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Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Federal Re-Certification Survey conducted on August 10, 2011, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C231.

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Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Critical Access Hospital Federal Re-Certification Survey conducted on August 10, 2011, the surveyors find that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.
See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated August 10, 2011.

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A. Based on a review of Medical Staff Bylaws, a review of Medical Staff and Certified Registered Nurse Anesthetist (CRNA) credential files, and staff interview, it was determined in 9 of 12 (P1, P6, P7, P8, P16, P17, P18, P19, P21) credential files reviewed, in which the practitioner had applied for recredentialing, the CAH failed to ensure the recredentialing process included an evaluation of services provided by the practitioner.

Findings include:

1. The Medical Staff Bylaws were reviewed on 8/10/11. It indicated "Article VII: Reappointment Issues: C. Re-appraisal... is based on an evaluation by the Medical Staff and the Board of Trustees which will consider various factors, including professional performance, clinical judgement and technical skills... b. (1) Attendance at Medical Staff meetings... 7.5 Performance Improvement/ Peer Review Information: A. Information on a member's health care practices... Such information shall at least include a statistical and narrative profile of the practitioner, objectively demonstrating the quality and appropriateness of the member's practice within the institution..."

2. On 8/10/11, 9 of 12 physician/CRNA recredential files were found to lack an evaluation of services provided by the practitioner. This was evident in physician files of P1, P6, P7, P8, P16, P17, and P18 and CRNA files of P19 and P21.

3. During a staff interview, conducted with the Chief Nursing Officer (CNO) on 8/10/11 at 2:30 PM, the above findings were confirmed.

B. Based on a review of Medical Staff and CRNA credential files and staff interview, it was determined in 12 of 12 credential files reviewed, in which the practitioner had Emergency Room (ER) Privileges, the CAH failed to ensure the privileges included the ability to perform Intravenous (IV) Conscious Sedation.

Findings include:

1. On 8/10/11, 12 of 12 credential files reviewed, in which the practitioner had ER Privileges, failed to include the privilege to perform IV Conscious Sedation.

2. During a staff interview, conducted with the CNO on 8/10/11 at 2:30 PM, the above findings were confirmed. It was verbalized that 5 of these physicians (P14, P15, P16, P17, P18) were the hospital's Internal Medicine, Surgery, and/or Family Practice physicians who had obtained ER privileges "just in case of a trauma and/or disaster."

A. Based on a review of policy and procedure, a review of anesthesia narcotic sign out sheets, and staff interview, it was determined that the CAH failed to ensure all narcotic sign out sheets were accurate.

Findings include:

1. The CAH policy and procedure titled, "Narcotic and Controlled Drugs" was reviewed. It indicated under "Responsibility: Anesthesia personnel will: 3. Ensure that narcotics and controlled drugs are...signed out appropriately on drug control forms."

2. The completed anesthesia narcotic sign out sheets for July/Aug were reviewed. On the Fentanyl 50mcg/ml sign out sheet with the Control No. 552561, it was noted that on 8/1/11 at 11:00 AM the narcotic count was indicated as "12". The next entry was 8/1/11 at 11:30 AM which indicated that 0 (zero) was given but 2 were subtracted which caused a variance of 2.

3. During an interview with the pharmacist, conducted on 8/9/11 at 1:45 PM, the above finding was confirmed.

B. Based on a review of CAH policy and procedure, review of nursing narcotic shift count logs, and staff interview, it was determined that a random count of 17 of 54 narcotic count r0eviews, the CAH failed to ensure all nursing shift narcotic counts were conducted appropriately.

Findings include:

1. The CAH policy and procedure titled, "CONTROLLED SUBSTANCES: MAINTENANCE, DISPENSING, ADMINISTRATION & ACCOUNTABILITY OF CONTROLLED SUBSTANCES" was reviewed. There was no policy or procedure related to the nursing change of shift narcotic count/inventory. It was verbalized by the CNO on 8/11/11 at 9:00 AM that the pharmacist stated "the requirement for 2 signatures for the nursing shift change narcotic count is a standard of care and there probably won't be a policy or procedure."

2. The Med/Surg "Floor Stock Narcotic Inventory Count" sheets for June/July/August 2011 were reviewed. Documentation indicated that 17 of 54 counts there was only 1 of the 2 required signatures.

