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Based on interview, record review and policy review, the Critical Access Hospital (CAH) was found not to be in compliance with the Conditions of Participation for Physical Environment (CFR 485.623) due to failure to ensure proper procedures were followed related to use of alcohol based skin preparation in anesthetizing locations to prevent the risk of surgical fires. Documentation was lacking that proper procedures had been followed to prevent the risk of surgical fires in 6 of 6 surgical records in the sample where an alcohol based skin preparation had been utilized. (S1, S2, S3, S4, S5, and S6)

Findings include: The CAH did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) had issued a Survey and Certification Memo dated 1/12/2007, addressing risk reduction techniques to permit safe use of alcohol based skin preparations in anesthetizing locations in CAHs. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systemic approach by the CAH to prevent surgery related fires.

On 6/8/2010, at 9:15 A.M. an interview was conducted with the Operating Room (OR) supervisor and with the Patient Care Director regarding policy/procedure for use of alcohol based skin preparation. It was learned the CAH had routinely used Dura Prep, an alcohol based skin prep, for surgical procedures performed at the CAH. It was indicated during interview the CAH physician surgical staff had recently requested a change to the alcohol based skin preparation, Chloraprep, but this had not yet been fully implemented as they were utilizing the current remaining stock of DuraPrep. The surveyor queried regarding the current practice for utilization of the alcohol based skin prep in the OR. It was stated by the OR Supervisor they routinely checked the patient to assure the alcohol based prep had completely dried prior to the procedure as required for safety reasons. However, it was learned there was no system currently in place for documentation in the patient record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparation.

During record review of 6 surgical procedures it was noted that an alcohol based skin preparation had been utilized during all six (6) surgical procedures for patients. DuraPrep had been utilized for: (S1) 4/28/10, (S2) 12/11/09, (S3) 4/20/10, (S4) 5/6/10, and (S5) 4/9/10. The alcohol based skin prep, Chloraprep, had been utilized during a surgical procedure for (S6) 2/18/2010. Review of the Nursing Operative Report for all six (6) patient records confirmed that alcohol skin preparation had been utilized as indicated by the surgical staff. No documentation was evident to indicate the alcohol based skin prep had been dried and/or the appropriate procedure implemented. When queried as to the method of alcohol skin prep application, interview with the OR Supervisor on 6/8/10 at 9:15 A.M. revealed the skin prep was utilized according to manufacturer's instructions, and was allowed to dry prior to beginning the surgical procedure. The CAH policy related to skin preparation in the OR, including any policy related to use of alcohol based skin prep was requested by the surveyor. It was learned there was no current approved policy/procedure related to use of alcohol based skin preparation. It was indicated that a new policy had been recently developed related to the transition to use of Chloraprep as requested by the physicians, however, this policy had not yet been approved by the medical staff.

Review of the current approved surgical policy #S-201, titled SKIN PREPARATION OF PATIENTS was conducted. The current policy included: "5. When indicated the surgical site and surrounding area will be prepared with an antimicrobial agent. The agent with be used according to the manufactures' written instructions. Selection of the agent will be based on patient's history of hypersensitivity reactions, location of the surgical site, and patient skin condition. Consideration of the length of the incision and all potential requirements for the surgical procedure will be given. Agents will be applied using sterile supplies and gloves or by using the no-touch technique and proceeding from the incision site to the periphery. Consideration will be given to the drape fenestration size. Skin Preparation will be performed in a manner that preserves skin integrity and prevents injury to the skin.
6. Documentation of skin preparation in patient record will include: Condition of the skin at the surgical site before and after procedure; Hair removal removal (if performed) including method; Skin preparation used; Name of person performing skin preparation; and Development of any hypersensitivity reactions." The policy lacked any information related specifically to the risk of fires in the surgical area associated with the use of alcohol based skin preps. The current policy also lacked directives for staff to document in the individual patient record related to the precautions taken to reduce this risk, including the dry time for the alcohol based skin prep.

Further interview with the Patient Care Director and the OR Supervisor was conducted on 6/11/10 at 11:30 A.M. It was confirmed there was no documentation evident in patient records regarding drying of the alcohol based skin prep prior to draping, even though the facility's practice had been to check for thorough drying of the area prior to beginning the surgical procedure. It was also confirmed the current approved policy related to skin preparation in the OR lacked required information related to reducing risk of surgical fires. It was confirmed it had not been the practice of the CAH staff to document in the individual patient record related to observance of the drying time of the alcohol based skin prep utilized.

