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Based on policy and procedure review, contract review, administrative staff and physician interviews and observations as referenced in the Life Safety Report of survey completed 04/21/2010, the hospital failed to have an effective governing body to ensure a safe environment for patients and failed to ensure contracted anesthesia services established anesthesia departmental policies.

The findings include:

1. The hospital failed to develop and maintain the facilities in a manner to ensure the safety of patients.

~cross refer 482.41 Physical Environment - Tag A0700

2. The hospital's leadership failed to ensure contracted anesthesia services were provided in a safe and effective manner as evidenced by failing to assure anesthesia departmental policies were established.

~cross refer 482.12(e)(1) Contracted Services - Tag A0084

Based on policy and procedure review, contract review and administrative staff and physician interviews the hospital's leadership failed to ensure contracted anesthesia services were provided in a safe and effective manner as evidenced by failing to assure anesthesia departmental policies were established.

The findings include:

Review of the hospital's "Policy Committee" policy revised May 1, 2008 revealed the hospital "implements and maintains organizational and Human Resources policies that support the vision, goals and values of the organization. In order to accomplish, policies are developed by the designated Responsible Party and presented to and reviewed by Executives/Directors who represent all areas of the corporation. I. Proposed policies and major revisions to existing policies will be communicated with the Executives/Directors for input and discussion via e-mail. II. The President/CEO will approve all policies for placement in the following manuals, which will be located in each department of the organization. A. WilMed Healthcare Policy Manual B. Human Resources Policy Manual III. It will be the responsibility of Administrator/Human Resources to ensure that these policies are reviewed, maintained and distributed to department management. IV. Department Management is responsible for communicating new and/or revised policies to employees in their area(s) of responsibility." Further review of the policy revealed no time frame identified for review of departmental policies.

Review of an "Anesthesia Services Agreement" revealed an agreement between the hospital and an anesthesia corporation to provide anesthesia services at the hospital. Review of the agreement revealed the agreement was signed July 1, 2006 with a yearly automatic renewable term. Review of the "Duties of the Corporation" revealed "3.5 Chief of Anesthesia Department. The corporation will provide a Chief for the Hospital's Anesthesia Department. The Chief will provide professional services in the Department and will also have administrative responsibility for establishing departmental policies and procedures.... Specifically, the Chief shall be responsible for supervising and overseeing the Corporation's provision of the administrative services set forth in Section 3.6 below. 3.6 The Corporation shall: (b) develop and recommend to the Hospital clinical policies relevant to provision of the services, including participation with Hospital departments in the development and implementation of clinical pathways, infection control standards and other quality control monitors...."

Review of Anesthesia policies and procedures revealed the policies had no effective dates and no approval dates or signatures. Interview on 04/21/2010 at 1745 with the Vice President of Medical Affairs revealed the Anesthesia policies that were presented to the surveyor were draft policies. Anesthesia policies that were currently in effect were requested on 04/21/2010 at 1745.

Interview on 04/22/2010 at 0950 with the Vice President of Medical Affairs revealed the Chief of Anesthesia is responsible for development, review and revision of anesthesia policies. The physician stated he did not know how often the policy review should be done but he would expect a review should be done annually. Anesthesia policies that were currently in effect were requested again on 04/22/2010 at 0950. Interview revealed the anesthesia policies available were in draft form and confirmed that the policies had not been approved. Interview revealed that the Chief of Anesthesia was unable to be contacted for interview. Interview revealed the physician was not aware of the lack of current anesthesia policies until the policies were requested by the surveyors. Interview confirmed that anesthesia is a contracted service.

Interview on 04/22/2010 at 1005 with an administrative nursing staff member revealed the Chief of Anesthesia is responsible for development, review and revision of anesthesia policies. Interview revealed that anesthesia policies were required to be reviewed by the Chief of Anesthesia every two years. Interview revealed that the Chief of Surgery would be expected to sign any anesthesia policy revisions. Interview revealed the Operating Room Manager would be responsible to assure the anesthesia policies were reviewed every two years.

Anesthesia policies that were currently in effect were requested again on 04/22/2010 at 1850. No current anesthesia policies were provided. Interview on 04/22/2010 at 1850 with an administrative nursing staff member revealed no approved anesthesia policies were available. Interview revealed the only anesthesia policies available were in draft form and the policies had not been completed and were not approved. Interview confirmed the the hospital's leadership failed to ensure anesthesia services provided under contract developed and maintained current policies.

Based on policy review, closed medical record review, Incident Report review and staff interview the hospital failed to report the death of 1 of 1 sampled patients that died within 24 hours of restraint to CMS by the close of business the next business day following knowledge of the patient's death (#18).

The findings include:

Review of current hospital policy entitled "Restraint Policy" dated 04/04/2008 revealed, "...Complete a Q.C.C. (Incident Report) and notify manager and/or designee when an injury or death occurs while a patient is in restraints or seclusion or deaths that occur within 24 hours after restraints have been released....The manager or designee will notify the Risk Manager....Deaths must be reported no later than the close of business the next business day following knowledge of the patient's death...."

