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A. Based on observation, review of checklist and staff interview, it was determined the facility failed to ensure the CAH emergency equipment and supplies were monitored to ensure they are functioning and are readily available for use. This has the potential to affect 100% of patients served by the emergency department.
Findings include:

1. During a tour of the Emergency Department conducted 7/16/13 2:00 PM, the "ER 400 Check List" was reviewed. The Check List indicated each shift to check: "equipment... O2 Flow Meter, Suction... Yankeur... Ambu bag, Lock number, Defibrillator..." and that daily checks are to consist of: Med Cart, IV tray, Accu check supplies stocked, and Accu check controls. There is no documentation that the shift check of equipment and supplies was performed for 1 of the 2 shifts on 6/7, 6/27, 6/28, 7/3, 7/4, 7/5, 7/6, 7/9, and for either shift on 7/15/2013. There is no documentation that the daily checks were performed on 7/9 or 7/15/13.

2. A staff interview was conducted with the Assistant Director of Nursing 7/16/13 at 2:30 PM. The Assistant Director of Nursing indicated no policy was in place for monitoring the crash cart although the staff is taught and the expectation is to conduct the monitoring as indicated on the Check List. The Assistant Director of Nursing confirmed the crash cart had not been monitored each shift as indicated on the Check List.

B. Based on observation and staff interview, it was determined the CAH failed to ensure expired supplies were not available for patient use. This has the potential to affect 100% of patients receiving services at the CAH.
Findings include:

1. During a tour of the Emergency Department conducted 7/16/13, the following outdated supplies were identified:
a. Cook Disposable Intraosseus Infusion Needle x 1 "Do not use" after 3/2013
b. Flexicare Laryngeal Airway Mask size 4 x 1 and size 5 x 1, expired 2/2012
c. Hollister Anchor Fast x 1, expired 12/2012
d. Hemoccult Sensa Developer 15 ml x 1 vial, expired 2/2013

2. During a tour of the Intensive Care Unit conducted on 7/16/13, the following outdated supplies were identified:
a. Cook Disposable Intraosseus Infusion Needle x 1 "Do not use" after 3/2013

3. During a tour of the Rehabilitation Department on 7/17/2013, the following outdated supplies were identified:
a. Safety Glide Insulin Syringe x 1 expired 11/2012

4. During a tour of the Surgery Department on 7/17/13, the following outdated supplies were identified:
a. LNOP POH Pediatric Sp02 (Saturation Peripheral Oxygen) Sensors x 15, expired 10/2012

5. During an interview with the Director of Quality on 7/17/2013 at 2:00 PM, it was confirmed the above supplies were expired and should have been removed from patient care areas.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Recertification Survey conducted on July 30, 2013, the surveyor finds 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.

Based on observation and staff interview, it was determined the facility failed to ensure a safe environment by identifying and acting on hazardous floor conditions. This has the potential to affect 100% of the patients who receive services in the Respiratory Therapy Department.
Findings include:

1. A tour of the Respiratory Therapy Department was conducted 7/17/13 at 3:30 PM. A large scale with a weighing plate was located in the patient access area. The weighing plate and the floor had a 3/4 inch gap which was 3 ft long on all four sides.

2. An interview with the Respiratory Therapist was conducted on 7/17/13 at 3:30 PM. The Respiratory Therapist verbalized all patients receiving services in the Respiratory Therapy Department must walk over or near this gap in the floor to get to the testing equipment and it is a potential hazard for injury.

3. An interview with the Director of Purchasing and Central Supply was conducted on 7/18/13 at 3:30 PM. The Director of Purchasing confirmed the weight plate had been identified via environmental rounds as a serious tripping hazard. The Director of Purchasing indicated no corrective action plan had been implemented to prevent injury.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Recertifcation Survey conducted on July 30, 2013, the surveyor finds 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 HCFA/CMS Form 2567, dated 07/30/13.

