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Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the Network Hospital staff evaluated the CAH's credentialing process, in accordance with the Network Agreement for Credentialing, since October 2012. The CAH staff reported 12 active, 155 consulting, 4 courtesy, and 31 allied health medical staff members.

Failure to ensure the Network Hospital staff evaluated the CAH's credentialing process, in accordance with the Network Agreement for Credentialing, could potentially result in the CAH's Medical Staff and Board of Directors failure to credential all medical staff members.

Findings include:

1. Review of the Network Agreement, dated November 25, 2002, revealed in part, ". . . Credentialing process overview documentation shall be provided by [Network Hospital] to CAH [Sioux Center Health] for purposes of evaluating its credentialing process. . . ."

Further document review revealed the CAH failed to ensure the Network Hospital completed an evaluation of the CAH's credentialing process since October 26, 2012.

2. During an interview on 6/25/14 at 1:30 PM, Staff G, Executive Assistant responsible for credentialing, reported the last documentation that showed the Network Hospital evaluated the CAH's credentialing process was June 15, 2011.

During an interview on 6/25/14 at 3:30 PM, Staff R, Nursing/Quality Officer, and Staff S, Education/Quality Coordinator reported the last documentation that showed the Network Hospital evaluated the CAH's credentialing process was October 26, 2012. Staff R and Staff S acknowledged the expectation was that the Network Hospital would evaluate the CAH's credentialing process annually.

Based on observation, documentation review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the high/low level glucometer control solutions (used to verify the glucose monitor is working accurately) and glucometer test strips were dated when opened for the Nova Statstrip glucometer located in the Medical/Surgical nursing area and the Emergency Department (ED). The CAH had a census of 8 patients.

Verifying accuracy of the glucometer requires two glucose control solutions, a high-level solution and a low-level solution. Each glucose control solution contains a known amount of glucose. Staff use these solutions to perform quality control checks to ensure the glucometer is working properly and the blood glucose results are reliable. Expired solutions may no longer contain the known amount of either high or low level glucose therefore; expired solutions are no longer a reliable way of verifying the glucometer is working accurately. Expired test strips could provide a false or inaccurate test result.

Findings for 2 of 2 observations (in the ED and the Medical/Surgical unit) include:

1. Review of manufacturer's information for the Nova Statstrip control solution bottles stated, "Use only for 3 months after first opening. When you open a new vial of control solution, count forward 3 months and write that date on the bottle. Discard any remaining solution after the date you have written on the vial." The manufacturer's information for the Nova Statstrip test strips stated, "The expiration date is printed on the vial of test strips. Once opened, the Statstrip test strips are stable when stored as indicated for up to 180 days or until the expiration date, whichever comes first".

Review of CAH policy titled "Glucose Nova Statstrip," dated 4/1/2014, revealed, in part. ... " D. Materials: When opening a new vial of test strips, write an outdate of 180 days from the day of opening the vial. Once opened, the test strips are stable when stored as indicated for up to 180 days or until the expiration date. When opening a new vial of control solutions, write an outdate of 3 months from the day of opening the vial. Once opened, solutions stored as indicated are stable for 3 months or until the expiration date."

2. Tour of the Medical/Surgical unit on 6/23/14 at 11:20 AM with Staff I, RN Care Coordinator revealed 2 opened and undated bottles of Nova Statstrip glucose quality control solution and 1 opened and undated container of test strips available for use and stored in the medication room.

Tour of the ED on 6/23/14 at 2:55 PM with Staff A, ED Nurse Manager revealed 2 opened and undated bottles of Nova Statstrip glucose quality control solution and 1 opened and undated container of test strips available for use.

3. During an interview on 6/23/14 at 2:55 PM, Staff A confirmed the Nova Statstrip control solutions and test strips were not dated when opened. Staff A acknowledged the CAH staff should date the control solutions and test strips upon opening.

