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Based on the nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Governing Body. The governing body of the facility failed to ensure that nursing care provided to patients was provided in a safe and effective manner, in compliance with facility policies/procedures and met all standards of the Condition of Participation of Nursing Services. In addition, the governing body of the facility failed to ensure that the facility's performance improvement mechanism/activities adequately investigated medication errors and instituted appropriate monitoring to prevent subsequent errors. The governing body of the facility failed to ensure that the performance improvement activities related to medication errors met all standards of the Condition of Participation of Quality Assurance/Performance Improvement. The governing body failed to ensure that all services, whether provided by the facility or as a contracted service were provided in a safe and effective manner and complied with Conditions of Participation and related Standards.

The facility failed to have an effective governing body legally responsible for the conduct of the hospital as an institution. According to the Governing Board By-Laws, in pertinent part: Article IX, 9.6, Patient Care- "The Governing Board shall support and participate in an institutional process to periodically review, evaluate, and revise Hospital policies and procedures to enhance integrated patient care for all disciplines,---"

The facility failed to provide Governing Body Meeting Minutes to evidence the compliance of the previous deficiencies cited. An "emergency" meeting was conducted on 8/18/10 during the re-certification survey.

An interview was conducted with the corporate administrator on 8/17/10 at 9:00 a.m. H/she stated that h/she was unaware that the Board needed to have a meeting by 8/10/10, (the latest correction date.)

Governing Body meeting minutes were provided for April 29, June 4, and July 15, 2010. It was noted on "these minutes that they were developed by the corporate administrator, based on his/her notes taken during the meeting. The facility has misplaced the original hand written minutes."

Cross Reference to A0263, A0289, A0385, A0395, A0398, A0405 and A0726.

Based on the nature of the deficiencies cited, the hospital failed to comply with the Condition of Participation of Quality Assurance and Performance Improvement (QAPI). The hospital failed to provide evidence they addressed and implemented a plan to correct the medication errors.

Based on staff interviews, and facility documentation review, the hospital failed to set priorities for its performance improvement activities that affect health outcomes, patient safety and quality of care. The hospital failed to complete in a timely manner action plans identified to assist personnel to prevent an adverse medication event. Failure to complete identified action plans in a timely manner created the potential for negative patient outcome.

Cross Reference to A0043, A0289, A0385, A0395, A0398, A0405 and A0726.

Based on the number and nature of deficiencies cited, the hospital failed to comply with the Condition of Participation of Nursing Services. The hospital failed to have an organized nursing service that consistently provided nursing services on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy. The facility failed to meet the following standards under the Condition of Nursing Services:

A0395 Registered Nurse Supervision of Nursing Care: The facility failed to provide a functioning nursing structure under which a registered nurse supervised and evaluated the nursing care of each patient.

A0398 Supervision of Contract Staff: The facility failed to maintain appropriate files on contracted nursing personnel thereby ensuring that the personnel were competent.

A0405 Administration of Drugs: The facility failed to adequately supervise the administration of medications in accordance with Federal and State laws and regulations and approved medical staff policies and procedures.

Based on medical record review and review of the emergent parameters for physician notification, the facility's nurses failed to evaluate the nursing care and inform the patient's physician regarding elevated blood pressures in four (#2, #10, #11 and #12) of 33 medical records reviewed. This failure created the potential for negative patient outcome.

The findings were:

The protocol for the Emergent-Telephone Notification parameters was reviewed on 8/18/10. The parameters for elevated blood pressures (BP) stated the following: "Elevated BP - Diastolic above 95/Systolic above 160."

The patient sample #2 was admitted to the facility on 6/4/10 with the primary diagnosis of Mood Disorder and discharged on 6/14/10. On 6/4/10, the patient's B/P at 8:00 p.m. was 174/111. There was no documentation that indicated that the B/P was retaken or evaluated by a nurse or that a physician had been notified.

The patient sample #10 was admitted to the facility on 7/13/10 with the primary diagnosis of Dementia-Alzheimers and discharged on 7/23/10. On 7/20/10, the patient's B/P at 8:00 a.m. was 177/96. On 7/23/10, the patient's B/P at 8:00 a.m. was 176/97. The patient's B/P's were consistently elevated throughout the admission. There was no documentation that indicated that a physician had been notified and there were no antihypertensive medication changes made.

