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Based on document review and interview the facility failed to adopt Medical Staff Bylaws which gave only the Governing Body the authority to grant medical staff privileges. This deficient practice affects all patients in the facility. The facility census was six.

Findings included:

1. Review of the facilities Medical Staff Bylaws, conducted on the morning of 08/29/12, showed the following.

4.8 TEMPORARY PRIVILEGES

(c) Procedure - A request for temporary Clinical Privileges may be granted only upon the concurrence of the Chief of Staff and the Chief Executive Officer (CEO), and such grant may be subject to such contingencies and conditions as the foregoing may determine. In the event either of the foregoing persons are unavailable, the person authorized to act in their absence may consent to the grant of temporary Clinical Privileges. Temporary Clinical Privileges may be terminated at any time, with or without cause, by the Chief of Staff and the CEO.

2. During an interview on 08/29/12 at 10:40 PM, Staff A, CEO, stated that the Chief of Staff and the CEO are not members of the Governing Body.

Based on observation, interview and record review the facility failed to post the correct contact information for patients or their representatives or to provide the correct contact information for seven (Patients #1, #2, #3, #4, #5, #6 and #7) of seven current patients to file a complaint/grievance with the appropriate State agency. The facility census at the start of the survey was six.

Findings included:

1. Observation of the facilities main lobby and waiting room area showed only two postings of the Patient's Bill of Rights to patients or their representatives located inside an alcove used for privacy during patient registration. No other postings were available to read in the waiting room area or contained in a brochure readily available to patients or their representative(s).

2. Review of the facility document titled, "Patient Bill of Rights" revised 04/10, and posted in the facility waiting room showed the following:
- Contact information (name, address and telephone number) for the facility Director of Quality Assurance and Risk Management;
- Contact information (name, address and telephone number) for the state Quality Improvement Organization (QIO); and
- The name of the Department of Health and Senior Services without address or telephone number.
The facility did not provide information to file concerns about the quality of care at this facility or to file a complaint or grievance with the Department of Health and Senior Services, Post Office Box 570, Jefferson City, MO 65102 or to include either the toll-free telephone number of (800)392-0210 or the direct number (573)751-6303.

3. During an interview on 08/27/12 at 11:35 AM, Staff B, Registered Nurse (RN), Quality Assurance and Risk Management stated that the Bill of Rights used to be posted on the waiting room walls but they needed more space for pictures so they removed the Bill of Rights postings.

4. During an interview on 08/27/12 at 11:40 AM, Staff LL, Front Desk Registration Representative, stated that the patients signed the Patient's Bill of Rights electronically at registration and the documents could be located in the electronic medical record.

5. Record review of the electronic medical records for Patients' #1, #2, #3, #4, #5, #6 and #7 showed no scanned Patient's Bill of Rights in the records. During an interview on 08/28/12 at 11:00 AM, Staff BB, RN, Infection Control Nurse, stated that the Patient's Bill of Rights would be located in the patients' paper charts if they were not scanned into the electronic patient charts.

6. Record review of the paper medical record for Patient #1 showed no evidence that the Patient's Bill of Rights had been received.

7. Record review of the paper medical record for Patient #2 showed no evidence that the Patient's Bill of Rights had been received. Patient #2 was verbal but had severe Alzheimer's and there was no representative present to speak for her.

8. During an interview on 08/29/12 at 10:10 AM, Staff C, RN, Chief Nurse Executive, stated that the Social Worker usually took care of this function but that she has been on sick leave. She stated the direct care nurses were supposed to be doing this function and they left the information on the patient's bed side table. Staff C stated that she didn't know about Patient
#2's representative because she came directly from a nursing home and didn't know how the patient's nurse handled the Patient's Bill of Rights notice. She also could not provide evidence that any special precautions were used to convey the information in the Patient's Bill of Rights to patients with eye sight or reading deficiencies.

9. Record review of the paper medical record for Patient #3 showed no evidence that the Patient's Bill of Rights had been received.

10. Record review of the paper medical record for Patient #4 showed no evidence that the Patient's Bill of Rights had been received. Patient #4 was non-verbal but her representative stated that she didn't remember seeing the Patient's Bill of Rights when signing the other documents for the patient's admission.

11. Record review of the paper medical record for Patient #5 showed no evidence that the Patient's Bill of Rights had been received.

12. Record review of the paper medical record for Patient #6 showed no evidence that the Patient's Bill of Rights had been received.

13. Record review of the paper medical record for Patient #7 showed no evidence that the Patient's Bill of Rights had been received.

14. During an interview on 08/29/12 at 10:30 AM, Staff B, RN, Quality Assurance and Risk Manager, stated that the facility did not have a policy and procedure regarding the Patient's Bill of Rights.

Based on record review and interview the facility failed to ensure that all Medicare Patients received An Important Message From Medicare to be informed of their rights pertaining to discharge for five (Patient #1, #2, #4, #6 and #7) of six current Medicare patients reviewed. The facility census was six.

Findings included:

1. Record review of the medical record for Medicare Patient #1 showed the patient had been admitted to the facility on 08/27/12. An Important Message From Medicare was in the medical chart but was not dated or signed by the patient or the patient's representative.

2. Record review of the paper medical record for Medicare Patient #2 showed the patient had been admitted to the facility on 08/22/12. An Important Message From Medicare was in the medical chart dated 08/23/12 but was not signed by the patient or the patient's representative.

3. Record review of the paper medical record for Medicare Patient #4 showed the patient had been admitted to the facility on 08/24/12. An Important Message From Medicare was not in the patient's medical chart. Patient #4's representative stated that she didn't remember getting a document or signing a document by that name. She stated that she didn't realize it had such important information about discharge for her mother.

4. Record review of the paper medical record for Medicare Patient #6 showed the patient had been admitted to the facility on 08/27/12. An Important Message From Medicare was not in the medical chart.

5. Record review of the paper medical record for Medicare Patient #7 showed the patient had been admitted to the facility on 08/20/12. An Important Message From Medicare was in the medical chart dated 08/19/12 but was not signed by the patient or the patient's representative.

6. During an interview on 08/29/12 at 9:45 AM, Staff C, RN, Chief Nursing Officer, stated the facility did not have a policy and procedure regarding An Important Message From Medicare. She stated this was a function of the Social Worker that had been on sick leave and the direct patient care nurses were supposed to be fulfilling this function in her absence. She stated that the facility did not document in the medical record where patients had received An Important Message From Medicare. Staff C stated that she acknowleged the facility had no evidence to show they are providing the information to the patient.

Based on observation, record review and interview the facility failed to provide education or training and require demonstrated knowledge from medical staff on first aid techniques for patients placed in restraints. Patients in restraints are placed at a higher risk for injuries or death. This had the potential to affect all patients placed in restraints. The facility census was six.

Findings included:

1. Observation showed that no patients were currently in restraints during the survey.

2. Record review of educational records for medical staff included:
- Staff E, Registered Nurse (RN), Director of Operating Room;
- Staff BB, RN, Director of Infection Control;
- Staff G, Respiratory Therapist;
- Staff J, RN, House Supervisor;
- Staff DD, Respiratory Therapist;
- Staff EE, Physical Therapist;
- Staff C, RN, Director of Nursing, Chief Nursing Officer;
- Staff GG, Doctor of Osteopathy, Emergency Room Physician; and
- Staff JJ, Speech Pathologist.
These staff members had no documentation that they received first aid education or training for patients placed in restraints. Although these employees may not directly apply restraints to patients they could potentially provide care to patients in restraints.

3. During an interview on 08/28/12 at 10:45 AM, Staff J, RN, House Supervisor, stated that the facility accepts patients requiring respiratory ventilators (a method to mechanically assist or replace spontaneous breathing using a machine) and that often the patients must be placed in restraints. She stated that a majority of their patient population is elderly and exhibit some form of dementia and may be placed in restraints to prevent them from pulling out their IV (in the vein) tubing.

4. During an interview on 08/29/12 at 2:00 PM, Staff MM, Director of Human Relations, stated she was not aware that nursing and/or medical staff were required to have first aid education for patients placed in restraints.

Based on record review and interview the facility failed to use medication error data and analysis to implement improvements or preventive actions and mechanisms to reduce medication errors and ensure patient safety. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Medication Error and Adverse Drug Reaction/Event Identification and Reporting" dated 11/06, gave the following direction:
- Hospital's pharmacy services must be integrated into its hospital-wide QAPI [Quality Assurance and Performance Improvement] Program;
- Medication Safety Policy Statement: Providers involved in medication use are required to participate in the detection and reporting of errors, the identification of the system causes of errors, and the implementation of system changes to decrease the likelihood of errors;
- The reporting program is coordinated through the Medication Safety Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff;
- The Medication Safety Committee reviews medication safety reports quarterly and provides recommendations for resolution through quality improvement projects, and/or root cause analysis or failure mode and effect analysis;
- To learn about the system causes of errors, a medication error should be categorized according to the level of harm experienced by the patient, the phase of the medication use process in which the error originated, and the type of error as indicated by the criteria listed below:
Patient Outcome Severity Categories:
A. Circumstances or events that have the capacity to cause error.
B. An error occurred but the error did not reach the patient.
C. An error occurred that reached the patient, but did not cause patient harm (an "error of omission")
D. An error occurred that reached that patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm.
E. An error occurred that may have contributed to or resulted in temporary harm to the patient and intervention.

2. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed the Pharmacy and Therapeutics (P&T): The [P&T] committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

3. Record review of the facility's "Incident Report Summary" dated 06/12 showed the following trend analysis for medication errors for the last six months:
- 01/12 = 131 medication errors reported;
- 02/12 = 131 medication errors reported;
- 03/12 = 369 medication errors reported;
- 04/12 = 274 medication errors reported;
- 05/12 = 205 medication errors reported; and
- 06/12 = 240 medication errors reported.
The report showed for the last 12 months (07/11 through 06/12) that 1,794 medical errors were reported and continued to increase throughout the year.

4. Record review of the facility's policy titled, "Quality Assessment and Improvement Plan" dated 11/06, was void of any writing (the page was blank).

5. Record review of the medication errors reviewed by Staff Q, Registered Pharmacist, Director of Pharmacy, for the last 13 days (08/13/12 through 08/25/12) totaled 30. The 30 medication transcription errors were analyzed and corrected by Staff Q but were not categorized according to the level of harm experienced by the patient as required by the facility policy and procedure to facilitate system improvements.

6. During an interview on 08/28/12 at 1:00 PM, Staff Q, stated that she had two QAPI projects and one of them was medication errors. The Pharmacist stated that she reviewed all physician orders, investigated all discrepancies in transcription of the physician orders to the eMAR (electronic medication administration record) and corrected the transcription errors but could not provide evidence that these errors were reported to the P&T or Medical Staff Committees or that program activities were implemented for system changes of performance improvement or quality assurance to reduce the amount of medication errors.

During an interview on 08/29/12 at 1:20 PM, Staff Q stated she has been employed with the facility since 05/11. She stated that neither the P&T Committee nor the Medical Staff have reviewed or approved any of the policies and procedures currently in use at the facility. The Pharmacist could only provide evidence of two meetings with the P&T Committee and the Medical Staff since her employment.

7. Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings for quarterly.
- The next meeting is scheduled for Thursday, October 20, 2011 at 12:00 noon in the Board room.

Record review of the P & T Committee meeting minutes dated Thursday, 09/29/11 showed Staff NN, Medical Doctor (MD), asked that a report on medication errors be put on the agenda for the next meeting.

Record review of the P & T Committee meeting minutes dated 07/19/12 (the next time the Committee met after 09/29/11) showed the minutes did not contain any report regarding medication errors.

8. During an interview on 08/29/12 at 9:40 AM, Staff Q stated that the P & T Committee had intended to meet monthly but the meetings had not taken place.

Based on record review and interview the facility failed to integrate contracted services into the facility wide Quality Assurance and Performance Improvement Program (QAPI). Contracted services provided to the facility must be organized and integrated into the facility QAPI program to ensure improved health outcomes. The census was six.

Findings included:

1. Record review of the facility 2012 Performance Improvement Plan showed a QAPI reporting calendar (a calendar showing which departments/services are due to report QAPI activities) which included contracted services for the cardiac rehabilitation services for the months of March, June, September and December.

2. Record review of the facility's Performance Improvement data and Quality Council Meeting minutes for the months of March 2012 and June 2012 showed no data collection, review or analysis of QAPI activity from the cardiac rehabilitation contracted service provider.

3. During an interview on 08/28/12 at 10:55 AM, Staff B, Director of Quality Assurance, verified she did not collect QAPI data from the cardiac rehabilitation contractor and she stated that she is aware of activities being conducted by the contractor however the activities are not included into the hospital wide QAPI program.

