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Based on interview and policy review, the critical access hospital (CAH) failed to implement its policy and procedure for reporting changes in the medical director to the State agency. Findings include:

The CAH's policy on notification to the Minnesota Department of Health dated 5/24/02, identified the chief executive officer (CEO) was responsible to report to the State agency whenever there were: changes in ownership; the person responsible for operations was changed; address was changed, and when the person responsible for medical direction was changed.

The CEO verified during interview on 8/18/10, at 3:15 p.m., the current medical director was newly appointed in 2007. The CEO was unable to locate documentation of the notification to the required State agency at the time of the change and verified the change had not been reported.

Based on policy review, staff interview, and record review, the CAH failed to ensure outpatient records were periodically reviewed by a physician for 2 of 2 emergency room patients (P13, P16) receiving services by physician assistants (PA-A, PA-B). Findings include:

P13's and P16's emergency room records indicated a physician had not reviewed the outpatient services provided by the PA as directed by the CAH's own policy.


The Medical Staff Bylaws revised 5/02, regarding physician assistants indicated, "All medical entries must be countersigned by the attending physician." In addition, the bylaws further indicated, "...orders must be countersigned by the physician within twenty-four hours."


P13 was seen in the emergency room on 8/09/10, and discharged on 8/10/10. Review of the record revealed PA-A wrote an Emergency Room Note dated 8/9/10, and gave a verbal order to give Toradol 60 mg IM (intramuscularly) for right shoulder pain. However, a physician had not reviewed or signed this record.

P16 was seen in the emergency room on 7/16/10, by PA-B for cellulitis. Review of the record revealed PA-B wrote a prescription for Bactrim DS twice a day for 5 days and Rocephin one gm IM (antibiotic medications). However, a physician had not reviewed or signed the record.

Interview with Hospital Patient Care Service Line Leader at 9:00 a.m. on 8/19/10, indicated services provided or orders written by the PAs in the emergency room were not periodically reviewed by a physician.

Based on observation, staff interview, manufacturer instructions for the use of a germicidal, and policy review, the Critical Access Hospital (CAH) failed to maintain an adequate system to identify and implement appropriate interventions to prevent the spread of infection for 1 of 1 patient (P14) who received blood glucose testing by the use of a glucometer. Findings include:

The CAH failed to ensure adequate disinfection of a glucometer used for multiple patients.

On 8/16/10, at 10:55 a.m. phlebotomist (LAB-A) was observed to take the multiple patient use glucometer to P14's room and precede to do a blood sugar check. She did not wash the glucometer before she began. LAB-A donned gloves, and stuck the patient's finger with the lancet. She completed a blood glucose test using the glucometer. Following this, LAB-A was observed to put the used glucometer back in its box and take the box back to the laboratory. She then removed the glucometer from the storage box and wiped it down with a "Sani Cloth Plus." This was completed in less than 15 seconds. The glucometer was dry by 30 seconds. She returned it to the storage box in less than 30 seconds. The glucometer was not in contact with the "Sani Cloth Plus" for the required 2 minutes.

Review of the "Sani Cloths Plus" instructions, undated, indicated the cloth had to have a contact time of two minutes be effective as a germicidal.

The policy for blood glucose testing dated 3/20/10, indicated: "Any visible blood will be washed with soap and water.. the glucometer will then be wiped down with the approved sani-cloths between each patient use." There was no other information on how to use the product or to clean the glucometer by the CAH staff.

Interview at 11:40 a.m. on 8/16/10, with the infection control coordinator indicated that she expected staff to wipe down the glucometer after each use with the "Sani Cloths Plus" wipes. She confirmed she had not considered the instructions of the germicidal, which indicated the wipes had to have a contact time of two minutes be effective.

Based on record review, policy review, and interview, the CAH (Critical Access Hospital) failed to ensure all entries made in the medical record were timed, dated, and authenticated for of 6 of 20 patients (P6, P7, P13, P15, P10, P11) reviewed receiving services at the CAH. Findings include:


P6 was admitted to the CAH on 8/2/10, and 8/3/10, with acute appendicitis. On 8/2/10, and 8/3/10, the physician orders lacked dated, timed and authenticated signatures from the physician. The admission, laboratory and discharge orders on 8/2/10 and 8/3/10, lacked authentication from the physician.

On 8/19/10, at 9:25 a.m. the HIM manager verified the orders were not signed by the physician.

P7 was admitted to the CAH on 5/27/10, with abdominal pain. The consultation report dated 5/27/10, lacked an authenticated signature from the physician.

P13 received services in the emergency room at the CAH on 8/09/10, for right shoulder pain. The verbal order for a pain medication dated 8/9/10, from the physician assistant lacked a signature and time.

On 8/19/10, at 12:25 p.m. the DON verified the findings.


P15's Pitocin Induction/Augmentation Orders standing orders from the physician dated 8/14/10, did not identify the time of the orders.

On 8/19/10, at 12:25 p.m. the DON verified the findings. She confirmed orders should include a time.

The CAH policy "Verbal Orders" dated 6/2005, identified all verbal orders must be signed by the ordering practitioner within 24 hours or as soon as physically possible.



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P10 was admitted 12/14/10, and discharged 12/21/10, with diagnoses of congestive heart failure and pneumonia. The electronic clinical record did not identify and display completion of signatures of the ordering physician for all verbal orders (13 orders) received/recorded during the stay.

P11 was admitted 3/25/10, and discharged 4/3/10, with diagnoses of pneumonia. The electronic clinical record did not identify and display completion of signatures of the ordering physician for 35 of 53 verbal orders received/recorded during the stay.

On 8/19/10, at 9:25 a.m. the Health Information (HIM) manager verified the orders were not electronically signed by the physician and the electronic record system used had apparently failed to consistently document that information.

On 8/19/10, at 12:25 p.m. the Hospital Care Service Line director/DON also verified the findings.

Based on interview and record review, the facility failed to ensure an effective quality assurance (QA) program to evaluate the quality and appropriateness of all treatment services and outcomes furnished in the CAH hospital was completed for 2 of 2 contracted providers providing services (radiology) at the CAH. Findings include:

The contract services utilized to provide selected diagnostic radiology procedures were not included in the facility quality assurance program.

The quality assurance director verified during interview on 8/17/10, at 1:30 p.m. the contract providers for imaging and ultrasound services were involved in the quality assurance program, "only if there was a problem." The director added the contracted provider did not regularly provide or analyze data, identify any areas that may be improved by corrective action or have measures to improve quality on a continuous basis.

The diagnostic manager responsible to direct the radiology and laboratory services at the CAH hospital verified on 8/18/10, at 4:15 p.m. there were two providers that supplied the nuclear medicine, mammography, magnetic imagining, and diagnostic ultrasound equipment and services. The department manager also reported the actual procedures were performed by a combination of facility staff and provider staff. The manager added the providers performed the required monitoring, testing and reporting of proper functioning of the equipment furnished; however, "were not involved in the QA process." The manager added, "That is something we should look at doing."

The CEO reported during an interview on 8/18/10, at 3:15 p.m., it was her expectation and understanding the contract providers in radiology were currently involved in the hospital QA process.