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A. Based on a review of Medical Staff Bylaws, a review of Delinquent record report, a review of the Medical Staff meeting minutes,and staff interview, it was determined that the CAH failed to ensure that it's Bylaws for the enforcement of record completion was followed.

Findings include:

1. The Medical Staff Bylaws were reviewed on 3/11/10. It indicated "Article X- Rules and Regulations: Section 1 e) ...The rest of the record must be completed and signed within 30 days of discharge. Physicians whose records are in delinquent status, will have their admitting privileges suspended until such time that they are in compliance with this rule... Medical Records Committee will be responsible at least monthly for notifying physician of delinquencies with a copy sent to the Chief Executive Officer, Chief Operating Officer, and President of Medical Staff."

2. The Delinquent record report for February 2009 thru February 2010 was reviewed on 3/9/10. It indicated delinquent records ranging from 22 to 132 records per month.

3. The Medical Staff minutes for February 2009 thru February 2010. There was no documentation to indicate that the Medical Staff Bylaws were followed, in relation to delinquent records.

4. During a staff interview, conducted with the QA Director and the Director of Nursing (DON) on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of Hospital policy and procedure, review of pharmacy Surgery Narcotic Records, a review of medication charge sheets, medical record review, and staff interview, it was determined that the Hospital failed to ensure narcotic use/waste is documented and monitored.

Findings include:

1. The Hospital policy and procedure titled, "Controlled Substances" for "Surgery" was reviewed on 3/9/10. It indicated under, "Procedures: 5. Wasted narcotics must be witnessed and signed for by two registered nurses. Anesthesia will record their drug use and waste on the Anesthesia Record. This will be reflected on the Narcotic Count Record...."

2. The "Surgery Narcotic Records for Jan 2010 were reviewed. The records dated 1/12/10 and 1/13/10 indicated that for a total of 3 patients, the dose and amount of narcotic wasted were reflected on the anesthesia record. There was no documentation that reflected the use/waste of the narcotic on the Surgery Narcotic Record or the anesthesia medication charge sheets.

3. The medical records of Pts #1, #7, and #8 were reviewed on 3/10/10 and 3/11/10. The following narcotic discrepancies were noted: The medical record for Pt #1 indicated a PCA was discontinued on 3/7/10. There was no documentation of the amount wasted or of the 2 required signatures for the waste. The record for Pt #7 indicated on the "Post Anesthesia Care Unit" order sheet "Substance wasted as stated by the anesthesia provider." Those substances were noted to be Fentanyl 50mcg and Versed 1mg. There was no witness signature to the wasted medications. The medical record of Pt #8 indicated a PCA pump was discontinued on 1/24/10. There was no documentation of the amount of medication wasted or witnessed.

4. During an interview with the QA Director, conducted on 3/12/10 at 2:00 PM, the above findings were confirmed.

B. Based on a review of the pharmacy controlled medication perpetual count book, a review of the pharmacy process for accounting for outdated and returned controlled medications, and staff interview, it was determined that the Hospital failed to ensure all controlled medications were properly accounted for.

Findings include:

1. During a tour of the pharmacy, conducted on 3/9/10 at 10:30 AM, it was observed that the perpetual count log book, used by the pharmacy to accurately count for all controlled medications, did not accurately reflect the outdated controlled medications.

2. The pharmacy process for accounting for outdated controlled medications was reviewed. It was noted that when a controlled medication is outdated and returned to the pharmacy, it is logged back into the pharmacy's perpetual count book. On the same day and time, it is logged out on the perpetual count as it is placed in the controlled medication return bin. The controlled return bin is picked up twice a year which leaves the uncounted outdated returns unaccounted for a possible 6 month period of time.

3. During an interview with the Pharmacist, conducted on 3/9/10 at 10:55 AM, the above findings were confirmed. She also verbalized that when the controlled return bin is picked up, there is no accounting of the actual returned medications against any pharmacy paperwork which would accurately reflect the name and amount of the medications being returned and log them out of the pharmacy.

C. Based on a review of Hospital policy and procedure, observation, and staff interview, it was determined that the Hospital failed to ensure all outdated drugs and biologicals were removed from patient use areas.

Findings include:

1. The Hospital policy and procedure titled, "Checking for Outdates and Expirations" was reviewed on 3/10/10. It indicated that all departments of the Hospital will check for expired medications once a month and the outdated medications would be collected and returned to pharmacy.