Based on interview and record review the facility failed:
-To protect the confidentiality of electronic patient medical records by failing to develop and maintain structured, routine monitoring of accesses into those electronic medical records to identify and prevent breaches by unauthorized persons.
-To protect paper patient medical records stored in the Rehabilitation Therapy department from unauthorized access. The facility census was six.

Findings included:

1. Record review of the facility's undated position description for the Medical Record Director, showed a professional requirement to maintain and ensure patient confidentiality at all times.

2. Record review of the facility's policy titled "Access to Medical Records" revised 06/12 showed authorized individuals having access to medical information would be the Medical Records staff members and any employee caregiver.

The policy failed to restrict accesses to caregivers who were directly providing care to the patient.

3. During an interview on 08/27/12 at 3:15 PM Staff D, Director of Medical Records stated the following:
-All staff were required to sign a confidentiality agreement on hire and annually thereafter.
-Staff caregivers and Medical Records staff have a user identification and password to access patient electronic medical record information.
-She did not have a structured, routine method of monitoring accesses into the patient electronic medical records.

4. Observation on 08/28/12 at 3:35 PM in the Rehabilitation Therapy secretary's office area showed the following:
-The glass enclosed secretary's office area was door-less and located in the waiting room of the Rehabilitation Therapy department.
-The secretary's office area had fifteen lateral (longer and wider than traditional file cabinets) file drawers all containing paper patient medical records.
-The lateral file drawers did not have locking mechanisms.
-The secretary's office area was not within line of sight of the Rehabilitation therapist's office area.

5. During an interview on 08/28/12 at 3:38 PM Staff H, Director of Rehabilitation Therapy confirmed the following:
-The fifteen lateral file drawers were full of paper patient medical records.
-The fifteen file drawers could not be locked.
-The Rehabilitation department was not operated seven days a week.
-When therapy staff was not on duty the department was locked but could be accessed by any staff with a key.
-Staff who had keys included Occupational therapy and Speech Language contractors who worked occasionally for the department and the facility Housekeeping staff.
-The paper patient medical records should be secured and locked up.

6. During an interview on 08/29/12 at 3:38 PM Staff D, Director of Medical Records confirmed the following:
-She knew the paper patient medical records were stored in the Rehabilitation Therapy department.
-She did not know there was access to those records by staff who were not directly involved in the care of the patient.
-The current storage method of paper patient medical records in the Rehabilitation Therapy department was not one hundred percent secure and did not maintain confidentiality of those records.

Based on interview, record review and policy review the facility failed to:
-Ensure that the current Pharmacy policies and procedures were reviewed, revised or approved by the Pharmacy and Therapeutics Committee or the Medical Staff. This had the potential to affect all patients in the facility.
-Have policies and procedures in place approved by the Medical Staff to minimize medication errors and the potential harm to patients during the time the pharmacy was closed. This had the potential to affect all patients in the facility. The facility also failed to follow facility policy regarding checking for outdated or recalled medications in all storage areas outside of the pharmacy including the Cardiopulmonary department, the Rehabilitation Services department and in the Operating Room (OR) anesthesia cart storage areas. This placed all surgical patients at risk for receiving unusable medication. The facility does an average of 40 surgical cases per month.
-Ensure the Pharmacy Department reported medication errors to the Pharmacy and Therapeutics (P&T) or Medical Staff Committees as required by policy and procedure and position description to implement corrective actions to reduce or prevent reoccurrences. This had the potential to affect all patients in the facility. The facility census was six.

The severity and cumulative effect of these practices resulted in the facility's non-compliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

Please see citations at A0491, A0500, A0505 and A0508.

Based on observation, record review and interview the facility failed to ensure that the current Pharmacy policies and procedures were reviewed, revised or approved by the Pharmacy and Therapeutics Committee or the Medical Staff. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility document titled, "Medical Staff By-Laws" undated, stated the Pharmacy and Therapeutics (P&T) function shall develop and recommend policies related to drugs and diagnostic testing materials.

2. Record review of the P&T Committee meeting minutes dated Thursday 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings quarterly.
- The next meeting is scheduled for Thursday October 20, 2011 at 12:00 noon in the Board room.

Review of the committee minutes showed the meeting scheduled for Thursday October 20, 2011 was not held. The minutes showed no further meeting until Thursday July 19, 2012.

3. Record review of the current policies and procedures for the Pharmaceutical Department showed no signatures or revision dates.

4. During an interview on 08/29/12 at 1:10 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated the current pharmacy policies and procedures in use by the facility had not been reviewed, revised or approved by the P&T Committee or the Medical Staff.

Based on policy review, interview and observation, the facility failed to have policies and procedures in place, which were approved by the medical staff, to minimize medication errors and the potential harm to patients during the time the pharmacy was closed. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed that the Pharmacy and Therapeutics (P&T) Committee shall develop and recommend policies related to drugs and diagnostic testing materials. The committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

2. Record review of the facility's policy titled, "Medication Acquisition after Pharmacy hours" reviewed 08/12, unapproved by the Medical Staff, gave the following direction to staff:
- The purpose of this policy is to allow for safe and accurate medication acquisition for newly admitted patients or new orders given for current inpatients when the pharmacy is closed;
- When the Pharmacy is closed and a new medication is ordered to be given before the Pharmacy staff returns, the nursing supervisor shall be permitted to enter the Pharmacy to retrieve enough medication to provide for the number of doses required until the pharmacy reopens. Pharmacy hours are 0730-1600 (7:30 AM - 4:00 PM) Monday-Friday;
- Before any medications obtained by the House Supervisor are administered, a second nurse will verify that the correct medication was obtained. If the medication was ordered via written order, the second nurse will use the original written order, not a printed eMAR (electronic Medication Administration Record) work-list, to verify medication names and doses;
- The Medication Sign-Out Sheet will be routinely reviewed by the pharmacist to verify the accuracy of medication acquisition compared to medications ordered, and to determine whether new procedures should be put in place to limit access to pharmacy.

3. Record review of the facility document titled, "Incident Report Summary" dated 06/12 showed the following for the month of June 2012:
- Medication errors 240;
- Summary: 240 medication -related incidents were reported for 06/12. These included:
Wrong Drug - 6 (incidents);
Wrong time - 97;
Wrong dose - 62
Wrong Route - 6;
Duplicate - 18;
Omission - 7;
Allergy (to medication administered) - 29;
No order - 1;
Continue Home Medications order - 7;
Respiratory Therapy orders entered by other - 2;
Wrong physician - 5.

4. During an interview on 08/28/12 at 1:33 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated, "With our electronic system, the physician puts the medication order in electronically and the nurses then transcribe into the eMAR for administration to the patient. We rely upon a visual double check by another nurse". She stated that she tracks all medication errors and that most of the medication errors occur when the pharmacy is closed and there is no review of the order by a pharmacist before the medication is administered to the patient. Staff Q stated that most of the medication errors occur on weekends and that if a patient is admitted to the facility on a Friday at 5:00 PM that the patient may be discharged before she arrives on Monday at 7:30 AM and reviews the medication order. She stated that the errors are mostly in transcription by the nurses when they transcribe the original order by the physician into the electronic system.

5. Record review of the medication errors tracked by Staff Q showed 26 medication errors in the last 13 days included (the comment section is taken directly from the notes of Staff Q):
- 08/23/12 at 5:27 PM - patient received a duplicate IV medication because the first dose was administered in the emergency room and the order stated every 24 hours;
- 08/25/12 (Saturday) at 6:40 PM - patient received two doses of a medication they were allergic to as listed in the computer and the medication was the incorrect strength of 10 mg (milligrams) instead of 5 mg;
- 08/24/12 at 11:26 PM - Four medications were entered as one order instructing the PO (by mouth medications) medications be administered as IV fluids;
- 08/20/12 (Monday) at 7:14 PM - Three ASA (aspirin) 243 mg entered by ER (emergency room) staff for administration in ER only. This order was not written on admission orders. Choosing the incorrect frequency caused this medication to be placed on the profile without the physician's orders. No doses were given, but if this had happened on a Friday night, the patient would have gotten 2 doses before the error was caught. **near miss;
- 08/14/12 (Tuesday) at 11:39 PM - The following medication was ordered and administered PO - HydrOXYzine 50 mg/mL (milliliters) inject subq;
- 08/14/12 at 9:37 PM - The incorrect drug, Mupirocin 2% (nasal ointment) was ordered and administered to patient;
- 08/16/12 at 8:57 PM - the physician ordered TAC solution (local anesthetic) topical liquid 1 mL dose - a 3mL dose was administered to the patient;
- 08/20/12 at 10:41 PM - the physician order was for Nitroglycerin (a medication causing dilation or relaxation of the blood vessels) 2% ointment prn (as needed) but the order was transcribed into the eMAR for every six hours 6:00, 12:00 18:00 and 24:00;
- 08/20/12 at 2:38 AM - medication ordered was Nalbuphine HCL (narcotic used for pain) 5 mg and the ordered was transcribed into the eMAR as 10 mg;
- 08/20/12 at 12:03 AM - medication ordered was Nalbuphine HCL 5 mg every 6 hours prn; the order was transcribed into the eMAR as 10 mg every 4 hours;
- 08/19/12 (Sunday)at 6:50 PM - physician's order for 9 medications including IV normal saline with 20 mEq (milliequivalents) KCL (a fluid that replenishes Electrolytes that affect the amount of water in your body, the acidity of your blood (pH), your muscle function, and other important processes) at 70 cc/hour - during transcription to the eMAR this order was omitted and the pharmacist entered the order on 08/20/12 at 9:00 AM;
- 08/19/12 at 5:00 PM - physician's order for Lorazepam (medication used to relieve anxiety) 0.5 mg tablets BID prn (2 times per day as needed) was transcribed to be given twice daily at 10:00 AM and 10:00 PM;
- 08/19/12 at 6:25 PM - Risperidone (medication used to treat the symptoms of schizophrenia [a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions]) 0.25 mg tabs (tablets) HS (at bedtime) - the order was transcribed to the eMAR to be taken at 6:00 PM every day - the patient did not receive the medication and the entire dose was missed;
- 08/19/12 at 6:25 PM - physician's order for Insulin (Lantus) (brand name for long-acting insulin that is taken once a day) 100 units/mL subq at HS (bedtime); the order was transcribed to the eMAR to be taken daily at 5:00 PM - the patient did not receive the insulin dose;
- 08/17/12 (Friday) at 3:39 AM - the physician wrote orders for 13 items including one for Hydromorphone (medicine used to relieve severe pain) 1 mg IVP (to be attached to infuse with the current IV medication) q 6 hours (every six hours) for pain - the medication was not transcribed onto the eMAR and the patient did not receive the medication;
- 08/14/12 at 11:26 PM - physician order for Guaifenesin (used to relieve chest congestion) 400 mg tab - the order was transcribed into the eMAR as 600 mg - Pharmacist note reads = not possible to give a 400 mg dose from a 600 mg tab *should not* give 600 mg without clarification since 400 mg was ordered. Medication was charted as 400 mg given from a 600 mg tab that isn't supposed to be split or crushed;
- 08/14/12 at 11:26 PM - physician order stated to give medication at 4:00 PM - medication was transcribed on the eMAR to be administered at 5:00 PM;
- 08/15/12 at 1:27 AM - physician's order was set to start at 08/15/12 at 10:00 AM for D5 ? NS plus 20 mEq KCL solution IV continuously - Pharmacist note read, "Set to start 08/15/12 at 10:00 AM instead of at time of entry. IV fluids are not hung in ER. IV fluid therapy delayed by several hours";
- 08/14/12 at 8:28 PM - order for Atorvastatin (a drug used for the treatment of high cholesterol) 40 mg tabs at HS - the order was transcribed into the eMAR to be administered at 10:00 AM - comments written by Pharmacist = give at HS per Med Staff. Always give statins (this class of medication) at HS. Due to this, dose that should have been given 08/14/12 at 10:00 AM was omitted. The patient did not receive the medication.

The current medication errors, many of which are high risk medications, made during the time the pharmacy was closed totaled 26 errors in 13 days.

6. During an interview on 08/29/12 at 1:20 PM, Staff Q stated she has been employed with the facility since 05/11. She stated that neither the Pharmacy and Therapeutics (P&T) Committee nor the Medical Staff had reviewed or approved any of the policies and procedures currently in use at the facility. The Pharmacist could only provide evidence of two meetings with the P&T Committee and the Medical Staff since her employment.

7. Record review of the Pharmacy and Therapeutics Committee meeting minutes dated Thursday, 09/29/11 showed Staff NN, Medical Doctor (MD) asked that a report on medication errors be put on the agenda for the next meeting.

Record review of the Pharmacy and Therapeutics Committee meeting minutes dated 07/19/12 (the next time the Committee met after 09/29/11) showed the minutes did not contain any report regarding medication errors.