During an interview on 6/24/14 at 7:50 AM, Staff D, Discharge Coordinator confirmed the Nova Statstrip control solutions and test strips were not dated when opened. Staff D acknowledged staff should date the control solutions and test strips when opened.

Based on policy review, document review and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure pharmacy oversight of drug samples and ensure the dispensing of samples to patients was conducted by employees within their scope of practice in 1 of 1 Diabetes Education Program.

The Diabetes Management Educator reported 153 diabetes education patients were scheduled in 2013. The sample drug log revealed 43 samples were dispensed to 31 patients over the past year.

Failure of pharmacy staff to provide oversight of sample medications could result in outdated, recalled, deteriorated, or otherwise unusable medications being available for use to patients, as well as, the potential for theft of medications by unauthorized persons.

Findings include:

1. Review of a pharmacy CAH policy titled "Drug Samples", with an approval date of 11/20/13, stated in part "The use of drug samples is not permitted for inpatients or outpatients within this Hospital . . . non-physician hospital personnel may not dispense drug samples to clinic patients under any circumstances."

2. During an interview on 6/23/14 at 3:45 PM, Staff O, Diabetes Management Educator, reported she provided prefilled insulin pens and insulin vial samples to diabetes education patients, to help manage their diabetes, as directed by a physician order. Staff O further reported she obtains a physician signature for the receipt of the samples but the physician had no further involvement in the dispensing or management of the samples. Staff O reported she maintained of a log of samples dispensed to patients, but did not maintain a log for the receipt of samples, thus had no inventory system to show the flow of the samples.

3. Observation of Staff O's sample supply, on 6/25/14 at 3:00 PM, revealed the following samples stored in her office refrigerator:

4 Lantus Solostar prefilled insulin pens
4 Novolog FlexPen prefilled insulin pens
1 Victoza prefilled insulin pens
3 Levemir FlexPen prefilled insulin pens
2 Humalog Mix KwikPen prefilled insulin pens
6 Humalog KwikPen prefilled insulin pens
7 Humalog insulin vials
3 Novolog insulin vials
6 Levimir insulin vials
2 Lantus insulin vials

Review of documents titled "SCCH Sample Drug Dispensing Record" revealed Staff O dispensed 43 samples to 31 patients over the past year.

4. During an interview on 6/24/14 at 9:50 PM, the Pharmacist reported approximately 2 to 3 months ago, she became aware Staff O stored and provided insulin samples to diabetes education patients, but had not taken any steps to become involved in the process, at the time of the survey. She acknowledged that she should be involved in oversight to provide for safe dispensing of the insulin and prevent potential drug diversion. Staff O confirmed the CAH policy identified the use of drug samples was not permitted for inpatient or outpatients.

During an interview on 6/25/14 at 2:45 PM, Staff O reported she thought the Pharmacist was aware she was providing insulin samples and was not aware the CAH had a policy against the practice. Staff O reported she did not have her own policy to address the procedure for managing the insulin samples.

I. Based on review of policy and procedures and staff interview the Critical Access Hospital (CAH) staff failed to correctly place the Biological Indicator (BI), known as ATTEST, in the autoclave used for sterilization of surgical instruments in the surgical department. The BI is used to test the effectiveness of the autoclave in sterilizing surgical instruments. The staff of the surgery department identified completing approximately 88 surgical procedures monthly.

Failure to correctly use the BI could potentially result in sterilization of surgical instruments ineffective that could potentially lead to post-operative infections.

Findings for interview with 1 of 3 surgical staff that did not correctly place the BI in the autoclave used to sterilize surgical instruments (Staff J, Surgical Technician) include:

1. An interview with Staff J, Surgery Technician, on 6/24/14 at 1:00 PM, revealed Staff J used the ATTEST, a biological indicator, to indicate the effectiveness of the sterilization process of the autoclave. The ATTEST was run weekly in the autoclave. Staff J reported placing the ATTEST on the top shelf to the front of the autoclave with the drain beneath it. A later interview with Staff J revealed she was aware of the need to place the ATTEST in the location closest to the drain, on the bottom rack, to be most challenged and show effective sterilization.