2. During tours of the Hospital, conducted on 3/910 and 3/10/10, the following outdated items were observed to be in patient use areas; In respiratory therapy - 85 10% sterile (15ml) Sodium Chloride for respiratory therapy, all expired 11/09 and 5 pre-filled 10ml syringes of Sodium Chloride all expired 12/1/09. In the PACU on the Malignant Hyperthermia Cart 2 purple top Vacutainers expired 11/09 and 2 red top Vacutainers expired 1/10; In the OR, 3 Alcare hand sanitizers - 2 expired 6/08 and 1 expired 7/06; In the Angio Room - all biologicals on the East wall were expired including items such as Sodium Chloride, Xylocaine 2% Jelly, Hemostasis Introducers, Brite Tip sheaths, Arrow Percutaneous Sheath Introducer Sets. All with expiration dates that ranged from 2/00 to 8/05.

3. During an interview with the Hospital Educator, conducted on 3/10/10 at 3:15 PM, the above findings were confirmed.

A. Based on a review of CAH policy, a review of pool/spa logs, and staff interview, it was determined that the CAH failed to ensure that the Therapy Pool/ Lap Pool/ and Spa were maintained in a manner to prevent the potential for cross contamination of infections.

Findings include:

1. The CAH policy titled "Pool Policies" was reviewed on 3/12/10. It indicated "7. Pool Maintenance: 2. General Chemical Guidelines as follows: a. Ph: 7.2 to 7.8, b. total alkalinity: 80 to 200 ppm; c. bromine: 3.0 to 5.0... B. Maintenance Guidelines; 1. Pool temperature 84 to 92 degrees F. for therapy exercise and 82 to 85 degrees F for aerobic (lap) pool..." The Spa pool is not addressed in the policy.

2. The Therapy pool, Lap pool, and Spa pool Chemical Test Reports for the December 2009 thru March 2010 were reviewed on 2/12/10. These indicate Chlorine versus Bromine levels. The report indicated that the Free Chlorine level is to be between 2.0 and 3.0. Three out of three months of each pools reports indicated greater than 50% of readings outside of this range with action sporadically documented. The report indicated that the Combined Chlorine Total- Free was to be 0.0 to 0.2. Three out of three months of each pool report indicted greater than 80% of readings outside of this range with action sporadically documented. Three out of three months of the Therapy Pool log indicated temperatures greater than 92 degrees F over 80% of the time.

3. During a staff interview, conducted with the Maintenance Supervisor on 3/12/10 at 12:45 PM, the above findings were confirmed. It was verbalized that the policy needs to be updated to current practice and to include the spa pool.

B. Based on a review of CAH policy, a review of Therapy logs, and staff interview, it was determined that the CAH failed to ensure that the whirlpool and hydrocolator were maintained in a manner to prevent potential cross contamination of infections

Findings include:

1. The CAH policy titled "Cleaning Process for Whirlpool" was reviewed on 3/11/10. It indicated "To be completed after each use of the whirlpool." The policy titled "Hot Packs (Hydrocolator Packs)" was reviewed on 3/11/10. It indicated "Care of the Equipment: 3..Record of cleaning unit will be maintained with log of temperature tracking."

2. The Whirlpool log for 9/09 thru 3/11/10 was reviewed on 3/12/10. There was no documentation as to when the whirlpool was cleaned. The Daily Hydrocolator sign off sheet for January 2010 thru March 2010. There was no documentation to indicate that the Hydrocolator had been cleaned.

3. During a staff interview, conducted with the Director of Nursing on 3/12/10 at 2:00 PM, the above findings were confirmed.

C. Based on observation and staff interview, it was determined that the CAH failed to ensure that biologicals available for patient care are stored in a manner to prevent potential infections.

Findings include:

1. During a tour of the CAH, conducted on 3/9/10 at 10:30 AM, 2 MediSkin I Frozen Perforated Porcine Xenograft were observed in the 400 Wing Freezer next to popsicles and sherbet. The following items were observed in the 400 Wing Refrigerator where puddings and snacks were stored for patient use: 5 Basic Metabolic Profile kits, 5 Comprehensive Metabolic Profile kits, 2 D-Dimer kits, 5 Triage Cardio Profile ER kits, 4 BNP, 2 Triage Toxicology Drug Screen, 3 General Chemistry, and 2 Met Lyte 8 Panel Kits. In the Emergency Room, the Eye Tray was observed stored in the same cabinet with cleaning supplies (Dawn dish soap and Virex). In the Laboratory, the following items were observed stored on cabinets along with office supplies and boxes of old files: 9 Formalin 450 ml, 6 cases of Histo Pak (12 40 ml vials), 2 cases of Formalin 120 ml, 8 boxes of 22 gauge Vacutainer needles, 8 boxes of 21 gauge Vacutainer needles, 8 rolls of gauze sponges, 5 boxes of Alcohol swabs. The cabinet under the laboratory draw room sink was observed to have flower vases, cleaning supplies, and miscellaneous items. In the laboratory cabinet, disposable laboratory coats, disposable shoe covers (used in surgery), computer panels, and miscellaneous were observed.

