HospitalInspections.org

Based on review of records, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the blood bank agreement. The Laboratory administrative staff reported the laboratory having 18 units of blood products available to CAH patients.

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 include:

1. Review of the "Blood Bank Services Agreement between the American Red Cross...and Clarinda Regional Health Center..." signed by the CEO (Chief Executive Officer) on 07/1/2010, with amendments to the contract signed by the CEO on 6/ 23/2010, showed both documents lacked approval by the CAH's Medical Staff.

2. During an interview on 11/30/11 at 11:15 AM, Staff A, CEO, acknowledged the Blood Bank Agreement and Amendment lacked approval by the CAH's Medical Staff.

I. Based on document review, observations and staff interviews, the Ultra Sound and Surgical staff failed to ensure their staff followed the Critical Access Hospital policy and manufacturer's instructions for use of Cidex POA when cleaning and disinfecting patient care equipment for the Ultra Sound and Surgery departments. The Radiology manager reported a monthly average of 30 pelvic ultrasounds. The Director of Operating Room (OR) reported a monthly average of 35 scope procedures.

Failure to use disinfection products as directed by the manufacturer potentially puts patients at risk for exposure to infections and bloodborne pathogens.

Findings include:

1. Review of the following documents revealed:

a. "Cidex OPA Solution Test Strips" revealed in part, "It is recommended that Cidex OPA Solution to be tested before each usage with the Cidex OPA Solution test strips in order to guard against dilution...Do not use any remaining strips 90 days after opening the bottle..."

b. "Disinfecting with Cidex OPA," reviewed 11/07 revealed in part, "It is the policy of the facility to appropriately use Cidex OPA as a replacement for glutaraldehyde in order to destroy micro-organisms on inanimate items that cannot withstand sterilization by steam...the test strips are good for 90 days after opened then replaced. Each instrument/endoscopes processed in the solution will be written in a logbook..."

c. "Transvaginal Probe cleansing Procedure" reviewed 4/5/11, revealed in part, "To ensure proper techniques are used in the cleansing of the transvaginal probe after each use...The transvaginal probe will be properly disinfected after each use...disinfecting with Cidex solution..."

d. "Glutaraldehyde [Cidex OPA] Record Keeping" revealed in part, "Monitoring Frequency: Every load to demonstrate the MEC [Minimum Effectiveness Concentration]...Chart recording: Read, date and initial as confirmation of physical parameters being attained...."

Review of the "Glutaraldehyde [Cidex OPA] Record Keeping" log for the months of September through November revealed testing of the Cidex OPA solution once daily. The log did not reflect if the staff tested the tub in the surgery area and/or the jar for the vaginal probe. The log did not reflect testing of the vaginal internal probe from the Ultra Sound room.

2. During initial tour of the surgery, on 11/29/11 at 2:45 PM, Staff P, Licensed Practical Nurse (LPN) in surgery, stated the staff checked the Cidex solution every morning with the Cidex Strips. Staff P explained the staff used the Cidex solution to sterilize equipment used to clean the colonoscopies.

Observation of the Cidex strips revealed an open date of 11/25/11 and discard date of 5/23/11. Staff P stated the staff used the strips for the 6 months, and then dispose the strips. Staff P reviewed the manufacture recommendations and acknowledged once the staff open the bottle of Cidex strips, the strips outdate in 90 days.

During initial tour of the Ultra Sound room on 11/30/11 at 8:00 AM, Staff S, Radiology Manager, stated the staff sterilized the internal probes in surgery. Staff Q, sonographer, stated the staff took the vaginal internal probe to the surgery area and placed it in a jar of Cidex solution. Staff Q stated the surgical staff monitored and tested the Cidex solution. Staff Q stated the ultra sound staff did not test the Cidex solution prior to usage.

During an interview on 11/30/11 at 8:20 AM, Staff R, surgical technician, stated the surgical staff tested the Cidex Solution once a day in the morning. Staff R stated the staff did not test the solution at any other time. Staff R and Staff Q reviewed the manufacture recommendations and acknowledged staff needed to test the Cidex Solution with the Cidex test strips prior to each usage.