2. Review of the Central Service Technical Manual 7th Edition, found in the surgical department revealed the BI is run in a fully-loaded chamber in the area of the chamber and load that is least favorable to sterilization (in other words, the area representing the greatest challenge to the BI), which is typically called the "cold point" in the manufacturer's instruction manual. This area varies with sterilizer design, but is normally in front or the center bottom section of the sterilizer, near the drain.

3. A review of the ATTEST sterilization records dated 5/22/14 to 6/24/14 revealed all test results were acceptable.

4. A review of Staff J's training records revealed training on the use of the BI was completed on 3/15/11.

5. An interview on 6/25/14 at 7:50 AM, with Staff P, Surgical Technician/RN (Registered Nurse) revealed she placed the ATTEST over the drain in the bottom of the autoclave rack.

An interview on 6/25/14 at 1:30 PM, with Staff Q, Surgical Technician/RN revealed she placed the ATTEST over the drain in the bottom of the autoclave rack.

II. Based on observation, review of policy and procedures, and staff interviews, the Critical Access Hospital (CAH) staff failed to limit access to the surgical department for 1 of 1 Practitioners (Practitioner B) who entered the surgical department without wearing surgical attire in accordance with the CAH policy. The surgical staff reported performing an average of 88 surgical procedures monthly.

Failure to enter the surgical department in the correct surgical attire could potentially result in the inability of the CAH to maintain a sterile environment for surgical procedures. Failure to maintain a sterile environment could potentially cause surgical patients to be exposed to bacterial contaminants and cause illness or surgical complications.

Findings include:

1. Observation on 6/24/14 at 1:15 PM, during the initial tour of the surgery department revealed a male dressed in street clothes, in the inner corridor of the operating room. An interview at the time with Staff R, RN Nursing/Quality Officer revealed the male was Practitioner B, ENT (Ear Nose Throat) Surgeon. Various staff of the surgery department failed to stop or question the lack of surgical attire of Practitioner B at the time of the observation.

2. Review of policy/procedure titled "Attire in the OR" dated 5/14, stated in part, ..." Purpose: To maintain environmental control and promote a high level of cleanliness and hygiene within the Surgical Department. Procedure: 3. The Or suite is considered to be a "controlled environment", therefore, all surgical staff entering this area will be required to wear surgical scrub clothing as provided by this facility. Surgical attire provides a barrier to contamination. Other authorized individuals will be provided with disposable outer covering (bunny suit)...".

Review of policy/procedure titled "OR Services Traffic Patterns Limited Access" dated New, stated in part, "... each individual is responsible for maintaining proper OR attire and traffic control...".

3. An interview on 6/24/14 at 1:30 PM, with Practitioner B revealed he was in search of an instrument to exam a patient suffering from laryngeal stridor. The instrument was not available in the specialty clinic, therefore he entered the OR. Practitioner B, ENT surgeon had badge access to the OR, allowing him to enter at any given time. Practitioner B was aware that he lacked the proper surgical attire to be in the OR, and stated he would repeat the same actions in the future. Practitioner B left the interview without answering any additional questions.




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III. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to disinfect the blood glucose monitors in 1 of 5 areas performing fingerstick blood sugars per manufacturer's recommendations and CAH policy, the Medical/Surgical unit. The CAH staff identified a census of 8 inpatients currently.

Failure to disinfect patient care equipment as directed by the manufacturer potentially puts patients at risk for exposure to infections and blood borne pathogens.

Findings include:

1. Observation on 6/23/14 at 11:25 AM on the Medical/Surgical unit revealed Staff B, Registered Nurse (RN) performed a blood glucose test for a patient in room 209. Staff B used the Nova meter blood glucose machine to perform the test. After completing the test, and without disinfecting the meter, Staff B returned the Nova meter to the Nova meter holder in the nursing medication room..