8. During an interview on 08/29/12 at 9:40 AM, Staff Q stated the Pharmacy and Therapeutics Committee had intended to meet monthly but the meetings had not taken place.

9. Record review of the pharmacy document titled, "Quality Assessment and Improvement Plan" dated 11/06, was blank.




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27029

Based on observation and interview the facility failed to ensure that all controlled substance (Schedule II through Schedule V) medications were stored and secured according to pharmacy policy and procedures for two (Patient's #3 and #4) of two patients. This failure had the potential to affect all patients bringing medications from home. The facility census was six.

Findings included:

1. Record review of the facility policy titled, "Inventory and Control of Schedule II through V Controlled Substances" revised 01/12 stated the following:
- The pharmacist shall ensure that Schedule II through V controlled substances are safely stored and that an accounting of the drugs is accurately maintained;
- Controlled substances CII through CV (Class II trough Class V) shall be stored in locked cabinets within the pharmacy. Only a pharmacist shall have access to the keys to these cabinets;
- A perpetual inventory of controlled substances CII through CV shall be maintained. The actual count of the substance should be verified each time a drug is removed from the locked cabinet.

2. Observation on 08/28/12 at 1:10 PM in the Pharmacy Department showed two envelopes containing home medications of two inpatients (#3 and #4) for safekeeping to return to the patients upon discharge. The envelopes were sealed with a transparent tape and stored in an unlocked drawer by the pharmacy door. Both of the envelopes contained pill bottles of a controlled substance, Hydrocodone 7.5/650 mg, (an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of Hydrocodone) quantity 75 marked on the pill bottle label. The patients were not currently receiving the home medications. Staff Q counted the pills in the bottle (for Patient #3) with a quantity of 28 and two half pills. She stated she had no way of knowing if the amount of pills in the bottle was correct or not and that they should have been locked up.

3. The second envelope for Patient #4 contained the same medication, Hydrocodone/APAP 10/650 mg but was sealed and had not been opened.

4. During an interview on 08/28/12 at 1:10 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated the narcotic medications should have been locked in a secure area and the clear tape that sealed the envelopes should have been marked to detect tampering.

Based on observation, interview and facility policy review the facility failed to:
-Ensure the Pharmacy department checked for outdated or recalled medications in all storage areas outside of the Pharmacy including the Cardiopulmonary and Rehabilitation Services and in the Operating Room (OR) anesthesia cart storage areas.
-Ensure the integrity of unlabeled multi-use medications used for wound cleansing were not available for patient use in the Emergency Department (ED). The failure to appropriately label and store all multiple use medications affects all patients who are treated in the ED. The average number of patients seen in the ED was approximately 750 per month;
-Label opened multi-dose medication (MDV) with the date opened and the initials of the staff member who opened the medication in the Operating Room (OR) and in the medication room located on the medical/surgical/telemetry floor; and
-Ensure that expired medications were not available for patient use in the ED, OR and out-patient departments. This deficient practice placed patients at risk to receive outdated, unusable drugs. The facility census was six.

Findings included:

1. Record review of the facility policy titled, "Multiple -Dose Injectable Vial (MDV) Usage" dated 08/12 showed all multiple dose medications must be dated and initialed by the staff at the time the container was opened. Any medication found open without a date of opening was considered expired and should be disposed of accordingly to assure that the product was safe for patient use.

Record review of the facility's policy titled, "Medication Acquisition and Storage", revised 08/2012, showed the following direction:
-MDV were stored in accordance with manufacturer's directions, State and Federal requirements, and may be used for 28 days after initial opening unless contaminated or otherwise instructed by the manufacturer or other respected agency.

Record review of the facility's policy titled, "Procedure for checking for outdated or recalled medications", provided by Staff E, OR manager, dated 11/2006, showed the following direction:
-All medication storage areas shall be checked monthly for outdated medications. The stock locations include:
-ICU/Telemetry
-Recovery Room
-Station I (medical/surgical)
-Emergency Department
-Surgery
-Anesthesia
-Same Day Surgery
-Respiratory (also called Cardiopulmonary) therapy
-Radiology
-Pharmacy Crash Carts
-Surgery personnel were responsible for checking outdates in recovery, same day surgery, anesthesia, and surgery and notifying the pharmacy department when complete.
-Respiratory therapy personnel were responsible for checking for outdates in respiratory department and notifying the pharmacy department when complete.
-Medications that expire before the next check period shall be removed from stock and returned to pharmacy for processing.
-After completion of monthly check for each location, the tracking log will be completed.

2. Observation on 08/28/12 at approximately 10:40 AM in the ED, Obstetrical and Gynecological treatment room and the Trauma treatment room showed medications available on open counter tops and shelves. The available medications were used primarily for wound cleansing. The following open multiple use medications were not labeled with the date the medications were opened and were not initialed by the person who opened the bottles:
-Hydrogen Peroxide 16 ounce bottle (three bottles);
-Povidone Iodine solution eight fluid ounce (five bottles);
-Isopropol Alcohol 16 ounces (two bottles;)
-Chlorhexedine Gluconate solution (four bottles);
-Betadine three fluid ounces (four bottles);
-Simply Saline Wound Wash (four bottles);
-Saf-Cleans AF-dermal wound cleanser 12 fluid ounces (four bottles).

3. During an interview on 08/28/12 at approximately 11:10 AM, Staff Q, the Director of Pharmacy Services stated that all open medications should be dated and labeled and that she wasn't aware of a specific policy for multiple use wound care cleansing medications. Staff Q verified the findings of the open wound cleansers in the ED, Obstetrical and Gynecological treatment room and stated that she was unaware of the open wound cleansers and stated that they should be secured, labeled and treated as if they were multiple dose medications.

4. Observation on 08/27/12 at 3:25 PM of the Recovery Room drug storage showed:
-Open MDV of alcohol- no date or initials when opened,
-Intravenous solution bag of Lactated Ringers and Dextrose 5% (to replace patient fluid during surgical intervention) bag with an expiration date of 3/12,
-Open MDV - Hurricaine topical anesthetic spray (used to numb back of throat) no date/initials when opened,
-Open MDV - Lidocaine oral topical solution 2% (used to numb back of throat) - no date/initials when opened

5. During an interview concurrent with observations, Staff E, OR Manager stated that MDV should be labeled and dated when opened. Staff E stated that Recovery nurse checked for outdates of medication weekly.

6. Observation on 08/28/12 at 9:00 AM in the medical/surgical/telemetry and Intensive Care medication room showed the following:
- Morphine sulfate oral solution (used to manage pain) 100 mg per 5 mL partially used and currently contained 16.75 mg of medication. The multi-use bottle contained two dates: 12/12 and 04/04/12 but no initials;
- Carvedilal (used to treat heart failure and high blood pressure) with an expiration date of 04/12.
- Three bottles of multi-use injectable Sterile water - all opened and partially used with expiration dates of 11/01/09; 03/01/10 and 03/01/10. The bottles contained no date/initials when opened.

7. During an interview on 08/28/12 at 9:00 AM, Staff B, Registered Nurse (RN), Quality Assurance and Risk Management, stated she would have to go look at the policy to determine how long the medications can be used after opening but she was sure they should have been dated and initialed.

8. Observation on 08/29/12 at 11:30 AM of the anesthesia cart in the Endoscopic procedure room showed:
-Epinephrine (used to stimulate the heart) four - 1 milligram (mg-unit of measure)/milliliter (ml-unit of measure) vials with an expiration date of June 2000,
-MDV - Brevibloc injection (slows the heart rate and decreases blood pressure) - one vial dated 07/06/12 (28 days from the open date would show the drug expired on 08/03/12)
-Open MDV - Neostigmine (reverses muscle relaxation produced by anesthesia) - no label when opened,
-Vitamin K (stops bleeding) five vials - expired 04/12
-Neosynephrine (prevent bleeding in nasal intubation) two - 15 ml bottles nasal spray expired of 11/11,
-Furosemide (stimulates urine production) one - 10 ml vial expired July 2012,
-Metoclopramide (stimulates gastric emptying) 10mg/2ml:
Three vials - expired 11/11
Two vials - expired 07/11
Six vials - expired 01/12
-Succinylcholine (medication used to relax skeletal muscles) - five 10 milliliter (ml- unit of measure) vials. The vials contained no date of placement in cart. Product information showed "store in refrigerator."
-Zemuron (medication used to relax skeletal muscles) - five (5 ml) vials. The vials contained no date of placement in cart. Product information showed "store in refrigerator."
-Famotidine (medication to empty the stomach) - nine (20 milligrams (mg-unit of measure). The bag had a label, which showed "refrigerate."

9. During an interview concurrent with the anesthesia cart observation, Staff X, Certified Registered Nurse Anesthetist (CRNA), stated that he did not know the medications needed to be refrigerated. Staff X stated that he did not know when the medication was stored in the cart. Staff X stated that medication loses potency at room temperature. Staff X stated that the CRNA's are responsible for the anesthesia cart. Staff X stated that he took the lead CRNA's, Staff Z's, word that everything was ready to go in the anesthesia cart.

10. During an interview on 08/29/12 at 2:00 PM, Staff Q, Pharmacist, stated that Succinylcholine, Zemuron and Famotidine medication needed to be stored in a refrigerator. Staff Q stated that she told Staff Z to store the medication in a refrigerator and that she was under the impression that they were storing the drugs properly. Staff Q stated that she does not do a monthly check on anesthesia carts in OR. Staff Q stated that she relied on CRNA's to inventory the stock.

11. Observation on 08/29/12 at 12:05 PM of the anesthesia cart for the OR showed:
-4% Lidocaine (local anesthesia for eye surgery) 10 vials - expired 01/12
-IV solution Normal Saline (fluid for antibiotic infusion) 100 ml - expired 05/12
-Suprane (anesthesia inhalant drug) - expired 12/2011.

12. During an interview concurrent with observations Staff X stated that Anesthesia staff was responsible for the supplies in the anesthesia cart. Staff X stated this was not my problem to fix, that most places trade out drugs weekly and sometimes daily.

13. During an interview concurrent with observations Staff E, OR manager confirmed drug outdates and removed outdated drugs from anesthesia supply cabinet.




15697




27029

Based on record review and interview the facility failed to ensure the Pharmacy Department reported medication errors to the Pharmacy and Therapeutics (P&T) or Medical Staff Committees and failed to implement corrective actions to reduce or prevent reoccurrences. This had the potential to affect all patients in the facility The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Medication Error and Adverse Drug Reaction/Event Identification and Reporting" dated 11/06, gave the following direction:
- Hospital's pharmacy services must be integrated into its hospital-wide QAPI [Quality Assurance and Performance Improvement] Program;
- Medication Safety Policy Statement: Providers involved in medication use are required to participate in the detection and reporting of errors, the identification of the system causes of errors, and the implementation of system changes to decrease the likelihood of errors;
- The reporting program is coordinated through the Medication Safety Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff;
- The Medication Safety Committee reviews medication safety reports quarterly and provides recommendations for resolution through quality improvement projects, and/or root cause analysis or failure mode and effect analysis;

2. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed the following:
- Pharmacy and Therapeutics (P&T): The [P&T] committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

3. Record review of the facility's "Incident Report Summary" dated 06/12 showed the following trend analysis for medication errors for the last six months:
- 01/12 = 131 medication errors reported;
- 02/12 = 131 medication errors reported;
- 03/12 = 369 medication errors reported;
- 04/12 = 274 medication errors reported;
- 05/12 = 205 medication errors reported; and
- 06/12 = 240 medication errors reported.
The report showed for the last 12 months (07/11 through 06/12) that 1,794 medical errors were reported and continued to increase throughout the year. This amount of medication errors is more than expected for the size and scope of services provided to patients by the facility.

4. Record review of the facility's document titled, "Position Description" for the Pharmacist dated 03/21/09, showed the following:
- General Responsibilities: Performs all aspects of patient care in an environment that optimizes patient safety and reduces the likelihood of medical/health care errors;
- Maintains established procedures concerning quality control;
- Professional Requirements: Maintains regulatory requirements; and
- Actively participates in performance improvement and continuous quality improvement activities.

5. Record review of the facility's policy titled, "Quality Assessment and Improvement Plan" dated 11/06, was void of any writing (the page was blank).

6. During an interview on 08/28/12 at 1:00 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated that she had two QAPI projects and one of them was medication errors. The Pharmacist stated that she reviewed all physician orders, investigated all discrepancies in transcription of the physician orders to the eMAR (electronic medication administration record) and corrected the transcription errors but could not provide evidence that these errors were reported to the P&T or Medical Staff Committees or that program activities were implemented for system changes of performance improvement or quality assurance to reduce the amount of medication errors.

