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I. Based on observation, policy/ procedure review and staff interview, the Critical Access Hospital (CAH) Nursing Staff failed to ensure patient care supplies, located in the medical/surgical crash cart, medical/ surgical kitchenette and operating room (OR) anesthesia cupboard were not outdated. The CAH had an average daily census of 8 patients. The CAH Surgery administrative staff reported approximately 25 surgical cases a month that required the use of identified outdated endotracheal tubes and 4 surgical cases a month that required use of the identified outdated spinal needles.

Failure to retain current medical supplies for patient care could potentially harm patients by using supplies that the manufacturer determined may be ineffective when outdated.

Findings include:

1. Observation during tour of the medical/ surgical unit on 9/6/11 at 10:30 AM, Staff O, (Vice President of Nursing and Ancillary Services) revealed (2) 500 ml (milliliter) IV (intravenous) bags of 2 gm (gram) Lidocaine solution, expired 9/1/11, stored in the locked crash cart next to the nurse's station. The kitchenette contained (6) 2 oz (ounce) Pedialyte Oral Electrolyte Maintenance bottles, expired 6/1/11, stored in a cupboard.

During an interview on 9/6/11 at 10:30 AM, Staff O, (Vice President of Nursing and Ancillary Services) confirmed the supplies were expired and nursing staff were responsible for checking the nursing unit monthly for expired supplies.

Review of the policy Emergency Medications- Crash Carts, revised 4/2010 revealed in part"... The pharmacist and/or assigned personnel will inspect the drug supply monthly as part of a monthly unit inspection."

2. Tour of the Anesthesia cupboard in the Surgery area on 9/6/11 at 3:15 PM with the Director of Surgery Services and Staff L, Certified Registered Nurse Anesthetist (CRNA) revealed the following outdated patient care supplies available for patient care:

- 17 of 17 Rusch Endotracheal tubes 2.5 no cuff expired 04-2011
- 1 of 4 Espocan Combined Spinal and Epidural Anesthesia Sets expired 10-2005
- 3 of 4 Espocan Combined Spinal and Epidural Anesthesia Sets expired 5-2007
- 1 of 8 Hudson Cuffed Endotracheal Tubes 3.0 expired 10-2009
- 7 of 8 Hudson Cuffed Endotracheal Tubes 3.0 expired 11-2010
- 5 of 20 BD Spinal Needle Quincke Type Point expired 3-2006
- 14 of 20 BD Spinal Needle Quincke Type Point expired 7-2006
- 1 of 20 BD Spinal Needle Quincke Type Point expired 11-2008

During an interview on 9/6/11 at 3:45 PM, Staff L acknowledged that outdated patient supplies were available for use. Staff L also reported that Anesthesia staff was responsible for checking for outdated supplies in the Anesthesia cupboard.



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II. Based on observation, review of records and staff interview the facility failed to ensure the annual inspection for 25 of 25 electric patient beds occurred, in accordance with Critical Access Hospital (CAH) policy. The (CAH) administrative staff identified a census of 8 patients.

Failure to complete the annual inspection of the electric patient beds could potentially result in unsafe and inadequate functioning of the patient beds.

Findings include:

Observation on 9/6/11 at 11:00 AM, during tour of the nursing department with Staff O, Vice-President of Nursing Service, revealed 25 of 25 patient electric beds with inspection dates of 6/2010. Staff O verified the lack of an annual inspection for 2011.

Review of the policy titled, " Equipment Management Program " reviewed on 3/15/10, stated in part ... " The department shall provide an equipment management program designed to assess and control the clinical and physical risks of fixed and portable equipment used for the diagnosis, treatment, monitoring, and care of patients. "

During an interview on 9/7/11 at 1:00 PM, Staff J, Director of Facilities, revealed that the facility was behind in checking the electric beds for safety and the last inspection was in 6/2010. At this time, all maintenance staff is busy completing the new heating system.