Observation on 6/24/14 at 7:30 AM on the Medical/Surgical unit revealed Staff C, RN performed a blood glucose test for a patient in room 209. Staff C used the Nova meter blood glucose machine to perform the test. After completing the test, and without disinfecting the meter, Staff C returned the Nova meter to the holder in the nursing medication room.

2. Review of CAH policy titled "Glucose Nova Statstrip" dated 4/1/14, revealed in part... "F. Maintenance: Clean the exterior surface of the Nova Statstrip glucose meter between each patient and when visibly soiled. Wipe all surfaces of the meter a minimum of 3 times horizontally and 3 times vertically."

3. During an interview on 6/24/14 at 7:50 AM, Staff D, RN, Discharge Coordinator stated staff should clean the Nova Statstrip glucose monitor after each patient use.


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IV. Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) dietary staff failed to handle food in a safe and sanitary manner. The administrative staff reported a census of 8 patients and the Nutrition and Food Service Assistant Manager reported the dietary staff provided an average of 12-15 patient meals daily.

Failure to handle food in a sanitary manner could potentially result in the contamination of the patients' food and potentially cause food borne illness.

Findings include:

1. Observation during patient lunch meal preparation and service, on 6/24/14 from 11:00 AM to 12:25 PM, revealed the following concerns.

Staff L, cook, donned gloves, but failed to perform handwashing prior to use. Staff L then touched multiple items including, but not limited to, frozen hamburger patties, Lawry's seasoning container, hamburger bun wrapper, under-grill freezer drawer, a margarine container, cold table countertop, fryer basket handle, shirt and apron. Staff L handled patient food items with the contaminated gloves, including hamburger bun, lettuce, tomato slices and pickles. Staff L left for her lunch break at 11:50 and returned at 12:07. Upon return, she donned gloves on clean hands then touched multiple items including, but not limited to, walk-in cooler handle, under-grill freezer drawer, frozen hamburger patties, fryer basket handle, Lawry's seasoning container and hamburger bun wrapper. Staff L changed her gloves at one point, but failed to wash her hands prior to donning clean gloves. Staff L handled patient food with the contaminated gloves, including hamburger bun, lettuce and tomato slices.

Staff K, Nutrition and Food Service Assistant Manager, donned gloves on clean hands. Staff K then touched multiple items including, but not limited to, condiments, pen, paper, refrigerator handles, hamburger bun wrapper, cafe steam table lid (handled by staff self-serving in the cafe) and the cafe register touch screen and handled patient food items with the contaminated gloves, including a hamburger bun and garlic bread.

Staff M, cook, donned gloves multiple times without performing handwashing before and after changing gloves. Staff M touched multiple items including, but not limited to, under-grill freezer drawer, frozen hamburger patties, salt shaker, pepper shaker, Lawry's seasoning container, hamburger bun wrapper, phone, pen and paper and handled patient food items with the contaminated gloves, including lettuce, sliced tomatoes, pickles and a hamburger bun.

2. During an interview on 6/23/14 at 2:30 PM, Staff M, reported as part of all dietary staff orientation, the department policies are reviewed and staff are required to complete a training module titled "Sanitation and Serving Safe Food". Review of the training materials revealed the module covers the common factors for foodborne illness, which include cross contamination from the hands. The module identifies proper food worker hygiene to include washing hands the right way and at the right time and to use clean gloves and utensils when handling food.

During an interview on 6/25/14 at 7:30 AM, Staff M, reported she was trained to change to clean gloves when she changed tasks. Staff M acknowledged she was not sure if she should wash her hands prior to donning clean gloves because one staff person told her she should, but another told her she shouldn't because it make the gloves harder to put on.

