HospitalInspections.org

Based on observations, review of facility documents and interviews with staff, it was determined that the facility failed to have an effective Governing Body to ensure that the policies, practices and environment in the hospital promotes safe and quality care to patients in accordance with accepted standards of practice.

The Governing Body failed to ensure that the environment was maintained to ensure patient safety as there was mold in the refrigerator, mattresses were torn and available for patient use, and an emergency call system was not consistently available for patients in the emergency department. Surgical instruments available for patient's use were not being properly sterilized. Endoscopy snares and biopsy forceps available for patient's use were not sterilized between patient's use in accordance with the manufacturer's requirements and accepted standards of practice for infection prevention. Drugs and biologicals were not stored or secured appropriately. Expired drugs were available for patient use. Personnel files were incomplete per facility policy. The facility list of contracts was incomplete and contracts were not being monitored.

Findings were:

1. During a tour conducted on 8-16-11 of the Emergency Department, the survey team found the area was not clean and there was no functioning emergency call system.

Cross Refer: Tag A0701

2. During a tour conducted on 8-16-11, the survey team found significant number of instruments labeled as "sterile instruments" but the instruments were improperly sterilized and were available for patient use.

Cross Refer: Tag A0749

3. During a tour conducted on 8-16-11, the survey team found colonoscopy snares and biopsy forceps that were not sterilized in accordance with the manufacturer's recommendation and in accordance with accepted standards for infection prevention were available for patient use.

Cross Refer: Tag A0749

4. During a tour conducted on 8-16-11 and 8-17-11, the survey team found that drugs and biologicals were not properly stored or secured according to pharmacy policy and procedure.

Cross Refer: Tag A0500, A0502

5. During a tour conducted on 8-16-11 and 8-17-11 on the nursing units, the survey team found expired medications available for patient use.

Cross Refer: Tag A0505

6. During a tour conducted on 8-17-11 of the food services area of the kitchen, the survey team found the area was not cleaned in accordance with the facility's approved policies.

Cross Refer: Tag A620

7. Based on review of personnel records, 10 out of 14 personnel records reviewed did not show any evidence of orientation or training, 6 out of 14 personnel records did not contain any evidence that the employee received a job description, and 8 out of 14 personnel records did not contain any evidence that the employee received an annual performance evaluation.

Review of policy entitled, "Wilbarger General Hospital Personnel Policy and Employee Handbook" revealed a requirement for "all new employees to attend a general orientation program ... orientation to your department and work situation will be given to you by your immediate supervisor. Department and work policies and a copy of your job description will be provided to you at that time and these will be discussed with you by your supervisor or Department Head." The above was confirmed in interview on 8-18-11 with Staff #2 and 35.

There was no oversight of these areas reported to the governing body.

Based on review of hospital records and staff interview, the hospital did not maintain a list of all contracted services, that included the scope and nature of the services provided.

Findings were:

On review of contract list and interview with Staff #3 on 8-18-11, the hospital did not maintain a complete list of all contracted services that included the scope and nature of the services provided. Staff #3 confirmed that the facility had not maintained a contract list and did not have a process for monitoring services provided to ensure that those services were provided in a safe manner and in accordance with accepted standards of practice.

Based on a review of facility documents, observations and staff interviews, the hospital failed to protect and promote each patient's right as contaminated devices and instruments available for patient use were not properly sterilized prior to patient use, there was no functioning emergency call system in the emergency department that was consistently available for patient's use, and the physical environment was not maintained to ensure the safety of the patients.

Findings were:

1. During a tour of the hospital conducted on 8-16-11 and 8-17-11, the physical environment of the hospital was not maintained to ensure the safety of the patients as there were broken items, holes in walls, broken floor tiles, cracked and water damaged ceilings, torn coverings on examination tables, rust in the operating rooms, which created an unsafe environment for patients.

Cross Refer: Tag A0701

2. During a tour conducted on 8-17-11 in the Behavioral Health Unit, the baseboard was secured with duct tape in the seclusion room and there were torn areas in mattresses preventing proper disinfection.

Cross Refer: Tag A0144

3. During a tour conducted on 8-17-11 on the medical/surgical unit and the behavioral health unit, the survey team found that drugs were not properly stored or secured according to pharmacy policy and procedure and were left unattended in the patient hallways.

