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Based upon review of employee records and interview with staff it was determined that the pharmacy was not administered in accordance with accepted professional principles, related to employing an individual as a pharmacist that lacked evidence of an active license. Additionally, medications were found not to be stored in accordance with manufacturer's directions.

Findings are as follows:

1) A review of said employee's file, on 12/6/10 and 12/8/10, revealed that this individual was hired on 10/18/10 as a pharmacist. There was no evidence, in the file, of licensure, in this or any other state as a pharmacist. It was confirmed through review with the RI State licensing agency that this individual was unlicensed in Rhode Island and additionally had not passed a pharmacy board exam in any other state.
During interview on 12/8/10, at 2:03 PM, with the Director of Human Services it was determined that this employee's license had not been verified prior to hire per Administration policy #197 which states under item IV, Procedure, B. Primary Source Verification:
"Prior to the employee's start of employment, the Human Resources Department will verify each relevant license, certification and/or registration by contacting the primary source via telephone or secure electronic communication."

2) During a tour of medication storage areas, suppositories were noted to be stored in an area that lacked proper cooling. The temperature in the Ambulatory Care unit sample medication closet registered at least 80 degrees F. Three boxes of Canasa suppositories were stored in this area. A review of the drug literature revealed that Canasa Suppositories should be stored under 77 degrees F.

Based upon record review and interview with staff it was determined that the hospital has failed to keep a receipt and distribution of all scheduled drugs.

Findings are as follows:

On 12/1/10 a review of pharmacy records revealed that there was no separate biennial inventory as per Federal 21 CFR 1304.11 for controlled substances. The inventory does not include all controlled substances in the Pyxis and Omnicell substations to be dispensed and in possession of the pharmacy at the time of the inventory.

On 12/1/10 a review of pharmacy records revealed that there was no separate biennial inventory as per Federal 21 CFR 1304.11 for controlled substances. The Pharmacist in charge was interviewed on 12/1/10, and was unable to produce a complete biennial inventory.

Based upon review of pharmacy records and interview with staff it was determined that the facility has failed to dispense all drugs per applicable standards of practice.

Findings are as follows:

Although there is no evidence any patients received inappropriate medications, on 11/30/10 a review of the Cancer chemotherapy dispensed to outpatients revealed that with the current system the pharmacist cannot adequately conduct a drug utilization review. The system is not linked with the patient EMR (electronic medical record) or the patient medication profiles.

Interview with the Pharmacist in charge, on 12/1/10, revealed that the current system lacks the ability to adequately conduct a comprehensive drug utilization review.

Based on review of records, at the sites where the hospital provides laboratory services, and interview with staff, it was determined that the hospital failed to have a CLIA certificate which covers laboratory services that are provided in multiple locations off the hospital campus.

Findings are as follows:

A review of the hospital's Premises listing revealed that the hospital operates three facilities off the main campus. Interview with the Laboratory Administrative Director on 12/6/10, confirmed that point of care laboratory testing takes place at all three sites, and patient results are transmitted to the main laboratory for entry on the patient's laboratory report. There was no current CLIA certificate to cover these laboratory services.

Based upon surveyor observation it was determined the hospital failed to maintain an air gap on 9 of 21 ice machines according to the FDA Food Code 2009.

Findings are as follows:

The Food Code, under 5-402.11, Backflow Prevention states:

"... a direct connection may not exist between the SEWAGE system and a drain originating from EQUIPMENT."

During a tour of the main kitchen, with the Director of Nutrition, on 11/30/2010 at 10:30 AM, and 12/1/10 at 11:00 AM, surveyor observation revealed that the tubing for drainage from the ice machine was located at least two inches inside the floor drain.

Inspection of the satellite kitchens on Hasbro 5 & 6, Co-op 2 & 4, Jane Brown 1, and Main 5,7,10 revealed that the ice machine drain tubes were located inside the floor drain. There was no air gap or back flow prevention device to prevent the possiblity of contaminated water from entering the unit.

Based on medical record review, review of the hospital's policy and procedure entitled "Discharge Planning", and staff interviews, it was determined that the hospital failed to complete a discharge planning evaluation on a timely basis for 4 of 36 relevant sample patients (ID # ' s 21, 22, 35, 39).

Findings are as follows:

The hospital's Discharge Planning policy, item 1 under Procedure states:

"Initial assessment of potential discharge needs within 24 hrs."

1. Clinical record review for patient ID #21 revealed that the patient was admitted on 11/12/10. The initial discharge planning evaluation was not completed until 11/19/10.

2. Clinical record review for patient ID # 22 revealed an admission on 11/12/10. The initial discharge planning evaluation was not completed until 11/19/10.

3. Clinical record review for patient ID #35 revealed that the patient was admitted on 12/1/10. The initial discharge planning evaluation was not completed until 12/6/10.

4. Clinical record review for patient ID #39 revealed that the patient was admitted on 11/11/10. The initial discharge planning evaluation was not completed until 11/16/10.

During an interview on 12/7/10 at 1:10 PM with the Director of Case Management, it was reported that the initial discharge planning assessments are to be completed within 24 hours. She also reported that should there be a reason why the patient may not be seen by a case manager, or an evaluation is not completed within 24 hours, a note to that effect should be entered in the clinical record.

Based on record review and staff interviews, it was determined that the hospital failed to include the patient's discharge planning evaluation in the patient's medical record early on, or show written evidence of discussion with the patient or individual acting on his or her behalf, for 7 of 36 relevant patients (ID#'s 11, 24, 27, 28, 29, 31and 148).

Findings are as follows:

1. A review of the clinical record for patient ID# 11 revealed an admission to the MICU (Medical Intensive Care Unit) on 11/19/10, with a transfer to the TICU (Trauma Intensive Care Unit). Although it was noted that the patient did have family support, there was no evidence of an initial discharge planning evaluation during record review on 12/2/10.

