applicable orders" every calendar day. Evidence of this assessment was to be documented "in progress notes or order forms for non-violent/non self-destructive behaviors every calendar day." This documentation of the assessment was to include the following information: "time visited patient; restraint order; reassessment/renewal of order."

Appendix D of the policy dictated "Restraint can only be used when less restrictive interventions have been determined to be ineffective to protect the patient or others from harm." Per the Non-Violent/Non Self-Destructive Restraint Orders form, "at least one" alternative attempted/considered was required to to be checked.

Appendix G of the same policy also dictated that vital signs were to be obtained a "minimum of every 8 hours."

2) The medical record for Patient #3 was reviewed beginning on 01/17/14. The record contained 39 separate "Non Violent/Non Self-Destructive Restraint Orders" for his/her 40 day hospitalization.

On 16 of those orders, there was a physician signature on the form but no date and time documented of when the restraint(s) were ordered.

An additional 19 of the orders lacked documented evidence of the time when the physician conducted his/her required face-to-face assessment of Patient #3 for the following days: 02/6/13, 02/5/13, 02/4/13, 02/3/14, 02/2/14, 01/31/13, 01/30/13, 01/29/13, 01/27/13, 01/26/13, 01/22/13, 01/21/13, 01/17/13, 01/16/13, 01/15/13, 01/10/13, 01/7/13, 01/6/13 and 01/5/13.


Five of the 39 orders lacked documentation of the "Alternatives Attempted/Considered" by staff prior to utilizing the restraint(s) on restraint order forms dated 1/20/13, 1/27/13, 2/6/13 and two of the forms missing dates.

Three of the 39 orders lacked documentation of the "Clinical Justification" for the restraint(s) on restraint order forms dated 2/6/13 and two of the forms missing dates.

3) The DDR's (daily data records) for Patient #3 were also reviewed. Although vital signs were to be obtained and recorded at least every 8 hours while Patient #3 was restrained, the medical record lacked evidence this task was completed on 31 of the 39 days the patient was restrained as follows:

12/31/12, 01/05/13, 01/06/13, 01/07/13, 01/08/13, 01/09/13, 01/10/13, 01/11/13, 01/13/13, 01/14/13, 01/15/13, 01/16/13, 01/17/13, 01/18/13, 01/20/13, 01/21/13, 01/22/13, 01/23/13, 01/24/13, 01/25/13, 01/26/13, 01/27/13, 01/28/13, 01/29/13, 01/30/13, 01/31/13, 02/01/13, 02/02/13, 02/03/13, 02/04/13 and 02/05/13.

The same DDR's revealed a pattern of staff routinely obtaining vital signs between 7:00 and 9:00 PM and then not again until change of shift at 7:00 AM, approximately 10-12 hours
later.

4) On the facility Non-Violent/Non Self-Destructive Flow sheets the following information was to be recorded by staff: restraint device utilized; skin/circulation and clinical condition; patient response to the restraint(s) every 2 hours; positioning/range of motion, hygiene and toileting every 2 hours; fluids/nutrition every 2 hours; review of criteria for release every 2 hours; and assessment for restraint need/outcome every 2 hours.

Review of the same restraint flow sheets from 12/29/12 to 02/06/13 for Patient #3 revealed inaccurate and/or lapsed restraint documentation on 14 of the 39 days Patient #3 was restrained. The type of restraint was frequently not specified, lapses in safety checks for periods of time as great as 14 hours, staff removing and reapplying restraints without an order, and staff reportedly using a type of restraint other than that which the physician ordered. This was noted on the following days:

12/29/12, 12/31/12, 01/02/13, 01/04/13, 01/05/13, 01/07/13, 01/08/13, 01/09/13, 01/18/13, 01/19/13, 01/20/13, 01/25/13, 01/26/13 and 01/27/13.

5) Staff D and Staff G were made aware of and confirmed the above findings during an interview on 01/21/14 at 1:30 PM. At that time, Staff D added that "there are a lot of major problems" with the medical record of Patient #3.