Cross Refer: Tag A0502

Based on observation during a tour of the hospital, review of records and staff interviews, the hospital failed to ensure that patients received care in a safe setting.

Findings were:

Observation of the emergency department during a tour of the facility accompanied by Staff #2 and Staff #9 on 8-16-11 at 10:55 am revealed there was no functioning emergency call system available for use in each of the emergency department rooms. In Trauma room #3, there was a call light cord, but it was several feet from the patient bed where a patient could not reach it in an emergency. The above was confirmed in interview with Staff # 2 and 9.

Observation of the behavioral health unit during a tour of the facility on 8-17-11 revealed the baseboard had separated from the wall and was being held in place with duct tape in the seclusion room bathroom, which could pose a tripping hazard or a weapon for an aggressive patient, and the area could not be cleaned properly. There were 2-inch tears and torn seams in the mattress in room 26 which prevented the mattress from being properly disinfected after patient use. The above was confirmed in interview with Staff #2 and 12.

Based on review of personnel records, hospital policy, and staff interviews, the hospital failed to ensure that nursing personnel were competent to perform all required duties.

Findings were:

Review of hospital policy #8022, "New Employee Orientation Surgical Services" revealed that "each employee will be oriented to all facets of his or her job, as well as working conditions ... Orientation to working conditions and specific aspects of the job will be conducted by that individual appointed by the department manager on an "on-the-job" basis ... may not be limited to safety and infection control issues pertinent to the organization and the employee ' s department, unit, work setting or program-specific duties and responsibilities." Review of personnel records for Staff # 32 and 33, operating room personnel, revealed no evidence that they received a job description informing them of their duties, and revealed no evidence of orientation at the time of employment for their duties, which involved cleaning and sterilization of surgical instruments. The above was confirmed in interview on 8-17-11 with Staff #2 and #35.

Based on review of records and staff interviews, all medical records were not complete, dated, timed, or authenticated for one of one record reviewed for an outpatient blood transfusion.

Findings were;

Review of one of one outpatient blood transfusion records revealed a written order on a lab report dated 7-27-11 for Patient #25 to " T&C 2 units and transfuse Friday. " The order was unsigned and was not dated or timed. The blood transfusion was completed on Friday, 7-29-2011. This was confirmed in interview with Staff # 2 in the conference room on 8-17-11.

Based on observation during a tour of the facility, review of facility documents and staff interviews, the hospital failed to ensure that pharmaceutical services were supervised according to hospital policies and procedures. There were expired and improperly stored drugs available for patient use. Medications in anesthesia carts were not under the control of the hospital. Drugs were not properly stored or secured.

Findings were:

1. During a tour conducted on 8-17-11 on the medical/surgical unit and the behavioral health unit, the survey team found that drugs were not properly stored or secured according to pharmacy policy and procedure and drugs were left unsecured and unattended in the patient hallways.

Cross Refer: Tag A0502

2. During a tour conducted on 8-16-11 and 8-17-11, the survey team found that drugs and biologicals were not properly stored or secured according to pharmacy policy and procedure.

Cross Refer: Tag A0500

3. During a tour conducted on 8-16-11 and 8-17-11, the survey team found outdated, mislabeled, and otherwise unusable drugs available for patient use in the pharmacy, operating room, and anesthesia carts, patient units.

Cross Refer: Tag A0505

Based on observation during a tour of the hospital and staff interviews, the pharmacy did not maintain control or accountability of drugs in accordance with applicable standards of practice or state laws. Two of two anesthesia carts containing medications for patient use were, at different times, locked without a key and access by pharmacy or any hospital staff was not possible.

Findings were:

Anesthesia cart #1 was locked and the medications were unable to be accessed by pharmacy or any other staff on 8-17-11. Staff #2, 4, 5, and 13 confirmed in interview on 8-17-11 that they were unable to locate a key to open the cart. Staff #13 confirmed in interview that the pharmacy did not have or maintain a key to anesthesia cart #1 on 8-17-11. The pharmacist failed to maintain control and accountability of drugs stored in the cart and failed to ensure that the drugs in the cart were not expired.

Anesthesia cart #2 was locked and the medications were unable to be accessed by pharmacy or any other staff on 8-16-11. Staff #2, 4, and 5 confirmed they were unable to locate a key to open the cart. Staff #2 stated she contacted the pharmacy and confirmed that the pharmacy also did not have a key to anesthesia cart #2 on 8-16-11. The pharmacist failed to maintain control and accountability of drugs stored in the cart and failed to ensure that the drugs in the cart were not expired.

