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Based on staff interview and review of the most current water agreement, the Critical Access Hospital (CAH) failed to develop a plan to ensure adequate water availability in the event of an emergency. This had the potential to affect all patients and staff of the CAH.

Findings include: During review of the CAH's emergency policies, it was noted the agreement in place for water delivery in the case of an interruption in the normal water supply, was with the City of Montevideo, dated 2/20/79 along with the CAH's Dialysis Unit dated 11/30/1997. (Note: at this time the CAH's Dialysis Unit is now under the ownership of an independent provider.) Neither contract identified the specific amount of potable/non-potable water that would be provided, nor was there a determination of the estimated amount required for use by CAH's individual departments.

During interview with the Director of Maintenance at 3:30 p.m. on 9/6/11, he confirmed the policy did not identify amounts needed for potable/non-potable water. He also stated there was no other contract or plan in place for emergency water access.

Based on observation, staff interview, and policy review, the Critical Access Hospital (CAH) failed to ensure that all drugs and biologicals were secure in 2 of 4 clinics. Findings include:

On 9/7/11, at 3:05 p.m. medications were observed to be stored in an unlocked cupboard in the main clinic's procedure rooms #1 and #4. Medications found in the cupboard in procedure room #1 included: Verucca Freeze, Ethyl Chloride, Benzoin Compound, Drysol (aluminum chloride w/anhydrous ethyl alcohol), Lydocaine jelly urojet, Bupivicaine, 1% Silver Sulfadizine Cream, Xylocaine, Xylocaine MPF 1%, and Lydocaine. Medications found in the cupboard in procedure room #4 included: FeSo4 (an iron preparation) for injection, Iodine, Benzoin Compound, Ethyl Chloride Mist Spray, Phenyl Liquified, Bupivicaine, Xylocaine and Lidocaine. In addition, exam rooms C11and C12, in the main clinic, Benzoin Compound was located in a small basket on the desk.

The main clinic's lead LPN (licensed practical nurse) was interviewed at 3:35 p.m. on 9/7/11. She stated the procedure room cupboards are unlocked each day at the beginning of the shift and remained unlocked until the end of the day. The LPN stated they left the cupboards unlocked to provide physician's with more immediate access to the medications.

During the tour of the off site clinic in Clara City at 9:05 a.m. on 9/8/11, biologicals were observed to be stored in an unlocked refrigerator in the unlocked lab draw room. It was learned during interview with the clinic staff, that cleaning staff enter the clinic after hours and could have access to the refrigerated medications. The medications in the refrigerator included: Adacel Vaccine; Gardasil Vaccine; Hepatitis A Vaccine (pediatric and adult doses); Hepatitis B Vaccine (pediatric and adult doses); Daptacel Vaccine; Inactivated Polio Vaccine; Meningococcal Vaccine; MMR Vaccine; Pentacil Vaccine; Pneumovax Vaccine; Prevnar Vaccine; Proquad Vaccine; Rotateq Vaccine; Tetanus/Diphtheria Vaccine (pediatric and adult doses); Varicella Vaccine; and Zostavax.

During interview with the pharmacist on 9/8/11 at 10:35 a.m., the pharmacist confirmed that medications in the clinic sites should be stored securely, including locking the refrigerator and cupboard doors containing medications when staff were not present.

Based on staff interview and policy review, the Critical Access Hospital (CAH) failed to obtain medical staff approval of the current Therapeutic Diet Manual. This had the potential to affect all patients in the CAH.

Findings include: In an interview with the registered dietician at 3:45 p.m. on 9/7/11, she stated she was unable to provide any documentation which would show the medical staff had approved the CAH's current use of the Florida Therapeutic Diet Manual dated 2007.

During an interview with the CAH's dietary manager at 3:15 p.m. on 9/8/11, she confirmed they were unable to provide the necessary documentation which would show the medical staff had given approval for the use the Florida Therapeutic Diet Manual. She acknowledged that she was aware of the need for medical staff approval of the Diet Manual.

Based on interview and record review the Critical Access Hospital (CAH) failed to ensure that the governing body received reports evaluating provision of care for services provided by arrangement or agreement. This had the potential to affect all patients receiving services from the hospital.

The findings include: The CAH failed to ensure that all services affecting patient care were evaluated with findings reported to the governing body.

The Quality Assurance (QA) manager was interviewed at 3:45 p.m. on 9/8/11. She confirmed that the services for organ procurement had not been evaluated as part of the hospital's quality assurance program. The CAH did have data provided to them from Life Source, (organ and tissue donation organization) however, they did not identify quality and performance problems, implement appropriate corrective or improvement activities, or have a system in place to ensure the monitoring and sustainability of those corrective or improvement activities.

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to ensure that each medical entry had been properly authenticated with a timed and dated signature for 8 of 20 inpatient records reviewed (P1, P2, P3, P7, P8, P9, P11 and P12).