Based on medical record review, staff interviews, observation, and review of facility policy, the hospital failed to ensure staff follow policy regarding electronic monitoring of patient cardiac alarms for one of one nursing units observed and two of two patient medical records reviewed for cardiac telemetry monitoring (Patients' #2 and #3). Staff also failed to perform hourly rounds, turn and reposition patients every two hours and perform oral care every four hours for one of one record reviewed for hourly rounds.(Patient #3) A total of 10 patient medical records were reviewed. The census at the time of the survey was 62.


Findings included:

During entrance conference on 01/15/14 at 12:50 PM, Staff D stated the expectation, though not in policy format, was for staff to round on every patient at least once an hour during the day shift and every two hours during night shift, from 10:00 PM to 6:00 AM . Staff D also stated that oral care was to be completed every four hours for those patients on a ventilator and turning/repositioning every two hours for those patients who need assistance. Rounding report sheets are completed but do not become a permanent part of the medical record.

1) The medical record for Patient #2 was reviewed beginning on 01/15/14. Patient #2 was admitted to the hospital on 01/07/14 with diagnoses of pulmonary (lung) edema and respiratory failure. Patient #2 was immediately placed on a cardiac telemetry monitoring device (allows for remote, continuous monitoring of heart rate and rhythm) per physician's order.

Review of the cardiac rhythm strips for Patient #2 revealed staff failed to monitor and record the cardiac rhythm of Patient #2 every 12 hours (Q shift) as required per by hospital policy on 6 of the 10 days he/she was hospitalized as follows:

01/08/14, 01/09/14, 01/10/14, 01/11/14, 01/12/14 and 01/13/14.

Lapses in monitoring ranged from approximately 19 hours to as much as 30 hours in between recordings and readings without documentation as to why.

Staff G was made aware of and confirmed the above findings related to Patient #2 on 01/06/14 at approximately 3:24 PM. At that time Staff G also confirmed that staff were expected to print and record the cardiac rhythm strips for patients' at the beginning of every shift.

2) The medical record for Patient #3 was reviewed beginning on 01/17/14. Patient #3 was admitted to the hospital on 12/28/12 with diagnoses of acute respiratory failure and encephalopathy. Patient #3 had a tracheostomy attached to a ventilator for breathing, a Foley catheter for urination, and a nasal feeding tube for nutrition in place. Patient #3 was placed on a cardiac telemetry monitoring device per physician's order on admission. Patient #3 was also noted to be restrained 39 of the 40 days he/she was hospitalized, therefore unable to perform the routine activities of daily living, including bathing, oral care and repositioning, on his/her own.

Review of the DDR's (daily data records) for Patient #3 lacked evidence of turning/repositioning every 2 hours, oral care every 4 hours, and/or hourly room checks by staff as required on the following 35 of the 40 days he/she was hospitalized:

12/29/12, 12/30/12, 12/31/12, 01/02/13, 01/03/13, 01/04/13, 01/05/13, 01/06/13, 01/07/13, 01/08/13, 01/09/13, 01/10/13, 01/11/13, 01/12/13, 01/13/13, 01/14/13, 01/15/13, 01/16/13, 01/17/13, 01/18/13, 01/19/13, 01/20/13, 01/21/13, 01/22/13, 01/24/13, 01/25/13, 01/26/13, 01/27/13, 01/28/13, 01/29/13, 01/30/13, 01/31/13, 02/02/13, 02/04/13 and 02/05/13.

The hourly rounding report sheets for Patient #3 were never provided for review.

Review of the same DDR's for Patient #3 also lacked evidence that he/she was bathed on 12/28/12, 12/30/12, 01/01/13 and 01/31/13.

