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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. This practice was evident for 3 of 3 patients (P1, P3 and P21) in the sample who required this type of surgical prep.

Findings include: The CAH did had not developed 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 inpatient 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, preferable as part of a systemic approach by the CAH to preventing surgery related fires.

During record review it was noted that alcohol based skin preparation had been utilized during three (3) surgeries on the following dates: (P1) 2/11/10 , (P3) 4/8/10, (P21) 3/11/10. Review of the Surgery Flow Sheet for all three (3) records confirmed that alcohol skin preparation (DuraPrep) had been utilized. No documentation was evident to indicate the alcohol based skin prep had been dried and/or the appropriate procedure implemented.

A surgical policy indicating the practice followed for skin preparation was lacking in the surgical policy and procedure manual on 6/1/10. Upon query as to the CAH policy followed for skin preparation of the surgical patient, the OR (operating room) manager indicated on 6/2/10 at 10:40 a.m. that she had found a policy on the Sanford website that had been indicative of Westbrook CAH practice, but she had just "run" off the policy on 6/1/10 as indicated on the Sanford Westbrook, Medical Center Surgical Services Policy #S-045 "Skin Preparation of a Patient". She stated "this is what we've always done" and confirmed it had been produced only after surveyor inquiry. The policy #S-045 stated "if commercially packaged antimicrobial agent with its own applicator (such as Dura-Prep or Chloraprep), apply according to manufacturer's written instructions and precautions. Any alcohol based antimicrobial agent must be allowed to dry for a time identified by manufacturer recommendations." It was verified with the OR manager that documentation on the "Surgery Flow Sheet" only indicated the type of skin prep utilized and did not indicate whether it had been dried prior to the procedure.

The Director of Nursing (DON) was interviewed at 11:45 a.m. on 6/3/2010, and confirmed their was no documentation evident in the patient records regarding drying of the alcohol based skin prep. The Health Information Manager indicated at 9:20 a.m. on 6/2/10, that the CAH had only completed 4 surgical procedures since January 2010.

Based on observation, medication inventory list review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that medications located in the Emergency Room (ER) and the Coronary Care Unit (CCU) were locked for safe storage. This had the potential to affect all patients and visitors in these areas.

Findings include: Unlocked medications were noted in the ER and the CCU.

During observations in the ER at 9:30 A.M. on 6/1/10, and again during a tour of the ER with RN-C at 11:00 A.M. on 6/2/10, the medication cart (ER crash cart) located in the ER was noted to have been unlocked. During the tour of the ER on 6/2/10 it was noted the top drawer of the medication cart had a red plastic break-away tab in place. During interview with RN-C at 11:05 A.M. on 6/2/10, it was confirmed that an intact red 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. Some of the medications contained in the cart included: Epinephrine pre-filled syringe, Lidocaine Hcl pre-filled carpujects, Diazepam carpujects, Benadryl carpujects, Nitrostat and Naloxone. The ER was located at the far end of the patient corridor away from the nurses' station. The entrance to the ER was located adjacent to an outside entrance to the building.

During observations in the CCU at 9:30 A.M. on 6/1/10, and again at noon on 6/2/10, it was noted that a plastic receptacle with stacking drawers, (identified as the "CCU Tower") contained medications. This plastic storage unit for medications was not locked, but was noted to have the break-away red tab system in place as described above. It was noted that drawers (containing medications) in this plastic storage tower could easily be removed by breaking the red tab and removing the whole drawer out of the stacking unit. Although the CCU was located near the nurses' station, unless facility staff was in the immediate area, an unauthorized person could potentially remove medications from the unlocked receptacle. Some of the medications contained in this CCU Tower included: Metoprolol, (tablets and ampules), Amiodarone ampules, Dopamine, and Lidocaine pre-filled syringes.

The Director of Nurses provided medication inventory lists for the ER cart and the CCU Tower. Medications observed unlocked were identified on the corresponding inventory lists and confirmed by the Director of Nurses (DON). Interview with the DON and the pharmacist at noon on 6/3/10, confirmed the medications in the ER crash cart and in the CCU tower were not routinely locked. 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 these locations.

Based on preventive maintenance review, policy review and staff interview, the Critical Access Hospital (CAH) failed to inspect and maintain their lead aprons, gloves and gonadal shields in a timely manner as designated per facility policy. This deficient practice had the potential to affect all patients who required X-Rays.