Based on observations, review of documentation, and staff interview, the Critical Access Hospital (CAH) anesthesia staff failed to ensure proper storage of anesthesia drugs as specified by the manufacturer's recommendations. (Anesthesia) The CAH Surgery administrative staff reported approximately 25 surgical cases a month that required use of the identified medications.

Failure to ensure proper temperature controls of pharmaceuticals could potentially cause pharmaceuticals to lose potency, thus not providing desired effect to patients.

Findings include:

1. Tour of the operating room (OR) on 9/6/11 at 2:25 PM revealed the following problems with anesthesia drugs stored in 2 of 2 anesthesia carts in the OR area:

Staff L's anesthesia cart:
- 1 of 1 unopened Atracurium Besylate Inj. 5 ml single dose vial that lacked evidence of the date staff removed the vials from the refrigerator and stored it at room temperature.


Staff P's anesthesia cart:
- 2 of 3 unopened Rocuronium Bromide Inj. Multidose Vials that lacked evidence of the date staff removed the vials from the refrigerator and them stored at room temperature.

- 1 of 3 opened Rocuronium Bromide Inj. Multidose Vials dated 7/29/11 that staff had opened, removed from the refrigerator, and stored at room temperature. According to the manufacturer's directions for use, staff must use Rocuronium Bromide within 30 days after opening.

- 1 of 4 unopened Atracurium Besylate Inj. 5 ml single dose vial dated 8/18/11 that was removed from the refrigerator and stored at room temperature. OR staff failed to discard the medication after 14-days, in accordance with the manufacturer's directions for use.

- 1 of 4 opened Atracurium Besylate Inj. 5 ml single dose vial dated 8/18/11 that was opened, removed from the refrigerator, and stored at room temperature. OR staff failed to discard the medication after 14-days, in accordance with the manufacturer's directions for use.

- 2 of 4 opened Atracurium Besylate Inj. 5 ml single dose vials dated 8/15/11 that were opened, removed from the refrigerator, and stored at room temperature. OR staff failed to discard the medication after 14-days, in accordance with the manufacturer's directions for use.

2. Rocuronium Bromide Inj. manufacturer's product insert stated in part ". . . Rocuronium Bromide Injection should be stored in a refrigerator, 2-8 degrees C (36-46 degrees F). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25 degrees C/77 degrees F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. . . ."

3. Atracurium Besylate Inj. manufacturer's product insert, dated May 2004, stated in part ". . . Atracurium Besylate Injection should be refrigerated at 2 - 8 degrees C (36 - 46 degrees F) to preserve potency. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25 degrees C/77 degrees F), use Atracurium Besylate Injection within 14 days even if rerefrigerated. . . ."

4. Review of Anesthesia policy/procedure titled "Refrigerated Medicine," dated May 15, 2007, stated in part, ". . .All medicines that require refrigeration and are sensitive to room temperature shall be dated when put in the anesthesia carts. If the medication is not used within a specific time period stated on vial, it shall be disposed of."

5. During an interview on 9/6/11 at 3:15 PM, Staff L acknowledged the Rocuronium and Atracurium Besylate vials lacked evidence of a date when removed from the refrigerator and were not disposed of within the specific time period stated on the vial.

I. Based on observation, document review, and staff interview, the CAH (Critical Access Hospital) failed to ensure that radiology staff followed the manufactures instructions for testing the disinfection product (Cidex Plus) used in cleaning the trans-vaginal probes used in the ultrasound area of the Radiology Department. The CAH administrative staff reported a monthly average of 5 ultrasound procedures using the trans-vaginal probes.

Failure to use disinfection products as directed by the manufacturer could potentially result in patients at risk for exposure to infections and blood borne pathogens.

