The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SEASIDE BEHAVIORAL CENTER 4201 WOODLAND DRIVE NEW ORLEANS, LA Jan. 28, 2011
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure all medications were administered as ordered by the physician resulting in 103 unreported medication variances for 13 of 14 sampled medical records (#1,#2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13). Findings:

Patient #1
Review of the medical record for Patient #1 revealed a [AGE] year old female admitted on [DATE] for Bi-Polar Disorder and Schizo-Affective Disorder. Review of the Physician's Orders dated/timed 01/18/11 at 1300 (1:00pm) revealed an order for Synthroid 0.100mcg (microgram) QD (every day). Review of the Medication Administration Record (MAR) for Patient #1 revealed documentation the drug was unavailable for administration on 01/19/11 at 0600 (6:00am).

Patient #2
Review of Patient #2's medical record revealed she was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]
Review of Patient #2's "Physician's Orders", dated 01/15/11, with no documented evidence of the time the order was written, revealed an order for Hydrocortisone Acetate 0.5% (per cent), apply to face lightly BID (twice a day).
Review of Patient #2's MAR revealed no documented evidence the cream was applied on 01/15/11, 01/16/11, and 01/17/11. Further review revealed the only documented time on the MAR that it was unavailable was at 9:00pm on 01/17/11. Review of the drug label attached to the Hydrocortisone Acetate cream revealed it was filled by contracted Pharmacy A on 01/16/11, the day after it was ordered by the physician.

In a face-to-face interview on 01/20/11 at 11:10am, RN (registered nurse) S23, Charge Nurse, indicated that they have difficulty get medications such as creams from the pharmacy. She further indicated the nurses could get pills from the emergency drug kit that are ordered and not available, but creams were not supplied in the kit.

Patient #3
Review of the medical record for Patient #3 revealed a [AGE] year old female admitted on [DATE] for dementia with behavioral problems, psychosis, and paranoia. Review of the Physicians' Orders dated/timed 01/18/11 at 1630 (4:40pm) revealed an order for Lamictal 100mg po ( by mouth) three times a day. Review of the Medication Administration Record (MAR) dated/timed 01/20/11 at 2100 (9:00pm) revealed the initial of the nurse was circled indicating the medication was not administered. Further review of the MAR and the Nurses' Narrative Notes revealed no documented evidence as to why the Lamictal was not administered to Patient #3 as ordered.

Review of the Physician's Orders for Patient #3 dated 01/18/11 (no time documented) revealed an order for Haldol 2mg i po BID (one twice a day). Review of the MAR dated 01/18/11 revealed no documented evidence Haldol 2mg was administered to Patient #3. Further review of the MAR and the Nurses' Narrative Notes for 01/18/11 revealed no documented evidence indicating the reason the medication had not been administered to the patient.
Review of the Physician's Orders for Patient #3 dated 01/19/11 (no time documented) revealed an order to increase Seroquel to 75mg i po Q HS (one every hour of sleep). Review of the MAR dated 01/19/11 revealed documentation Seroquel 50 mg i po Q HS had been discontinued and a new order written for Seroquel 75mg i po Q HS; however there was no documented evidence the medication had been administered.
Review of the Nurses' Narrative Notes and MARs for Patient #3 dated 01/18/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Observation on 01/20/11 at 11:00am of the PAR levels of the "Emergency Drug Stock" used for after hour new orders revealed Seroquel 75mg was not available; however there were (10) 25mg Seroquel, 3 of which could have been used to equal the ordered dosage until the medication arrived from the pharmacy the next day.

Patient #4
Review of the medical record for Patient #4 revealed a [AGE] year old woman admitted on [DATE] after hospitalization for a drug overdose of Dilaudid and depression. Review of the Physicians' Orders dated 01/06/11 (no time documented) revealed an order for Benzphetamine 50mg i po (one by mouth) 30 minutes before each meal. Review of the Medication Administration record (MAR) revealed no documented evidence Benzphetamine 50mg had been administered on 01/06/11 at 1100 (11:00am) and 1700 (5:00pm); 01/07/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm); 01/08/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm); and 01/09/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm).
Review of the Physicians' Orders for Patient #4 dated 01/15/11 (no time documented) revealed an order for Cogentin 1mg po (by mouth) BID (twice a day). Review of the Medication Administration Record (MAR) dated/timed 011/15/11 at 2100 (9:00pm) revealed no documented evidence Cogentin 1mg had been administered to Patient #4.
Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 01/06/11 and 01/15/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #5
Review of the medical record for Patient #5 revealed a [AGE] year old male admitted on [DATE] with the diagnosis of [DIAGNOSES REDACTED]"out" and not administered to the patient.

Review of the Nurses' Narrative Notes and MARs for Patient #5 dated 01/06/11 revealed no documented reason as to why the medications was "out" and had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #6
Review of the medical record for Patient #6 revealed an [AGE] year old female admitted on [DATE] for Dementia, Psychosis and Hallucinations. Review of the Physician's Orders dated 01/05/11 (no time documented) revealed an order for Klonopin 0.25mg po bid. Review of the MAR revealed documented evidence on 01/06/11 at 0900 (9:00am) "none available".

Review of the Nurses' Narrative Notes and MARs for Patient #6 dated 01/06/11 revealed no documented reason as to why the medications were not available, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #7
Review of the medical record for Patient #7 revealed an [AGE] year old female admitted on [DATE] for dementia with behavioral dyscontrol and a history of schizophrenia. Review of the Physician's Admit Orders dated/timed 12/07/10 at 1300 (1:00pm) revealed an order for Geodon 80mg po (by mouth) with supper daily and Prozac 20 mg po QAM (every morning). Review of the MAR revealed no documented evidence Geodon had been administered to Patient #7 at 2100 (9:00pm) on 12/07/10 at 0900 (9:00am) or Prozac on 12/09/10 at 0900 (9:00am) and 12/19/10 at 0900 (9:00am).
Review of the Physician's Orders dated/timed 12/08/10 1830 (6:30pm) revealed an order for Aldactone 25mg qd (every day). Review of the MAR for Patient #7 revealed no documented evidence the Aldactone had been administered to Patient #7 as ordered.

Review of the Nurses' Narrative Notes and MARs for Patient #7 dated 12/09/10 revealed no documented reason as to why the medications were not available, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #8
Review of the medical record for Patient #8 revealed a [AGE] year old male admitted on [DATE] with Paranoid Psychosis and Dementia. Further review revealed #8 had a history of asthma, COPD (Chronic Obstructive Lung Disease) and CHF (Congestive Heart Failure). Review of the Physician's Orders dated/timed 12/01/10 at 2340 (11:40pm) revealed an order for Synthroid 50mcg po QD; Combivent Inhaler 2 puffs QID; and Albuterol 2.5/5ml with Atrovent 0.2% per nebulizer every 8 hours.

Review of the MAR for Patient #8 revealed no documented evidence the following medications were administered: Synthroid 50mcg on 12/02/10 at 0600 (6:00am) and 1400 (2:00pm); Albuterol 2.5/5ml with Atrovent 0.2% on 12/02/10 at 0600 (6:00am) and 1400 (2:00pm); and Combivent Inhaler Combivent Inhaler on 12/02/10 at 0800 (8:00am), 12 noon, 1600 (4:00pm) and 2000 (8:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #8 dated 12/02/10 revealed no documented reason as to why the medications were not administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #9
Review of the medical record for Patient #9 revealed an [AGE] year old female on 12/21/10 for dementia with behavioral changes. Review of the Physician's Admit Orders dated 12/20/10 at 1530 (3:30pm) revealed an order for Aricept 75mg i po daily. Review of the Medication Administration Record (MAR) dated 12/21/10 at 0900 (9:00am) revealed no documented evidence Aricept 75mg was administered to Patient #9.

Review of the Physicians' Orders dated/timed 12/24/10 6:30pm revealed an order for Risperdal 0.25mg po (by mouth) bid (twice a day). Review of the Medication Administration Record (MAR) dated 12/24/10 revealed no documented evidence Patient #9 received Risperdal 0.25mg on 01/24/10 at 2100 (9:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 12/21/10, 01/06/11 and 01/15/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #10
Review of the medical record for Patient #10 revealed a [AGE] year old male admitted on [DATE] for Dementia with behavioral problems. Review of the Physician's Orders dated/timed 12/23/10 at 1445 (2:45pm) revealed the following orders: Sinemet 10/100 po tid (three times a day); Muro Ointment 128 apply to bilateral eyelids Q hs (every hour of sleep); Travatan i gtt (one drop) OU (both eyes) QHS; Zylet i gtt OU tid; and Cosopt i gtt OU bid.

Review of the MAR for Patient #10 revealed no documented evidence the following medications were administered : Sinemet 10/100mg had been administered on 12/23/10 at 2100 (9:00pm), 12/24/10 at 0600 (6:00am) and 12/29/10 ay 1400 (2:00pm); Muro Ointment 12/23/10 at 2200 (10:00pm) ; Travatan at 12/23/10 at 2100 (9:00pm); Zylet 12/23/10 at 2200 (10:00pm) and 12/24/10 at 0600 (6:00am); and Cosopt 12/23/10 at 2100 (9:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 12/23/10, 01/06/11 and 12/24/10 revealed no documented reason as to why the medications were not available for administration as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #11
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed the following orders:
01/08/11 at 11:00am - Clonidine 0.2 mg by mouth twice a day; Lisinopril 40 mg by mouth daily, and Metoprolol 100 mg by mouth daily;
01/10/11 at 11:10am - Lexapro 5 mg by mouth every AM (morning);
01/11/11, with no documented evidence of the time the order was received (the order was noted by the nurse on 01/11/11 at 6:45am) - Clonidine 0.1 mg by mouth times 1 now, then every 4 hours prn (as needed) for systolic blood pressure (BP) greater than 180; and
01/21/11, with no documented evidence of the time the order was received (the order was noted by the nurse on 01/21/11 at 9:00am) - Lasix 20 mg by mouth daily and KCl (potassium chloride) 10 meq (milliequivalents) by mouth daily times 5 days.

Review of Patient #11's MARs and "Nurses Progress Notes" revealed Metoprolol 100 mg orally was administered at 9:00am on 01/09/11, 01/10/11, 01/11/11, 01/12/11, 01/13/11, 01/14/11, 01/15/11, 01/17/11, 01/18/11, 01/19/11, 01/20/11, and 01/21/11 with no documented evidence Patient #11's pulse was checked prior to administration of Metoprolol (as required by review of the medication resource manual accepted by the hospital as a resource to the nurses). Further review revealed Lisinopril 40 mg by mouth and Metoprolol 100 mg by mouth (patient's routine medications) were administered at 5:30am on 01/16/11 for elevated blood pressure by contracted agency RN S24 instead of the prescribed prn Clonidine ordered to be given for systolic blood pressure greater than 180. Further review revealed Lexapro 5 mg ordered to be given every morning on 01/10/11 at 11:10am was not administered until 9:00am on 01/11/11, and
there was no documented evidence Lasix and KCl were administered as ordered on [DATE] (MAR revealed day 1 for KCl was to be 01/22/11).

Review of the 31st edition of the "Nursing 2011 Drug Handbook", presented by DON S2 as the nursing staff's resource reference for medication administration, revealed, in part, ...Metoprolol Succinate ... Nursing Considerations Always check patient's apical pulse rate before giving drug. If it's lower than 60 beats/minute, withhold drug and call prescriber immediately...".

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed the above findings. She indicated routine medications should not have been administered early without an order from the physician, and the prn Clonidine should have been given 01/16/11. She could not explain why the nursing staff was not checking Patient #11's pulse prior to administering the Metoprolol.

Patient #12
Review of the medical record for Patient #12 revealed an [AGE] year old female admitted on [DATE] for Senile Dementia with behavioral disturbances. Further review revealed #12 had a medical history which included HTN (Hypertension) and CHF (Congestive Heart Failure). Review of the Physician's Orders dated 12/01/10 (no time documented) revealed an order to restart Tenormin 25mg po at HS "hold" if SBP (Systolic Blood Pressure) < (less than) 110.

Review of the MAR for Patient #12 revealed Tenormin 25mg was administered at 2100 (9:00pm) on the following dates: 12/05/10, 12/06/10, 12/0710, 12/08/10 and 12/09/10. Review of the "Daily Vital Signs" form, utilized by the Mental Health Techs to record vital signs including blood pressure, revealed the following: 12/05/10 at 9:00pm - BP 102/67; 12/06/10 at 9:00pm BP 103/66; 12/07/10 at 9:00pm - no documented evidence the blood pressure had been assessed; 12/08/10 at 9:00pm - no documented evidence the blood pressure had been assessed; and 12/09/10 - no documented evidence the blood pressure had been assessed.

Review of the Nurses' Narrative Notes and MARs for Patient #12 dated 12/05/10 through 12/09/10 revealed no documented evidence the blood pressure had been assessed before administration of the Tenormin as ordered by the physician or that any of the nursing staff had identified the medication had been given on 12/05/10 and 12/06/10 when Patient #12's blood pressure was below the ordered parameters for administration of the Tenormin.