Review of the rhythm strips for Patient #3 revealed staff failed to monitor and record the cardiac rhythm of Patient #3 every 12 hours (Q shift) as required per by hospital policy on 21 of the 40 days he/she was hospitalized as follows:

12/30/12, 12/31/12, 01/01/13, 01/04/13, 01/05/13, 01/09/13, 01/10/13, 01/13/13, 01/14/13, 01/16/13, 01/19/13, 01/22/13, 01/23/13, 01/24/13, 01/25/13, 01/26/13, 01/29/13, 01/30/13, 01/31/13, 02/01/13 and 02/05/13.

Lapses in monitoring ranged from approximately 15 hours to as much as 45 hours in between recordings and readings without documentation as to why.

Four direct, patient care staff members were interviewed on 01/17/14. Staff L (patient care assistant) was interviewed beginning at 9:16 AM. At that time Staff L reported safety checks/rounds are performed every hour and recorded on the "rounding sheet." Staff L also stated he/she documents a lot of detail on those same forms, one is completed for every day the patient was hospitalized, and the the forms are kept in the patient's medical record.

Staff L was asked how often patients' are bathed and stated daily. Staff L stated the "total" baths , or those for patients who require maximum assistance, are completed on the night shift. Those that are not completed on night shift are then to be completed on day shift. This information was to be recorded on the DDR (daily data record) kept in the patient's medical record.

Staff M (PCA) was interviewed beginning at 9:30 AM. Staff M stated he/she was assigned eight patients today and most of them required a lot of assistance with activities. Staff M confirmed that patients' are bathed at a minimum once every day. The baths should be recorded on the DDR with date, time and staff initials documented.

Staff M further stated he/she rounds on patients at least once an hour and this was documented on the hourly rounding log. Staff M was asked how often he/she turns/repositions patients and stated there was no set schedule. Staff M turns patients as needed, for instance, when a patient is eating.

Staff K (registered nurse) was interviewed beginning at 9:50 AM. Per Staff K, patient assessments are completed every 12 hours or shift, at the beginning of the shift. This information is recorded on the DDR. Rhythm strips are printed at the beginning of every shift too and should be read, initialed by staff, and posted in the patient's medical record. The strip should be read and posted again any time there is a change in the rhythm.

Staff A (RN) was interviewed beginning at 11:04 AM. Staff A stated assessments are completed at the beginning of every shift and rhythm strips should be printed, read and posted at that time. Staff A stated this was not a new hospital practice. Per Staff A, rounds on patients are completed at least every hour and should be documented.

Staff D and Staff G were made aware of and confirmed all of the above findings related to Patient #3 on 01/21/14 at approximately 1:30 PM.



31597

Staff F, unit secretary, was interviewed on 1/17/14 at 3:00 PM. Staff F reported the facility's nurses expect Staff F to address the cardiac monitor alarms. Staff F reported not receiving training on how to read/interpret the alarms and stated most of the time when monitors are alarming, the nurses are with patients and unable to address the alarm. Staff F stated nurses will ignore the alarms and make comments such as "oh, she/he is always alarming " when the alarm is brought to their attention.

On 1/16/14 at 3:51 PM, the facility's Alarm Safety policy was reviewed. The policy stated clinical staff will respond to all clinical alarms in a timely fashion. The policy stated clinician carried communication devices are utilized to improve communication of alarms, reduce noise levels, produce faster response times and improve communication links between the patient and the nurse.

On 1/21/14 at 1:30 PM, Staff F was interviewed. Staff F reported the nurses do not receive electronic notification of monitor alarms and do not carry communication devices.

On 1/21/14 at 1:18 PM, Staff D was interviewed. Staff D stated the facility is in the process of implementing a new monitoring system which uses communication devices. The process had not been implemented on the nursing units as of survey exit on 01/21/14.

Observation on 01/21/14 at 10:08 AM revealed Staff J, a personal care assistant (PCA), silencing a cardiac monitor alarm. Staff J, interviewed on 1/21/14 at 10:08 AM, reported a night nurse trained her/him how to monitor blood pressure readings and pulse oximeter readings on the monitor. Staff J reported he/she silences the alarms depending on the readings on the alarm.