2. During a staff interview, conducted with the Director of Nursing on 3/9/10 at 11:00 AM, the above findings were observed.

A. Based on a review of Hospital policy and procedure, observation, and staff interview, it was determined that the Hospital failed to ensure all dietary chemical sanitizers were tested to ensure proper strength of the sanitizer.

Findings include:

1. The Hospital policy and procedure titled, "Illinois Food Code Cleaning and Sanitizing" was reviewed on 3/9/10. It indicated under, "POLICY: Manual Cleaning and Sanitizing e) When chemicals are used for sanitizing, they shall not have concentrations higher than the maximum permitted...and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.

2. During a tour of the dietary kitchen, conducted on 3/9/10 at 9:00 AM, it was observed that test tapes were at the 2 sanitizer dispensing stations. However, there was no documentation that indicated the test strips were used to ensure the proper strength of the sanitizing agent.

3. During an interview with the Dietary Manager, conducted on 3/9/10 at 9:15 AM, the above findings were confirmed.

A. Based on a review of contracted services and staff interview, it was determined that the Critical Access Hospital (CAH) failed to ensure that contracted services were evaluated for compliance with applicable conditions of participation.

Findings include:

1. The list of contracted services was reviewed on 3/10/10. There was no documentation to indicate that the contracted services were evaluated for compliance with applicable conditions of participation.

2. During a staff interview, conducted with the Materials Management Director on 3/10/10 at 1:00 PM, the above finding was confirmed.

A. Based on a review of Hospital policy and procedure, medical record review, and staff interview, it was determined in 3 of 3 (Pts #14, #15 and #16) medical records reviewed, in which the patient received blood transfusions, the Hospital failed to ensure there were 2 nurse signatures verifying the transfusion information at the bedside.

Findings include:

1. The Hospital policy and procedure titled, "Blood and Blood Product Administration/Transfusion" was reviewed on 3/11/10. It indicated under, "Policy Verification Process 4. The RN checking blood with lab personnel will carry the product to bedside with another nurse who will perform a second label check and confirm the patient's identity. This will be done as follows: a. Second Label Check - follow steps in #6, a through h above. b. Check the Patient's ID bracelet against the blood product...5. The second nurse at bedside should sign the "Blood Administration" form..."

2. The medical record of Pt #14 was reviewed on 3/11/10. It indicated Pt #14 was admitted on 3/4/10 with a diagnosis of Gastrointestinal Bleed. Documentation indicated that Pt #14 received a blood transfusion on 2/19/10 at 1515. There was no documentation in the medical record that indicated a second label check was preformed by 2 nurses at the patient's bedside.

3. The medical record of Pt #15 was reviewed on 3/11/10. It indicated Pt #15 was admitted on 2/21/10 with a diagnosis of Acute Lower Gastrointestinal Bleed. Documentation indicated that Pt #15 received a blood transfusion on 2/23/10 at 1830. There was no documentation in the medical record that indicated a second label check was preformed by 2 nurses at the patient's bedside.

4. The medical record of Pt #16 was reviewed on 3/10/10. It indicated Pt #16 was admitted on 2/14/10 with a diagnosis of Gastrointestinal Bleed. Documentation indicated that Pt #16 received a blood transfusion on 2/14/10 at 1910. There was no documentation in the medical record that indicated a second label check was preformed by 2 nurses at the patient's bedside.

5. During an interview with the Hospital Educator, conducted on 3/11/10 at 2:45 PM, the above findings were confirmed.

A. Based on a review of Medical Staff Bylaws, a review of Delinquent record report,and staff interview, it was determined that the CAH failed to ensure that physicians completed the medical record within the 30 day timeframe.

Findings include:

1. The Medical Staff Bylaws were reviewed on 3/11/10. It indicated "Article X- Rules and Regulations: Section 1 e) ...The rest of the record must be completed and signed within 30 days of discharge."