Patient #13
Review of Patient #13's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]
Review of Patient #13's "Physician's Orders" revealed the following orders:
01/07/11 at 12:30pm - Saphres 10 mg by mouth BID; Cogentin 2 mg by mouth TID; Benadryl 100 mg by mouth TID; Synthroid 50 mg by mouth daily;
01/20/11 at 4:00pm - Colace 100 mg by mouth daily; and
01/21/11, with no documented evidence of the time the order was written and noted by the nurse on 01/21/11 at 8:00am - Miralax 17 grams by mouth daily mixed with 8 ounces of water.

Review of Patient #13's MARs revealed the nurse's initials were circled at 9:00pm on 01/07/11 indicating Saphres was not administered. Further review revealed notations on the MAR for 01/08/11 at 9:00am and 9:00pm, 01/09/11 at 9:00am and 9:00pm, and 01/10/11 at 9:00am that Patient #11 had refused the medication Saphres. Further review of the "Nurses Progress Notes" revealed no documented evidence the LPN reported the patient's refusal to the RN and the physician. Further review revealed Cogentin and Benadryl were not administered until the 9:00pm dose on 01/07/11; the dose due at 1:00pm was not administered. Further review revealed Benadryl was not administered at 9:00pm on 01/16/11 and at 9:00am and 1:00pm on 01/17/11. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.
Review of Patient #13's MAR revealed no documented evidence Synthroid was administered as ordered at 6:00am on 01/19/11 and 01/20/11. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.
Review of Patient #13's MAR for Miralax for 01/21/11 through 01/23/11 revealed the nurse's circled initials indicating the medication was not administered on 01/22/11 at 9:00am. Further review revealed Miralax was first administered on 01/23/11, two days after the order was received. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed there were no medication variances completed for the above listed medication variances. S1 indicated she tried to perform chart audits in the past, but lately she had not been able to do so due to her being responsible for nursing, QAPI (quality assurance/performance improvement), and infection control. She further indicated she had been out most of the month of November, and upon her return, many things she had put in place had fallen by the wayside.

Review of the hospital policy titled "Administration Of Medications Using The MAR System", policy 12.2 and submitted by DON S2 as a medication administration policy, revealed, in part, "...There are several reasons for putting a note regarding medications into the nurses notes. Some include: Medication refusal, Medication omission, PRN medication... 10. If the medication is refused or omitted for any reason, instead of initials, place a red asterisk (*) in the appropriate square. ... 24. Blank spaces on the MAR indicate a medication error; therefore, each nurse should check the forms before going off duty to make sure all squares are properly initiated. ... 26. Remember to record all medication refusals, omissions, and PRNs in the nurses notes as well as the MAR...".

Review of the hospital policy titled "Occurrence Reports (Incident reporting)", policy 8.6 and submitted by DON S2 as the medication variance reporting policy, revealed, in part, "...1) Occurrences for which an HOR (hospital occurrence report) should be completed include, but are not limited to, the following (if doubt remains, the HOR should be completed): ... d. Medication Errors 1. Omissions 2. Wrong medication administered 3. Incorrect dose administered 4. Transcription Error... Report interventions that occurred following the incident... d. Report patient status twenty-four (24) hours after the incident. e. Record the occurrence in the patient's medical chart as well as on the Hospital Occurrence Report form. ... 7. Hospital occurrence reporting shall be sent to PI (performance improvement) coordinator who will trend same and process via the hospital PI committee structure".
VIOLATION: PHARMACY PERSONNEL Tag No: A0493
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure pharmaceutical services provided quality services including 24 hour, 7 day emergency coverage as evidenced by:1) failure to have medications available for patient administration at their next scheduled dose once the order was received for 2 of 14 sampled patients (#1, #2) and 2) failure to have documented evidence of daily delivery of medications for 16 of 52 days reviewed for medication delivery by UPS (United Parcel Service). Findings:

1) Failure to have medications available for patient administration at their next scheduled dose once the order was received:
Patient #1
Review of the medical record for Patient #1 revealed a [AGE] year old female was admitted on [DATE] for Bi-Polar Disorder and Schizo-Affective Disorder. Review of the Physician's Orders dated/timed 01/18/11 at 1300 (1:00pm) revealed an order for Synthroid 0.100mcg (microgram) QD (every day). Review of the Medication Administration Record (MAR) for Patient #1 revealed documentation the drug was unavailable for administration on 01/19/11 at 0600 (6:00am).

Patient #2
Review of Patient #2's medical record revealed she was admitted on [DATE] with diagnoses of Depression with Suicidal Ideation, COPD (chronic obstructive pulmonary disease), Hypertension, and Non-Insulin Dependent Diabetes Mellitus.
Review of Patient #2's "Physician's Orders", dated 01/15/11, with no documented evidence of the time the order was written, revealed an order for Hydrocortisone Acetate 0.5% (per cent), apply to face lightly BID (twice a day).
Review of Patient #2's MAR revealed no documented evidence the cream was applied on 01/15/11, 01/16/11, and 01/17/11. Further review revealed the only documented time on the MAR that it was unavailable was at 9:00pm on 01/17/11. Review of the drug label attached to the Hydrocortisone Acetate cream revealed it was filled by contracted Pharmacy A on 01/16/11, the day after it was ordered by the physician.

In a face-to-face interview on 01/20/11 at 11:10am, RN (registered nurse) S23, Charge Nurse, indicated that the hospital has difficulty getting medications such as creams from the pharmacy. She further indicated the nurses could get pills from the emergency drug kit that are ordered and not available, but creams were not supplied in the kit.

In a face-to-face interview on 01/21/11 at 9:50am, DON (Director of Nursing) S2 indicated the hospital had been having difficulty getting medications delivered timely, so that patients could receive their ordered medication at the next scheduled dose. She further indicated if a patient was admitted on a Friday after 6:00pm (time Contracted Pharmacy S closed), the patient's medication would not be delivered until Monday and sometimes Tuesday. She indicated medications were shipped UPS (United Parcel Service), and since Pharmacy A was closed on Sunday, medications would not be filled until Monday and shipped that day. S2 indicated for the most part medications were delivered Tuesday through Saturday one time a day.

2) Failure to have documented evidence of daily delivery of medications for 16 of 52 days reviewed for medication delivery by UPS:
Review of "UPS Tracking Information" provided by S5, CEO (chief executive officer) of Pharmacy A, from 12/01/10 through 01/21/11 revealed no documented evidence a UPS delivery of medication was made to the hospital on [DATE], 12/06/10, 12/12/10, 12/13/10, 12/19/10, 12/20/10, 12/25/10, 12/26/10, 12/27/10, 01/01/11, 01/02/11, 01/03/11, 01/09/11, 01/10/11, 01/15/11, and 01/16/11.

In a telephone interview on 01/21/11 at 12:20pm (prior to receipt of the UPS tracking information), S5, CEO of Pharmacy A, indicated he was not a pharmacist but had pharmacists who work for him who were responsible for the pharmacy services. S5 further indicated he contracted with Pharmacy Consultant S3 to perform the monthly pharmacy inspections. S5 indicated the pharmacy was open from 8:00am to 6:30pm, and there was a pharmacist on-call whose telephone number was provided to all facilities. He further indicated if 1st dose medications were not available in the emergency drug kit, he would arrange to have it available at a local pharmacy for the nurse to pick up.

Review of the hospital's contract with Pharmacy A, submitted by Administrator S1 as the current contract with Pharmacy A, revealed it was a 5 page document with pages 2 and 4 not attached. Further review revealed a diagram depicting the flow of physician orders being faxed to the pharmacy. Further review revealed Exhibit A, a 3 page document, was attached with page 2 not attached.

Review of the hospital's contract with Pharmacy A presented by QAPI (quality assurance performance improvement) RN (registered nurse) S4 on 01/25/11 at 11:30am, after the surveyor requested a complete contract with all pages attached, revealed the contract was a 6 page document and included a 2 page Business Associate Agreement between the hospital and Contract Pharmacy A. There was no documented evidence of the diagram that was attached to the previous contract reviewed. Further review revealed, in part, "...This Exclusive Pharmaceutical Service Agreement ("Agreement") is made and entered into as of the 2nd day of September, 2009... Section 3. Obligations of Contractor 3.1 Contractor will dispense and refill medications for Facility and the residents of Facility during the hours of 8:00 o'clock a.m. to 5:00 o'clock p.m. "normal business hours", Monday through Friday, except for holidays. ... 3.2 Prescriptions will be filled for the Facility per the "Facility Procedures - Exhibit A". 3.2.a Stat Orders - A formulary for the facility will be established so in the case of Stat orders, the facility may dose immediately for such resident(s) from the medication cabinet. If these orders are not in the medication cabinet, the Stat order will be delivered the same day they are ordered and shipped to the facility within one (1) hour and will be coordinated by Pharmacy A with 1st Call Pharmacy per the Medication Cabinet Procedures... 3.3 Contractor will provide a licensed pharmacist "on call" seven (7) days per week, three hundred sixty-five (365) days per year. 3.4 In addition to furnishing medications, Contractor will provide medication information and drug interaction information as requested by the Facility...". The contract was signed by S5, CEO of Pharmacy A, and former Administrator S19. Review of "Exhibit A" revealed, in part, "1.) Drug delivery: Emergency After Hours: Such orders will be for New resident(s) and New Drug Order(s), refill orders should be handled during normal business hours. ... Saturday-Sunday Delivery: Such orders will be for New Resident(s) and New Drug Order(s), refill orders should be handled during normal business hours... Facility Patients - medication dispensed at facility shall be a fourteen (14) day supply. Facility Medications - medication dispensed at facility shall be for a three (3) dose supply unless otherwise documented at time of order from facility. ... Prescriptions received for new residents and/or new prescription order at the facility will be delivered the same day the pharmacy receives the prescription order...".
VIOLATION: GOVERNING BODY Tag No: A0043
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, record reviews, and interviews, the hospital failed to meet the Condition of Participation for Governing Body as evidenced by:

1) Failing to ensure a system was developed and implemented to ensure all members of the medical staff and allied health professionals were credentialed and privileged according to the medical staff and governing body bylaws. Review of credentialing files revealed the hospital failed to ensure all credentialing requirements for appointment to the medical staff and/or allied health professional had been submitted and reviewed prior to recommendation by the medical staff and approval by the governing body. This failure was evident for 4 of 4 physicians reviewed who were on the medical staff (S7, S13, S14, S15) and 2 of 2 nurse practitioners appointed as allied health professionals (AHP) (S8, S12). (see findings in tag A0046).

An immediate jeopardy situation was identified on 01/25/11 at 5:35pm and reported to Administrator S1, Director of Nursing S2, and Consultant S17. The immediate jeopardy situation was a result of:
1) Failing to follow the bylaws relative to the credentialing process. This was evidenced by failure to provide documentation that 2 of 2 psychiatrists (S14, S15) submitted the required documents for appointment to the medical staff including a completed application and request for privileges to provide care in the hospital. There was no documented evidence the medical staff made a recommendation to the governing body or that the governing body formally approved the two psychiatrists for membership to the medical staff to provide psychiatric care and treatment to patients; and
2) Failing to properly credential 1 of 2 medical physicians (S7) for membership to the medical staff and 1 of 2 nurse practitioners (S8) as an allied health professional per the hospital's medical staff and governing body bylaws. This was evidenced by S7 failing to request and obtain approval for any privileges prior to providing care to patients in the hospital and S8 failing to request privileges to perform history and physical examinations (H&Ps) prior to performing them. Documentation in the credentialing files for Physician S7 and Nurse Practitioner S8 revealed that a member of the medical staff recommended appointment to the governing body and the governing body appointed S7 to the medical staff and S8 as an allied health professional even though S7 and S8 did not request any privileges to provide care.

A corrective action plan was submitted by the hospital on [DATE] at 2:00pm to address the immediate jeopardy situations. The corrective action plan included the following:
a) a Medical Executive Committee was conducted on 01/26/11 at 4:00pm to review and approve the privileges of Physician S7 and Nurse Practitioner S8 and to review the credentialing files of Psychiatrists S14 and S15 and make recommendation of their appointment to the medical staff to the governing body;
b) Governing Board meeting was conducted on 01/26/11 at 4:30pm at which time the governing board approved the privileges of Physician S7 and Nurse Practitioner S8 and appointed to the medical staff and approved the privileges of Psychiatrists S14 and S15;
c) Administrator S1 created a physician log that covered all requirements for membership to the medical staff and allied health professionals. The log will be maintained by the administrative assistant, reviewed monthly at the medical executive committee meeting as well as during monthly operations/governing body meetings. Any member of the medical staff or allied health professional with required data needing updating will be notified by the administrative assistant 60 days and 30 days prior to the date of expiration. The failure of the administrative assistant to obtain the required data prior to expiration will result in disciplinary action according to the hospital's human resources policies. Administrator S1 will be responsible for monitoring the administrative assistant's maintenance of the physician log;
d) Failure of the physician or allied health professional to provide the updated requested data for their credentialing file will result in disciplinary action according to the medical staff bylaws;
e) Administrator S1 requested a contract with a credentialing company and will continue to have credentialing performed by Medical Staff Coordinator S16 until the contract is in place.