During an interview on 08/29/12 at 1:20 PM, Staff Q stated she has been employed with the facility since 05/11. She stated that neither the P&T Committee nor the Medical Staff have reviewed or approved any of the policies and procedures currently in use at the facility. The Pharmacist could only provide evidence of two meetings with the P&T Committee and the Medical Staff since her employment.

7. Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings for quarterly.
- The next meeting is scheduled for Thursday, October 20, 2011 at 12:00 noon in the Board room.

Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed Staff NN, Medical Doctor (MD), asked that a report on medication errors be put on the agenda for the next meeting.

Record review of the P & T Committee meeting minutes dated 07/19/12 (the next time the Committee met after 09/29/11) showed the minutes did not contain any report regarding medication errors.

8. During an interview on 08/29/12 at 9:40 AM, Staff Q stated that the P & T Committee had intended to meet monthly but the meetings had not taken place.

Based on interview and record review the facility failed to develop a comprehensive policy for notification of patients of potentially infectious blood and blood component exposure. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Look-Back Plan" dated 11/01/10, showed the facility failed to provide specific timelines and guidance for notification of recipients who may have received potentially infectious blood and or blood components.

2. During an interview on 08/29/12 at approximately 11:00 AM, Staff Y, Laboratory Department Manager, stated he was not aware of any policy which had the specific timelines for patient notification in the event of a potential exposure. Staff Y verified a notification policy needed to be more specific and that the current policy in place did not meet the regulatory requirements.

Based on interview and record review the facility failed to ensure the current online Diet manual (a reference for patient's diets) was approved for use by the Medical Staff and the Clinical Dietitian. The facility census was six.

Findings included:

1. Review of a paper copy of the current online facility diet manual (Nutrition Care Manual) provided by Staff H, Manager of the Dietary department, showed staff failed to obtain required approvals (a signature page) of the Medical Staff and the Clinical Dietitian.

2. Review of an invoice for the Nutrition Care Manual Web subscription from the American Dietetic Association dated 10/28/11 showed the facility used the online diet manual since that date.

3. During an interview on 08/28/12 at 9:48 AM Staff H confirmed the current online diet manual was:
-Not approved for use in the facility by the Medical Staff and the Clinical Dietitian.
-Previous diet manuals had been paper copies and had signature pages to show approval by the Medical Staff and the Clinical Dietitian.
-The current diet manual was on-line and Staff H had not obtained approvals (signature page) from the Medical Staff and the Clinical Dietitian.

Based on observation and interview, the facility failed to maintain areas in the operating rooms, patient rooms, intensive care unit, emergency department and same day surgery in an easily cleanable and orderly manner. This deficient practice affects all patients in the facility. The facility census was six.

Findings included:

1. Observation on 08/27/12 of the facility operating suite showed the following:
-At 3:42 PM one edge of the wooden door to operating room #2 was cracked and splintered leaving a jagged edge approximately 4 inches in length.
-At 3:58 PM a hole, approximately 6 inches in length by ? inch in width, in the wall behind the door in operating room #1.

2. During an interview on the same date and at the same times of the observations Staff F, Scrub Tech, confirmed the need for repairs to the wall and the doors.

3. Observations during a tour of the facility, conducted on the morning of 08/28/12 showed the following:
-At 9:14 AM one edge of the wooden door to patient room 107 was cracked and splintered leaving a jagged edge approximately twelve inches in length.
-At 9:27 AM one edge of the wooden door to patient room 119 was cracked and splintered leaving a jagged edge approximately 12 inches in length.
-At 9:40 AM the tile floor of the linen room, adjacent to the Intensive Care Unit, was stained and chipped with gaps between the tiles.
-At 10:05 AM one edge of the wooden door to the trauma room in the Emergency Department was cracked and splintered leaving a jagged edge approximately eight inches in length.

4. During an interview on the same date and at the same times Staff L, Facilities Manager, confirmed the doors and the floors were in need of repair and could not be properly cleaned.

5. Record review of the facility's policy titled, "Infection Control - EVS (Environmental Services) General Cleaning Procedures", revised 07/11 showed the following direction:
-Disinfect bed (including bed rails), patient furniture, ledges, frequently touched or high-touch surfaces (like light switches, nurse call bell, door knobs, medical equipment).
-Observe and report structural damage and/or equipment malfunction to proper person.

6. Observation on 08/28/12 at 9:15 AM in Same Day Surgery (SDS) patient rooms showed all four side rails on beds in rooms - 107, 108, 109, 115, 116, 117, and 118 had exposed metal which was brown and discolored. The plastic coating on all side rails was jagged and missing at spots making cleaning of rails difficult. Organisms could multiply under edges of coating where cleaning was difficult to complete. Patient beds in these rooms also showed missing plastic coating on head and foot boards, providing another area for bacteria to grow. Adequate cleaning of head and foot boards was impossible due to missing plastic coating which exposed particle board that was not cleanable.

7. During an interview concurrent with observations, Staff KK, Compliance Officer Life Safety, confirmed the facility has a few problems. Staff KK also confirmed the bed rails should have been taken off, sand blasted and repainted to make them easily cleanable.

8. During an interview concurrent with observations, Staff E, Operating Room (OR) manager confirmed the beds posed a risk of infection to any patient who may occupy the beds.





15697

Based on observation, interview and record review the facility failed to:
-Provide safe, sanitary supplies and supply storage conditions by maintaining usable supplies with current dates and intact packaging in the
Recovery Room supply cabinet, Same Day Surgery (SDS) storage room and the anesthesia supply cart in the Endoscope procedure room and the Operating Room (OR).
-Provide two of eight blood pressure monitoring cuffs in good repair in the Emergency Department (ED) treatment rooms.

Failure to remove expired supplies from stock had the potential to expose patients to unsterile, unstable supplies which could cause infection. Failure to ensure blood pressure monitoring equipment is in good repair has the potential to cause inaccurate blood pressure monitoring/readings which is an important diagnostic measurement for health emergencies and treatment response. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Monitored Shelf Life" dated 01/12 provided by Staff E, OR manager showed the following direction:
-Prior to releasing packaged sterile goods, the expiration date must be checked.
-Items at or beyond the stated expiration date shall not be used for patient care.

2. Observation on 08/27/12 at 3:45 PM of the recovery room supply cabinet showed:
-Intravenous (IV) needles (used for medication injection in patient vein)
-#24 gauge (ga - size) two with an expiration date (exp) of 03/2012
-#18 ga - one - exp of 02/2009, seven - exp of 03/2010, and four - exp of 07/2010
-Specimen trap- two - exp of 01-2011 ( a specimen trap is a device used to obtain sputum to identify possible bacteria in the lungs.)

3. During an interview concurrent with supply observation Staff E, stated that the Registered Nurse (RN) in the recovery room was responsible for checking for outdates weekly.

4. Observation on 08/28/12 at 9:30 AM, the Same Day Surgery (SDS) supply room showed the following expired IV needles:
-#24 ga - one - exp of 09/2006,
-#24 ga - one- exp of 01/2007,
-#24 ga - six - exp of 10/2008,
-#24 ga - four - exp of 01/2009.

5. During an interview at the time of observation, Staff E, stated that SDS RN was responsible for checking supplies for outdates and replacing outdated supplies. Staff E confirmed the needles had expired. Staff E took the needles and disposed of them.

6. Observation on 08/29/12 at 11:30 AM, in the anesthesia supply cart in the Endoscope procedure room showed:
-Open Endo Tracheal tube (tube placed down the throat and into the windpipe to provide an airway during a surgical procedure) with syringe and stylet (guide wire to assist in placement of airway) attached to the tube. The package was labeled the airway supplies were sterile unless the package was opened or damaged.
-Quick trach (emergency airway) package exp of 05/2005.
-#14 ga IV needle exp of 08-2008.

7. Observation on 08/29/12 at 11:45 AM of anesthesia supply cart for the OR room showed expired IV needles:
-14 ga - one - exp of 07/2012
-20 ga - one - exp of 04/2012
-22 ga - one - exp of 01/2012
-24 ga - two - exp of 03/2012
The supply cart also contained:
-ECG (electrocardiogram) electrodes (used to trace the heart rhythm) 20 packages with a use by date of 04/2012.
-Septisol Foam - used for hand hygiene- with an exp of 02/94
-Quick Trach (emergency airway) with an exp of 05/2005

8. During an interview on 08/29/12 at 12:00, noon, Staff X, Certified Registered Nurse Anesthetist (CRNA) stated that expired needles should not be in the cart. Staff X stated that ECG electrodes would probably not pick up the heart tracing after they expired.

9. During an interview concurrent with observation, Staff E stated that anesthesia was responsible for checking their carts. Staff E confirmed the outdated supplies and disposed of them.

10. Observation in the ED Obstetrics and Gynecology (OB/GYN) treatment room on 08/27/12 at 3:40 PM showed one examination table with a vinyl padded cover with torn areas with exposed padding material. The torn areas with exposed materials prohibit a sealable surface and do not allow for appropriate disinfection of surfaces. Folds in the surface area of the exam table had an accumulation of dust and small debris. The metal base of the examination table had more than five areas of dried tan colored liquid splattered throughout the surfaces.

11. Observation in the ED treatment Room 2 on 08/28/12 at 10:55 AM showed two blood pressure cuffs hanging from the wall. One adult size cuff was attached to a wall mounted blood pressure monitor and ready for use. The tubing attached to both of the cuff 's were cracked, discolored and deteriorated.

12. Observations in ED treatment rooms OB/GYN, Room 2, and the Trauma Room had multiple areas of dried liquid splatters on approximately of dried liquid splatters on approximately 50% of wall surfaces beginning at the floor surface extending up approximately 48 inches. Areas noted more heavily soiled were behind the examination tables, above and around the trash cans and on the lower and upper cabinets. The floor surfaces were visibly soiled with dried liquid stains and accumulated dried dirt, dust and debris.

13. During an interview on 08/28/12 at approximately 11:00 AM, Staff J, RN ED Manager stated that the blood pressure cuffs are old and should have been replaced and taken out of use. Staff J verified the soiled surfaces of walls and floors throughout the treatment rooms in the ED department and stated that the cleanliness of the ED is not acceptable for patient care areas. Staff J was not aware of a policy for cleaning the ED or evaluating the usefulness and replacement of patient care equipment.



17863

Based on interview and policy review, the facility failed to ensure daily temperature and humidity checks were documented. Temperature and humidity control help provide an electrically safe environment and could impact any patient having surgery. The facility does an average of 20 surgical cases per month and 20 Endoscope procedures per month.
The facility census was six.

Findings included:

1. Review of the Association of Perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices, 2012, showed:
-The quality of air entering the operating room should be carefully controlled.
-Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.
-Low humidity increased the risk of electrostatic charges, which posed a fire hazard in an oxygen-enriched environment or when flammable agents were in use and increased the potential for dust. High humidity increased the risk of microbial growth in areas where sterile supplies were stored or procedures were performed.
- Humidity should be monitored and recorded daily using a log format or documentation provided by the heating, ventilation and air conditioning (HVAC) system.
-Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68? F to 73? F (20? C to 23? C) within the operating room suite and general work areas in sterile processing.

2. Review of the facility's policy titled, "Infection Control Procedures of the Operating Room" review date of 10/11, showed the policy did not include directions to document the humidity and temperature readings.

3. During an interview on 08/28/12 at 10:35 AM, Staff E, Registered Nurse (RN) Operating Room (OR) manager stated that staff did not check the temperature and humidity ranges daily. Staff E stated that maintenance controlled the temperature and humidity in the OR, that the OR was in an old part of the building.

Based on observation, interview, and policy review, the facility failed to adhere to approved facility dress code for nursing personnel to prevent the spread of infection to patients and employees by failing to ensure staff kept fingernails trimmed and nail polish, if worn, was light in shade and not chipped, for three of three staff (N, O and P) observed during wound care observation. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Dress Code for Nursing Personnel" dated 03/09, showed direction for staff to keep fingernails trimmed and if nail polish was worn, use clear or light shades.

2. Record review of Center for Disease Control (CDC) 2002 Guideline for Hand Hygiene in Health-Care Settings showed to keep natural nails tips less than ?-inch long and chipped nail polish may support the growth of larger numbers of organisms on fingernails

3. Observation on 08/28/12 at 1:30 PM showed Staff P, Registered Nurse (RN) with long uneven nails, longer than ? inch in length.

4. During an interview concurrent with nail observation Staff P stated that she didn't manicure her nails and she didn't know nails could not be longer than ? inch in length.

5. Observation on 08/28/12 at 1:40 PM showed Staff O, RN with long nails, longer than ? inch.

6. During an interview concurrent with nail observation Staff O stated that she just wasn't thinking, she knew her nails were too long.

