HospitalInspections.org

Based on review of credential files and staff interview, the Governing Body failed to assure that all physicians had privileges related to their appointment for one (#3) of six practitioners reviewed. Findings included:

1. Review of credential files at 2:15 P.M. on 5/27/2010, revealed that the privileges of Physician #3 did not include privileges in rehabilitation services. The physician's privileges were in orthopedic surgery. Interview with the staff member in charge of physician credentialing, at the time of credential file review, confirmed that Physician #3 was the hospital's Director of Rehabilitation Medicine.

2. Interview with the Chief Medical Officer (CMO) at 10:30 A.M. on 5/28/2010, indicated that Rehabilitation Medicine was a specialty that required specific experience and training, and that he was unaware that Physician #3 lacked Rehabilitation Medicine privileges. The CMO also indicated that Physician #3 should have been credentialed in Rehabilitation Medicine.

3. Interview with the Chief Executive Officer at 9:00 A.M. on 6/1/2010 indicated that "he must have missed that one (the fact that Physician #3 was not privileged in Rehabilitation Medicine)."

4. For Patient #24, medical record review, confirmed during interview with the Unit 22 Nursing Director, at 9:00 A.M. on 5/26/2010, revealed that the patient did not sign the Acknowledgement of Receipt of Notice of Privacy Practices. Review of the form revealed the words "J Verbal" documented on the signature line. There was no documentation on the form to indicate why Patient #24 did not sign the form.

Interview with the patient, at approximately 9:00 A.M. on 5/25/2010, indicated that the patient did not recall being informed of the Patient's Rights.

Interview with the Quality Manager, at approximately 2:00 P.M. on 5/26/2010, revealed "Sometimes we get a verbal acknowledgement from the patient. For the future we need to be sure to get the patients' signatures."



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Based on medical record review, review of Hospital Policies, review of the Conditions of Treatment Agreement, review of the Acknowledgement of Receipt of Notice of Privacy Practices and acknowledged during interview with Administrative staff, the hospital failed to inform five (5) Patient (Patient #7, #9, #10, #18 and #24) out of a total sample of 48 patients of their rights, in advance of furnishing patient care. Findings included:

1(a). For Patient #7, the hospital failed to secure the patient's consent prior to taking pictures of the patient's coccyx and scrotum.

Patient #7 was admitted to the Hospital in 5/10.

Review of the Hospital's current Photography Policy indicated that it was the Hospital's policy to protect its patients from invasion of privacy that might occur from the use of patient photography. Further review revealed that consent must be obtained by the patient or appropriate guardian before any patient photography.

Review of the Nursing Progress Note of 5/6/10 revealed "...pictures taken of coccyx and scrotum - wound care consult requested...."

During an interview with the Clinical Nursing Director of 35 North (5/25/10 at 2:35 P.M.), she indicated that at the time of the hospital admission the patient was capable of signing consent forms. She further acknowledged that the hospital had no written evidence that they had secured the patient's consent prior to taking pictures of the patient's coccyx and scrotum on 5/6/10.

1(b). For Patient #7, the hospital failed to secure the patient's consent on the Conditions of Treatment Agreement Form upon hospital admission.

Review of the Hospital's current Condition of Treatment Agreement Form policy and the Agreement form indicated that it is the hospital's policy that at the completion of the patient's registration, patients are asked to sign, date and time the agreement after the Patient Access staff briefly explain to the patient the following different statements on the Condition Of Treatment Agreement Form:
1. Consent to Medical and Related Health Care - patient's consent to treatment and/or admission for medical care;
2. Medical and Allied Health Care Providers - patient's informed that many of the physicians in the hospital are independent contractors and not employees of the hospital;
3. Teaching Program - patient's knowledge that the hospital may enter into agreements with academic medical, nursing and allied health programs which would allow residents, interns, medical students, nursing students, and various allied health profession students to participate in the patient's care;
4. Release of Information - patient's understanding that their medical information may need to be shared with other providers/individuals either directly involved in their care or involved in the payment of the care;
5. Medicare/Champus/Tricare Rights - patient's acknowledgement of their receipt of the Important Message from Medicare/Champus;
6. Patient's Rights and Responsibilities - patient's acknowledgement of their receipt of their rights/responsibilities as a patient in the hospital;
7. Personal Property - patient's understanding that the hospital would not be liable for loss of personal property unless placed in a secure area;
8. Payment of Medical and Related Care - patient's agreement to pay for the charges incurred for their care;
9. Assignment of Benefits - patient's authorization and assignment of payment to the hospital for any reimbursement of payment due from Medicare, Medicaid or any other third party payor;
10. Medicare Assignment of Insurance Benefits - patient's certification to the truth of information provided on the Medicare Secondary Payor form for the purpose of applying for payment under Medicare;
11. Notice of Exclusions of Insurance Benefits - patients understanding that their insurance may not cover all their health care costs. The Agreement form further indicates that the patient or person legally authorized to act for the patient, have read the agreement, understood its contents and accept its terms. The policy indicates that the Patient Access staff will witness the patient's signature or if the patient is unable to sign the form and no family member is available to sign, then the staff would document on the Agreement form the reason why the patient was unable to sign.