Closed medical record review for Patient #18 revealed a 77 year-old female that was admitted on 03/12/2010 with bilateral pneumonia. Record review revealed the patient was in bilateral soft wrist restraints to prevent removal of medical devices from 03/14/2010 at 1500 until 03/15/2010 at 0930. Record review revealed the patient expired on 03/15/2010 at 1830 (9 hours after restraints were removed). Review of a progress note signed by the Risk Manager dated 04/02/2010 at 0845 revealed, "Risk Management - Death reported to CMS..." (13 days after the patient expired).

Review of an Incident Report (QCC) revealed a nurse documented the death of the patient within 24 hours of restraint and the manager reviewed and signed the report on 03/16/2010. Review of the report revealed on 03/20/2010 the Risk Manager signed she had received the report. Further review of the report revealed the Risk Manager noted that she had reported the death to CMS on 04/02/2010 (13 days after the patient expired).

Interview with the Risk Manager on 04/21/2010 at 1130 revealed the manager that signed the Incident Report regarding Patient #18's death was out of town and not available for interview. Interview revealed the Risk Manager knew restraint deaths had to be reported, but did not know they had to be reported by the close of business the next business day following knowledge of the patient's death. Interview revealed a few weeks ago consultants that were auditing the hospital informed her of the requirement for immediate reporting of restraint deaths. Interview confirmed the Risk Manager reported Patient #18's death to CMS on 04/02/2010 (13 days after the patient expired) and not on the next business day following her knowledge of the patient's death.

Based on hospital policy review, observations during tour, and staff interview, the hospital failed to ensure unauthorized individuals cannot gain access to confidential health information stored in patient medical records by failing to limit access to the Health Information Management (HIM) Department after normal hours of operation.

The findings include:

Review of hospital policy "Security and Integrity of Health Information" Number 42.5 revised 06/25/2009 revealed "...The hospital staff is responsible to protect the security and integrity of the patient health information... 3. The HIM Department is locked when not staffed and only accessible by badge reader..." Further review revealed no available documentation the policy identified the hospital staff authorized to access the HIM department after normal hours of operation.

Observation during tour on 04/22/2010 at 0930 of the HIM department revealed the main entry door was located off of a main corridor used by staff and visitors. Observation revealed the main entry door was secured with an electronic badge reader locking system. Observation revealed upon entry into the department files containing confidential health information were visibly stored in large roller file cabinets and on various other desktop/work space surfaces located throughout the department. Further observation revealed a second entry door into the department located in the far left corner of the department adjacent to the transcription area. Observation revealed the second entry door was secured with an electronic badge reader locking system. Further observation revealed an unsecured entry door with no locking mechanism leading into an interior room (doctor's dictating room) located proximally and to the right of the main entry door. Observation revealed the doctor's dictating room contained file cabinets and/or shelves with individual spaces labeled with physician's names with files containing confidential health information being stored. Observation revealed a second unsecured entry door with no locking mechanism leading into the room from the coding area. Further observation revealed a third entry door (into the doctor's dictating room and HIM department) secured with an electronic badge reader locking system that leads into the doctors dictating room from a hallway that allowed access to restrooms, the physician's lounge, and to the main corridor.

Interview with the HIM Director on 04/22/2010 at 0930 during tour of the HIM department revealed the department's normal hours of operation are 0600 to 0000, seven days per week. Interview revealed HIM staff are present during the normal hours of operation. Interview revealed if medical records are needed from 0001 to 0559 an HIM staff member is on-call to access and retrieve records if needed. Interview revealed incomplete medical records are stored in the doctor's dictation room within the HIM department for completion by the medical staff. Interview revealed the doctor's dictation room is accessible to the medical staff 24 hours per day, seven days per week via badge access. Interview revealed the medical staff are to only have access to the records in which they provided care in order to complete the documentation and close the record. Interview revealed the door leading from the doctor's dictation room into the main HIM file room is unsecured and has no locking mechanism on the door. Further interview revealed the door leading from the doctor's dictation room into the coding area is unsecured and has no locking mechanism on the door. Interview revealed the medical staff should not have access to the medical records stored in the main HIM file room. Interview confirmed the medical staff currently have access to the main HIM file room after normal hours of operation via the two unsecured doors leading out of the doctor's dictation room. Interview revealed the hospital's HIM policies do not specifically identify who is authorized to have access to confidential health information contained in the medical records. Interview revealed the HIM department was staffed 24 hours per day until about one year ago, however, no changes were made regarding limiting the medical staff's access after normal hours of operation were decreased. Interview confirmed medical staff access to the main HIM file room is a confidentiality and security issue.

Based on the hospital's drug record review, staff interview and policy and procedure review, the hospital failed to ensure accurate records for scheduled drug waste by registered nurses in order to minimize the risks of diversion or actual loss of the drugs.

