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Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Critical Access Hospital Sample Validation Survey conducted on December 1, 2015, the surveyors find 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 document review, observation and staff interview it was determined the Critical Access Hospital (CAH) failed to ensure mechanical and electrical equipment available for patient use was inspected and had routine preventive maintenance. This has the potential to affect all patients receiving services at the CAH.

Findings include:

1. A tour of the Acute Care/ Medical Surgical Unit was conducted on 12/1/15 at approximately 1:00 PM, with the Administrator/Director of Nursing (E#1). It was observed in room 227, the wall suction unit included a maintenance sticker on it, with the last date of inspection of 5/14/98. The wall suction unit in room 226 included a maintenance sticker on it with the last date of inspection of 10/12/13.

2. The CAH policy titled "Medical Equipment Management Plan" (effective date 3/2/15) was reviewed on 12/3/15 at 2:00 PM. The policy indicated "...Policy Statement... The objective of the Medical Equipment Management Program is to manage the effective, safe and reliable operation of medical equipment used in pt. care setting...B. 1 Documentation of service, testing and inspection is maintained by database in the department file and/or Denman Bio Med Services."

3. An interview with E#1 was conducted on 12/4/15 at approximately 1:00 PM. E#1 verbalized that the CAH only does routine maintenance checks on the electrical equipment.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Critical Access Hospital Sample Validation Survey conducted on December 1, 2015, the surveyors find 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 CMS Form 2567, dated December 1, 2015.

Based on document review, observation and staff interview, it was determined in 1 of 1 (Pt #3) patient clinical record reviewed, the Critical Access Hospital (CAH) failed to ensure there was a procedure to control the distribution, use and disposition of medications including schedule 1 medications. This has the potential to affect all patients and employees of the CAH.

Findings include:

1. The Pharmacist job description was reviewed 12/4/15 at approximately 11:00 AM. The job description required the pharmacist to participate in the medication use evaluation process, adverse drug reaction reporting, medication error reporting and quality assurance by collecting data, conducting inspections, maintaining logs and records and ensures all dispensed drugs are recorded and delivered appropriately.

2. The Pharmacy Director job description was reviewed on 12/4/15 at approximately 11:05 AM. The job description required the director to develop plans to achieve goals of the pharmacy, implement and ensure policies and procedures where adhered to and implements quality improvement for the department.

3. During an observational tour of the Pharmacy on 12/1/15 at approximately 12:45 PM, E#6 (Director of Pharmacy) provided a medication discrepancy report dated 11/19/15 to 11/24/15. E#6 was unable to explain the discrepancies or how they were resolved. E#6 stated "Pharmacy is not responsible to monitor discrepancies. That is the nurses responsibility... There are no alerts to me when a medication discrepancy is over ridden. I do run a report weekly to ensure they are all resolved but I don't know how they resolved it.... yes two nurses can resolve the discrepancy... The pharmacy tech (technician, E#7) cannot override a discrepancy of any kind..."

4. The clinical record of Pt #3 was reviewed on 12/2/15 at approximately 12:30 PM. Pt #3 was admitted to the emergency department on 11/19/15 for complaints gross hematuria and pain. The medication administration record (MAR) was compared to the medication discrepancy report. The MAR noted Pt #3 received Hydromorphone (schedule 1 drug) at 9:13 AM by E#8 RN (registered nurse). The medication discrepancy report noted the E#8 withdrew the Hydromorphone at 9:20 AM for another patient. The electronic health record displayed 2 patients with that name although the last visit dates were noted as 5/28/2006 and 5/18/2010.