7. Observation on 08/28/12 at 1:45 PM showed Staff N, RN with dark purple polish and nail polish was chipped.

8. During an interview concurrent with nail observation Staff N, RN stated that she just wanted her nails to look pretty.

Based on interview and record review the facility Swing Bed (SB) program staff failed to ensure the SB policy for abuse and neglect prohibited all forms of abuse. The facility census was six with one of those a SB resident.

Findings included:

1. Review of the facility's policy titled, "Elder/Adult Abuse", reviewed 08/06 showed the following direction:
-The purpose of the policy was to ensure staff would be able to recognize signs of adult/elder abuse.
-The definition that apply for the policy included an eligible adult was a person who was sixty years of age or older.
-The definition of abuse was the infliction of physical, sexual or emotional injury or harm.

The facility policy did not include, define or address verbal abuse or financial abuse.

2. Review of the undated pamphlet titled, "Patient Rights in Swing Bed," provided by the SB Coordinator, showed the following direction:
-The resident has the right to a safe and secure environment.
-The resident has the right to be free from verbal, sexual, physical and mental abuse, corporal punishment and involuntary seclusion.

The undated pamphlet did not include, define or address financial abuse.
The undated pamphlet advised the resident of the right to be free from verbal abuse however the facility policy failed to include, define or address verbal abuse for the staff who would apply the policy to possible incidents of abuse.

Review of the undated pamphlet titled "Swing Bed Program FAQ (frequently asked questions)," provided by the SB Coordinator, showed the facility had no age restriction for qualification for the SB program.

3. During an interview on 08/29/12 at 9:20 AM Staff W, SB Coordinator confirmed the following:
-The SB program did not have a separate policy for abuse and neglect.
-The SB program used the facility policy titled "Elder/Adult Abuse".
-The abuse policy failed to address verbal abuse and financial abuse.

Based on interview and record review the facility failed:
-To protect the confidentiality of electronic patient medical records by failing to develop and maintain structured, routine monitoring of accesses into those electronic medical records to identify and prevent breaches by unauthorized persons.
-To protect paper patient medical records stored in the Rehabilitation Therapy department from unauthorized access. The facility census was six.

Findings included:

1. Record review of the facility's undated position description for the Medical Record Director, showed a professional requirement to maintain and ensure patient confidentiality at all times.

2. Record review of the facility's policy titled "Access to Medical Records" revised 06/12 showed authorized individuals having access to medical information would be the Medical Records staff members and any employee caregiver.

The policy failed to restrict accesses to caregivers who were directly providing care to the patient.

3. During an interview on 08/27/12 at 3:15 PM Staff D, Director of Medical Records stated the following:
-All staff were required to sign a confidentiality agreement on hire and annually thereafter.
-Staff caregivers and Medical Records staff have a user identification and password to access patient electronic medical record information.
-She did not have a structured, routine method of monitoring accesses into the patient electronic medical records.

4. Observation on 08/28/12 at 3:35 PM in the Rehabilitation Therapy secretary's office area showed the following:
-The glass enclosed secretary's office area was door-less and located in the waiting room of the Rehabilitation Therapy department.
-The secretary's office area had fifteen lateral (longer and wider than traditional file cabinets) file drawers all containing paper patient medical records.
-The lateral file drawers did not have locking mechanisms.
-The secretary's office area was not within line of sight of the Rehabilitation therapist's office area.

5. During an interview on 08/28/12 at 3:38 PM Staff H, Director of Rehabilitation Therapy confirmed the following:
-The fifteen lateral file drawers were full of paper patient medical records.
-The fifteen file drawers could not be locked.
-The Rehabilitation department was not operated seven days a week.
-When therapy staff was not on duty the department was locked but could be accessed by any staff with a key.
-Staff who had keys included Occupational therapy and Speech Language contractors who worked occasionally for the department and the facility Housekeeping staff.
-The paper patient medical records should be secured and locked up.

6. During an interview on 08/29/12 at 3:38 PM Staff D, Director of Medical Records confirmed the following:
-She knew the paper patient medical records were stored in the Rehabilitation Therapy department.
-She did not know there was access to those records by staff who were not directly involved in the care of the patient.
-The current storage method of paper patient medical records in the Rehabilitation Therapy department was not one hundred percent secure and did not maintain confidentiality of those records.

Based on observation, record review and interview the facility failed to ensure that the current Pharmacy policies and procedures were reviewed, revised or approved by the Pharmacy and Therapeutics Committee or the Medical Staff. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility document titled, "Medical Staff By-Laws" undated, stated the Pharmacy and Therapeutics (P&T) function shall develop and recommend policies related to drugs and diagnostic testing materials.

2. Record review of the P&T Committee meeting minutes dated Thursday 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings quarterly.
- The next meeting is scheduled for Thursday October 20, 2011 at 12:00 noon in the Board room.

Review of the committee minutes showed the meeting scheduled for Thursday October 20, 2011 was not held. The minutes showed no further meeting until Thursday July 19, 2012.

3. Record review of the current policies and procedures for the Pharmaceutical Department showed no signatures or revision dates.

4. During an interview on 08/29/12 at 1:10 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated the current pharmacy policies and procedures in use by the facility had not been reviewed, revised or approved by the P&T Committee or the Medical Staff.

Based on record review and interview the facility failed to ensure that all Medicare Patients received An Important Message From Medicare to be informed of their rights pertaining to discharge for five (Patient #1, #2, #4, #6 and #7) of six current Medicare patients reviewed. The facility census was six.

Findings included:

1. Record review of the medical record for Medicare Patient #1 showed the patient had been admitted to the facility on 08/27/12. An Important Message From Medicare was in the medical chart but was not dated or signed by the patient or the patient's representative.

2. Record review of the paper medical record for Medicare Patient #2 showed the patient had been admitted to the facility on 08/22/12. An Important Message From Medicare was in the medical chart dated 08/23/12 but was not signed by the patient or the patient's representative.

3. Record review of the paper medical record for Medicare Patient #4 showed the patient had been admitted to the facility on 08/24/12. An Important Message From Medicare was not in the patient's medical chart. Patient #4's representative stated that she didn't remember getting a document or signing a document by that name. She stated that she didn't realize it had such important information about discharge for her mother.

4. Record review of the paper medical record for Medicare Patient #6 showed the patient had been admitted to the facility on 08/27/12. An Important Message From Medicare was not in the medical chart.

5. Record review of the paper medical record for Medicare Patient #7 showed the patient had been admitted to the facility on 08/20/12. An Important Message From Medicare was in the medical chart dated 08/19/12 but was not signed by the patient or the patient's representative.

6. During an interview on 08/29/12 at 9:45 AM, Staff C, RN, Chief Nursing Officer, stated the facility did not have a policy and procedure regarding An Important Message From Medicare. She stated this was a function of the Social Worker that had been on sick leave and the direct patient care nurses were supposed to be fulfilling this function in her absence. She stated that the facility did not document in the medical record where patients had received An Important Message From Medicare. Staff C stated that she acknowleged the facility had no evidence to show they are providing the information to the patient.

Based on observation, interview and record review the facility failed to post the correct contact information for patients or their representatives or to provide the correct contact information for seven (Patients #1, #2, #3, #4, #5, #6 and #7) of seven current patients to file a complaint/grievance with the appropriate State agency. The facility census at the start of the survey was six.

Findings included:

1. Observation of the facilities main lobby and waiting room area showed only two postings of the Patient's Bill of Rights to patients or their representatives located inside an alcove used for privacy during patient registration. No other postings were available to read in the waiting room area or contained in a brochure readily available to patients or their representative(s).

2. Review of the facility document titled, "Patient Bill of Rights" revised 04/10, and posted in the facility waiting room showed the following:
- Contact information (name, address and telephone number) for the facility Director of Quality Assurance and Risk Management;
- Contact information (name, address and telephone number) for the state Quality Improvement Organization (QIO); and
- The name of the Department of Health and Senior Services without address or telephone number.
The facility did not provide information to file concerns about the quality of care at this facility or to file a complaint or grievance with the Department of Health and Senior Services, Post Office Box 570, Jefferson City, MO 65102 or to include either the toll-free telephone number of (800)392-0210 or the direct number (573)751-6303.

3. During an interview on 08/27/12 at 11:35 AM, Staff B, Registered Nurse (RN), Quality Assurance and Risk Management stated that the Bill of Rights used to be posted on the waiting room walls but they needed more space for pictures so they removed the Bill of Rights postings.

4. During an interview on 08/27/12 at 11:40 AM, Staff LL, Front Desk Registration Representative, stated that the patients signed the Patient's Bill of Rights electronically at registration and the documents could be located in the electronic medical record.

5. Record review of the electronic medical records for Patients' #1, #2, #3, #4, #5, #6 and #7 showed no scanned Patient's Bill of Rights in the records. During an interview on 08/28/12 at 11:00 AM, Staff BB, RN, Infection Control Nurse, stated that the Patient's Bill of Rights would be located in the patients' paper charts if they were not scanned into the electronic patient charts.

6. Record review of the paper medical record for Patient #1 showed no evidence that the Patient's Bill of Rights had been received.

7. Record review of the paper medical record for Patient #2 showed no evidence that the Patient's Bill of Rights had been received. Patient #2 was verbal but had severe Alzheimer's and there was no representative present to speak for her.

8. During an interview on 08/29/12 at 10:10 AM, Staff C, RN, Chief Nurse Executive, stated that the Social Worker usually took care of this function but that she has been on sick leave. She stated the direct care nurses were supposed to be doing this function and they left the information on the patient's bed side table. Staff C stated that she didn't know about Patient
#2's representative because she came directly from a nursing home and didn't know how the patient's nurse handled the Patient's Bill of Rights notice. She also could not provide evidence that any special precautions were used to convey the information in the Patient's Bill of Rights to patients with eye sight or reading deficiencies.

9. Record review of the paper medical record for Patient #3 showed no evidence that the Patient's Bill of Rights had been received.

10. Record review of the paper medical record for Patient #4 showed no evidence that the Patient's Bill of Rights had been received. Patient #4 was non-verbal but her representative stated that she didn't remember seeing the Patient's Bill of Rights when signing the other documents for the patient's admission.

11. Record review of the paper medical record for Patient #5 showed no evidence that the Patient's Bill of Rights had been received.

12. Record review of the paper medical record for Patient #6 showed no evidence that the Patient's Bill of Rights had been received.

13. Record review of the paper medical record for Patient #7 showed no evidence that the Patient's Bill of Rights had been received.

14. During an interview on 08/29/12 at 10:30 AM, Staff B, RN, Quality Assurance and Risk Manager, stated that the facility did not have a policy and procedure regarding the Patient's Bill of Rights.

Based on policy review, interview and observation, the facility failed to have policies and procedures in place, which were approved by the medical staff, to minimize medication errors and the potential harm to patients during the time the pharmacy was closed. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed that the Pharmacy and Therapeutics (P&T) Committee shall develop and recommend policies related to drugs and diagnostic testing materials. The committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

2. Record review of the facility's policy titled, "Medication Acquisition after Pharmacy hours" reviewed 08/12, unapproved by the Medical Staff, gave the following direction to staff:
- The purpose of this policy is to allow for safe and accurate medication acquisition for newly admitted patients or new orders given for current inpatients when the pharmacy is closed;
- When the Pharmacy is closed and a new medication is ordered to be given before the Pharmacy staff returns, the nursing supervisor shall be permitted to enter the Pharmacy to retrieve enough medication to provide for the number of doses required until the pharmacy reopens. Pharmacy hours are 0730-1600 (7:30 AM - 4:00 PM) Monday-Friday;
- Before any medications obtained by the House Supervisor are administered, a second nurse will verify that the correct medication was obtained. If the medication was ordered via written order, the second nurse will use the original written order, not a printed eMAR (electronic Medication Administration Record) work-list, to verify medication names and doses;
- The Medication Sign-Out Sheet will be routinely reviewed by the pharmacist to verify the accuracy of medication acquisition compared to medications ordered, and to determine whether new procedures should be put in place to limit access to pharmacy.

3. Record review of the facility document titled, "Incident Report Summary" dated 06/12 showed the following for the month of June 2012:
- Medication errors 240;
- Summary: 240 medication -related incidents were reported for 06/12. These included:
Wrong Drug - 6 (incidents);
Wrong time - 97;
Wrong dose - 62
Wrong Route - 6;
Duplicate - 18;
Omission - 7;
Allergy (to medication administered) - 29;
No order - 1;
Continue Home Medications order - 7;
Respiratory Therapy orders entered by other - 2;
Wrong physician - 5.