Staff Q stated, at times the staff used the vaginal internal probe more than once a day and that the ultra sound staff did not test the solution prior to usage. Staff Q stated, the staff was not aware they needed to test the Cidex solution prior to each usage. Staff R confirmed, the surgical staff were not aware this manufacture recommendation.

During an interview, on 11/30/11 at 12:10 PM, Staff P stated, staff entered the pass/fail in the Glutaraldehyde [Cidex OPA] log each morning. This Cidex Test entry would be for both the tub in surgery and the jar of Cidex solution for the vaginal internal probe. Staff P acknowledged the log lacked documented evidence of when staff cleaned the vaginal probe.

Staff P reviewed the manufacture recommendations and acknowledged the staff needed to test the Cidex solution with the Cidex test strips prior to each usage. Staff P stated, the Ultra Sound staff took care of cleaning the vaginal probe, the ultra sound staff placed the vaginal probe in the solution and the ultra sound staff removed the vaginal probe. Staff P stated the surgical staff did not know when the ultra sound staff brought in the probe or removed it.


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II. Based on observation, review of records, and staff interviews, the CAH (Critical Access Hospital) revealed 1 of 1 soiled utility room located in the Emergency Department (ED) contained clean and soiled supplies/equipment. The ED staff reported approximately 337-395 monthly visits to the ED.

Failure to separate soiled and clean supplies could potentially result in contamination of the clean items and spread of infections.

Findings include:

1. Observation, during the initial tour of the ED, on 11/29/11 at 10:50 AM, revealed a soiled utility room that contained crutches wrapped in clear plastic wrap, clean over bed tables, patient garment bags, and casting supplies.

2. Review of a policy/procedure on 11/30/11, titled, "Clean/Dirty Areas" reviewed on 11/08, stated in part, "...Dirty utility rooms shall house no clean equipment or supplies..."

3. During an interview on 11/29/11 at 10:50 AM, Staff B, ED RN (Registered Nurse), verified that clean supplies were stored with soiled supplies in the soiled utility room. An additional interview, on 12/1/11 at 8:00 AM, Staff B, Infection Control RN, verified clean and dirty supplies should not be stored together.

Based on clinical record review, policy review, facility menu and diet manual review, observation, and staff interviews, the Critical Access Hospital (CAH) dietary staff failed to follow the physician ordered diet documented for 1 of 1 patients (Patient #1) on a renal diet. The hospital administrative staff reported a census of 7 patients. The Manager of Nutrition Services reported an average of 24-30 patient meals served daily.

