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Based on observation, interview, and record review, the hospital failed to ensure unauthorized individuals could not gain access to patient records, which had the potential to result in unauthorized access to patient records.

Findings:

1. During a concurrent interview and observation of the fifth floor Nursing Department with RMRN (Risk Management Registered Nurse) on 10/16/12 beginning at 11 AM, it was observed that a physician was documenting on an electronic device at a desk in the hallway. The twenty-inch computer screen had no privacy screen attached to it so patient information was fully visible to any person walking by. Further observation showed multiple screens with patient information fully visible to any one that stood behind the nurses documenting protected patient information on the computers. The RMRN stated the facility had privacy screens at one point, but they may have been removed with the recent computer changes.



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2. During an observation of the Medical/Surgical patient area on 10/16/12 at 10:35 AM, nursing staff was accessing Patient 30's medication administration record (MAR) on a computer outside her room. The large computer screen displayed Patient 30's name and listed the medications she was currently taking and was visible from the nurses station that was approximately four feet away. In the hallway by the nurses station were two visitors for another patient who were observed glancing at the computer screen.

During an interview with the medical/surgical manager (MSM) on 10/16/12 at 10:45 AM, she stated she had not identified any issues with the computer screens. She verified the protected health information (PHI) on the computer screens could be seen by persons in the hallways.

The hospital policy and procedure titled "Safeguarding protected health information (PHI) in the Physical Environment" dated 5/2009, read "Computer Screens and Locations of Workstations--Computers and workstations should be placed in such a way as to minimize the possibility of casual viewing or inappropriate access of PHI."

Based on observation, interview and record review, one intra-venous medication was not prepared and given in accordance with the facility policy and procedure on safe medication administration. This failure had the potential to create a patient medication error due to the unsafe handling and preparation of one medication.

Findings:

During an observation in the facility Surgical Intensive Care Unit on 10/15/2012, at 10:50 AM, Registered Nurse (RN) 7 handed Dialysis Nurse (DRN) 1 an intravenous medication she had obtained from the medication dispensing system, stating, "I'll take the medication out, but you'll have to give it." DRN 1 had requested RN 7 to medicate Patient 12 for agitation before he started dialyzing Patient 12. DRN 1 stated, "I can't start dialysis till she's medicated." After DRN 1 received the medication in his hand he gave the IV medication to Patient 12, before the surveyor could question him.

During a concurrent interview with DRN 1, he stated he had not checked Patient 12's medication record for the medication order, including allergy, dosage, route and when the medication was last given. When asked who would be responsible for documenting the medication and who had checked the medication order he pointed to RN 7. He further stated this was not his usual practice and that he should have checked the medication order for allergies, dosage, route and when the last dose was given.

The clinical record for Patient 7 was reviewed on 10/15/2012 at 11 AM and the Medication Administration Record indicated the medication given for agitation had been removed by RN 7 at 9:57 AM from the medication dispensing system.

The facility policy and procedure titled "Medication Administration Decision Guide", undated, indicated, "Prior to administering any medication, licensed staff will verify the six rights. 1. Right patient, 2. Right drug 3. Right dose 4. Right route 5. Right time 6. Right indication. Nursing staff assumes the responsibility of administering medications based on complete and validated orders."

Based on observation of the Floor Nursing Department and staff interview, the hospital failed to ensure unauthorized individuals could not gain access to patient records, which had the potential to result in unauthorized access to patient records.

Findings:

During a concurrent interview and observation of the fifth floor Nursing Department with Risk Management Registered Nurse (RMRN) on 10/16/12 beginning at 11 AM, it was observed that a physician was documenting on an electronic device at a desk in the hallway. The twenty-inch computer screen had no privacy screen attached to it so patient information was fully visible to any person walking by. Further observation showed multiple screens with patient information fully visible to any one that stood behind the nurses documenting protected patient information on the computers. The RMRN stated the facility had privacy screens at one point, but they may have been removed with the recent computer changes.

Based on interview and record review, the hospital failed to document and to monitor the use of sedation medication timely in accordance to the hospital policy. This failure had the potential to cause significant harm to patients receiving an inappropriate dose of the medication.

Findings:

The clinical records of patients who received Propofol (medication for sedation) in the CCU (Critical Care Unit) were reviewed with Pharmacy Supervisor (PS) 1 and Registered Nurse (RN) 1 on 10/17/12. Review of the clinical records showed Patient 35 was ordered Propofol drip on 10/16/12 at 7:30 AM and to be administered intravenously (IV) with sedation target of -3 in term of the RASS (Richmond Agitation Sedation Scale) score by titrating the medication at a rate of 5 mcg/kg/min to a maximum rate of 50 mcg/kg/min.

Further review of Patient 35's clinical record revealed the sedation scales assessment for Propofol was not documented after 4 PM on 10/16/12 while the medication was administered continually at a rate of 30 mcg/kg/min until 1 AM on 10/17/12. Thus the administration and or titration of Propofol were not monitored in accordance to the specific time interval as outlined in the hospital policy and procedure to maintain at a desired level of sedation.

Review of the hospital policy and procedure entitled "Sedation and Analgesia for Mechanically Ventilated Patient " on page 2 it read, "C. RASS will be documented in IVIEW or paper chart every 4 hours and with changes in the sedation drip rate(s)."

During interview with RN 1 on 10/17/12 at 10:10 AM, he acknowledged that mechanically ventilated patients who were on Propofol for sedation should have their RASS scores documented minimally into the system every 4 hours.

Based on observation, interviews, and record review, the pharmacy failed to provide supervision for the distribution of medications stored in the OR (Operating Room) medication cart inside the OR medication room, which had the potential to all ow unauthorized personnel to access medications.