The above was confirmed in interview with Staff #2, 4, and 5.

Based on observation and staff interview, drugs were not kept in a secure area and appropriately locked when in patient hallways on the medical/surgical unit and the behavioral health unit.

Findings were:

Based on observation in the medical/surgical hallway during a hospital tour on 8-17-11, a medication cart was observed to be unlocked and unattended. The medications in the cart were unsecured and accessible to passersby. The medication cart contained Lasix, Digoxin, Klor Con, Spironolactone and other medications. The above was confirmed in interview with Staff #2 and #7.

Based on observation in the behavioral health unit hallway during a hospital tour on 8-17-11, a pharmacy technician who was delivering medications for the behavioral health patients left an unlocked medication cart unattended in the patient hallway. The unlocked medication cart contained at least six drawers of medications. The pharmacy technician was observed leaving the unsecured cart unattended and out of her line of sight as she walked through the nurses station and then into the medication room. Two patients were observed in the hallway walking past the unsecured carts while the pharmacy technician was in the medication room. Interview with the Staff #2 and Staff #7 confirmed that the carts were unattended and unlocked containing unsecured medications which were accessible to patients on the behavioral health unit.

Review of hospital policy #3002 revealed that "Lockable medication carts are used to store unit-of-use medications in the patient medication dose system. These carts will be locked when not attended."

Review of hospital policy # 3002 revealed that "The Pharmacy Department is locked at all times. Access is limited to pharmacists and Pharmacy Department staff under the direct supervision of a Pharmacist." Review of hospital policy #3201 revealed that "The Pharmacy Department is locked at all times ... Ancillary personnel (housekeeping etc.) will be allowed access only in the presence of pharmacy personnel." Review of hospital policy #3419, "Authorized Access to the Pharmacy" revealed that "Only Authorized Persons Shall Be Allowed in the Pharmacy: Access to the main Pharmacy is limited to the Pharmacists and his/her staff during Pharmacy operating hours. Medical staff, nursing service, administrative, Environmental Services and other personnel are authorized admission only in conjunction with their duties and under supervision of Pharmacy staff." The pharmacy had the above conflicting policies for staff use.

The above was confirmed in interview with Staff #2 in the conference room.

Based on observation during a hospital tour, there were outdated, mislabeled, and otherwise unusable drugs available for patient use in the pharmacy, operating room, anesthesia carts, and patient units.

Findings were:

Observation in the pharmacy during a tour of the hospital on 8-16-1, the surveyor found 48 (100 mLs) IV bags that had the manufacturer overwrap removed in the pharmacy stock and were available for dispensing to patients. The 100 mL IV bags had patient labels attached indicating an expiration date, including 2 bags of Cefoxitin expired 6-6-11, 9 bags of Nafcillin expired 3-31-11, 3 bags of Imipenem 50 mg expired 7-15-11, and 34 others. The manufacturer instructions stated, "Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier." Review of hospital policy #1047 revealed that "IV solutions removed from the overwrap are stable for 30 days according to manufacturer recommendations." Review of a letter provided to the survey team dated 8-16-11 faxed from the manufacturer to Staff #35 revealed that the manufacturer "recommends only removing the overwrap from the plastic container just before the drug or solution is to be administered. However, where there are pharmacy space limitations or the need to remove a single bag from an overwrap containing several bags, containers may be stored at room temperature for no more than the following time periods: 50 mL or less: 15 days; 100 mL or greater: 30 days."

Interview with pharmacy staff revealed the IV bags and the medication solutions had been dispensed from the pharmacy to the patient floor and had been returned to the pharmacy for restock as they were not administered to the patient. Review of hospital policy #3423 "Unusable and Outdated Drugs" revealed that "All discontinued patient drugs; outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal." The above was confirmed in interviews with pharmacy staff and Staff #2 and 34.

Observation in the pharmacy during a hospital tour on 8-16-11 revealed 7 medication bottles containing a liquid solution observed in the pharmacy stock ready for dispensing to patients with patient labels attached indicating an expired date. Medications included Nystatin 5 mL expired 3-23-11, Megace expired 7-28-11, Ferrous sulfate 7.5 mL expired 4-9-11, Centrum liquid expired 3-24-11, and others.