4. During an interview on 08/28/12 at 1:33 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated, "With our electronic system, the physician puts the medication order in electronically and the nurses then transcribe into the eMAR for administration to the patient. We rely upon a visual double check by another nurse". She stated that she tracks all medication errors and that most of the medication errors occur when the pharmacy is closed and there is no review of the order by a pharmacist before the medication is administered to the patient. Staff Q stated that most of the medication errors occur on weekends and that if a patient is admitted to the facility on a Friday at 5:00 PM that the patient may be discharged before she arrives on Monday at 7:30 AM and reviews the medication order. She stated that the errors are mostly in transcription by the nurses when they transcribe the original order by the physician into the electronic system.

5. Record review of the medication errors tracked by Staff Q showed 26 medication errors in the last 13 days included (the comment section is taken directly from the notes of Staff Q):
- 08/23/12 at 5:27 PM - patient received a duplicate IV medication because the first dose was administered in the emergency room and the order stated every 24 hours;
- 08/25/12 (Saturday) at 6:40 PM - patient received two doses of a medication they were allergic to as listed in the computer and the medication was the incorrect strength of 10 mg (milligrams) instead of 5 mg;
- 08/24/12 at 11:26 PM - Four medications were entered as one order instructing the PO (by mouth medications) medications be administered as IV fluids;
- 08/20/12 (Monday) at 7:14 PM - Three ASA (aspirin) 243 mg entered by ER (emergency room) staff for administration in ER only. This order was not written on admission orders. Choosing the incorrect frequency caused this medication to be placed on the profile without the physician's orders. No doses were given, but if this had happened on a Friday night, the patient would have gotten 2 doses before the error was caught. **near miss;
- 08/14/12 (Tuesday) at 11:39 PM - The following medication was ordered and administered PO - HydrOXYzine 50 mg/mL (milliliters) inject subq;
- 08/14/12 at 9:37 PM - The incorrect drug, Mupirocin 2% (nasal ointment) was ordered and administered to patient;
- 08/16/12 at 8:57 PM - the physician ordered TAC solution (local anesthetic) topical liquid 1 mL dose - a 3mL dose was administered to the patient;
- 08/20/12 at 10:41 PM - the physician order was for Nitroglycerin (a medication causing dilation or relaxation of the blood vessels) 2% ointment prn (as needed) but the order was transcribed into the eMAR for every six hours 6:00, 12:00 18:00 and 24:00;
- 08/20/12 at 2:38 AM - medication ordered was Nalbuphine HCL (narcotic used for pain) 5 mg and the ordered was transcribed into the eMAR as 10 mg;
- 08/20/12 at 12:03 AM - medication ordered was Nalbuphine HCL 5 mg every 6 hours prn; the order was transcribed into the eMAR as 10 mg every 4 hours;
- 08/19/12 (Sunday)at 6:50 PM - physician's order for 9 medications including IV normal saline with 20 mEq (milliequivalents) KCL (a fluid that replenishes Electrolytes that affect the amount of water in your body, the acidity of your blood (pH), your muscle function, and other important processes) at 70 cc/hour - during transcription to the eMAR this order was omitted and the pharmacist entered the order on 08/20/12 at 9:00 AM;
- 08/19/12 at 5:00 PM - physician's order for Lorazepam (medication used to relieve anxiety) 0.5 mg tablets BID prn (2 times per day as needed) was transcribed to be given twice daily at 10:00 AM and 10:00 PM;
- 08/19/12 at 6:25 PM - Risperidone (medication used to treat the symptoms of schizophrenia [a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions]) 0.25 mg tabs (tablets) HS (at bedtime) - the order was transcribed to the eMAR to be taken at 6:00 PM every day - the patient did not receive the medication and the entire dose was missed;
- 08/19/12 at 6:25 PM - physician's order for Insulin (Lantus) (brand name for long-acting insulin that is taken once a day) 100 units/mL subq at HS (bedtime); the order was transcribed to the eMAR to be taken daily at 5:00 PM - the patient did not receive the insulin dose;
- 08/17/12 (Friday) at 3:39 AM - the physician wrote orders for 13 items including one for Hydromorphone (medicine used to relieve severe pain) 1 mg IVP (to be attached to infuse with the current IV medication) q 6 hours (every six hours) for pain - the medication was not transcribed onto the eMAR and the patient did not receive the medication;
- 08/14/12 at 11:26 PM - physician order for Guaifenesin (used to relieve chest congestion) 400 mg tab - the order was transcribed into the eMAR as 600 mg - Pharmacist note reads = not possible to give a 400 mg dose from a 600 mg tab *should not* give 600 mg without clarification since 400 mg was ordered. Medication was charted as 400 mg given from a 600 mg tab that isn't supposed to be split or crushed;
- 08/14/12 at 11:26 PM - physician order stated to give medication at 4:00 PM - medication was transcribed on the eMAR to be administered at 5:00 PM;
- 08/15/12 at 1:27 AM - physician's order was set to start at 08/15/12 at 10:00 AM for D5 ? NS plus 20 mEq KCL solution IV continuously - Pharmaci

Based on observation, interview and facility policy review the facility failed to:
-Ensure the Pharmacy department checked for outdated or recalled medications in all storage areas outside of the Pharmacy including the Cardiopulmonary and Rehabilitation Services and in the Operating Room (OR) anesthesia cart storage areas.
-Ensure the integrity of unlabeled multi-use medications used for wound cleansing were not available for patient use in the Emergency Department (ED). The failure to appropriately label and store all multiple use medications affects all patients who are treated in the ED. The average number of patients seen in the ED was approximately 750 per month;
-Label opened multi-dose medication (MDV) with the date opened and the initials of the staff member who opened the medication in the Operating Room (OR) and in the medication room located on the medical/surgical/telemetry floor; and
-Ensure that expired medications were not available for patient use in the ED, OR and out-patient departments. This deficient practice placed patients at risk to receive outdated, unusable drugs. The facility census was six.

Findings included:

1. Record review of the facility policy titled, "Multiple -Dose Injectable Vial (MDV) Usage" dated 08/12 showed all multiple dose medications must be dated and initialed by the staff at the time the container was opened. Any medication found open without a date of opening was considered expired and should be disposed of accordingly to assure that the product was safe for patient use.

Record review of the facility's policy titled, "Medication Acquisition and Storage", revised 08/2012, showed the following direction:
-MDV were stored in accordance with manufacturer's directions, State and Federal requirements, and may be used for 28 days after initial opening unless contaminated or otherwise instructed by the manufacturer or other respected agency.

Record review of the facility's policy titled, "Procedure for checking for outdated or recalled medications", provided by Staff E, OR manager, dated 11/2006, showed the following direction:
-All medication storage areas shall be checked monthly for outdated medications. The stock locations include:
-ICU/Telemetry
-Recovery Room
-Station I (medical/surgical)
-Emergency Department
-Surgery
-Anesthesia
-Same Day Surgery
-Respiratory (also called Cardiopulmonary) therapy
-Radiology
-Pharmacy Crash Carts
-Surgery personnel were responsible for checking outdates in recovery, same day surgery, anesthesia, and surgery and notifying the pharmacy department when complete.
-Respiratory therapy personnel were responsible for checking for outdates in respiratory department and notifying the pharmacy department when complete.
-Medications that expire before the next check period shall be removed from stock and returned to pharmacy for processing.
-After completion of monthly check for each location, the tracking log will be completed.

2. Observation on 08/28/12 at approximately 10:40 AM in the ED, Obstetrical and Gynecological treatment room and the Trauma treatment room showed medications available on open counter tops and shelves. The available medications were used primarily for wound cleansing. The following open multiple use medications were not labeled with the date the medications were opened and were not initialed by the person who opened the bottles:
-Hydrogen Peroxide 16 ounce bottle (three bottles);
-Povidone Iodine solution eight fluid ounce (five bottles);
-Isopropol Alcohol 16 ounces (two bottles;)
-Chlorhexedine Gluconate solution (four bottles);
-Betadine three fluid ounces (four bottles);
-Simply Saline Wound Wash (four bottles);
-Saf-Cleans AF-dermal wound cleanser 12 fluid ounces (four bottles).

3. During an interview on 08/28/12 at approximately 11:10 AM, Staff Q, the Director of Pharmacy Services stated that all open medications should be dated and labeled and that she wasn't aware of a specific policy for multiple use wound care cleansing medications. Staff Q verified the findings of the open wound cleansers in the ED, Obstetrical and Gynecological treatment room and stated that she was unaware of the open wound cleansers and stated that they should be secured, labeled and treated as if they were multiple dose medications.

4. Observation on 08/27/12 at 3:25 PM of the Recovery Room drug storage showed:
-Open MDV of alcohol- no date or initials when opened,
-Intravenous solution bag of Lactated Ringers and Dextrose 5% (to replace patient fluid during surgical intervention) bag with an expiration date of 3/12,
-Open MDV - Hurricaine topical anesthetic spray (used to numb back of throat) no date/initials when opened,
-Open MDV - Lidocaine oral topical solution 2% (used to numb back of throat) - no date/initials when opened

5. During an interview concurrent with observations, Staff E, OR Manager stated that MDV should be labeled and dated when opened. Staff E stated that Recovery nurse checked for outdates of medication weekly.

6. Observation on 08/28/12 at 9:00 AM in the medical/surgical/telemetry and Intensive Care medication room showed the following:
- Morphine sulfate oral solution (used to manage pain) 100 mg per 5 mL partially used and currently contained 16.75 mg of medication. The multi-use bottle contained two dates: 12/12 and 04/04/12 but no initials;
- Carvedilal (used to treat heart failure and high blood pressure) with an expiration date of 04/12.
- Three bottles of multi-use injectable Sterile water - all opened and partially used with expiration dates of 11/01/09; 03/01/10 and 03/01/10. The bottles contained no date/initials when opened.

7. During an interview on 08/28/12 at 9:00 AM, Staff B, Registered Nurse (RN), Quality Assurance and Risk Management, stated she would have to go look at the policy to determine how long the medications can be used after opening but she was sure they should have been dated and initialed.

8. Observation on 08/29/12 at 11:30 AM of the anesthesia cart in the Endoscopic procedure room showed:
-Epinephrine (used to stimulate the heart) four - 1 milligram (mg-unit of measure)/milliliter (ml-unit of measure) vials with an expiration date of June 2000,
-MDV - Brevibloc injection (slows the heart rate and decreases blood pressure) - one vial dated 07/06/12 (28 days from the open date would show the drug expired on 08/03/12)
-Open MDV - Neostigmine (reverses muscle relaxation produced by anesthesia) - no label when opened,
-Vitamin K (stops bleeding) five vials - expired 04/12
-Neosynephrine (prevent bleeding in nasal intubation) two - 15 ml bottles nasal spray expired of 11/11,
-Furosemide (stimulates urine production) one - 10 ml vial expired July 2012,
-Metoclopramide (stimulates gastric emptying) 10mg/2ml:
Three vials - expired 11/11
Two vials - expired 07/11
Six vials - expired 01/12
-Succinylcholine (medication used to relax skeletal muscles) - five 10 milliliter (ml- unit of measure) vials. The vials contained no date of placement in cart. Product information showed "store in refrigerator."
-Zemuron (medication used to relax skeletal muscles) - five (5 ml) vials. The vials contained no date of placement in cart. Product information showed "store in refrigerator."
-Famotidine (medication to empty the stomach) - nine (20 milligrams (mg-unit of measure). The bag had a label, which showed "refrigerate."

9. During an interview concurrent with the anesthesia cart observation, Staff X, Certified Registered Nurse Anesthetist (CRNA), stated that he did not know the medications needed to be refrigerated. Staff X stated that he did not know when the medication was stored in the cart. Staff X stated that medication loses potency at room temperature. Staff X stated that the CRNA's are responsible for the anesthesia cart. Staff X stated that he took the lead CRNA's, Staff Z's, word that everything was ready to go in the anesthesia cart.

10. During an interview on 08/29/12 at 2:00 PM, Staff Q, Pharmacist, stated that Succinylcholine, Zemuron and Famotidine medication needed to be stored in a refrigerator. Staff Q stated that she told Staff Z to store the medication in a refrigerator and that she was und

Based on observation, record review and interview the facility failed to provide education or training and require demonstrated knowledge from medical staff on first aid techniques for patients placed in restraints. Patients in restraints are placed at a higher risk for injuries or death. This had the potential to affect all patients placed in restraints. The facility census was six.

Findings included:

1. Observation showed that no patients were currently in restraints during the survey.

2. Record review of educational records for medical staff included:
- Staff E, Registered Nurse (RN), Director of Operating Room;
- Staff BB, RN, Director of Infection Control;
- Staff G, Respiratory Therapist;
- Staff J, RN, House Supervisor;
- Staff DD, Respiratory Therapist;
- Staff EE, Physical Therapist;
- Staff C, RN, Director of Nursing, Chief Nursing Officer;
- Staff GG, Doctor of Osteopathy, Emergency Room Physician; and
- Staff JJ, Speech Pathologist.
These staff members had no documentation that they received first aid education or training for patients placed in restraints. Although these employees may not directly apply restraints to patients they could potentially provide care to patients in restraints.