The patient sample #11 was admitted to the facility on 7/28/10 with the primary diagnosis of Bipolar I disorder and discharged on 8/4/10. On 7/30/10, the patient's B/P was 161/110 at 8:00 a.m. On 8/2/10, the patient's blood pressure was 166/105 at 8:00 a.m. There was no documentation that indicated that any B/P rechecks were done or that a physician had been notified.

The patient sample #12 was admitted to the facility on 7/22/10 with the primary diagnosis of Hallucinations-psychosis and was still a patient. On 8/14/10, the patient's B/P was 192/120 in the left arm at 8:00 p.m. and 199/92 in the right arm. There was no documentation that a physician had been notified of the elevated B/P.

Based on staff interview, review of personnel files, and policies and procedures, it was determined that the facility failed to ensure that all non-employee files contained proper orientation documentation for the position working, as evidenced in one contract-staff file reviewed. This failure did not ensure that non-employee nurses adhere to the policies and procedures of the hospital. This created the potential for negative patient outcome.

The findings were:

A review of eight contract staff personnel files on 8/17/2010 revealed that two of eight sample agency staff (samples #1 and #4) did not have proof of being licensed in the state. Sample #7's license expired 1/31/10. Sample staff #1, #3, #4 and #7 had no evidence of current certification, such as CPR. Sample staff #1 and #4 orientation documentation was absent. Sample #1 and #6 had no evidence of evaluations. There was documentation on the staffing sheet from 8/3/10 through 8/9/10 that five (sample #s 1, 3, 4, 6, 7) of eight were assigned to duty during this time period without assuring that those agency staff were indeed licensed, certified in CPR and had been oriented and evaluated.

The policy and procedure titled "Nursing Agencies" was reviewed on 8/17/2010. It stated the following, in pertinent part:

"PROCEDURE ...
1. Agency personnel are booked through local registries. An Agency Employee Profile is completed by the Agency on each agency personnel working at HB and kept on file at HB. A service agreement is designed to insure the following: a. "Proof of psychiatric competencies need to be forwarded to the facility prior to registry personnel working on the units. The agency validates that appropriate training and orientation has taken place for all employees. b. All agency nurses must possess a current, valid state license, verified by the contracting agency. c. Current CPR training. d. PPD within the past year.
4. Agency personnel will be oriented to the hospital and instructed regarding their individual assignment by the shift Registered Nurse or Director of Nursing, prior to working. Agency personnel will be given an orientation packet upon arrival for their review. Orientation will be documented on the agency Orientation Checklist and include:
a. Fire b. Safety c. Infection Control d. Confidentiality e. Reading the Agency Orientation Manual.
5. Agency staff member will sign off on the Agency Orientation Sheet, verifying completion of these requirements. If the person has worked at the facility within the past 90 days, they do not have to complete a new orientation packet ..."

In an interview with the corporate DON (Director of Nursing) on 8/17/10 at 11:25 a.m., revealed that h/she met with each agency manager, they were given packets and they need to complete the packet prior to staff arriving. Our staff does check list of required documents. Interview with the corporate DON on 8/17/10 at 3:00 p.m., revealed the agencies are supposed to fax over the paperwork (packet) ahead of time. The RNs and Mental Health Technicians are supposed to complete the paperwork and hand deliver to us. Upon request for the agency staff files from the facility it was noted the facility did not have all the files onsite and the agency faxed the information to Haven Behavioral Senior Care.

Based on staff interview, review of medical records, medication variance reports and the facility's policies and procedures, the facility failed to adequately assess and document any corrective action regarding the numerous medication irregularities and/or errors.

The findings were:

During the medical record review, it was noted that the Medication Administration Records (MARs) were hand written by the nursing staff. Also, it was the responsibility of the nursing staff to copy all physician orders and forward a copy to pharmacy to be filled.

The pharmacist was interviewed on 8/18/10 at approximately 11:00 a.m. The pharmacist stated that pharmacy hours are 9 to 5 Monday through Friday and a pharmacist is on-call 24/7 (twenty four hours a day/seven days a week.) The pharmacist acknowledged that the MARs were hand written by the nursing staff; however, the pharmacy had the capability to print them and provide a pharmacy printed MAR.