Interview with pharmacy Staff #34 revealed that the 7 medications had been returned to the pharmacy stock to be re-dispensed to other patients. Review of hospital policy #3423, "Unusable and Outdated Drugs" revealed that "All discontinued patient drugs; outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal." Review of hospital policy #5037, "Infection Control and Prevention" revealed that "medications that have been in the room of a patient shall be destroyed." Interview with pharmacy staff also confirmed that they did not know whether or not the previously dispensed restocked medications were taken into the patient rooms prior to return to the pharmacy for restocking. The above was confirmed in interview with pharmacy staff and Staff #2 and 34.

Anesthesia cart #1 contained 5 opened, empty syringes pre-labeled with various medication names in the drawer and 31 empty, syringes pre-labeled with various medication names on the top of the cart, which increases the risk for preparation and administration of a wrong medication or dose to a patient.

Review of hospital policy #2006, Procurement of Medication, states that "The Pharmacy Director and staff pharmacists shall be responsible for maintenance and the supply as well as assuring that all drugs are properly labeled and stored." The above was confirmed in interview by Staff #2, 4, and 5 on 8-16-11.

Observation in the surgical suite during a hospital tour on 8-16-11 revealed that anesthesia cart #1 contained expired medications, including Lidocaine jelly expired 3/11, Dexamethasone 1 mL expired 5/11, two vials of Epinephrine 1:10,00 expired 7/11, and antacid tablets expired 1/08. Anesthesia cart #1 contained Xopenex IFA 45 mcg expired on 10/09 which was loaded into an opened syringe and "opened 1-20-2011" was hand-written on the syringe. There were 5 vials of medications that were opened but not dated, including Labetalol, Lidocaine 2%, and Rocuronium 5 mL. Review of hospital policy #2006, Procurement of Medication, states that "The Pharmacy Director and staff pharmacists shall be responsible for the maintenance and the supply as well as assuring that all drugs are properly labeled and stored." The above was confirmed in interview by Staff #2, 4, and 5 on 8-16-11.

Observation in the Emergency Department during a hospital tour on 8-16-11 with Staff #2 and #9 revealed an acetaminophen suppository expired 4/09 in the refrigerator and 4 undated vials of opened Lidocaine in the nursing station. Observation in the medical/surgical unit medication room with Staff #2 and #7 revealed 5% Dextrose and 0.9% Sodium Chloride expired 9/2010, and Phenol/oral anesthetic expired 5/2011. The above was confirmed in interview with Staff #2 on 8-16-11.

Observation in the Pharmacy during a hospital tour on 8-16-11, a bottle of Hydrocodone Polistinex and Chlorpheniramine Oral Suspension, 473 mLs was observed opened in the pharmacy narcotic medication stock, available for patient use. This medication bottle had been opened and still contained approximately 1/5 of a thick yellow solution. The medication bottle was not dated to indicate the date opened or an expiration date. The neck of bottle was sticky to the survey ' s fingers, and contained a crusted, crystallized yellow substance the same color as the liquid medication contents around the interior and exterior of the mouth of the bottle, which would contaminate the medication when poured. The shelf life of the bottle was 10/12. The above was confirmed with Staff #34 and Staff #2 at 8:50 am on 8-16-11.

Review of hospital policy #3002, "Drug Inventory Control" revealed that "All drug storage areas within the hospital will be inspected monthly by the Pharmacy Department ...expired, damaged, and/or contaminated medications will be removed from drug storage areas within the hospital during the Pharmacy inspection and will be returned to the Pharmacy Department for proper disposal."

Review of hospital policy #3423, "Unusable out Outdated Drugs" revealed that "All discontinued patient drugs; outdated drugs, contaminated drugs, improperly stored drugs and containers with worn, illegible or missing labels shall be returned to the Pharmacy Department for proper disposal."

Review of hospital policy #1012, "Use of Multiple Dose Vials" revealed that, "the beyond-use date for an opened or entered (i.e., needle-punctured) multiple dose container with antimicrobial preservatives shall be 28 days, unless otherwise specified by the manufacturer. The healthcare provider shall write the expiration date on the vial, when opened ... MDVs [multiple dose vials] shall be discarded when the manufacturer ' s established expiration date is reached." Review of hospital policy #4004, "Use of Multidose Vials" revealed that "The expiration date for multidose vials will be the 28 days from the date the vial is opened ... the vial is dated and initialed when opened."