As a result of the plan submitted by the hospital, the immediate jeopardy situation was removed, but the non-compliance remained at the condition level.

2) Failing to ensure all patients were admitted by a physician who had been granted admitting privileges by the governing body. This was evidenced by 14 of 14 sampled patients and 4 of 4 random patients had been admitted by Psychiatrists S14 and S15 who had not been credentialed, privileged, and approved by the governing body as members of the medical staff. (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #R1, #R2, #R3, #R4) (see findings in tag A0065);

3) Failing to ensure contracted pharmacy services were provided so that the hospital would remain in compliance with the Conditions of Participation for Pharmacy Services as evidenced by: a) failure to ensure the contracted pharmacist developed, supervised, and coordinated all activities of the pharmacy service; b) failure to ensure pharmaceutical services provided quality services 24 hours, 7 day a week including emergency pharmaceutical coverage. There was no documented evidence of daily delivery of medications for 16 of 52 days reviewed for medication delivery; and c) failure to ensure drug administration errors were immediately reported to the attending physician and the hospital-wide quality assurance program (see findings in tag A0083); and

4) Failing to to ensure contracted pharmacy services were provided in a safe and effective manner as evidenced by failure to have a systematic program of ongoing review and evaluation of pharmacy quality indicators which furnished information and recommendations necessary to assure continuing improvement in the quality of patient care within a safe, responsible and cost-effective framework. There was no documented evidence of any indicators, problems identified by the hospital, or actions/recommendations for improving patient care relative to any of the services provided by the hospital which was reviewed by the Governing Body via meeting minutes (see findings in tag A0084).
VIOLATION: MEDICAL STAFF - APPOINTMENTS Tag No: A0046
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the governing body failed to develop and implement a system to ensure all members of the medical staff and allied health professionals were credentialed and privileged according to the medical staff and governing body bylaws as evidenced by failure to to ensure all requirements for appointment to the medical staff and/or allied health professional had been collected and reviewed prior to recommendation by the medical staff and approval by the governing body and current professional licenses and professional liability insurance were maintained as required by the medical staff and governing body bylaws for 4 of 4 physicians reviewed from a total of 4 physicians appointed to the medical staff (S7, S13, S14, S15) and 2 of 2 nurse practitioners appointed as allied health professionals (AHP) from a total of 2 AHPs appointed by the governing body (S8, S12). Findings:

Physician S7
Review of Physician S7's credentialing file revealed "departmental recommendation" dated 03/29/10, signed by Physician S18, former Medical Director, on 04/07/10 and S19, former Administrator and former Governing Body member, on 04/07/10 stating "after review of the credentials file of Physician S7 I recommend appointment to the Medical Staff and granting of privileges". Further review of the file revealed a letter dated 03/29/10 (prior to the date of appointment of 04/07/10) addressed to Physician S7 notifying S7 that he had been appointed to the Medical Staff with active staff privileges.
Review of the Governing Body meeting minutes submitted by Administrator S1 revealed no documented evidence of a governing body meeting on 03/29/10 or 04/07/10. Further review of all the governing body meeting minutes since the hospital was established revealed no documented evidence that Physician S7's credentialing file had been submitted for review by the governing body.
Review of Physician S7's application submitted 03/17/10, with a clinical specialty of Family Practice, revealed the following sections with no documented evidence of information written in the blanks: education data to include premedical education, medical education, internship, residencies, institution, and fell owships; post graduate and continuing education courses; institutional affiliations; name of the physician who would attend his patients in his absence; and professional liability data.
Review of Physician S7's "Delineation of Privileges: Family Practice" revealed the following instructions: "please indicate by a check in the requested column those privileges that are commensurate with your clinical ability, training and experience for which you are applying. You must be able to provide competency and proof of privileges requested". Review of the form revealed the privileges column labeled "requested" for general family practice ("diagnosis and treatment of general medical conditions and diseases with regard to appropriate consultation when prudence and good medical care so require"), metabolic and endocrine disease, and gastrointestinal diseases was blank, the column labeled "not requested" had a check mark in each blank, and the columns labeled "approved" and "denied" were blank. Further review revealed the "requested" column for privileges for renal disease, cardiac disease, rheumatology, and hematologic/oncologic disease was blank. Further review revealed the "not requested" column had a check mark for central venous catheterization, paracentesis, and endotracheal intubation. The "approved" column had a check mark for renal disease, cardiac disease, rheumatology, and hematologic/oncologic disease, except for the 3 procedures that were specifically not requested. Further review revealed no documented evidence of a check mark in the columns of "requested", "not requested", and "denied" for respiratory privileges. The column "approved" was checked for respiratory. Further review revealed the only requested item on the delineation of privileges list checked by Physician S7 was peritoneal dialysis, and there was no documented evidence of a check in the "approved" column. The delineation of privileges form was signed by Physician S7 and former Medical Director S18 on 03/25/10.
Further review of the credentialing file revealed Physician S7's medical license expired on [DATE].

Review of the privileges approved by the governing body at the Governing Board meeting held on 01/26/11 revealed Physician S7 dated his request for privileges 01/27/11 which was after the date of the governing body meeting. Medical Director S18's signature of approval was dated 01/26/11.

Physician S13
Review of Physician S13's credentialing file revealed "departmental recommendation" dated 03/29/10, signed by Physician S18, former Medical Director, on 04/07/10 and S19, former Administrator and former Governing Body member, on 04/07/10 stating "after review of the credentials file of Physician S13 I recommend appointment to the Medical Staff and granting of privileges". Further review of the file revealed a letter dated 03/29/10 (prior to the date of appointment of 04/07/10) addressed to Physician S13 notifying S13 that he had been appointed to the Medical Staff with active staff privileges.
Review of Physician S13's delineation of privileges revealed the requested privileges were approved by former Medical Director S18 on 04/13/10 which was after S13's appointment by the governing body.
Review of the three letters of reference required by the medical staff bylaws for appointment revealed one reference was received 04/12/10 which was after S13 had been appointed by the governing body. Further review of the file revealed S13's CDS (controlled dangerous substance) license expired on [DATE].
Review of the Governing Body meeting minutes submitted by Administrator S1 revealed no documented evidence of a governing body meeting on 03/29/10 or 04/07/10. Further review of all the governing body meeting minutes since the hospital was established revealed no documented evidence that Physician S13's credentialing file had been submitted for review by the governing body.

Psychiatrist S14
Review of Psychiatrist S14's credentialing file, submitted by Administrator S1, revealed no documented evidence S14 had been recommended for appointment by the medical staff and his appointment and privileges had been approved by the governing body. Further review revealed a "Temporary Application/Privileges" with S14's name, address, social security number, Louisiana license number, and DEA (drug enforcement administration) number written in each applicable blank. Further review revealed instructions of "please submit a copy of the following: M.D. (medical doctor) License, Insurance Certificate, Federal DEA License, CDS License". Further review revealed no documented evidence of completion of the following blanks: date of birth, age, medical school, year graduated, specialty, and privileges requested. Further review revealed the following statement with no documented evidence that the blanks had been filled in: "Under the condition of medical necessity, temporary privileges in ______ for a period not to exceed 120 days are granted ______". Further review revealed no documented evidence of signatures of Physician S14, the Administrator, and the Medical Director.
Review of the "Application for Appointment to the Medical Staff" completed and signed by Psychiatrist S14 on 10/15/10 revealed no documented evidence the health status portion of the application had been completed. Further review revealed no documented evidence of CDS license, a request for and approval of privileges, and the certificate of insurance in the file had expired 01/01/11.
Review of S14's credentialing file revealed no documented evidence of the completion of a National Practitioner Data Bank query and three peer references as required by the bylaws.
Review of Governing Body meeting minutes dated 10/15/10, the date of Psychiatrist S14's application for appointment to the medical staff, revealed, in part, "...Psychiatrist S14's contract was reviewed and approved. Managing Member S6 will meet with him next week to discuss and secure signatures...".

Review of Psychiatrist S14's credentialing file which was (MDS) dated [DATE] revealed no documented evidence the National Practitioner Data Bank (NPDB) had been queried until 01/28/11, two days after S14 was approved and granted temporary privileges by the governing body.
In a face-to-face interview on 01/28/11 at 11:50am, Administrator S1 presented the NPDB query which was processed on 01/28/11 and confirmed it was not done prior to S14's approval by the governing body.

Psychiatrist S15
Review of Psychiatrist S15's credentialing file, submitted by Administrator S1, revealed no documented evidence S15 had been recommended for appointment by the medical staff and his appointment and privileges had been approved by the governing body. Further review revealed a "Temporary Application/Privileges" with S15's name, address, date of birth, age, social security number, Louisiana license number, DEA number, medical school, year graduated and specialty of psychiatry written in each applicable blank. Further review revealed instructions of "please submit a copy of the following: M.D. License, Insurance Certificate, Federal DEA License, CDS License". Further review revealed no documented evidence of completion of the blank for privileges requested. Further review revealed the following statement with no documented evidence that the blanks had been filled in: "Under the condition of medical necessity, temporary privileges in ______ for a period not to exceed 120 days are granted ______". Further review revealed no documented evidence of signatures of Physician S15, the Administrator, and the Medical Director.
Review of the "Application for Appointment to the Medical Staff", with no documented evidence of the date it was signed or submitted, revealed pages 4, 8, and 10 were not included in the file. There was no documented evidence of a request for and approval of privileges by the governing body, a CDS license, three peer references, and a query of the National Practitioner Data Bank.
Review of the governing body meeting minutes submitted by Administrator S1 revealed no documented evidence Psychiatrist S15's credentialing file had been submitted for review and approval by the governing body.

Review of Psychiatrist S15's credentialing file which was (MDS) dated [DATE] revealed no documented evidence the National Practitioner Data Bank (NPDB) had been queried until 01/28/11, two days after S15 was approved and granted temporary privileges by the governing body. Further review revealed S15's signature on his request for privileges was dated 01/27/11 as well as the signature of Medical Director S18.

In a face-to-face interview on 01/28/11 at 11:50am, Administrator S1 presented the NPDB query which was processed on 01/28/11 and confirmed it was not done prior to S15's approval by the governing body.

In a telephone interview on 01/28/11 at 1:45pm, Governing Body Managing Member S6 indicated he attended the governing body meeting by telephone. When asked how he could approve Psychiatrists S14 and S15 for membership without having documentation of the quality of their work, S6 indicated he didn't realize a NPDB query had not been done. He confirmed that he did not have the credentialing files for Psychiatrists S14 and S15 in his presence for review. S6 indicated he'd had a relationship with these two physicians in the past, but "as far as looking at data, we didn't look at any data".

Nurse Practitioner S8
Review of Nurse Practitioner (NP) S8's credentialing file revealed "departmental recommendation" dated 04/15/10, signed by former Medical Director S18 on 04/15/10 and S19, former Administrator and former Governing Body member, on 04/15/10 stating "after review of the credentials file of NP S8 I recommend appointment to the Medical Staff and granting of privileges as an Allied Health Professional".
Review of the Governing Body meeting minutes dated 06/30/10 and submitted by Administrator S1 revealed, in part, "...The following individuals have requested appointment to the Medical Staff and clinical privileges. Their credentialing files are complete and are ready for recommendation for granting full clinical privileges:...NP S8...Actions/Follow Up: ...Granted full privileges for ...NP S8...". S8's file revealed she was appointed and approved on 04/15/10 which was prior to the date of the documented governing body meeting where her file was submitted for review.
Review of the delineation of privileges for Allied Health Professional revealed S8 checked "not requested" for completing admission history and physicals. Further review revealed it was signed by S8 and former medical Director S18 on 04/15/10, and there was no documented evidence of the signature of S8's supervising physician as required on the form.
Review of S8's credentialing file revealed the National Practitioner Data Bank query was processed on 05/02/10 which was after her appointment had been approved. Further review revealed her three peer references were requested on 04/18/10 which was after S8 had been approved by the governing body and received on 04/18/10, 04/21/10,and 04/29/10, all which were after S8 had been approved by the governing body. Further review revealed her certificate of insurance had expired 06/28/10, her CPR (cardiopulmonary resuscitation) certification had expired 07/10, her ACLS (advanced cardiac life support) certification had expired 07/10, and her CDS license had expired 05/01/10.
Review of 6 of 6 H&Ps, 2 of 14 sampled patients (#13, #14) and 4 random patients (#R1, #R2, #R3, #R4), revealed they were performed by NP S8, who was not privileged to perform H&Ps. Further review revealed S8 had a collaborative agreement with Physician S7 who had failed to request and obtain approval by the medical staff and governing body for any privileges prior to providing care to patients in the hospital.