These findings substantiate the allegation(s) contained in Substantial Allegation #OH00070358.

Based on medical record review, staff interview, and review of facility policy, the hospital failed to ensure nursing staff functioned within their scope of practice and referred to the attending physician for the pronouncement of a patient's death. This affected one of one patient who had expired. (Patient #2) and failed to ensure nurses reassessed a patient's response to nursing interventions for one (Patient #1) of one patient whose record was reviewed for pain assessment. A total of ten patient medical records were reviewed. The census at the time of the survey was 62.


Findings included:

1) On 01/15/14 at 2:30 PM a "Code Blue" was announced over the hospital's loud speaker system. Observation upon arriving at Patient #2's room revealed multiple physicians and nursing staff were providing care. Patient #2's medical record was searched for information related to advance directives and it was noted that on admission, 01/07/14, Patient #2 was declared a "Full Code" as evidenced by signed advance directives.

The complete medical record for Patient #2 was then requested for review on 01/16/14 at 9:00 AM. At that time, Staff G (Director of Quality) reported that Patient #2 expired last night (01/15/14).

Review of the medical record revealed a "DO NOT RESUSCITATE" physician order form had been completed on 01/15/14 at 6:40 PM. Patient #2's designated power of attorney signed the form also.

A hospital "Pronouncement of Death Flow sheet" was also observed. The form contained the signatures of two registered nurses, who documented "absence of auscultated apical" and "flat line ECG rhythm, in two leads, observed for one minute on cardiac monitor."

The area on the flow sheet where "observable facts recited to attending physician", physician name, date and time were left blank.

The record was further reviewed for a physician progress note indicating the physician was present at the time of Patient #2's death but there was none.

Staff I was made aware of and confirmed all of the above findings related to Patient #2 on 01/16/14 at 3:07 PM. At that time, Staff I stated two nurses may pronounce a patient deceased in a LTAC (long term acute care) setting per hospital policy. Staff I was unable to explain why the Pronouncement of Death Flow Sheet was incomplete.

Facility policy "Death; Pronouncement of" (D 2) was reviewed on 01/16/14. Per said policy, the "RN will immediately recite to attending physician, via telephone, the observations of the facts of the deceased's present medical condition." Observations are to be documented on the "Pronouncement of Death Flow Sheet."

The same policy also quoted language from the State Medical Board rule 4732-14-01, which reads "an individual as defined in above paragraph may pronounce a person dead without personally examining the body of the deceased only if a competent observer has recited the facts of the deceased's present condition to the physician and the physician is satisfied that the death has occurred."

2) The medical record review for Patient #1 was completed on 1/17/14. The record contained nursing documentation of the patient having an eight out of ten pain score on 1/12/1/4 at 8:00 AM and at 8:20 PM. The record contained evidence the patient was administered pain medications on 1/12/14 at 9:00 AM and 8:40 PM. The medication administration record was reviewed on 1/16/14 at 3:49 PM. The medication administration record did not have the patient's post-rating of pain after the pain medication administration.

On 1/21/14 at 8:35 AM, the facility's Assessment/Reassessment of Patients policy was reviewed. The policy stated the purpose of reassessment is to determine the patient's responses to the plan of care.

On 1/21/14 at 8:34 AM, the facility's Assessment; Pain policy was reviewed. The policy stated after any active pain management intervention, initial pain scores must be reassessed to an appropriate interval for the given intervention. If pain scores are still greater than or equal to five, an additional pain management intervention must be undertaken or the managing physician contacted unless the patient requests that no further intervention be initiated. The policy stated any patient with pain scores at an unacceptable level or under active pain interventions may be reassessed at least every two hours while awake or PRN(as needed). The policy stated the effectiveness of pain management interventions, both pharmaceutical and non-pharmaceutical, should be documented on the daily data record narrative and/or MAR (medication administration record) in the spaces provided.