The findings include:

A review of the hospital's emergency department automated drug dispensing machine drug records for "Returns and Wastes" (dated 03/22/2010 through 04/21/2010) revealed a list of the scheduled drugs that were removed from the automated drug dispensing machine by registered nurses for medication administration. Documentation on the record also revealed the date and times of the removed drugs along with the waste times that were automatically documented when the nursing staff wasted any leftover amounts of the scheduled drugs. Review of the automated documentation revealed dates and times of removal from machine and documented waste by nursing staff for the scheduled drugs as;

~Valium 10 milligrams vial removed 03/31/2010 at 2119 with 5 milligrams wasted on 04/01/2010 at 0409 (total of 6 hours and 50 minutes after removal),
~Fentanyl 100 micrograms injectable removed on 04/05/2010 at 1029 and wasted on 04/05/2010 at 1700 (total of 6 hours and 31 minutes after removal),
~Dilaudid 2 milligram injectable removed on 03/29/2010 at 1317 and wasted on 03/29/2010 at 1932 (total of 6 hours and 15 minutes after removal),
~Dilaudid 2 milligram injectable removed on 04/11/2010 at 0005 and wasted on 04/11/2010 at 0728 (total of 7 hours and 23 minutes after removal),
~Dilaudid 2 milligram injectable removed on 04/11/2010 at 0325 and wasted on 04/11/2010 at 0728 (total of 4 hours and 3 minutes after removal),
~Dilaudid 2 milligram injectable removed on 04/11/2010 at 2245 and wasted on 04/12/2010 at 0154 (total of 3 hours and 9 minutes after removal),
~Dilaudid 2 milligram injectable removed on 04/11/2010 at 2201 and wasted on 04/12/2010 at 0502 (total of 7 hours and 1 minute after removal),
~Ativan 2 milligram vial removed on 03/21/2010 at 2043 and wasted on 03/22/2010 at 0301 (total of 7 hours and 18 minutes after removal),
~Ativan 2 milligram vial removed on 03/22/2010 at 2023 and wasted on 03/23/2010 at 0721 (total of 10 hours and 58 minutes after removal), and
~Ativan 2 milligram vial removed on 04/04/2010 at 0910 and wasted on 04/04/2010 at 1506 (total of 5 hours and 56 minutes after removal).

The review of the documentation revealed no documentation of where the schedule drugs waste was kept during from the time of the patient administration to the time that the controlled substance was documented as wasted by the nursing staff.

An interview on 04/22/2010 at 1500 with the hospital's pharmacy director and administrative nursing staff revealed that the report was something that was not checked for times. The interview further revealed that the nursing staff should not be keeping the scheduled drugs waste around without wasting the medications as soon as possible. The interview did revealed that the hospital does not have a system in place that would be readily available in identifying any possible loss or diversion to the time of detection for the controlled substances wasted in the emergency department.

A review of the hospital's policies and procedures revealed that the hospital does not have any policies and procedures that minimizes scheduled drug diversion. The interview with the pharmacy director on 04/22/2010 at 1500 confirmed that the hospital only has policies that address discrepancies.

Based on policy and procedure reviews, observations during tour, and staff interviews the hospital's dietary staff failed to carry out their respective duties in a competent manner to ensure that foods were stored in a safe and sanitary manner.

The findings include:

1. Review of hospital policy "Dented Cans," P&P 102, last reviewed 03/02/2010 revealed, "...a. Place any dented cans found on the dented can shelf. b. Do not use dented cans. 4. Dented cans will be returned to the supplier, for credit..."

Review of hospital policy "Food Refrigeration Storage," last reviewed 03/02/2010 revealed, "...General Storage Policies 1. ...Document temperatures twice daily. If temperatures are not within appropriate degree range as listed on each log, document action taken in the space provided. 2. ...Keep frozen food at 0*F (Farenheit) or below except during thawing periods. ...Storage of Perishable Foods ...2. All prepared refrigerated foods are properly covered and dated while in storage. ...4. Keep fresh meat, fish and poultry which will not be used within two days in the freezer at 0*F or below. ...8. Store all frozen foods immediately at 0*F when received. ..."

Review of hospital policy "Cooling of Foods," last reviewed 03/02/2010 revealed "...4. Date and identify all chilled foods which are not scheduled for immediate service."

2. Observations during tour of the hospital's main kitchen on 04/22/2010 from 1030-1230 revealed:

In the dry storage areas:
a. Observation on 04/22/2010 at 1030 in the dry storage room revealed the following dented (damaged) canned food items stored on the same shelf as undamaged canned food items: (1) chillie Verde, (1) roasted red peppers, (1) peaches, (1) pears, (1) lemon pudding, (1) pineapple tidbits, and (1) ravioli. Interview during tour with supervisory dietary staff, revealed dented cans are not suppose to be stored on the same shelves as undamaged canned foods. Interview revealed damaged cans are separated, removed and stored on the "dented can shelf" and are to be returned to the supplier for credit. Interview revealed the dietary staff failed to follow hospital policy and procedure.

