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3400 WAKE FOREST RD

RALEIGH, NC 27609

PATIENT RIGHTS: GRIEVANCE REVIEW TIME FRAMES

Tag No.: A0122

Based on review of hospital policy, closed record review, grievance files and staff interviews the hospital failed to ensure a written response per the hospital's specified time frames for 2 of 3 grievance files reviewed (#32 and 33).

The findings include:

Review of the hospital policy, "Complaint and Grievance Management", revised 10/2008, revealed "...Upon receipt of a grievance, the person who receives the grievance: ...2. Acknowledges receipt of grievance, in writing, to patient/patient representative within 7 days. ...8. Provides written response regarding resolution of grievance to the patient/patient representative:...b. If not resolved within the 7 working days, a follow-up letter that substantively addresses the grievance and resolution will be sent within 30 days. ...".

1. Closed record review of Patient #32 revealed a 55 year-old admitted to the hospital's emergency department on 07/21/2009. Review of the grievance file revealed Patient #32 made a complaint to the hospital on 10/06/2009. Grievance file review revealed a letter dated 10/13/209 acknowledging receipt of the grievance written to the patient. Grievance file review revealed a letter written by the hospital's risk manager to Patient #32 on 11/20/2009 (38 days later) with the hospital's response to the patient's grievance.

Interview on 02/24/2010 at 1400 with the hospital's risk manager revealed "it is the hospital's policy to resolve and respond to the patient's grievance within 30 days". Interview confirmed that a resolution letter was sent to Patient #32 on 11/20/2009, 38 days after acknowledging the patient's grievance. Interview confirmed the hospital's grievance policy was not followed.

2. Closed record review of Patient #33 revealed a 43 year-old admitted to the hospital's outpatient department on 11/04/2009. Review of the grievance file revealed Patient #33 made a complaint to the hospital on 11/23/2009 related to his experience in the outpatient department. Grievance file review revealed a letter written by the hospital's risk manager to Patient #33 on 12/09/2009 (16 days later) with the hospital's response to the patient's grievance.

Interview on 02/24/2010 at 1400 with the hospital's risk manager revealed "it is the hospital's policy to respond to the patient's grievance within 7 days". Interview confirmed that an acknowledgement letter was sent to Patient #33 on 12/09/2009, 16 days after receiving the patient's grievance. Interview confirmed the hospital's grievance policy was not followed.

MEDICAL STAFF RESPONSIBILITIES - UPDATE

Tag No.: A0359

Based on review of the hospital's Medical Staff By-Laws, Rules and Regulations, medical record review, staff and physician interviews, the hospital failed to ensure that an updated history and physical was performed prior to surgery for 2 of 5 surgical records reviewed (#12, 10).

The findings include:

Review of the hospital's Medical Staff By-Laws, Rules and Regulations, revised 08/2009, revealed "...For Patients for whom a medical history and physical examination was completed within 30 days prior...an update documenting in the medical record (on forms if applicable) an examination...must have been completed within 24 hours prior to surgery or a procedure requiring anesthesia services...".

1. Open record review of Patient #12 revealed a 59 year-old admitted on 02/18/2010 with a pancreatic tumor and had a distal pancreatectomy (removal of a portion of the pancreas) and splenectomy on 02/18/2010. Record review revealed a "Surgical Physician Record" dated 01/25/2010 with a handwritten history and physical. Review of the "Surgical Physician Record" revealed a block for "Reassessment", signed by the physician, not dated.

Interview with administrative staff at 02/23/2010 at 1130 revealed "the history and physical should be updated prior to surgery". Interview confirmed the date of the reassessment was not completed by the physician.

Interview with the chief medical officer on 02/24/2010 at 1150 revealed "the history and physical should be updated within 24 hours of surgery. We have identified this as a problem and are working on it". Interview confirmed the physician failed to ensure the history and physical was updated prior to surgery for Patient #12.



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2. Open record review of Patient #10 revealed a 48 year-old admitted on 02/19/2010 with hydradenitis (inflammation of the sweat glands) and had bilateral excision of axillary hydradenitis and flap closure on 02/19/2010.

Record review revealed a "Wound Center Progress Note" dated 02/15/2010 ( 4 days before surgery) as the typewritten history and physical. Record review revealed no documented evidence of an updated history and physical performed prior to surgery.

Interview with administrative staff at 02/24/2010 at 1130 revealed "the history and physical should be updated prior to surgery". Interview confirmed the date of the reassessment was not completed by the physician.