3. During an interview with the CNO, conducted on 8/10/11 at 10:45 AM, the above findings were confirmed.



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C. Based on observation, a review of CAH policies, and staff interview, it was determined the CAH failed to ensure outdated drugs and/or biologicals were not available for patient use.

Findings include:

1. During a tour of the CAH, conducted on 8/9/11 thru 8/10/11, the following outdated drugs and/or biologicals were observed, available for patient use. In Radiology Room #1, 5 Betadine Swab sticks expired 10/10. In both the Computerized Tomography and Radiology Room #2 emergency boxes, Solumedrol 125 mg/ 2 ml expired 7/11. In the Nuclear Medicine room, 4 Stopcocks expired 1/09. In Physical Therapy (PT) department, on the cart next to the Hydrocollator, 1 Hydrocortisone lotion 2.5% expired 7/09. In the Surgery medication refrigerator, 7 Atracurium 100 mg/ 10 ml expired 12/10. In the OR sterilizing room, 32- 3M Attest 1261 B.I./ Steam Spore Test expired 7/11 and 1 expired 11/10. In the ER, 3 soft PVC Nasopharyngeal airways (two 12 French expired 5/09 and one 14 French expired 5/09). In the pharmacy compounding room, 2 Unasyn 1 gm with 50 ml 0.9% Normal Saline IV piggybacks expired 7/11. In the PT department, 1- 16 ounce jar Free-Up Professional Massage Cream with no date as to when opened and 1 jar 6gm/24gm Hydrocortisone cream with no date as to when it was opened (both had finger marks in the cream and it was verbalized by the PT assistant that the ungloved hand is used to remove what is needed for each patient).

2. The CAH policy titled "Floor Stock Medication- Par Level" was reviewed on 8/9/11. It indicated "All floor stock medications including crash carts and transport boxes shall be inspected monthly by pharmacy personnel for any outdated medications or missing medications... Pharmacy shall check surgery's floor stock quarterly, at which time, all meds will be inspected..." The policy "Rx Update: Drug Expiration Dating on Patient Care Areas" was also reviewed. It indicated "Floorstock topical medications such as ointments... discard date/ maximum time period for use: 28 days after opening."

3. During a staff interview, conducted with the CNO on 8/10/11 at 2:30 PM, the above findings were confirmed.

D. Based on observation, a review of policy, and staff interview, it was determined the Critical Access Hospital (CAH) failed to ensure anesthesia drugs were stored in a locked area.

Findings include:

1. During a tour of the surgical area, conducted on 8/10/11 at 1:15 PM, the following anesthesia drugs were observed in an unlocked medication refrigerator: 7 Atracurium 10 ml vials (100 mg/ 10 ml), 3 Succinylcholine 200 mg/ 10 ml, and 5 Rocuronium Bromide 10 mg/ 10 ml. It was verbalized by the Operating Room (OR) Nurse Manager that these items were always stored there.

2. The CAH policy titled "Narcotics and Controlled Drugs" was reviewed on 8/10/11. It indicated "Anesthesia personnel will: 3. Ensure that narcotics and controlled drugs are stored in locked containers..."

3. During a staff interview, conducted with the CNO on 8/10/11 at 2:30 PM, the above findings were confirmed.

A. Based on a review of dietary temperature logs and staff interview, it was determined that the CAH failed to ensure all appropriate serving line temperatures were monitored.

Findings include:

1. During a tour of the Dietary Department, conducted on 8/9/11, the temperature logs for all dietary monitoring were reviewed for the last 3 months (May, June, July 2011). It was noted that there were no temperature recordings for the cold foods on the cafeteria serving line.

2. During an interview with the Dietary Manager, conducted on 8/9/11 at 2:30 PM, the above findings were confirmed.

B. Based on observation, a review of CAH policy, and staff interview, it was determined the CAH failed to ensure the IV warmer temperature was monitored and followed the recommended expiration date guidelines, as per it's policy.

Findings include:

1. During a tour of the OR department, conducted with the OR Manager on 8/10/11 at 1:15 PM, the IV warmer was observed to contain 5 liters Lactated Ringers (LR) with dates marked (1 with 6/20, 1 with 6/27 and 3 with 6/29) and 4 500 ml LR with date 7/15 marked on it. The temperature read 99 degrees at that time. A memo on the warmer door indicated "for every week in warmer, subtract 4 weeks from expiration date." There was no documentation to indicate the warmer temperature was monitored.