5. The "AcuDose-Rx Discrepancy by Station" report dated 11/19/15 to 11/24/15 was reviewed on 12/2/15. The report noted the following discrepancies were resolved by E#7 (Pharmacy Technician) on 11/19/15:
a) outpatient chemotherapy unit- tbo-filgrastim 480 micrograms/0.8 milliliter syringe surplus of 1
b) psychiatric unit: folic acid 1 milligram (mg) tab deficiency of 1, ferrous sulfate 325 mg tab surplus of 1, calcium carb (carbonate)/vit (vitamin) d 250 mg/125 international unit tab deficiency of 2

6. During an interview on 12/3/15 at approximately 2:00 PM, E#1 (Administrative Director of Nursing) stated "I don't know how a non active patient can be pulled up in the system and charged for a medication they couldn't have received. Someone should have caught the mistake by now. The emergency department is the only department that medications can be dispensed without an order in the system. The ED does not use the bar code system." E#1 verbally confirmed there was not a policy specific to the ED about "over rides" and medication dispensing process without the bar code system. E#1 stated "I don't think we have control of our medications like we thought. I see now that we may not pick up on a diversion for along time." E#1 stated the Pharmacist should be monitoring the Pharmacy Technician's resolved discrepancies. E#1 stated "If they are just fixed and not investigated, we would never know if someone is stocking up on their own medications. It should be tracked by unit, person, date and medication name to identify trending for investigation. I agree that all narcotic discrepancies need to be immediately resolved and monitored but all medications discrepancies should have some type of oversight."

Based on document review and staff interview, it was determined the CAH (Critical Access Hospital) failed to ensure medication errors/reactions were identified. This has the potential to affect all patients who receive medications from the CAH.

Findings include:

1. The Pharmacy Director job description was reviewed on 12/4/15. The job description required the pharmacist to oversee adverse drug reactions.

2. The Performance Improvement & Patient Safety Plan (revised 12/14) was reviewed on 12/3/15. The plan required on page 5-6 "...identified the following organization-wide functions as most important to the delivery of patient care service and to patient outcomes. The activities chosen for monitoring and potential improvement... Pharmacy & Therapeutics/Medication Management includes medication errors)..."

3. During an interview on 12/1/15 at approximately 12:45 AM, E#6 (Director of Pharmacy) stated "I review any occurrence report that has been assigned to me for review. I wouldn't know about it if the staff member reporting the incident didn't put my name on it and send it to me."

4. During an interview on 12/3/15 at approximately 3:00 PM, E#1 (Administrative Director of Nursing) stated there are no high risk medications or indicator drugs identified to ensure adverse drug reactions are monitored by the Pharmacist and to assess the effectiveness of the CAH's internal reporting process of medication errors and Adverse Drug Reactions.

A. Based on document review, observation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure in 14 of 14 reprocessed endoscopes listed on the Endoscopic Sterilization Log as used for patient procedures, were properly cleaned after each use, potentially affecting all patients receiving care with the use of the endoscopes.

Findings include:
1. The CAH policy titled "Flexible Endoscopes Reprocessing" (effective date: 3/1/15) was reviewed on 12/4/15 at 8:45 AM. The policy required, "f...Rinse the flexible endoscope and flush the internal channels with 70% to 90% ethyl or isopropyl alcohol... g. Dry the flexible endoscope and the internal channels using low-pressure forced air."
2. A tour of the sterile processing room of the endoscopes was conducted on 12/03/15 at approximately 8:30 AM with the Lead Sterilization Technician (E#5) and the Administrative Director of Nursing (E#1). During the tour the "Endoscopic Sterilization Log" was reviewed. Between 11/3/15 and 12/1/15, fourteen out of fourteen reprocessed endoscopes, used for patient procedures, lacked documentation of the scope being flushed with alcohol and dried using low-pressure forced air.
3. On 12/3/15 at approximately 9:00 AM, an interview with E#5 was conducted. E#5 stated "The alcohol flush is only done after the last case of the day, but not after each sterilization and it doesn't get documented anywhere."
4. An interview was conducted with the Administrative Director of Nursing (E#1) on 12/4/15 at approximately 8:45 AM. E#1 had reviewed the the Endoscopic Sterilization Log during the tour and had reviewed the CAH policy. E#1 stated "We should have been flushing the endoscopes and drying them with air after each use and we weren't."


B. Based on document review and interview, it was determined for 6 out of 7 (R#1, R#2, R#4, R#5, R#6, and R#7) refrigerators, the Critical Access Hospital (CAH) failed to ensure outlying temperatures were monitored and followed up on in accordance with its policy. This has the potential to affect all patients serviced by the CAH.

