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ROCK VALLEY, IA 51247

No Description Available

Tag No.: C0206

Based on review of a blood bank agreement and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAHs Medical Staff approved the updated blood bank agreement by the hospital's medical staff.

Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings included:

1. Review of Blood Product Supply Agreement revealed revisions in the contract commencing on January 1, 2006.

2. During an interview on 12/7/10, at 3:00 PM Staff F, Utilization Review/Regulatory Director reported, he/she did not believe the medical staff had approved the blood agreement. A department manager at [Hospital Name] made the change in the 2006 agreement. Staff F did not know the Medical Staff had to approve the agreement. Staff F reported looking through late 2005 and 2006 Medical Staff minutes and was unable to locate documented evidence that showed Medical Staff approval of the blood agreement.

3. During an interview on 12/8/10, at 7:56 AM, Staff F reported discussing the blood agreement with the CAH administrator and determined that the Medical Staff had not approved the agreement. Staff F stated he/she would put the blood agreement on the agenda for the Medical to review next Tuesday.

No Description Available

Tag No.: C0277

Based on review of policies/procedures, documentation, and staff interview, the Critical Access Hospital (CAH) pharmacy staff failed to ensure physician notification for the occurrence of a medication error for 9 of 10 medication errors reviewed. (Patients # 11, 12, 13, 14, 15, 16, 17, 18, 19) The CAH reported a census of 2 patients.

Failure to notify the physician of medication errors could potentially result in life threatening conditions, or other related health conditions that could lead to serious harm.

Findings include:

1. Review of the Quality Services policy/procedure titled "Categorization of Medication Errors", revised 6/10, revealed the following, in part. "Procedure 2. The error should be documented in the patient record and reported after discovery. a. For clinically significant errors (any errors that would require increased patient monitoring and/or potential patient harm) an oral notice should be provided to physicians immediately (within 60 minutes) of discovery. b. Errors not considered clinically significant will be reprted to the physician within 24 hours of discovery. . . ."

Review of the Pharmacy policy/procedure titled "Medication Errors", dated 7/10/07, stated in part. "The error should be documented and reported after discovery. For clinically significant errors an oral notice should be provided to physicians immediately (within 60 minutes) of discovery. Errors not considered clinically significant will be reprted to the physician within 24 hours of discovery. . . ."

2. Review of the medication errors from June to November 2010 revealed 9 of 10 medication errors lacked physician notification of the medication errors. Patients # 11, 12, 13, 14, 15, 16, 17, 18, 19

Review of the "Medication Event Occurrence Analysis" form, dated 8/09, showed in the following in part. "Include the following in your nursing documentation in the patient chart: Dr. Notified, Treatment plan (if any), Pt response to treatment, Family Notified (include names of family notified).

Review of patient medical records for Patients # 11, 12, 13, 14, 15, 16, 17, 18, 19 showed staff failed to notify each patients physician of the medication error.

3. During an interview on 12/8/10 at 1:00 PM, the Director of Nursing and the Infection Control/Quality staff person acknowledged the lack of documentation of physician notification of the medication errors for Patients # 11, 12, 13, 14, 15, 16, 17, 18, 19 in the patient's medical record.

The Director of Nurses stated nurses receive education in the use of the Medication Event Occurrence Analysis form during their orientation to the nursing floor, receive instruction to completely fill out the form, and notify the physician of the occurrence of a medication error per policy.

PATIENT CARE POLICIES

Tag No.: C0278

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) Radiological Services staff failed to ensure Ultrasound technical staff tested the disinfecting solution in 1 (of 1) Cylindrical Soak Containers for internal probes before each use. Radiological Services administrative staff identified an average of approximately 8.5 internal probe procedures per month.

Failure to test the disinfecting solutions, using the manufacturer's test strips, prior to each use could potentially result in the disinfecting solution lacking sufficient strength of the active ingredient to kill all microorganisms, resulting in the spread of infectious microorganisms between patients.

Findings included:

1. Observations, during a tour of the Radiology department, on 12/6/10 at approximately 2:55 PM, revealed 1- Cylindrical Soak Container that contained Cidex OPA Solution. Staff A, Ultrasound tech stated, "There's a probe soaking in the solution now, I did a [internal] ultrasound today at 1:45 PM.

