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Based upon observation, record review (privileging files, policies and procedures, Medical Staff Bylaws, committee minutes) and interviews, the Condition of Participation for Governing Body is not met.

Review of the information provided by the facility during the conduct of the survey revealed the hospital does not have a Governing Body for Harlem Hospital Center.

Based on interview with the hospital CEO on 11/29/10 at 4:50 PM, and review of the meeting minutes of New York City Health and Hospital Corporation (HHC) Board of Directors it was determined that Harlem Hospital Center did not have a Governing Body that carries out the functions required under the Medicare Hospital Conditions of Participation (CoP).

On interview with the CEO, at 4:55, it was stated that the HHC Board of Directors of HHC was "the Governing Body of the hospital". Upon reading the meeting minutes for the January and February 2010 HHC Board of Directors meetings, it was found that Harlem Hospital Center was seldom mentioned. Based upon review of the meeting minutes, the business of the HHC was conducted, but not the business and Governing Body functions required under the Medicare hospital CoP for Harlem Hospital Center.

Additionally, the failure of the facility to have an effective Governing Body responsible for the conduct of the hospital is evidenced by findings found at:

482.12- ( See findings at A 046 & A 049).

482.13- ( See findings at A 115; A 121; A 130; A 143; A 144; A 154; A 164; A 165; A 168; A 169; A 186; A 214).

482.21 (See findings at A 285).

482.22 (See findings at A 338; A 339; A 341; A 355; A 357).

482.23 ( See findings at A 395; A 396).

482.24 (See findings at A 431; A 438; A 450; A 464; A 467).

482.28 (See findings at A 620).

482.41 (See findings at A 700; A 710; A 724) and K020; K021; K022; K025; K029; K033; K034; K038; K045; K046; K050; K052, K062; K072; K075; K076; K144 and K145.

482.42 (See findings at A 747; A 749).

482.51 (See findings at A 945).

482.52 ( See A 1001; A 1005).

Based upon review of facility Medical Staff Bylaws, personal files and interviews, the facility failed to provide evidence that the Governing Body was responsible for the granting of privileges to medical staff members of the hospital. Evidence includes the following:

An interview was conducted with the Harlem Hospital Medical Director, SP # 13 on 12/1/10 at 10 :45 AM after a review of the Harlem Hospital Center Medical Staff Bylaws. The Bylaws indicate that physicians may be granted temporary privileges once a review by the Medical Staff is complete and the President of the Medical Staff grants approval. The Bylaws do not require the hospital ' s Governing Body to approve a physician ' s temporary privileges prior to that physician providing care to patients. Additionally, a physician with temporary privileges is immediately appointed to the organized medical staff without being appointed by the hospital ' s Governing Body.

Personnel file for SP #36 was reviewed on 12/2/10 while in the presence of facility staff. The Chief of the department had requested temporary privileges as documented on 11/15/10. Privileges were granted by the Medical Director and Executive Director for 45 days beginning on 11/29/10.

The Medical Staff Bylaws provide that Physician Assistant ' s (PA), Certified Registered Nurse Anesthetist ' s (CRNA), and Nurse Practitioner ' s (NP) medical staff privileges are reappointed without approval by the hospital ' s Governing Body. The Bylaws provide that once a PA, CRNA, or NP are initially granted privileges, the reappointment or re-privileging process allows the President of the Medical staff to grant the privileges rather than the hospital ' s Governing Body.

Based upon record reviews and interviews, the facility failed to ensure that the medical staff worked within the scope of privileges granted as reference in A 0046 and is accountable to the Governing Body.

During the interview on 12/1/10 at 10:45 Am with SP #13, an interview on 12/1/10 at 12:00 PM with SP #35 and again with SP #13, it was revealed and confirmed that Physician Assistant ' s (PA), and Nurse Practitioner ' s (NP) medical staff privileges are reappointed without approval by the hospital ' s Governing Body. It was also stated that "allied health doesn't fall under the Bylaws of the Governing Body is at the Medical Board here and with the Executive Director".

Based upon medical record review, review of patients rights information, review of restraint policy, observations and interview, it was determined that the facility failed to meet the Condition of Participation for Patient Rights as evidenced by:

1. Failing to clearly explain the grievance process to patients. (See findings at A 121).

2 . Failing to provide evidence and notify patients of their right to participate in the development and implementation of their care plan. (See findings at A 130).