Review of the revised privileges for NP S8 which were approved by the governing body on 01/26/11 revealed the signatures for herself, Physician S7, and Medical Director S18 were all dated 01/27/11, the day after the governing body meeting.

Nurse Practitioner S12
Review of NP S12's credentialing file revealed "departmental recommendation" dated 03/29/10, signed by former Medical Director S18 on 04/07/10 and S19, former Administrator and former Governing Body member, on 04/07/10 stating "after review of the credentials file of NP S12 I recommend appointment to the Medical Staff and granting of privileges. S12 will practice as a nurse practitioner under the supervision of Physician S13".
Review of a letter sent to NP S12, dated 03/23/10 (prior to her date of appointment and approval by the governing body), revealed she was notified of her appointment to the Medical Staff at Seaside Behavioral Center.
Review of the Governing Body meeting minutes dated 06/30/10 and submitted by Administrator S1 revealed, in part, "...The following individuals have requested appointment to the Medical Staff and clinical privileges. Their credentialing files are complete and are ready for recommendation for granting full clinical privileges:...NP S12... Actions/Follow Up: ...Granted full privileges for ...NP S12...". S12's file revealed she was appointed and approved on 04/07/10 which was prior to the date of the documented governing body meeting where her file was submitted for review.
Review of NP S12's file revealed one of her references was received on 04/20/10 which was after she had been appointed and approved as a NP. Further review revealed S12's collaborative agreement with Physician S13 was signed by S12 and S13 on 07/07/10, three months after she had been approved by the governing body.

In a face-to-face interview on 01/25/11 at 2:05pm, Administrator S1 indicated she became Administrator in December 2010. She further indicated, when informed that NP S8 had performed H&Ps for 6 patients reviewed and S8 had not requested nor been approved to perform H&Ps, "that's what they have NP S8 here for, to do H&Ps". S1 could offer no explanation for S8 having a collaborative agreement with Physician S7, who had not requested or obtained approval for any privileges by the governing body to provide care to patients at the hospital. S1 indicated S16, whose title on the letters and forms documented in the credentialing file was Medical Staff Coordinator, had been responsible for the credentialing process. S1 confirmed the above findings from review of the credentialing files.

An unsuccessful attempt was made by the surveyor to contact Medical Staff Coordinator S16 by telephone on 01/25/11 at 2:20pm. A message was left on voice mail for S16 to return the surveyor's call. As of the exit date of this survey, a return call was not received from S16.

In a face-to-face interview on 01/25/11 at 4:05pm, Administrator S1 indicated S16 was responsible for credentialing, but S1 had not seen S16's credentials. S1 indicated she was not sure if S16 was an employee of the hospital or a contracted position of the corporate office. Review of the "employee list" requested of Administrator S1 and submitted by Director of Nursing S2 on 01/25/11 at 4:45pm, listed S16 as "Medical Records".

Review of the "Governing Board Bylaws", submitted by Administrator S1 as the current bylaws and adopted June 8th (with no documented evidence of the year) with no documented evidence of signatures of S6, President, S22, former Vice President, and S19, former Administrator and former Secretary of the Governing Board, revealed, in part, "...The Governing Board is responsible for the overall oversight and direction of the Hospital. responsibilities of the Board include the following: ...k. Determine, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the Medical Staff. l. Approval (as necessary) of the organization, bylaws, rules and regulations of the Medical Staff and all other ancillary and affiliate organizations m. The selection, employment and termination of any physician employed by the Hospital. ...Medical Staff Representation: ... b. The purpose of Medical Staff representation shall be: ...iii. To provide Medical Staff recommendations for Privileging and Appointment to the Medical Staff...".

Review of the "Medical And professional Staff Organization Bylaws", approved 03/01/10 and submitted by QAPI (quality assurance performance improvement) RN (registered nurse) S4 as the hospital's current medical staff bylaws, revealed, in part, "...Article II Purposes And Responsibilities ... Section 2 - Responsibilities The responsibilities of the Medical Staff are to account for the quality and appropriateness of patient care rendered by all Practitioners and Allied Health Professionals authorized to provide patient care services in the Hospital, through the following measures: A. processing credentials ... B. making recommendations to the Board with respect to Medical Staff appointments, reappointments, Staff category, Clinical Privilege delineation... Article III Medical Staff Membership ... Section 2 - Qualifications And Obligations Of Membership Or Privileges A. General Qualifications. Only Practitioners who can comply with the following qualifications shall be eligible for staff membership: (1) a current, unrestricted license to practice in this State who can document their background, professional experience, worthy character, education, relevant training, clinical judgement, and demonstrated current competence; ... B. General Obligations. ... (11) maintain a professional liability insurance policy with an approved carrier with policy limits of no less than $1,000,000 per claim and $3,000,000 aggregate per year or participate in the applicable professional liability fund/insurance plan of the State and provide the Hospital with a current certificate of insurance... (17) continuously meet the qualifications for membership as set forth herein; ... Section 3 - Conditions And Duration Of Appointments And Reappointment's A. Appointments and Reappointment's: Initial appointments and reappointment's to the Medical Staff shall be made by the Board upon a recommendation from the Medical Executive Committee, and shall be for a period not to exceed two (2) years from the month of appointment. ... Article V Allied Health Professionals (Health Professional Affiliates) Section 1 - General Allied Health Professionals (AHPs) are health care providers other than Practitioners who hold a license, certificate, or such other legal credentials as are required by this State which authorizes the AHP to provide health care services. ...AHPs may be granted permission to participate in the provision of certain patient care services within the Hospital, but such permission shall not be construed to afford AHPs the rights of medical Staff membership. ...Section 2 - Categories of AHPs Eligible For Practice Prerogatives ... The Medical Executive Committee shall make recommendations to the Board as to the categories of AHPs that should be eligible for Prerogatives, and to the Prerogatives and the terms and conditions that apply to each AHP category. ... A. Nurse Practitioner (1) All Nurse Practitioners must have a binding contract agreement with a member of Seaside Behavioral Center's active medical staff. (2) Must have a supervising physician who is a member of Seaside Behavioral Center's active medical staff. ... (4) Nurse practitioners are subject to the same performance improvement monitors and peer review activities as all other medical staff members. (5) Nurse practitioners are limited to practice prerogatives that are within their Nurse Practice Act And within the scope of practice stipulated in their contract agreement with the active medical staff physician. ... Section 3 - Qualifications To be eligible for Prerogatives, and AHP must ...A. Hold a current,unrestricted State license, certificate or other appropriate legal credential in a category of AHPs that the Board has identified as eligible for Prerogatives. B. Document his background, qualifications, relevant training, experience, demonstrated current competence, judgement, character, and physical and mental health status, with sufficient adequacy to demonstrate that patient care services will be provided by the AHP at the professional level of quality and efficiency established by the Medical Staff and the Hospital. ...D. Maintain a professional liability insurance policy with a carrier approved by the Board with policy limits of no less than $1,000,000 per claim and $3,000,000 aggregate per year, ...and provide the Hospital with a current certificate of insurance. ...Section 4 - Procedure For Granting Practice Prerogatives... Applications for appointment, reappointment and Privileges for AHPs shall be submitted and processed pursuant to an Application and in the same manner as provided in Articles VI and VII for Medical Staff Membership and Clinical Privileges. ... Article VI Procedure For Appointment Section 1 - Pre-Screening Upon receipt of any request for an Application, the applicant shall be pre-screened before being sent an initial Application. The applicant will be asked to supply documentation of the following threshold requirements: 1. Current, unrestricted license to practice in this State. 2. Current, unrestricted DEA registration. 3. Professional liability insurance in the required amounts. If the Applicant meets all of these requirements, he shall be provided with an Application. ... Section 2 - General procedure ... Each Application for appointment to the Staff shall be in writing, submitted on the prescribed form, and signed by the applicant. ...The Medical Staff, through its services, committees, and officers, shall investigate, verify, and consider each Application for appointment or reappointment to any staff status and each request for modification of staff status and shall adopt and transmit recommendations thereon to the Board. The Medical Staff shall consider each Application for appointment, reappointment, and Privileges, and each request for modification of Medical Staff category using the standards set forth in these Bylaws and Rules. The Board shall be ultimately responsible for granting membership and Privileges. The Medical Staff shall also perform this function for Practitioners who seek temporary Privileges and AHPs. ...Any application, whether for initial appointment or reappointment, will not be deemed to be complete and therefore ready for transmission to the Credentials Committee or other applicable Medical Staff Committee, until all information and attachments requested in the application are provided. ... Section 4 - Submission Of Application The Application shall be submitted to the Medical Staff Office, who shall initially process the Application and then submit it to the Credentials Committee Chairman, or his designee, to have all information verified. The hospital shall query the National Practitioner Data Bank and the State licensing authority for all Practitioners and AHPs who are applying for Staff membership or Privileges. Section 5 - Application Form/Information Required ... B. Specific Information Required. The information shall include but not be limited to, the following: ... (i) state licensure(s) with expiration date(s); (j) Drug Enforcement Administration (DEA) registration with expiration date; (k) professional references: references [three (3)] from persons other than family or affiliated by marriage who must have personal knowledge of the applicant's recent professional performance, his ethical character, current competence, and his ability to work cooperatively with others; ... (o) professional liability insurance, including carrier, amount and dates of coverage, and professional litigation and liability history (past and present); ... Section 7 - Review And Recommendation Procedures A. Credentials Committee Review. Within ninety (90) Days of receipt of the completed Application by the Hospital Medical Staff office and all verification procedures are complete, the Hospital Medical Staff office shall forward the Application to the Credentials Committee. The Credentials Committee shall review the Application, conduct any interviews as it deems appropriate, and within sixty (60) days following receipt of the Application, shall make a written recommendation to the Medical Executive Committee as to membership, and, if membership is recommended, as to Staff or Service category, Privilege delineation, and any conditions attached to the appointment. B. Medical Executive Committee Review And Recommendation. At its next regular meeting after receipt of the recommendations of the Credentials Committee, but not later than sixty (60) days after receipt of the Credentialing Committee report, the Medical Executive Committee shall submit its written recommendation to the Board relating to membership, and if appointment is recommended, to Staff Category, Clinical Privileges, and any special requirements or conditions. The recommendation shall be based on the review of all available information. ... C. Action by the Board (1) Unless subject to the provisions of Article X of these Bylaws, the Board...shall act on the matter at its next regular meeting following receipt of the recommendation of the Medical Executive Committee. ... (4) ...notice of the Board's final decision shall be given in writing through the Administrator to the applicant within five (5) working days of the final decision. The President shall give notice to the Medical Executive Committee, and the Credentials Committee. ... Article VII Clinical Privileges Section 1 - Exercise of Privileges Every Practitioner providing direct clinical services within this Hospital, by virtue of staff membership or otherwise, shall, in connection with such practice and except as provided in Section 3 and 4 below, be entitled to exercise only those Privileges specifically granted to him by the Board. ... Section 2 - Delineation Of Clinical Privileges A. Application. Clinical Privileges may be granted only upon formal request on forms provided by the Hospital with subsequent processing and approval. Every Application for Staff appointment and reappointment must contain a request for specific Clinical Privileges desired by the applicant. ... C. Procedure All requests for Clinical privileges shall be processed, evaluated, granted, modified, and/or derived pursuant to the procedures outlined in Article III for medical Staff membership. ... E. Special Conditions for Privileges. Requests for Clinical Privileges from non-physician practitioners ... shall be processed, evaluated, granted or denied in the manner specified in Section 2 above. ... Section 3 - Temporary Privileges... Prior to Temporary Privileges being granted, a Practitioner must demonstrate that he has appropriate professional qualifications, a valid, unrestricted State license, a current unrestricted DEA registration, and professional liability insurance coverage, and a query must be submitted as required by federal law to the National Practitioner Data Bank. ... The Administrator, with written concurrence of the chairman of the department where the Privileges will be exercised and of the chairman of the Medical Executive Committee, may grant Temporary Privileges under the circumstances noted below. In all cases, Temporary Privileges shall be granted for a specific period of time, not to exceed thirty (30) days. After that period of time the Practitioner may request a renewal of Temporary Privileges for another specific period of time. Temporary Privileges shall terminate automatically at the end of the specific period for which they were granted... The applicant's professional degree must be verified... as well as his current license, current DEA registration, any specialty claimed, at least two (2) references relating positively to his professional and ethical status, and documentation of the current requisite amount of professional liability insurance coverage. Except pursuant to appropriate Board action, under no circumstances shall Temporary Privileges be extended ... for more than a total of 180 Days...".
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
Based on record review and interview, the hospital failed to develop a policy and procedure to ensure prompt resolution of patient grievances that included who to contact to file a grievance as evidenced by having a policy that failed to define a complaint versus a grievance, provided the phone number and address of the state agency where a patient could report grievances, addressed how grievances related to abuse, neglect, and/or patient harm would be handled, and provided direction to the staff relative to reporting complaints and/or grievances of patients or their caregivers. Findings:

Review of the hospital's policy titled "Section 504 Grievance Procedure", policy 1.30B, presented as the hospital's grievance policy by Administrator S1, revealed, in part, "Seaside Behavioral Center has adopted an internal grievance procedure providing for prompt and equitable resolution of complaints alleging any action prohibited by the U.S. (United States) Department of Health and Human Services regulation... implementing Section 504 of the Rehabilitation Act of 1973 as amended... Section 504 states, in part, that "no otherwise qualified disabled individual ... shall solely by reason of his/her disability, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.."... The Administrator has been designated to coordinate the efforts of Seaside Behavioral Center to comply with the regulations. Procedure 1. A complaint should be in writing... 2. A complaint should be filed in the office of the Section 504 Coordinator within 30 days after the person filing the complaint becomes aware of the discriminatory act. 3. The Administrator, or designee, will investigate the complaint. The investigation will be informal but thorough, affording all interested persons and their representative an opportunity to submit evidence relevant to the complaint. 4. The Administrator shall issue a written decision determining the validity of the complaint no later than 30 days after its filing. ... 6. An individual who files a complaint may pursue other remedies. This includes filing with: U.S. Department of Health and Human Services...".