Findings include:

1. Observation on 09/7/11 at 10:30 AM, during a tour of the Radiology department, with Staff H, Director of Radiology, showed staff used Cidex Plus disinfectant used to disinfect the ultrasound trans-vaginal probes. Staff used Comply Glutaraldehyde Chemical Indicator strips to test the disinfectant's strength before each use.

2. Review of the product insert found on the Cidex Plus stated in part ... " Although test strips from other manufactures may give a color reaction with Cidex Plus Solution, their use has not been validated with the product. Only Cidex Plus Solution Strips can be used with Cidex Plus Solution as they monitor the effectiveness of the solution. "

3. During an interview on 9/7/11 at 10:30 AM, Staff I, Ultrasound Sonographer, verified staff used the Comply strips when testing the Cidex Plus Solution.

An additional interview with Staff H revealed that the CAH administrative staff failed to develop and implement a policy delineating the use and testing of Cidex Plus Solution.


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II. Based on observation, policy review and staff interviews, the Critical Access Hospital (CAH) dietary staff failed to properly store food and maintain a sanitary environment. The CAH administrative staff reported a census of 8, with an average daily census of 9. The Dietary Manager reported the dietary staff provided approximately 25 patient meals daily.

Failure to properly store food and maintain the kitchen environment in a sanitary manner could potentially result in the contamination of the patient's food.

Findings include:

1. Observation during the initial kitchen tour on 9/6/11 at 11:55 AM, revealed the following:

a. The walk-in cooler contained an unlabeled, undated pan of ham. In an interview at the time of the observation, Staff A, Dietary Manager, reported he/she had no knowledge of when staff had placed the pan of ham in the cooler and confirmed the pan lacked a label and date.

b. A Hobart refrigerator contained an undated, unlabeled 1-quart container of a dark brown liquid. Staff B, Director of Dietary, identified the substance as beef stir fry sauce. In an interview at the time of the observation, Staff B confirmed the product lacked a label and date.

2. Review of a dietary policy, approved in 5/10, titled "Sanitation", with Section A Part 3 titled "Food Storage", revealed in part "... 2 e. All foods will be identified and dated on label.

3. The walk-in freezer contained the following items stored on the floor. A case of flame roasted corn, 3 cases of cookies, 4 cases of breaded chicken patties, a case of lemon herb chicken fillets, a plastic bag of french toast sticks, a plastic bag of muffins, a plastic tub of egg rolls, a case of cut-out cookie dough and a small box of cream cheese wontons. During an interview at the time of the observation, Staff A acknowledged the storage of the identified items on the floor and reported their usual practice was to store items off the floor.

4. Observation during the full kitchen environment tour on 9/6/11 at 2:00 PM, revealed the following:

a. The ceiling vent, above the dish machine, had a covering of dust. During an interview at the time of the observation, Staff A, acknowledged the soiled condition of the ceiling vent and reported he/she contacted maintenance as needed to clean the ceiling vents.

b. A large wall-mounted fan, located by the walk-in cooler and directed toward the 3-compartment sink, had a covering of dust on the fan guard and blades. During an interview at the time of the observation, Staff A reported the department cleaning schedule did not include the fans, so staff cleaned the fans "as needed " and was unsure of the date staff last cleaned the fans.

c. 1 of 1 large and 2 of 4 medium cutting boards had multiple surface cuts and a marred, stained, unsanitizable surface.

5. Review of a dietary policy, approved 5/10, titled "Sanitation", Section B, Part 1 "Personal Cleanliness and Hygiene" stated in part "... Personal cleanliness and proper hygiene will be maintained by all Dietary employees". Part 2 "Dress Code" stated in part "1. Wear proper attire for work: ... b. hair restraint".

6. Observation during the kitchen environment tour on 9/6/11 at 2:00 PM revealed Staff C's, PM tray assembler, hair net did not cover their bangs.

7. Observation during meal service on 9/6/11 from 5:10 PM to 5:33 PM, revealed Staff D's, PM helper, hair net did not cover their bangs and sides of hair.