Review of hospital policy #3002, "Drug Inventory Control" states that, "All medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates and appropriate warnings."

Review of hospital policy #1012, "Use of Multiple Dose Vials" states that, "The Pharmacy Department shall verify that MDVs are stored and labeled correctly when inspecting medication storage areas."

The above was confirmed in interview with Staff # 2 and #13 on 8-17-11.

Based on observation of the kitchen during a hospital tour, the director of dietary services failed to ensure that all areas of the kitchen and food storage areas were maintained to ensure the safety of the patient food service delivery system.

Findings were:

Observation in the kitchen during a tour of the hospital on 8-17-11 at 1:30 PM accompanied by Staff #2 and #11 revealed open live bait traps on a shelf in the food storage area and a brown/gray dust covering the ice machine side vent. A black furry substance (mold-like in appearance) was growing on the ceiling in the walk in refrigerator and there were 2 inch circular openings in the ceiling of the refrigerator. The temperature of the meat freezer was 20 degrees; the expected range is zero to -10 degrees. Rusted and dirty ceiling vents were observed in the kitchen and dishwashing rooms. The above was confirmed in interview with Staff #2 and #11 during the tour on 8-17-11.

Observation on the medical/surgical unit during a hospital tour on 8-17-11 with Staff #2 and #7 revealed two bottles of Pedialyte expired 7-2011. The above was confirmed in interview with Staff #2 and #7.

Based on observation during a tour of the hospital and interview with staff, the physical environment was not maintained to ensure the safety of the patients as there were broken items, holes in walls, broken floor tiles, cracked and water damaged ceilings, torn coverings on examination tables, rust in the operating rooms, and other safety issues.

Findings were:

Observation in the emergency department during a tour of the hospital accompanied by Staff #2, 7 and 9 on 8-16-11 revealed that in the nurses station and trauma rooms #1 and #2, the base of the cabinet under the sinks was covered in visible raised dust, and brown and black dirt and debris, had multiple can/bottle rings, and dead insects were observed. A dead roach and a dead cricket were observed on the floor in the ED supply room. In Trauma room #3, there were 7 holes observed in the wall/sheet rock. Ten cracked and chipped floor tiles were observed in the ambulance entrance hallway. The metal front of the water fountain in the ED lobby was observed to be damaged, revealing open metal edges and holes. The above was confirmed in interview in the ED on 8-16-11 with Staff #2, 7, and 9.

Observation in the surgical suite during a tour of the hospital accompanied by Staff #2, 4, and 5 on 8-16-11 at 1:30 PM revealed that in OR Rooms A and B, the ceiling was cracked around the medical gasses outlets. The vinyl covering of the OR table was worn at the edges, two electrosurgical units were held to their respective carts with bandage tape prevent it from tipping over when moved. It was also observed that approximately 1/3 of the surfaces of metal cabinets along one wall of both operating rooms contained rust that had penetrated the paint on the edges, the horizontal surfaces, the shelving units, the cabinet doors, and the sides and base of the drawers. There were sterile instruments and other surgical supplies stored in these metal cabinets, which could not be properly disinfected. In the equipment storage area, there was a 3 x 6 inch and a 2 x 1 inch brown area resembling a spill on the floor. The above was confirmed in interview with Staff #2, 7, and 9 in the surgical suite on 8-16-11.

Observation in the medical/surgical unit during a hospital tour on 8-17-11 revealed that the wall in the patient care area had four direct openings approximately 1/2 inch in diameter which could allow entry of dirt particles, rodents, and insects. A 3 x 2 inch hole was observed in the wall sheetrock in the patient care area and there was a layer of brown and white dust visible on horizontal surfaces. There were open sticky traps for insects on the floor in the clean room. This was confirmed in interview with Staff #2 and 7 in the medical surgical unit on 8-17-11.

Observation in the Central Supply room for cleaning instruments during the hospital tour accompanied by Staff #2, 4, and 5 on 8-16-11 revealed damaged ceiling tiles. Approximately 120 ceiling tiles (one-third of the ceiling area) were discolored and water damaged. Several of the ceiling tiles were still visibly moist. This was confirmed in interview with Staff #2, 4, and 5 in the Central Supply room on 8-16-11.