A list of incident/variance reports for the last two months were requested of the facility during the entrance conference. The following is a list of medication variances that occurred between 7/1/10 through 8/17/10 that were discovered and investigated by the Pharmacy Department:

1. Occurrence dated 7/7/10: Order written on 7/2/10 at 11:00 p.m. for Metformin (oral antidiabetic). Did not get Rx (drug) until 7/7; however, further documentation revealed that an agency nurse gave first dose on 7/3. Still further investigation revealed the copier was not working on 7/2 so pharmacy did not get medication orders. Further investigation by pharmacy revealed the nurse apparently took the Metformin from another patient's medication drawer instead of taking it from the ward stock. There was no notation on the medication communication board by the nurse to indicate the administration history of this medication variance.

2. Occurrence #10-07-211 MAR dated 7/7/10: Order for Simvastatin (antilipidemic) 20 mg qhs (every evening) was written on 6/18/10. The pharmacist did not get the order until 7/7 but according to the MAR the patient was getting the medication. The medication was charted as being given from 6/28 to 7/4; however, the only days the medication was removed from ward stock was on 7/5 and 7/6. The pharmacy questioned where the nurses were getting the medication and were they really administering it.

3. Occurrence #10-07-214 MAR audit dated 7/7/10: Vitamin E 400 IUs given instead of the reduced 200 IUs. "They never checked strength. 20 extra doses given."

4. Occurrence #10-07-215 MAR audit dated 7/7/10: Bactrim DS (antiinfective) 1 BID (twice a day) X 5 days (Q 12 hours). Transcribed on MAR as HS (evening) only. As of 7/7, 3 doses missed so far.

5. Occurrence #10-07-216 MAR audit dated 7/7/10: Pharmacy never got order from 7/4/10 for ASA (aspirin) 81 mg.

6. Occurrence #10-07-217 MAR audit dated 7/7/10: Magnesium oxide (electrolyte) discontinued on 7/3. Never got order. Zocor (antilipidemic) not carried over to new MAR. Missed 5 doses.

7. Occurrence #10-07-218 MAR audit dated 7/7/10: Namenda (anti-Alzheimer agent) 5 mg qhs (nightly) X 1 week, then 5 mg BID (twice a day). Five extra doses given. Dose for qhs X 1 week never put on MAR. Started patient with BID dosing.

8. Occurrence #10-07-219 dated 7/10: Patient missed 5 doses of Prozac (antidepressant) 10 mg. Pharmacy never got copy of order so we (the pharmacy) thought order was discontinued. Finally got copy of order on 7/8.

9. Occurrence #10-07-228 dated 7/13/10: Patient did not receive meds X 3 days. His MAR was placed with another patient's MAR. Lisinopril (antihypertensive) 40 mg daily, ASA (aspirin) 81 mg daily, Lexapro (antidepressant) 10mg qhs, Wellbutrin (antidepressant) 75 mg daily.

10. Occurrence #10-07-227 dated 7/13/10: Wrong MAR labeled as patients. Patient received Rx X 3 days. Lisinopril (antihypertensive) 40 mg daily, ASA (aspirin) 81 mg daily, Lexapro (antidepressant) 10 mg qhs, Wellbutrin (antidepressant) 75 mg daily.

11. Occurrence dated 7/19/10: Order for plain Effexor (antidepressant) 37.5 mg bid. Effexor XR (extended release) 2 doses removed from ward stock. Wrong drug and wrong amount. (Only needed 1 cap.) Order clear - written on MAR incorrectly. Took XR out instead of plain.

12. Occurrence dated 7/20-21/10: Removed from ward stock Effexor (antidepressant) 37.5 mg XR instead of plain.

13. Occurrence dated 7/26/10: Order (admission) written for Lipitor (antilipidemic) - we don't carry Lipitor. Signed out by nurse from ward stock (not in ward stock) and marked on MAR as given. Did she give Zocor? Not removed from ward stock. Admission order for drug we don't have on formulary. Marked on ward stock and MAR as given. Asked nurse said she may have taken Simvastatin from another patient, but could not remember who.

14. Occurrence dated 7/15/10: Lexapro (antidepressant) 10 mg at HS given after it was discontinued 7/8.

15. Occurrence #10-07-231 dated 7/15/10: MAR missing from chart dated 7/8 - 7/14. (This was occurrence written by a RN and she/he did not indicate that pharmacy had been notified.)