3. Failing to provide personal/auditory privacy for patients. (See findings at A 143).

4. Failing to ensure that patients received care in a safe setting. ( See findings at A 144).

5. Failing to ensure that all patients are free from unnecessary restraints. (See findings at A 154).

6. Failing to provide evidence that less restriction interventions were ineffective prior to the use of restraints. (See findings at A 164).

7. Failing to provide evidence that the restraints used is the least restrictive intervention to meet patient needs. (See findings at A 165).

8. Failing to ensure restraints were used in accordance with a written physician's order. (See findings at A 168).

9. Failing to ensure orders were not written for the use of restraints or seclusion on a PRN ( as needed) basis. ( See findings at A 169).

10 . Failing to provide documented evidence that less restrictive interventions were attempted. (See findings at A 186).

11. Failing to notify CMS timely of deaths associated with restraints/seclusion and failing to document according to CMS requirements. (See findings at A 214).

Based on patient interviews, record review, and staff interviews the facility failed to inform patients of the grievance process and failed to ensure implementation of its policy and procedure for complaints and grievance for 2 of 2 applicable sampled patients. ( PT # 32 and PT #33).
Evidence includes the following:

On afternoon of 12/01/2010 during a tour of the 11-th floor Surgical Unit, in the presence of the medication nurse, and the Assistance Director of Quality Management, patient #32 was loudly verbalizing concerns to staff person #19 stating "I am tired of not receiving the correct medications " .
Patient # 32 was admitted on November 09, 2010 secondary to a right ankle closed bimalleolar fracture (right ankle fracture). Medical history includes: Diabetes, Hypertension, Hypothyroidism, and End Stage Renal Disease that is being treated with Hemodialysis three times per week (M, W, F,).
Review of the patient ' s Admission Assessment Record indicates the following:
1. Mental status- oriented to person, place and time
2. Learning assessment: .... receptive readiness: motivated/ask questions abilities: understands verbal information
Review of the History and Physical record indicates the following:
1. Reconcile Meds: will obtain medicine consult and add additional medication if recommended
During an interview with patient #32 on 12/01/2010, between 3:30 and 4:30 p.m., patient #32 stated " since my admission I have been having trouble getting my medications (Synthroid, a thyroid hormone, Folic Acid, Calcium, Multi Vitamins). Patient #32 stated, " I was admitted on 11/09/2010, from 11/11/10 thru 11/13/10 I did not get my Synthroid. I told my Dialysis doctor about the medication problem and he said that he would call the unit and have them order them. Then, two days after speaking to my dialysis doctor they started giving me the Synthroid but they gave me Synthroid 150 mg and they gave it to me at same time as my Folic Acid pill. I told them, these pills should not be taken together because the Synthroid will be neutralized. I also I told them that Synthroid is supposed to be taken on an empty stomach but they kept giving it to me after breakfast. I told them that at home I take 750 mgs of Synthroid. Well, I said to myself, at least they are giving me the medications, even if it was the wrong dose. Then, they stopped giving me the Synthroid; I haven not gotten any in about week. I complained to everybody about not receiving my medications, I complained to all the nurses, on all shifts, I told my dialysis doctor, the surgical and medical doctors, I even told the lady that brings my food and no one did anything. "
The surveyor asked patient #32 if the facility provided information about how to file a hospital's complaint/ grievance. Patient #32 replied, no.
The surveyor asked patient #32 if any written or verbal information regarding " Patients Rights " had been provided, patient #32 replied " no, nothing was read to me, no one told me about my rights, I did not received an admission package. What I know about " patients rights " I received from my Dialysis Center-they gave it to me, they explained it to me, they made sure to put it into my wheelchair pouch".
During an interview with staff person #28 on the evening of 12/01/2010, it was confirmed that patient #32 had enlisted help to deal with the above mentioned complaints regarding the medications and signage issues ( the sign above the bed read and still reads "Visually impaired). An interview with staff person #28 revealed that on 11/17/2010 a worker from Guest Relationship was contacted by staff person #28 on behalf of patient #32. Staff person #28 stated "the patient feels that because the sign does not say legally blind, the hospital staffs are under the misconception that the patient can do more than the patient actually can do, therefore, they don't assist as the patient as they should. Staff person #28 states " the patient can only see shadows and some light".
On December 01, 2010 at approximately 11:40 AM, an interview was conducted with staff person #30, the Patient Representative assigned to the 11- th floor. The surveyor asked her to explain how patients are informed of their rights. Staff person #30 stated " they are given the information in the admission packet upon their admission". When asked, is there any special provision for the visually impaired patients, staff person #30 stated," for those patients, the information may be read to them, and it is also provided to their family members." Staff person #30 stated " We, as Patient Reps try to see all the new patients on our assigned units, we review the information in the Guest Relations pamphlet which includes review of the patients rights and responsibilities including Advance Directive Information".
The surveyor asked staff person #30 if patient #32 had filed any complaints or grievance during this admission. The Patient Representative replied, "yes, the Guest Relation Log shows that a call was made to the Guest Relations Department on 11/17/2010". The log shows that it was staff person #28 who contacted us on behalf of patient #32 and that it had to do with patient #32 not receiving certain medications. The log indicated that medications in question were the following medications: Synthroid, Folic Acid, Calcium, and Multi-vitamins. The log also list the patient's concern about the sign above the bed which read " Visually Impaired " but which the patient felt it should have said " blind " .
