The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST CATHERINE OF SIENA HOSPITAL 50 ROUTE 25A SMITHTOWN, NY 11787 Jan. 30, 2015
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on documentation review and interview, the facility failed to maintain current Annual Heath Assessments for two (2) out of seven (7) Physician Records reviewed (Staff Members #7 and #8).

Findings:

Review of Physician #7's Personnel Record revealed a prior Annual Health assessment dated [DATE]. An Annual Health Assessment was noted in the Record with a date of 01/30/15, after the start of the survey.

The Physician's Personnel Record lacked an Annual Health Assessment for 2014.

This was confirmed with Staff #10 on 01/30/15 at 1:00PM in the presence of Staff #9.

Review of Physician #8's Personnel Record revealed a prior Annual Health assessment dated [DATE]. An Annual Health Assessment was noted in the Record with a date of 01/28/15, after the start of the survey.

The Physician's Personnel Record lacked an Annual Health Assessment for 2014.

This was confirmed with Staff #10 on 01/30/15 at 1:05PM in the presence of Staff #9.
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VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
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Based on record review and interview, the facility failed to ensure that all patients were provided information regarding their rights, including patients who were cognitively impaired at the time of admission, but became alert and oriented during their hospital stay. This was evident in four (4) out of four (4) Records reviewed (Patients #1, #13, #24 and #31).

Findings:

Review of the Medical Record for Patient #1 revealed that the patient was admitted with diagnoses of Septicemia with Pneumonia and Altered Mental Status on 01/22/14. The Patient Consent Forms were documented as "Unable to sign" at 2:15AM on the day of admission.

On 09/24/14 at 8:05PM, a Physician's Note documented that the patient's mental status was "improving". On 09/25/14 at 2:09AM a Nursing Note documented the patient as "alert and appropriate".

There is no documented evidence that the patient was approached, after she became coherent, to sign her Admission Consent Forms during her hospital stay.

Review of the Medical Record for Patient #31 revealed that the patient was admitted with diagnoses of Anemia and Renal Failure on 01/12/15. The Patient Consent Forms were documented as "Unable to sign" at 5:15PM on the day of admission with no reason given for the inability to consent.

On 01/14/15 at 12:07PM, the Nursing Flow Sheet documented the patient's Orientation Level as "Oriented x 4". The patient was able to sign a Consent for Surgery at that time.

There is no documented evidence that the patient was re-approached, after he became coherent, to sign his Admission Consent Forms during his hospital stay.

Review of the Medical Record for Patient #24 revealed that the patient was admitted with diagnoses of Syncope and Pulmonary Emboli on 01/23/15. The Patient Consent Forms were documented as "Unable to sign" at 10:22PM on the day of admission. No reason was given for the inability to consent. Physician Notes document the patient's spouse at the bedside.

On 01/24/15 at 8:00AM, Nursing Flow Sheets document the Orientation Level as "Oriented x 4". The patient was able to sign a Consent for Surgery on 01/27/15.

There is no documented evidence that the patient was re-approached, after she became coherent, to sign her Admission Consent Forms during her hospital stay.

Review of the Medical Record for Patient #13 revealed that the patient was admitted with a diagnosis of Gastrointestinal Bleed on 01/23/15. The Patient Consent Forms were documented as "Unable to sign" at 8:49AM on the day of admission. No reason was given for the inability to consent.

A Nursing Note on 01/25/15 at 3:00PM listed the patient as "Oriented to person, Disoriented to place, Oriented to situation, Disoriented to time".

On 01/28/15 the patient was documented as alert and oriented and was able to sign a Consent for Blood.

There is no documented evidence that the patient was re-approached, after she became coherent, to sign her Admission Consent Forms during her hospital stay.

On 01/29/15 at 2:55PM, an interview with Staff #5 revealed that "If the patients are unable to sign Consents, we usually leave a message for the family to come see Admitting, but they don't always come down".

During an interview on 01/29/15 at 3:00PM with Staff #6, the staff member stated that the facility lacked a Policy to address Consent Forms that were not signed by patients due to lack of capacity on admission.
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VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
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Based on documentation review and interview, the facility failed to ensure that Physicians who are granted Privileges maintain Annual Hospital Inservices for six (6) out of seven (7) Personnel Records reviewed (Staff Members #7, #8, #11, #12, #13 and #14).

Findings:

Review of Physician #7's Personnel Record revealed that the Record lacked evidence of Hospital Annual Mandatory Inservices including Advance Directives, Child Abuse, Domestic Violence, Fire and Safety and Patient Rights.

This was confirmed with Staff #10 on 01/30/15 at 1:00PM in the presence of Staff #9.

Review of Physician #8's Personnel Record revealed that the Record lacked evidence of Hospital Annual Mandatory Inservices including Advance Directives, Child Abuse, Domestic Violence, Fire and Safety and Patient Rights.