16. Occurrence dated 7/9 and 7/10/10: Discontinued medication given on 7/9/10 and 7/10/10. Ritalin (cerebral stimulant) 10 mg daily. (This occurrence was written by a RN and did not indicate that pharmacy had been notified.)

17. Occurrence dated 7/8/10: Depakote (anticonvulsant) given at wrong time and wrong dose. Ritalin (cerebral stimulant) was the wrong medication given. (This was occurrence was written by a RN and did not indicate that pharmacy had been notified.)

18. Occurrence dated 8/2/10: One nurse removing from ward stock. Another nurse administering medication. Zocor (antilipidemic) 40 mg. Said removed 1 tab (10 mg). Should be 4 tabs. 8 tabs removed (4 unaccounted for.). Lisinopril (antihypertensive) 20 mg. Said removed 1 tab (10 mg). Should be 2 tabs but only 1 removed from ward stock. Uroxatral (urinary tract, antispasmodic) 10 mg indicated removed from ward stock - not in ward stock - not signed off on MAR.

19. Occurrence dated 8/2/10 and 8/3/10: Dose not documented on ward stock as being pulled. Zyprexa (antidepressant) 1 mg not signed out of ward stock - dose given at 3 a.m. Dose missing from ward stock.

20. Occurrence dated 8/2/10: Potassium 5 meq. (Gave 1/2 of 10 meq tab instead of liquid. Tabs are DO NOT CUT OR CRUSH. Liquid was on top of med cart. Asked RN to indicate on MAR that dose is liquid. Never did.

21. Occurrence dated 8/4/10: MAR was labeled with patient name with medications from different patient. (This occurrence was written by a RN and was not passed on to the pharmacist according to the documentation.)

22. Occurrence dated 8/5/10: Looking for Fentanyl (opioid analgesic) patch removed. Found the following meds still in UD (unit dose) packages inside sharps container with the Fentanyl: Tamsulosin (peripheral adrenergic blocker), Levothyroxine (thyroid hormone) 88 mcq, Omeprazole (antiulcer) 20 mg, Effexor (antidepressant) 37.5 mg and Metoprolol (antihypertensive) 25 mg. (It was unknown if the medication was ever given.)

23. Occurrence dated 8/10/10: Patient did not get Abilify (antipsychotic) 2 mg tab - we only carry 5 mg tabs. RN did not call pharmacist on-call for med. Wrote med not available. Said she/he did not know she/he had to call.

24. Occurrence dated 8/14/10: Medication order written to discontinue Synthroid (thyroid hormone) 200 mcq daily and change to 100 mcq. Both orders active on patient's MAR. RN says she/he did not give 200 mcq dose today. However, it was not circled on MAR.

25. Occurrence dated 8/17/10: Metformin (antidiabetic) pulled out of ward stock. Order was on hold. Found by pharmacy technician before given to patient. It had been marked HOLD on MAR.

26. Occurrence dated 8/16/10: Prescription written 8/13/10 7:00 a.m. Just got order on 8/16/10 for Vitamin B-12. Pharmacist on-call never notified over weekend. Order never got to pharmacy until 8/16/10. (Found out patient is LOA (leave of absence) and pharmacy never notified.)

27. Occurrence dated 8/16/10: Order for Acidophilus TID (three times a day) X 7 days on 8/13/10 at 6:00 a.m. Pharmacist on-call never notified over weekend. Order never sent to pharmacy until 8/16/10. RN wrote "ON-ORDER" on MAR on 8/13, 8/14, 8/15.

28. Occurrence dated 8/16/10: Comtan (antiparkinson agent) 200 mg ordered on 8/15. Pharmacist on-call never notified. Pharmacy technician even called on 8/15/10 to see if they needed anything - told no. Prescription for Comtan to start 8/15 p.m. Dose not given. Written on MAR as "ON Order." It was not on order - had in pharmacy. All they needed to do was call pharmacist on-call.

29. Occurrence dated 8/16/10: Order written 8/13/10 at 11:00 p.m. for B-12 1000 mcq. Pharmacist on-call never notified over weekend. N/A (not available) written on MAR for 8/14 and 8/15. Not true - pharmacist not called.

30. Occurrence dated 8/16/10: Order written for Vitamin B-12 on 8/15 6:00 a.m. Pharmacist on-call never notified. Just crossed off on 8/15 MAR.