Based on review of Policy and Procedures, Medical Staff Bylaws, review of Physician Deficiency Report and staff interview it was determined the CAH failed to send a delinquent notification letter and failed to suspend privileges for physicians with delinquent records 30 or more days. It was determined that 2 of 127 (E2, E3) physicians were noncompliant.
Findings include:

1. The Hospital Policy "Deficiencies over Thirty Days" (revised March 2010) was reviewed 7/16/2013 at 2:00 PM. It indicated the "Medical Records Director or his/her designee will by the 10th of each month send a report of delinquent physician records which are 30 or more days in delinquency to the delinquent physician and a copy to the medical director. 4. ...Medical Staff President or Chairperson of the meeting shall issue an immediate suspension of privileges for any physician who has not signed all delinquent charts at the meeting."

2. The Medical Staff Bylaws (approved 3/19/2013) was reviewed on 7/16/2013. The Medical Staff Bylaws indicated under Article X "The rest of the record must be completed and signed within thirty (30) days of discharge. Physicians whose records are in delinquent status in excess of thirty (30) day, will have their admitting privileges suspended until ... Medical Records Committee will be responsible at least monthly for notifying physician of delinquencies ..."

3. The Physician Deficiency Report was reviewed on 7/16/2013. It indicated E2 had 13 deficient records and E3 had 17 deficient records as of 7/16/2013.

4. A staff interview was conducted on 7/16/2013 at 2:00 PM with the Director of Revenue Cycle. During the interview it was verbalized, she "does not send delinquent notification letters to the physicians. To her knowledge no physician has been suspended as of 7/16/2013, or since her employment of approximately one year." There is no documentation delinquent notification letters are sent to physicians as of 7/16/2013. There is no documentation that any physician has been suspended as of 7/16/2013.

Based on a review of CAH policy and procedure and staff interview, it was determined that the CAH failed to ensure that the policies are developed with the advice of a group of professionals (GOP) that included at least one member that is not a member of the Hospital staff. This has the potential to affect 100% of the patients who receive services at the CAH.
Findings include:

1. The CAH policy and procedure titled, "Policies and Procedures" (With a revised date of 9/30/08) was reviewed. It indicated under, "POLICY: The department head must create, review, revise... All new policies and procedures will be signed off, when necessary, by any or all of the following: administrators, medical directors, chief executive officer, chief operating officer, and Hopedale Medical Foundation authority if necessary." There is no documentation to indicate that an outside member is part of the GOP that develops policies.

2. During an interview with the Director of Outpatient Services/Quality, conducted on 7/17/13 at 1:30 PM, it was verbalized that the CAH's policies and procedures have gone electronic, so when a policy is drafted by the department head(s) it is electronically sent through the process of editing and approval to the Medical Director, then to the Chief Operating Officer, and then for final approval to the Governing Board. It was verbalized that an outside member does not participate in the development of policies.

A. Based on review of policy and procedure, observation and staff interview, it was determined the CAH failed to ensure expired drugs were not available for patient use. This has the potential to affect 100% of patients receiving services at the
CAH.
Findings include:

1. The policy titled "Expirations and Outdates" (approved 11/26/12) was reviewed 7/16/13. The policy indicated under "Procedure: 1. Location of drugs that must be checked for expiration: e. crash carts (ICU, ER, Nas Cart)... 3. Departments with biologicals and biological supplies will be responsible for checking those supplies for outdates and returning to the pharmacy..."