Findings:

During a visit to the OR Department with Pharmacy Supervisor (PS) 1 and the Surgical Services Manager (SSM) on 10/15/12 at 4:25 PM, it was observed, numerous medications including various kinds of antibiotics (medications to treat bacterial infection) and Propofol (medication for sedation) etc. were in a medication cart inside the OR medication room.

Concurrently, PS 1 stated, the pharmacy restocks the medications in the OR medication cart but does not reconcile the missing dose with a physician's order. Since all the nurses in the OR have full access to the medication cart in the medication room, PS 1 and the SSM both acknowledged that any nurse can remove a medication leaving no record of its removal. And since pharmacy does not reconcile the restocking of the medication with a physician's order, pharmacists are unaware of unmonitored access. This results in a lack of supervision of the medications and non-compliance with hospital policy.

Review of the hospital policy entitled "Storage of Medications ", dated 1/2012 on Page 1 under definitions it read, "A secure area means that drugs and biological are stored in a manner to prevent unmonitored access by unauthorized individuals."

Based on observation and interview, the hospital failed to remove expired medications from availability for use, the hospital failed to date opened multiple dose vials of injectable medications and biologicals in accordance to hospital policy and procedure to ensure potency of drugs. These failures could result in the loss of integrity of the medications and potentially harm patients by not providing the expected therapeutic effect.

Findings:

1. On 10/15/12 at 4:55 PM, during an inspection of the MH (Malignant Hyperthermia) Crash Cart located by the entrance inside the OR (Operating Room) Department, three 1000 ml bags of 0.9% sodium chloride intravenous (IV) fluid were found inside the MH refrigerator with expiration date of September 2012.

During interview with the Surgical Services Manager on 10/15/12 at 4:57 PM, she acknowledged the three bags of IV fluid were expired and should be removed out of the MH refrigerator.

On 10/16/12 at 3:43 PM, an inspection of the ED (Emergency Department) with Pharmacy Supervisor (PS) 1 found an opened MDV (Multiple Dose Vial) of Lantus Insulin inside one of the ED Omnicell (automatic dispensing cabinet). The opened MDV was not dated and there was no information on the MDV to indicate how long the medication had been left opened inside.

Interview with PS 1 on 10/16/12 at 3:45 PM he acknowledged that the MDV should be dated with a new expiration upon opening.



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2. During an initial tour of the Medical Surgical floor (4 th floor) on 10/15/12 at 9:45 AM, one open undated bottle of sterile water for irrigation was observed in Room 4114.

During an interview with the Nursing Director (ND to the 3rd/4th/5th floor), on 10/16/12 at 3:30 PM, she indicated the irrigating solution should have been labeled with date and initials of staff who opened the bottle.

3. During an observation with the Operation's Manager of the outpatient radiological service, on 10/17/12 at 4 PM, in the medication storage area there was one vial of Amiodarone Hydrochloride (medication used to treat irregular heart rhythms) 50 milligram/ milliliter with an expiration date of March 2012.

Based on observation, interview, and record review, the hospital failed to ensure the outpatient radiological service provided safe and effective services.

1. The outpatient radiological service failed to maintain and properly store lead aprons according to the hospital's guidelines.
2. The outpatient radiological service failed to have a system in place to ensure adequate monitoring of lead shielding once a defect was identified.

These failures had the potential to result in physical harm for the staff who were exposed to radiation due to inadequately maintained and defective lead shielding.

Findings:

1. During an observation with the Operation's Manager (OM) of the outpatient radiological service, on 10/17/12 at 3:25 PM, lead aprons (used for shielding against radiation exposure) were noted. The lead aprons were observed to be hanging on hangers in the "Interventional" room. Some of the aprons were folded and then hung on the clothes hangers.

During an interview with OM and X-Ray Technician (XRT) 1, on 10/17/12 at 3:30 PM, she indicated she was responsible for maintaining the lead aprons. XRT 1 stated, she "Fluoro's (real time x-ray image) them" annually and she documented this on a log. The last time the lead aprons were examined under the fluoroscopy machine was December 2011. She also indicated, she visually checked the aprons randomly to ensure there were no observed cracks or leaks around the seams. Each lead apron was marked with an identifying number.

During an observation with OM of X-Ray Room 1 on 10/17/12 at 3:45 PM, one lead apron was noted folded in a drawer. There was no identifying number on the apron. XRT 1 examined the apron and she was unable to find an identifying number on the apron; therefore, she could not provide documented evidence the lead apron was examined annually under the fluoroscopy machine to ensure it was safe to use.

During an interview with the Director of Regulatory Compliance (DRC), on 10/18/12 at 1:40 PM, she was informed the lead aprons were being stored folded on clothes hangers and one was found folded in a drawer. She was also informed the one lead apron folded in the drawer, did not have an identifying number; therefore, it could not be determined if the apron had been examined under the fluoroscopy machine annually.

The undated, hospital's guidelines for lead apron checks was reviewed on 10/18/12. Under "Lead Apron Integrity Check" it read in part, "Note: Lead aprons should never be folded. Cracks in the lead lining can develop at the fold, reducing the useful life of the apron." The guidelines indicated to perform at least an annual fluoroscopic check for lead aprons, gloves, gonadal and thyroid shields. The steps included:

1. Lay out the item on the table. 2. Examine the entire item using the fluoroscope.
3. Closely inspect for any irregularities, pin holes, or tears.
4. Mark any area that shows a loss of integrity to x-ray - Any pin hole, tear or larger defect.
5. Record results on the Personnel Protective Apparel Inventory Sheet."