3. During an interview on 08/28/12 at 10:45 AM, Staff J, RN, House Supervisor, stated that the facility accepts patients requiring respiratory ventilators (a method to mechanically assist or replace spontaneous breathing using a machine) and that often the patients must be placed in restraints. She stated that a majority of their patient population is elderly and exhibit some form of dementia and may be placed in restraints to prevent them from pulling out their IV (in the vein) tubing.

4. During an interview on 08/29/12 at 2:00 PM, Staff MM, Director of Human Relations, stated she was not aware that nursing and/or medical staff were required to have first aid education for patients placed in restraints.

Based on document review and interview the facility failed to adopt Medical Staff Bylaws which gave only the Governing Body the authority to grant medical staff privileges. This deficient practice affects all patients in the facility. The facility census was six.

Findings included:

1. Review of the facilities Medical Staff Bylaws, conducted on the morning of 08/29/12, showed the following.

4.8 TEMPORARY PRIVILEGES

(c) Procedure - A request for temporary Clinical Privileges may be granted only upon the concurrence of the Chief of Staff and the Chief Executive Officer (CEO), and such grant may be subject to such contingencies and conditions as the foregoing may determine. In the event either of the foregoing persons are unavailable, the person authorized to act in their absence may consent to the grant of temporary Clinical Privileges. Temporary Clinical Privileges may be terminated at any time, with or without cause, by the Chief of Staff and the CEO.

2. During an interview on 08/29/12 at 10:40 PM, Staff A, CEO, stated that the Chief of Staff and the CEO are not members of the Governing Body.

Based on observation and interview, the facility failed to maintain areas in the operating rooms, patient rooms, intensive care unit, emergency department and same day surgery in an easily cleanable and orderly manner. This deficient practice affects all patients in the facility. The facility census was six.

Findings included:

1. Observation on 08/27/12 of the facility operating suite showed the following:
-At 3:42 PM one edge of the wooden door to operating room #2 was cracked and splintered leaving a jagged edge approximately 4 inches in length.
-At 3:58 PM a hole, approximately 6 inches in length by ? inch in width, in the wall behind the door in operating room #1.

2. During an interview on the same date and at the same times of the observations Staff F, Scrub Tech, confirmed the need for repairs to the wall and the doors.

3. Observations during a tour of the facility, conducted on the morning of 08/28/12 showed the following:
-At 9:14 AM one edge of the wooden door to patient room 107 was cracked and splintered leaving a jagged edge approximately twelve inches in length.
-At 9:27 AM one edge of the wooden door to patient room 119 was cracked and splintered leaving a jagged edge approximately 12 inches in length.
-At 9:40 AM the tile floor of the linen room, adjacent to the Intensive Care Unit, was stained and chipped with gaps between the tiles.
-At 10:05 AM one edge of the wooden door to the trauma room in the Emergency Department was cracked and splintered leaving a jagged edge approximately eight inches in length.

4. During an interview on the same date and at the same times Staff L, Facilities Manager, confirmed the doors and the floors were in need of repair and could not be properly cleaned.

5. Record review of the facility's policy titled, "Infection Control - EVS (Environmental Services) General Cleaning Procedures", revised 07/11 showed the following direction:
-Disinfect bed (including bed rails), patient furniture, ledges, frequently touched or high-touch surfaces (like light switches, nurse call bell, door knobs, medical equipment).
-Observe and report structural damage and/or equipment malfunction to proper person.

6. Observation on 08/28/12 at 9:15 AM in Same Day Surgery (SDS) patient rooms showed all four side rails on beds in rooms - 107, 108, 109, 115, 116, 117, and 118 had exposed metal which was brown and discolored. The plastic coating on all side rails was jagged and missing at spots making cleaning of rails difficult. Organisms could multiply under edges of coating where cleaning was difficult to complete. Patient beds in these rooms also showed missing plastic coating on head and foot boards, providing another area for bacteria to grow. Adequate cleaning of head and foot boards was impossible due to missing plastic coating which exposed particle board that was not cleanable.

7. During an interview concurrent with observations, Staff KK, Compliance Officer Life Safety, confirmed the facility has a few problems. Staff KK also confirmed the bed rails should have been taken off, sand blasted and repainted to make them easily cleanable.

8. During an interview concurrent with observations, Staff E, Operating Room (OR) manager confirmed the beds posed a risk of infection to any patient who may occupy the beds.





15697

Based on interview and record review the facility failed to ensure the current online Diet manual (a reference for patient's diets) was approved for use by the Medical Staff and the Clinical Dietitian. The facility census was six.

Findings included:

1. Review of a paper copy of the current online facility diet manual (Nutrition Care Manual) provided by Staff H, Manager of the Dietary department, showed staff failed to obtain required approvals (a signature page) of the Medical Staff and the Clinical Dietitian.

2. Review of an invoice for the Nutrition Care Manual Web subscription from the American Dietetic Association dated 10/28/11 showed the facility used the online diet manual since that date.

3. During an interview on 08/28/12 at 9:48 AM Staff H confirmed the current online diet manual was:
-Not approved for use in the facility by the Medical Staff and the Clinical Dietitian.
-Previous diet manuals had been paper copies and had signature pages to show approval by the Medical Staff and the Clinical Dietitian.
-The current diet manual was on-line and Staff H had not obtained approvals (signature page) from the Medical Staff and the Clinical Dietitian.

Based on interview and record review the facility failed to develop a comprehensive policy for notification of patients of potentially infectious blood and blood component exposure. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Look-Back Plan" dated 11/01/10, showed the facility failed to provide specific timelines and guidance for notification of recipients who may have received potentially infectious blood and or blood components.

2. During an interview on 08/29/12 at approximately 11:00 AM, Staff Y, Laboratory Department Manager, stated he was not aware of any policy which had the specific timelines for patient notification in the event of a potential exposure. Staff Y verified a notification policy needed to be more specific and that the current policy in place did not meet the regulatory requirements.

Based on observation, interview and record review the facility failed to:
-Provide safe, sanitary supplies and supply storage conditions by maintaining usable supplies with current dates and intact packaging in the
Recovery Room supply cabinet, Same Day Surgery (SDS) storage room and the anesthesia supply cart in the Endoscope procedure room and the Operating Room (OR).
-Provide two of eight blood pressure monitoring cuffs in good repair in the Emergency Department (ED) treatment rooms.

Failure to remove expired supplies from stock had the potential to expose patients to unsterile, unstable supplies which could cause infection. Failure to ensure blood pressure monitoring equipment is in good repair has the potential to cause inaccurate blood pressure monitoring/readings which is an important diagnostic measurement for health emergencies and treatment response. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Monitored Shelf Life" dated 01/12 provided by Staff E, OR manager showed the following direction:
-Prior to releasing packaged sterile goods, the expiration date must be checked.
-Items at or beyond the stated expiration date shall not be used for patient care.

2. Observation on 08/27/12 at 3:45 PM of the recovery room supply cabinet showed:
-Intravenous (IV) needles (used for medication injection in patient vein)
-#24 gauge (ga - size) two with an expiration date (exp) of 03/2012
-#18 ga - one - exp of 02/2009, seven - exp of 03/2010, and four - exp of 07/2010
-Specimen trap- two - exp of 01-2011 ( a specimen trap is a device used to obtain sputum to identify possible bacteria in the lungs.)

3. During an interview concurrent with supply observation Staff E, stated that the Registered Nurse (RN) in the recovery room was responsible for checking for outdates weekly.

4. Observation on 08/28/12 at 9:30 AM, the Same Day Surgery (SDS) supply room showed the following expired IV needles:
-#24 ga - one - exp of 09/2006,
-#24 ga - one- exp of 01/2007,
-#24 ga - six - exp of 10/2008,
-#24 ga - four - exp of 01/2009.

5. During an interview at the time of observation, Staff E, stated that SDS RN was responsible for checking supplies for outdates and replacing outdated supplies. Staff E confirmed the needles had expired. Staff E took the needles and disposed of them.

6. Observation on 08/29/12 at 11:30 AM, in the anesthesia supply cart in the Endoscope procedure room showed:
-Open Endo Tracheal tube (tube placed down the throat and into the windpipe to provide an airway during a surgical procedure) with syringe and stylet (guide wire to assist in placement of airway) attached to the tube. The package was labeled the airway supplies were sterile unless the package was opened or damaged.
-Quick trach (emergency airway) package exp of 05/2005.
-#14 ga IV needle exp of 08-2008.

7. Observation on 08/29/12 at 11:45 AM of anesthesia supply cart for the OR room showed expired IV needles:
-14 ga - one - exp of 07/2012
-20 ga - one - exp of 04/2012
-22 ga - one - exp of 01/2012
-24 ga - two - exp of 03/2012
The supply cart also contained:
-ECG (electrocardiogram) electrodes (used to trace the heart rhythm) 20 packages with a use by date of 04/2012.
-Septisol Foam - used for hand hygiene- with an exp of 02/94
-Quick Trach (emergency airway) with an exp of 05/2005

8. During an interview on 08/29/12 at 12:00, noon, Staff X, Certified Registered Nurse Anesthetist (CRNA) stated that expired needles should not be in the cart. Staff X stated that ECG electrodes would probably not pick up the heart tracing after they expired.

9. During an interview concurrent with observation, Staff E stated that anesthesia was responsible for checking their carts. Staff E confirmed the outdated supplies and disposed of them.

10. Observation in the ED Obstetrics and Gynecology (OB/GYN) treatment room on 08/27/12 at 3:40 PM showed one examination table with a vinyl padded cover with torn areas with exposed padding material. The torn areas with exposed materials prohibit a sealable surface and do not allow for appropriate disinfection of surfaces. Folds in the surface area of the exam table had an accumulation of dust and small debris. The metal base of the examination table had more than five areas of dried tan colored liquid splattered throughout the surfaces.

11. Observation in the ED treatment Room 2 on 08/28/12 at 10:55 AM showed two blood pressure cuffs hanging from the wall. One adult size cuff was attached to a wall mounted blood pressure monitor and ready for use. The tubing attached to both of the cuff 's were cracked, discolored and deteriorated.

12. Observations in ED treatment rooms OB/GYN, Room 2, and the Trauma Room had multiple areas of dried liquid splatters on approximately of dried liquid splatters on approximately 50% of wall surfaces beginning at the floor surface extending up approximately 48 inches. Areas noted more heavily soiled were behind the examination tables, above and around the trash cans and on the lower and upper cabinets. The floor surfaces were visibly soiled with dried liquid stains and accumulated dried dirt, dust and debris.

13. During an interview on 08/28/12 at approximately 11:00 AM, Staff J, RN ED Manager stated that the blood pressure cuffs are old and should have been replaced and taken out of use. Staff J verified the soiled surfaces of walls and floors throughout the treatment rooms in the ED department and stated that the cleanliness of the ED is not acceptable for patient care areas. Staff J was not aware of a policy for cleaning the ED or evaluating the usefulness and replacement of patient care equipment.



17863

Based on interview and policy review, the facility failed to ensure daily temperature and humidity checks were documented. Temperature and humidity control help provide an electrically safe environment and could impact any patient having surgery. The facility does an average of 20 surgical cases per month and 20 Endoscope procedures per month.
The facility census was six.

Findings included:

1. Review of the Association of Perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices, 2012, showed:
-The quality of air entering the operating room should be carefully controlled.
-Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas.
-Low humidity increased the risk of electrostatic charges, which posed a fire hazard in an oxygen-enriched environment or when flammable agents were in use and increased the potential for dust. High humidity increased the risk of microbial growth in areas where sterile supplies were stored or procedures were performed.
- Humidity should be monitored and recorded daily using a log format or documentation provided by the heating, ventilation and air conditioning (HVAC) system.
-Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68? F to 73? F (20? C to 23? C) within the operating room suite and general work areas in sterile processing.

2. Review of the facility's policy titled, "Infection Control Procedures of the Operating Room" review date of 10/11, showed the policy did not include directions to document the humidity and temperature readings.

3. During an interview on 08/28/12 at 10:35 AM, Staff E, Registered Nurse (RN) Operating Room (OR) manager stated that staff did not check the temperature and humidity ranges daily. Staff E stated that maintenance controlled the temperature and humidity in the OR, that the OR was in an old part of the building.

Based on observation, interview, and policy review, the facility failed to adhere to approved facility dress code for nursing personnel to prevent the spread of infection to patients and employees by failing to ensure staff kept fingernails trimmed and nail polish, if worn, was light in shade and not chipped, for three of three staff (N, O and P) observed during wound care observation. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Dress Code for Nursing Personnel" dated 03/09, showed direction for staff to keep fingernails trimmed and if nail polish was worn, use clear or light shades.

