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Based on medical staff bylaws, interview and credentialing file review, the CAH failed to monitor compliance with policies of the governing body to ensure 4 of 4 physicians (R1, R2, R3 and R4) had completed the appointment process. Findings include:


R1, R2, R3, and R4 were employed by the CAH as radiologists; however, the CAH failed to complete credentialing on the radiologists according to the medical staff bylaws.

R1's hire date was 11/11/09. R1's credentialing file lacked an application for employment including privileges requested.

R2's hire date was 11/11/09. R2's credentialing file lacked an application for employment including privileges requested.

R3's hire date was 11/11/09. R3's credentialing file lacked an application for employment including privileges requested.

R4's hire date was 11/11/09. R4's credentialing file lacked an application for employment including privileges requested.

On 9/28/10, at 9:40 a.m. the human resources manager verified the CAH had not completed the full credentialing process for the radiologists. She stated the CAH had verified current licensure and education history because the company they had contracted the radiologists with, had provided them with the information. She stated they had never credentialed radiologists prior to this.


The contract for the radiologists dated 11/16/09, indicated: "further credentialing requirements as stipulated per client facility bylaws are the responsibility of the client."

The medical staff bylaws dated 3/8/10, indicated: "no applicant shall be entitled to membership on the medical staff or the exercise of particular clinical privileges in the hospital merely by virtual of the fact that the person is duly licensed." The bylaws indicated the appointment process would begin once a complete application and credentials from the person(s) seeking appointment was complete.

Based on interview and policy review, the CAH failed to ensure adequate pharmaceutical services for the development and oversight of policies and procedures for the administration of drugs and biologicals. Findings include:


The CAH lacked adequate oversight, by the contracted pharmacists, of policies and procedures related to the administration of drugs and biologicals and lacked policies related to adverse drug reactions.


The CAH did not have a pharmacy and utilized a formulary of stock medications with supplies maintained by the director of nursing. Two contracted pharmacists provided pharmaceutical services and were available for consultation by phone. The CAH utilized a pharmacy policy book that included the "Pharmaceutical Services Policy and Procedure Manual" table of contents from the "Medical Consultants Network Inc." However, only 5 printed policies were located in the pharmacy policy book. Also included with the policies was the job description of the pharmacist and an undated statement that identified the medical staff represented pharmacy and therapeutics within the CAH.


The CAH's printed pharmacy policies were as follows:
1. Emergency Room After Hours Dispensing Policy
2. Pharmaceutical Procedures-a 3 page policy that included:
- Individual Patient Care Plan
- Methods and Procedures for the Ordering of Drugs
- Methods and Procedures for the Administration of Drugs
- Methods and Procedures for the Disposal of Drugs
3. Valid Medication Orders
4. Calculation of Medication Dosages IV Route
5. IV Admixture Preparation

However, the CAH lacked policies and procedures to minimize drug errors that would include:
-high alert medications
-alert systems for look-alike and sound alike drugs names
-definitions of, and alert systems for adverse drug events and near miss medication errors
-systems for proactive identification of medication errors and adverse drug reactions


On 9/28/10, at 10:05 a.m., the director of nursing reported the CAH staff had identified only 1 medication error over the last year.


During interview on 9/29/10, at 9:45 a.m., the contracted pharmacist stated he would spend about 4-5 hours at the CAH quarterly to review a sampling of 6-8 patient records from the prior quarter. He added he would also spend about an hour monthly and check in with the director of nursing at the CAH after completing the monthly drug regimen reviews at the attached nursing home. He stated he attended the monthly medical staff meetings which functioned as the CAH's pharmacy & therapeutics committee. He verified the monthly staff meetings included review of the nursing home pharmaceutical services and medication errors. He stated the CAH had the current printed policies in place when he had started employment at the CAH. He verified he had not reviewed all the policies in the table of contents from the "Medical Consultants Network Inc." He indicated the CAH's pharmaceutical policies were "a lot less in depth" than usual and that he had not had a lot of input in them. He also stated he was unaware of any pharmacy activity related to quality assurance (QA) in the CAH although he participated in the nursing home QA.

The "Addendum to Pharmacy Consultant Contract" dated 12/05, directed the pharmacist duties would include:

-Assist as needed the hospital's Director of of Nursing Service in developing policies related to the storage of drugs and biological, and record keeping.
-Annually review of the policies and procedures related to the storage, record keeping, and administration of drugs and biologicals.
-Advise the Director of Nursing Service on methods/areas to measure for Quality Assurance.
-Make recommendations regarding what resource books or other information that should be made available to the medical and nursing staff.