2. Review of the "...Cidex Testing Log" for the Cidex OPA solution revealed ultrasound services staff documented in the Cidex Testing log every 14 days when they changed the Cidex solution. However, the testing log lacked documented evidence that showed the ultrasound services staff tested the efficacy of the Cidex solution prior to each use, in accordance with the manufacturer ' s recommendations.
3. During an interview at the time of the tour, Staff A stated ultrasound staff did not test the Cidex solution after the probes were placed in the Cidex solution for processing and immediately prior to an internal ultrasound procedure. Staff A stated, "I did not know it was required. I don't think we have test strips for it." Staff B, Radiology Director stated, "I'm not positive if we have a policy for testing Cidex OPA but I will check." Staff B stated ultrasound staff reprocessed up to 5.2 [internal] probes per week and were not testing the Cidex solution for adequate levels of the active ingredient prior to each use.

4. During an interview on 12/6/10 at 3:00 PM, the Utilization/Compliance Director stated, "I checked, we don't have the Cidex OPA test strips in house."

5. Review of the manufacturer's directions for the Cidex OPA revealed, in part, "...Reuse Period for Disinfection...DO NOT rely solely on days in use. Concentration of this product during its reuse life must be verified by the Cidex OPA Solution test strip prior to each use to determine that the concentration of the ortho-phthalaidehyde is above the minimum effective concentration (MEC) of 0.3%..."

6. During an interview on 12/8/10 at approximately 9:25 AM, Staff B acknowledged the manufacturer recommended testing the Cidex solution concentrations prior to each use and stated, "I'm glad I know now. We have the test strips now and have started a log sheet. I have talked with the two ultrasound technicians that were here about this and have spoken with [Diagnostic group] and they have a meeting scheduled for 12/9/10 to educate all staff who preform ultrasounds here at [Hospital name]. We did not have a policy for Cidex OPA usage before but I implemented one yesterday and it will go to policy review on 12/14/10. It was in force on 12/7/10."

No Description Available

Tag No.: C0279

Based on review of Critical Access Hospital (CAH) documents, policies, observation, and staff interview, the dietary staff failed to measure and record the hot and cold food temperatures for all food served to patients of the CAH, in accordance with CAH policy. The administrative staff identified an average daily census of 3 in-patients.

Failure to ensure dietary staff measure and record hot and cold food temperatures could potentially result in a food borne illness.

Findings include:

1. Review of hospital position descriptions for dietary cooks revealed in part "...Follow appropriate guidelines for temperature control and sanitation guidelines to prevent food borne illnesses."

2. Review of hospital dietary policies titled "Food Temperatures for Hospital" dated 12/10 revealed in part "...Dietary staff will check the temperatures of potentially hazardous foods before leaving the kitchen...The temperatures of food prepared...will be checked and the temperatures recorded on the temperature log sheet immediately prior to transport to the hospital."

During an interview at the time of the evening meal observation on 12/7/10, at 4:45 PM, Staff D, dietary cook, stated, "There are spaces in the food temp charts and days where it [hot and cold food temperature checks] was not done. We've been talking about that at our staff meetings. The cooks are responsible for taking hot food temps and the dietary aides are responsible for taking cold food temps. It's [the process for food temperature monitoring] for food safety, we were taught this."

Review of food temperature charts revealed the dietary staff failed to follow hospital policy for food temperatures and sanitation practices as noted below:
a. 14 of 30 days in June 2010.
b. 8 of 31 days in July 2010.
c. 11 of 31 days in August 2010.
d. 23 of 30 days in September 2010.
e. 18 of 31 days in October 2010.
f. 12 of 30 days in November 2010.
g. 2 0f 7 days in December 2010.


During an interview on 12/8/10, at 9:15 AM Staff C, Dietary Director stated, "In June of this year the dietician and myself instructed staff [dietary] to document hot and cold food temps on the temp logs. We're struggling with this and working on this process. Our policy is that hot and cold food temps are taken before each meal and documented on the temp logs."