2. Record review of Center for Disease Control (CDC) 2002 Guideline for Hand Hygiene in Health-Care Settings showed to keep natural nails tips less than ?-inch long and chipped nail polish may support the growth of larger numbers of organisms on fingernails

3. Observation on 08/28/12 at 1:30 PM showed Staff P, Registered Nurse (RN) with long uneven nails, longer than ? inch in length.

4. During an interview concurrent with nail observation Staff P stated that she didn't manicure her nails and she didn't know nails could not be longer than ? inch in length.

5. Observation on 08/28/12 at 1:40 PM showed Staff O, RN with long nails, longer than ? inch.

6. During an interview concurrent with nail observation Staff O stated that she just wasn't thinking, she knew her nails were too long.

7. Observation on 08/28/12 at 1:45 PM showed Staff N, RN with dark purple polish and nail polish was chipped.

8. During an interview concurrent with nail observation Staff N, RN stated that she just wanted her nails to look pretty.

Based on record review and interview the facility failed to integrate contracted services into the facility wide Quality Assurance and Performance Improvement Program (QAPI). Contracted services provided to the facility must be organized and integrated into the facility QAPI program to ensure improved health outcomes. The census was six.

Findings included:

1. Record review of the facility 2012 Performance Improvement Plan showed a QAPI reporting calendar (a calendar showing which departments/services are due to report QAPI activities) which included contracted services for the cardiac rehabilitation services for the months of March, June, September and December.

2. Record review of the facility's Performance Improvement data and Quality Council Meeting minutes for the months of March 2012 and June 2012 showed no data collection, review or analysis of QAPI activity from the cardiac rehabilitation contracted service provider.

3. During an interview on 08/28/12 at 10:55 AM, Staff B, Director of Quality Assurance, verified she did not collect QAPI data from the cardiac rehabilitation contractor and she stated that she is aware of activities being conducted by the contractor however the activities are not included into the hospital wide QAPI program.

Based on record review and interview the facility failed to ensure the Pharmacy Department reported medication errors to the Pharmacy and Therapeutics (P&T) or Medical Staff Committees and failed to implement corrective actions to reduce or prevent reoccurrences. This had the potential to affect all patients in the facility The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Medication Error and Adverse Drug Reaction/Event Identification and Reporting" dated 11/06, gave the following direction:
- Hospital's pharmacy services must be integrated into its hospital-wide QAPI [Quality Assurance and Performance Improvement] Program;
- Medication Safety Policy Statement: Providers involved in medication use are required to participate in the detection and reporting of errors, the identification of the system causes of errors, and the implementation of system changes to decrease the likelihood of errors;
- The reporting program is coordinated through the Medication Safety Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff;
- The Medication Safety Committee reviews medication safety reports quarterly and provides recommendations for resolution through quality improvement projects, and/or root cause analysis or failure mode and effect analysis;

2. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed the following:
- Pharmacy and Therapeutics (P&T): The [P&T] committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

3. Record review of the facility's "Incident Report Summary" dated 06/12 showed the following trend analysis for medication errors for the last six months:
- 01/12 = 131 medication errors reported;
- 02/12 = 131 medication errors reported;
- 03/12 = 369 medication errors reported;
- 04/12 = 274 medication errors reported;
- 05/12 = 205 medication errors reported; and
- 06/12 = 240 medication errors reported.
The report showed for the last 12 months (07/11 through 06/12) that 1,794 medical errors were reported and continued to increase throughout the year. This amount of medication errors is more than expected for the size and scope of services provided to patients by the facility.

4. Record review of the facility's document titled, "Position Description" for the Pharmacist dated 03/21/09, showed the following:
- General Responsibilities: Performs all aspects of patient care in an environment that optimizes patient safety and reduces the likelihood of medical/health care errors;
- Maintains established procedures concerning quality control;
- Professional Requirements: Maintains regulatory requirements; and
- Actively participates in performance improvement and continuous quality improvement activities.

5. Record review of the facility's policy titled, "Quality Assessment and Improvement Plan" dated 11/06, was void of any writing (the page was blank).

6. During an interview on 08/28/12 at 1:00 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated that she had two QAPI projects and one of them was medication errors. The Pharmacist stated that she reviewed all physician orders, investigated all discrepancies in transcription of the physician orders to the eMAR (electronic medication administration record) and corrected the transcription errors but could not provide evidence that these errors were reported to the P&T or Medical Staff Committees or that program activities were implemented for system changes of performance improvement or quality assurance to reduce the amount of medication errors.

During an interview on 08/29/12 at 1:20 PM, Staff Q stated she has been employed with the facility since 05/11. She stated that neither the P&T Committee nor the Medical Staff have reviewed or approved any of the policies and procedures currently in use at the facility. The Pharmacist could only provide evidence of two meetings with the P&T Committee and the Medical Staff since her employment.

7. Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings for quarterly.
- The next meeting is scheduled for Thursday, October 20, 2011 at 12:00 noon in the Board room.

Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed Staff NN, Medical Doctor (MD), asked that a report on medication errors be put on the agenda for the next meeting.

Record review of the P & T Committee meeting minutes dated 07/19/12 (the next time the Committee met after 09/29/11) showed the minutes did not contain any report regarding medication errors.

8. During an interview on 08/29/12 at 9:40 AM, Staff Q stated that the P & T Committee had intended to meet monthly but the meetings had not taken place.

Based on observation and interview the facility failed to ensure that all controlled substance (Schedule II through Schedule V) medications were stored and secured according to pharmacy policy and procedures for two (Patient's #3 and #4) of two patients. This failure had the potential to affect all patients bringing medications from home. The facility census was six.

Findings included:

1. Record review of the facility policy titled, "Inventory and Control of Schedule II through V Controlled Substances" revised 01/12 stated the following:
- The pharmacist shall ensure that Schedule II through V controlled substances are safely stored and that an accounting of the drugs is accurately maintained;
- Controlled substances CII through CV (Class II trough Class V) shall be stored in locked cabinets within the pharmacy. Only a pharmacist shall have access to the keys to these cabinets;
- A perpetual inventory of controlled substances CII through CV shall be maintained. The actual count of the substance should be verified each time a drug is removed from the locked cabinet.

2. Observation on 08/28/12 at 1:10 PM in the Pharmacy Department showed two envelopes containing home medications of two inpatients (#3 and #4) for safekeeping to return to the patients upon discharge. The envelopes were sealed with a transparent tape and stored in an unlocked drawer by the pharmacy door. Both of the envelopes contained pill bottles of a controlled substance, Hydrocodone 7.5/650 mg, (an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of Hydrocodone) quantity 75 marked on the pill bottle label. The patients were not currently receiving the home medications. Staff Q counted the pills in the bottle (for Patient #3) with a quantity of 28 and two half pills. She stated she had no way of knowing if the amount of pills in the bottle was correct or not and that they should have been locked up.

3. The second envelope for Patient #4 contained the same medication, Hydrocodone/APAP 10/650 mg but was sealed and had not been opened.

4. During an interview on 08/28/12 at 1:10 PM, Staff Q, Registered Pharmacist, Director of Pharmacy, stated the narcotic medications should have been locked in a secure area and the clear tape that sealed the envelopes should have been marked to detect tampering.

Based on record review and interview the facility failed to use medication error data and analysis to implement improvements or preventive actions and mechanisms to reduce medication errors and ensure patient safety. This had the potential to affect all patients in the facility. The facility census was six.

Findings included:

1. Record review of the facility's policy titled, "Medication Error and Adverse Drug Reaction/Event Identification and Reporting" dated 11/06, gave the following direction:
- Hospital's pharmacy services must be integrated into its hospital-wide QAPI [Quality Assurance and Performance Improvement] Program;
- Medication Safety Policy Statement: Providers involved in medication use are required to participate in the detection and reporting of errors, the identification of the system causes of errors, and the implementation of system changes to decrease the likelihood of errors;
- The reporting program is coordinated through the Medication Safety Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff;
- The Medication Safety Committee reviews medication safety reports quarterly and provides recommendations for resolution through quality improvement projects, and/or root cause analysis or failure mode and effect analysis;
- To learn about the system causes of errors, a medication error should be categorized according to the level of harm experienced by the patient, the phase of the medication use process in which the error originated, and the type of error as indicated by the criteria listed below:
Patient Outcome Severity Categories:
A. Circumstances or events that have the capacity to cause error.
B. An error occurred but the error did not reach the patient.
C. An error occurred that reached the patient, but did not cause patient harm (an "error of omission")
D. An error occurred that reached that patient and required monitoring to confirm that it resulted in no harm to the patient and/or required intervention to preclude harm.
E. An error occurred that may have contributed to or resulted in temporary harm to the patient and intervention.

2. Record review of the facility document titled, "Medical Staff By-Laws" undated, showed the Pharmacy and Therapeutics (P&T): The [P&T] committee shall review in detail all reported drug reactions and drug errors and recommend appropriate action; it shall also prepare a quarterly report regarding drug reactions and drug errors, their probable causes, the actions taken to resolve problems, and the final resolution.

3. Record review of the facility's "Incident Report Summary" dated 06/12 showed the following trend analysis for medication errors for the last six months:
- 01/12 = 131 medication errors reported;
- 02/12 = 131 medication errors reported;
- 03/12 = 369 medication errors reported;
- 04/12 = 274 medication errors reported;
- 05/12 = 205 medication errors reported; and
- 06/12 = 240 medication errors reported.
The report showed for the last 12 months (07/11 through 06/12) that 1,794 medical errors were reported and continued to increase throughout the year.

4. Record review of the facility's policy titled, "Quality Assessment and Improvement Plan" dated 11/06, was void of any writing (the page was blank).

5. Record review of the medication errors reviewed by Staff Q, Registered Pharmacist, Director of Pharmacy, for the last 13 days (08/13/12 through 08/25/12) totaled 30. The 30 medication transcription errors were analyzed and corrected by Staff Q but were not categorized according to the level of harm experienced by the patient as required by the facility policy and procedure to facilitate system improvements.

6. During an interview on 08/28/12 at 1:00 PM, Staff Q, stated that she had two QAPI projects and one of them was medication errors. The Pharmacist stated that she reviewed all physician orders, investigated all discrepancies in transcription of the physician orders to the eMAR (electronic medication administration record) and corrected the transcription errors but could not provide evidence that these errors were reported to the P&T or Medical Staff Committees or that program activities were implemented for system changes of performance improvement or quality assurance to reduce the amount of medication errors.

During an interview on 08/29/12 at 1:20 PM, Staff Q stated she has been employed with the facility since 05/11. She stated that neither the P&T Committee nor the Medical Staff have reviewed or approved any of the policies and procedures currently in use at the facility. The Pharmacist could only provide evidence of two meetings with the P&T Committee and the Medical Staff since her employment.

7. Record review of the P & T Committee meeting minutes dated Thursday; 09/29/11 showed the following:
- Next Meeting Time: Meetings will be scheduled on the third Thursday of each month for the time being since it has been such a long time since a P&T meeting was held. Once the committee gets caught up with new business, we will schedule the meetings for quarterly.
- The next meeting is scheduled for Thursday, October 20, 2011 at 12:00 noon in the Board room.

Record review of the P & T Committee meeting minutes dated Thursday, 09/29/11 showed Staff NN, Medical Doctor (MD), asked that a report on medication errors be put on the agenda for the next meeting.

Record review of the P & T Committee meeting minutes dated 07/19/12 (the next time the Committee met after 09/29/11) showed the minutes did not contain any report regarding medication errors.

8. During an interview on 08/29/12 at 9:40 AM, Staff Q stated that the P & T Committee had intended to meet monthly but the meetings had not taken place.

Based on interview, record review and policy review the facility failed to:
-Ensure that the current Pharmacy policies and procedures were reviewed, revised or approved by the Pharmacy and Therapeutics Committee or the Medical Staff. This had the potential to affect all patients in the facility.
-Have policies and procedures in place approved by the Medical Staff to minimize medication errors and the potential harm to patients during the time the pharmacy was closed. This had the potential to affect all patients in the facility. The facility also failed to follow facility policy regarding checking for outdated or recalled medications in all storage areas outside of the pharmacy including the Cardiopulmonary department, the Rehabilitation Services department and in the Operating Room (OR) anesthesia cart storage areas. This placed all surgical patients at risk for receiving unusable medication. The facility does an average of 40 surgical cases per month.
-Ensure the Pharmacy Department reported medication errors to the Pharmacy and Therapeutics (P&T) or Medical Staff Committees as required by policy and procedure and position description to implement corrective actions to reduce or prevent reoccurrences. This had the potential to affect all patients in the facility. The facility census was six.

The severity and cumulative effect of these practices resulted in the facility's non-compliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

Please see citations at A0491, A0500, A0505 and A0508.