During review of the Conditions of Treatment Agreement form in Patient #7's medical record with the Clinical Nursing Director of 35 North on 5/25/10 at 2:35 P.M., she acknowledged that the hospital staff did not secure the patient's signature/family members signature on the Agreement form nor document why the patient was unable to sign, per hospital policy.

1(c). For Patient #7, the hospital failed to secure the patient's signature on the Acknowledgement of Receipt of Notice of Privacy Practices (NPP) form upon hospital admission.

Review of the Hospital's current Notice of Privacy Practices policy indicated that it is the hospital's policy at the time of registration, that the Patient Access staff would provide the patient with the NPP and have the patient sign, date and time the receipt of the NPP. The policy indicates that the Patient Access staff will witness the patient's signature or if the patient is unable to sign the form and no family member is available to sign, then the staff would document on the NPP receipt form the reason why the patient was unable to sign.

During review of the Acknowledgement of Receipt of the Notice of Privacy Practices form in Patient #7's medical record with the Clinical Nursing Director of 35 North on 5/25/10 at 2:35 P.M., she acknowledged that the hospital staff did not obtain written acknowledgement from the patient or family member of receipt of the NPP nor document why the patient was unable to sign the receipt form, per hospital policy.

2 (a). For Patient #9, the hospital failed to secure the patient's consent on the Conditions of Treatment Agreement Form upon hospital admission.

Patient #9 was admitted to the Hospital in 5/10.

Review of the Hospital's current Condition of Treatment Agreement Form policy and the Agreement form indicated that it is the hospital's policy that at the completion of the patient's registration, patients are asked to sign, date and time the agreement after the Patient Access staff briefly explain to the patient the Condition Of Treatment Agreement Form. The Agreement form indicates that the patient or person legally authorized to act for the patient, have read the agreement, understood its contents and accept its terms. The policy indicates that the Patient Access staff will witness the patient's signature or if the patient is unable to sign the form and no family member is available to sign, then the staff would document on the Agreement form the reason why the patient was unable to sign.

During review of the Conditions of Treatment Agreement form in Patient #9's medical record with the Clinical Nursing Director of 35 North on 5/25/10 at 4:00 P.M., she acknowledged that the hospital staff did not secure the patient's signature/family members signature on the Agreement form nor document why the patient was unable to sign, per hospital policy.

2 (b). For Patient #9, the hospital failed to secure the patient's signature on the Acknowledgement of Receipt of Notice of Privacy Practices (NPP) form upon hospital admission.

Review of the Hospital's current Notice of Privacy Practices policy indicated that it is the hospital's policy, at the time of registration, that the Patient Access staff would provide the patient with the NPP and have the patient sign, date and time the receipt of the NPP. The policy indicates that the Patient Access staff will witness the patient's signature or if the patient is unable to sign the form and no family member is available to sign, then the staff would document on the NPP receipt form the reason why the patient was unable to sign.

During review of the Acknowledgement of Receipt of the Notice of Privacy Practices form in Patient #9's medical record with the Clinical Nursing Director of 35 North on 5/25/10 at 4:00 P.M., she acknowledged that the hospital staff did not obtain written acknowledgement from the patient or family member of receipt of the NPP nor document why the patient was unable to sign the receipt form, per hospital policy.

3. For Patient #10, the hospital failed to secure the patient's consent on the Conditions of Treatment Agreement Form upon hospital admission.

Patient #10 was admitted to the Hospital in 5/10.

Review of the Hospital's current Condition of Treatment Agreement Form policy and the Agreement form indicated that it is the hospital's policy that at the completion of the patient's registration, patients are asked to sign, date and time the agreement after the Patient Access staff briefly explain to the patient the Condition Of Treatment Agreement Form. The Agreement form indicates that the patient or person legally authorized to act for the patient, have read the agreement, understood its contents and accept its terms. The policy indicates that the Patient Access staff will witness the patient's signature or if the patient is unable to sign the form and no family member is available to sign, then the staff would document on the Agreement form the reason why the patient was unable to sign.

During review of the Conditions of Treatment Agreement form in Patient #10's medical record with the Clinical Nursing Director of 34 North on 5/26/10 at 10:00 A.M., she acknowledged that the hospital staff did not secure the patient's signature/family members signature on the Agreement form nor document why the patient was unable to sign, per hospital policy.