2. A review of the clinical record for patient ID# 24 revealed that the patient was admitted to Co-op 3 on 11/24/10. There was no evidence of an initial discharge planning evaluation during record review conducted on 12/3/10.

3. A review of the clinical record for patient ID# 27 revealed that the patient was admitted to Hasbro 5B on 12/2/10. During clinical record review on 12/6/10, there was no evidence that an initial discharge planning evaluation had been conducted.

4. A review of the clinical record for patient ID# 28 revealed that the patient was admitted on 11/6/10. There was no evidence of an initial discharge planning evaluation duing clinical record review on 12/6/10.

5. A review of the clinical record for patient ID# 29 revealed that the patient was discharged to home on 11/24/10 and readmitted within 5 hours to the hospital on the same day. The patient met the high-risk criteria for readmission within 30 days and required assistance with activities of daily living. There was no documented evidence of an initial discharge planning evaluation

6. A review of the clinical record for patient ID #31 revealed that the patient was initially admitted to the 5th floor on 11/4/10 with a transfer to the PICU (Pediatric Intensive Care Unit) on 11/11/10. Record review completed on 12/6/10, failed to reveal evidence of an initial discharge planning evaluation until 11/11/10.

7. A review of the clinical record for patient ID# 148 revealed an initial admission to the MICU on 11/19/10, with transfer to the RICU (Respiratory Intensive Care Unit). During clinical record review on 12/3/10, there was no evidence of an initial discharge planning evaluation.

Case Managers for all above patients were interviewed on 12/2/10, 12/3/10, 12/6/10, 12/7/10, and 12/8/10. Although it was apparent that these Case Managers did know the patients well, had visited with patients and spoken with patients and/or family members, and could readily articulate their needs, evidence of this had not been documented in these patients' clinical records.

During an interview on 12/7/10 at 1:10 PM, with the Director of Case Management, it was reported that the initial discharge planning assessments are to be completed within 24 hours. She further stated that Case Managers do know the patients and their needs, and that they need to open the case (by documenting) to verify that they have seen the patient. She also reported that should there be a reason why the patient may not be seen by a case manager, or an evaluation is not completed within 24 hours, a note to that effect should be entered in the clinical record.

Based on medical record review, review of the hospital policy entitled "Discharge Planning", and staff and patient interviews, it was determined that the hospital failed to reassess patient's discharge needs and discharge plan appropriateness, on a timely basis and in accordance with the policy for 4 of 36 relevant patients (ID#'s 14, 17, 78, 105).

Findings are as follows:

The hospital's policy entitled "Discharge Planning", item 7 under Procedure states:

"Assessment of patients needs and appropriateness of plan will be reassessed on an on-going basis, minimally q72hrs (every 72 hours) and prior to discharge."

1) A review of the clinical record for patient ID# 14 revealed an admission on 11/10/10. Reassessment of the patient's needs was not performed on a timely basis as of 11/22. He was not reassessed again until 11/26, and then 11/30.

During an interview with the patient on 12/1/10 regarding his discharge planning, it was reported that that there was "no consistency, no coordination" between that unit's case managers.

2) A review of the clinical record for patient ID# 17 revealed an admission on 11/8/2010, with a discharge planning evaluation completed on 11/9. However, this patient was not reassessed until 11/22/2010.

3) A review of the clinical record for patient ID# 78 revealed an admission on 7/6/2010, with a discharge planning evaluation on 7/7/2010. However, this patient was not reassessed until 7/12/2010.

4) A review of the clinical record for patient ID# 105 revealed an admission on 11/18/2010, with a discharge planning evaluation on 11/19. This patient was reassessed on 11/22, and not again until 11/26/10.

During an interview on 12/2/2010 at approximately 11 AM with the Director of Case Management, it was reported that patients are to be reassessed every 72 hours, or whenever there is a change in status. She was unable to produce evidence that these reassessments were completed timely, and in accordance with hospital policy.

Based on medical record review and staff interview, it was determined the hospital failed to transfer 4 of 12 patients (ID#'s 147, 73, 78, and 81), who had been discharged to nursing facilities for rehabilitation, with the necessary medical information for follow-up care, specifically, the necessary physician's orders.

Findings are as follows:

1) A review of the clinical record for patient ID# 147 revealed an admission on 11/5/2010 for a right above-the-knee amputation (AKA). On 11/16/2010, he was discharged back to a nursing facility he had resided in prior to his AKA. The CoC form sent with this patient was incomplete, containing no physician's orders regarding care to his recent AKA site, and no orders for physical therapy. In fact, a pertinent CoC form field, for this patient, entitled "Surgery this admission (with date)", was left blank.

2) A review of the clinical record for patient ID# 73 revealed a 77 year-old patient discharged to a nursing facility on 5/3/2010 with a stage III pressure ulcer on the coccyx area. The CoC form contained no treatment orders for the coccyx wound.

3) A review of the clinical record for patient ID# 78 revealed an 87 year-old patient who was discharged to a nursing facility for rehabilitation on 7/17/2010, following a left total hip replacement. The CoC form contained no physician's orders for physical therapy.

4) A review of the clinical record for patient ID# 81 revealed a 72 year-old patient who was discharged to a nursing facility for rehabilitation on 8/23/2010, following a right total hip arthroplasty. The CoC form contained no physician's orders for physical therapy.

During discussions/interviews with Director of Case Management on 12/1 and 12/2/2010, she was unable to provide evidence that these CoC forms were complete, or that the nursing facilities that these patient's were transferred to received the necessary, complete physician's orders for follow-up care.