Findings include:

1. The CAH policy titled "Refrigerator and Freezer Temperatures" (reviewed/revised 2/15) was reviewed on 12/2/15 at approximately 11:45 AM. The policy stated acceptable temperatures for refrigerators were 35 to 40 degrees Fahrenheit (F) and when the refrigerators do not meet the recommended temperatures the Nutritional/Environmental Services Manager or Building Services need to be contacted immediately.

2. The Kitchen refrigerator logs for October and November 2015 were reviewed on 12/1/15 at approximately 9:50 AM with the Dietary Director (E#10) and the Assistant Food and Nutrition (E#11). The logs stated the refrigerator temperature range was 32 degrees to 40 degrees F instead of 35 to 40 degrees F as per the CAH policy.
a. Six out of seven refrigerators lacked temperatures one day out of each month (October and November).
b. The following outlying temperatures lacked documentation of follow up in accordance with CAH policy for temperatures less than 35 degrees F.
R#1: October - 23 out of 30 days and November- 28 out of 29 days
R#2: October- 26 out of 30 days and November- 25 out of 29
R#4: October- 16 out of 30 and November- 28 out of 29 days
R#5: November- 24 out of 29 days
R#6: October- 18 out of 30 days and November- 22 out of 29 days
R#7: October- 17 out of 30 days and November- 23 out of 29 days

3. An interview was conducted with E#10 and E#11 on 12/1/15 at approximately 10:00 AM. Both were unaware the policy failed to match the logs and both also stated being unaware the outlying refrigerator temperatures had not been followed up on in accordance with the policy.


C. Based on document review and interview, it was determined for 2 of 2 (October, November 2015) months the Critical Access Hospital (CAH) failed to ensure outlying dishwasher temperatures were followed up on in accordance with its policy.

1. The CAH policy titled "Dish Machine Temperatures" (reviewed/revised 2/15) was reviewed on 12/2/15 at approximately 11:45 AM. The policy stated the acceptable temperature for hot water sanitation for the wash cycle was 160 degrees Fahrenheit (F) and temperatures that do not reach the acceptable temperature were to be conveyed to the Nutritional Services Manager or Building Services before any further use takes place.

2. The "Dishwasher Temperature Log" for October and November 2015 were reviewed on 12/2/15 at approximately 9:50 AM with the Dietary Director (E#10) and the Assistant Food and Nutrition (E#11). The following outlying temperatures lacked documentation of follow up in accordance with CAH policy when the dishwasher temperature was less than 160 degrees F:
Morning Wash: October- 7 out of 31 days and November- 11 out of 30 days
Noon Wash: October- 9 out of 31 days and November- 13 out of 30 days
Evening Wash: October- 15 out of 31 days and November- 12 out of 30 days

3. An interview was conducted with E#10 and E#11 on 12/1/15 at approximately 10:00 AM. Both stated being unaware the outlying dishwasher temperatures had not been followed up on in accordance with the policy.


D. Based on observation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure infection control measures were observed to prevent the potential for cross contamination. This has the potential to affect all patients serviced by the CAH.

Findings include:

1. On 12/2/15 at approximately 9:05 AM upon entry into the CAH with the Regulatory Compliance Officer (E#3), an Environmental Service personnel was observed entering the elevator with a cleaning cart with a stack of floor cones sitting on the top of the cart with a stack of cleaning cloths sitting next to and touching the floor cones. E#3 verbally agreed the floor cones should not be stored/transported on top of the cart touching the cleaning clothes.

2. A tour of the Emergency Department was conducted on 12/2/15 at approximately 1:30 PM with the Emergency Department Supervisor (E#9) and the Administrative Director of Nursing (E#1). Two blue large bags, one green large bag, one black large bag, and one red box was observed sitting on the floor in the alcove area at the ambulance entrance. E#9 stated these bags were stored in this area for the Disaster Incident Command plan and stated "Should they not be put there?" E#1 verbally agreed the bags should not be stored on the floor.