2. During a tour of the Emergency Department conducted 7/16/13, the following outdated drugs were identified:
a. Magnesium Sulfate Injection 50% 5 grams/10ml x 2, expired 3/2013
b. Calcium Gluconate Injection 10% 100mg/ml (10 ml vial) x 2, expired 4/2013
c. Flumozenil Injection 0.5mg/5ml (0.1 mg/ml) x 2, expired 4/2013
d. Amiodarone Hydrochloride Injection 150 mg/3 ml x 3, expired 6/2013
e. Naloxone Hydrochloride Injection 0.4 mg/ml (1 ml vial) x 1, expired 2/2013
f. Atropine Sulfate Injection 1 mg/ml x 4, expired 6/2013
g. Heparin Injection 5,000 units (1 ml vial) x 2, expired 4/2013

3. During a tour of the Intensive Care Unit conducted on 7/16/13, the following outdated drugs were identified:
a. Amiodarone Hydrochloride Injection 150 mg/2 ml x 2, expired 6/2013

4. During a tour of the Rehabilitation Department on 7/17/2013, the following outdated drugs were identified:
a. Atropine Sulfate Injection 1 mg/ml x 1, expired 6/2013
b. Dextrose 50%/ 25 mg/50 ml x 1, expired 6/2013
c. Glucagon 1 mg vial x 1, expired 6/2013

5. During a tour of the Surgery Department on 7/17/13, the following outdated drugs were identified:
a. Lactated Ringers Injection 1000 ml, expired 3/2013
b. 0.9% Sodium Chloride Injection 50 ml x 2, expired 9/2012

6. During an interview with the Director of Quality on 7/17/2013 at 2:00 PM, it was confirmed the above drugs were expired and should have been removed from patient care areas.

B. Based on review of policy and procedure, observation and staff interview, it was determined the CAH failed to ensure medications are accurately labeled when available for patient use. This has the potential to affect 100% of patients receiving care at the CAH.
Findings include:

1. The policy titled "Labeling Standards" (date unknown) was reviewed 7/17/13. The policy indicated "The hospital pharmacy will dispense all medications with a label listing the following information: 1. patient's name 2. room number 3. physician's name 4. drug and strength (whatever has been added to the bag) 5. directions on how the medication should be given 6. any special instructions on administration of the medication 7. the amount of the medication being sent and charged for 8. the pharmacist/technician's initials (whoever entered the order) 9. the date 10. route of administration."

2. During a tour of the Emergency Room conducted 7/16/13, a 250 ml Intravenous (IV) solution bag was observed on the crash cart. Attached to the IV solution was a label with the following information crossed out: patient's name, room number, physician's name, directions on how the medication should be given, the pharmacist/technician's initials and the date." The label indicated that the IV solution was mixed with 250 ml NACL (Sodium Chloride) 0.45% 250 ml; 20,000 units Heparin 10,000 1 ml vial; and 5,000 units Heparin Sodium Injection 5,000 units. Affixed to the IV solution was a plastic bag with 3 sealed Heparin vials (2 were expired 4/2013). There was no identifying information to determine if the IV solution included or excluded the medications as labeled.

3. During an interview with the Assistant Director of Nursing and the Director of Nursing on 7/16/13, it was confirmed the IV solution was unidentifiably labeled and should have been removed from patient care.

Based on review of policy and procedure, observation and staff interview, it was determined the facility failed to ensure infection control measures were maintained to prevent cross contamination in the laundry department by ensuring contaminated gowns worn by staff while transporting dirty / infectious laundry were laundered after use as per CAH policy. This has the potential to affect 100% of patients receiving services at the CAH.
Findings include:

1. The policy titled "Infection Control in Laundry Department" was reviewed 7/18/13. The policy indicated under "B. Infectious Linen: 3. When handled by Laundry staff proper protective equipment (gowns, gloves, mask, etc.) shall be worn... 5. When the individual has finished loading the machine... b. Gowns should be removed and placed in washer."

2. A tour of the Laundry Department was conducted 7/16/13. A cloth scrub jacket was identified on laundry bins containing dirty laundry. No disposable gowns or clean cloth scrub jackets were available for use.