Interview with the chief medical officer on 02/24/2010 at 1430 revealed "the history and physical should be updated within 24 hours of surgery. We have identified this as a problem and are working on it". Interview confirmed the physician failed to ensure the history and physical was updated prior to surgery for Patient #10.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation during tour, pharmacy policy review and pharmacy staff interview the pharmacy failed to ensure outdated medications were removed from the medication refrigerator and not available for use.

Findings include:

The hospital pharmacy policy entitled "Beyond-Use Dating (Expiration of Sterile Compounded Products)" with a revision date of January 2010 states under Policy: "All sterile preparations must bear an appropriate beyond-use (expiration) date"...under Beyond-Use Date Steps 4. "Inspect all containers for defects, beyond-use date, and preparation integrity"...under Monitoring Controlled Storage Area "...pharmacists must monitor the drug storage area within the pharmacy. Controlled temperatures storage areas in the pharmacy (refrigerator; freezers; and incubators), should be monitored at least once daily...." Interview with the Pharmacy manager on 02/25/2010 at 1100 revealed this policy included the refrigerators on the patient units.

During the Medical and Oncology unit tour on 02/24/2010 at 1030 the medication refrigerator was observed to contain two syringes of pre-drawn flu vaccine, for specific patients, one with an expiration date of 06/30/2009 and one with an expiration date of 02/20/2010. Interview with the pharmacy manager on 02/24/2010 at 1045 indicated this refrigerator is to be checked by the pharmacy staff daily for expired medications and expired medications should be removed. Interview with the unit manager on 02/24/2010 at 1100 revealed these two patients had already received flu vaccinations and did not need the pre-drawn flu vaccine.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observations and staff interviews the hospital dietary staff failed to ensure a clean and sanitary environment for the safe handling of food and equipment used in the dietary services area.

Findings include:

1. During the dietary departmental tour on 02/23/2010 at 1000 it was noted the floor in the freezer was covered with food crumbs and dirt and a cart containing many different seasonings was covered with splashed dirt and liquid products. At 1345 during the inspection of the tray/dish washing process it was noted a cart which held the insulated bottoms and tops of the serving dishes was dirty, with dust and grime from continued use. Further observation revealed a fan with a wire cage around the fan blades was covered with dust and blowing on clean plates/dishes that came out of the washer. Interview with the dietary manager at the time of this tour confirmed this was inappropriate dietary practice.

2. During the 02/23/2010 tour observation, at 1030, of the dietary dry food storage area a bag of peanuts with a use by date of 01/24/2010 and another bag of peanuts with a use by date of 02/15/2010 was noted on the shelves as well as an opened box of Uncle Bens Rice with no date as to when the rice had been opened. Interview with the dietary cook who was present at the time of this tour indicated these items should not have been on the shelves.

3. Observation of the serving line on 02/23/2010 at 1200 revealed an employee putting dishes of served food on the carts that would go to the floors, wearing a glove on her right hand but no glove on her left hand. Interview with the dietary manager at the time of this observation indicated the staff should be wearing gloves on both hands.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, the hospital's equipment/supply guidelines and staff interviews, the facility failed to maintain and use manufacture's guidelines for use and guidance in total chlorine testing of water used for treatment in hemodialysis patients.

The findings include:

Observation on 02/24/2010 at 0950 in the hospital's hemodialysis area revealed that the hospital's staff conducted total chlorine testing for the purpose of determining levels of chlorine in water used for hemodialysis patients at the hospital. The testing was conducted with the brand "RPC K100-0118 Ultra-Low Total Chlorine Test Strips" by the hospital's hemodialysis registered nurse. A review of the hospital's hemodialysis equipment and supply instruction guidance during the observation revealed that the facility did not have any maintained guidance or instructions for use of the "RPC K100-0118 Ultra-Low Total Chlorine Test Strips."

An interview on 02/24/2010 at 1010 with the hospital's hemodialysis staff to determine the guidelines for use and safety of the total chlorine strips revealed that there were no manufacture guidelines available for staff reference at the hospital. The interview revealed that the strips were put into use at the hospital in January of 2010 and are different in the way that the testing is done in determining total chlorine levels for safe water use in hemodialysis patients. The interview revealed that temperature variances of the hemodialysis water effected the testing with the new strips and that time testing changes have been made in the time length of the testing since the strips were put in use in January (2010). The interview confirmed that the the hospital should have had the manufacturer guidelines available for the hospital's hemodialysis staff testing the water in addition to policies and procedures for determining those temperature variances.