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5. For Patient #18 review of the medical record, on 5/26/10 at 7:40 A.M., indicated that on 5/22/10 the patient was admitted to the Hospital and had a language barrier. Patient #18 understood spoken English; however, Patient #18 could speak little English. Patient #18's family member (Family Member #1) was the patient's caretaker and acted as the patient's interpreter.

Family Member #1 was interviewed on 5/26/10 at 3:30 P.M. The Family Member reported being present at the Hospital with Patient #18 since admission with the exception of approximately 3-4 hours during which time another family member was present.

Further review of Patient #18's medical record indicated that the Acknowledgement of Receipt of Privacy Notices, dated 5/22/10 and the Important Message from Medicare about Your Rights Form, dated 5/24/10, indicated Patient #18 was unable to sign or was unavailable. There was no documentation in either form to indicate why Patient #18 did not sign the forms or that attempts were made to have Family Member #1 sign the forms.

Based on review of hospital policy and acknowledged during interview with Administrative staff, the hospital failed to ensure that 1 patient (Patient #11), out of a total sample of 48 patients, had the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives. Findings included:

Review of the Advance Directive policy indicated "...(Hospital name) will maintain written policies and procedures related to advance directives in general...that concerns the following: a.) The individual's right under state law to make decisions concerning medical care, including the right to accept or refuse medical ... treatment...."

Patient #11 was admitted (from a local nursing home) to the hospital in 5/10.

During review of a Statement of Advance Directive, signed by the patient on 10/31/09, (forwarded by the Nursing Home to the hospital's Emergency Department and found in the patient's medical record), with the Clinical Nursing Director of 34 North (5/26/10 at 3:30 P.M.), she acknowledged that the patient's wishes were for DNR (Do Not Resuscitate). Further review of the Statement of Advance Directive with the Clinical Nursing Director revealed that the patient had not revoked the DNR decision prior to being transported to the hospital's Emergency Department on 5/24/10.

Review of the Nurse's Note of 5/24/10 (completed in the Emergency Department) revealed that the patient was oriented to person, place and time.

Review of the Hospital's Admission Orders of 5/24/10, signed by Intern #1, indicated that the patient's code status was a Full Code.

Review of the Team Progress Notes of 5/26/10, signed by Intern #2, indicated that the patient's code status was a Full Code.

During an interview with the Clinical Nursing Director on 5/26/10 at 3:30 P.M., she acknowledged that the current hospital physician orders were for Patient #11 to be a Full Code. She stated that based on the patient's previously executed Statement of Advance Directives, "...we (hospital staff) would not be honoring his DNR wishes...."

During an interview with Patient #11 on 5/27/10 at 8:25 A.M., he informed the surveyor that he did not recall any physician/intern having a discussion with him when he was in the Emergency Department nor in his room relative to his wishes for a DNR. He further stated "...I never have changed my mind regarding DNR, I'm 89 years old and I've had a good life, just let me go if something happens...."

5. For Patient #26, medical record review, confirmed by interview with the Unit 22 Nursing Director at 3:00 P.M. on 5/26/2010, revealed that the patient was admitted for alcohol withdrawal, hypertension, and was a risk for falls. Review of the care plan revealed that it lacked nursing goals and interventions regarding the above issues for three days since the patient's admission.

6. For Patient #21, medial record review, confirmed by interview with the Director of the Center for Women and Infants and the Manager of Post Partum and Nursery Units at 11:30 A.M. on 5/25/2010, revealed that after delivery of the baby, the patient had an acute onset of right-sided facial and hand numbness associated with transient aphasia (lack of language abilities), visual deficits, and vomiting. The patient also had asthma.

Review of the care plan revealed that it lacked nursing goals and interventions for the above problems.



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7. For Patient # 28, medical record review on 5/26/2010 at 9:30 A.M. indicated that the patient was admitted to the Hospital through the Emergency Department (ED) on 5/15/10, with a vascular occlusion left leg. After surgery for a thrombectomy, the patient was admitted to the Intensive Care Unit (ICU). Surgery performed on May 19, 2010, included a Left Femoral By-pass Graft. A few hours after the surgery the patient developed a Compartment Syndrome (the compression of nerves, blood vessels and muscle inside a closed space) and was returned to the Operating Room (OR) for a Fasciotomy (a surgical procedure where the fascia is cut to relieve tension or pressure and treat the resulting loss of circulation to an area of tissue or muscle). The patient returned to the OR on May 24, 2010 for a debridement of the fasciotomy site and was readmitted to Unit 21. The patient's care plan was not initiated until May 19, 2010, four days after admission to the hospital.

Observation of the patient's dressing change at approximately 10:00 A.M. on May 26, 2010, and interviews with RN #14 and Patient #28, revealed that the dressing change was very uncomfortable for the patient. The RN said that the patient had to be medicated before the dressing was changed. The intervention for pain/discomfort was not documented on the Care Plan.