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Based on document review and staff interview, it was determined in 6 of 20 (Pts #1, #2, #5, #17, #11, and #12) patients, the Critical Access Hospital (CAH) failed to ensure medical records were accurate and complete.

Findings include:

1. The Medical Staff Bylaws/Rules and Regulations (amended 6/16/15) were reviewed on 12/4/15 at approximately 12:15 PM. The Bylaws (page 68) required the history and physical examination to be performed and documented by a Physician or other qualified licensed individual 24 hours after admission or registration. The Rules and Regulations (page 48) required all orders for treatment to be put in writing and verbal/telephone orders must be signed by the physician in good time and (page 51) required a hospitalized acute care patient should be seen every day by a qualified licensed individual.

2. The policy titled "Assessment of Patients" (effective 6/16/15) was reviewed on 12/4/15 at 12:35 PM. The policy required a full history and physical to be performed on all inpatients. The policy required a full history to include chief complaint, history of present illness, pertinent past medical and surgical history, family history, psycho-social history/needs, review of systems and a full physical to include an assessment of the head, ears, eyes, nose, throat, neck, heart, abdomen, extremities and other appropriate systems.

3. The clinical record for Pt #1 was reviewed on 12/2/15 at approximately 12:00 PM. Pt #1 was admitted with a diagnosis of Congestive Heart Failure on 11/30/15. The Emergency Department (ED) Assessment dated 11/30/15 at 1:11 PM stated "The H and P (History and Physical) that was done for the emergency room can be used as the H and P for the admission." The ED Assessment dated 11/30/15 at 8:09 AM failed to include a chief complaint, pertinent past medical and surgical history, family history, psycho-social history/needs, review of systems and a full physical to include an assessment of the head, ears, eyes, nose, throat, neck, heart, abdomen, extremities and other appropriate systems. The record failed to include any other ED documentation by the Physician or other qualified licensed individual.

During an interview on 12/3/15 at approximately 1:00 PM, E#1 (Administrative Director of Nursing) verbally agreed the ED Assessment dated 11/30/15 at 8:09 AM was the document which was referred to as the H and P and did not include all the required components.

4. The clinical record for Pt #2 was reviewed on 12/3/15 at approximately 1:00 PM. Pt #2 was admitted on 11/30/15 with a diagnosis of Pneumonia and discharged on 11/3/15. The discharge instructions stated "azithromycin 500 mg (milligram) oral tablet 1 tab(s) orally once a day". The instructions failed to include a duration or discontinue date for azithromycin.

5. The clinical record for Pt #5 was reviewed on 12/3/15 at approximately 2:00 PM. Pt #5 was admitted on 11/6/15 with a diagnosis of Metastatic Breast Cancer. The ED Assessment dated 11/6/15 at 8:29 PM was electronically signed by the physician on 11/27/15 although the assessment included blanks such as "Review of Systems: All other symptoms *****, except... The patient will not be give **** yet." The ED Nursing flowsheet dated 11/6/15 at 3:35 PM stated "Time patient in bed: 15:35... Time O2 (oxygen) Initiated: 15:35... Time Patient Left ED: ... 15:35... Hand Off...15:35... Date/Time to Surgery 15:35..." The record noted Pt #5 was admitted to the nursing units from the ED at 10:29 PM and Pt #5 did not have any surgical procedures. The record noted multiple orders with an entry date and completion date of 11/6/15 for Sodium Chloride 0.9% intravenous (IV) infusion and nursing documentation on 11/6/15 at 7:34 PM that notes the IV bolus and rate change was completed. The record lacked documentation that an IV was inserted or what type of IV access was utilized for the infusion. Pt #5 had an order dated 11/6/15 for daily weights. The record lacked documentation of daily weights.

During an interview on 12/3/15 at approximately 2:30 PM, E#1 verbally explained and demonstrated that when the nurse is documenting in the electronic medical record, an autofill date and time function can be utilized to insert the date and time to any documentation field which requires a date and time. E#1 stated the entries are incorrect and do not reflect accurate times of Pt #5's timeline of interventions. E#1 verbally agreed daily weights were ordered although the record lacked documentation of any weights and should have.

