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Based on interview and record review, the Governing Body failed to ensure the quality of care provided to patients by Medical Staff was evaluated according to written criteria.

Findings:

During an interview and review of credential files for Staff 1, 2, 3, 4, and 5, with the hospital's Medical Staff Coordinator (Staff 6) on April 5, 2010 at 1 PM, she indicated the current process of evaluating the competencies of provisional and re-appointed medical staff was accomplished by having the appropriate proctor document his or her evaluation of proctored staff. This evaluation would then be filed into the credential file and the recommendation for appointment then sent to the credentialing committee. Staff 6 was asked to present the written criteria that articulated the process by which the proctor evaluated the proctored medical staff competencies. Staff 6 stated the hospital did not have any written criteria.

A review of the hospital's Administrative Policy entitled: "Proctoring Policy and Procedure version #1" (effective date of October 18, 2007) was conducted. On page 2 of 3, the policy delineated proctoring requirements for the following medical specialties: Emergency Medicine; Internal Medicine; Obstetrics and Gynecology; Pediatrics; General Surgery; and Family Practice. There were no written criteria for Anesthesiology and Certified Registered Nurse Anesthetists (CRNAs).

On Page 3 of 3, the policy read: "General Guidelines for Other (Sub) Specialties ...Proctoring of another sub-specialty not specified in the Proctoring Policy and Procedure should be a minimum of [six] cases including direct observation of invasive procedures and should be of a sufficient variety to ascertain competency."

During a review of the hospital's Medical Staff Bylaws conducted on April 5, 2010, it read: Medical Staff Bylaws state on page 12 " 4.6 RESPONSIBILITIES Each AHP (Allied Health Professional) shall:

a) Meet those responsibilities required by the Medical Staff Rules & Regulations and if not so specified in Section 2.4 of Article II as are generally applicable to the more limited practice of the AHP.
b) Retain appropriate responsibility within his or her area of professional competence for the care of each patient in the Hospital for whom he or she is providing services.
c) Participate, when requested, in patient care audit and other quality review, evaluation, and monitoring activities required of AHP's, in evaluating AHP applicants, in supervising initial AHP appointees of his or her same occupation of profession or of an occupation or profession which is governed by a more limited scope of practice statute, and in discharging such other functions as may be required by the Medical Staff from time to time." According to the hospital's Medical Staff Bylaws, the Appointed Medical Staff is responsible for ensuring the competence of proctored staff. However, the Medical Staff Bylaws does not delineate any written criteria for CRNAs.

Further review of the credential files of the five staff members indicated that all five had CRNA Proctoring Forms with the evaluation date of September 14, 2009. There was no documentation of a minimum of six cases including direct observation of invasive procedures as required by the hospital proctoring policy.

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Based on interview and record review, the Governing Body failed to ensure that service furnished in the hospital by contracted providers were provided in compliance with Medicare Conditions of Participation. The hospital failed to provide a mechanism to ensure Quality Assurance for two services provided under contract.

Findings:

On April 6, 2010, record review of eight of the hospital's service contracts was conducted. The review of contracts for blood bank services and Pathology/Laboratory services indicated that these two contracts did not have any mechanism to ensure quality assurance as required by the Condition of Participation.

During an interview with hospital's Chief Executive Office, on April 6, 2010, he stated that he was solely responsible for all contracted services that are furnished in the hospital. He agreed that the two contracts in question did not have any quality assurance procedure that would assure compliance.

Based on interview and record review, the hospital failed to develop written criteria for evaluating the qualifications of Certified Registered Nurse Anesthetists (CRNAs) during the proctoring process. Subsequently, the hospital could not evaluate the individual medical staff appointee's competence as required by regulation and hospital's policy.

Findings:

During an interview and review of the credential files for Staff 1, 2, 3, 4, and 5, with the hospital's Medical Staff Coordinator (Staff 6) on April 5, 2010 at 1 PM she indicated the current process of evaluating the competencies of provisional and re-appointed medical staff was accomplished by having the appropriate proctor document his or her evaluation of the proctored staff. This evaluation would then be filed into the credential file and the recommendation for appointment sent to the credentialing committee. Staff 6 was asked to present the written criteria that articulated the process by which the proctor evaluated the proctored medical staff competencies. Staff 6 stated that the hospital did not have any written criteria.

A review of the hospital's Administrative Policy entitled "Proctoring Policy and Procedure version #1" (effective date of October 18, 2007) was conducted. On page 2 of 3, the policy delineated criteria for proctoring requirements for the following medical specialties: Emergency Medicine; Internal Medicine; Obstetrics and Gynecology; Pediatrics; General Surgery; and Family Practice. There were no written criteria for Anesthesiology and CRNAs.