In freezer storage areas:
b. Observation on 04/22/2010 at 1045 revealed the temperature of walk-in freezer #1 was 23 degrees Farenheit (23 degrees high). Review of the temperature log for April 2010 for freezer #1 revealed "Acceptable Temps: Freezer: Zero degrees F or below..." Review revealed temperatures recorded twice daily from 04/01/2010 to 04/21/2010 and once on 04/22/2010 (22 days). Further review revealed documented temperatures between the range of 16 degrees F to 35 degrees F. Review failed to reveal freezer #1 was maintained at an acceptable temperature of Zero (0) degrees F or below. Further review revealed no actions were taken by dietary staff for abnormal temperatures on 15 of 22 days in April 2010 for freezer #1. Observation of the inside of walk-in freezer #1 revealed a metal tray of frozen biscuits covered with clear wrap stored on a cart, not dated or labeled. Further observation revealed two metal trays of left over meat loaf dated 02/25/2010 (56 days old) stored on a cart. Observation on 04/22/2010 at 1055 revealed the temperature of walk-in freezer #2 was 18 degrees Farenheit (18 degrees high). Review of the temperature log for April 2010 for freezer #2 revealed "Acceptable Temps: Freezer: Zero degrees F or below..." Review revealed temperatures recorded twice daily from 04/01/2010 to 04/21/2010 and once on 04/22/2010 (22 days). Further review revealed documented temperatures between the range of 10 degrees F to 20 degrees F. Review failed to reveal freezer #2 was maintained at an acceptable temperature of Zero (0) degrees F or below. Further review revealed no actions were taken by dietary staff for abnormal temperatures on 22 of 22 days in April 2010 for freezer #2. Observation at 1055 inside of walk-in freezer #2 revealed (1) container of Philly steak meat partially uncovered stored on a shelf, (3) pans of roast beef partially uncovered stored on a shelf, and (1) container of vegetable lasagna partially uncovered stored on a shelf. Interview with supervisory dietary staff during tour revealed "we have been having issues with the walk-in freezers for several years now." Interview revealed freezer #1 and #2 have been running abnormal high temperatures because "we are unable to get them down to zero." Interview revealed multiple PM (preventative maintenance) requests have been submitted to fix the freezers. Interview revealed dietary policy requires foods to be stored at zero (0) or below in the freezers. Further interview revealed all left over foods or prepared foods are to be dated and labeled when placed into the freezer. Interview revealed all foods placed into the freezer should be completely covered. Interview revealed meats are generally not placed in freezer #1. Interview revealed the meat loaf should have been discarded within 30 days after being placed in the freezer. Interview revealed dietary staff failed to follow hospital policy and procedures.

Interview on 04/22/2010 at 1500 with hospital administrative management staff revealed the dietary director brought the need to replace the walk-in freezers to the attention of the hospital administration. Interview revealed the freezers are considered a capital expenditure item and were placed on the 3 year capital expenditure list. Interview revealed items are purchased on the capital expenditure list based on priority. Interview revealed "we will have to look at the list and re-prioritize."

In the food preparation areas:
c. Observation on 04/22/2010 at 1100 in the main kitchen food preparation areas revealed seven (7) large storage bins with clear lids. Further observation revealed bin #1 (three-quarters full) of brown rice; bin #2 (three-quarters full) of white sugar; bin #3 (almost completely empty) with brown gravy mix; bin #4 (three-quarters full) with seafood breading; bin #5 (one-quarter full) with chicken gravy; bin #6 (one-half full) with biscuit mix; and bin #7 (one-half full) with white flour. Further observation revealed one serving/measuring scoop being stored inside of each bin pushed down into the contents. Interview with supervisory dietary staff during tour revealed the hospital did not have a dietary policy regarding the storage of serving/measuring scoops in food storage bins. Interview revealed he was not aware the serving/measuring scoops in each of the seven bins should not be stored pushed down into the contents of the bins.

In refrigerator storage areas:
d. Observation on 04/22/2010 at 1115 inside of walk-in cooler #3 revealed a metal pan containing lettuce and onions covered with clear wrap, not dated or labeled. Observation at 1130 inside of walk-in cooler #4 revealed a metal pan containing pineapple tidbits, not dated or labeled. Further observation revealed unfrozen/thawed beef and ground beef in individual packages (with visible blood tinged liquid in the packages) stored in cardboard boxes with no drip pans under the cardboard boxes to contain liquids. Observation revealed other food items being stored beneath the cardboard boxes on a shelf. Interview with supervisory dietary staff during tour revealed all left over foods, prepared foods, or foods removed from their original container and placed into the refrigerators are to be dated and labeled when placed into the refrigerator. Interview revealed a drip pan should have been placed under the cardboard boxes containing the beef and ground beef in order to contain any possible leakage. Interview revealed the dietary staff failed to follow hospital policy and procedure.

Based on observations as referenced in the Life Safety Report of Survey completed 04/21/2010 the hospital failed to develop and maintain the facilities in a manner to ensure the safety of patients.

The findings include:

1. The hospital failed to develop and maintain a safe physical plant and overall safe environment to assure the safety and well being of patients.

~Cross-refer to 482.41(a) Physical Environment Standard Tag A0701.

2. The hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

~Cross-refer to 482.41(b)(1)(2)(3) Physical Environment Standard Tag A0710.

Based on observations during tour as referenced in the Life Safety Report of Survey completed 04/21/2010, the hospital failed to ensure the condition of the physical plant and overall hospital environment was developed and maintained in a manner that the safety and well being of patients were assured by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

The findings include:

Building 01:
1. Based on observations on 04/20/2010, 10 AM onward, the following was noted:

a. The facility utilizes delayed egress locks and NC special locking systems (electromagnetic locks) on required exit doors. These systems are allowed only in facilities that are fully covered by either an automatic, supervised sprinkler system and/or an automatic, supervised smoke or heat detection system. This facility is not fully covered by either or a combination thereof.

b. The sixth (6) floor exit doors have these locks that are no longer in use. These locks must have at least one of the magnetic plates removed in order to be considered disabled.

c. In the birthing center, the path of egress directs you through a NC special locking system and then through a delayed egress system. You can not be required to pass through two (2) systems in order to exit the facility.