6. The clinical record of Pt #17 was reviewed on 12/1/15 at approximately 11:00 AM. Pt #17 was admitted on 11/25/15 with a diagnosis of Suicidal Ideation. A progress note dated 11/27/15 noted to consult a hospitalist for an evaluation of ears. A contact note authored by a Registered Nurse dated 11/27/15 at 11:10 AM noted a medical consult for right ear pain/cerumen impaction was called and orders received. The clinical record lacked documentation that Pt #17 was evaluated by the hosptalist. An assessment and intervention note authored by the supervisor dated 11/27/15 at 2:48 PM noted "...Bilateral ears irrigated with H20 (water) at this time per physician order..." The clinical record lacked an order for irrigating the ears.

During an interview on 12/1/15 at approximately 3:00 PM, E#1 stated "It appears the hospitalist did not assess the patient. Orders were received when the consult was made." E#1 verbally agreed the clinical record lacked an order for bilateral ear irrigation.

7. On 12/3/15, the following observations/interviews were conducted for Pt #11's providers:
a. Pt #11 was observed sitting in the pre-operative area, gowned with abrasion over left forehead, and left ankle was elevated with an ice pack on it. An interview was conducted in the pre-operative area with the Certified Registered Nurse Anesthetist (CRNA#1) on 12/3/15 at approximately 8:20 AM with the Administrator/Director of Nursing (E#1) present. CRNA#1 stated Pt #11 presented for an elective Esophagogastroduodenoscopy this morning and stated had sustained a fall this morning and "got kinda banged up" and had a swollen ankle which an ice pack had been applied to. CRNA#1 stated having just conducted a pre-anesthesia evaluation to determine any obvious causes for the fall, stated the surgery "will probably be canceled" and has instructed pre-operative staff to not start intravenous line or proceed with any further surgical preparation until the surgeon (Medical Doctor- MD#7) arrives to assess Pt #11 and determines whether the surgery would be canceled.
b. An interview was conducted in the pre-operative area with MD#7 on 12/3/15 at approximately 8:45 AM with E#1 present. MD#7 stated after assessing Pt #11, the surgery was canceled and felt Pt #11 needed to be evaluated for any other causes of the fall and any other injuries that may have occurred.

Pt #11's record was reviewed on 12/4/15 at approximately 8:30 AM. Pt #11 was admitted to the CAH on 12/3/15 for an Elective EGD. The following discrepancies were identified:
a. Pt #11's record lacked documentation of CRNA#1 and MD#7's assessments.
b. The record stated "Summary Statement MD (Medical Doctor) has decided to postpone this procedure..." and that Pt #11 was taken to the Emergency Department by the surgery nurse. The record further stated "Discharge To Home Status Stable... Discharge instructions: Exit Care" (for the EGD) and was dated as entered 12/2/15 at 10:21 AM, the day prior to Pt #11's arrival and Pt #11 did not go home and did not have the EGD.
c. Pt #11's record lacked an order to cancel the procedure.

An interview was conducted with the Administrative Director of Nursing (E#1) on 12/4/15 at approximately 8:45 AM. E#1 was present during the observations and interviews and had reviewed Pt #11's record. E#1 stated there was no CRNA or MD documentation on the record and there should be; the surgery nurse "must have charted the day before in preparation of Pt #11's procedure and shouldn't have"; and there was no cancellation order written for the procedure and there should have been.

8. Pt #12's record was reviewed on 12/3/15. Pt #12 presented to the outpatient Express Clinic on 11/30/15 with the Chief Complaint of Rash with Fever for two days. Pt #12's record stated the presence of an Advance Directive. Pt #12 was less than three years of age.

An interview was conducted with E#1 on 12/4/15 at approximately 8:45 AM. E#1 reviewed Pt #12's record and verbally agreed "This area shouldn't apply to any patient less than 18 years of age" and would not be assessed. E#1 stated "I'm not sure why this (documentation of the presence of an Advance Directive) is here but it shouldn't be."




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