On Page 3 of 3, the policy read: "General Guidelines for Other (Sub) Specialties...Proctoring of another sub-specialty not specified in the Proctoring Policy and Procedure should be a minimum of [six] cases including direct observation of invasive procedures and should be of a sufficient variety to ascertain competency."

According to the hospital's Medical Staff Bylaws, the appointed medical staff is responsible for ensuring the competence of the proctored staff. However, the Medical Staff Bylaw does not delineate any written criteria for CRNAs. The hospital's Medical Staff Bylaws read as follows:

Medical Staff Bylaws: Responsibilities [page 12, section 4.6] "Each AHP (Allied Health Professional) shall:

a) Meet those responsibilities required by the Medical Staff Rules & Regulations and if not so specified in Section 2.4 of Article II as are generally applicable to the more limited practice of the AHP.
b) Retain appropriate responsibility within his or her area of professional competence for the care of each patient in the hospital for whom he or she is providing services.
c) Participate, when requested, in patient care audit and other quality review, evaluation, and monitoring activities required of AHP's, in evaluating AHP applicants, in supervising initial AHP appointees of his or her same occupation of profession or of an occupation or profession which is governed by a more limited scope of practice statute, and in discharging such other functions as may be required by the Medical Staff from time to time."

Further review of the credential files of the five staff members indicated that all five had CRNA Proctoring Forms documenting an evaluation date September 14, 2009. This could indicate that the proctoring had been completed retrospectively. There was no documentation of a minimum of six cases that included direct observation of invasive procedures as required by the hospital proctoring policy.

Based on interview, observation and document review, the hospital failed to control and provide medication in a safe manner by NOT:

1. Ensuring surface sampling was performed consistently to assure aseptic technique in accordance to its QA (quality assurance) monitoring policy and procedure.

2. Ensuring the proper storage of three 50 ml 0.9% Sodium Chloride IV bags.

Findings:

1. During the interview with the DOP (Director of Pharmacy) on April 6, 2010 at 3:15 PM, documentation for surface sampling on the IV laminar hood was requested. Review of the surface sampling record showed that the QA testing on the IV laminar flow hood was last completed on December 17, 2009. When the DOP was asked regarding the surface sampling record for the first quarter of 2010, he stated that this was the only record that he was aware of and he acknowledged that the last complete surface sampling was performed on December 17, 2009. Review of the policy and procedure on QA monitoring of the hospital read "Surface sampling will be performed on a quarterly basis..."

2. During inspection of the drug storage area in the ED (Emergency Department) on April 6, 2010 at 2:10 PM, it was noted in the third drawer from the top of the blue metal drug storage cart that there were six 50 ml IV bags of 0.9% Sodium Chloride. Three of the six bags had their overwrap removed without an opened date on them. Further examination of the drawer revealed that there was white, powdery substance everywhere underneath the six IV bags. When the DOP was asked what he thought that white, powdery substance might be, he said "It looks like it is Sodium Chloride." And when he was further questioned about where the Sodium Chloride came from, he stated that it probably leaked out of the bags with the overwrap removed. Examination of the three opened bags showed that there was white, powdery substance around the protective covering of the IV ports.

Based on observation, interview and record review, the Dietary Director failed to ensure foods were stored in a safe manner. The Dietary Manager also failed to ensure the hospital's Plan of Correction, regarding safe food storage, for the survey of June 6, 2009, was completed. This had the potential to expose patients to food borne illness.

Findings:

During observations of the hospital kitchen, on April 5, 2010 at 11:50 AM, foods where noted to be stored in the walk-in refrigerator and two walk-in freezers in a unsafe manner. In the walk in refrigerator a 5 pound package of chorizo was noted on a shelf above two cream pies. In the walk in freezer, located in the kitchen area, 4 halibut stakes and two 20 pound boxes of frozen pollock steaks where observed stored on a shelf above hot dog buns. In the walk in freezer located outside of the kitchen area, a 10 pound box of beef steaks and a 20 pound box of chicken breasts were stored on a shelf above bagels. These findings where verified with the Dietary Manager.

During an interview with the Dietary Manager on April 5, 2010 at 12:10 PM she stated dietary staff only inspect the freezers and refrigerators on Fridays. She indicated that these inspections where not documented. During a subsequent interview and review of dietary staff training records, at 12:45 PM the Dietary Manager indicated she was unable to find documentation that staff had been trained regarding safe food storage practices. She stated "If you look at the documentation, I do not see anything for in-service regarding food storage."

During an interview with Dietary Staff E and F on April 5, 2010 at 1 PM, Staff E stated he had received no special training on how to store foods in the freezer. Staff F stated that other then the usual yearly training she also had not received any training on storing foods in the freezer.

The hospital's Plan of Correction for the survey completed on June 26, 2009 indicated that Dietary Manager would conduct and log daily visual inspections to ensure foods were stored properly. The Plan of Correction also indicated that the Dietary Manager would "provide re-education to supervisors and staff regarding proper food storage.