The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to ensure safety from fire during surgery, therefore they were unable to meet this condition.

Based on observation and staff interview, the facility failed to ensure the safety and well being of all patients related to use of hospital beds that did not comply with acceptable levels of safety and quality for 12 of 15 of the beds utilized by the hospital. Findings include:

During observation of the patient rooms on 6/10/10 at 11:00 a.m., 12 of 15 beds employed side rail devices that exceeded the dimensional guidelines of U.S. Health and Human Services, Food and Drug Administration(FDA) dated 3/10/2006, "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment."

The rooms noted to contain beds (Hill-Rom) with side rail devices that did not meet the dimensional standards were as follows: 107(1 bed,) 108(1 bed,) 109(1 bed,) 118(1 bed,) 120(1 bed,) 121(2 beds,) 122(2 beds,) 123(1 bed,) 124(2 beds.)
The openings on these beds for Zone 1 (within the rails) was 7 and 1/2 inches by 8 to 8 and 1/2 inches. The maximum safe opening for this Zone per FDA guidance was 4 and 3/4 inches.

The hospital Acute Care Manager verified during interview on 6/10/10 at 12:45 p.m. the hospital was aware the beds exceeded the guidance by the FDA and initial contacts with vendors had been made and the facility was awaiting some screening information from a bed manufacturer to determine which beds could be retrofitted with side rails and which ones should be replaced. The Acute Care Manager also verified the hospital policy was,"side rails were automatically up," but did not currently have a system in place to assess patients for safety and potential for entrapment or have interventions in place to minimize risks in use of the beds.

On 6/11/10 at 9:30 a.m., the Acute Care Manager provided a new policy that had just been drafted (dated 6/2010) entitled, "Entrapment Prevention Protocol," that outlined a system to screen patients for safety who used the Hill-Rom bed; in addition, temporary interventions were developed to reduce the risk of entrapment of head or extremities in the rails with a method to monitor use. When the census was less than 3 patients, the newer Stryker beds that complied with FDA guidance would be used.

Based on observation and staff interview, the facility failed to ensure proper ventilation in all locations where oxygen and nitrous oxide were stored or transferred from one container to another.

Findings include: The oxygen storage room (206) was noted to contain several large volume oxygen containers and numerous smaller oxygen cylinders. This room was also utilized to fill the smaller oxygen cylinders. In addition, a cylinder of nitrous oxide was stored in the room. There was no functional active ventilation system that serviced the storage room.

The Maintenance Manager verified during interview at 2:30 p.m. on 6/10/10, that the facility was aware of the problem as noted by a State Fire Marshall during a licensure survey; however, the oxygen storage room had only a small area of passive air flow that only functioned when the door was open and a motorized ventilator would probably be required, but had not been scheduled to be completed.

Based on observation, medication inventory list review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that medications located in the Intensive Care Unit (ICU) Room 118 were locked for safe storage. This had the potential to affect all patients and visitors in this area.

Findings include: Unlocked medications were noted in the crash cart in the only room designated as ICU in the CAH (room 118.)

During observations in Room 118/ICU at 3:00 P.M. on 6/8/10, it was noted the medication/crash cart was stored unlocked. The medication cart was noted to have a yellow plastic numbered break-away tab in place on the drawer of the cart. During interview with the Acute Care Manager on 6/8/10 at 3 P.M. it was confirmed that an intact yellow tab signified the contents of the cart had been stocked/restocked as per the physician approved medication list. Although this plastic tab system allowed staff to track utilization of medications from the cart, it provided no physical security from unauthorized persons simply breaking the tab and removing medications. Interview with the Acute Care Manager at this time confirmed the crash cart containing medications in this room was not routinely locked. It was also indicated that although room 118 was located across from the nurses station, there were times when nurses were occupied elsewhere and would not be able to provide direct visual supervision of the room. Some of the medications noted in the cart included: Epinephrine, Lidocaine Hcl 100 mg bolus, Benadryl 50 mg amp, Nitrostat, and Naloxone.