The surveyor asked the Patient Representative SP #30 why the Patient Complaint Log did not have PT #32 complaint(s) listed. SP #30 stated " It was not added to the Complaint list because all of patient ' s issues were resolved on the same day and the patient was content".
On 12/01/2010 between 3:30 PM and 4:30 PM, staff person #19, acknowledge that patient #32 medical records indicated that patient #32 last received Synthroid 150 mg on 11/25/2010. The surveyor observed staff person #19 enter the room of patient # 32, then in the presence of the surveyor and staff person #28 made the following statements: " So, it looks like the order expired and it appears that the order was not renewed, that is why you didn't get the Synthroid. The doctor is renewing the order and starting tomorrow morning, you will be getting it ( the Synthroid) in the mornings before breakfast".
Review of the booklet titled "Department of Guest Relations " bullet #1 states " Provides a Patient Advocate who will work on the patient's behalf to resolve issues and concerns that the patient may have while they are at Harlem Hospital Center."
Patient #33
On morning of 12/01/2010 during a tour of the 13 th floor Medical Unit, in the presence of the Assistant Director of Quality Management staff person # 31, patient #33 and a female staff member were observed in the patient ' s room, engaged a in loud conversation regarding the patient's belongings. Patient #33 requested the female staff member locate and provide the missing personal belongings.
Patient #33 has a medical history which includes: Dyslipidemia, End Stage Renal Disease, and Hypertension, Hepatitis B, and Polysubstance abuser. Patient #33 presented with complaint of vomiting, abdominal pain and generalized weakness and was admitted to ICU with diagnoses of Hyperkalemia / Metabolic Acidosis.
Review of the patient's Admission Assessment Record dated 11/28/2010 revealed the following:
1. Mental Status: oriented to person, place and time
2. Chief Complaint: chest pain and shortness of breath for the past two weeks
3. Visual Impaired- no
4. Hearing Impaired- no
5 Speech Impaired- no
6 Rights Packet Given? Yes, packet given and received by patient/SO
7 Advance Directive: no
8 Action Taken: Wish to complete new Adv Directive; referred to Guest Relations.
9. Property: sent to property office
As of 12/1/2010 there was no documented evidence that patient #33 had received assistance with completing a new Advance Directive.
Review of the booklet titled "Department of Guest Relations " bullet #2 states " Provide education to patients regarding their rights and responsibilities; this includes their right to participate in care or treatment " . Bullet # 7 states, " Assist patient in formulating Advance Directives and assigning a Healthcare Proxy " .
On December 01, 2010, at an interview with patient #33, the patient stated " can you help me? I have been trying to get my belongings; my stuff did not come to unit. I was in the Intensive care but I got transferred to this floor (13) but my things were not transferred. I need to call the people about my place. I want my belongings, I need my phone, and I do not want to lose my place at the shelter".
The surveyor asked patient #33 if any written or verbal information regarding " Patients Rights " had been provided, patient #33 replied, "no, they did not tell me anything".
The surveyor asked the patient #33 if an admission packet had been provided in the Emergency room or since the transfer to this floor (13), patient #33 replied, " no, I didn't get a admission packet, I did not get a thing. "
The surveyor asked patient #33 if a report or complaint had been made to the staff, specifically, to the Patient Representative, Social Worker or Nurse about the missing belongings. Patient # 33 replied, " Yes, I told the Social Worker and the Nurses " .
The surveyor asked patient #33 if the facility provided information about how to file a hospital's complaint/ grievance. Patient #33 replied, "no".
On 12/1/2010 at approximately 12:45 p.m., an interview was conducted with staff person #32 assigned to patient #33. Staff person #32 was asked to explain the Social Worker's role in the complaint process. The Social Worker stated, " I usually instruct patients to contact Guest Relations about grievances. Complaints are handled by the Guest Relations staff unless the complaint is health related. The Patient Representative attends the weekly Wednesday Discharge Rounds at which time they coordinate with the other interdisciplinary team members.
The surveyor asked the staff person #32 if a report regarding patient #33 missing belonging had been included in the report received from the staff. The response was, " no, but this patient was newly assigned to me and I have not had a chance to do my assessment as yet."
On 12/1/2010 an interview was conducted with staff person #33, the question was asked, how are patients informed of their rights at this facility? The response was that during the admission process patients usually receive the information in the admission packet and upon admission to unit either the clerk or the assigned nurse will give the packet to patient if they did receive one prior to their admission or transfer to the unit.
The surveyor shared with the staff person#33 that patient made the following assertions: no information on Patients Rights was given and no admission packet was provided. Staff person# 33 stated " I find that hard to believe " and then proceeded to patient's room to investigate the matter. Staff person # 33 was unable to find any evidence in the room indicative of information from the Guest Relation pamphlet or an admission packet documents.
The surveyor asked the staff person #33 if a reported regarding patient #33 complaints missing belongings, staff person #33 replied, " Yes, I am aware. Staff person #33 stated that between 11 AM and 12 noon a code was called on the unit (a medical emergency) and that patient #33 was told that the nurse would initiate an investigation after the situation with the " code " got resolved. The nurse stated, " I did follow up with patient #33 as I said I would. I explained the process for retrieving property from the property office. Patient #33 did not mention anything about the shelter, if it had been mentioned I would have helped sooner ".
Review of the booklet titled "Your Rights as a Hospital Patient in New York State" item number 17 found on page 13, states the (patient)..."complain without fear of reprisals about the care and services you are receiving and to have the hospital respond to you and if you request it, a written response. This same information is also found on page 19, item #17 of the booklet titled" Patient Guide to Good Health".