Findings include: It was noted during review of preventive maintenance records that the lead aprons, gloves and gonadal shields in the radiology department had not been inspected for leaks for over three (3) years. The facility policy, "Safety Checks of Lead Aprons, Gloves and Gonadal Shields" indicated the following: "All lead gloves, aprons and gonadal shields will be checked via the method of X-Ray for safety defects once every two years, as to not exceed 24 months in between checks; documentation as to this survey will be kept; and all defective equipment will be repaired, replaced and/or disposed of as necessary". During review of documentation of the safety checks it was noted the (3) aprons, (1) half apron, (1) gonad shield and (3) gloves had last been checked in January 2007. They had not been rechecked again until 6/2/10 (40 months later), after the surveyor had requested information about the safety checks.

Upon interview with the radiology supervisor at 10:40 a.m. on 6/3/2010, it was verified the lead aprons, gloves and gonadal shields had not been checked according to the facility's policy.

Based on record review and staff interview, the CAH failed to ensure that each medical entry by the physician, mid-level, nurse, and therapist included a timed and /or dated signature for 7 of 7 emergency records reviewed (E1, E2, E3, E4, E5, E6 and E7), 20 of 20 inpatient records reviewed (P1, P2, P3, P4, P5, P6, P7, P8, P9, P10, P11, P12, P13, P14, P15, P16, P17, P18, P19 and P20), and 3 of 3 outpatient surgical records reviewed (O1, O2, and O3).

Findings include: Three outpatient surgical records (O1, O2 and O3) reviewed lacked timed physician signatures on the operative report and/or with the initial RN nursing assessment signature.



02980

Authentication of records by physicians, physician assistants, and registered nurses lacked dated and timed signatures on 7 of 7 emergency records reviewed. Examples of documents in the emergency records which lacked timed and dated signatures included physician order forms, nursing emergency room records, and the emergency physician record.

Authentication of records by physicians, physician assistants, nurse practitioners, physical therapists, and registered nurses lacked dated and timed signatures for 20 of 20 inpatient records reviewed. Documents in the records lacking proper authentication included therapy assessments/evaluations and progress notes, physician progress notes, physician orders, discharge summaries, admission nursing assessments, and history and physical exams.

Interview with the Health Information Manager at 11:45 a.m. on 6/3/10, verified that entries in the medical records reviewed lacked consistent authentication of the date/time the entry had been made by the author. It was further indicated this had been an ongoing problem in the CAH, however, as the facility converts to electronic authentication of signatures, the problem should resolve.

Based on review of surgical privileges and staff interview, the Critical Access Hospital (CAH) failed to assure the current roster listing each practitioner's surgical privileges had been updated and made available in the surgical suite.

Findings include: An updated and current surgical privilege roster had not been available to the surgical staff. Upon interview with the OR (operating room) manager at 10:40 a.m. on 6/2/10, it was indicated she had not been aware the availability of any roster delineating each practitioner's surgical privileges for surgical staff to review. She stated a list had been kept in the health information manager's office and that they "knew the surgeons".

During interview with the Health Information Manager (HIM) at 12:30 p.m. on 6/2/10, it was verified that the delineation of privileges roster had been available to the OR staff but the OR manager had forgotten the location. The HIM also verified that the most recent surgeon (C), who had been providing services since the beginning of 2010, and who had been approved by the governing body on 4/29/09, had not had his surgical privileges added to the roster available to the surgical staff. The surgical privilege roster had been updated on 6/2/10, after surveyor inquiry and made available for surgical staff.

Based on record review and staff interview the Critical Access Hospital (CAH) failed to document in 1 of 4 surgical records (P1) reviewed that the surgical patient had been discharged in the company of a responsible adult.

Findings include: Documentation was lacking in the record of (P1) to indicate the patient had been discharged in the company of a responsible adult.

It was noted during record review that (P1) had received general anesthesia during surgery on 2/11/2010. Documentation on the PACU Flowsheet Recovery form was left blank ["Driver present to escort patient home: yes__"]. Upon interview with the Director of Nurses at 2:00 p.m. on 6/1/2010, it was verified that the information was lacking on the required "PACU Flowsheet Recovery" form and that the information had also not been documented in the nursing progress notes. The Health Information Manager indicated at 9:20 a.m. on 6/2/10, that the CAH had conducted only 4 surgical procedures since January 2010.