Based on information provided by staff, snares, biopsy forceps and alligator clips used in endoscopy procedures had never been sterilized since 1994. The facility failed to ensure that all surgical instruments and devices were processed in accordance with facility policies, manufacturer's recommendation, and/or Center for Disease Control and Prevention (CDC) requirements.

Findings were:

1. During a tour of the surgical suite on 8-16-11, there were unpackaged snares, biopsy forceps and alligator clip wires that had not been sterilized according to manufacturer's directions, facility policy, and CDC requirements available for patient use.

Cross Refer: Tag A0749

2. During a tour of the surgical suite on 8-16-11, potentially contaminated items, including drink containers and foil-wrapped brown candy were found in and on anesthesia carts in the surgical suite.

Cross Refer: Tag A0749

3. During a tour of the surgical suite on 8-16-11, multiple surgical instruments were available for patient use which had been put through the sterilization process in the closed or clamped position, which prevents the sterilizing agent from penetrating all surfaces of the instruments to ensure complete sterilization.

Cross Refer: Tag A0749

4. During a tour of the hospital on 8-16-11 and 8-17-11, there were holes in the walls which could allow entry of dirt particles, rodents, and insects. There were water damaged ceiling tiles, chipped floor tiles and cabinets which contained rust which could not be properly disinfected.

Based on review of facility documents and staff interview, the infection control officer failed to ensure that the facility had or fully implemented a system for identifying, investigating, and controlling infections and communicable diseases of patients and personnel.

Findings were:

Observation during a tour of the hospital on 8-16-11 accompanied by Staff #2, 4, and 5 in the alcove between the surgery hall and the scope processing area, the surveyor saw approximately 17 unpackaged snares, biopsy forceps, and alligator clip wires, (hereafter called " devices " ) hanging on hooks on a peg board attached to the wall, available for patient use. These devices are used during a colonoscopy to isolate and remove polyps from the inside lining of the colon by inserting the device into ports of the endoscopy unit.

Since these devices come in contact with blood and body fluids during the polyp removal procedure, the manufacturer instructions, manufacturer operation's manuals, and the Center for Disease Control and Prevention require sterilization of these devices in an autoclave prior to and between patient use. The process of sterilization includes packaging the devices in a manner which protects them from recontamination. The devices observed unpackaged on the pegboard available for patient use were manufactured by Olympus and Fujinon, which specifically require sterilization prior to and between patient use.

The Fujinon device manual states, "4.2 Washing and sterilizing (7) Carry out an autoclaving operation in accordance with the operation manual of the autoclaving unit" The Olympus manual states, "4.6 Sterilization 1. Before sterilization, the instrument, CD handle and cord must be thoroughly cleaned and dried."

The Centers for Disease Control and Prevention (CDC) article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: , in the section entitled, "Recommendations for disinfection and sterilization in healthcare facilities; High-Level Disinfection of Endoscope" provides instructions to "[m]echanically clean reusable accessories inserted into endoscopes (e.g., biopsy forceps or other cutting instruments) that break the mucosal barrier (e.g., ultrasonically clean biopsy forceps) and then sterilize these items between each patient" (page 86).

Facility policy #4022, "High Level Disinfection of Endoscopes" states "all reusable accessories which penetrate mucosal barriers will be mechanically cleaned and sterilized between each patient or discarded."

Interview with staff #32 and #33 on 8-16-11 in the surgical suite revealed that these devices had been cleaned of blood and tissue, cleaned with an enzymatic cleaner, soaked in a glutaraldehyde solution, rinsed with distilled water, rinsed with alcohol, and then hung to dry unpackaged as observed on the peg board in the surgery hallway alcove. Staff #32 and 33 stated that the devices had not been sterilized and were available for patient use. Staff #32 and 33 stated that this is the usual process for cleaning the devices.

Staff #32 and #33 stated that the usual process for use of the devices is that a physician will request a specific device just before a procedure. Staff would then select the requested device from the peg board and carry it into the operating room for the procedure, without further treatment of the device. Interview in the conference room with Staff #2 on 8-16-11 confirmed the above procedure and findings.

Review of the patient surgery log for the facility and review of the facility's report of notifiable conditions to the Texas Department of State Health Services between 10/29/2010 and 2/1/2011 revealed three patients that had reactive tests for the Hepatitis C antibody and the same three patients had endoscopies performed at the facility. The surgery log showed that a different endoscope was used for each of the three patients, scopes #3, #4, and #5, and that snares and biopsy forceps (devices) were used during the procedures of these three patients. The log did not contain an entry to determine which of the devices were used during each of the three patient ' s procedures. Interview with Staff #4 and #5 confirmed that the facility did not track which devices were used with each patient.