2. During an interview with XRT 1 and review of the 12/1/11 log titled, "Personnel Protective Apparel Inventory", a notation was written for an apron identified as "T4 Apron - Flowers". The notation indicated the condition of the apron was "good" but there was additional written information which read, "keep an eye on (left) side". XRT 1 indicated she wrote "keep an eye on (left) side" to make sure she checked it more closely. The T4 apron was observed with XRT 1 and it was noted to have a small section of the hem on the left side coming loose. A thyroid shield (lead shielding used to protect the thyroid gland) identified as "GE 5", was noted on the counter in X-Ray Room 1. There was some fraying of the edges noted. A second thyroid shield, identified as "T2" was examined with XRT 1 and it was noted the Velcro was coming loose. A lead apron identified as "T3" was noted, which had fraying and the Velcro coming loose. XRT 1 was unable to provide information on how frequently she was required to monitor a lead shield when it was noted to have a defect such as the hem coming loose. She was also unable to provide documented evidence how often she had checked the lead apron identified as T4 since December 2011. There was also no additional information provided to indicate the hospital's guidance once a defective lead shield was observed or when to remove the defective lead shield (lead aprons and lead thyroid shields) from use.

During an interview with the DRC, on 10/18/12 at 1:40 PM, she was informed defects in lead shields were noted but the staff monitoring the lead shields was unable to indicate the hospital's policy and procedure or guidance once a defect in the lead shielding was noted or when to remove from use.

Based on interview and record review, the hospital failed to ensure that stat (immediate) laboratory tests for four patients (1, 2, 3, and 4) were obtained and results available to nursing staff in a safe and reasonable time frame. This failure had the potential for delay in treatment for the affected patients.

Findings:

1. Patient 1 was a 66 year old male admitted to the intensive care unit (ICU) on 10/12/2012. He has a history of a coronary artery bypass and respiratory failure. The Physician's Progress note dated 10/14/2012, indicated the physician was going to start the patient on kidney dialysis the next day. The note also indicated the patient had a high potasium level on 10/14/12, therefore a potasium level had to be redrawn on 10/15/2012 to help determine the need to start the patient on kidney dialysis.

The clinical record for Patient 1 was reviewed on 10/16/12 at 3 PM. The Clinical Nursing Notes dated, 10/15/2012 at 5:20 AM, indicated, "received call from lab stating blood hemolyzed (clotted) and potasium level was 6.0 (normal value 3.5 to 5.0). Nurse requests a redraw of the potasium level STAT (immediately)." The second nursing note at 5:40 AM indicated the nurse again requested the laboratory to come draw the STAT laboratory. A third nursing note at 6:32 AM indicated the nurse again requested a stat draw. At 6:48 AM the nursing note indicated that a fourth call to laboratory was placed requesting a STAT Potasium level be drawn. The laboratory order sheets dated 10/15/12, indicated the potasium level was placed as a STAT order at 5:49 AM, twenty-nine minutes after the nurse first ordered the STAT laboratory, the laboratory specimen was actually drawn at 6:57 AM and the results were available at 7:20 AM. The total time it took for the nurse to have the results of the potasium level, after it was ordered was two hours.

2. The clinical record for Patient 2 was reviewed on 10/16/2012 at 4 PM. Patient 2 was a 53 year old male admitted on 10/2/12, to the intensive care unit with a history of a fall and seizure disorder. In the post-operative period the patient had a high fever and was being diagnosed with sepsis (infection). Patient 2 had a STAT lactic acid (laboratory study that helps determine if a patient is septic) ordered on 10/14/12 at 11:38 AM. The STAT laboratory was drawn at 12 PM and the laboratory result was ready for the nurse at 1:30 PM. The total time it took for the nurse to have the results of the lactic acid, after it was ordered was one hour and 52 minutes.

3. The clinical record for Patient 3 was reviewed on 10/16/12 at 4:30 PM. Patient 3 was a 59 year old male who was admitted to the intensive care unit on 10/12/12 with a diagnosis of lung cancer and placed on a ventilator. On 10/15/12 the physician' progress notes indicated the patient had gone into septic shock, (a severe infectious state). On 10/14/12, Patient 3 had a STAT, complete blood count ordered at 12:10 PM, the laboratory was drawn at 12:50 PM and results were ready for the nurse at 1:37 PM. The total time it took for the nurse to have the results was one hour and 27 minutes.

4. The clinical record for Patient 4 was reviewed on 10/16/12 at 4:30 PM. Patient 4 was a 61 year old female who was admitted to the intensive care unit on 10/13/12 with a diagnosis of acute respiratory failure secondary to narcotics and placed on a ventilator. On 10/14/12, Patient 4 had a STAT basic metabolic panel ordered at 9:30 AM, the laboratory was drawn at 9:52 PM and results were ready for the nurse at 10:44 AM. The total time it took for the nurse to have the results was one hour and 14 minutes.

During an interview with the Assistant Laboratory Supervisor on 10/16/12, at 10 AM, she stated, "Our usual turn around for STAT labs is 60 minutes." She was unable to find documentation in Patient's 1, 2, 3 or 4's clinical record regarding issues that may have delayed the obtaining of the STAT laboratory tests.

The hospital policy and procedure titled, "Lab STAT Test Policy" revised 1/2012, indicates in part, "1. STAT means that the procedure is vital and urgently needed for patient treatment. 2. After receiving a STAT request from a nursing unit, a phlebotomist is dispatched immediately to the patient location. Response time for a STAT blood draw is expected to be immediate within 20 minutes. 3. Turn around time for STAT test is defined as an in lab receipt to result within 40 minutes. Turn around for STAT test is defined as order to result within 60 minutes. Documentation of issues that may cause delay with collecting or resulting of STAT labs, is made in the patient record."

Based on review of hospital nutrient analysis, menu and staff interview, the hospital failed to ensure that the menu met the nutritional needs of it's patients. The nutrient analysis that had been completed did not include the recognized nutritional standard it had used to determine its nutrient adequacy. There was discrepancies in the amount of nutrients contained in items that had been analyzed, resulting in inaccurate nutrient analysis.