Failure to follow the physician's order for a diet could potentially result in patient complications including in part, fluid imbalance contributing to swelling in the arms, legs, lungs and/or abdomen, irregular heart beat, shortness of breath, dizziness, and reduced urine output.
Findings include:
1. Review of the clinical record for Patient #1 revealed the current diet order was; regular, high calorie, renal, ordered on 11/18/11.
2. Review of a document titled "Patient Diets," dated 11/30/11, revealed a diet order for Renal, High Calorie.
3. Review of a CAH policy/procedure titled "Diet Order Guidelines," last reviewed on 7/22/11, revealed in part "...11. ... If a "Renal Diet " is ordered, the standard pattern will be for 60 grams of protein, 1800 calories, and 1845 milligrams of sodium, 60 milliequivalents potassium and 890 milligrams phosphorus ...."
4. Review of a CAH policy/procedure titled "Renal Diet", last reviewed on 7/22/11, revealed in part " . . . If a Renal Diet " is ordered, the standard pattern will be for 60 grams of protein, 1800 calories, and 1845 milligrams of sodium, 60 milliequivalents potassium and 890 milligrams phosphorus . . . Following are sample meal patterns for the Protein and Electrolyte Controlled Diet . . .". The policy revealed in part, the following meal pattern, to provide the nutrient levels specified above:
Milk servings 1
Meat servings 5
Vegetable servings - low potassium 1, medium potassium 2, high potassium 1
Fruit servings - low potassium 1, medium potassium 2, high potassium 1
5. Review of the CAH's diet manual titled "Simplified Diet Manual, tenth addition", approved on 5/20/11, revealed in part, the following defined serving size guidelines for a "Protein and Electrolyte Controlled Diet":
Milk products 1/2 cup
Meat/protein group 1 ounce
Vegetable group 1/2 cup
Fruit group 1/2 cup
6. Review of the approved CAH diet manual titled "Simplified Diet Manual, tenth addition", approved on 5/20/11, revealed in part, the Low Sodium/2000 milligram Diet guidelines included the following daily servings guidelines:
Milk 2-3 cups
Meat 2-7 ounces
Fruits 1-2 1/2 cups (all fruits and juices)
Vegetables 1-4 cups (including potatoes, fresh,frozen or unsalted canned vegetables . . . )
7. The CAH menus lacked a planned menu for a Renal diet.
8. Observation on 11/29/11 at 10:25 AM and 11/30/11 at 11:35 AM revealed a diet order for Renal, high calorie, 2 gram sodium on the meal tray ticket for Patient #1.
9. During an interview on 11/29/11 at 10:45 AM, Staff H, Dietary Manager reported a patient on a Renal diet receives a 2 gram sodium menu. Staff H further reported the dietitian may direct staff to restrict the diet further after the completion of a nutrition assessment. She confirmed the facility lacked a specific menu planned for a Renal diet.
10. During an interview on 11/30/11 at 11:20 AM, Staff N, diet clerk, reported a patient on a renal diet receives a 2 gram sodium menu unless told otherwise. Staff N further reported there may be an additional restriction, such as potassium, with a reference sheet available to guide staff on food items to be removed from the 2 gram sodium menu.
11. During an interview on 12/1/11 at 8:05 AM, Staff I, Clinical Dietitian confirmed staff have been directed to follow a 2 gram sodium diet for a patient placed on a Renal diet and reported further restrictions may be directed following a nutrition assessment. Staff I relayed in most cases a 2 gram sodium diet is appropriate for renal patients. He/she acknowledged the Renal diet policy listed specific nutrient levels and confirmed a 2 gram sodium diet could exceed the amount of protein, potassium and phosphorus content outlined by the facility's Renal diet policy.

Based on observation, record review and staff interviews the Critical Access Hospital (CAH) administrative staff failed to ensure the Diabetes Management Department developed and implemented policies and procedures. The Diabetes Management Coordinator reported the diabetes education program currently had approximately 5 active patients.

Written policies and procedures provide guidance and consistency among staff and serves as a resource for staff in the provision of care. Failure to ensure policies and procedures were in place could potentially result in miscommunication of expected practices and performances in the provision of patient care and result in patients receiving less than optimal care or failure to provide the patient with the care and services needed resulting in patient harm.

Findings include:

1. During an interview on 11/29/11 at 2:00 PM, Staff L, Diabetes Management Coordinator, reported the department lacked policies and procedures specific to the function of the department.

During an interview on 11/29/11 at 3:25 PM, Staff D, Director of Nursing, demonstrated the CAH's electronic policy and procedure system and attempted to locate Diabetes Management Department policies and procedures in the electronic MCN Healthcare Policy Library. Staff D located the Diabetes Management Department policies and procedures folder that contained one policy titled "Hypoglycemia".

During an interview on 11/30/11 at 1:10 PM, Staff G, Chief Operating Officer, confirmed the CAH considered Diabetes Management an individual department and was included on the organizational chart, approved 10/25/10 by the CAH board. Staff G confirmed the department lacked policies and procedures specific to the department function.

2. Review of the Administration policy titled "Policies and Procedures", reviewed and approved by the CAH committee on 7/22/11, revealed in part "... Each organization department (clinical and nonclinical) is required to develop, implement and monitor department specific policies and procedures that outline how the department assesses and meets the needs of their customers. Each department within the organization must have an organized, functional and current electronic policy and procedure manual that is readily available ..."