Based on medical record review, interview and policy review, the facility failed to ensure four (Patients' #1, 3, 9, 10) of four patients reviewed who received medication for diabetes, two (Patients' # 9, #11) of two patients reviewed who received medication for infection, one (Patient #2) of one patient reviewed who received medication for blood pressure, one (Patient #1) of one patient reviewed who received medication for breathing, one (Patient #13) of one patient reviewed who received medication to prevent blood clotting and one (Patient #13) of one patient reviewed who received medication for acid reflux, were administered the medication in accordance with the physician order in a sample of 10 records reviewed. The census at the time of the survey was 62.

Findings included:

1) The medical record review for Patient #1 was completed on 1/17/14. The record contained a sliding scale insulin order. The order stated the patient was to receive five units of insulin for a blood sugar between 151-200 per physician order dated 01/06/14 at 6:00 PM. The MAR was reviewed on 1/16/14 at 3:49 PM. The MAR revealed Patient #1 received eight units of insulin for a blood sugar of 200 on 1/15/14 at 6:00 AM. The record did not contain evidence of a second licensed nurse who verified the amount of insulin.

The record contained an order dated 01/06/14 7:00 PM for Albuterol/Ipratrop inhalation Duoneb 3 milligram per 0.5 milligram per 3 milliliter (a bronchodilator to relax muscles in the airways and increase airflow to the lungs) treatment to be administered every four hours. The MAR for 1/16/14 was reviewed on 1/16/14 at 4:02 PM. The MAR did not have evidence the 3:00 AM dose was administered.

On 1/17/14 at 1:46 PM, Staff D reported the dose and volume of insulin administered to Patient #1 on 01/15/14 should have been verified by a second nurse.

On 1/17/14 at approximately 3:00 PM, Staff D reported she/he did not think the insulin dose was verified and the documentation did not appear to have a second nurse's initials.

On 1/17/14 at 2:36 PM, the facility's Medication; Insulin Heparin Verification policy was reviewed. The policy stated to ensure patient safety, a system of double check is put in place to verify insulin dosages prior to administration. A second nurse is to verify the dosage to be given on the medication administration record, the actual vial of insulin, and the dose actually in the syringe. Both licensed nurse document their initials on the medication administration record in the appropriate time slot.


2) The medical record for Patient #3 was reviewed beginning on 01/17/14. The medical record revealed a physician order dated 012/28/13 at 12:00 PM for Novolog/Humalog/Apidra 0.03 to 0.3 milliliters per sliding scale subcutaneous ever 6 hours. Per the MAR, Patient #3 was to receive sliding scale Novolog insulin every six hours.

Closer review of the MAR's for Patient #3's entire length of stay revealed staff failed to follow hospital policy # M 31, that required a 2 person verification of insulin prior to administration of insulin, 20 of the 64 times Patient #3 was scheduled to receive insulin on the following days:

12/30/12, 01/01/13, 01/04/13, 01/06/13, 01/11/13, 01/12/13, 01/15/13, 01/16/13, 01/17/13, 01/21/13, 01/23/13, 01/24/13, 01/25/13, 01/29/13 and 01/30/13.

Patient #3 was also administered an incorrect dose of insulin one of the 64 times. On 01/05/13 when the 2 person verification was documented as performed the patient was given 3 units of insulin for a blood sugar of 159 instead of 5 units for a blood sugar reading between 151-200 as directed per the sliding scale .

Staff D and Staff G were made aware and confirmed the above findings during an interview on 01/21/14 at 1:30 PM.


3) The medical record review for Patient #9 was completed on 1/21/14. Patient #9 had an order dated 1/21/14 at 8:00 AM for Vancomycin 200 milliliters piggyback IV every day. The MAR revealed the Vancomycin was scheduled for administration on 1/21/14 at 8:00 AM. The MAR did not contain evidence the Vancomycin had been administered as of 1/21/14 at 9:20 AM. On 1/19/14 at 8:09 AM, a nurse administered four units of Novolin insulin to the Patient #9 for a blood sugar of 129. The physician order dated 01/15/14 for sliding scale for a blood sugar of 111-150 revealed the patient should receive 0 units.