2. The CAH policy titled "Warmed IV fluids and Irrigation Fluids in ER/OR" was reviewed on 8/10/11. It indicated "The warming cabinet shall be controlled by a calibrated thermometer... Hence for every one week stored... 5 weeks should be deducted from the original expiration date." The memo on the warmer indicated 4 weeks.

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

C. Based on observation, a review of CAH policy, and staff interview, it was determined the CAH failed to ensure Flash Sterilization was conducted in a manner to assure sterility of instruments.

Findings include:

1. During a tour of the OR department, conducted with the OR Manager on 8/10/11 at 1:15 PM, the sterilizing pan utilized for flash sterilization was observed to have a perforated bottom and metal sides. It was verbalized that instruments (mainly eye) were placed in the pan and flash sterilized, then a towel is placed over the top and it is walked to the OR room. The pan is not self contained and the instruments are not wrapped to ensure sterility.

2. The CAH policy titled "Verification of the Sterilization Process" was reviewed on 8/10/11. It indicated "Protocol for Flash Sterilization: 4. Place items in a perforated tray to ensure that steam comes in contact with all surfaces. 12. Remove items from the sterilizer only after ... 1. Scrub personnel remove the items after covering the tray with a sterile towel or... Indications for Flash Sterilization: 1. Limited instrument supply. 4. Turn around time."

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

D. Based on observation, a review of CAH Material Safety Data Sheet (MSDS), and staff interview, it was determined the CAH failed to ensure outdated cleaning solutions and/or hand sanitizers were not available for use in the patient care areas.

Findings include:

1. During tour of the CAH, conducted 8/9/11 thru 8/10/11, the following outdated and/or potentially outdated cleaning and/or hand sanitizers were observed in the patient care areas. In the Radiology department, 5 rooms were observed to have bottles of Steris Coverage Spray HB with no dates as to when they expire. The Radiology Manager indicated that these were refilled as needed by housekeeping. It was later verbalized that this product has not been used "for a very long time" and therefore it was unknown as to how long the bottles had been in the department for use. In the PT department, 5 TB Quat Disinfectant bottles with no dates as to when opened or when they expire. The following areas were observed to have outdated Alcare Plus Antiseptic Handrubs: Mammography room expired 1/09, PT department outside bathroom door expired 6/11, and ER department one expired 6/11.

2. The CAH MSDS for TB Quat Disinfectant was reviewed on 8/10/11. There was no guidance to indicate how long the disinfectant was determined to be sterile once opened.

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

E. Based on observation, a review of CAH policy, a review of Hydrocollator temperature log, and staff interview, it was determined the CAH failed to ensure Hydrocollator temperature and cleaning was conducted in accordance with it's policy.

Findings include:

1. During a tour of the PT department, conducted with the PT Assistant on 8/9/11 at 2:00 PM, 2 Hydrocollator machines were observed in the PT area. It was verbalized by the PT assistant the this modality is utilized on "most all of our patients both in house and outpatient". On 8/11/11, it was reported by the PT Manager that the following number of patients were treated with Hydrocollator therapy over the last 3 months: May- 335, June-310, July-323. The Hydrocollator Temperature log indicated 2 readings in the month of March, 3 readings in the month of April, one reading in May, and one reading in August. All readings were 150 degrees F. There were no logs prior to this time.

2. The CAH policy titled "Hot Moist Packs" was reviewed on 8/10/11. It indicated "Procedure: 6. Check temperature in Hydrocollator (165 degrees F) and make sure packs have been in machine at least 20 minutes since last use per hot pack rotation procedure. 16. Clean unit monthly, by draining and washing with disinfectant (see Infection Control Manual)." All temperatures were 150 degrees F. The temperatures were not checked prior to each patient use. There was no documentation to indicate cleaning of the machines had occurred. There was no Infection Control manual policy related to cleaning of the Hydrocollators.

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

F. Based on observation and staff interview, it was determined the CAH failed to ensure laundry services were performed and monitored to assure proper temperature and disinfection of laundry utilized in patient care to decrease the risk of potential cross contamination.

Findings include:

1. During a tour of the CAH laundry facility, conducted with the laundry personnel on 8/11/11 at 1:00 PM, it was observed and verbalized that both heat and chemical disinfection was utilized in laundering patient care items. There was no documentation to indicate the temperature of water (washer) and/or heat (dryer) were monitored to ensure proper ranges were maintained. It was verbalized, by both the laundry personnel and the Maintenance Manager that logs were not maintained for this area.

2. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above finding was confirmed.

A. Based on a review of the list of contracted services and staff interview, it was determined that the CAH failed to ensure it maintained a list of all services provided by arrangement or agreement and that the list described the nature/scope of the service provided.

Findings include:

1. The list of contracted services was reviewed. It listed only 8 services and did not include services such as organ/blood procurement, trash services, dietary services, Emergency Department physician services, nuclear med services, etc.

2. During an interview with the Chief Nursing Officer, conducted on 8/10/11 at 2:45 PM, it was verbalized that there was no complete list of those services provided by arrangement or agreement.

A. Based on a review of policy and procedure, a review of internal documentation identifying delinquent medical records, and staff interview, it was determined that the CAH failed to ensure all medical records were completed within the required time frame.

Findings include:

1. The CAH policy and procedure titled, "Policy and Procedure for Completion of Inpatient and Outpatient Record Delinquencies" was reviewed. It indicated under, "Purpose: The purpose is to help the physicians complete their record delinquencies within the required period. Inpatients - 30 day per IDPH..."

2. Internal documentation indicated that as of 8/9/11 there were 53 medical records that had exceeded the 30 day time frame for the completion of the record.

3. During an interview with the Chief Nursing Officer, conducted on 8/9/11 at 1:30 PM, the above finding was confirmed.

A. Based on medical record review and staff interview, it was determined in 2 of 2 (Pts #15, #16) medical records reviewed, in which the patient underwent outpatient pain management services, the CAH failed to ensure an informed consent for the procedure was obtained.

Findings include:

1. The medical record of Pt #15 was reviewed on 8/11/11. Pt #15 was admitted to the CAH on 7/7/11 with the diagnosis Degenerative Joint Disease with Radicular Pain Right Lumbar 4-5, Lumbar 5 to Sacral 1 Neuroforminal Stenosis and underwent an epidural anesthetic injection with fluoroscopic guidance. There was no documentation of an informed consent for this procedure to be performed.

2. The medical record of Pt #16 was reviewed on 8/11/11. Pt #16 was admitted to the CAH on 7/7/11 with the diagnosis Degenerative Joint Disease with Radicular Pain Right Lumbar 4-5 Neuroforminal Stenosis and underwent an epidural anesthetic injection under fluoroscopic guidance. There was no documentation of an informed consent for this procedure to be performed.

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

A. Based on medical record review and staff interview, it was determined in 2 of 4 (Pts #17, #18) medical records reviewed, in which the patient underwent surgical intervention, the CAH failed to ensure pre-operative laboratory orders were completed prior to the surgical procedure.

Findings include:

1. The medical record of Pt #17 was reviewed on 8/11/11. Pt #17 was admitted to the CAH on 3/31/11 with the diagnosis Postmenopausal Bleeding and underwent an Abdominal Hysterectomy, Adhesiolysis, and Repair of Ventral Hernia. On 3/31/11, there was a physician's order for a pre-operative urine pregnancy test. There was no documentation to indicate that this test was completed.

2. The medical record of Pt #18 was reviewed on 8/11/11. Pt #18 was admitted to the CAH on 5/12/11 with the diagnosis Acute and Subacute Cholecystitis with Cholelithiasis and underwent Cholecystectomy. On 5/12/11, there was a physician's order for Liver Profile, Urinalysis, and Type and Crossmatch for 2 units Packed Cells. There was no documentation to indicate that these tests were completed.

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.

A. Based on a review of the Medical Staff Rules/Regulations, medical record review, and staff interview, it was determined that in 5 of 21 (Pts #7, #8, #13, #14, and #19) medical records reviewed, the CAH failed to ensure all medical records were complete.

Findings include:

1. The CAH's Med Staff Rules/Regulations were reviewed. They indicated under "MEDICAL RECORD CHARACTERISTICS 3. All entries in the medical record must be legible and complete and must be authenticated and dated promptly by the person (name and title) who is responsible for the entry...."

2. The medical record of Pt #7 was reviewed on 8/11/11. It indicated Pt #7 presented with a diagnosis of Cataract. There was no date/time on the anesthesia pre-op orders.

3. The medical record of Pt #8 was reviewed on 8/11/11. It indicated Pt #8 presented for Left Knee Arthroscopy. There was no date/time on the anesthesia pre-op orders.