Findings:

Review of the hospital's diet manual and seven day nutrient analysis of its menus and different diets revealed totals for various nutrients including calories, protein, fat, carbohydrate, sodium, etc. None of these diets had reference levels to determine whether the diets were adequate in the nutrients that they needed to contain.

The director of nutrition (DN) was interviewed on 10/17/12 at approximately 12: 30 PM. She indicated that the DRI (Dietary Reference Intakes) for a male 19 - 30 is the reference level. The DRI is the daily intake level of a nutrient that is considered to meet the requirements of most individuals in a group. The analysis did not reflect this and as such, the hospital did not evaluate the adequacy of its menu to meet the nutritional needs of its patients.

Further review of the nutrient analysis revealed that the sodium content of the chicken sandwich that was served on 10/17/12 was inaccurate. According to the nutrient analysis, the grilled chicken sandwich on whole wheat bread had 372.50 milligrams (mg) of sodium. This amount was incorrect as the amount of sodium of the bread according to the nutrition information on the label was 350 mg and the sodium level of 3 oz of chicken was 323.99 mg. Based on these two items, the amount of sodium in the sandwich was at least 674 mg. This is of significance in diets where the amount of sodium is restricted.

The DN stated the information that had been provided by the corporate office that managed the information was incorrect.

Based on observation and interview, the outpatient radiological service failed to ensure a safe eye wash station. This had the potential to result in burns from the hot water.

Findings:

During an observation with the Operation's Manager (OM) of the outpatient radiological service, on 10/17/12 at 5 PM, an eye wash station was noted. When the water faucet was turned on, it was noted hot water was running through it. The OM acknowledged the hot water could cause harm if a person were to accidentally turn on the hot water to use the eye wash station.

Based on observation and staff interview, the hospital failed to ensure that food was stored in a manner to maintain quality. Several cans of food were stored in the warm area of the kitchen at temperatures above what is recommended for food storage, which had the potential to cause food born illness to the community.

Findings:

At approximately 2:30 PM on 10/15/12, a large cart was observed in the back kitchen holding several cans of food. The temperature of the room and the cans was 80 degrees Fahrenheit. The cans of food were not stored in the dry storage food where room temperature is monitored.

The Director of Nutrition who was present during the tour indicated that due to limited storage space some of the food items were stored in the area. According to the USDA (United States Department of Agriculture), the recommended temperature of dry storage is between 50 degrees and 70 degrees Fahrenheit. Maintaining food at the correct temperature will ensure that food quality, nutrient content are maintained and prevent bacterial growth.

Based on observation, interview and record review, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

1. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted could be performed in a manner that protects the lives of all patients. (Refer to A 0749)

2. Surgical instruments were not sterilized in accordance with nationally accepted infection control standards when hinged instruments were not sterilized in the open position. (Refer to A 0749)

3. Staff followed the hospital's intravenous infusion policies and procedures and professional standards of practice. (Refer to A 0749)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment placing patients and staff at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and record review, the hospital's infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by:

1. The hospital failed to sterilize hinged surgical instruments in an open position.

2. The hospital failed to ensure sterile supplies were stored in a appropriate area when these supplies were located in the instrument processing room where cross contamination with infectious agents was likely.

3. The hospital failed to ensure surgical staff used a high level disinfectant in accordance with manufacturer's recommendations.

4. The hospital failed to correct out-of-range air temperature and humidity levels in the operating rooms before proceeding with surgical procedures.

5. The hospital failed to ensure staff followed standards of practice while setting-up the sterile table with sterile surgical supplies for a surgical procedure.

6. The hospital failed to monitor the air temperature and humidity in the instrument processing room per the Association of Operating Room Nurses (AORN) standards of practice.

7. The hospital failed to ensure staff followed the hospital's intravenous infusion policies and procedures and professional standards of practice.

8. The hospital failed to properly store refrigerated medications separate from biopsy specimens.

These failures place patients at risk of coming into contact with disease causing organisms.

Findings:

1. During a concurrent interview and observation of the perioperative area with the Surgical Services Manager (SSM) on 10/16/12 at 1:30 PM, multiple pairs of hinged surgical instruments (an instrument used in surgery or medical procedures for grasping and holding objects, i.e. clamps and needle holders) were in the closed position in sealed peel pouches (peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. They are used primarily when visibility of the instrument is critical for its effective use). Thirty-five peel pouches were inspected with the SSM. She confirmed the instruments viewed were in the closed position. She agreed the majority of the hinged instruments in the perioperative area were probably in the closed position including the hinged instruments in the surgical cases (a pan or tray with a lid where surgical instruments are placed and then the whole case is sterilized). She confirmed the hospital follows the recommendations of the AORN for the Operating Room (OR) and infection control. (The AORN is a national recognized organization for standards of practice for the perioperative area.)

The hospital policy and procedure titled "Processing of instruments-Care and Cleaning" dated 12/2011, read "Hinged instruments should be opened, and instruments with more than one part should be disassembled as they are placed in an instrument pan or tray."

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. Direction given read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces....and instruments with hinges should be opened...."

2. During a concurrent interview and observation of the perioperative area with the SSM on 10/15/12 at 10:05 AM, the following OR sterile supplies were found in the instrument processing room (a room were reusable contaminated surgical instruments and devices are received, sorted, and cleaned): a box of Chloraprep stick applicators (used to disinfect skin before a surgical incision), multiple bottles of Betadine solution (a solution used to disinfect skin before a surgical procedure), multiple rolls of medical tape, and multiple disinfecting wipes in large plastic containers used in the OR to disinfect equipment. The SSM stated, "We have limited space to store supplies so we keep some here. The infection control nurse told us if the doors (the doors of the cabinet containing the above supplies) are closed it would be okay."