During an interview on 6/25/14 at 8:40 AM, the Consultant Dietitian reported dietary staff should wear gloves any time ready-to-eat food is handled and should change gloves any time another surface is touched to contaminate the gloves, for example a bread wrapper or equipment handles. In addition, she expected dietary staff to wash their hands prior to putting on clean gloves.

During an interview on 6/25/14 at 10:55 AM, Staff L reported she wears gloves with any food handling and usually washes her hands when she removes gloves but does not recall being told to wash her hands prior to donning clean gloves.

3. Review of a Food Service policy titled "Gloves, Proper Usage", approved on 11/20/13, revealed in part " This policy is for proper glove use when handling food. Proper glove use is necessary to reduce the risk of contaminating food . . . 1. Wash your hands . . . 4. If you use your gloves to handle food do not use gloves for any other purpose. 5. If you do another task with your glove (i.e. opening cooler door) you must discard your gloves and repeat steps . . ."

The Food Code, published by the Food and Drug Administration and considered a standard of practice for the food service industry, in both the 2005 and 2013 editions, requires single-use gloves be used for only one task, such as working with ready-to-eat food and for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation. In addition, food employees shall clean their hands immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, after handling soiled equipment or utensils, and before donning gloves for working with food.

Based on document review and staff interview, the Critical Access Hospital (CAH) failed to delineate privileges for 2 of 2 surgical technicians, who were not employees of the hospital, and assisted with ophthalmic surgical procedures. The surgical technicians assisted with surgical procedures completed by Practitioner A (Staff E and Staff F).

The Operating Room (OR) Manager reported Practitioner A performed approximately 9 ophthalmic surgical procedures at the CAH per month.

Failure to privilege all assistants that accompany providers could result in patients receiving surgical intervention from unqualified professionals.

Findings include:

1. Review of "Medical Staff Rules and Regulations", adopted by the Medical Staff on 6/24/13 and Governing Body on 7/11/13, revealed, in part, ". . .Clinical privileges...privileges to practice at the hospital are granted by the Executive board following recommendation of the Active Medical Staff...the applicant must delineate the privileges that are requested, based on the procedures, etc, that will be performed at this organization...the applications shall then be presented to the Credentialing Chairperson for review and pre-approval and then presented to the Active Medical Staff for approval, followed by approval of the Executive Board."

Section IV. Surgery: ...We consider all operative procedures to be of major clinical significance and so any arbitrary delineation of major and minor surgical procedures is really of minimal if any value...The assisting personnel can be...an appropriately trained surgical technician...with the primary goal to be always to provide the utmost in care to the surgical patient."

2. The Surgical Procedures Manual kept in the Surgery area and reviewed on 6/3/14, at 1:00 PM, lacked documentation of privileges for Surgical Technician E and Surgical Technician F.

3. During an interview at the time of the review of the surgical procedures manual, Staff H, OR Manager verified the manual lacked documentation of privileges for both Surgical Technician E and Surgical Technician F. Staff H reported Staff G would have that information.

Staff G, Executive Assistant/Credentialing Specialist, provided Staff E and Staff F's files.

4. Staff E's credential file, reviewed on 6/24/14 at 3:00 PM, lacked documentation of privileges.

Staff F's credential file, reviewed on 6/24/14 at 3:00 PM, lacked documentation of privileges.

5. During an interview on 6/25/14 at 8:15 AM, Staff G, Executive Assistant acknowledged she was responsible for credentialing all providers and any staff who may accompany them to provide care and serv ices to patients at their hospital including but not limited to Practitioner A and Surgical Technicians E and F. Staff G verified that Surgical Technicians E and F lacked surgical privileges to provide assistance during surgical procedures with Practitioner A. Staff G said she was unaware that surgical technicians needed to be included in the credentialing process and approved by the Medical Staff and Governing Board.

During a follow up interview on 6/25/14 at 8:30 AM, Staff H said she was unaware that surgical technicians needed to be included in the credentialing process and approved by the Medical Staff and Governing Board.