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Based upon interview and review of policies, 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 the use of alcohol based skin preparation products in anesthetizing locations to prevent the risk of surgical fires. This practice was evident for every patient who underwent a Caesarean section and any patient of a specific orthopedic surgeon who routinely utilized DuraPrep as a surgical skin prep. Findings include:

The CAH 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 Suite. The Centers for Medicare and Medicaid Services (CMS) 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 or outpatient anesthetizing locations in CAHs. The use of an alcohol based skin preparation in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systematic approach by the CAH to prevent surgery related fires.

The Operating Room/Endoscopy Manger and the Pre-Admit/ Post Anesthesia Care Unit manager were interviewed on 7/13/2010 at 2:10 PM. They stated one orthopedic surgeon routinely used DuraPrep (alcohol based product) as a skin prep preoperatively. They also stated that alcohol was routinely used as a preoperative skin prep for all patients undergoing a Caesarean section. The Operating Room/Endoscopy Manager stated she had developed a policy entitled "Perioperative Skin Antiseptic Agents: Handling and Storing" however, the policy had not been reviewed nor approved for use in the Surgical Suite. The Operating Room/Endoscopy Manager verified that staff were not currently documenting when the alcohol based skin preparation was applied and when it had dried in the medical record. She stated she was not sure that all staff were aware that alcohol based skin preparations must be allowed to thoroughly dry as the new policy had not been implemented.

Based on interview and record review the facility did not ensure clearly delineated renewal of privileges for 4 of 11 practitioners (MDs H, K, I, and J) and failed to ensure timely renewal of credentialing for 1 of 1 Certified Registered Nurse Anesthetists (CRNA-A). Findings include:

MD-H's reappointment privileges were not clearly defined.

MD-H's Recommendation For Reappointment and /or Renewal of Privileges form dated 04/20/2009, and signed by the chief of staff and chairperson of the governing board, indicated MD-H sought the same privileges as those "currently granted" and the "privileges requested should be appended to this form." The second page of the renewal of privileges form indicated the board concurred with the medical staff to reappoint and renew privileges that were requested. The governing body indicated the privileges would not be modified and privileges would remain the same as they were at the last renewal. The privileges listed on the appended form dated 04/20/09 did not correspond with those included on the renewal dated 12/07. The privileges listed on 4/20/2009 omitted specific surgical or therapeutic diagnostic procedures privileges, such as general anesthesia, spinal anesthesia, exploratory laparotomy, appendectomy, and cesarean section that were included on 12/07.

Interview with the Director of Quality and Health Information at approximately 2:30 p.m. on 07/14/2010, confirmed MD-H currently defined privileges were not consistent with the previous list and the differences were not addressed by the governing board.

MD-K reappointment privileges were not clearly defined.

MD-K's list of privileges requested on 10/09/2008 omitted the procedures of spine surgery, laminectomy and discotomy that were approved on 9/12/2006. The new reappointment list of privileges (11/24/2008) was reviewed by the governing board but did not clarify the changed privileges.

MD-K's Recommendation For Reappointment and /or Renewal of Privileges dated 11/24/2008 was signed by the chief of staff and chairperson of the governing board. The document indicated MD-K sought the same privileges as those "currently granted" and the "privileges requested should be appended to this form." The governing body indicated the same privileges would be granted and no modifications were required.

The Director of Quality and Health Information, interviewed at approximately 2:30 p.m. on 07/14/2010, verified the change of privileges for MD-K and that the changes were not addressed by the governing board. She further confirmed that when privileges are modified, the document should be specific as to those changes.

MD-I's reappointment of privileges documentation was not clear in regard to governing board approval for the additional privilege of supra pubic catheter insertion.

The 03/23/09 list of privileges requested the addition of supra pubic catheter insertion under the specific internal medicine privileges. The previous list of privileges dated 2/28/2007, did not include supra pubic catheter insertion. The governing board reappointment and renewal of privileges document dated 3/23/3009 indicated no modification of privileges.

The Director of Quality and Health Information, interviewed at approximately 2:30 p.m. on 07/14/2010 verified the change in requested privileges for MD-I. She further confirmed that when privileges are modified, the document should be specific as to those changes.

MD-J's reappointment of privileges documentation was unclear in regard to governing board awareness and approval of revised privileges.