Review of the Patient Complaints, Concerns, Compliments, and Referral Mechanism policy and procedure date of 1/09, on page 2 section C states ..... " All patients will have access to the complaint process.
Review of the booklet titled "Department of Guest Relations " bullet #2 states " Provide education to patients regarding their rights and responsibilities; this includes their right to participate in care or treatment " . Refer to A 130).

Based upon review of the information provided to patients/families and/or responsible parties, and interview, the facility failed to fully inform the patients of their rights as it relates to participation in the development of their care plan. Evidence includes the following:

On 12/3/10, the booklet titled "Your Rights as a Hospital Patient in New York State" was reviewed. On page 13, item #14, indicates the patient has the right to "participate in all decisions about (your) treatment" but fails to inform the patient they have the right to participate in the development and implementation of their care plan. The booklet titled "Your Guide to Good Health" on page 19, item #14 also fails to inform the patient of this right.

Interview on 12/2/10 at 10:20 AM, with PT #1 revealed s/he was not aware the option to participate in the care plan was possible.

Based upon observation in the presence of facility staff, the facility failed to ensure personal privacy for 5 patients in the Urgent Care area, 1 patient on Unit 14 and all patients in the Pediatric Emergency Department triage room.

Evidence includes the following:

1. During a walk-through of the Urgent Care area on 11/29/10 at 1:45 PM, 3 patients were observed lying on stretchers in the hallway and 1 patient was standing outside the cubicle bay with full view of all hallway activities. None of the patients had been afforded visual privacy.

2. At approximately 2:00 PM on 11/29/10, 2 other patients were noted in room 12 and 13 lying in bed without the cubicle curtains and/or glass door being closed to provide personal & auditory privacy. When directed by surveyors, SP #4 addressed the privacy issues.

3. During a walk-through on the 14 th floor on 12/2/10 at 9:30 AM, the patient in room 14-116 was noted to be receiving a treatment without being afforded the opportunity of personal privacy.