31. Occurrence dated 8/16/10: Potassium CHL 5 meq. Took tab from ward stock when liquid in patient's drawer. (Should have been liquid form in patient drawer. Tab cannot be cut or crushed.) Not written on MAR that should be liquid.

The facility's policy and procedure entitled "Performance Improvement Medication Errors" #PCS-15-04 stated, in pertinent part: "The primary purpose of the quality assurance review should be to advance error prevention by investigation, individually, and collectively, all data and information collected in response to a medication error so as to assess the cause and any contributing factors such as human factors, process factors, and/or system failure. A record of the findings of the Quality Assurance Review should be prepared by the Hospital staff involved in the Q.A. Review. The Record should contain at least the following:
a. Date(s), location, and participants in the Q.A. Review.
b. All data and information relating to the incident.
c. Documentation of communication to the patient and prescriber.
d. Findings and determinations generated by the Q.A. Review.
e. Recommended changes to pharmacy/hospital policy, procedures, systems of processes; and
f. Method of educating staff of changes...
The medical staff shall, as part of its Pharmacy and Therapeutics Committee (or Hospital Equivalent) function:
a. Review and evaluate medication errors and Quality Assurance Reports.
b. Monitor the effectiveness of improvements in policies, procedures, or systems."

According to corporate administration on 8/17/10, there were no previous Q. A. minutes that could located. Therefore, a Quality Council Meeting was called on 8/18/10 at approximately 11:00 a.m. However, the data recorded in the Q. A. minutes did not reflect the medication/error inconsistencies revealed in the internal occurrences documented above.

The Medical Executive meeting minutes were reviewed on 8/17/10. It was noted that the previous Medical Director did not include the pharmacist in the meetings and did not address the medication variance reports.

An interview was conducted with the corporate vice president (VP) on 8/18/10 at approximately 3:45 p.m. The VP stated that he/she was acting director of nursing (DON) at the time of Occurrences #10-07-228 and #10-07-227 and stated that he/she was aware of the issues. He/she admonished the registered nurse (RN) who was involved in the alleged omission and/or administration of the medications. The VP stated that "the RN stated that he/she would not do anything like that and that it really didn't happen." Furthermore, there was no evidence that the VP/acting DON pursued any further investigation in the matter.

In summary, the lack of in-depth investigation and tracking in the Quality Council meetings and failure to have pharmacy representation in the Medical Executive meetings regarding the numerous medication errors/inconsistencies created the potential for negative patient outcome.

Based on observations and staff interview it was determined the facility failed to have ventilation and temperature controls in the medication preparation room on the Phase II unit. This failure created the potential for the deterioration and instability of medications which were to be administered to the patients. Additionally, there was no "red plug" (emergency power) for the medication refrigerator in the Phase II Unit. The findings were:

On 8/17/10 at 9:00 a.m., during the observation of medication pass it was noted that the medication preparation room on the Phase II unit was very warm and there was no ventilation. On 8/18/10 the wall thermometer revealed the temperature in the medication room was 79.9 degrees at approximately 2:00 p.m. and on 8/19/10 the temperature was 79.7 degrees. A floor fan had been placed in the medication room on 8/18/10 to help circulate the air.

Interview with the Consultant Pharmacist on 8/18/10 revealed h/she had never been consulted when the building owner had renovated the hospital. There was not a "red plug" or ventilation provided in the medication room on the Phase II Unit.

Interview with the Consultant Pharmacist on 8/19/10 revealed that some days in June and July the temperature in the medication room gets as high as 84 degrees. H/she agreed that the medication room should be ventilated and that had been discussed in the past with the building's owner. Having inconsistently high and low temperatures will cause deterioration of medications and the drugs must be stored according to manufacturer's guidelines.

Based on review of the facility's Quality Council Performance Improvement Meeting minutes for August 18, 2010, and interview with corporate administration, medication errors were alluded to, however, there was no documented evidence the facility took actions aimed at addressing these error/variances. This failure created the potential for negative patient outcome.

According to corporate administration on 8/17/10, there were no previous Q.A. minutes that could be located. Therefore a Quality Council Meeting was called on 8/18/10 at approximately 11:00 a.m. However, the data recorded in the Q.A. minutes did not reflect the medication errors and inconsistencies revealed in the internal occurrences identified by the surveyors. H/she stated that the data from the past Q.A. meetings "disappeared". The minutes were never "typed up" officially, per the corporate administrator, however, the facility did meet.