Based on review of policy/procedure, documents, and medical records, and staff interview, Critical Access Hospital (CAH) anesthetists staff failed to sign, date and or time the post anesthesia notes for 1 of 1 active medical records (Patient #1) and 7 of 10 closed medical records (Patients #2, #3, #4, #5, #6, and #7). The CAH surgical nurse manager identified and average monthly census of approximately 35 endoscopy/colonoscopy procedures and approximately 70 surgical cases monthly.

Failure to sign, date, and or time, post anesthesia notes could cause harm to patients by a delay in the evaluation and treatment of post anesthetic complications.

Findings include:

1. Review of hospital policy "Recording of Anesthesia" revealed in part, "...The operative anesthetist will be responsible for the accurate and timely documentation of the entire anesthetic course ... the presence of minimal acceptable technique will be utilized and contemporaneously documented... Accurate anesthesia from constant pre-operative attendance to the transfer of care to qualified post anesthesia care personnel will be recorded on the anesthesia record."

2. Review of hospital policy " Medical record Guidelines for Physicians" approved 7/22/11 revealed in part, "...All entries must be time, dated and authenticated."

3. Review of "Medical Staff Rules and Regulations", dated 2010, revealed in part, "... Medical record entries... shall be accurately dated and signed by the author... The post anesthesia follow up must be written on all inpatients and outpatients prior to discharge from surgery and anesthesia services...The post anesthesia evaluation must be written by the individual who is qualified to administer the anesthesia."

4. Review of active medical records revealed Staff U, Certified Registered Nurse Anesthetist (CRNA) failed to sign, date, and time Patient #1 post anesthesia note.

5. Review of closed medical records revealed:

a. Staff U failed to sign, date, and time Patient #2's post anesthesia note.

b. Staff U failed to sign, date, and time Patient #3's post anesthesia note.

c. Staff U failed to time Patient #4's post anesthesia note.

d. Staff U failed to time Patient #5's post anesthesia note.

e. Staff U failed to date and time Patient #6's post anesthesia note.

f. Staff U failed to time Patient #7's post anesthesia note.

g. Staff U failed to sign, date, and time Patient #8's post anesthesia note.

5. During an interview on 12/1/11 at 10:15 AM, Staff U stated the anesthesiologist assigned to the surgical patient completed the post anesthesia note. Additionally, Staff U said post anesthesia notes "must be" signed, timed, and dated. Staff U acknowledged he failed to sign, date, and or time the post anesthesia notes for Patients #1, #2, #3, #4, #5, #6, and #7.

Based on observation, review of policies/procedures, and staff interviews, the Critical Access Hospital (CAH) physician's clinic administrative staff failed to protect all confidential patient information from unauthorized access in:

1. 1 of 1 Physician's Clinic (Clarinda Medical Associates). The CAH physician's clinic administrative staff identified an average of 2,000 out-patient clinic visits per month.

2. The medical record storage area in the CAH's basement and in 4 of 4 shredding bins. The Health Information Manager identified several thousand medical records stored in the basement area.

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

Findings include:

1. Observation on 11/30/11 at 1:00 PM, during the tour of the Clarinda Medical Associates Clinic, with Staff F, Outpatient Clinic Director, revealed 11 of 11 open shelving units in the clinic medical records area. The open shelving units contained approximately 7,500 unsecured clinic outpatient records with confidential patient information.

a. Review of CAH policy/procedure titled, "Security", last reviewed July 22, 2011, stated in part ". . . Policy: It is the policy of Clarinda Regional Health Center that the medical records are maintained in a secure and confidential manner. Areas housing health information shall be restricted to authorized personnel. . . . Medical records housed within the hospital shall be kept in secure areas at all times. Medical records shall not be left unattended in areas accessible to authorized individuals. . . ."

b. During an interview on 11/30/11 at 1:00 PM, Staff F, Outpatient Clinic Director, stated the housekeeping staff cleaned the Clinic medical records area after the clinic is closed for the the day. Staff F stated the housekeeping staff has a master key to obtain access to the clinic medical record area after clinic hours.