Review of the entire policy revealed no documented evidence of an explanation of the difference between a complaint and a grievance. There also was no documented evidence that patients would be informed of their right to file a grievance with the State agency responsible for licensing hospitals along with the state agency phone number and address, regardless of whether the patient had first used the hospital's grievance process. The policy further failed to address how grievances related to abuse, neglect, and/or patient harm would be handled and to provide direction to the staff relative to how to handle reports of complaints and/or grievances by patients or their caregivers.

In a face-to-face interview on 01/20/11 at 2:00pm, S1 Administrator indicated she was aware the grievance policy did not contain the difference between a grievance and a complaint. Further S1 indicated all of the hospital policies were in the process of being revised.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interviews, the hospital failed to ensure the RN (registered nurse) supervised and evaluated the nursing care for each patient as evidenced by failure to: 1) assess a patient's blood pressure every 4 hours to determine when ordered prn (as needed) Clonidine was needed (patient had a history of hypertension, post CVA [cerebrovascular accident], and right-sided weakness) for 1 of 1 patient reviewed with orders for prn Clonidine from a total sample of 14 patients (#11); 2) assess a patient's pulse prior to administration of Metoprolol as directed in the hospital's medication resource reference for 1 of 1 patient reviewed with orders for Metoprolol from a total sample of 14 patients (#11); 3) develop and implement a policy for assessment of the effectiveness of prn medications that includes the time interval for reassessment which resulted in 1 of 14 sampled patients receiving prn medications without documented evidence of an assessment for effectiveness (#11); and 4) ensure the LPN (licensed practical nurse) reported a patient's elevated blood pressure (#11) and a patient's (with a diagnosis of [DIAGNOSES REDACTED]

1) Assess a patient's blood pressure every 4 hours to determine when ordered prn Clonidine was needed: (#11)
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed an order on 01/11/11, with no documented evidence of the time the order was received (the order was noted by the nurse on 01/11/11 at 6:45am), for Clonidine 0.1 mg by mouth times 1 now, then every 4 hours prn (as needed) for systolic blood pressure (BP) greater than 180.

Review of Patient #11's "Graphic Sheet", "Daily Vital Signs", and "Nurses Progress Notes" revealed no documented evidence Patient #11's blood pressure was checked every 4 hours to determine if Clonidine needed to be administered after the order was received for prn use of Clonidine for systolic blood pressure greater than 180 on 01/11/11.

In a face-to-face interview on 01/28/11 at 9:50am, DON (director of nursing) S2 confirmed Patient #11's blood pressure should have been assessed every 4 hours once the order was received for prn Clonidine.

In a face-to-face interview on 01/28/11 at 2:00pm, DON S2 indicated the hospital did not have a policy for nursing assessment and reassessment with a change in condition.

2) Assess a patient's pulse prior to administration of Metoprolol: (#11)
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed an order on 01/08/11 at 11:00am for Metoprolol 100 mg by mouth daily. Review of Patient #11's MARs and "Nurses Progress Notes" revealed Metoprolol 100 mg orally was administered at 9:00am on 01/09/11, 01/10/11, 01/11/11, 01/12/11, 01/13/11, 01/14/11, 01/15/11, 01/17/11, 01/18/11, 01/19/11, 01/20/11, and 01/21/11 with no documented evidence Patient #11's apical pulse was checked prior to administration of Metoprolol.

Review of the 31st edition of the "Nursing 2011 Drug Handbook", presented by DON S2 as the nursing staff's resource reference for medication administration, revealed, in part, ...Metoprolol Succinate ... Nursing Considerations Always check patient's apical pulse rate before giving drug. If it's lower than 60 beats/minute, withhold drug and call prescriber immediately...".

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed the absence of an assessment of Patient #11's apical pulse prior to the administration of Metoprolol. She could not explain why the nursing staff was not checking Patient #11's pulse prior to administering the Metoprolol.

In a face-to-face interview on 01/28/11 at 2:00pm, DON S2 indicated the hospital did not have a policy for nursing assessment.

3) Develop and implement a policy for assessment of the effectiveness of prn medications that includes the time interval for reassessment which resulted in 1 of 14 sampled patients receiving prn medications without documented evidence of an assessment for effectiveness (#11):
Patient #11
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed an order on 01/11/11, with no documented evidence of the time the verbal order was received, for Clonidine 0.1 mg (milligram) by mouth, one now, then every 4 hours as needed for systolic blood pressure greater than 180.

Review of the MAR and the "Nurses Progress Notes" for Patient #11 revealed the following prn medications administered with no documented evidence of timely reassessment for effectiveness:
01/11/11 - Clonidine 0.1 mg administered orally by LPN S25 at 7:00am; there was no documented evidence the blood pressure was reassessed for effectiveness of the medication administered until 4:00pm;
01/12/11 - Clonidine administered at 7:00am; reassessment of the blood pressure for effectiveness of the medication was performed by LPN S10 at 9:00am; there was no documented evidence of an assessment of Patient #11's vital signs by RN S26 during her eight hour shift;
01/15/11 - Clonidine administered at 6:30am for blood pressure 192/79; review of the MAR revealed notation by LPN S25 of "effective" in the column titled "response or results" with no documented evidence of the time of reassessment or the result of the blood pressure check; there was no documented evidence of an assessment of Patient #11's blood pressure by RN S9 throughout her shift on 01/15/11 from 7:00am to 7:00pm;
01/16/11 - contract agency RN S24 administered Patient #11's routine medications, Lisinopril 40 mg and Metoprolol 100 mg, at 5:50am for blood pressure of 215/85 rather than the prescribed prn Clonidine; there was no documented evidence of a reassessment of the blood pressure until 8:00am (no documented evidence of the result of the blood pressure check at 8:00am);
0117/11 - contract agency RN S24 administered Patient #11's routine medications, Lisinopril 40 mg and Metoprolol 100 mg, at 7:00am for blood pressure of 204/85; review of the MAR revealed no documented evidence the Lisinopril and Metoprolol were administered at 7:00am; the MAR revealed Lisinopril and metoprolol were administered at 9:00am by LPN S27; review of the medical record revealed no documented evidence the blood pressure was reassessed until 11:00am;
01/18/11 - Clonidine was administered at 6:30am by LPN S25 for a blood pressure of 170/95; Clonidine was ordered to be given for a systolic blood pressure greater than 180; there was no documented evidence the blood pressure was reassessed until 6:00am on 01/19/11; and
01/19/11 - Clonidine was administered by LPN S28 at 6:00am for blood pressure of 194/84 as documented by LPN S28 on the MAR (194/84 was documented on the 8:00am column on the graphic sheet for 01/19/11); a blood pressure result was documented on the graphic sheet in the column of 01/19/11 between the time of 8:00am and 4:00pm with no documented evidence of the actual time the blood pressure was checked.

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 indicated the hospital policy for medication administration did not specify the length of time after administration that the patient should be assessed for effectiveness of the medication.

Review of the hospital policy titled "Administration Of Medications Using The MAR System", policy 12.2 and submitted by DON S2 as the policy for assessment for effectiveness of medication administration, revealed, in part, "...Remember to document the evaluation of the effectiveness of the PRN medications in the nurses notes...". Further review revealed no documented evidence of the time interval for reassessment of effectiveness.

4) Ensure the LPN reported a patient's elevated blood pressure (#11) and a patient's continued refusal of medication ordered to treat bipolar disorder (#13) to the RN:
Patient #11
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed an order on 01/11/11, with no documented evidence of the time the verbal order was received, for Clonidine 0.1 mg (milligram) by mouth, one now, then every 4 hours as needed for systolic blood pressure greater than 180.

Review of the MAR revealed Clonidine was administered at 6:30am on 01/18/11 by LPN S25 for a blood pressure of 170/95. Clonidine was ordered to be given for a systolic blood pressure greater than 180; there was no documented evidence the blood pressure was reassessed until 6:00am on 01/19/11, and there was no evidence a RN and the physician was notified of the Clonidine being administered incorrectly.

Review of the MAR revealed Clonidine was administered by LPN S28 on 01/19/11 at 6:00am for blood pressure of 194/84 as documented by LPN S28 on the MAR (194/84 was documented on the 8:00am column on the graphic sheet for 01/19/11). Further review revealed a blood pressure result was documented on the graphic sheet in the column of 01/19/11 between the time of 8:00am and 4:00pm with no documented evidence of the actual time the blood pressure was rechecked. Review of the medical record revealed no documented evidence LPN S28 reported Patient #11's elevated blood pressure to the RN and that #11 was assessed by the RN.

Patient #13
Review of Patient #13's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #13's "Physician's Orders" revealed an order on 01/07/11 at 12:30pm for Saphres 10 mg by mouth BID (twice a day).

Review of Patient #13's MARs revealed the nurse's initials were circled at 9:00pm on 01/07/11 indicating Saphres (medication used to treat bipolar disorder) was not administered. Further review revealed notations on the MAR for 01/08/11 at 9:00am and 9:00pm, 01/09/11 at 9:00am and 9:00pm, and 01/10/11 at 9:00am that Patient #11 had refused the medication Saphres. Further review of the "Nurses Progress Notes" revealed no documented evidence the LPN reported the patient's refusal to the RN and the physician.

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed there were no medication variances completed for the omitted Saphres. S1 indicated the LPN should have notified the RN of Patient #13's refusal to take the medication, and the physician should have been notified. She further indicated LPN S28 should have reported Patient #11's elevated blood pressure to the RN for assessment.

In a face-to-face interview on 01/28/11 at 2:00pm, DON S2 indicated the hospital did not have a policy for nursing assessment, reassessment with a change in condition, or what should be reported by the LPN to the RN.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interviews, the hospital failed to ensure the nursing staff implemented the patients' plan of care as ordered by the physician as evidenced by failure to monitor the blood pressure four times a day on admission and then two times a day thereafter for 4 of 4 patients reviewed with orders for vital sign checks four times a day and then two times a day thereafter from a total sample of 14 patients (#10, #11, #12, #14). Findings:

Patient #10
Review of the medical record for Patient #10 revealed a [AGE] year old male admitted on [DATE] for Dementia with behavioral problems. Review of the Physician's Orders dated/timed 12/23/10 at 1445 (2:45pm) revealed VS (Vital Signs) 4 times a day (6am, 11am, 4pm, 9pm) on admission, then 2 times a day.
Review of the Daily Vital Signs form for Patient #10 revealed the following:
12/23/10 (admit) one set of vital signs obtained at 4:00pm;
12/24/10 - one set of vital signs obtained at 6:00am;
12/26/10 - one set of vital signs obtained at 9:00pm;
12/27/10 - one set of vital signs obtained at 6:00am;
12/28/10- one set of vital signs obtained at 6:00am;
12/30/10- one set of vital signs obtained at 6:00am;
12/31/10- one set of vital signs obtained at 6:00am; and
01/04/11- one set of vital signs obtained at 6:00am.

Patient #11
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of major depression with suicidal thoughts, hypertension, right-sided weakness, stroke in the past, and pacemaker. Review of #11's "Physician's Admit Orders" revealed an order for vital signs four times a day on admission at 6:00am, 11:00am, 4:00pm, and 9:00pm and then 2 times a day.

Review of Patient #11's nurses' notes, "Graphic Sheet", and "Daily Vital Signs" revealed the following:
01/08/11 - no documented evidence vital signs were checked at 9:00pm;
01/10/11 - one set of vital signs obtained at 6:00am;
01/12/11 - one set of vital signs obtained at 4:00pm; and
01/15/11 - one set of vital signs obtained at 6:00am.

Patient #12
Review of the medical record for Patient #12 revealed an [AGE] year old female admitted on [DATE] for Senile Dementia with behavioral disturbances. Further review revealed #12 had a medical history which included HTN (Hypertension) and CHF (Congestive Heart Failure). Review of the Physician's Orders dated/timed 11/29/10 at 1330 (1:30pm) revealed VS (Vital Signs) 4 times a day (6am, 11am, 4pm, 9pm) on admission, then 2 times a day.