The 2012 Perioperative Standards and Recommended Practices, published by the AORN, under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation VII read, "Instruments should be decontaminated in an area separate from locations where clean activities are performed....physical separation from areas where clean items are handled minimizes the risk of contamination. Cross-contamination can occur when soiled items are placed in close proximity to clean items or place on surfaces upon which clean items are later placed. Aerosols created during cleaning can also result in cross-contamination."

3. During a concurrent observation and interview of the OR with the SSM on 10/16/12 at 3:15 PM, staff was observed cleaning the OR during "turn over" (the time between surgical procedures where the OR equipment is disinfected). Surgical Aide Staff (SAS) 1 was cleaning the OR equipment with Super Sani-Cloth germicidal disposable wipes. The SAS 1 was wiping the surgical patient table with the wipes but was missing multiple areas with the chemical disinfectant from the wipes. After he had removed several wipes and placed them into his hand, he was observed cleaning the tops of two large OR tables, a small stand, and the legs of both tables with the same wipes. When he had moved to the second table, the areas cleaned were not wet. This was verified by the SSM.

The manufacturer's recommendations printed on the container read "Treated surface must remain visibly wet for a full two (2) minutes. Use additional wipe(s) if needed to assure continuous two (2) minute wet contact time."

4. During a concurrent observation of the OR and interview with the SSM on 10/15/12 at 10:05 AM, she stated the Plant Operations (PO) monitors the temperature and humidity in the eight ORs and if those numbers were out of range, the PO would notify someone in the OR. She stated if the temperature was out of range during the night when they were doing surgical procedures, an alarm would alert the hospital operator and he/she would notify the PO staff to come in to fix the problem and this person would notify the OR staff. She stated the PO staff had never contacted her about out of range temperatures or humidity in the ORs since she had become the SSM nine months ago. She stated she did not have any documentation of any out of range OR temperatures and humidity. At this time, an OR temperature and humidity report was requested.

The OR temperature and humidity report was reviewed. This report indicated for the past year, several of the ORs had been out of range for temperature and humidity multiple times. Per this report the ranges were: temperature--68 F (Fahrenheit) to 73 F and humidity-->30% <60%. The report for the month of October 2012 were reviewed (15 days). The eight ORs were out of the above range for temperature and/or humidity for 15 out of 15 days.

During an interview with the Plant Operations Manager (POM) and a review of the past year of temperature and humidity reports on 10/17/12 at 8:10 AM, he verified the multiple times the eight ORs were out of the above ranges for temperature and humidity. He verified that in 4/12, OR 5 was out of range for temperature and humidity for 15 out of 30 days. He verified that on 10/15/12 all eight operating rooms were below 68 degrees (54 to 67 degrees). He stated the PO staff would not call the OR staff when the OR temperatures and humidity were out of range. He stated the hospital operator did not have an alarm that sounded when the OR temperature and/or humidity were out of range. He stated the OR staff were expected to access the report on the computer everyday and take care of the problem. He stated he did not have any documentation of corrective action concerning the out of range temperatures and humidity.

The hospital document for Surgical Site Infections was reviewed and indicated the following patients were Class 1 for developing surgical site infections. The Class 1 category means a clean wound (surgical incision) that is nontraumatic, noninflamed and does not include entry into the gastrointestinal tract (the stomach and intestines), genitourinary tract (the kidneys, bladder, and reproductive organs), respiratory tract or inside the throat area. These patients would be the least likely to develop surgical incision infections but per the hospital's documentation, they developed surgical site infections.

The following patient's clinical records were reviewed and compared with the OR temperature and humidity reports.

For Patient 16:
a. Had a surgical procedure on her right ankle on 5/1/12 in OR 1 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/1/12, read "OR 1 T(temperature) 58 (degrees).

For Patient 17:
a. Had a surgical procedure on his spine on 5/30/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/30/12, read "OR 7 T 63 (degrees).

For Patient 18:
a. Had a surgical procedure on her chest area on 6/6/12 in OR 5 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/6/12, read " OR 5 T 62 (degrees).

For Patient 19:
a. Had a surgical procedure on his spine on 5/8/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/8/12 , read "OR 7 T 62 (degrees).

For Patient 20:
a. Had a surgical procedure on her spine on 6/20/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/20/12, read "OR 7 T 63 (degrees).

For Patient 21:
a. Had a surgical procedure on her knee on 6/19/12 in OR 3 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/19/12, read "OR 3 T 61 (degrees).

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN, made the following recommendations related to Safe Environment of Care: "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68 (degrees) F to 73 (degrees) F within the operating room suite.... Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms.... Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed.... Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system."

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN titled "Recommended Practices for the Prevention of Unplanned Perioperative Hypothermia" (means unplanned decrease in body temperature during an operation) read "Randomized clinical trials have demonstrated that mild hypothermia increases the incidence of serious adverse consequences including surgical site infections.... Mild hypothermia inhibits platelet activation (clotting of the blood), resulting in increased blood loss. A 2 (degree) drop in (body) temperature increases blood loss by approximately 500 ml (milliliters)."

5. During a concurrent observation and interview in the OR with the SSM on 10/16/12 at 3:30 PM, OR Technician 2 was opening sterile supplies onto the OR table. He was observed dropping a suture pack (a package containing string and a needle to sew up the surgical incision) onto the floor, then picking up the now contaminated pack and placing it on a table that contained unopened sterile supplies to be used for the next surgical procedure. He proceeded to open the remaining sterile supplies and dropping them on the table without performing hand hygiene. (Hand hygiene relates to the removal of visible soil and the removal or killing of transient microorganisms from the hands and may be accomplished using soap and running water or an alcohol-based hand rub.)

He then dropped a surgical blade (a blade used to cut skin) and picked it up with his hands and discarded it. He did not perform hand hygiene after picking up the blade and proceeded to open the remaining sterile supplies. At this time, the SSM directed him to dispose of the suture pack and she verified the above observations. She stated OR Tech 2 should have discarded the suture pack and performed hand hygiene and when he picked up the surgical blade, he should have performed hand hygiene.