d. The delayed egress system on the birthing and nursery floor (2nd floor) is activated by a transmitter. If the delayed egress process is activated by pressure applied to the release device, the door must unlock and remain unlocked until manually relocked. These locks automatically relock if another transmitter is brought with in range of the door.

e. Some of these doors/locks relock if the fire alarm is placed in the silenced mode and has not been reset. These doors may not relock until the Fire Alarm has been reset.

f. There are electromagnetic locks on the first (1) floor that only have a card swipe to unlock the door (no emergency override switch). This also includes the exit door at the birthing area.

g. There is not a hard surface Exit discharge path from the exit at Cardiac Rehabilitation and Virtual Learning.

h. There are some doors on all floors that require two (2) motions of the hand in order to exit the rooms.

i. There is an electrical closet near the 6th. floor nurses station that can not be opened from the inside if the door is locked. A person can be locked out any room but they can not be locked in the room.

42 CFR 483.70 (a)

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 038.

2. Based on observation on 04/20/2010:

a. When tested, there was a sprinkler tamper alarm that did not sound the alarm.

b. There were tamper alarms attached to the valves with "J" hooks.

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 061.

3. Based on observation on 04/20/2010:

a. There was storage in front of the electrical panel in the O.R. (operating room) dark room.

b. There were two (2) surge protectors connected in tandem in the 4th (fourth) FACP room.

c. There was a cover missing from a 4x4 junction box in the penthouse.

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 147.

Based on observations as referenced in the Life Safety Report of survey completed 04/21/2010, the hospital failed to ensure the safety and well-being of patients by failing to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA).

The findings include:

Building 01:
1. Based on observation on 04/20/2010 there was an area in Telemetry that no Exit sign in view to designate the exit path.

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 047.

2. Based on observation on 04/20/2010 there was no audible/visual trouble signal received when the battery back-up was disconnected in the 4th floor FACP (Fire Alarm Control Panel).

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 051.

3. Based on observation on 04/20/2010:

a. A large amount of supplies were permanently stored in the egress corridor at #7 O.R.

b. There were Computer on Wheels (C.O.W.s) (6), B.P. machines (3) being charged in the exit egress corridor outside a nurses station. This area had been wired for this purpose.

c. There is a linen closet near room 216A that has two (2) doors that open into the egress corridor. These doors do not open 180 degrees nor do they have closers on them. These doors reduce corridor width and obstruct the exit egress path when left in the open position.

~ Cross refer to NFPA 101 Life Safety Code Standard - Tag K 072.

Based on observation, staff interview and review of the hospital's policies and procedures, the hospital failed to prevent infection control cross-contamination between staff, equipment and patients in the hospital's hemodialysis unit.

The findings include:

Observation on 04/21/2010 in the hospital's hemodialysis unit revealed that the unit had a total of 4 observed hemodialysis stations/beds where 4 patients were undergoing hemodialysis. At 1012, observation revealed that a registered nurse (orientation) at station #4 was not wearing any PPE (personal protective equipment) or gloves while at the stations machine providing patient care. The observation revealed that the registered nurse touched the hemodialysis machine (considered dirty and contaminated while in use) without wearing any gloves or other PPE. Observation revealed that the unit's charge nurse instructed the registered nurse to put on PPE.

On 04/21/2010 at 1024, observation revealed that a wooden clipboard was located on top of the hemodialysis machine (considered dirty and contaminated while in use). Observation then revealed that the registered nurse assigned to patient care for station #1 was observed to pick up the wooden clipboard without gloves for documentation. Observation further revealed that the nurse then placed the wooden clipboard back on top of the hemodialysis machine without every washing or sanitizing her hands.

On 04/21/2010 at 1030, observation revealed that all 4 stations had bedside tables for the patients with strips of tape placed on the corner of the metal bedside table. The observation revealed that the tape was used for the patient's vascular access security after the hemodialysis treatment was completed.

An interview on 04/21/2010 at 1100 with the unit's nurse manager revealed that the staff should not be cross-contaminating patients while in hemodialysis. The interview revealed that the nurse in orientation should have had his PPE on and gloves on before touching the dirty machine. The interview also revealed that the wood clipboard was considered dirty and should also have gloves used when holding it. The interview further revealed that the tape was used for the vascular access sites of the patients and she did not think of the fact that the tape was touching dirty bedside table and then placed on the vascular access site that is clean.

An interview with the infection control officer on 04/22/2010 at 1145 revealed that the dialysis unit staff did cross-contaminate the patients by the observed actions of the staff. The interview also revealed that presently no policies and procedures have been approved that uses the contracted dialysis company's policy's specific to hemodialysis care.

A review of the hospital's policies and procedures revealed that the hospital had no documentation to use the contracted dialysis company's policy's for infection control. The review revealed a rough draft with the documentation to use the company's policy's, but the policy for the hospital was not approved during the survey.

Based on credential file review, staff and Phrygian interviews the Surgical Services department failed to delineate privileges for a Physicians Assistant (PA) to suture (close) a surgical incision in 1 of 1 PA's reviewed (PA #1).

The findings include:

Interview with administrative surgery nursing staff on 04/20/2010 at 1500 revealed the Surgery Department had one PA that assisted one of the orthopedic surgeons. The interview revealed the PA closes (sutures) the surgical incisions for the surgeon at the end of the surgery. The interview revealed the staff were not aware if the PA had privileges to suture a surgical incision. The interview revealed the staff was not sure if the PA was suturing dermis (skin), subcutaneous tissue (tissue between skin and muscle) or fascia (muscle).