3. An interview with the Director of Environmental Services was conducted on 7/16/13 at 2:00 PM. The Director of Environmental Services indicated the cloth scrub jacket is put on by the staff prior to transporting the dirty/infectious laundry from the bins to the washing machines, then the staff member removes the scrub jacket and returns it to the dirty laundry holding area where it is placed on top of the dirty laundry bins. The Director of Environmental Services confirmed the scrub jacket is reused for an unknown length of time.

4. An interview with the Director of Quality Management was conducted on 7/17/13. The Director of Quality Management indicated the cloth scrub jackets should be used only one time before disposed.

A. Based on a review of policy and procedure, medical record review, and staff interview, it was determined that in 1 of 1 (Pt #13) medical records reviewed in which the nutritional screening identified the patient at nutritional risk, the CAH failed to ensure a dietary assessment was conducted for the patient.
Findings include:

1. The CAH policy and procedure titled, "Nutrition Screening and Assessment Policy for Acute Hospital Care" (with a revised date of 1/26/09) was reviewed. It indicated under, "Procedure: C. The dietitian will evaluate, completing an assessment as indicated within two business days. D. The following triggers will be used to identify patients at nutritional risk, supporting the need for a full dietary assessment. d. Inadequate Intake/Poor Appetite for 5 or more days."

2. The medical record of Pt #13 was reviewed on 7/18/13. It indicated Pt #13 was admitted on 3/28/13 with an initial diagnosis of Urinary Tract Infection. Documentation on the "Nutrition Screening Form" indicated Pt #13 had the risk factor of "Inadequate Intake/Poor Appetite for 5 or more days." check marked. There was no documentation that the registered dietitian (RD) conducted a nutritional assessment.

3. During an interview with the RD, conducted on 7/18/13 at 11:40 AM, it was stated that the RD is notified of patients identified as having nutritional risks. The RD reviewed Pt #13's medical record and stated that there was no documentation of a nutritional assessment being performed.

B. Based on Policy and Procedure, Observation and Staff interview, it was determined the Dietary Department failed to ensure expired food was removed from hospital use, potentially affecting 100% of patients who receive dietary services.
Findings Include:

1. The policy "Illinois Food Code General Preparation and Handling" (no approval date) was reviewed on 7/18/13. Under "READY-to-EAT, Not Potentially Hazardous Foods 1)" it indicated "Manufactured date will be followed. Once date exceeds manufacturer's date, item will not be used and be disposed of properly."

2. During a tour of the Dietary Department on 7/17/13 at 9:00 AM, it was observed in the food storage area a case (96 individual boxes) of Wheaties had expired 25 May 13.

3. During an interview with the Dietitian on 7/17/13, it was confirmed the food had expired and should have been removed from the Dietary Department.

C. Based on observation and staff interview if was determined the CAH failed to ensure expired test strips were not available for use in the Dietary Department. This has the potential to affect 100% of the patients who receive dietary services.
Findings include:

1. During a tour of the Dietary Department on 7/17/13, the following outdated test strips were identified:
a. Hydrion Papers QT-10 Test Strips x 1, expired 5/2012

2. During an interview with the Director of Quality on 7/17/2013 at 2:00 PM, it was confirmed the above test strips were expired and should have been removed from patient care areas.

Based on Observation and Staff interview, it was determined the CAH failed to ensure those staff utilizing the Computed Tomography (CT) room and potentially exposed to radiation, had proper dosimetry monitoring, potentially affecting all staff working in the CT room.
Findings include:

1. During a tour of the Radiology Department on 7/17/13 at 11:30 AM, it was observed in the CT room, that no control dosimetry badge was being utilized.

2. During an interview with the Lead Technologist on 7/17/13 at 12:00 PM it was confirmed there was no control dosimetry badge in the CT room and there should have been a badge posted behind the protective barrier at all times. The Lead Technologist indicated he sends all dosimetry badges to Landauer for Dose Equivalent readings but was not sure why the CT room did not have a control dosimetry badge behind the shielded area. He immediately retrieved a new control dosimetry badge and placed it behind the shielded area in the CT room.