MD-J's Recommendation For Reappointment and/or Renewal of Privileges dated 3/23/2009 was signed by the chief of staff and chairperson of the governing board. The document indicated MD-J sought the same privileges as those "currently granted." The appended privilege request document dated 10/26/2008 indicated MD-J wanted to give up various privileges included with the previous list dated 2/28/2007. The revised list of privileges was not addressed by the governing board.

The Director of Quality and Health Information, interviewed at approximately 2:30 p.m. on 07/14/2010, verified the change of privileges for MD-J and that the changes were not addressed by the governing board. She further confirmed that when privileges are modified, the document should be specific as to those changes.

CRNA-A's anesthesia privileges expired on 1/31/2010.

CRNA-A's credentialing file included the Medical Staff Appointment dated 1/28/2008, for Allied Health Professional status and CRNA privileges through January 31 2010. The credentialing file reviewed 7/14/2010 did not include documentation of renewal on or after 1/31/2010.

The Director of Quality and Health Information, interviewed at 2:25 p.m. on 7/14/2010, stated CRNA-A continued to provide anesthesia services in the CAH on a regular basis. She further indicated the renewal date was incorrectly entered to the data base and was not flagged for timely renewal of anesthesia privileges.

Based on interview and policy review, the CAH failed to designate an individual who is responsible for the operation of the Outpatient Services department. Findings include:

The CAH outpatient departments included Cardiac Rehabilitation, Physical Therapy, Occupational Therapy, Chemotherapy, Out Patient Surgery, Radiology, Ambulance Services, and Laboratory. Review of the organizational chart indicated there was not an identified person in charge of outpatient services. Review of the policies and procedures and director of nursing and administrative's job descriptions did not indicate who was in charge of outpatient services.

Interview with the administrator at approximately 10:00 a.m. on 07/14/2010 confirmed the CAH did not have documented information to indicate who was in charge of outpatient services and did not have a description for the coordination of outpatient services.

Based on interview and record review the facility did not ensure documented dates and times for medical record entries for 9 of 20 patient medical records (P 2, 3, 4, 5, 1, 26, 28, 29,and 30) reviewed. Findings include:

P2 was admitted to the hospital for outpatient testing on 7/19/2010. The order for bilateral mammogram from physician (MD-E) lacked the date and time.

P3 was admitted to the hospital for outpatient testing on 7/16/2010. The order from physician (MD-F) lacked the date and time.

P4 was admitted to the hospital for outpatient testing on 7/19/2010. The verbal order for the bilateral mammogram by physician (MD-L) lacked a signature, date and time the order was received.

P5 was admitted to the hospital for outpatient surgery on 7/14/2010. The faxed pre-operative orders dated 7/12/2010 lacked a time and signature by the ordering physician.

Review of the Health Information Services policy dated 6/06 indicated all orders would be signed and dated by the physician. Review of the By Laws page 69 indicated that the physicians would sign, date and time all physician's orders and verbal orders would be counter signed as soon as possible.


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P1 was admitted to the hospital with diagnoses which included aspiration pneumonia and Diabetes Mellitus. P1's "Adult Admission Standing Orders" were dated but did not indicate what time the physician (MD-G) had signed the orders. "Adult Insulin Sliding Scale Standing Orders" indicated P1 was to have a blood glucose measurement completed four times a day and was to receive insulin via a "Medium Dose Scale," however MD-G did not date or time the order. The "Pneumonia Supplemental Orders," signed by MD-G, did not include the date nor the time the orders were written.

P1's orders by MD-E included Lasix (diuretic medication) 20 milligrams intravenously on 7/6/2010, however there was no time documented to indicate when the order had been written.


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P26 was admitted on 7/8/2010 with end stage congestive heart failure, osteomyelitis, and weakness. Verbal orders and telephone orders dated 7/8/2010 had not been signed or timed by MD-H.

P28 was admitted on 710/2010 with falls and weakness. Admission standing orders dated 7/10/2010 were signed but MD-D did not document the time of the orders. Adult Venous Thromboembolism Prophylaxis protocols dated 7/11/2010 were signed by MD-E but no documentation of time the orders were signed was evident. Physical Therapy plan of treatment orders dated 7/11/2010 were not signed or timed by MD-F. Occupational Therapy plan of treatment orders dated 7/12/2010 were not signed or timed by MD-F.