Review of the credential file for PA #1 revealed no documentation of privileges granted to suture a surgical incision.

Interview with administrative staff on 04/21/2010 at 1615 revealed the administration was not aware that PA #1 was closing surgical cases. The interview revealed after a discussion with administrative staff the evening before (04/21/2010) it was discovered there were three different thoughts about the PA #1's practice. The interview revealed some staff did not know PA #1 closing surgical cases, some staff thought PA #1 was closing the dermis only and some thought PA #1 was suturing the fascia. The interview revealed there was no documentation of PA #1 requesting or being granted privileges to suture a surgical incision.

Interview with the Medical Director on 04/22/2010 at 1630 revealed PA #1 did not have current privileges to sutures a surgical incision. The interview revealed PA #1 should have been granted privileges to perform suturing /closing a surgical case.

Based on Medical Staff Rules and Regulations review, medical record review and staff interview, the hospital failed to ensure an updated history and physical was completed within 24 hours after admission and prior to surgery for 3 of 8 sampled surgical patients (#'s 15, 12, and 16).

The findings include:

Review of Medical Staff Rules and Regulations revised 11/2009 revealed, "...A relevant history and physical examination is required on each patient having surgery...." Further review of the Rules and Regulations revealed no documentation of a rule to ensure physician's updated history and physical examinations within 24 hours after admission and prior to surgery for patients that had history and physical examinations completed within 30 days before admission.

1. Closed medical record review for Patient #15 revealed a 34 year old male admitted to Same Day Surgery on 01/05/2010 for an open reduction and internal fixation of the right ankle (surgical repair of a fractured ankle) with spinal anesthesia. Record review revealed the surgery started at 1041 and ended at 1128. Record review revealed the patient was discharged to home on 01/05/2010 in the afternoon. Record review revealed physician's documentation of a history and physical examination that was dictated on 12/29/2009 (7 days before the patient's admission and surgery). Record review revealed the dictated history and physical was transcribed on 01/05/2010 at 1003 (38 minutes prior to surgery) and was signed by the physician on 01/12/2010 (7 days after surgery). Further record review revealed no documentation of an updated history and physical within 24 hours after admission and prior to surgery.

Interview on 04/22/2010 at 1330 with the Same Day Surgery/PACU Manager revealed an updated history and physical must be completed within 24 hours of admission and prior to surgery. Interview confirmed there was no documented evidence of an updated history and physical within 24 hours of admission and prior to the patient's surgery.



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2. Closed medical record review for Patient #12 revealed a 65 year old male admitted on 11/09/2009 for a Left Total Knee Replacement surgery using spinal anesthesia. Record review revealed the patient had a Left Total Knee Arthroscopy without complications on 11/09/2009. Record review revealed the patient was discharged to home on 11/12/2009. Record review revealed documentation of a history and physical examination completed and dictated by a Physician's Assistant (PA) on 11/05/2009 (4 days before the patient's admission and surgery). Record review revealed the dictated history and physical was transcribed on 11/05/2010 and was signed by the physician and PA on 11/09/2009. Further record review revealed on the "History & Physical Examination" form with documentation hand written across the form "Dictated" with no date, time or signature. Further review revealed on the "UPDATE TO HISTORY & PHYSICAL" form a physician signature in the "MD Signature" section without a date or time. Further review of the form revealed no documentation (blank) under the "There have been no changes subsequent to the attached History and Physician dated". Record revealed no documentation of an updated H & P prior to surgery.

Interview on 04/21/2010 at 1340 with the Surgery Administrative nursing staff revealed an updated history and physical must be completed within 24 hours of admission and prior to surgery. Interview confirmed there was no documented evidence of an updated history and physical within 24 hours of admission and prior to the patient's surgery. The interview revealed it is the responsibility of the Pre-Op RN to ensure that an H & P is in the record.

3. Closed medical record review of Patient #16 revealed a 3 year-old admitted on 12/02/2009 for chronic otitis media and retained ear tube. Record review revealed the patient had bilateral myringotomy with ear tube placement, removal of ear tube with paper patch myringoplasty and an Adenoidectomy performed on 12/02/2009. Record revealed no documentation of an updated H & P prior to surgery.

Interview on 04/21/2010 at 1340 with the Surgery Administrative nursing staff revealed an updated history and physical must be completed within 24 hours of admission and prior to surgery. Interview confirmed there was no documented evidence of an updated history and physical within 24 hours of admission and prior to the patient's surgery. The interview revealed it is the responsibility of the Pre-Op RN to ensure that an H & P is in the record.

Based on Medical Staff Rules and Regulations review, medical record review and staff interview, the hospital failed to ensure an operative report was completed immediately following surgery for 7 of 8 sampled surgical patients (#15, #20, #17, #14, #13, #16, #32).