2. The Delinquent record report for February 2009 thru February 2010 was reviewed on 3/9/10. It indicated delinquent records ranging from 22 to 132 records per month.

3. During a staff interview, conducted with the QA Director and the Director of Nursing (DON) on 3/11/10 at 2:00 PM, the above findings were confirmed.

B. Based on medical record review and staff interview, it was determined in 6 of 20 (Pts #1, #3, #7, #8, #9, #18) medical records reviewed, that the CAH failed to ensure that documentation was complete.

Findings include:

1. The medical record of Pt #1 was reviewed on 3/10/10. Pt #10 was admitted to the CAH on 3/6/10 with the diagnosis of Severe Traumatic Joint Effusion Right Knee. On 3/9/10, pre-operative nursing medication documentation indicated "0515- Ampicillin intravenous, 0550- Gentamicin intravenous." There was no documentation of the dose given.

2. The medical record of Pt #3 was reviewed on 3/10/10. Pt #3 was admitted to the CAH on 3/6/10 with the diagnosis of Acute Pulmonary Edema. There was no documentation to indicate who completed the nursing admission assessment or when it was completed.

3. The medical record of Pt #7 was reviewed on 3/11/10. Pt #7 was admitted to the CAH on 2/11/10 with the diagnosis of Symptomatic Biliary Disease. There was no documentation of the time at which the pre-anesthesia or post-anesthesia assessment were completed.

4. The medical record of Pt #8 was reviewed on 3/11/10. Pt #8 was admitted to the CAH on 1/20/10 with the diagnosis of Acute Cholecystectomy. There was no documentation of the time at which the pre-anesthesia or post-anesthesia assessment were completed. The "Frequent Observation Flowsheet for Post Op" failed to include initials and/or signature of the staff providing the care.

5. The medical record of Pt #9 was reviewed on 3/11/10. Pt #9 was admitted to the CAH on 2/5/10 with the diagnosis of Pneumonia. There was no date on the nursing admission assessment to indicate when it was completed.

6. The medical record of Pt #18 was reviewed on 3/11/10. Pt #18 was admitted to the CAH on 11/24/09 with the diagnosis of Chest Pain. On 11/24/09, the Emergency Room physician's order sheet failed to include physician signature as of 3/11/10.

7. During a staff interview, conducted with the Director of Nursing on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of CAH policy, medical record review, and staff interview, it was determined 2 of 20 (Pts #6, #8) medical records reviewed, that the CAH failed to ensure that verbal/telephone orders were put into writing and signed within 24 hours, as per CAH policy.

Findings include:

1. The CAH policy titled "Verbal and Written Orders- General" was reviewed on 3/11/10. It indicated "The prescriber shall co-sign the order within 24 hours."

2. The medical record of Pt #6 was reviewed on 3/11/10. Pt #6 was admitted to the CAH on 1/3/10 with the diagnosis of Respiratory Compromise. The following is a partial list of the verbal/ telephone orders which had not been co-signed as of 3/11/10: 1/3/10- 1 order; 1/5/10- 3 orders; 1/7/10- 2 orders; 1/9/10- 5 orders.

3. The medical record of Pt #8 was reviewed on 3/11/10. Pt #8 was admitted to the CAH on 1/20/10 with the diagnosis of Acute Cholecystectomy. On 1/24/10, nursing documentation indicated that Pt #8 was notified of impending discharge after speaking with the physician. There was no documentation of a physician's order.

4. During a staff interview, conducted with the Director of Nursing on 3/11/10 at 2:00 PM, the above findings were confirmed.

B. Based on a review of CAH policy, medical record review, and staff interview, it was determined in 3 of 5 (Pts #3, #9, #10) medical records reviewed, in which the patient was discharged from acute care, that the CAH failed to ensure that "blanket" orders were not utilized, as per CAH policy.

Findings include:

1. The CAH policy titled "Verbal and Written Orders- General" was reviewed on 3/11/10. It indicated "Blanket Orders Prohibited... but are not limited to: Continue previous medications; Resume preoperative orders; Resume orders from floor; Discharge on current medications."

2. The medical record of Pt #3 was reviewed on 3/10/10. Pt #3 was admitted to the CAH on 3/7/10 with the diagnosis of Acute Pulmonary Edema. On 3/10/10, there was a physician's order "Discharge to nursing home. Avelox 400 mg by mouth daily for 7 days. Discharge with no change in meds."