On 9/29/10, at 11:00 a.m., the director of nursing verified the CAH had only a few particular policies pulled out from the "Medical Consultants Network Inc." She indicated there was not a system to proactively identify near miss medication errors and potential adverse drug reactions.

On 9/30/10, at 8:15 a.m., the director of nursing stated she was not sure "what all" was in the "Pharmaceutical Services Policy and Procedure Manual" from the table of contents listing provided by the "Medical Consultants Network Inc."

Based on interview and record review, the CAH failed to ensure each patient's individualized plan of treatment had been established by the physician ordering the service for 1 of 3 outpatients (P23) reviewed receiving therapy services. Findings include:

P23 lacked documentation of physician orders for the occupational therapy services provided.


P23 had been admitted to the CAH for outpatient occupational therapy (OT) services on 7/23/10. P23 had been referred to the CAH following an initial occupational therapy evaluation at another hospital on 7/14/10, by the occupational therapist. The OT therapy treatment notes indicated the patient had received OT services three times weekly from 7/23/10-9/8/10. However, the medical record lacked documentation of a physician establishing the treatment plan.

On 9/29/10, at 9:20 a.m., the OT director of the rehab department verified these findings. She indicated she was not aware physician orders were needed for treatment if the patient was not receiving Medicare funding.

On 9/29/10, at 9:25 a.m. the director of nursing stated the rehab department does not report to her although she had identified she was the individual responsible for outpatient services.

Based on record review and interview, the CAH failed to ensure a discharge summary was completed for all inpatients following discharge to Swing Bed admission for 1 of 1 inpatient (P18) reviewed who had been discharged to Swing Bed status. Findings include:

P18 was admitted to the CAH on 6/8/10, for treatment of congestive heart failure and significant dependent edema. P18 was discharged to Swing Bed status on 6/13/10. However, the inpatient record lacked a discharge summary.

On 9/29/10, at 3:05 p.m., the director of nursing verified this findings. She added that patient medical records are separated by inpatient and Swing Bed status.

Based on record review and interview, the CAH failed to ensure all entries in the medical record were timed, dated and authenticated for 15 of 20 inpatients (P5, P6, P19, P4, P14, P16, P20, P21, P24, P8, P9, P11, P12, P15, P18) and 2 of 3 (P22, P23) outpatients reviewed receiving services at the CAH. Findings include:

P5 was admitted to the CAH with a UTI (urinary tract infection) on 7/25/10. The 7/25/10, progress note lacked a date and time of the physician signature.


P6 was admitted to the CAH with pneumonia on 7/20/10. The 7/23/10, discharge summary lacked a date and time of the physician signature.


P19 was admitted to the CAH with renal failure on 10/20/09. The verbal/telephone orders for medications, treatments and discharge dated 10/20/09, 10/21/09, and 10/26/09, lacked a date and time of the physician signature.


P4 was admitted to the CAH with pneumonia on 8/26/10. The 8/26/10, history and physical lacked a date and time of the physician signature.


P14 was admitted to the CAH with CHF (congestive heart failure) on 1/29/10. The 2/1/10, history and physical and the 2/4/10, discharge summary lacked a date and time of the physician signature. In addition, the telephone orders for medication on 1/31/10, 2/1/10, 2/3/10, and 2/4/10, lacked a date and time of the physician signature as well as the consent for blood transfusion. The undated physician assessment and certification related to transferring P14 to another facility lacked a signature, date and time of when the consent was obtained. The patient consent to transfer dated 2/4/10, obtained by the RN lacked a time when the consent was obtained.

P16 was admitted to the CAH with a MI (heart attack) on 6/1/10. The 6/1/10, history and physical, lacked a date and time of the physician assistants signature.


On 9/29/10, at 12:00 p.m. the DON verified all entries in the clinical record required a signature and a date and time of the signature.



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P20 was admitted to the CAH with a Gastrointestinal bleed on 2/25/10. The progress notes dated 2/25/10, 2/28/10, and 3/1/10, lacked the time the entries were made in the medical record.

P21 was admitted to the CAH with a Gastrointestinal bleed on 9/28/10. The admission orders dated 9/28/10, and progress notes dated 9/28/10, and 9/29/10, lacked the time the entries were made in the medical record.


P24 was admitted to the CAH with Congestive Heart Failure on 9/24/10. Physicians orders dated 9/24/10, 9/25/10, and 9/26/10, and physician progress notes dated 9/24/10, 9/25/10, and 9/27/10, lacked the time the entries were made in the medical record.