8. Observation on 9/7/11 at 7:45 AM revealed Staff D's hair net did not cover their bangs and sides of their hair. Additional observation showed Staff E's, Cafeteria Helper and Staff F's, Dishroom Aide hair nets did not cover their bangs.

9. Observation on 9/7/11 at 11:40 AM revealed Staff G's, Cook, hair net did not cover their bangs.

10. During an interview on 9/7/11 at 9:30 AM, Staff A acknowledged the staff identified, during the observation, had partially unrestrained hair and acknowledged the concern for potential contamination of food from the unrestrained hair.

11. During an interview on 9/7/11 at 10:00 AM, Staff S, Infection Control, confirmed infection control policies failed to address the degree to which hair restraints should cover the head and reported he/she left this to the discretion of Staff A and Staff B. Staff S relayed it would be best to cover the entire head of hair.

12. Review of the Food and Drug Administration Food Code 2009: Chapter 2 Part 4 - Hygienic Practices stated in part "... food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles".

Based on observation, review of records, staff interview, the CAH (Critical Access Hospital) failed to secure confidential patient medical records from unauthorized users in the HIM (Health Information Management) office, Diabetic Education office, and bins containing information to be shredded. The CAH administrative staff identified a census of 8 patients.

Failure to secure patient's medical records could potentially result in access to patient information by unauthorized users.

Findings include:

1. Observation on 9/6/11 at 2:30 PM, with Staff J, Director of Facilities, revealed approximately 10,000 confidential patient medical records in the HIM department. CAH housekeeping staff cleans the department after hours, with no HIM staff present. Housekeeping staff do not need to know protected health information to complete their job duties and should not have access to confidential patient medical records.

During an interview on 9/6/11 at 2:30 PM, Staff N, Clerk Analysis, stated housekeeping staff clean the HIM department after hours, with no HIM staff present.

Observation on 9/6/11 at 2:30 PM, with Staff J, during the tour of the environment, revealed small brown garbage cans used for gathering confidential patient information to be shredded. The garbage cans lacked a lid and mechanism for securing the contents.

During an interview on 9/6/11 at 2:30 PM, Staff J stated that maintenance men gather the confidential information and transport it to secure storage bins to await storage.

2. During an interview on 9/7/11 at 1:30 PM, Staff M, Maintenance man, stated that he collects the confidential patient information from the brown garbage cans on Monday, Wednesday, and Fridays and transports it to the secure shred bins.


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3. Periodic observations on 9/7/11 between 7:00 AM and 8:30 AM, revealed Staff B's, Director of Dietary, office area was unattended with the doors open. Staff B's office was located in a main hallway near the cafeteria, with a door that was open to the hallway and a door that was open to the kitchen.

Observation on 9/7/11 at 8:30 AM, with Staff B, revealed medical records stored in an unsecured file box on the floor in Staff B's office. The medical record files contained personal information that included patient diagnoses, medications and laboratory results.

During an interview on 9/7/11 at 8:30 AM, Staff B reported storing approximately 25-outpatient diabetes and nutrition education records in their office. Staff B reported leaving the office unattended and unlocked periodically throughout their workday. Staff B further reported housekeeping accessed the area for cleaning.

Based on review of policies/procedures, documentation, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to provide documentation, that showed an appropriate external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH, to the Medical Staff and Governing Body for review, prior to or during the credentialing for 7 of 7 applicable physicians reviewed. (Physicians A, B, C, D, E, F, G) The CAH administrative staff reported a current census of 8 in-patients.

Failure to ensure an appropriate external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH then provide that information to the Medical Staff and Governing Body for review, prior to credentialing could potentially result in medical staff members misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of documentation related to the credentialing period from 8/2010 - 8/2012, revealed the CAH quality staff failed to include external peer review results during the credentialing process for all physicians that provided care and services to the CAH patients (Physician C).