P29 was admitted on 7/5/2010 with abdominal pain and vomiting. On 7/6/2010, P29 had surgery for a small bowel obstruction. MD-C signed Adult TPN Standing orders, but they were not timed or dated. Post op abdominal surgery protocols dated 7/6/2010 were signed by MD-C but not timed. Telephone orders for Adult Insulin Sliding Scale Standing Orders dated 7/9/2010 and 7/10/2010 by MD-C were not signed, dated or timed. Adult Venous Thromboembolism Prophylaxis orders dated 7/5/2010 and 7/9/2010 were signed by MD-E but were not timed.

P30 was admitted 7/12/2010 for a left mastectomy procedure. Post-Op Mastectomy protocols/orders dated 7/12/2010 were signed but not timed by MD-C. Admission and Discharge Reconciliation of Medications/Physician order forms dated 7/12/2010 and 7/13/2010 were signed but not timed by MD-C.

The pharmacy operational policies and procedures reviewed and revised with date of 6/09 was reviewed. The policy states "All orders, including verbal orders, for drugs and biologicals must be legible, timed, dated and authenticated with a signature by the ordering practitioner. "Nursing policies and procedures addressing physician orders with reviewed and revised date of 7/2010 were reviewed and stated under 1.3 "All orders, including verbal orders, for drugs and biologicals must be clear, legible and complete. Orders must include date, time, and be authenticated with a signature by the ordering practitioner.

On 7/15/2010 at 10:30 a.m., the director of patient services (director of nursing) was interviewed. She verified the physicians should be signing, dating, and timing all entries. The director indicated the staff follow the medical by laws for this. She also provided the policy from the pharmacy department and the nursing policies to the surveyor.

Based on interview, policy review, and a review of hospital contracts, the Critical Access Hospital (CAH) was found not to be in compliance with the Condition of Participation of Surgical Services. The CAH failed to ensure proper sterilization of surgical instruments for 15 of 15 outpatients (OPS 6-18, 19 and 20) patients who underwent a cataract extraction with an intraocular lens implant. This potentially could effect every patients who underwent this surgical procedure at the CAH. Findings include:

During the tour of the surgical department on 7/13/2010 at approximately 2:10 pm, the Operating Room/Endoscopy Manager and the Manager of the Pre-Admit and Post Anesthesia Care Unit (PACU) were interviewed regarding the use of flash sterilization. They stated the surgical eye instruments were washed between cases and then placed in the flash sterilizer in a tray (not wrapped). The OR/Endoscopy Manager stated the Operating Room policy indicated flash sterilization should only be used in an emergency situation. A review of the "Flashing Record for Autoclave #2", dated 6/17/2010, indicated eye instruments had been flash sterilized for ten patients of MD-A (OPS 12-18, 19 and 20). The log indicated the reason for flashing the instruments was because only two instrument trays were available. The "Flashing Record for Autoclave #2", dated 7/1/2010, indicated eye instruments had been flash sterilized for five patients of MD-B (OPS 6-11). The log indicated the instruments had been flash sterilized as there were several patients scheduled to have a cataract extraction and only two instrument trays were available.

A review of the "Surgical Services/Sterile Processing" policy, last reviewed January 2010, indicated flash sterilization should be avoided whenever possible. The policy indicated flash sterilization could be utilized only if situations occurred when no replacement instruments were available. A review of the CAH policy "Cleaning/Disinfection/Sterilization of Reusable Patient Equipment/Items", last reviewed 4/08, indicated that flash sterilization was restricted to unplanned or emergency situations.

The OR/Endoscopy Manager and the Manger of the Pre Admit/PACU stated the CAH had a contract with SightPath Medical who provided the CAH with staff to assist the ophthalmologist performing the cataract extractions as well as all instrumentation required. They stated the contract service only provided two to three sets of instruments with each visit which was not dependent upon the number of patients scheduled for cataract surgery on a given day. They stated MD-A was scheduled one day a month and would perform ten to twelve cataract extractions with each visit. They stated MD-B worked one day every other month and would schedule four to six procedures each visit.

A review of the contract from SightPath Medical entitled "Agreement Mobile Cataract and Specialty Services", signed 6/28/2006, indicated SightPath Medical would provide two complete instrument trays with each contracted visit. The contract did not specify the number of instrument trays provided would be dependent upon the number of patients scheduled to undergo a cataract extraction when SightPath provided an onsite visit to the CAH.