Review of the Daily Vital Signs form for Patient #12 revealed the following:
11/29/10 (admit) one set of vital signs obtained at 9:00pm;
11/30/10 - one set of vital signs obtained at 6:00am;
12/04/10 - one set of vital signs obtained at 6:00am;
12/07/10- one set of vital signs obtained at 6:00am;
12/08/10- one set of vital signs obtained at 6:00am; and
12/09/10- one set of vital signs obtained at 6:00am.

Patient #14
Review of the medical record for Patient #14 revealed [AGE] year old male admitted on [DATE] for Dementia, Self-Mutilation and Schizophrenia. Further review revealed #14 had a history of CHF (Congestive Heart Failure) and Hypertension. Review of the Physician's Orders dated/timed 01/22/11 at 1620 (4:20pm) revealed VS (Vital Signs) BID (twice a day).

Review of the Daily Vital Signs form for Patient #14 revealed only one set of vital signs was obtained at 8:00am.

In a face-to-face interview on 01/28/11 at 9:50am, DON (Director of Nursing) S2 could offer no explanation for the vital signs not being checked as ordered by the physician. S1 indicated she tried to perform chart audits in the past, but lately she had not been able to do so due to her being responsible for nursing, QAPI (quality assurance/performance improvement), and infection control. She further indicated she had been out most of the month of November, and upon her return, many things she had put in place had fallen by the wayside.
VIOLATION: CARE OF PATIENTS - ADMISSION Tag No: A0065
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the governing body failed to ensure all patients were admitted by a physician who had been granted admitting privileges by the governing body as evidenced by 14 of 14 sampled patients and 4 of 4 random patients admitted by Psychiatrists S14 and S15 who had not been credentialed, privileged, and approved by the governing body as members of the medical staff with privileges to admit and treat patients (#1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #R1, #R2, #R3, #R4). Findings:

Review of the medical records of the 14 sampled patients and 4 random patients revealed the following admitted s and the respective attending psychiatrist:
Patient #1 admitted [DATE] by Psychiatrist S14;
Patient # 2 admitted on [DATE] by Psychiatrist S15;
Patient #3 admitted on [DATE] by Psychiatrist S14;
Patient #4 admitted on [DATE] by Psychiatrist S14;
Patient #5 admitted on [DATE] by Psychiatrist S15;
Patient #6 admitted on [DATE] by Psychiatrist S15;
Patient #7 admitted on [DATE] by Psychiatrist S14;
Patient #8 admitted on [DATE] by Psychiatrist S14;
Patient #9 admitted on [DATE] by Psychiatrist S14;
Patient #10 admitted on [DATE] by Psychiatrist S14;
Patient #11 admitted on [DATE] by Psychiatrist S14;
Patient #12 admitted on [DATE] by Psychiatrist S14;
Patient #13 admitted on [DATE] by Psychiatrist S14;
Patient #14 admitted on [DATE] by Psychiatrist S14;
Patient # R1 admitted on [DATE] by Psychiatrist S15;
Patient # R2 admitted on [DATE] by Psychiatrist S15;
Patient # R3 admitted on [DATE] by Psychiatrist S14; and
Patient # R4 admitted on [DATE] by Psychiatrist S14.

Review of the credentialing files of Psychiatrists S14 and S15 revealed no documented evidence they had been appointed to the medical staff and granted privileges to admit and treat patients by the governing body (see findings in tag A0046).

In a face-to-face interview on 01/25/11 at 2:05pm, Administrator S1 confirmed there was no documented evidence that Psychiatrists S14 and S15 had been appointed to the medical staff and their privileges requested and approved by the governing body. S1 further confirmed S14 and S15 were the only two psychiatrists admitting patients to the hospital.

Review of the "Governing Board Bylaws", presented by Administrator S1 as the current bylaws, revealed, in part, "...The Governing Board is responsible for the overall oversight and direction of the Hospital. Responsibilities of the Board include the following: .... Approval (as necessary) of the organization, bylaws, rules and regulations of the Medical Staff and all other ancillary and affiliate organizations...".

Review of the "Medical And Professional Staff Organization Bylaws", presented by Administrator S1 as the current medical staff bylaws, revealed, in part, "...Article IV Categories Of The Medical Staff... Section 3 - Prerogatives And Responsibilities A. Prerogatives. The prerogatives available to a Medical Staff Member, depending on staff category enjoys, are: (1) Admit patients consistent with approved Privileges; (2) Exercise privileges which have been approved...".
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the hospital failed to implement a process for identification and reduction of medical errors as evidenced by no documented evidence medication variances were being monitored resulting in 103 medication variances not identified by the hospital. Findings:

Patient #1
Review of the medical record for Patient #1 revealed a [AGE] year old female admitted on [DATE] for Bi-Polar Disorder and Schizo-Affective Disorder. Review of the Physician's Orders dated/timed 01/18/11 at 1300 (1:00pm) revealed an order for Synthroid 0.100mcg (microgram) QD (every day). Review of the Medication Administration Record (MAR) for Patient #1 revealed documentation the drug was unavailable for administration on 01/19/11 at 0600 (6:00am).

Patient #2
Review of Patient #2's medical record revealed she was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]
Review of Patient #2's "Physician's Orders", dated 01/15/11, with no documented evidence of the time the order was written, revealed an order for Hydrocortisone Acetate 0.5% (per cent), apply to face lightly BID (twice a day).
Review of Patient #2's MAR revealed no documented evidence the cream was applied on 01/15/11, 01/16/11, and 01/17/11. Further review revealed the only documented time on the MAR that it was unavailable was at 9:00pm on 01/17/11. Review of the drug label attached to the Hydrocortisone Acetate cream revealed it was filled by contracted Pharmacy A on 01/16/11, the day after it was ordered by the physician.

In a face-to-face interview on 01/20/11 at 11:10am, RN (registered nurse) S23, Charge Nurse, indicated that they have difficulty get medications such as creams from the pharmacy. She further indicated the nurses could get pills that are ordered and not available from the emergency drug kit, but creams were not supplied in the kit.

Patient #3
Review of the medical record for Patient #3 revealed a [AGE] year old female admitted on [DATE] for dementia with behavioral problems, psychosis, and paranoia. Review of the Physicians' Orders dated/timed 01/18/11 at 1630 (4:40pm) revealed an order for Lamictal 100mg po ( by mouth) three times a day. Review of the Medication Administration Record (MAR) dated/timed 01/20/11 at 2100 (9:00pm) revealed the initial of the nurse was circled indicating the medication was not administered. Further review of the MAR and the Nurses' Narrative Notes revealed no documented evidence as to why the Lamictal was not administered to Patient #3 as ordered.

Review of the Physician's Orders for Patient #3 dated/timed 01/18/11 (no time documented) revealed an order for Haldol 2mg i po BID (one twice a day). Review of the MAR dated 01/18/11 revealed no documented evidence Haldol 2mg was administered to Patient #3. Further review of the MAR and the Nurses' Narrative Notes for 01/18/11 revealed no documented evidence indicating the reason the medication had not been administered to the patient.
Review of the Physician's Orders for Patient #3 dated/timed 01/19/11 (no time documented) revealed an order to increase Seroquel to 75mg i po Q HS (one every hour of sleep). Review of the MAR dated 01/19/11 revealed documentation Seroquel 50 mg i po Q HS had been discontinued and a new order written for Seroquel 75mg i po Q HS; however there was no documented evidence the medication had been administered.
Review of the Nurses' Narrative Notes and MARs for Patient #3 dated 01/18/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Observation on 01/20/11 at 11:00am of the PAR levels of the "Emergency Drug Stock" used for after hour new orders revealed Seroquel 75mg was not available; however there were (10) 25mg Seroquel, 3 of which could have been used to equal the ordered dosage until the medication arrived from the pharmacy the next day.

Patient #4
Review of the medical record for Patient #4 revealed a [AGE] year old woman admitted on [DATE] after hospitalization for a drug overdose of Dilaudid and depression. Review of the Physicians' Orders dated/timed 01/06/11 (no time documented) revealed an order for Benzphetamine 50mg i po (one by mouth) 30 minutes before each meal. Review of the Medication Administration record (MAR) revealed no documented evidence Benzphetamine 50mg had been administered on 01/06/11 at 1100 (11:00am) and 1700 (5:00pm); 01/07/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm); 01/08/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm); and 01/09/11 at 0800 (8:00am), 1100 (11:00am) and 1700 (5:00pm).
Review of the Physicians' Orders for Patient #4 dated/timed 01/15/11 (no time documented) revealed an order for Cogentin 1mg po (by mouth) BID (twice a day). Review of the Medication Administration Record (MAR) dated/timed 011/15/11 at 2100 (9:00pm) revealed no documented evidence Cogentin 1mg had been administered to Patient #4.
Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 01/06/11 and 01/15/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #5
Review of the medical record for Patient #5 revealed a [AGE] year old male admitted on [DATE] with the diagnosis of [DIAGNOSES REDACTED]"out" and not administered to the patient.

Review of the Nurses' Narrative Notes and MARs for Patient #5 dated 01/06/11 revealed no documented reason as to why the medications was "out" and had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #6
Review of the medical record for Patient #6 revealed an [AGE] year old female admitted on [DATE] for Dementia, Psychosis and Hallucinations. Review of the Physician's Orders dated/timed 01/05/11 (no time documented) revealed an order for Klonopin 0.25mg po bid. Review of the MAR revealed documented evidence on 01/06/11 at 0900 (9:00am) "none available".

Review of the Nurses' Narrative Notes and MARs for Patient #6 dated 01/06/11 revealed no documented reason as to why the medications were not available, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #7
Review of the medical record for Patient #7 revealed an [AGE] year old female admitted on [DATE] for dementia with behavioral dyscontrol and a history of schizophrenia. Review of the Physician's Admit Orders dated/timed 12/07/10 at 1300 (1:00pm) revealed an order for Geodon 80mg po (by mouth) with supper daily and Prozac 20 mg po QAM (every morning). Review of the MAR revealed no documented evidence Geodon had been administered to Patient #7 at 2100 (9:00pm) on 12/07/10 at 0900 (9:00am) or Prozac on 12/09/10 at 0900 (9:00am) and 12/19/10 at 0900 (9:00am).
Review of the Physician's Orders dated/timed 12/08/10 1830 (6:30pm) revealed an order for Aldactone 25mg qd (every day). Review of the MAR for Patient #7 revealed no documented evidence the Aldactone had been administered to Patient #7 as ordered.

Review of the Nurses' Narrative Notes and MARs for Patient #7 dated 12/09/10 revealed no documented reason as to why the medications were not available, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #8
Review of the medical record for Patient #8 revealed a [AGE] year old male admitted on [DATE] with Paranoid Psychosis and Dementia. Further review revealed #8 had a history of asthma, COPD (Chronic Obstructive Lung Disease) and CHF (Congestive Heart Failure). Review of the Physician's Orders dated/timed 12/01/10 at 2340 (11:40pm) revealed an order for Synthroid 50mcg po QD; Combivent Inhaler 2 puffs QID; and Albuterol 2.5/5ml with Atrovent 0.2% per nebulizer every 8 hours.

Review of the MAR for Patient #8 revealed no documented evidence the following medications were administered: Synthroid 50mcg on 12/02/10 at 0600 (6:00am) and 1400 (2:00pm); Albuterol 2.5/5ml with Atrovent 0.2% on 12/02/10 at 0600 (6:00am) and 1400 (2:00pm); and Combivent Inhaler Combivent Inhaler on 12/02/10 at 0800 (8:00am), 12 noon, 1600 (4:00pm) and 2000 (8:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #8 dated 12/02/10 revealed no documented reason as to why the medications were not available, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #9
Review of the medical record for Patient #9 revealed an [AGE] year old female on 12/21/10 for dementia with behavioral changes. Review of the Physician's Admit Orders dated/times 12/20/10 at 1530 (3:30pm) revealed an order for Aricept 75mg i po daily. Review of the Medication Administration Record (MAR) dated 12/21/10 at 0900 (9:00am) revealed no documented evidence Aricept 75mg was administered to Patient #9.

Review of the Physicians' Orders dated/timed 12/24/10 6:30pm revealed an order for Risperdal 0.25mg po (by mouth) bid (twice a day). Review of the Medication Administration Record (MAR) dated 12/24/10 revealed no documented evidence Patient #9 received Risperdal 0.25mg on 01/24/10 at 2100 (9:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 12/21/10, 01/06/11 and 01/15/11 revealed no documented reason as to why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #10
Review of the medical record for Patient #10 revealed a [AGE] year old male admitted on [DATE] for Dementia with behavioral problems. Review of the Physician's Orders dated/timed 12/23/10 at 1445 (2:45pm) revealed the following orders: Sinemet 10/100 po tid (three times a day); Muro Ointment 128 apply to bilateral eyelids Q hs (every hour of sleep); Travatan i gtt (one drop) OU (both eyes) QHS; Zylet i gtt OU tid; and Cosopt i gtt OU bid.