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2. During the facility environment tour on 11/30/11 at 7:30 AM, with Staff J, Facilities Director and Staff K, Environmental Services Manager, observed a large storage room in the basement with multiple shelves of medical records. Entrance to the storage room required an access punch code. In an interview at the time, Staff J reported plant services personnel possessed the access code and facilitated transport of medical records to the storage area. In a follow-up interview at 10:45 AM, Staff K verified the access code required a key to change and the plant service personnel completed this task. Staff K confirmed medical records staff did not always accompany the plant services staff during the transport of records.

During an interview on 11/30/11, while the facility environment tour in progressed, Staff J reported plant services staff possessed keys to the shred bins and emptied the small bins into the large shred bins, on a weekly basis. During a follow-up interview at 10:45 AM, Staff K reported 2 shred bins located on the first floor and 1 each on the second and third floors.

a. Review of CAH policy/procedure titled, "Waste Disposal (Confidential)" last reviewed July 22, 2011, stated in part, " . . . A. Disposal of confidential material, business records and patient identifiable data is handled by the Plant Service Department . . ."

Review of CAH policy/procedure titled, "Data Protection and Confidentiality Guidelines for Department" last reviewed July 22, 2011, stated in part "Policy: Clarinda Regional Health Center has considered the need for access to and appropriate levels of security and confidentiality of data and information . . ."

b. During an interview on 12/1/11 at 9:15 AM, regarding the Data Protection policy, Staff M, Health Information Manager, reported the policy did not identify plant services personnel as authorized to access any confidential patient information.

Based on review of policy/procedure, documents, and medical records, and staff interview, the Critical Access Hospital (CAH) CRNA staff failed to document an evaluation that showed the patients had properly recovered from their anesthesia for 1 of 1 active medical records (Patient #1) and 3 of 10 closed medical records (Patients #2, #3, and #8). The CAH surgical nurse manager identified and average monthly census of approximately 35 endoscopy/colonoscopy procedures and approximately 70 surgical cases monthly.

Failure to document the patent's recovery from anesthesia could potentially result in longer than necessary stays in the recovery area and/or delay in treatment of post anesthetic complications.

Findings include:

1. Review of policy/procedure "Recording of Anesthesia" revealed in part, "The operative anesthetist will be responsible for the accurate and timely documentation of the entire anesthetic course including relevant during induction, maintenance, and emergence from anesthesia... the presence of minimal acceptable monitoring techniques appropriate to the anesthetic technique will be utilized and contemporaneously documented... Accurate anesthesia time from constant preoperative attendance to the transfer of care to qualified post anesthesia care personnel will be recorded on the anesthesia record."

2. Review of Medical Staff Rules and Regulations, dated 2010, revealed in part, "The post anesthesia follow up must be written on all inpatients and outpatients prior to discharge from surgery and anesthesia services. The post anesthesia evaluation must be written by the individual who is qualified to administer the anesthesia."

3. Review of Patient #1's medical record revealed no documented evidence that showed Staff U, Certified Registered Nurse Anesthetist (CRNA) had evaluated Patient #1 for recovery from anesthesia after the procedure, and prior to transfer to the post-anesthesia care unit (PACU).

4. Review of Patient #2 medical record revealed no documented evidence that showed Staff U had evaluated Patient #2 for recovery from anesthesia after the procedure, and before discharge from the CAH.

5. Review of Patient #3 medical record revealed no documented evidence that showed Staff U had evaluated Patient #3 for recovery from anesthesia after the procedure, and before discharge from the CAH.

6. Review of Patient #8 medical record revealed no documented evidence that showed Staff U had evaluated Patient #8 for recovery from anesthesia after the procedure, and before discharge from the CAH.

7. During an interview on 12/1/11 at 10:15 AM, Staff U said the post anesthesia note recorded the patient's status prior to transfer to recovery. Additionally, Staff U verified if complications had occurred after surgery including but not limited to abnormal blood pressure, heart rate, temperature, pulse and breathing issues "they would be" documented on the post anesthesia note for the personnel in PACU for reference. Staff U, acknowledged he failed to document the post anesthesia notes for Patient #1, #2, #3, and #8.