The Acute Care Manager provided a medication inventory list for the ICU. Medications observed unlocked were identified on the corresponding inventory list and confirmed by the Acute Care Manager. Interview with the pharmacist at 10:30 A.M. on 6/10/10 confirmed that medications in the crash cart in Rm 118/ICU were routinely stored unlocked. It was also confirmed there was no system in place to prevent unauthorized persons from potentially removing medications in the event nursing staff was unable to visualize/supervise this location.

Based on record review and staff interview, the CAH failed to ensure that each medical entry was properly authenticated by the physician, mid-level, nurse, and nurse anesthetist with a timed and dated signature for 6 of 8 emergency records reviewed (E1, E3, E4, E5, E7 and E8), 15 of 20 inpatient records reviewed (P1, P2, P3, P4, P5, P6, P7, P8, P9, P10, P11, P13, P17, P19, and P20), and 7 of 7 surgical records reviewed (S1, S2, S3, S4, S5, S6, and S7.)

Findings include: Seven surgical records (S1, S2, S3, S4, S5, S6, and S7) reviewed lacked proper authentication of entries into the medical record including dated and timed signatures. Examples include: All seven surgical records reviewed (S1-S7) lacked dated and timed signature authentication by the surgeon or physician on the Operative/Procedure Reports, and Pre and/or Post-Operative physician orders.

The Surgical Pre-Operative Checklist lacked authentication/signature by the nurse for surgical records S2, S3, S4, S5, S6, and S7. Surgical records S3, S4, S5, and S7 also lacked dated and timed signatures by the physician and/or the physician assistant certified (PA-C) on the pre-surgical History and Physical examinations. The Pre-Anesthesia evaluation for record S2, and the Post Anesthesia evaluation for S6 lacked timed signatures by the Certified Registered Nurse Anesthetist.

Authentication of the Emergency Room Notes by physicians, and/or the PA-C lacked dated and timed signatures on 6 of 8 emergency records reviewed (E1, E3, E4, E5, E7, and E8.)

Authentication of records by physicians, physician assistants, and registered nurses lacked dated and timed signatures for 15 of 20 (P1, P2, P3, P4, P5, P6, P7, P8, P9, P10, P11, P13, P17, P19, and P20.) inpatient records reviewed. Examples include: Dated and timed physician signatures were lacking on Discharge Summaries and/or History and Physical examinations in records P1, P2, P3, P4, P5, P6, P7, P8, P9, P10, P11, P19, and P20. Nurses did not properly authenticate signatures with time and date on the Discharge Planning Assessments for records P1, P2, P4, P5, P6, P7, P9, P10, P19 and P20.
Records P4 and P5 lacked dated and timed signatures by the PA-C and lacked dated/timed co-signatures by the physician on History and Physical Exams performed by the PA-C.

Interview with the Medical Records supervisor on 6/10/10 at 11:30 A.M. verified that entries in the medical records reviewed lacked consistent authentication of the time and/or date and time the entry had been made by the author. It was further indicated this had been an ongoing problem in the CAH.

Based on policy review and staff interview, the facility failed to ensure the Rehabilitative Services health care policies were evaluated, reviewed and/or revised as part of the annual program evaluation.

Findings include: The Rehabilitative Services department (Physical,Occupational and Speech Therapies) was noted to lack policies and procedures defined in written format for all procedures performed; in addition, the policies had not been approved by the Medical staff or reviewed annually.

The hospital directly provided Rehabilitative Services that included Physical Therapy(PT) and Occupational Therapy(OT). In addition the hospital provided Speech Therapy (ST) by contract. During a tour of the therapy department, policies were reviewed for compliance and were noted to lack dates of implementation and approval; most of the policies had been dated as having been developed from 2003 to 2005 and had not been updated/revised
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The Physical Therapy/Rehab Director verified during interview at 10:15 a.m. on 6/10/10, that she "had just started revising policies" however she was not aware of any that had been approved yet by the Medical staff, either for PT, OT or Speech Therapy. The Rehab Director did not have any policies on site for the Speech Therapy that was provided by contract agency.

At 3:15 p.m., the Patient Care Director also verified Rehabilitative Services had not had policies and procedures approved by the Medical staff and the annual policy review did not receive Rehabilitative Services policies and none had been reviewed.