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P8 was admitted to the CAH on 6/6/10. The physician's signatures of the admission history and physical dated 6/6/10, the Acute MI/Ischemic Type Chest Pain Orders protocol, and the discharge summary dated 6/7/10, had not been timed or dated.

P9 was admitted to the CAH on 5/17/10, on observation status. P9 was admitted as an inpatient on 5/18/10. The physician's signatures of the admission history and physical dictated 5/17/10, and the progress note dated 5/17/10, had not been timed and/or dated.

P11 was admitted to the CAH on 5/1/10. The physician's signatures on the telephone orders dated 5/2/10 and 5/3/10, and the discharge summary dictated 5/5/10, had not been timed or dated.

P12 was admitted to the CAH on 3/23/10. The admission history and physical dictated 3/26/10, the progress note dictated 3/26/10, and the discharge summary dictated 3/26/10, lacked a time and date of the physician's signature.

P15 was admitted to the CAH on 1/14/10. The physician orders of 1/14/10, 1/16/10, 1/17/10, and 1/18/10, the history and physical dictated 1/13/10, the physician progress notes dated 1/14/10, and 1/15/10, the discharge summary dictated 2/1/10, and the occupational therapy progress note dated 1/18/10, lacked the time and/or date of the entries or signatures.

P18 was admitted to the CAH on 6/8/10. The physician orders dated 6/10/10, 6/11/10, and 6/12/10, the admission history and physical dictated 6/9/10, and the physician progress notes dated 6/11/10, 6/12/10, and 6/13/10, all lacked the time and/or date of the entries or signatures.

P22 was admitted for outpatient physical therapy (PT) services on 8/31/10. The physical therapy progress notes dated 9/14/10, 9/16/10, 9/22/10, and 9/28/10, lacked a time of the entries by the therapist.

P23 was admitted for outpatient occupational therapy (OT) services on 7/23/10. The occupational therapy prgress notes dictated on 7/26/10, 8/13/10, and 9/10/10, lacked a time and date of the OT's signature. The progress notes by the therapist dated 8/6/10, 8/11/10, 8/12/10, 8/13/10, and 8/16/10, lacked a time of the entries.


On 9/29/10, at 3:05 p.m., the director of nursing verified these findings.

Based observation, interview, policy review and review of hospital contracts, the Critical Access Hospital (CAH) was found not to be in compliance with the Condition of Participation of Surgical Services. The CAH failed to ensure proper sterilization of surgical instruments for 5 of 5 surgical outpatients (SOP1, SOP2, SOP3, SOP4, and SOP5) in the sample who underwent a cataract extraction with an intraocular lens implant. This practice could potentially effect all patients provided eye surgery at the CAH. Findings include:


The CAH used flash sterilization as the primary method of sterilizing surgical eye instruments for SOP1, SOP2, SOP3, SOP4, and SOP5, who were provided eye surgery during the survey on 9/28/10.


On 9/28/10, at 7:25 a.m., the surgical manager was interviewed and indicated 5 cataract surgeries were scheduled for that morning for SOP1, SOP2, SOP3, SOP4, and SOP5. The surgical manager indicated that she acted as the circulating nurse and a contracted surgical technician from SIGHTPATH (pool agency) would bring the surgical instruments and act as the scrub nurse.

At 8:10 a.m., the surgical technician (ST-A) was interviewed and indicated she had brought 3 sets of instruments for the 5 surgeries scheduled for the day. ST-A indicated she had sterilized the instruments earlier that morning and the instruments used during the 1st and 2nd cases would be re-sterilized and used in the 4th and 5th cases of the day.

On 9/28/10, SOP1 was observed at 8:10 a.m. undergoing a cataract extraction with an intraocular lens implant. Following the surgery, at approximately 8:30 a.m., ST-A was observed cleaning the instruments. At that time, she indicated she was going to flash sterilize the instruments, unwrapped at 273 to 275 degrees for 10 minutes, and use the instruments for another eye surgery scheduled later that morning.

The surgical manager was then interviewed at approximately 8:31 a.m. and verified that the contracted ophthalmologist and ST-A performed surgery once a month at the CAH and the instruments were routinely flash sterilized between patients if needed. The manager verified she was aware that the instruments should "go into the autoclave" between patients; however, she added the facility had no issues with post surgical infections.

SIGHTPATH was contacted via phone at approximately 12:00 p.m. on 9/28/10, and a policy regarding sterilization of surgical instruments was requested.

A faxed copy of "SIGHTPATH Medical-Statement on surgical instruments care, handling and sterilization" was obtained at 12:32 p.m. The statement indicated: "SIGHTPATH Medical Technicians will be held to each contracted facility's policies and procedures for the entire process involving surgical instrument management." Included in the statement was a list of all surgical instruments the company supplied and how they should be sterilized. The company statement indicated the instruments should only undergo flash sterilization in a emergency situation only.