Observation of the patient also revealed an approximate 2.5 inch wound on the left elbow. There was an approximate 1.5 inch black area in the middle of the wound. The patient said, "When he pushed himself up in the bed, the dressing came off and irritated the elbow." There was no indication of this pressure area with goals and interventions for care on the care plan.

Interview with the Unit 21 Nurse Manager, during the observation, confirmed that there were no goals and interventions for the pressure areas and that updates or changes to the care plan had not been documented, even though daily multidisciplinary rounds took place.




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Based on observation, record review and staff interviews, the Hospital failed to develop and keep current a nursing care plan for seven patients (#15, #18, #21, #26, #28, #38, #39) in a total sample of 48. Findings included:

1. For Patient #15, medical record review on 5/26/10 at 8:35 A.M., indicated that Patient #15 presented to the Hospital with chest pain. A cardiac catheterization was performed and stents were placed. Patient #15 was discharged on 5/21/10. On 5/24/10 Patient #15 returned to the Hospital with recurring episodic chest pain. Patient #15 was admitted to the Hospital for telemetry monitoring and a cardiac stress test. Patient #15's medical history was significant for coronary artery disease and anxiety.

Review of Patient #15's care plan on 5/26/10 at 8:35 A.M., indicated that the care plan was initiated on 5/24/10. The care plan did not address the patient's anxiety or include interventions to assist the patient to reduce anxiety.

2. For Patient #18, medical record review on 5/26/10 at 7:40 A.M., indicated that on 5/22/10 the patient was brought to the Hospital by a family member. Patient #18 had a language barrier and the family member who was also the caretaker acted as the interpreter. Patient #18 suffered from increasing abdominal pain, loss of appetite, shortness of breath, and had bilateral lower extremity edema up to the mid-thighs. Patient #18 ' s medical history was significant for Diabetes and hypertension. Diagnostic testing was performed and determined Patient #18 had new onset atrial fibrillation and congestive heat failure. Patient #18 was admitted to the Telemetry Unit and placed on a cardiac monitor. Physician orders included a cardiac diabetic diet with fluid restrictions, sliding scale insulin coverage, and anticoagulation therapy to prevent blood clot formation.

Further review of Patient #18's care plan, indicated that the care plan was initiated on 5/22/10. The care plan did not address or include interventions for the following: abdominal pain; loss of appetite, Diabetes, and Patient #18's language barrier.



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3. For Patient #38, medical record review, confirmed by interview with staff at 4:30 P.M. on 5/26/2010, revealed that the patient was admitted post-operatively to the Pulmonary Care Unit (PCU) after removal of a lung lesion. While being visited by his wife, the wife was observed administering medication to the patient. The nursing shift notes read, "that the patient's wife was not to visit alone with the patient and to ensure medications were only administered by authorized hospital personnel." The patient's care plan was not updated to reflect the visitation limitations.

Subsequent to lung surgery, the patient developed respiratory distress and required intubation and mechanical ventilation. The patient's care plan was not updated to reflect this change in the patient's status.

4. For Patient #39, medical record review at 8 A.M. on 5/27/2010, revealed that the patient was initially admitted to a Medical/Surgical floor with a diagnosis of pneumonia. Later, the patient developed respiratory distress and was transferred to the PCU where the patient required intubation and mechanical ventilation.

The patient's care plan in the PCU was not updated to include interventions after the patient was intubated and ventilated.

Based on medical record review and staff interview, the Hospital failed to assure that reports of invasive procedures necessary to monitor the patients' condition were documented in the record for one (#24) of 48 patients. Findings included:

1. For Patient #24, medical record review at 9:00 A.M. on 5/26/2010, revealed that the patient had been admitted for chest pain and was scheduled for a cardiac catheterization on 5/25/2010. Review of progress notes revealed that the patient's physician had not documented a report of the procedure.

2. Review of Hospital General Rules and Regulations at 12:30 P.M. on 5/26/2010, read "Operative and Special Procedure Reports must contain a detailed report of the following: technical procedures used; post-op diagnosis; name of performing practitioner and assistant(s). The physician must write a comprehensive note immediately after the surgery. The progress note must supply sufficient and pertinent information for use by any practitioner who is requested to attend the patient, including indication for procedure, findings and complications."

The patient's physician failed to adhere to Hospital policy.