The findings include:

Review of Medical Staff Rules and Regulations revised 11/2009 revealed, "...Operative and Special Procedure Reports Operative and special procedure reports must contain, as applicable, a detailed account of the findings, the technical procedures used, the specimens removed, the post-operative diagnosis, and the name of the primary performing practitioner and any assistants. If the report is dictated and not immediately transcribed or not written in the record immediately after the procedure, the practitioner must enter a comprehensive operative progress note in the medical record immediately after the procedure providing sufficient and pertinent information for use by any practitioner who is required to attend the patient. The complete report must be written or dictated immediately following the procedure, filed in the medical record as soon after the procedure as possible, and promptly signed by the primary performing practitioner...."

1. Closed medical record review for Patient #15 revealed a 34 year old male admitted to Same Day Surgery on 01/05/2010 for an open reduction and internal fixation of the right ankle (surgical repair of a fractured ankle) with spinal anesthesia. Record review revealed the surgery started at 1041 and ended at 1128. Record review revealed the patient was monitored in the Post Anesthesia Care Unit (PACU) until 1245. Record review revealed the patient was discharged to home on 01/05/2010 in the afternoon. Record review revealed the surgeon dictated an operative report on 01/05/2010 at 1140. Record review revealed the dictated operative report was transcribed on 01/06/2010 at 1217 (the day after the patient had surgery and was discharged to home). Further record review revealed no documentation of an immediate operative report.

Interview on 04/22/2010 at 1330 with the Same Day Surgery/PACU Manager revealed, "All physicians are supposed to do an immediate post-operative note, even for outpatients." Interview revealed an immediate operative report was important because it informed staff and physicians that treated the patient following surgery to know what had occurred during surgery, in case the patient had post-operative complications. Interview confirmed there was no available documentation of an immediate operative report.

2. Closed medical record review for Patient #20 revealed a 75 year-old female that was admitted on 02/22/2010 with acute abdominal pain. Record review revealed the patient underwent an exploratory laparotomy with small bowel resection (surgical abdominal exploration with removal of small intestines). Record review revealed the surgery started at 1802 and ended at 1832. Review of the immediate operative report signed by the surgeon on 02/22/2010 at 1832 revealed no documentation of pre-operative or post-operative diagnoses. Further record review revealed no documentation of a dictated operative report. Record review revealed on 02/28/2010 at 0535 the patient expired.

Interview on 04/21/2010 at 1315 with the Risk Manager revealed the surgeon must dictate an operative report, even if he has written an operative report in the progress notes. Interview confirmed there was no available dictated operative report for Patient #20's surgery on 02/22/2010. Further interview revealed the immediate operative report must contain the patient's pre-operative and post-operative diagnoses. Interview confirmed the immediate operative report for Patient #20 did not include pre-operative and post-operative diagnoses.



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3. Closed medical record review of Patient #17 revealed a 77 year-old female admitted on 03/01/2010 for osteoarthritis left knee. Record review revealed the patient had a left total knee arthroplasty performed on 03/01/2010 beginning at 0734 and ending at 0908. Review of the "Post Op(erative) Progress Note" signed by the surgeon on 03/01/2010 at "9" revealed no documentation of a date and time of the surgery, pre and post operative diagnosis, type of anesthesia administered, complications, description of operative findings, specimens removed or a description of specific surgical tasks that were conducted by practioners other than the surgeon. Review of a dictated "Operative Note" transcribed 03/03/2010 (2 days after the surgery) and signed by the surgeon 03/11/2010 (10 days after the surgery) revealed a Certified Physician's Assistant (PAC) was recorded as assisting with the surgical procedure. Further review revealed no documentation of the specific surgical tasks that were conducted by the PAC.

Interview on 04/22/2010 at 1625 with administrative staff revealed an operative note is supposed to be written immediately after surgery to ensure communication about the surgery prior to the dictated operative report being placed in the patient's chart. Interview confirmed the brief operative note for Patient #17 was not complete. Interview confirmed the surgeon did not document the time of the post operative note accurately and the staff member was unable to verify the note was written immediately following the surgical procedure. Further interview confirmed the dictated operative note was not available immediately after surgery and failed to include the specific surgical tasks performed by the PAC.

4. Closed medical record review of Patient #14 revealed a 44 year-old male admitted on 02/26/2010 with a melanoma on the right shoulder. Record review revealed the patient had a sentinel node biopsy in right axilla and wide excision of right shoulder mass on 02/26/2010 beginning at 1348 and ending at 1440. Record review revealed a dictated "Operative Note" that was transcribed on 02/26/2010 at 1642 (2 hours and 2 minutes after surgery) and signed by the surgeon on 03/01/2010 (3 days after surgery). Record review revealed no further documentation of an immediate post operative note.

Interview on 04/22/2010 at 1740 with administrative staff revealed an operative note is supposed to be written immediately after surgery to ensure communication about the surgery prior to the dictated operative report being placed in the patient's chart. The interview revealed the dictated operative report was not available immediate following the surgical procedure and there was no evidence an immediate operative note was completed as required.



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5. Closed medical record review of Patient #13 revealed a 32 year-old admitted on 02/22/2010 for uterine fibroids. Record review revealed the patient had a Total Abdominal Hysterectomy, left salpingo-oophorectomy and lysis of adhesions performed on 02/22/2010. Review of the pre-printed "Post Op(erative) Progress Note" signed by the surgeon on 02/22/2010 at 0843 revealed no documentation of the time of the surgery, pre-operative diagnosis, type of anesthesia administered, description of operative findings/techniques.