Based on review of Medical Staff Bylaws, review of Physician Deficiency Report and staff interview it was determined the CAH (Critical Access Hospital) failed to ensure 30 medical records were completed within 30 days of patient discharge as of 7/16/13. This has the potential to affect 100% of patients receiving care.
Findings include:

1. The Medical Staff Bylaws (approved and reviewed 3/19/2013) were reviewed on 7/16/13. It indicated "(e) Patients shall be discharged ...The rest of the record must be completed and signed within thirty (30) days of discharge."

2. The Physician Deficiency Report was reviewed on 7/16/2013. It indicated two physicians have delinquent records greater than 30 days. E2: March 2013, 2 medical records; May 2013, 4 medical records; June 2013, 7 medical records. E3: May 2013, 2 medical records; June 2013, 15 medical records.

3. A staff interview was conducted 7/16/2013 at 2:00 PM with the Director of Revenue Cycle. It was indicated the policy for signing delinquent medical records was not followed. It was confirmed the Physician Deficiency Report for July 16, 2013 had a total of 30 deficient medical records.

Based on a review of policy and procedure, record review, and staff interview it was determined the CAH failed to ensure restraint orders indicated duration (time frame). This was evident in 1 of 1 (Pt #20) medical record reviewed in which the patient was placed in restraints.
Findings include:

1. The CAH policy titled "Restraints" revised 5/29/09, was reviewed on 7/18/13. Under "Orders for restraint must specify" it indicated all orders for restraints must contain "Reason, type of restraint, extremity or body part(s) to be restrained and the duration (time frame) for restraint application."

2. The medical record of Pt #20 was reviewed on 7/18/13. It indicated Pt #20 was admitted on 6/6/13 with a diagnosis of Seizures. Documentation on the "PHYSICIAN'S ORDERS" sheet indicated "Bilateral soft wrist restraints." There is no documentation by the physician that indicated duration of time to be restrained. Documentation on the Restraint Flow Sheet indicated Pt #20 was restrained from 6/7/13 at 0400 hours and released at 1900 hours.

3. An interview with the Assistant Director of Nursing on 7/18/13 at 200 PM confirmed that the physician order should have indicated the duration of time for restraints and that the physician order for Pt #10 did not indicate duration.

A. Based on review of policy and procedure, medical record review and staff interview, it was determined in 2 of 20 (Pt #1 and #2) medical records reviewed the facility failed to ensure physician orders were dated and timed by the ordering physician.
Findings include.

1. The policy titled "Medical Record Standards / Documentation" was reviewed on 7/17/13. The policy indicated under "Organization: 5. Entries are to be legible, dated and signed."

2. The medical record of Pt #1 was reviewed on 7/17/13 at 3:00 PM. Pt #1 was admitted to the Emergency Department on 6/7/13 with complaints of chest pain. The Emergency Department Record labeled "Orders" did not indicate a date or time for the physician's orders.

3. The medical record of Pt #2 was reviewed on 7/17/13 at 3:15 PM. Pt #2 was admitted to the Emergency Department on 6/23/13 with complaints of weakness. The Emergency Department Record labeled "Orders" did not indicate a date or time for the physician's orders.

4. An interview was conducted with the Medical Record Manager and the Director of Revenue Cycle on 7/18/13 at 3:30 PM. The Medical Record Manager and the Director of Revenue Cycle indicated the policy has been revised and pending approval to include the statement that "All records are to be signed, dated and timed." The Medical Record Manager and the Director of Revenue Cycle confirmed the documentation expectation of all staff is that all medical record entries are dated and timed identified. They indicated the medical records are reviewed and flagged for correction for missing documentation elements.

B. Based on medical record review and staff interview, it was determined in 2 of 20 (Pt #4 and #5) medical records reviewed, the facility failed to ensure physician orders were authenticated.
Findings include:

1. The medical record of Pt #4 was reviewed on 7/18/13 at 8:00 AM. Pt #4 was admitted to the Operating Room on 7/18/13 for excision of scalp lesions x 2. The document labeled "Ambulatory Surgery Admission Orders" dated 7/16/13 was not authenticated.