The 2012 Perioperative Standards and Recommended Practices, published by the AORN read "A hand wash should be performed any time there is a possibility that there has been contact with blood or other potentially infectious materials or surfaces."

6. During a concurrent interview and observation of the surgical decontamination room with the SSM on 10/15/12 at 10:05 AM, she stated the hospital does not monitor the temperature or humidity in the decontamination room.

During an interview with the POM on 10/17/12 at 8:10 AM, he verified the hospital does not monitor the temperature or humidity in the decontamination room.

The 2012 Perioperative Standards and Recommended Practices, published by the AORN read "Safe environment of care, Recommendation V, V.b. "Humidity should be maintained between 30%- 60% within instrument processing areas....V.b.2 Humidity should be monitored and recorded daily....V.c. Temperature should be monitored and recorded daily....V.c.2 The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F."



28467

7. During an observation on 10/16/12 at 10 AM the following was observed on the Fifth floor Surgical Wards.

A. In Patient 5's room a bag of IV (intravenous) solution was infusing into the patient with no label indicating the patients name, time and date the solution was started. The intravenous catheter site to the right antecubital (inner arm) was not labeled with a date and time and the name of the person who started the IV. During a concurrent interview with Registered Nurse (RN) 4, she indicated, "This is a very troublesome IV, it keeps stopping, it was started at the Urgent Care, yes I expect all IV sites to be labeled."

B. Patient 6 had two unlabeled IV sites. One IV was placed in the right antecubital vein and the second was placed in the right wrist. The IV site to the right wrist had a dressing that was partially intact and peeling off.

C. In Patient 7's room an IV solution was hanging and infusing into the patient with no label indicating the patient's name, time or date started. The patient had two IV sites that were not labeled as to the date and time they were inserted.

D. Patient 8 had an IV site to his left antecubital vein that was unlabeled and a bag of IV fluids that was unlabeled.

E. Patient 9 had an IV site to his left ante-cubital vein that was unlabeled with an IV solution infusing into it that was unlabeled.

F. Patient 10 had an IV site to his left ante-cubital vein that was unlabeled with an IV solution infusing into it that was also unlabeled. At Patient 10's bedside was a bottle of Normal Saline solution used to irrigate gastrostomy tubes, dated 10/09/12. During a concurrent interview with RN 5 she indicated, "these irrigation solutions should be changed every 24 hours, I will throw this out."

During an observation on 5/16/12 at 11 AM, of the four pediatric rooms in use, four out of five pediatric patients (11, 12, 13 and 14) had unlabeled IV sites.

The hospital policy and procedure titled, "Peripheral IV Management" not dated, indicated in part: "Label IV sites, with date and time. Change transparent dressings every 48 hours or earlier if it becomes loosened or visibly soiled."

During an interview with the Infection Control Nurse (ICN) and ICN 2, on 10/17/12 at 1 PM, ICN 2, stated, "My expectation would be that the temperatures and humidity in the surgical area would be in range. We expect the staff to check before each procedure. When asked, how the infection control department monitors the surgical suites, he indicated they do "spot checks." When asked what temperature range and humidity indicators he would use as out of range, he stated, "I don't know the parameters. I would have to look at your sheet. We have no cases of surgical infections based on body temperatures. We rely on body temperatures." When ICN 2 was asked if the Infection Control Department was involved in the teaching of proper cleaning of the surgical suites, he stated, "No,we are not involved with that. We expect the surgery staff to deal with that."

During a concurrent interview with the ICN, when questioned regarding intravenous infusion sites and bag labeling, she stated, "I'm not involved in the peripheral (intravenous catheters placed in surface veins in the the arms) IV site care, we are just looking at central (intravenous lines placed in deep veins) IV lines."

The hospital Position Description entitled, "Infection Prevention Nurse", dated 12/2011, indicated in part, "The infection Prevention Nurse assures that the Continuums of Care is a high quality from admit to discharge by reducing infection risks to patients and personnel through surveillance, assisting in teaching pertinent Infection Prevention procedures at all employee levels, and ascertaining the needs for monitoring programs in any given area in an effort to identify and minimize to the lowest infection hazards in the environment."



21905

During an initial tour on 10/15/12 at 9:45 AM, on the 4 th floor medical surgical floor the following patients were noted with the intravenous (IV) tubing unlabeled with no date of when to change the tubing:

a. Patient 36 had two IV solutions hanging with no date of when to change the tubing.
b. Patient 37 had three IV solutions hanging with no date of when to change the tubing.
c. Patient 38 had one IV solution hanging with no date of when to change the tubing.
d. Patient 39 had two IV solutions hanging with no date of when to change the tubing.

During an interview with the Nursing Director (ND to the 3rd/4 th/5 th floor), on 10/16/12 at 3:30 PM, she indicated the IV tubing should be labeled with the date it should be changed.

During an interview with the Registered Nurse Manager 2, on 10/15/12 at 10:20 AM, she indicated the hospital wide practice is to change the IV tubing every four days. She indicated there should be a sticker placed on the tubing to indicate the day of the week it should be changed.

The hospital policy and procedure titled, "Peripheral I.V. Management Protocol", revision date 1/12, indicated under the subheading, "TUBING AND SOLUTION CHANGES" read in part, "7. a. Replace administration sets every 96 hours (4 days)..."

8. During an observation with the Operation's Manager of the outpatient radiological service and RN 8 on 10/17/12 at 4:15 PM the medication refrigerator was noted. The refrigerator contained medications and two biopsy specimens waiting for the laboratory to pick up.

During an interview with the Director of Regulatory Compliance, on 10/18/12 at 1:40 PM, she was informed there were biopsy specimens stored in the medication refrigerator at the outpatient radiological service. No additional information was provided.