On 1/24/14 at 9:35 AM, Staff H reported the Vancomycin had not been administered to Patient #9 due to the Vancomycin was "Icy cold" when he/she removed the medication from the refrigerator.

On 1/21/14 at 3:26 PM, the facility's Medication; Administration Times policy was reviewed. The policy stated medications are to be administered at the standard administration times to promote consistent medication therapy and minimize medication errors. It is suggested that all medications be administered within a 1/2 hour before and 1/2 hour after scheduled time unless the medication is not eligible for scheduled dosing. The policy stated Insulin and Heparin must be administered 30 minutes before or after scheduled dosing times. The policy stated antibiotics must be administered one hour before or after scheduled time.


4) The medical record review for Patient #10 was completed on 1/17/14. The MAR revealed Patient #10 was to receive 14 Units of Lantus (a long acting insulin used to control high blood sugar) at 8:00 AM daily per the physician order dated 01/16/14 at 2:45 PM. The MAR did not have evidence the medication was administered. The medical record did not contain evidence Patient #10 received the Lantus on 1/16/14. The medical record revealed Patient #10 last received Lantus on 1/15/14 from the transferring facility.

On 1/17/14 at 9:39 AM, Staff A was interviewed. Staff A reported the Lantus had not been administered to Patient #10 on 01/17/14. Staff A reported he/she was assigned three patients who required insulin. She/he stated she/he prioritized and administered ordered insulin to two of her/his patients receiving oral nutrition before administering the insulin to Patient #10, who was receiving tube feedings.

The manufacturer's prescribing information was reviewed on 1/21/13 at 9:00 AM. The prescribing information stated Lantus is to be administered at the same time every day.


5) The medical record review for Patient #11 was completed on 1/17/14. The physician order was dated 01/14/14 at 8:00 AM for Vancomycin 200 milliliters piggyback intravenous every day and ordered on 01/14/14 at 10:00AM Meropenem 500 milligrams piggyback intravenous every 12 hours.

The MAR revealed Patient #11 was to receive intravenous Vancomycin (an antibiotic) on 1/17/14 at 8:00 AM and intravenous Meropenem (an antibiotic) on 1/17/14 at 10:00 AM. The MAR revealed the Vancomycin was administered at 9:30 AM. The MAR did not have evidence the Meropenem was administered. The medical record review revealed Patient #11 last received the Vancomycin on 1/16/14 at 8:00 AM and the Meropenem on 1/16/14 at 10:00 PM. .

On 1/17/14 at 10:30 AM, Staff A stated the Vancomycin was administered late due to the medication was frozen and had to thaw. Staff A reported the Meropenem was not administered due to the Meropenem was not available and reported the pharmacy had been notified.

On 1/17/14 at approximately 11:00 AM, Staff I reported he /she one time had a "slushy" dose of intravenous Vancomycin. He/she reported the pharmacy staff informed him/her the Vancomycin was "OK" to administer once the medication thawed.

On 1/17/14 at 12:13 PM, Staff B was interviewed. Staff B reported the manufacturer had been contacted on 1/17/14 regarding the frozen Vancomycin and the manufacturer stated the Vancomycin was not to be frozen. Staff B reported the manufacturer stated the Vancomycin was no longer stable after it had been refrozen and thawed.


6) The medical record for Patient #2 was reviewed on 01/15/14. The medical record revealed a physician order dated 01/07/14 at 6:00 PM for Cardizem (to treat high blood pressure) 30 milligrams orally every 6 hours. Per the MAR (medication administration record), Patient #2 was to receive Cardizem 30 milligrams orally every six hours with a bolded note on the MAR that read "TAKE AND RECORD BLOOD PRESSURE".