This was confirmed with Staff #10 on 01/30/15 at 1:05PM in the presence of Staff #9.

Review of Physician #11's Personnel Record revealed that the Record lacked evidence of Hospital Annual Mandatory Inservices including Advance Directives, Child Abuse, Domestic Violence, Fire and Safety and Patient Rights.

This was confirmed with Staff #10 on 01/30/15 at 1:10PM in the presence of Staff #9.

Similar findings were noted for Personnel Records #12, #13 and #14.
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VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
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Based on record review and staff interview, the facility failed to ensure that all Orders for Drugs and Biologicals were obtained from a Practitioner responsible for the care of the patient, prior to administration in four (4) out of seven (7) Newborn Records reviewed (Patients #20, #21, #22 and #25).

Findings:

Review of the Medical Record for Patient #20, revealed the infant was born on 01/26/15. The Electronic Medical Record (EMR) documents that the Nurse indicated "Placing Order" and then selected "per protocol cosign required" for the administration of Erythromycin 0.5% ophthalmic ointment once to each eye and Phytonadione 1mg injection once, then administered the medications at 10:26AM on 01/26/15. The Physician did not sign the Order until 1:09PM on 01/26/15, after the medications were given.

Review of the Medical Record for Patient #21, revealed the infant was born on 01/27/15. The EMR documents the Nurse indicated "Placing Order" and selected "per protocol cosign required" for the administration of Erythromycin 0.5% ophthalmic ointment once to both eyes and Phytonadione injection 1mg once, then administered the medications at 8:07PM on 01/27/15. The Physician did not sign the Order until 10:14AM on 01/28/15, the day after the medications were given.

Review of the Medical Record for Patient #22, revealed the infant was born on 01/26/15. The Electronic Medical Record (EMR) documents the Nurse indicated "Placing Order" and then selected "per protocol cosign required" for the administration of Erythromycin 0.5% ophthalmic ointment once to both eyes and Phytonadione injection 1mg once, then administered the medications at 12:50PM on 01/26/15. The Physician did not sign the Order until 12:06PM on 01/27/15, the day after the medications were given.

Review of the Medical Record for Patient #25, revealed the infant was born on 01/29/15. The Electronic Medical Record (EMR) documents the Nurse indicated "Placing Order" and then selected "per protocol cosign required" for the administration of Erythromycin 0.5% ophthalmic ointment once to both eyes and Phytonadione injection 1mg once then administered the medications at 10:55AM on 01/29/15. The Physician did not sign the Order until 11:40AM after the medications were given.

During an interview with Staff #1 at 11:35AM on 01/29/15, the staff member stated "we do it (enter the Order and administer the medications) per protocol and then the MD (Medical Doctor) signs after".

Review of the Policy titled "Vitamin K and Eye Prophylaxis for Newborns" dated 08/01/14, documented: Item #2. All newborns should receive Vitamin K prophylaxis one (1) to six (6) hours after birth, Item #3. Erythromycin 0.5% ointment as prophylaxis for Ophthalmia Neonatorum and Item #4. These medications are available via the "Newborn Management Order Set" in the EMR. The Pediatrician or Authorized Provider will co-sign the Order within one (1) calendar day of delivery.

During interview at 1:50PM on 01/28/15, the Director of Maternal Child Services stated "New York States says we have to give it (the medications) within one (1) to six (6) hours of the baby being born. The Nurse gives it (the medications) "per protocol" and the Physicians then sign it within twenty-four (24) hours".

During an interview on 01/29/15 at 12:55PM the Chief Medical Officer stated "the purpose of the Vitamin K and Eye Prophylaxis protocol was to ensure safe and timely care" and "it was the belief of the Health Care System that the protocol met both CMS Requirements and New York State Education Law".
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VIOLATION: RESPIRATORY CARE SERVICES POLICIES Tag No: A1160
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Based on observation, record review and staff interview, the facility failed to develop and implement a written Policy for the processing and cleaning of respiratory care equipment used for Pulmonary Function Testing.

Findings:

During a tour of the Cardiopulmonary Department on 01/29/15 observations in the Physician Consultation Area designated for Pulmonary Function Testing, revealed there was no way to determine that the "Detachable V-Max Mass Flow Sensor" was new or had been cleaned after use.

An interview with the Director of Cardiopulmonary Services on 01/29/15 at 11:00AM revealed that the "Flow Sensor does not require sterilization after each use when using a filter but that it is his practice to have the 'Flow Sensor' cleaned after each use for a patient on Isolation, then by Central Supply monthly, but there is no current written Policy or Log documenting this is done".

Review of the Manufacturer's booklet titled "Care Fusion - Mass Flow Sensor - Cleaning Instructions" confirmed that "you do not need to sterilize the sensor after each use when using a bacterial filter", and that "low temperature ethylene oxide sterilization is acceptable" but "the most appropriate cleaning interval and decontamination method should be determined by your hospital".