OPERATIVE REPORT

Tag No.: A0959

Based on review of medical staff by-laws, rules and regulations, medical records, staff and physician interviews, the hospital failed to ensure the completion of an operative report immediately following surgery for 5 of 5 surgical records reviewed (#13, 14, 11, 12 and 10).

The findings include:

Review of the hospital's Medical Staff By-Laws, Rules and Regulations, revised 08/28/2009, revealed "...E. Medical Records...4. ...Operative reports shall be written (or dictated) immediately following surgery...and the report promptly signed by the surgeon and made a part of the Patient's current medical record...".

1. Open record review of Patient #13 revealed a 26 year-old admitted on 02/23/2010 for a right stapedectomy (surgery of the middle ear). Record review revealed the procedure was completed on 02/23/2010 at 0930. Record review on 02/23/2010 at 1130 (2 hours after the surgery was completed)revealed the patient was an inpatient on the general surgical unit. Record review revealed a form, "Post-Operative/Post-Procedure Note" with a chart label affixed with Patient #13's name, medical record number and surgeon's name. Review of the "Post-Operative/Post-Procedure Note" revealed it was not completed by the surgeon.

Interview on 02/23/2010 at 1135 with administrative staff revealed "the immediate post-operative report should be completed by the surgeon immediately after surgery and certainly before the patient comes to the floor". Interview confirmed there was no documented evidence in Patient #13's medical record of an immediate post-operative report.

Interview on 02/24/2010 at 1150 with the chief medical officer revealed "an immediate post-operative report should be completed by the surgeon". Interview confirmed Patient #13's surgeon did not follow the Medical Staff By-Laws, Rules and Regulations for completing the immediate post-operative report.

2. Open record review of Patient #14 revealed a 58 year-old admitted on 02/24/2010 for a cervical fusion. Record review revealed a form, "Post-Operative/Post-Procedure Note" dated 02/24/2010 with no time of completion documented.

Interview on 02/23/2010 at 1135 with administrative staff revealed "the immediate post-operative report should be completed by the surgeon immediately after surgery. If it's not timed, you don't know when it was written". Interview confirmed there was no documented time of the operative report completed for Patient #41.

Interview on 02/24/2010 at 1150 with the chief medical officer revealed "an immediate post-operative report should be completed by the surgeon immediately after surgery and should be timed". Interview confirmed there was no documented time of the operative report completed for Patient #14.

3. Open record review of Patient #11 revealed a 55 year-old admitted for an exploratory laparotomy on 02/21/2010. Record review revealed a form, "Post-Operative/Post-Procedure Note" dated 02/21/2010 with no time of completion documented.

Interview on 02/23/2010 at 1135 with administrative staff revealed "the immediate post-operative report should be completed by the surgeon immediately after surgery. If it's not timed, you don't know when it was written". Interview confirmed there was no documented time of the operative report completed for Patient #11.

Interview on 02/24/2010 at 1150 with the chief medical officer revealed "an immediate post-operative report should be completed by the surgeon immediately after surgery and should be timed". Interview confirmed there was no documented time of the operative report completed for Patient #11.

4. Open record review of Patient #12 revealed a 59 year-old admitted on 02/18/2010 with a pancreatic tumor and had a distal pancreatectomy (removal of a portion of the pancreas) and splenectomy on 02/18/2010. Record review revealed a form, "Post-Operative/Post-Procedure Note" dated 02/18/2010 with no time of completion documented.

Interview on 02/23/2010 at 1135 with administrative staff revealed "the immediate post-operative report should be completed by the surgeon immediately after surgery. If it's not timed, you don't know when it was written". Interview confirmed there was no documented time of the operative report completed for Patient #12.

Interview on 02/24/2010 at 1150 with the chief medical officer revealed "an immediate post-operative report should be completed by the surgeon immediately after surgery and should be timed". Interview confirmed there was no documented time of the operative report completed for Patient #12.



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5. Open record review of Patient #10 revealed a 48 year-old admitted on 02/19/2010 for bilateral excision of axillary hydradenitis (inflammation of sweat glands) and flap closure. Record review revealed a form, "Post-Operative/Post-Procedure Note" dated 02/19/2010 with no time of completion documented.

Interview on 02/24/2010 at 1430 with administrative staff revealed "the immediate post-operative report should be completed by the surgeon immediately after surgery. If it's not timed, you don't know when it was written". Interview confirmed there was no documented time of the operative report completed for Patient #10.

Interview on 02/24/2010 at 1150 with the chief medical officer revealed "an immediate post-operative report should be completed by the surgeon immediately after surgery and should be timed". Interview confirmed there was no documented time of the operative report completed for Patient #10.