Based on observations and staff interviews, the hospital failed to ensure that medications were stored in accordance with accepted professional principles. Findings include:

1. On 5/25/10 at 2:13 P.M. in Unit 33S, the surveyor observed and reviewed the Medication Refrigerator Temperature Log. Staff failed to record the daily temperature on the log sheet 9 of 25 days in May 2010. There were no temperatures recorded on 5/11; 5/12; 5/14; 5/16; 5/18; 5/19; 5/20; 5/22 and 5/23. Staff failed to follow the hospital's policy of recording medication refrigerator temperatures to ensure that medications were stored in proper temperature range. This was reviewed with the Director of Pharmacy on 5/25/10 at 2:13 P.M..

2. On 5/25/10 at 2:25 P.M. in Unit 32S, the surveyor observed and reviewed the Medication Refrigerator Temperature Log. Staff failed to record the daily temperature on the log sheet 7 of 25 days in May 2010. There were no temperatures recorded on 5/13; 5/14; 5/15; 5/16; 5/18; 5/19 and 5/20. Staff failed to follow the hospital's policy of recording medication refrigerator temperatures to ensure that medication were stored in proper temperature range. This was reviewed with the Director of Pharmacy on 5/25/10 at 2:25 P.M..

3. On 5/27/10 at 7:35 A.M. in Unit IC "D," the surveyor observed and reviewed the Medication Refrigerator Temperature Log. Staff failed to record the daily temperature on the log sheet 11 of 26 days in May 2010. There were no temperatures recorded on 5/2; 5/6; 5/7; 5/9; 5/10; 5/11; 5/15; 5/22; 5/23; 5/25 and 5/26. The facility staff failed to follow the hospital's policy of recording medication refrigerator temperatures to ensure that medication were stored in proper temperature range. This was reviewed with the Director of Pharmacy on 5/27/10 at 7:35 A.M..

Based on observation and interview with staff, the hospital failed to remove outdated and beyond date drugs and biologicals. Findings include:

1. On 5/25/10 at 10:10 A.M. on unit 34N in room 4270, the surveyor observed three sealed bottles of Normal Saline 0.9% Irrigating Solution with an expiration date of "August 08." The bottles of solution were outdated the last day of August 2008. This was confirmed with the Director of Pharmacy on 5/25/10 at 10:10 A.M..

2. On 5/25/10 at 2:25 P.M. on unit 32S in the nursing area, the surveyor observed a bottle of Nova Stat Strip Glucometer Test Strips which was not dated by staff when first opened. The manufacturer states that an open bottle should discarded 90 days after opening. The open and not dated bottle is considered beyond use date (out of date). This was confirmed with the Director of Pharmacy on 5/25/10 at 2:25 P.M..

3. On 5/25/10 at 3:05 P.M. on unit 23 in the nursing area, the surveyor observed a bottle of Nova Stat Strip Glucometer Test Strips which was not dated by staff when first opened. The manufacturer states that an open bottle should be discarded 90 days after opening. The open and not dated bottle is considered beyond use date (out of date). This was confirmed with the Director of Pharmacy on 5/25/10 at 3:05 P.M..

4. On 5/25/10 at 3:30 P.M. on unit PCU in the nursing area, the surveyor observed two bottles of Nova Stat Strip Glucometer Test Strips which were not dated by staff when first opened. The manufacturer states that an open bottle should discarded 90 days after opening. The open and not dated bottles are considered beyond use date (out of date). This was confirmed with the Director of Pharmacy on 5/25/10 at 3:30 P.M..

5. On 5/27/10 at 7:35 A.M. in unit ICU "D" the surveyor observed an open bottle of Nova Stat Strip Glucometer Test Strips that the cover of the bottle was not replaced by staff after opening. The manufacturer states that open bottle should be recapped to prevent the glucometer strips from being exposed to air. The open and not capped bottle is considered beyond use date due to improper storage. This was confirmed with the Director of Pharmacy on 5/27/10 at 7:35 A.M..

Based on policy review and staff interviews, the hospital allowed the Registered Dietitians to write orders for therapeutic diets, vitamin and mineral supplements, and laboratory tests. Findings include:

Review of the Centers for Medicare and Medicaid (CMS) Regulations for Hospitals, Sections 482(c)(1), 482(c)(2) and 482(c)(4) address that patients have to be admitted and under the care of a licensed Doctor of Medicine (M.D.) or Osteopathy (O.D.). If the hospital allows other licensed health care practitioners to admit patients, evidence of being under the care of an M.D. or O.D. has to be present in the record.

Review of the hospital policy No. 9.1.57, "Medical Nutrition Therapy Order-Writing Policy for Registered Dietitians (R.D.)" dated 6/30/09, indicated that the "R.D. is granted the privileges to write orders per physician consent and to use the hospital's nutrition order protocols authorized by the hospital governing body."

This policy states after the initial diet order is written by the physician, the R.D. has the privilege to write specific orders and change orders, and the physician must co-sign the orders within 48 hours. The physician may discontinue the RD's order at any time.