Review of the MAR for Patient #10 revealed no documented evidence the following medications were administered : Sinemet 10/100mg had been administered on 12/23/10 at 2100 (9:00pm), 12/24/10 at 0600 (6:00am) and 12/29/10 ay 1400 (2:00pm); Muro Ointment 12/23/10 at 2200 (10:00pm) ; Travatan at 12/23/10 at 2100 (9:00pm); Zylet 12/23/10 at 2200 (10:00pm) and 12/24/10 at 0600 (6:00am); and Cosopt 12/23/10 at 2100 (9:00pm).

Review of the Nurses' Narrative Notes and MARs for Patient #4 dated 12/23/10, 01/06/11 and 12/24/10 revealed no documented reason as to why the medications were not available for administration as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

Patient #11
Review of Patient #11's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]

Review of Patient #11's "Physician's Orders" revealed the following orders:
01/08/11 at 11:00am - Clonidine 0.2 mg by mouth twice a day; Lisinopril 40 mg by mouth daily, and Metoprolol 100 mg by mouth daily;
01/10/11 at 11:10am - Lexapro 5 mg by mouth every AM (morning);
01/11/11, with no documented evidence of the time the order was received (the order was noted by the nurse on 01/11/11 at 6:45am) - Clonidine 0.1 mg by mouth times 1 now, then every 4 hours prn (as needed) for systolic blood pressure (BP) greater than 180; and
01/21/11, with no documented evidence of the time the order was received (the order was noted by the nurse on 01/21/11 at 9:00am) - Lasix 20 mg by mouth daily and KCl (potassium chloride) 10 meq (milliequivalents) by mouth daily times 5 days.

Review of Patient #11's MARs and "Nurses Progress Notes" revealed Metoprolol 100 mg orally was administered at 9:00am on 01/09/11, 01/10/11, 01/11/11, 01/12/11, 01/13/11, 01/14/11, 01/15/11, 01/17/11, 01/18/11, 01/19/11, 01/20/11, and 01/21/11 with no documented evidence Patient #11's pulse was checked prior to administration of Metoprolol (as required by review of the medication resource manual accepted by the hospital as a resource to the nurses). Further review revealed Lisinopril 40 mg by mouth and Metoprolol 100 mg by mouth (patient's routine medications) were administered at 5:30am on 01/16/11 for elevated blood pressure by contracted agency RN S24 rather the prescribed prn Clonidine ordered to be given for systolic blood pressure greater than 180. Further review revealed Lexapro 5 mg ordered to be given every morning on 01/10/11 at 11:10am was not administered until 9:00am on 01/11/11, and
there was no documented evidence Lasix and KCl were administered as ordered on [DATE] (MAR revealed day 1 for KCl was to be 01/22/11).

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed the above findings. She indicated routine medications should not have been administered early without an order from the physician, and the prn Clonidine should have been given 01/16/11. She could not explain why the nursing staff was not checking Patient #11's pulse prior to administering the Metoprolol.

Patient #12
Review of the medical record for Patient #12 revealed an [AGE] year old female admitted on [DATE] for Senile Dementia with behavioral disturbances. Further review revealed #12 had a medical history which included HTN (Hypertension) and CHF (Congestive Heart Failure). Review of the Physician's Orders dated/timed 12/01/10 (no time documented) revealed an order to restart Tenormin 25mg po at HS "hold" if SBP (Systolic Blood Pressure) < (less than) 110.

Review of the MAR for Patient #12 revealed Tenormin 25mg was administered at 2100 (9:00pm) on the following dates: 12/05/10, 12/06/10, 12/0710, 12/08/10 and 12/09/10. Review of the "Daily Vital Signs" form, utilized by the Mental Health Techs to record vital signs including blood pressure, revealed the following: 12/05/10 at 9:00pm - BP 102/67; 12/06/10 at 9:00pm BP 103/66; 12/07/10 at 9:00pm - no documented evidence the blood pressure had been assessed; 12/08/10 at 9:00pm - no documented evidence the blood pressure had been assessed; and 12/09/10 - no documented evidence the blood pressure had been assessed.

Review of the Nurses' Narrative Notes and MARs for Patient #12 dated 12/05/10 through 12/09/10 revealed no documented evidence the blood pressure had been assessed before administration of the Tenormin as ordered by the physician or that any of the nursing staff had identified the medication had been given on 12/05/10 and 12/06/10 when Patient #12's blood pressure was below the ordered parameters for administration of the Tenormin.

Patient #13
Review of Patient #13's medical record revealed he was admitted on [DATE] with diagnoses of [DIAGNOSES REDACTED]
Review of Patient #13's "Physician's Orders" revealed the following orders:
01/07/11 at 12:30pm - Saphres 10 mg by mouth BID; Cogentin 2 mg by mouth TID; Benadryl 100 mg by mouth TID; Synthroid 50 mg by mouth daily;
01/20/11 at 4:00pm - Colace 100 mg by mouth daily; and
01/21/11, with no documented evidence of the time the order was written and noted by the nurse on 01/21/11 at 8:00am - Miralax 17 grams by mouth daily mixed with 8 ounces of water.

Review of Patient #13's MARs revealed the nurse's initials were circled at 9:00pm on 01/07/11 indicating Saphres was not administered. Further review revealed notations on the MAR for 01/08/11 at 9:00am and 9:00pm, 01/09/11 at 9:00am and 9:00pm, and 01/10/11 at 9:00am that Patient #11 had refused the medication Saphres. Further review of the "Nurses Progress Notes" revealed no documented evidence the LPN reported the patient's refusal to the RN and the physician. Further review revealed Cogentin and Benadryl were not administered until the 9:00pm dose on 01/07/11; the dose due at 1:00pm was not administered. Further review revealed Benadryl was not administered at 9:00pm on 01/16/11 and at 9:00am and 1:00pm on 01/17/11. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.
Review of Patient #13's MAR revealed no documented evidence Synthroid was administered as ordered at 6:00am on 01/19/11 and 01/20/11. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.
Review of Patient #13's MAR for Miralax for 01/21/11 through 01/23/11 revealed the nurse's circled initials indicating the medication was not administered on 01/22/11 at 9:00am. Further review revealed Miralax was first administered on 01/23/11, two days after the order was received. Review of the Nurses' Narrative Notes and MARs for Patient #13 revealed no documented reason why the medications had not been administered as ordered, the RN Charge Nurse notified, the MD notified, or any action taken.

In a face-to-face interview on 01/28/11 at 9:50am, DON S2 confirmed there were no medication variances completed for the above listed medication variances.

In a face-to-face interview on 01/25/11 at 11:20am, RN (registered nurse) S4, Director of Quality Assurance/Performance Improvement (QA/PI), verified medication variances were not being monitored.

Review of the Performance Improvement Plan, dated January 2010, revealed .... "Program Operation: A. Quality Monitoring and Evaluation Process- b. Identify those key functions which are to be measured on a continuous basis. These would include those which: ... (5) involve ordering, dispensing, and administering of medications and monitoring for effects of medications...".
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on record review and interview, the hospital failed to implement the Quality Assurance/Performance Improvement (QA/PI) Plan as evidenced by the hospital's failure to monitor the quality of patient care; develop indicators; conduct quarterly QA/PI meetings; monitor all ancillary patient care services, infection control, complaints/grievances, clinical staff credentials, or staff competency. Findings:

The hospital was unable to submit any indicators, problems which were identified by the hospital concerning patient care, monitoring of ancillary services, grievances, or meeting minutes.

Review of the Performance Improvement Plan, dated January 2010, revealed, in part, "... E. Each department/services will address: 1.) patient care problems. 2.) cause of problems. 3.) documented correctional actions and monitoring or follow up to determine effectiveness. Each department/services will save and document appropriate remedial actions to assure deficiencies found thru quality assurance of all remedial actions thru the PI committee process. The performance Improvement Committee meets at least quarterly to review and analyze data from the following for any patterns or trends or opportunities to improve performance, make recommendations for corrective actions, and to monitor effectiveness of corrective actions taken...".

In a face-to-face interview on 01/24/11 at 1:40pm, S6, owner and voting member of the Governing Body, indicated discussions concerning pharmacy problems took place; however he verified there was no documentation for the meetings held.

In a face-to-face interview on 01/25/11 at 11:20am RN S4, Director of Quality Assurance/Performance Improvement (QA/PI), indicated she has no formal training in QA/PI but has served as Director of Nursing in several hospitals which required her to perform data collection, data aggregation and attendance at QA/PI meetings. Further RN S4 indicated she was originally hired as the Marketer for the hospital and then became the Director of Nursing at another hospital owned by the same company. At present she serves as the QA/PI Director for Hospital A and Seaside Behavioral Center; however, due to Hospital A having surveyors in the facility for complaint investigation, she was instructed by the owners to devote her attention to that hospital. S4 indicated this was the reason QA/PI was not implemented other than chart checks and confirmed no meetings were conducted for performance improvement.

Review of the Performance Improvement Plan, last revised January 2010, revealed, in part, "... A. Board of Directors: ...The Board of Directors, in accordance with its Bylaws, recognizes this responsibility and requires that the senior management team and the Medical and Professional Staff implement a systematic program of ongoing review and evaluation which can furnish the governing board with the information and recommendations necessary to assure continuing improvement un the quality of patient care within a safe, responsible and cost-effective framework".
VIOLATION: QAPI Tag No: A0263
Based on record and interview the hospital failed to meet the requirements of the Condition of Participation for Quality Assurance as evidenced by:

1) Failing to implement the Quality Assurance/Performance Improvement (QA/PI) Plan as evidenced by the hospital's failure to follow policies and procedures relative to the development of departmental indicators for each hospital service to include patient care problems, infection control issues, complaints/grievances, and to conduct QA meetings as required in policy in order to develop corrective action plans for problems identified. (See findings at Tag A0264);

2) Failing to implement a system for identification and reduction of medical errors as evidenced by the hospital failing to identify 103 medication variances which had occurred during the time period of 11/29/10 to 01/23/11. There was no evidence that a system to review medical records for medication errors was implemented. (See findings at A0266);

3) Failing to ensure the Governing Body periodically reviewed and evaluated QAPI data, ensured that corrective actions were implemented for problems identified, and monitored the action plans for sustained correction. (See findings at Tag A0310).
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on record review and interview the Governing Body of the hospital failed to ensure a systematic program of ongoing review and evaluation which furnished information and recommendations necessary to assure continuing improvement in the quality of patient care within a safe, responsible and cost-effective framework was implemented as evidenced by no documentation of any indicators, problems identified by the hospital, or actions/recommendations for improving patient care which was reviewed by the Governing Body and via meeting minutes. Findings:

The hospital was unable to submit any documentation of Governing Body Meeting Minutes or Performance Improvement Committee Meeting Minutes in which quality of care issues were identified, action taken and monitoring for effectiveness was discussed.

In a face to face interview on 01/25/11 at 11:20am RN S4, Director of Quality Management verified no QA/PI meetings had been conducted from 04/10 through the present time.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on record review and interview, the Governing Body of the hospital failed to ensure contracted pharmacy services were provided in a safe and effective manner as evidenced by failure to have a systematic program of ongoing review and evaluation which furnished information and recommendations necessary to assure continuing improvement in the quality of patient care within a safe, responsible and cost-effective framework was implemented. There was no documented evidence of any indicators, problems identified by the hospital, or actions/recommendations for improving patient care which was reviewed by the Governing Body via meeting minutes. Findings:

The hospital was unable to submit any documentation of Governing Body Meeting Minutes or Performance Improvement Committee Meeting Minutes in which quality of care issues were identified, action taken, and monitoring for effectiveness was discussed.

In a face-to-face interview on 01/25/11 at 11:20am, RN (registered nurse) S4, Director of Quality Management, verified no QA/PI (quality assurance/performance improvement) meetings had been conducted from 04/10 through the present time.
VIOLATION: SECURE STORAGE Tag No: A0502
Based on observation, record review and interview the hospital failed to ensure all drugs were secured as evidenced by the door of the medication room containing the unlocked medication cart, medication refrigerator and unlocked stock medication cabinets left open. Findings:

Observation on 01/21/11 at 11:50am revealed the medication room located off the back of the nurses' station unlocked. Further observation revealed the medication cart unlocked with the keys to the narcotics box in the top drawer.

In a face-to-face interview on 01/21/11 at 11:50am, LPN (licensed practical nurse) S10 indicated that before last Thursday, only the medication nurse had a key; however new management had made a change and now all nurses are responsible for administering their own medication to the patients he/she are assigned. Further S10 indicated housekeeping comes in the medication room to clean and verified there are outside vendors in the hallway directly outside of the medication room, all of whom have access to the medication room when it is unlocked.