Findings include: Eight of twenty inpatient records lacked proper authentication of entries by the physician for orders and or reports.

P11 had been admitted to the facility 8/13/11. The operative report was not dated/timed by the physician. In addition, not all orders were timed and dated by the physician's signature.

P12 had been admitted to the facility 6/21/11. Not all physician orders were authenticated by the physician with date and time.



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P7 had been admitted 7/14/11. Not all physician orders were authenticated with date and time of the physician's signature.

P8 had been admitted 4/14/11. Telephone and Verbal physician orders in the record had been co-signed by the physician, but were not authenticated with date and time of the physician's signature.

P9 had been admitted 7/1/11. Not all physician orders were authenticated with date and time of the physician's signature.


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P1 was admitted to the facility on 8/28/11 with a diagnosis of small bowel obstruction. The admission orders lacked a date and time the physician had written them. In addition the physician orders dated 8/29, 8/30, 9/3, and 9/4/11 lacked the time the orders were written.

P2 was admitted to the facility on 9/3/11 with a diagnosis of Clostridium-Difficle. The "Inpatient Home Medication Reconciliation Form" dated 9/3/11, lacked the time the physician had signed it. A physician order, signed as reviewed by a RN on 9/7/11, lacked the date and time the physician had written the order.

P3 was admitted to the facility on 9/6/11 due to weakness and falls. The "Inpatient Home Medication Reconciliation Form" and "Admission Order" form dated 9/6/11 lacked the time the physician had signed it. Two physician orders, signed as reviewed by a RN on 9/6 & 9/7/11, lacked the date and time the physician had written the orders.

The director of nursing indicated during interview at 9:40 a.m. on 9/8/11, that all physician orders were expected to be dated and timed when written.

The facility's "Telephone,Verbal and Written Orders" policy last reviewed 9/11, indicated: "All orders for medications shall include the date and time of the order."

Based upon interview and review of manufacturer's recommendations, the Critical Access Hospital (CAH) was found not to be in compliance with the Condition of Participation of Surgical Services 485.639. The CAH did not ensure proper sanitation of surgical instruments for outpatients who underwent cataract extraction with an intraocular lens implants. This deficient practice had the potential to affect all patients who undergo this surgical procedure at the CAH. Findings include:

The CAH failed to ensure that proper sterilization of surgical equipment occurred for outpatients undergoing cataract extraction with a lens implant. Between January 2011 and the time of survey the facility had performed 91 cataract surgeries.

During an interview with licensed practical nurse (LPN)-A and surgical technician (ST)-A at 11:50 a.m. on 9/8/11, it was revealed that there were two ophthalmologists who performed cataract surgeries at the CAH each month. LPN-A indicated that each of the physicians was accompanied by a surgical technician from Sightpath (a medical supply provider of intraocular surgical equipment). ST-A stated the Sightpath ST would bring two wrapped trays of surgical instruments to use for the day of the surgery. Between surgical cases the ST from Sightpath would wash the instruments and either LPN-A or ST-A would place the unwrapped instruments on a tray and flash sterilize them at 270 degrees for ten minutes, and would then dry them for one minute. According to ST-A the unwrapped tray would then be carried out of the processing room, thru the storage room and handed to the Sightpath ST in the surgical suite. LPN-A stated one of the ophthalmologists had done up to 21 outpatient cataract surgeries in one day and the instruments had been (flash) sterilized between patients. ST-A stated the trays provided by the Sightpath ST were not put through a long or terminal sterilization cycle prior to starting the first case or after completion of the last case.

The CAH's Surgical Service Director (SSD) was interviewed at 12:40 p.m. on 9/8/11, and verified the two microsurgical trays that were brought into the surgical suite by the Sightpath ST were sterilized between cataract cases via the flash sterilization method. The SSD verified she was unsure which instruments were on the trays, therefore she did not know the manufacturer's recommendations for sterilizing them. In addition, the SSD further indicated she could not verify whether the instruments had ever gone through a long sterilization or terminal cleaning prior to being brought into the CAH by the Sightpath ST.

At 1:20 p.m. on 9/8/11, a Sightpath ST was interviewed via telephone. He indicated that it was the CAH's preference to do flash sterilization of the cataract trays. When was asked when the instruments were taken through a full cycle of sterilization or terminal cleaning, the Sightpath ST stated it depended on how the other hospitals they worked with wanted things done, however he stated a long cycle was done "most the time." He verified that he did not sterilize the instruments via the long cycle at the Montevideo CAH prior to the first case of the day.

At 1:45 p.m. on 9/8/11, ST-A stated that he had reviewed the manufacturer's recommendations for the sterilizer used by the CAH. ST-A indicated the recommendation was that when instruments are sterilized via the flash method, the items should be wrapped. ST-A also verified he did not know the manufacturer's recommendation for sterilizing the specific instruments used during the cataract surgeries.