Based on observation, interview, and record review, it was determined the hospital did not meet the Conditions of Participation (COP) for Surgical Services as evidenced by:

1. Failure to sterilize surgical hinged instruments in the open position. (An instrument used in surgery or medical procedures for grasping and holding objects, i.e. clamps and needle holders). (Refer to A 951)

2. Failure to ensure sterile supplies were not stored in the instrument processing room (room were surgical instruments are cleaned) where cross contamination with infectious agents was likely. (Refer to A 951)

3. Failure to ensure the staff was trained and competent to effectively disinfect the perioperative environment. (Refer to A 951)

4. Failure to correct the air temperature and humidity in the eight operating rooms when the plant operations office determined the numbers were out of the accepted range. (Refer to A 951)

5. Failure to ensure operating room staff followed standards of practice while setting up the sterile table for a surgical procedure. (Refer to A 951)

6. Failure to monitor the air temperature and humidity in the instrument processing room per AORN standards of practice. (The AORN is a national recognized organization for standards of practice for the perioperative area.) (Refer to A 951)

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure the provision of quality surgical care in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure policy and procedures for surgical services were implemented and standards of practice were followed as evidenced by:

1. The hospital did not sterilize hinged surgical instruments in an open position as per the recommendation of the Association of Perioperative Registered Nurses (AORN).

2. The hospital failed to ensure sterile supplies were stored in an appropriate area when these supplies were located in the instrument processing room where cross contamination with infectious agents was likely.

3. The hospital failed to ensure surgical staff used a high level disinfectant in accordance with manufacturer's recommendations.

4. The hospital failed to correct out of range air temperature and humidity in the operating rooms before proceeding with surgical procedures.

5. The hospital failed to ensure staff followed standards of practice while setting-up the sterile table with sterile surgical supplies for a surgical procedure.

6. The hospital failed to monitor the air temperature and humidity in the instrument processing room per AORN standards of practice.

These failures had the potential to spread infection to surgical patients resulting in adverse surgical outcomes.

Findings:

1. During a concurrent interview and observation of the perioperative area with the Surgical Services Manager (SSM) on 10/16/12 at 1:30 PM, multiple pairs of hinged surgical instruments (an instrument used in surgery or medical procedures for grasping and holding objects, i.e. clamps and needle holders) were in the closed position in sealed peel pouches (peel pouches are flexible packaging materials that combine a paper or synthetic barrier material and a transparent plastic film. They are used primarily when visibility of the instrument is critical for its effective use). Thirty-five peel pouches were inspected with the SSM. She confirmed the instruments viewed were in the closed position. She agreed the majority of the hinged instruments in the perioperative area were probably in the closed position including the hinged instruments in the surgical cases (a pan or tray with a lid where surgical instruments are placed and then the whole case is sterilized). She confirmed the hospital follows the recommendations of the AORN for the Operating Room (OR) and infection control. (The AORN is a national recognized organization for standards of practice for the perioperative area.)

The hospital policy and procedure titled "Processing of instruments-Care and Cleaning" dated 12/2011, read "Hinged instruments should be opened, and instruments with more than one part should be disassembled as they are placed in an instrument pan or tray."

The 2012 Perioperative Standards and Recommended Practices published by the AORN were reviewed. Direction given read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces....and instruments with hinges should be opened...."

2. During a concurrent interview and observation of the perioperative area with the SSM on 10/15/12 at 10:05 AM, the following Operating Room (OR) sterile supplies were found in the instrument processing room (a room were reusable contaminated surgical instruments and devices are received, sorted, and cleaned): a box of Chloraprep stick applicators (used to disinfect skin before a surgical incision), multiple bottles of Betadine solution (a solution used to disinfect skin before a surgical procedure), multiple rolls of medical tape, and multiple disinfecting wipes in large plastic containers used in the OR to disinfect equipment. The SSM stated, "We have limited space to store supplies so we keep some here. The infection control nurse told us if the doors (the doors of the cabinet containing the above supplies) are closed it would be okay."

The 2012 Perioperative Standards and Recommended Practices, published by the AORN, under Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation VII read, "Instruments should be decontaminated in an area separate from locations where clean activities are performed....physical separation from areas where clean items are handled minimizes the risk of contamination. Cross-contamination can occur when soiled items are placed in close proximity to clean items or place on surfaces upon which clean items are later placed. Aerosols created during cleaning can also result in cross-contamination."

3. During a concurrent observation and interview of the OR with the SSM on 10/16/12 at 3:15 PM, staff was observed cleaning the OR during "turn over" (the time between surgical procedures were the OR equipment is disinfected). Surgical Aide Staff (SAS) 1 was cleaning the OR equipment with Super Sani-Cloth germicidal disposable wipes. The SAS 1 was wiping the surgical patient table with the wipes but was missing multiple areas with the chemical disinfectant from the wipes. After he had removed several wipes and placed them into his hand, he was observed cleaning the tops of two large OR tables, a small stand, and the legs of both tables with the same wipes. When he had moved to the second table, the areas cleaned were not wet. This was verified by the SSM.

The manufacturer's recommendations printed on the container read "Treated surface must remain visibly wet for a full two (2) minutes. Use additional wipe(s) if needed to assure continuous two (2) minute wet contact time."

4. During a concurrent observation of the OR and interview with the SSM on 10/15/12 at 10:05 AM, she stated Plant Operations (PO) monitors the temperature and humidity in the eight ORs and if those numbers were out of range, the PO would notify someone in the OR. She stated if the temperature was out of range during the night when they were doing surgical procedures, an alarm would alert the hospital operator and he/she would notify the PO staff to come in to fix the problem and this person would notify the OR staff. She stated the PO staff had never contacted her about out of range temperatures or humidity in the ORs since she had become the SSM nine months ago. She stated she did not have any documentation of any out of range OR temperatures and humidity. At this time, an OR temperature and humidity report was requested.