During an interview on 12/8/10 at 11:30 AM, following noon meal observation and delivery of meal to the patient, Staff C stated, "Not all alternative foods were temped at lunch today, you are correct, that includes the French Fries and cottage cheese. These Aids and Cooks are not new, we have been doing a lot of temperature education. I think they are more focus on the temps in Long Term Care not the hospital. I will speak with them personally today."

Review of the Dietary inservices from February, April, May, August and September of 2010 revealed the Dietician provided education on importance of taking hot and cold food temperatures and documenting the results. A review of the food safety handout in the September 2010 meeting revealed in part, "...cooking food to the proper temperature kills harmful bacteria..."

No Description Available

Tag No.: C0308

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure that a system was in place that assured the Hegg Memorial Clinic staff secured all patient records against unauthorized access.

Failure to secure medical records against unauthorized access could result in inappropriate release of medical information and/or identity theft.

Findings include:

1. Tour of the clinic area on 12/7/10 at 1:15 PM, revealed a double doorway to an open room, identified by the Clinical Supervisor as a transcription room. Observation showed 11 stacks of medical records on the desk. Each stack contained 8-15 medical records. Two shelves on the wall contained more than 40 " death records " dated 2008 and 2009.

The Health Information Supervisor stated staff stored the medical records in the transcription room for 3 years. After 3 years, clinic staff moves the medical records to the basement storage area.

Observation in a medical record storage room located next to the transcription area revealed 13 floor to ceiling shelving units that contained unsecured medical records. The shelving units contained medical records labeled with patient identifying information.

Observation of a counter in the hallway across from the medical record storage area revealed a stack of billings. The billings contained labels with patient identifying information.

Tour of the clinical area noted 3 Physician offices with doors open to reveal stacks of medical records on the physicians desks. The Clinical Supervisor stated the Physicians do not lock their offices at the end of the day. The Clinical Supervisor reported the Physicians keep the medical records in their office until their dictation is completed. The Clinical Supervisor stated the patients were "self rooming," which meant the patient would enter the hallway where patient rooms and open Physician offices were located and enter an empty patient room un accompanied by clinic staff.

2. During an interview on 12/7/10 at 1:50 PM, the Clinical Supervisor acknowledged the labeled medical records stored in the transcription area, medical record storage room and the counter in the hallway held patient identifying information.

During an interview on 12/7/10 at 1:45 PM, The Health Information Supervisor acknowledged the housekeeping staff had access to these areas unsupervised. The Health Information Supervisor stated the clinical staff discussed the security of medical records and housekeeping cleaning the area unsupervised, but nothing had changed.

3. Review of the "Confidentiality and Release of Patient Information" policy, revised 9/2009, revealed, in part: "Security procedures should be followed at all times to prevent unauthorized access and to ensure the integrity of the data... When the department is not staffed and when the clinic is closed, the clinic is locked and entry of only authorized personnel is allowed."

QUALITY ASSURANCE

Tag No.: C0340

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to include all practitioners that provided care and services to the CAH patients, in their external peer review process for 8 of 10 applicable physicians (Practitioners C, D, E, F, G, H, I, and J). The CAH staff reported a census of 2 patients with a daily average of 3 patients.

Failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of CAH policy/procedure titled "Medical staff Peer Review" reviewed 2/2010, revealed the following in part, "Medical staff Committee will determine which cases should be referred to external peer review by using the following levels of significance: Level 0 (No problem) thru level 5 (Death attributed to acts of omission or commission). ...levels 3-5 would be sent on for external peer review."

2. Review of peer review documentation for the past credentialing period of 2 years revealed the CAH staff failed to include all Practitioners, that provided care to patients of the CAH, (Practitioners C, D, E, F, G, H, I, and J) in the CAH's external peer review process.

3. During an interview on 12/8/10 at 3:20 PM, the Director of Health Information acknowledged the CAH quality staff failed to send out records of patients cared by Practitioners C, D, E, F, G, H, I and J for external peer review for the last credentialing period. The Director of Health Information verified Practitioners C, D, E, F, G, H, I and J provided services to patients of the CAH during the last credentialing period.