4. The medical record of Pt #13 was reviewed on 8/11/11. It indicated Pt #13 was admitted on 6/16/11 with a diagnosis of Transient Ischemic Attack. There was no physician signature/date/time on the document titled, "Inpatient Prevention Orders" dated 6/16/11.

5. The medical record of Pt #14 was reviewed on 8/11/11. It indicated Pt #14 was admitted on 4/29/10 with a diagnosis of Cardiovascular Accident. There was no physician signature/date/time on the document titled, "Inpatient Prevention Orders" dated 4/29/10.

6. The medical record of Pt #19 was reviewed on 8/11/11. It indicated Pt #19 was admitted on 6/8/11 with a diagnosis of Gastrointestinal Bleed. The History and Physical, dictated 6/8/11 was not signed by the physician as of survey date 8/11/11. There was no physician signature/date/time on the document titled, "Inpatient Prevention Orders" dated 6/8/11.

7. During an interview with the CNO, conducted on 8/11/11 at 1:30 PM, the above findings were confirmed.

A. Based on a review of the Performance Improvement (PI) committee meeting minutes and staff interview, it was determined that the CAH failed to ensure the services provided by contract were periodically evaluated.

Findings include:

1. The PI committee meeting minutes for the last 12 months were reviewed. There was no documentation that indicated the contracted services were evaluated.

2. During an interview with the Chief Nursing Officer, conducted on 8/10/11 at 1:15 PM, it was verbalized that there was no documentation that indicated the CAH's contracted services were evaluated.

B. Based on a review of Performance Improvement (PI) committee meeting minutes for 2010/2011, Nursing/Pharmacy Meeting Minutes for August 1, 2011, and staff interview, it was determined that the CAH failed to ensure the PI program intervened in such a manner as to reduce the amount of medication errors related to the dispensing of medications.

Findings include:

1. The PI committee reports from 2010 were reviewed. In Sept 2010 it was noted that approximately 25% of the medication errors were identified as dispensing. The cause of the errors were belived to be the pharmacy staff being interrupted during the refill of the night Emergency Depart and Medical/Surgical medication lockers. The solution was to place signs on the pharmacy door notifying non-pharmacy personnel that the medication refill was taking place and not to disturb the pharmacy personnel.

2. The Nursing/Pharmacy Meeting Minutes for August 1, 2011 were reviewed. It indicated under "New Business: Dispensing errors were 25% of the errors listed above. This was discussed at length with no formal decisions being made...."

3. During an interview with the CNO, conducted on 8/10/11 at 10:30 AM, it was verbalized that although the overall medication error rate remains small, the total medication errors identified as being related to dispensing errors remains at 255.

A. Based on a review of the CAH policy and procedure and staff interview, it was determined that the CAH failed to ensure it's Quality Assurance program included a peer review by an outside review organization to determine that the Medical Staff provided quality treatment and appropriate diagnoses to the patients served by the Critical Access Hospital.

Findings include:

1. The CAH policy and procedure titled, "Protocol: Peer Review Plan" was reviewed. There was no system for sending medical records out for peer review to assure the appropriateness of diagnosis and treatment of the CAH patients.

2. During an interview with the Chief Nursing Officer, conducted on 8/11/11 at 10:30 AM, it was verbalized that the CAH did not send out any medical records for peer review and confirmed the above finding.

A. Based on medical record review, a review of CAH policy, and staff interview, it was determined in 1 of 2 (Pt #9) medical records reviewed, in which the patient expired, the CAH failed to ensure the designated party for organ donation suitability was notified.

Findings include:

1. The medical record of Pt #9 was reviewed on 8/11/11. Pt #9 was admitted to the CAH on 3/23/11 with the diagnosis Terminal Care status post Cerebrovascular Accident and expired 3/26/11. There was no documentation of a reference number on the Organ Procurement Organization form and there was no documentation to indicate the "MTS Phone Care Request of Anatomical Gifts Program" was completed.

2. The CAH policy titled "Organ and Tissue Donation Policy" was reviewed on 8/11/11. It indicated "All approaches... will be performed by Mid America Transplant Services (MTS) trained requestors... this determination will be documented in the medical record."

3. During a staff interview, conducted with the CNO on 8/11/11 at 2:45 PM, the above findings were confirmed.