Findings for Physician C include:

Review of Physician C's credential file showed the Medical Staff re-credentialed Physician C on 7/20/2010 and the Governing Body re-credentialed Physician C on 8/24/2010. The credential file lacked documentation that showed the external peer review results were available and reviewed by the Medical Staff and Governing Body at the time they re-credentialed Physician C.

The CAH administrative staff identified Physician C had provided services to 204 outpatients during the previous 12 months.

2. Review of documentation related to the credentialing period from 4/1/2010- 4/1/2012, revealed the CAH quality staff failed to include external peer review results during the credentialing process for all physicians that provided care and services to the CAH patients (Physician G).

Findings for Physician G include:

Review of Physician G's credential file showed the Medical Staff re-credentialed Physician G on 4/21/2010 and the Governing Body re-credentialed Physician G on 4/27/2010. The credential file lacked documentation that showed the external peer review results were available and reviewed by the Medical Staff and Governing Body at the time they re-credentialed Physician G.

The CAH administrative staff identified Physician G had provided services to 36 outpatients during the previous 12 months.

3. Review of documentation related to the credentialing period from 12/10/2010- 12/10/2012, revealed the CAH quality staff failed to include external peer review results during the credentialing process for all physicians that provided care and services to the CAH patients (Physician B).

Findings for Physician B include:

Review of Physician B's credential file showed the Medical Staff re-credentialed Physician B on 12/15/2010 and the Governing Body re-credentialed Physician B on 1/25/2011. The credential file lacked documentation that showed the external peer review results were available and reviewed by the Medical Staff and Governing Body at the time they re-credentialed Physician B.

The CAH administrative staff identified Physician B had provided services to 62 outpatients during the previous 12 months.

4. Review of documentation related to the credentialing period from 4/26/2011- 4/26/2013, revealed the CAH quality staff failed to include external peer review results during the credentialing process for all physicians that provided care and services to the CAH patients (Physician A).

Findings for Physician A include:

Review of Physician A's credential file showed the Medical Staff re-credentialed Physician A on 4/20/2011 and the Governing Body re-credentialed Physician A on 4/26/2011. The credential file lacked documentation that showed the external peer review results were available and reviewed by the Medical Staff and Governing Body at the time they re-credentialed Physician A.

The CAH administrative staff identified Physician A had provided services to 24 outpatients during the previous 12 months.

5. Review of documentation related to the credentialing period from 4/26/2011 - 4/26/2013, revealed the CAH quality staff failed to include external peer review results by an approved entity during the credentialing process for all physicians that provided care and services to the CAH patients (Physician D, E, F).

Findings for Physicians D, E, and F include:

Review of Physician D, E, and F's credential files showed the Medical Staff re-credentialed Physicians D, E, and F on 4/20/2011 and the Governing Body re-credentialed Physicians D, E, and F on 4/26/2011. The credential file lacked documentation that showed the external peer review results were available and reviewed by the Medical Staff and Governing Body at the time they re-credentialed Physicians D, E, and F.

The CAH administrative staff identified Physician D had provided services to 718 inpatients and outpatients during the previous 12 months.

The CAH administrative staff identified Physician E had provided services to 856 inpatients and outpatients during the previous 12 months.

The CAH administrative staff identified Physician F had provided services to 1040 inpatients and outpatients during the previous 12 months.

6. Review of the Medical Staff Bylaws, dated August 2010, stated in writing in part, "Each officer and committee of the Medical Staff is hereby constituted a peer review body and each such officer and committee and their agents (including Administer and his or her designees, and representatives of the Network Hospital when acting pursuant to the CAH Network Agreement) are authorized to engage in peer review activity and to investigate and make recommendations tot he Executive Committee concerning applicants or members and privileges or on the quality of patient care at the Hospital. . . ."