At 2:10 p.m. on 9/28/10, ST-A was interviewed regarding flashing the instruments. ST-A indicated it was her routine to arrive at the CAH before the ophthalmologist and flash sterilize 3 trays of eye instruments. ST-A indicated she would clean and flash the unwrapped instruments between patients if needed, and again when they were done with surgery for the day. When asked if the instruments were sterilized in a autoclave at some point, ST-A verified they were not. ST-A indicated that she was directed by SIGHTPATH to sterilize equipment as directed in the CAH's policies.

The CAH's undated "Sterilization" policy indicated that flash sterilization "is an emergency cycle and is not intended for the routine sterilization of items."

During interview at 8:45 a.m. on 9/29/10, the director of nursing (DON) indicated she was unaware of the use of flash drive sterilization "exclusively" on eye instruments in the operating room. The DON also verified she did not have a copy of the "SIGHTPATH Medical-Statement on surgical instruments care, handling and sterilization" policy.

Based on meeting minutes, and interview, the CAH failed to determine whether the utilization of all service provided were appropriate. Findings include:

The CAH lacked documentation all services provided had been evaluated.

The Annual Program Assessment meeting minutes dated 6/30/10, indicated the CAH staff had evaluated programs they had decided not to implement. However, documentation related to the review of current services provided including pharmaceutical and rehab services was lacking.

On 9/27/10, at 1:50 p.m. the human resource manger verified she runs the meetings and helps facilitate the topics discussed at the meetings. She stated the committee members meet, but they do not review any documents at the meeting. She was unaware the results of clinical record reviews completed should be included in the annual review in order to evaluate the services provided. She stated pharmaceutical and rehab services were not discussed during the annual meeting.

On 9/27/10, at 2:45 p.m. the DON stated she felt the meeting minutes did not reflect all of the topics discussed at the meeting, including the evaluation of services provided. She verified pharmaceutical and rehab services were not included on the meeting minutes. The DON did not provide further documentation regarding an evaluation of the utilization of services upon request.

Based on review of quality assurance records and interview, the CAH failed to evaluate all patient care services in the quality assurance program for infection control, pharmaceutical services and dietary as part of the overall quality improvement program. Findings include:


The CAH did not evaluate all patient care services as part of the overall quality assurance (QA) program.


On 9/28/10 at 2:00 p.m., during review of the CAH's system for surveilance and monitoring of infections, the infection control RN stated each department was responsible for picking their own infection control quality improvement. The RN stated she compiles and summarizes the infection control logs. However, she verified she was not involved with any current infection control quality assurance program to evaluate treatments furnished and outcomes affecting patients. No other documentation for infection control QA was identified.


During interview on 9/29/10, at 9:45 a.m., the contracted pharmacist stated he was unaware of any pharmacy activity related to quality assurance (QA) in the CAH, although he participated in the nursing home QA.

The "Addendum to Pharmacy Consultant Contract" dated 12/05, directed the pharmacist duties would include:
-Advise the Director of Nursing Service on methods/areas to measure for Quality Assurance.

On 9/29/10, at 10:50 a.m., the director of nursing stated she thought the consultant pharmacists were doing QA for the pharmaceutical services.



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The CAH's dietary program was not being evaluated in the Quality Assurance program.
During the tour of the kitchen at 2:00 p.m. on 9/29/10, the dietary manager indicated that she was monitoring the temperature of the dishwasher as a QA project. The manager verified that monitoring daily temperatures of the dishwasher and other equipment in the kitchen is a standard of practice and the project did not evaluate the ability of the dietary department to meet the needs of their patients.

Based on interview, medical staff bylaws and policy review, the CAH failed to ensure the quality and appropriateness of diagnosis and treatment furnished by consulting medical staff physicians with surgical privileges was evaluated. Findings include:

A system had not been defined and/or developed by the CAH's medical staff to conduct peer review for the surgical staff physicians.

Review of Quality Improvement information and review of the medical staff bylaws dated 3/8/10, revealed no policy or procedure for peer review of the consulting physicians providing ophthalmic surgical services had been identified.

On 9/28/10, at 10:00 a.m. the human resources manager verified the CAH had not been completing peer review for the surgical cases. She stated they have few surgical cases, but verified ophthalmic surgical services, including cataract surgeries, were provided on a monthly basis. She stated the facility would need to find an outside source for peer review of these cases. She indicated concerns related to flash sterilization could have possibly been detected if peer review had been completed.

Refer to C 320