The CAH staff provided a copy of Table 5, page 462 of the "Preoperative Standards and Recommendation Practices" book as their policy for flash sterilization. Table 5 indicated that flash steam sterilization could be used at 270 - 275 degrees for ten minutes with a dry time of zero to one minute. However, the recommendations included that items should be wrapped in a single ply wrapper to help contain the item to the point of use and manufacturer instructions should be consulted.

Based on review of facility policies, quality assurance documentation, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure periodic evaluation and Quality review of their services. The cumulative effect of these systemic problems resulted in the Critical Access Hospital's inability to maintain effective quality assurance processes in order to ensure provision of quality health care. Therefore, the CAH was unable to meet this condition of participation. These deficient practices have the potential to impact all patients receiving services from the CAH. The findings include:

The CAH failed to conduct an annual evaluation of the its total program (Refer to C331).

The CAH failed to evaluate the utilization of services, including at least the number of patients and the volume of services (Refer to C332).

The CAH failed to evaluate their health care policies as a component of an overall CAH annual review (Refer to C334).

The CAH failed to evaluate the appropriateness of services provided to patients (Refer to C335).

The CAH failed to evaluate all patient care services (Refer to C337).

Based on review of policy and governing board meeting minutes, and on staff interview, the Critical Access Hospital (CAH) failed to conduct an annual evaluation of its total program at least once a year. This had the potential to impact all patients receiving services from the CAH.

Findings include: Documentation was lacking to indicate an annual review of the CAH's total program had been conducted since November 2006. Review of the governing board minutes for the past 2 years was conducted. It was noted there was NO mention of an annual review of the CAH's total program documented in the minutes.

Interview was conducted with the Administrator on 9/8/11 at 4:00 p.m. regarding the facility process for the annual CAH evaluation. He verified the last annual evaluation and policy review meeting had occurred in November 2006.

Based on review of governing board minutes and staff interview, the Critical Access Hospital (CAH) failed to conduct an evaluation at least once a year that included a review of the utilization of CAH services with respect to numbers of patients and the scope of CAH services provided. This had the potential to impact all patients receiving services at the CAH.

Findings include: The CAH failed to conduct an annual evaluation of its total program which included a review of the utilization of CAH services.

Documentation was lacking in the governing body board minutes, or in any of the quality assurance documents/minutes, to indicate an annual review of the CAH's total program had been conducted, including a review of utilization of services since November 2006.

Interview with the Administrator at 4:00 p.m. on 9/8/11, confirmed the CAH had not conducted an annual evaluation of its total program for several years, thus, no review of the utilization of CAH services was available to surveyors for review.

Based on review of meeting minutes documentation, and staff interview, the Critical Access Hospital (CAH) had not determined the appropriateness of the services offered including evaluation of health care policies. This had the potential to affect all patients receiving services at the CAH.

Findings include: Documentation was lacking to indicate an overall program evaluation had been conducted to include: whether health care policies were followed and/or whether any revisions to the health care policies were needed.

Documentation was lacking in the governing body board minutes, or in any of the quality assurance documents/minutes, to indicate an annual review of the CAH's total program had been conducted, including a review of health care policies since November 2006.

Interview with the Administrator at 4:00 p.m. on 9/8/11, confirmed the CAH had not conducted an annual evaluation of its total program for several years.

Based on review of meeting minutes documentation, and staff interview, the Critical Access Hospital (CAH) had not determined the appropriateness of the services offered including evaluation of policy implementation and/or if any changes were required. This had the potential to affect all patients receiving services at the CAH.

Findings include: Documentation was lacking to indicate an evaluation had been conducted to determine whether the utilization of services was appropriate, whether policies were followed & whether any changes were needed.

Although the CAH had discussed utilization of services at Quality Assurance meetings in January 2010 and August 2011, there had been no annual review of the CAH's total program conducted, including a review of appropriateness of utilization of services and appropriateness of policies.

Interview with the Administrator at 4:00 p.m. on 9/8/11, confirmed the CAH had not conducted an annual evaluation of its total program since November 2006.

Based on record review and interview the facility failed to evaluate organ procurement services and swing bed services as a component of their quality assurance program. This had the potential to affect all residents who receive these services. Findings include:

The Director of Nursing was interviewed at 9:30 a.m. on 9/8/11, she verified that the facility's swing bed services did not have a formal evaluation and quality assurance project.
The facility's Quality Assurance (QA) manager was interviewed at 2:25 p.m. on 9/8/11, and verifed that the swing bed services were not part of the facility's quality assurance activities.

The QA manager was interviewed again at 3:45 p.m. on 9/8/11. She confirmed that the services for organ procurement had not been evaluated as part of the hospital's quality assurance program. The CAH did have data provided to them from Life Source, (organ and tissue donation organization) however, they did not identify quality and performance problems, implement appropriate corrective or improvement activities, or have a system in place to ensure the monitoring and sustainability of those corrective or improvement activities.