Review of policy 8.4 titled "Key Control" originated 2009 and submitted as the one currently in use, revealed ....5) At the beginning of each shift, the Registered Nurse will assign keys to the medication room/cart, including the narcotics key, to a member of the nursing staff who is licensed to pass medications, including narcotics. Medication keys are to remain with the designated staff member throughout their tour of duty ...".

Review of the hospital policy titled "Medication Administration", policy 12.14 and submitted by DON (director of nursing) S2 as a medication administration policy, revealed, in part, "...Keep medicine room door locked. Only hospital staff nurses are permitted to carry the key. ... All areas where there are medications are to be locked when not in use. These include the Pharmacy, the medication room and the medication cart. 9. All narcotics and controlled drugs are to be under double lock, the medicine room door and the narcotic drawer in the medicine cart are locked...".
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
Based on observation, record review, and interview, the hospital failed to follow their policy and procedure for security of narcotic drugs as evidenced by failing to ensure the door to the medication room was kept locked at all times and the keys to the medication cart were kept on the assigned nurse resulting in the failure of the narcotics to be stored in a double locked system. Findings:

Observation on 01/20/11 at 10:00am revealed the medication cart, stored in the locked medication room unlocked with the keys to the narcotics box in the top drawer.

Observation on 01/21/11 at 11:50am revealed the medication room located off the back of the nurses' station unlocked. Further observation revealed the medication cart unlocked with the keys to the narcotics box in the top drawer.

Review of policy 8.4 titled "Key Control" originated 2009 and submitted as the one currently in use, revealed ....5) At the beginning of each shift, the Registered Nurse will assign keys to the medication room/cart, including the narcotics key, to a member of the nursing staff who is licensed to pass medications, including narcotics. Medication keys are to remain with the designated staff member throughout their tour of duty ...".

Review of Policy No. 14-01 titled "Security of Staff and Drugs" dated 02/01/10 and submitted by the hospital as the one currently in use and developed by contract pharmacy "A" revealed .... Requirements for Lockable Storage: Lockable storage units or lockable drug carts shall be provided for drug storage throughout the facility. Drugs shall be kept in locked storage or be inaccessible to patients, visitors, and unauthorized staff. Access to Drug Storage Areas: Access to drug storage areas is limits to pharmacy and persons authorized to handle and administer these drugs. The medication nurse on duty shall be responsible for keeping the drug storage keys in his/her possession at all times during his/her shift".

Review of the hospital policy titled "Medication Administration", policy 12.14 and submitted by DON (director of nursing) S2 as a medication administration policy, revealed, in part, "...Keep medicine room door locked. Only hospital staff nurses are permitted to carry the key. ... All areas where there are medications are to be locked when not in use. These include the Pharmacy, the medication room and the medication cart. 9. All narcotics and controlled drugs are to be under double lock, the medicine room door and the narcotic drawer in the medicine cart are locked...".

In a face-to-face interview on 01/21/11 at 3:00pm Administrator S1 indicated she made a change last week to the way medication administration was assigned. S1 indicated the previous regime was to assign one medication nurse to administer all medications. Now the nurse assigned to the patient administers medications. Administrator S1 verified no changes have been made to the current policy and procedures.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review ,and interview, the hospital failed to ensure unlabeled, outdated, or expired medications were not available for administration to patients as evidenced by multi-dose vials opened greater than 30 days and expired medications available for use in the medication stock drawers and/or cabinet. Findings:

Observation on 01/20/11 at 10:00am of the unlocked medication refrigerator located behind the door of the medication room revealed the following opened multi-dose vials of insulin with the date of puncture:
Lantus 11/20/10, Humulin R 11/19/10, Humulin R 10/21/10 and Levemir for Patient #8(discharged on [DATE]).

Observation on 01/20/11 10:15am of the top of the medication cart located in the medication room revealed an opened multi-dose vial of Sterile Water with no documented date of puncture.

Observation of the medication cabinet in the medication room on 01/21/11 at 11:10am revealed a multi-dose vial of Zyprexa injection 10 mg/ml (milligrams per milliliter) with the date of puncture of 09/12/10 at 2300 (11:00pm). This observation was confirmed by LPN (licensed practical nurse) S10 at the time of the observation.

Observation of the medication stock drawers on 01/12/11 at 10:50am revealed 1 broken ampule of Cogentin 2 mg (1 mg/ml), Amikacin 500 mg/2 ml with an expiration date of 12/10, and two vials of Albuterol 0.83 % (per cent) solution with an expiration date of 01/10. These observations were confirmed by LPN S10 at the time of the observation.

Review of the hospital policy and procedure manual and the manual provided by the contract pharmacy revealed no documented evidence of a policy addressing multi-dose vials.

Review of the pharmacy policy titled "Expiration Dates", and presented by Administrator S1 as contracted Pharmacy A's policy and procedure manual, revealed, in part, "...Expiration dates of drugs and devices shall be checked during the routine medication area inspections and all drugs and devices scheduled to expire during the next month shall be removed from stock".

In a face-to-face interview on 01/21/10 at 10:15am, RN (registered nurse) S2, Director of Nursing (DON), indicated the pharmacy consultant is supposed to check for expired medications during his monthly inspections; however, she indicated to the best of her knowledge, the consultant was not coming regularly every month. Further S2 indicated it was the nurse ' s responsibility to check the refrigerator for expired medications.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on record review and interviews, the governing body failed to ensure the contracted pharmacy services were performed in compliance with the Conditions of Participation for Pharmacy Services as evidenced by: 1) failure to ensure there was a single contracted pharmacist responsible for developing, supervising, and coordinating all activities of the pharmacy service; 2) failure to ensure pharmaceutical services provided quality services including 24 hour, 7 day emergency coverage as evidenced by: a) failure to have medications available for patient administration at their next scheduled dose once the order was received for 2 of 14 sampled patients (#1, #2) and b) failure to have documented evidence of daily delivery of medications for 16 of 52 days reviewed for medication delivery by UPS (United Parcel Service); and 3) failure to ensure drug administration errors were immediately reported to the attending physician and the hospital-wide quality assurance program as evidenced by having no evidence medication variances were being monitored which resulted in 103 medication variances not identified by the hospital (see findings in tags A0490, A0492, A0493, A0508, A0503).
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on record review and interviews, the hospital failed to ensure the contracted pharmacist was responsible for developing, supervising, and coordinating all pharmacy services activities as evidenced by failure to have a single pharmacist responsible for the overall administration of the pharmacy service at the hospital. Findings:

Review of the "Exclusive Pharmaceutical Service Agreement" entered into on 09/02/09 by and between Seaside Behavioral Center and contract Pharmacy A revealed no documented evidence of the name of the pharmacist responsible for the overall administration of the pharmacy services at the hospital. It was signed by S5, CEO (chief executive officer) of Pharmacy A and S19, former Administrator and former governing body member. Further review of the attachment to the contract of "Exhibit A" revealed, in part, "...8.) Therapeutics Committee/Performance Improvement Committee: A Pharmacy A representative will be available to participate on the Pharmacy and Therapeutics Committee and when necessary the performance Improvement Committee. The meeting will be approximately one hour during business hours no more than once a month".

In a telephone interview on 01/21/11 at 12:20pm, S5, CEO of Pharmacy A, indicated he was the owner of Pharmacy A but was not a pharmacist. He further indicated he had pharmacists who worked for him who were responsible for pharmacy services, and he contracted with Pharmacist Consultant S3 to perform the monthly pharmacy inspection. When asked by the surveyor what S3 was responsible to monitor, S5 indicated he had a list of about 25 items to check, and S3 had begun doing 3 to 5 random chart audits about two months ago. When S5 was informed by the surveyor of observation of inaccurate par levels and expired medications in the medication room, S5 indicated that he thought "once he transferred drugs from his DEA (drug enforcement administration) number to the hospital's DEA number, the hospital was to maintain the par level and maintain drugs once in their custody". S5 further indicated that once physician orders were faxed to the pharmacy, a pharmacist would review the order before sending the medication. He confirmed that the MARs (medication administration record) were written by the nurses, a pharmacist doesn't see them, and thus it could not be determined by the pharmacist that medications were administered correctly as ordered.

Review of the faxed "Consultant Pharmacist Agreement" from S5 CEO of Pharmacy A, received on 01/21/11 at 4:17pm, revealed, in part, "This agreement made and entered into this day of January 1, 2011 by and between Pharmacy A... and (name of consulting service of Consultant Pharmacist S3) ... 2. Consultant Responsibilities Consult shall be a qualified pharmacist who is responsible to provider for developing, coordinating, supervising, and reviewing all consultant pharmaceutical services and for assessing distributive services upon request of Facility's Administrator. Consultant shall be responsible for rendering the following consulting services to designated Facilities contracted through the Pharmacy: a. Submit, at least (monthly) a written report to Provider to be available for review when requested by Quality Assurance and Assessment or Pharmaceutical Services Committee on the status of Facility's pharmaceutical service and nursing staff performance related to medication procurement and disposal policy and procedures and perform the following duties: 1. A review and ongoing assessment of compliance with all federal, state or local laws, regulations, or rules and all of facility's pharmaceutically related policies and procedures. 2. Recommendations, if any, for improving the delivery of pharmaceutical services, with the goal of correcting or preventing instances of noncompliance and enhancing the level of resident care in Facility. ... c. Assist Facility in the reconciliation, destruction, and reconciliation of unused controlled substances as prescribed by law, rule, or regulation...". Further review revealed no documented evidence that the agreement had been signed by S5 CEO of Pharmacy A or S3 Consultant Pharmacist.

In a face-to-face interview on 01/24/11 at 9:15am, S3 Consultant Pharmacist indicated the hospital had a "closed system" which he described by saying that there was no Pyxis or Omnicell medication distribution system, so therefore, "there was no pharmacy involvement with stocking medications and maintaining par levels". S3 further indicated he had no authority to check medications when he performed the monthly inspections once a month. He further indicated he was responsible for making sure the hospital complied with the Board of Pharmacy's regulation related to the destruction of medications. S3 indicated he was never told that he was responsible for the medication room. He further indicated he had attended one pharmacy and therapeutic committee meeting at the hospital. When told by the surveyor that review of his monthly inspections for April 2010 through December 2010 revealed positive reports of his inspection of the non-narcotic cabinet drug inventory, narcotic cabinet drug inventory, narcotic cabinet refrigerator drug inventory, reporting discrepancy in medications, reporting medication errors to pharmacy, cleanliness, security, and safety in the medication room, and review of 5 patients charts for proper administration of medications, timeliness of medications administered, and medications administered correctly per physician orders, S3 could not explain how he performed these inspections and yet had been given no authority to check medications when he performed his monthly inspections.

In a face-to-face interview on 01/24/11 at 1:40pm with S6, Managing Member of the governing body and S11 spouse of the owner of the hospital who was responsible for negotiations with vendors present, S6 indicated the problems related to the pharmacy services provided by Pharmacy A had not been discussed at the governing body meetings. S11 indicated former Administrator S19 was responsible for setting up systems with Pharmacy A. S11 further indicated he didn't recall the problems that had been reported by S19, because he "didn't have a paper trail". S11 further indicated "we had someone running out ship that we discovered was not addressing the concerns like we thought they were".

In a telephone interview on 01/24/11 at 2:20pm, S5, CEO of Pharmacy A, indicated Pharmacy Manager S29 was a pharmacy tech and not a pharmacist. He further confirmed he did not have a single pharmacist who was responsible for Seaside Behavioral Center. When asked if he was knowledgeable of the federal regulations for pharmacy services provided in an acute care hospital, S5 indicated he tried to keep abreast, but he was not aware that the regulations required a single pharmacist to be responsible for the hospital's pharmacy services.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on record review and interviews, the hospital failed to meet the requirements for the Condition of Participation for Pharmaceutical Services as evidenced by:

1) Failing to ensure the hospital contracted with a pharmacist who was responsible for developing, supervising, and coordinating all pharmacy service activities. (see findings in tag A0492);

2) Failing to ensure the hospital provided pharmaceutical services 24 hours a day, 7 days a week including emergency medication coverage as evidenced by failure to have documented evidence of daily delivery of medications for 16 of 52 days (12/05/10, 12/06/10, 12/12/10, 12/13/10, 12/19/10, 12/20/10, 12/25/10, 12/26/10, 12/27/10, 01/01/11, 01/02/11, 01/03/11, 01/09/11, 01/10/11, 01/15/11, and 01/16/11) reviewed for medication delivery. (see findings in tag A0493);

3) Failing to ensure that pharmacy services was included in the hospital-wide QA as evidenced by the hospital failing to have a system for monitoring of medication errors. This failure resulted in the hospital having 103 medication errors from 11/29/10 to 01/23/11 without evidence the hospital was aware. This was evident for 13 of 14 sampled medical records (#1,#2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13) (see findings in tag A0508); and

4) Failing to follow their policy and procedure for security of narcotic drugs. This was evidenced by failing to ensure the door to the medication room was kept locked at all times. (see findings in tag A0503).