4. During a walk-through of the Pediatric Emergency Department on 11/30/10 at 10:15 AM, it was observed that patients, family members and visitors can see through the opaque glass while patient's are been triaged and examined by the nurse. The facility staff stated that the reason one can see through the opaque glass was because the lighting inside the room is too bright, which defeats the purpose of the use of opaque glass.

These observations were all made in the presence of facility staff.

Based on observation and staff interview conducted from 11/29/10 to 11/30/10, it was determined that the facility failed to ensure that each patient received care in a reasonably safe environment.

The findings include:

On 11/29/10 at 11:45 AM., a tour was conducted of the adult emergency department (ED)with the Associate Medical Director for the adult Emergency Department, SP #34. During this time, it was observed that all walk-in patients, after entering the emergency waiting room area, had to follow on their own the written directions on the wall to go to the triage room, then proceed to the registration desk and were then seated in the waiting area for their name to be called.

The adult ED had two triage rooms and they were located in the hallway facing each other away from the waiting area.

It was observed that the waiting area where the patients entered the emergency department had no staff stationed to monitor the walk-in patients if they needed immediate medical attention.

If patients did not know or could not read that they had to go to the triage area they may have been seated in the waiting area for indefinite time waiting to be called in.

When this observation was shared with the Associate Medical Director she stated that the hospital is aware of it and are in the processes of staffing a greeter in the reception area to greet patients and offer assistance as needed.

The facility failed to ensure patients had a safe environment by failing to have mechanisms in place to call for assistance. Evidence includes the following:

During a walk- through tour of the Urgent Care Area on 11/29/10 at 1:45 PM, a female patient was noted lying on a stretcher in the hallway calling out for help. The tour escorts who accompanied the surveyors needed to respond to the patient calling out because there was no mechanism for the patient to call for help.

Further down the hallway, in room 140, a patient who had just been admitted, was noted to be lying on a stretcher at 1:50 PM. The patient was asked if staff had provided any orientation to the room to which the answer was "no". When asked how the patient would call if help was needed, the patient just shrugged her shoulders. Please refer to A 701.

Based upon facility restraint policy review, the facility failed to develop a policy and procedure that ensures all patients are free from the use of restraints. Evidence includes the following:

Review of the restraint policy, Section ADM 0575, page 6 states "Voluntary Restraint: When a patient requests restraints for reasons that are considered therapeutic, the restraint procedures shall be implemented according to the procedures outlines in this policy". The facility policy fails to articulate that before any device that meets the definition of a restraint is used, there must be a clinical assessment for the need of the intervention.

Based upon record reviews and interview, the hospital failed to provide evidence that any of the alternatives attempted prior to the use of restraints for 4 of 4 sampled patients were ineffective. The facility failed to document how the alternatives attempted did not meet the needs for ( Pt # 5, PT #6, PT #7 and PT #8). Evidence includes the following:

The 2/08 form titled "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #5 indicated in the first section of the form titled "Alternative Measures Tried Prior to Restraint" on 1/30/10 that medications and a quiet room were alternative measures tried prior to the use of bilateral wrist restraints. There was no documented evidence or assessment data that indicated these mechanisms were not effective and warranted the use of bilateral wrist restraints.

The 6/08 form titled "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #6 indicated in the first section of the form titled "Alternative Measures Tried Prior to Restraint" on 10/30 and 11/23 through 12/2/10 included reorientation, quiet room, and soft light as alternatives measures tried prior to the use of bilateral wrist restraints. There was no documented evidence or assessment data that indicated these mechanisms were not effective and warranted the use of bilateral wrist restraints.

The form titled "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #7 indicated in the first section of the form titled "Alternative Measures Tried Prior to Restraint" that measures attempted included environmental modification such as a soft light, frequent reorientation, and limit setting. There was no documented evidence or assessment data that indicated these mechanisms were not effective and warranted the use of bilateral wrist restraints from 11/15/10 through 12/2/10.

The form titled "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #8 indicated in the first section of the form titled "Alternative Measures Tried Prior to Restraint" environmental modification such as a soft light, medication, quiet room and frequent reorientation was attempted. There was no documented evidence or assessment data that indicated these mechanisms were not effective and warranted the use of bilateral wrist restraints from 11/26/10 through 12/2/10.

During a discussion with SP #9 while in the presence of other facility staff these findings were confirmed.