In an interview with Staff #4, he stated that devices, specifically snares, biopsy forceps and alligator clips and wires, had never been sterilized during his employment at the facility in the operating room. He stated that his employment at the facility began in 1994. Interview with Staff #32 and #33, surgical techs, revealed that they had never autoclaved or sterilized these devices. The facility could not ensure that patients undergoing a colonoscopy with the use of these devices were not exposed to Hepatitis C or other blood borne pathogens or diseases, as these devices were not properly sterilized between patient use. The above was confirmed in interview with Staff #2 on 8-17-11.

Observation in the surgical suite during a hospital tour on 8-16-11 revealed that an unlabeled bottle of white tablets, an over-the-counter analgesic in a resealable plastic zipper storage bag, a coffee cup, and a plastic beverage glass, potentially contaminated items, were observed on the top of anesthesia cart #2. Anesthesia cart #1 contained approximately 30 pieces of foil wrapped brown candy. This was confirmed in interview by Staff #2, 4, and 5.

Observation in OR Room A during a tour of the hospital on 8-16-11 revealed 39 forceps and scissors that had been sterilized and stored in the closed position and those with a locking mechanism were observed with the locking mechanism in a closed and clamped position. There were 45 instrument packages observed with water damage and available for patient use. Observation in OR Room B revealed 15 forceps and scissors that had been sterilized and stored in the closed position and those with those with a locking mechanism were observed with the locking mechanism in the closed and clamped position. The locking mechanism is a series of interlocking teeth on each handle that clamps and holds the instruments in place with tension. When the locking mechanism is closed, the sterilizing agent cannot penetrate all surfaces to ensure complete sterilization of all surfaces of the instruments.

Observation in OR Room B during a tour of the hospital on 8-16-11 revealed that 26 instrument packages were observed with water damage. When a sample of two packages of the scissors were opened, the interior of the closed surface of the scissors was reddish-brown in appearance. It could not be determined that these surfaces were appropriately cleaned. When instruments are closed, the sterilizing agent cannot penetrate all surfaces to ensure complete sterilization of all surfaces of the instruments.

Hospital policy #188, "Cleaning and Disinfecting Instruments" requires in Step 3, "hinged instruments should be opened and instruments with more than one part should be dissembled." Facility policy #4008, "Event-related Shelf Life, Sterile Storage" states that, "All items sterilized by Central Service will be considered sterile unless the package/pack/tray/container is damaged or wet. Damage includes exposure to any type of moisture." The above was confirmed in interview with Staff #2, 4, and 5 during the tour on 8-16-11.

The Centers for Disease Control and Prevention (CDC) article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf, states on page 74 that hinged instruments and instruments that close should be opened during the process of sterilization.

Interview on 8-18-11 with Staff #6, Infection Control Nurse, confirmed that she was not aware of potentially infectious or contaminated items in and on the anesthesia carts. Staff #6 also stated she was unaware of required procedures for cleaning, decontamination and sterilizing equipment, instruments, or devices in the operating room, including endoscope snares and biopsy forceps, and surgical instruments.

Review of hospital policy #1006, "Infection Control Committee" revealed "Functions: Provide the hospital with pertinent information, counsel and advice in relation to infection control, including evaluation of new equipment and procedures for cleaning, decontamination and sterilizing."

Based on a review of swingbed patient records, 3 of 3 records were incomplete to include information on charges that the patient is responsible for at the time of admission.

Findings were:

Review of 3 of 3 swingbed patient records revealed that there was no documentation that these patients were informed by the facility of any charges for services not covered under Medicare or by the facility's per diem rate.
The above was confirmed in interview with Staff # in the conference room.

Based on review of the facility swingbed policy manual, personnel files and staff interview, the facility failed to have documented evidence that a criminal background check was conducted on all staff working in the swingbed unit.

Findings were

The facility failed to have a policy or knowledge of the requirement to perform a criminal background check on staff working with the elderly. There was no documentation to ensure that staff had not been found guilty of abuse, neglect, or mistreatment of residents by a court of law. This was confirmed in interview with Staff #8 in the conference room.