Closer review of the MAR revealed staff failed to obtain and/or record Patient #2's blood pressure 17 of the 31 times he/she was administered Cardizem on the following recorded dates:

01/08/14, 01/09/14, 01/10/14, 01/11/14, 01/12/14, 01/13/14 and 01/14/14.

Staff G was made aware of and confirmed the blood pressure was to be completed prior to administration of the medication and the above findings during an interview on 01/16/14 at 3:24 PM.


7) The medical record review for Patient #13 was completed on 1/21/14. The record contained an order dated 01/20/14 2:00 PM for Heparin (used to prevent blood clotting) 5000 units subcutaneous every eight hours and order dated 01/20/14 6:00 AM for Protonix (used to relieve symptoms of acid-related damage to the esophagus) 40 milligrams oral daily. The MAR did not contain evidence the Heparin was administered to Patient #13 at it's scheduled time on 1/21/14 at 6:00 AM. The MAR did not contain evidence the Protonix was administered to Patient #13 at it's scheduled time on 1/21/14 at 6:00 AM.

On 1/21/14 at 11:35 AM, the findings were shared with Staff C and confirmed. Staff C reported the medications had been removed from the medication system but there was no evidence the nurse administered the medications.

These findings substantiate the allegation(s) contained in Substantial Allegation #OH00070358















31597

Based on medical record reviews, staff interviews and review of facility policy, the hospital failed to follow policy and procedure for obtaining informed consent prior to the administration of blood products. This affected two of four patient medical records reviewed who were administered blood products (Patients' #1 and #3). A total of 10 patient medical records were reviewed. The census at the time of the survey was 62.

Findings included:

1) The medical record for Patient #3 was reviewed beginning on 01/17/14. A hospital "Consent to Blood Transfusion" form was observed and appeared to have been completed on 01/11/13. Closer review of the form revealed two separate registered nurses, Staff P and Staff Q, appeared to have obtained telephone consent from Patient 3's spouse for a blood transfusion. The same form contained no documentation by the physician indicating he/she "explained the benefits, alternatives and risks of" the blood transfusion to either Patient #3 or his/her spouse. The physician also failed to sign and date the form.

A progress note completed by the renal physician on 01/11/13 read "anemia transfuse 2 units." The note lacked any evidence of communication between the physician and Patient #3 or Patient #3's spouse regarding the need for a blood transfusion.

Four hospital "Blood Transfusion Time Out Procedure" forms were also observed in Patient 3's medical record. These forms revealed Patient #3 received two units of blood product on 01/11/13 and two units on 02/04/13.

Staff D (Chief Nursing Officer) was made aware and confirmed the above findings during an interview on 01/17/14 at approximately 2:56 PM. At that time, Staff D also stated that if the physician did not fill out the "Consent to Blood Transfusion" form in its entirety, he/she should document that risks and benefits were explained to the patient and/or the patient's representative in the progress notes.



31597

2) The medical record review for Patient #1 was completed on 1/17/14. The record showed the patient received one unit of packed red blood cells on 1/15/14 at 3:00 PM. The medical record did not contain consent from Patient #1 or patient representative to receive the blood product. The physician's progress note from 1/15/14 did not contain evidence of Patient #1's consent for blood.

Interview on 1/16/14 at 12:14 PM revealed Staff C reported the facility probably did not have a signed consent for Patient #1 to receive the blood products due to an assignment change and he/she did not inform the newly assigned nurse of the need to obtain consent for the blood transfusion.

The facility's Blood Administration policy was reviewed on 1/16/14 at 12:03 PM. The policy stated the physician or designee must obtain consent for blood use prior to the initiation of therapy. Documentation of informed consent for transfusion of blood/blood components will be obtained on form, Consent to Blood Transfusion (NR-16).

On 1/21/14 at 8:34 AM, the facility's Patient Rights/Informed Consent policy was reviewed. The policy stated consent is recommended for blood and blood products.