Based upon record review, observations and interview, the facility failed to ensure that restraints used were the least restrictive for 4 of 4 sampled patients ( PT # 5, PT #6, PT #7 and PT #8.) The facility failed to provide any documented evidence of the clinical rationale for the use of bilateral wrist restraints. Evidence includes the following:

The 2/08 form titled "Interdisciplinary Integrated Restraint Record" for PT #5 was reviewed and found no documented evidence that the bilateral wrists restraints were the least restrictive choice of physical restraints to meet the needs of the patient when ordered on 1/30/10 through 12/2/10.

The 6/08 form titled "Interdisciplinary Integrated Restraint Record" in the medical record for Pt #6 was reviewed. Restraints were ordered on 10/30; 10/31; 11/1; 11/23; and 11/24 through 12/2/10 without any documented evidence that the bilateral wrists restraints were the least restrictive intervention. On 12/2/10 at approximately 9:30 AM, PT #6 was observed lying in bed in a semi conscious state, without movement, while both wrists were restrained.

The "Interdisciplinary Integrated Restraint Record" for PT #7 was reviewed and found no documented evidence that the bilateral wrists restraints were the least restrictive choice of physical restraints to meet the needs of the patient when ordered/renewed from 11/15/10 through 12/2/10.

The "Interdisciplinary Integrated Restraint Record" for PT #8 was reviewed and found no documented evidence that the bilateral wrists restraints were the least restrictive choice of physical restraints to meet the needs of the patient when ordered/renewed from 11/26/10 through 12/2/10. Observation on 12/2/10 at approximately 9:35 AM, PT #8 was observed lying in bed with both wrists restrained.

These findings were discussed with clinical facility staff including SP#9 on 12/3/10 at 8:35 AM.

Based upon policy review, the facility failed to ensure initiation of restraint use was conducted by authorized staff only. Evidence includes the following:

A review of the restraint policy, Section ADM 0575 on page 4 under "Initiation of Restraints and Restraint Orders" states..."Initiation of Restraint in the absence of a physician: a patient may be placed in restraints only by/or under the direct supervision of a registered professional nurse". The policy fails to indicate that an RN may only initiate the use of restraints in an emergency according to CMS requirements.

Based upon review of the facility restraint policy, the facility failed to develop a policy and procedure that prevents the use of standing orders for restraints. Evidence includes the following:

A review was conducted of the hospital restraint policy. Located in section 0575, page 7, item " C. Release" states " ... When restraint is terminated early and the same behavior persists, the original order can be reapplied if less restrictive measures are ineffective. The RN must inform the physician and document the reason for discontinuing restraint and its reapplication, if that was necessary". The facility failed to ensure that new orders for restraint use are obtained after the device has been discontinued.

Based upon record reviews and interview, the hospital failed to ensure alternatives were attempted prior to the use of restraints for 2 of 4 sampled patients ( Pt # 6 and PT #7). Evidence includes the following:

The 6/08 form titled "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #6 was reviewed on 12/1 through 12/3/0. Noted in the first section of the form titled "Alternative Measures Tried Prior to Restraint" on 10/31/10 and 11/1/10 had no indicators of alternatives identified as being tried prior to the application of bilateral wrist restraints.

The "Interdisciplinary Integrated Restraint Record" from the Medical Record of PT #7 had no indicators of alternative measures identified as being tried prior to the application of the bilateral wrist restraints ordered on 11/19 and 11/24/10.

During a discussion with SP #9 while in the presence of other facility staff these findings were confirmed.

Based upon review of facility death reporting system and interview, the facility failed to meet all required CMS reporting components for deaths associated with the use of restraints. For 2 of 9 death reports reviewed, CMS notification was not timely and in 9/9 death reports reviewed, there was no documentation in the medical record of the notification to CMS. Evidence includes the following:

On 12/2/10 at 12:00 PM, 9 reports of deaths associated with restraints/seclusion were reviewed in the presence of SP #3. The facility staff failed to notify CMS timely of the deaths of 2 of the 9 sampled records. (PT#2 and PT#3.)

The death of PT #2 was noted by the facility on 9/28/10 and not reported to CMS until 9/30/10.

The death of PT #3 was noted by the facility on 11/1/10 and not reported to CMS until 11/3/10. Interview with SP#3 agreed that the reporting did not meet the required CMS time frames.