The Registered Dietitians are allowed to write the following orders based on their clinical assessment and specific hospital defined criteria:

1. Modify Diets
2. Fortify Diets
3. Supplement Diets with Vitamins and Minerals
4. Initiate or Modify Enteral Nutrition
5. Initiate or Modify Parenteral Nutrition (PN) - TPN (total) and PPN ( peripheral)
6. Order Labs and other Metabolic Test
7. Order other Interventions
8. Write orders on the physician's order sheet

A meeting was held on 5/27/10 at 9:30 A.M. with the Clinical Nutritional Manager, Director of Food and Nutrition, and Director of Ancillary Services. The staff verified that the Dietitians are reviewed by the Allied Health Professional (AHP) Credentials Committee to receive specific clinical privileges. Staff stated that the Registered Dietitians are allowed to write orders within the policy guidelines and with a physician co-signing within 48 hours. Staff shared with the surveyor the policy regarding order writing. Staff confirmed that the Dietitians do write orders per the policy.

An additional meeting was held with the Director of Quality on 5/27/10 at 11:15 A.M.. She shared additional information with the surveyor. This included: Policies Governing AHP's, which included evaluation for privileges, R.D. Appendix-Policies Specific to Registered Dietitians, Standards of Practice for American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) and American Dietetic Association (ADA) Standards of Practice and Standards of Professional Performance for Registered Dietitians in Nutrition Support, ADA Revised 2008 Standards of Practice for Rd in Nutritional Care, as well as 268 CMR 5.00: Professional Standards and Ethical Codes (for Dietitian / Nutritionist).

Review of 268 CMR 5.00 does not give Licensed Dietitian/ Nutritionist (LDN) the authority to prescribe diets or write orders. In 268 CMR 5.01 (2) (c) "Recommending diet prescriptions and methods of feeding" and 268 CMR 5.01(2) (j) "Collaborating with physicians and allied health personnel as provider of nutritional care...". Review of the other documents were professional standards and they did not address the legal aspect of order writing. A.S.P.E.N. states "These standards have been formulated to be used for individual self-evaluation and the development of practice guidelines, but not for institutional credentialing...".

Interview with RD #1 on 5/27/10 at 2:20 P.M., confirmed that the Dietitians do write orders as outlined in Policy No. 9.1.57 with a physician co-signature within 48 hours.

Interviews and policy review confirmed that the Registered Dietitians do write orders in accordance with the policy. Under state regulations, the Registered Dietitians are not legally authorized to do so and this is beyond their scope of practice.

6. Observations of a dressing change performed by Registered Nurse (RN) #4 on 5/26/2010 at 10:45 A.M., for Patient NS 'B' revealed that the RN failed to adhere to hospital infection control policies as follows:

Interview with RN #4, just prior to the procedure, revealed that the patient was on contact precautions for a diagnosis of Vancomycin Resistant Enterococcus (VRE) in the urine and she was going to perform a clean dressing change for the patient.

After obtaining the dressing supplies and donning an isolation gown and gloves, RN #4 entered the isolation room, opened the dressing supplies, and placed them on the patient's over-the-bed table. The over-the-bed table was cluttered with food and drinks ( i.e. a banana, four eight ounce paper cups containing assorted drinks). RN#4 failed to remove the food and liquids from the table and provide a clean, flat surface for the dressing supplies, as required by Hospital policy.

The RN#4 then performed the following steps:

RN #4 squeezed the ointment Duogell onto a 2 inch by 2 inch sponge that she had placed immediately between the banana and the cups of liquid;

RN#4 poured Normal Saline from the bottle directly onto 4 inch by 4 inch sponges which were placed near the cups of liquid. The sponges were contained in a pervious paper outer wrap that could allow liquids to pass through to the table; thereby, creating a risk of cross-contamination of the sponges.

RN #4 then moved the waste basket to the side of the bed. The RN did not change her gloves and wash her hands after touching the dirty/contaminated wastebasket.

With the same contaminated gloves used to touch the wastebasket, RN#4 removed the soiled dressing from the patient's left heel and disposed of the dressing in the wastebasket.

Still with the same gloves and failing to remove her gloves and wash her hands after removing the soiled dressing, RN#4 used the saline-soaked sponges to cleanse the patient's heel wound.

With the same contaminated gloves, the dressed and wrapped the patient's wound.

After completing the dressing change and wearing the same contaminated gloves, RN#4 inspected and touched the dressing on the patient's right heel to assess if it needed to be changed. The nurse failed to remove the contaminated gloves, wash her hands and don clean gloves before touching the patient's right heel dressing, although required by Hospital policy.

Interview with the Nursing Educator, at approximately 9:30 A.M. on 5/28/2010, confirmed that Hospital policy required staff to change gloves and perform hand hygiene between the dirty and clean steps of a dressing change. Additionally, the Educator indicated that the Hospital lacked a procedure for a clean dressing change.