3. The medical record of Pt #9 was reviewed on 3/11/10. Pt #9 was admitted to the CAH on 2/5/10 with the diagnosis of Pneumonia. On 2/8/10, there was a physician's order "Discharge to Swing Bed." There were no written orders for medications, etc.

4. The medical record of Pt #10 was reviewed on 3/11/10. Pt #10 was admitted to the CAH on 12/14/09 with the diagnosis of Pneumonia. On 12/18/09, there was a physician's order "Discharge to Swing Bed. Discontinue Duoneb four times a day. Discontinue Albuterol." There was no written orders for medications, etc.

5. During a staff interview, conducted with the Director of Nursing on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of Annual Governing Board reports and staff interview, it was determined that the CAH failed to ensure that the annual evaluation included a representative sample of both active and closed medical records.

Findings include:

1. The Annual Governing Board reports for 2007 through 2009 were reviewed on 3/11/10. There was no documentation to indicate that the evaluations included an evaluation of a representative sample of both active and closed medical records in 3 of the 3 years reviewed.

2. During a staff interview, conducted with the Quality Assurance (QA) Director on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of CAH policy, a review of Annual Governing Board reports, and staff interview, it was determined that the CAH failed to ensure that the annual evaluation included a review of the CAH healthcare policies.

Findings include:

1. The CAH policy titled "Annual Review of Policies, Procedures and Manual" was reviewed on 3/11/10. It indicated "Policy: It shall be the policy of the Hopedale Medical Complex that all policies and procedure manuals must be reviewed annually."

2. The Annual Governing Board reports for 2007 through 2009 were reviewed on 3/11/10. There was no documentation to indicate that the evaluations included an evaluation of the CAH healthcare policies in 2009.

3. During a staff interview, conducted with the Quality Assurance (QA) Director on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of Annual Governing Board reports and staff interview, it was determined that the CAH failed to ensure that the annual evaluation included an evaluation as to whether the utilization of services was appropriate, the established policies were followed, and any changes are needed.

Findings include:

1. The Annual Governing Board reports for 2007 through 2009 were reviewed on 3/11/10. There was no documentation to indicate that the evaluations included an evaluation as to whether the utilization of services was appropriate, the established policies were followed, and any changes are needed in 2009.

2. During a staff interview, conducted with the Quality Assurance (QA) Director on 3/11/10 at 2:00 PM, the above findings were confirmed.

A. Based on a review of contracted services and staff interview, it was determined that the Critical Access Hospital (CAH) failed to ensure that contracted services were evaluated for compliance with applicable conditions of participation.

Findings include:

1. The list of contracted services was reviewed on 3/10/10. There was no documentation to indicate that the contracted services were evaluated for compliance with applicable conditions of participation.

2. During a staff interview, conducted with the Materials Management Director on 3/10/10 at 1:00 PM, the above finding was confirmed.

A. Based on a review of Critical Access Hospital agreements/contracts and staff interview, it was determined that the CAH failed to ensure that it's QA program included adequate peer review.

Findings include:

1. The CAH agreements/contacts were reviewed on 3/11/10. There was documentation to indicate that any medical records had been sent out for peer review by the contracted QIO.

2. During a staff interview, conducted with the Quality Assurance (QA) Director on 3/11/10 at 3:15 PM, the above finding was confirmed.

A. Based on a review of QA audits, a review of Medical Staff meeting minutes, and staff interview, it was determined that the CAH failed to ensure that it followed up on QA findings and took corrective action if necessary.

Findings include:

1. The QA audits titled "Transfusion Audit" for February 2009 thru January 2010 were reviewed on 3/11/10. 7 out of the 11 Transfusion Audit reports indicated "needs review" or "review." The November 2009 audit indicated that 2 transfusions "needs review" and that the "H&H done post transfusion... sent to the Hospital Director of Nursing (DON) for review and appropriate follow up." There was no documentation of follow up.

2. The Medical Staff meeting minutes for February 2009 thru January 2010 were reviewed on 3/11/10. The meeting minutes indicated in 6 out of the 7 Transfusion Audit reports, in which "needs review" or "review," "Transfusion Audit acceptable", "Audit required no reviews", "No changes or concerns..." There was no documentation in 6 out of the 7 reports to indicate that the reviews recommended by the Transfusion Audit QA were completed.

3. During a staff interview, conducted with the QA Director and the DON on 3/11/10 at 2:00 PM, the above findings were confirmed. It was verbalized that, at this time, there is no process in place for the tracking and follow up of findings related to QA projects.