2. The medical record of Pt #5 was reviewed on 7/18/13 at 8:30 AM. Pt #5 was admitted to the Operating Room on 7/18/13 for excision of a breast lesion. The document labeled "Ambulatory Surgery Admission Orders" dated 7/17/13 was not authenticated.

3. An interview was conducted with the Medical Record Manager and the Director of Revenue Cycle on 7/18/13 at 3:30 PM. The Medical Record Manager and the Director of Revenue Cycle indicated the policy has been revised and pending approval to include the statement that "All records are to be signed..." The Medical Record Manager and the Director of Revenue Cycle confirmed the documentation expectation of all staff is that all medical record entries should have the author identified.

Based on review of policy and procedure, observation and staff interview, it was determined the facility failed to ensure medical records in the Respiratory Therapy Department were securely safeguarded to prevent unauthorized access. This has the potential to affect 100% of outpatients being served by the Respiratory Therapy Department.
Findings include:

1. The Policy titled "Medical Record Standards/Documentation" (effective date 4/7/2011) was reviewed July 18, 2013. The policy indicated "Confidentiality: 1. The medical record is considered highly confidential. Storage is away from public access..."

2. A tour of Respiratory Therapy Department was conducted 7/17/13. Patient medical records were observed in file cabinets and on top of cabinets.

3. A staff interview was conducted with the Respiratory Therapist 7/17/13 at 3:30 PM. Upon inquiry the Respiratory Therapist confirmed the department is located off a publicly accessed hallway, frequently unattended with the door not closed or locked and is utilized as a patient care area.

Based on a review of policy and procedure, the CAH's Quality Improvement Plan Manual, the CAH's FY2011 and FY2012 Annual Program Evaluations, internal documentation, and staff interview, it was determined that in 2 of 2 Annual Program Evaluations reviewed, the Hospital failed to ensure medical records were sent to an outside organization for peer review of appropriate diagnoses and treatment furnished. This has the potential to affect 100% of the patients who receive services at the CAH
Findings include:

1. The CAH policy and procedure titled, "Annual Evaluation of CAH" (With a revised date of 1/13/2005) was reviewed. It indicated under "Purpose: 1. The Chief Operating Officer shall be charged with the responsibility of obtaining information required for a thorough evaluation of the Critical Access Hospital program...." In the list of information to be included in the evaluation, it indicated under "IV. Evaluation of Quality Improvement C. Peer Review program"

2. The Quality Improvement Plan Manual (revised date 9/22/2009) was reviewed. It indicated under "Hopedale Medical Complex Medical Staff: Internal peer review as well as external peer review can be useful in monitoring performance..."

3. The Hospital's Annual Program Evaluations for FY2011 and FY2012 were reviewed. Documentation indicated "An External Peer Review contract remains active through the ICAHN network" however there was no documentation that indicated any medical records were sent to an outside organization for peer review to determine the appropriateness of diagnoses and treatment furnished.

4. An internal document, dated July 18, 2013 regarding the "External Peer Review, Hopedale Medical Complex/Hopedale Hospital" was reviewed. It indicated that the Director of Outpatient Services and Quality has been in this position "from July 2008 to present". In the document it is stated that during this time period no medical records were sent out for peer review.

5. During an interview with the Director of Outpatient Services and Quality, conducted on 7/17/13 at 10:45 AM, it was verbalized that E-1 is solely responsible for peer review in the Hospital which includes internal peer review as well as external peer review. E-1 then stated that in the last 2 years no physician medical records have been sent outside the Hospital for peer review. It was stated that this is the reason why the Annual Program Evaluation does not contain any information related to the physician peer review of diagnoses and appropriate treatment.