Interview on 04/22/2010 at 1340 with administrative staff revealed an operative note is supposed to be written immediately after surgery. The interview revealed the pre-printed "POST-OP PROGRESS NOTE" formate stamp did not contain the required elements to be included in the immediate operative report. Interview confirmed the brief operative note for Patient #16 was not complete. Interview confirmed the surgeon did not document the time of the surgery, pre-operative diagnosis, type of anesthesia administered, complications, description of operative findings or specimens removed. The interview revealed there was no further documentation available.

6. Closed medical record review of Patient #16 revealed a 3 year-old admitted on 12/02/2009 for Chronic otitis media and retained ear tube. Record review revealed the patient had bilateral myringotomy with ear tube placement, removal of ear tube with paper patch myringoplasty and an Adenoidectomy performed on 12/02/2009. Review of the pre-printed "Post Op(erative) Progress Note" signed by the surgeon on 12/02/2009 at 0810 revealed no documentation of the time of the surgery, pre-operative diagnosis, type of anesthesia administered, complications, description of operative findings/techniques or specimens removed. Review of the sections for description of findings and specimens removed revealed the sections were blank.

Interview on 04/22/2010 at 1340 with administrative staff revealed an operative note is supposed to be written immediately after surgery. The interview revealed the pre-printed "POST-OP PROGRESS NOTE" formate stamp did not contain the required elements to be included in the immediate operative report. Interview confirmed the brief operative note for Patient #16 was not complete. Interview confirmed the surgeon did not document the time of the surgery, pre-operative diagnosis, type of anesthesia administered, complications, description of operative findings or specimens removed. The interview revealed there was no further documentation available.



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7. Closed medical record review of Patient #32 revealed a 43 year-old female, diagnosed with renal cancer of the left kidney, admitted on 03/24/2010 for a scheduled surgery to remove the left kidney. Record review revealed the patient developed a pneumothorax (free air in the chest outside the lung) during surgery. Record review revealed a "POST-OP PROGRESS NOTE" dated 03/24/2010 at 0950 and signed by the surgeon. Review of the "POST-OP PROGRESS NOTE" revealed the following pre-printed headings: "Surgeon/Assistant, Procedure(s) Performed, Estimated Blood Loss, Specimens Removed, Description of Findings, and Post-Op Diagnosis." Review of the "POST-OP PROGRESS NOTE" the surgeon documented in hand-writing adjacent to each heading. Record review revealed the "POST-OP PROGRESS NOTE" dated 03/24/2010 at 0950 did not document the date and time of surgery, type of anesthesia used, or complications.

Interview on 04/22/2010 at 1625 with administrative staff revealed the "POST-OP PROGRESS NOTE" form completed by the surgeon of Patient #32 did not include the date and time of surgery, type of anesthesia used, or complications.

Based on medical record review and staff interview the hospital failed to ensure a post-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia no later than 48 hours after surgery for 3 of 8 sampled surgical patients (#15, #13, #16).

The findings includes:

1. Closed medical record review for Patient #15 revealed a 34 year old male admitted to Same Day Surgery on 01/05/2010 for an open reduction and internal fixation of the right ankle (surgical repair of a fractured ankle) with spinal anesthesia. Record review revealed anesthesia start time was 1014 and and anesthesia end time was 1142, at which time the patient was taken to the Post Anesthesia Care Unit (PACU). Record review revealed the patient was discharged from the PACU at 1245. Record review revealed the patient was discharged to home on 01/05/2010 in the afternoon. Record review revealed no documentation a post-anesthesia evaluation was completed by an individual qualified to administer anesthesia prior to the patient's discharge.

Interview on 04/22/2010 at 1330 with the Same Day Surgery and PACU revealed anesthesia staff did not evaluate outpatient surgery patients prior to discharge prior to "a month or so ago" when consultants that were auditing the hospital pointed out the requirement. Interview confirmed there was no available documentation of a post-anesthesia evaluation completed by an individual qualified to administer anesthesia prior to Patient #15's discharge. Further interview revealed in January 2010 (when the patient had surgery) the hospital did not have a policy for post anesthesia evaluations.




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2. Closed medical record review of Patient #13 revealed a 32 year-old hemodialysis patient admitted on 02/22/2010 for uterine fibroids. Record review revealed the patient had a total abdominal hysterectomy, left salpingo-oophorectomy and lysis of adhesions performed under general anesthesia on 02/22/2010. Record review revealed no documentation of a post anesthesia evaluation.

Interview on 04/22/2010 at 1340 with administrative staff revealed a post anesthesia evaluation should be completed. The interview revealed there was no documentation available of a post anesthesia evaluation for patient #13.

3. Closed medical record review of Patient #16 revealed a 3 year-old admitted on 12/02/2009 for Chronic otitis media and retained ear tube. Record review revealed the patient had bilateral myringotomy with ear tube placement, removal of ear tube with paper patch myringoplasty and an adenoidectomy performed on 12/02/2009. Review of the "POST ANESTHESIA PROGRESS NOTES" form revealed the form was not completed. Review of the form revealed all sections were blank. Further record revealed revealed no documentation of a post anesthesia evaluation.

Interview on 04/22/2010 at 1340 with administrative staff revealed a post anesthesia evaluation should be completed. The interview revealed there was no documentation available of a post anesthesia evaluation for patient #16.