7. Observations in the Intensive Care Unit (ICU) on 5/27/2010 at 11:35 A.M., confirmed by interview with Respiratory Therapist (RT) #1, revealed that the RT failed to follow Hospital infection control policy as follows:

Interview with RT #1, on 5/27/2010 at 11:45 A.M., revealed that she went into the room of a patient on contact and respiratory precautions "just to change the ventilator (vent) settings and didn't secure the isolation gown around her neck and waist, although required by Hospital policy." The RT indicated that "while in the room, she decided to change the vent water bottle and spilled water on the machine and floor."

Observation revealed that when RT #1 bent over to wipe-up the water from the floor and the machine, the gown fell down over her shoulders, to almost waist level. The RT continued to wipe the water off the vent and floor with her uniform exposed. The RT failed to stop and secure the gown before wiping up the water, creating a risk for cross-contamination.

Interviews with the Educator and Nursing Director, during the observation, confirmed the RT should have secured the gown at the neck and around the waist, and that the RT failed to adhere to Hospital Isolation Technique Policy.

8. Observations on Unit 34 at 9:05 A.M. on 5/28/2010, revealed that RN #12 failed to adhere to Hospital infection control policy while administering oral medications to Patient NS 'C'. The RN was observed to take a medication from the packaging with her fingers and hand it to the patient.

Interview with the Unit 34 Nursing Director and RN #13 at 9:30 A.M. on 5/28/2010, revealed that Hospital policy prohibited nurses from touching patients' medications.



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Based on observations, review of disinfection logs, and staff interviews, although the Infection Control Coordinator developed a system for identifying, reporting, investigating, and controlling infections, the Hospital failed to ensure that staff consistently implemented Hospital infection control protocols. Findings included:

1. Observations on 5/26/2010 at 10:15 A.M. of the Cidex OPA (a chemical used for disinfection) station in the Ultrasound Unit revealed that a thermometer was not available for temperature monitoring. According to interview with Ultrasound Technologist #1, on 5/26/2010, the staff had not been monitoring the temperature of the product. Additionally, review of the "Cidex OPA Log" revealed it lacked evidence that temperature monitoring was consistently completed.

2. Observations on 5/27/2010 at 11:50 A.M. of the Cidex OPA station in the Cardiology Suite revealed there was no thermometer available. According to interview with the Cardiology Manager, there was no temperature monitoring of the product and the "Cidex OPA Log" lacked any evidence of temperature monitoring.

3. Observations of the Cidex OPA stations on 5/26/2010 between 8:10 A.M. and 9:30 A.M. in Operating Room (OR) II (second level) and OR III (third level) revealed that the stations were set up as needed when performing certain gastro-intestinal procedures. While there was a thermometer available at both of these stations, observation of the Cidex OPA logs of the OR III revealed that temperatures were not monitored. Temperature monitoring of the Cidex OPA in the OR II was not consistently performed.

4. Review of the Cidex OPA manufacturer's guidelines 5/26/2010 at 12:00 P.M., revealed regular testing of the solution with test strips to ensure adequate concentration of the solution was required.

In order to ensure the efficacy of the test strips, they were to be tested using a Pass/ Fail method described by the manufacturer using full strength and diluted Cidex OPA. According to interview with staff on 5/26 and 5/27/2010, no quality assurance (QA) monitoring of the test strips was completed, and the "Cidex OPA Log" lacked any evidence of QA monitoring of the test strips in the Ultrasound, Cardiology or OR II and III manual chemical monitoring procedures.

Observations, confirmed by interviews on 5/26 and 5/27/2010, revealed that the Hospital manually reprocessed both vaginal probes, Transesophageal Echocardiography (TEE) endoscope(s), and specialty endoscopes for use in Operating Room (OR) procedures, using the chemical Cidex OPA for high level disinfection. The manufacturer's guidelines for use required monitoring of immersion time (12 minutes minimum) and solution temperature (20? Centigrade, 68? Fahrenheit) to ensure the effectiveness of the chemical.

5. On 5/27/2010 at 11:10 A.M. in the OR pre-holding area, the surgeon of Patient #45 was examining the patient's left eye. The area around the patient's eye was palpated repeatedly by the surgeon who removed a container of ophthalmic solution from his scrub suit pocket. After administering the eye drops to the patient, the surgeon returned the medication to his scrub suit pocket. He did not perform hand hygiene immediately before or after contact with the patient.

Based on documentation review, it was determined the Hospital failed to ensure that a complete post anesthesia evaluation was documented by an anesthesiologist or designee for two patients (#13, #28) in a sample of 48.