The OR temperature and humidity report was reviewed. This report indicated for the past year, several of the ORs had been out of range for temperature and humidity multiple times. Per this report the ranges were: temperature--68 F (Fahrenheit) to 73 F and humidity-->30% <60%. The report for the month of October 2012 were reviewed (15 days). The eight ORs were out of the above range for temperature and/or humidity for 15 out of 15 days.

During an interview with the Plant Operations Manager (POM) and a review of the past year of temperature and humidity reports on 10/17/12 at 8:10 AM, he verified the multiple times the eight ORs were out of the above ranges for temperature and humidity. He verified that in 4/2012, OR 5 was out of range for temperature and humidity for 15 out of 30 days. He verified that on 10/15/12 all eight operating rooms were below 68 degrees (54 to 67 degrees). He stated the PO staff would not call the OR staff when the OR temperatures and humidity were out of range. He stated the hospital operator did not have an alarm that sounded when the OR temperature and/or humidity were out of range. He stated the OR staff were expected to access the report on the computer everyday and take care of the problem then. He stated he did not have any documentation of corrective action concerning the out of range temperatures and humidity.

The hospital document for Surgical Site Infections was reviewed and indicated the following patients were Class 1 for developing surgical site infections. The Class 1 category means a clean wound (surgical incision) that is nontraumatic, noninflamed and does not include entry into the gastrointestinal tract (the stomach and intestines), genitourinary tract (the kidneys, bladder, and reproductive organs), respiratory tract or inside the throat area. These patients would be the least likely to develop surgical incision infections but per the hospital's documentation, they developed surgical site infections.

The follow patient's clinical records were reviewed and compared with the OR temperature and humidity reports.

For Patient 16:
a. Had a surgical procedure on her right ankle on 5/1/12 in OR 1 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/1/12, read "OR 1 T(temperature) 58 (degrees).

For Patient 17:
a. Had a surgical procedure on his spine on 5/30/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/30/12, read "OR 7 T 63 (degrees).

For Patient 18:
a. Had a surgical procedure on her chest area on 6/6/12 in OR 5 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/6/12, read "OR 5 T 62 (degrees).

For Patient 19:
a. Had a surgical procedure on his spine on 5/8/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 5/8/12 , read "OR 7 T 62 (degrees).

For Patient 20:
a. Had a surgical procedure on her spine on 6/20/12 in OR 7 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/20/12, read "OR 7 T 63 (degrees).

For Patient 21:
a. Had a surgical procedure on her knee on 6/19/12 in OR 3 per the intraoperative report dated the same day.
b. The temperature and humidity report dated 6/19/12, read "OR 3 T 61 (degrees).

The hospital policy and procedure titled "Humidity and Temperature Monitoring" dated 1/2012, read "The temperature and humidity of the operating rooms are controlled within acceptable standards to inhibit bacterial growth and prevent infection, prevention of fir, and promote patient comfort. The temperature range of the Operating Rooms.... shall be kept between 68 degrees Fahrenheit and 73 degrees Fahrenheit. The humidity range of the Operating Room.... shall be maintained between 30% and 60%. Plant Operations shall monitor temperature and humidity levels of areas in question via the building automation system and take appropriate actions to restore the designated range, if required."

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN, made the following recommendations related to Safe Environment of Care: "Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. Temperature should be maintained between 68 (degrees) F to 73 (degrees) F within the operating room suite.... Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms.... Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed.... Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system."

The 2012 edition of Perioperative Standards and Recommended Practices, published by the AORN titled "Recommended Practices for the Prevention of Unplanned Perioperative Hypothermia" (means unplanned decrease in body temperature during an operation) read "Randomized clinical trials have demonstrated that mild hypothermia increases the incidence of serious adverse consequences including surgical site infections.... Mild hypothermia inhibits platelet activation (clotting of the blood), resulting in increased blood loss. A 2 (degree) drop in (body) temperature increases blood loss by approximately 500 ml (milliliters)."

5. During a concurrent observation and interview in the OR with the SSM on 10/16/12 at 3:30 PM, OR Technician (Tech) 2 was opening sterile supplies onto the OR table. He was observed dropping a suture pack (a package containing string and a needle to sew up the surgical incision) onto the floor, then picking it up the now contaminated pack and placing it on a table that contained unopened sterile supplies to be used for the next surgical procedure. He proceeded to open the remaining sterile supplies and dropping them on the table without performing hand hygiene. Hand hygiene relates to the removal of visible soil and the removal or killing of transient microorganisms from the hands and may be accomplished using soap and running water or an alcohol-based hand rub.

He then dropped a surgical blade (a blade used to cut skin) and picked it up with his hands and discarded it. He did not perform hand hygiene after picking up the blade and proceeded to open the remaining sterile supplies. At this time, the SSM directed him to dispose of the suture pack and she verified the above observations. She stated OR Tech 2 should have discarded the suture pack and performed hand hygiene and when he picked up the surgical blade, he should have performed hand hygiene.

The 2012 Perioperative Standards and Recommended Practices, published by the AORN read "A hand wash should be performed any time there is a possibility that there has been contact with blood or other potentially infectious materials or surfaces."

6. During a concurrent interview and observation of the surgical decontamination room with the SSM on 10/15/12 at 10:05 AM, she stated the hospital does not monitor the temperature or humidity in the decontamination room.

During an interview with the Plant Operations Manager on 10/17/12 at 8:10 AM, he verified the hospital does not monitor the temperature or humidity in the decontamination room.

The 2012 Perioperative Standards and Recommended Practices, published by the AORN read "Safe environment of care, Recommendation V, V.b. "Humidity should be maintained between 30%- 60% within instrument processing areas....V.b.2 Humidity should be monitored and recorded daily....V.c. Temperature should be monitored and recorded daily....V.c.2 The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F."