7. During an interview on 9/8/11 at 9:35 AM, Staff O, the Vice President Nursing Services and Ancillary Services, acknowledged the lack of documented evidence that showed an evaluation of the quality and appropriateness of the diagnosis and treatment they furnished to CAH patients had occurred by an approved entity at the time Physicians A, B, C, D, E, F, G re-credentialed. Staff O confirmed Physicians A, B, C, D, E, F, G had provided services to patients of the CAH during their last credentialing period.

Therefore, the medical staff and governing body lacked information from the external peer review process, including the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH, in the physician's credential files at the time of reappointment for 7 of 7 physicians.

I. Based on review of policies, Swing Bed (SWB) clinical record review and staff interviews, the Critical Access Hospital (CAH) activity staff failed to ensure SWB patient's activity care plans were individualized to meet the patient's mental and psychosocial needs gathered from the activity comprehensive assessment for 2 of 2 inpatients (Patient #1 and #2) and 5 of 5 closed records (Patient #3, #4, #5, #6 and #7). The CAH administrative staff reported an average daily census of 3 SWB patients.

The activity assessment determines the content of the care plan. All SWB patients should have an activity care plan with individual activity-related interventions gathered from the information in the comprehensive assessment. The individualized care plans sets realistic, measurable goals, patient interventions and should be patient-centered driven. Failure to create individualized activity care plans for SWB patients could potentially neglect a patient's mental and psychosocial needs that could enhance healing and lessen their stay at the hospital.

Findings include:

1. Review of the medical record for Patient #1 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

2. Review of the medical record for Patient #2 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

3. Review of the medical record for Patient #3 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

4. Review of the medical record for Patient #4 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

5. Review of the medical record for Patient #5 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

6. Review of the medical record for Patient #6 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

7. Review of the medical record for Patient #7 revealed he/she received SWB care treatment while in the CAH. However, the medical records lacked an activity care plan with individual activity-related interventions during the SWB patient's hospital stay.

Review of the CAH policy titled Care Plan Policy, revised 11/2010 revealed in part "... The plan of care will address, as appropriate, medical, nursing, mental, psychological and environmental needs. It will include measurable objectives and timetables to meet needs that are identified. It will describe services that are to be furnished to attain or maintain the patient's highest level of functioning."

During an interview on 9/6/11 at 12:20 PM, Staff P, (Occupational Therapist/Activity Coordinator), said if the medical record lacked activity documentation in the care plan, it did not get completed. Staff P said he/she did not know activities needed to be care planned.

During an interview on 9/7/11 at 9:25 AM, Staff Q (Emergency Room Supervisor), said the activity department were not including activities on the patient care plans.

During an interview on 9/7/11 at 9:25 AM, Staff R (Director od Quality), said the activity department were not including activities on the patient care plans.

II. Based on observations, review of policies, SWB clinical record review and staff interviews, the Critical Access Hospital (CAH) activity staff failed develop and provide SWB patients a monthly activity calendar to meet the patient's mental and psychosocial needs gathered from the activity comprehensive assessment for 2 of 2 inpatients (Patient #1 and #2) and 5 of 5 closed records (Patient #3, #4, #5, #6 and #7). The CAH administrative staff reported an average daily census of 3 SWB patients.

Failure to create a monthly activity callender for SWB patients could potentially neglect a patient's mental and psychosocial needs that could enhance healing and lessen their stay at the hospital.

Findings include:

Observation during the environmental tour on 9/6/11 at 10:30 AM with Staff O, (Vice President of Nursing and Ancillary Services), revealed no activity calendars posted in patient rooms or on the nursing unit.

Review of medical records for Inpatients (#1 and #2) and Discharged patients (#3, #4, #5, #6, and #7) revealed no documentation that showed staff provided a monthly activity calendar to the patients.

During an interview on 9/6/11 at 12:20 PM, Staff P, (Occupational Therapist/Activity Coordinator), said the medical records lacked a monthly activity calendar. Staff P said he/she did not know monthly activity calendars were required for SWB patients.