Findings included:

1. For Patient #28, medical record review on 5/26/2010 at approximately 9:30 A.M., revealed that the patient had been to the Operating Room (OR) on four different occasions. Review of the 5/16/2010 post-operative anesthesia documentation indicated the patient was extubated, anesthesia was discontinued, and the patient was transported out of the OR to the post anesthesia care unit (PACU). However, the medical record lacked documentation that a post anesthesia evaluation was performed by a qualified anesthesiologist, although required.

Review of the post anesthesia evaluation section on the anesthesia record revealed that the anesthesiologist had only documented check marks. The record lacked an actual cardio-pulmonary evaluation with heart sounds, lung sounds, vital signs, and level of consciousness (LOC), although required.

Interview with the Chief of Anesthesia during record review, agreed that a more complete documentation of a cardio-vascular and respiratory assessment, with actual lung sounds, LOC, and vital signs must be documented.



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2. For Patient #13, medical record review on 5/26/10 at 3:10 P.M., revealed that the Postoperative Anesthesia Evaluation dated 5/26/10 did not document the patient's level of consciousness.

Review of the Anesthesia Record indicated that there was a preprinted area to document the post-anesthesia evaluation. The area contained a checklist to indicate if follow-up care was standard, if there were no apparent complications, if vital signs were stable, if the airway was adequate, and to document the level of consciousness. There was an area to document additional notes as needed. The evaluation was to be signed, dated, and timed by the individual completing the evaluation.

Review of the Hospital's Policy/Procedure titled Post-Anesthesia Evaluation at 4:00 P.M., on 5/26/2010, indicated that at a minimum the post-anesthesia note should document cardiopulmonary status, level of consciousness, any follow-up care and/or observations, any complications during post-anesthesia recovery, and any follow-up care needed or patient instructions given.

Based on review of Respiratory Services Protocol, facility documentation, and interview, the Hospital failed to ensure that services were provided only on, and in accordance with, the orders of a doctor of medicine or osteopathy and that Respiratory Therapists functioned within their scope of practice. Findings included:

Interview with RT #1 at 8:50 A.M. on 5/28/2010, revealed "According to a Respiratory Therapy Protocol a RT could change a physician's order from a nebulizer treatment to a metered dose inhaler (MDI) based on the condition of the patient, reason for administering the nebulizer treatment, and what MDI was prescribed for patient use at home. The RT also added that "the medication as given by nebulizer therapy might not be exactly the same as the medication administered by MDI."

Interview with the Clinical Director of Respiratory at 1:40 P.M. on 5/28/2010, confirmed the interview with RT #1. The Clinical Director of Respiratory indicated that "the medication in the MDI was not exactly the same medication as given by nebulizer. In an MDI one medication was Combivent and in the nebulizer the medication was Duoneb-Albuterol 3 mg with Ipratropium 0.5 mg."

Review of a draft Respiratory Therapy policy revealed that another medication given via MDI was Atrovent. However, via nebulizer the medication was Ipratropium Bromide. Additionally, the Clinical Director of Respiratory said that the RTs could also order arterial blood gasses (ABG) based on the Respiratory Therapy Protocol.

The Clinical Director of Respiratory said, "He had contacted the Massachusetts Board of Respiratory Care to verify the scope of practice of RTs." He added, "The Board said that the RTs could not write orders and they needed to follow physician's orders. However, if specific protocols were developed, approved and signed by the Medical Executive Committee or similar authority, RTs could follow that protocol."

Review of the Physician Order Form for Bronchodilator Therapy (Respiratory Therapy Protocol) revealed that the protocol did not provide specific physician orders or give clear instructions for the RT to follow. For example:

"The Respiratory Therapist will determine the mode of delivery (nebulizer vs. MDI)." However, the specific medication and the equivalent dosages of the two modes were not identified in the protocol.

"Respiratory Therapist may order and obtain an ABG for any patient who exhibits any of the following: Dyspnea; Cyanosis; suspected increasing partial pressure of carbon dioxide (PCO2)." However, the above symptoms were not specifically quantified/measured in the protocol.

Review of two letters (dated 3/30/2009 and 4/22/2009) regarding RT scope of practice from the Executive Director Board of Respiratory Care at 2:00 P.M. on 5/28/2010, and telephone interview with the Executive Director Board of Respiratory Care at 12:00 P.M. on 6/1/2010, revealed, "If medications needed to be changed, a physician's order would be required. the order would need to be spelled out and an equivalency documented. RTs can not change a medication."

The letter dated 3/30/2009 read, "a physician's order may be contained in a protocol that identifies the specific circumstances under which an RT may order a test or measurement. In the absence of a protocol which delineates specific circumstances, an RT works (under) a physician's order."

The protocol did not provide the equivalency of the exact medication dosage exchange between the MDI and the nebulizer or provide a full description of the circumstances under which an RT could draw ABGs, although required.