During the interview of 12/2/10 with SP #3, it was confirmed that the hospital does not record the time the death is reported to CMS in the medical record in accordance with CMS requirements.

Based upon review of the Medical/Dental Board Minutes and interview, the facility failed to provide evidence that priorities were set for the facility performance improvement activities. Evidence includes the following:

Review of the Medical/Dental Board minutes between January 2010 and September 2010 documented twelve committees responsible for reporting to the Board. They include the Anesthesia, Operative/Operating Room; Blood Transfusion; Cardiopulmonary Resuscitation; Ethics; GME; Infection Control; Hospital-wide Performance Improvement; Medical Records/Utilization management; Pharmacy & Therapeutics; Special Care Units; Wellness; and Credentials Committee.

Review of the Medical Board minutes do not reflect substantive deliberation about committee findings and recommendations. The Hospital-wide Performance Improvement Committee did not set any priorities for performance improvement. The committee did not bring any issue to the Board for deliberation between December 2009 and September 2010, even though the period included the May 25, 2010 publication of the New York Times article about thousands of unread echocardiograms. The Medical Board minutes do not document any reference to, or discussion of, the impact of the findings, the potential for similar delays in other departments, or a mechanism to ascertain whether diagnostic study reporting delays exist in other hospital departments.

During a review of the minutes, it was noted that the committee ' s representative to the Board had " no issues to report " during the December 2009 meeting; " no incidents to report " during the February 2010 meeting; " no issues to report " to the Medical Executive Committee of the Board during the April 2010 meeting; and " no issues to report " during the July 2010 meeting, even though the meeting took place two months after an audit revealed more than 7000 echocardiograms were either incompletely read or unread between 2004 and 2010. The September 2010 Board minutes also documented that there were " no issues to report " by the committee.

Based upon record and document review( Medical Staff Bylaws), and interview, the facility failed to provide evidence that it operated under the bylaws approved by the Governing Body and as a result the Condition of Medical Staff is not met as evidenced by :

Failing to have an effective Governing Body (See A 043).

Failing to appoint members in accordance with CMS requirements. (See A 046).

Failing to ensure accountability to the medical staff. (See A 049).

Failing to ensure that the Governing Body appointed practitioners to the Medical Staff
( See A 339).

Failing to make recommendations to the Governing Body. (See A 341)

Failing to have all required component for privileging incorporated into the Bylaws.
( See A 355).

Failing to provide a mechanism whereby recommendations regarding medical staff are provided to the Governing Body. ( See A 357).

Based upon review of the Harlem Hospital Center Medical Staff Bylaws and interview with the Harlem Hospital Medical Director, SP #13, the facility failed to ensure that practitioners are appointed by the Governing Body.

Please refer to A 046 and A 049.

Based upon review of the Harlem Hospital Center Medical Staff Bylaws and interview with the Harlem Hospital Medical Director, SP #13, it was determined that that Medical Staff failed to make appropriate recommendations to the hospital ' s Governing Body on the appointment of candidates to the hospital ' s medical staff that were specific to the type of appointment and extent of the individual practitioner ' s specific clinical privileges.

Evidence includes the following:
Please Refer to A 046, A 049.

Based upon review of the hospital ' s Medical Staff Bylaws and interviews the facility failed to ensure that the Bylaws stated all necessary duties and scope for practitioner categories. Evidence includes the following:

Review of the Bylaws on 11/29 through 12/3/10 revealed the document failed to include all required components for the hospital ' s medical staff privileging process. The Bylaws did not include the duties and privileges for the various categories of practitioners, such as the different types of surgeons, pediatricians, emergency physicians, CRNA, PA, NP, etc., that practice at the hospital.

During interview with SP #13 on 12/1/10 at 10: 45 AM, these findings were confirmed.

Based upon review of the hospital ' s Medical Staff Bylaws and interview, the facility failed to have necessary a system that would allow the medical staff to make recommendations to the Governing Body. Evidence includes the following:

Review of the Bylaws revealed the facility failed to include all required components of the hospital ' s medical staff privileging process in their Bylaws. The Bylaws did not include the criteria (qualifications) such as the training, education, current competencies, and other criteria that a category of practitioner, such as the different types of surgeons, pediatricians, emergency physicians, CRNA, PA, NP, etc., must demonstrate in order to be granted privileges in that category of medical staff.

This finding was discussed with SP #13 during the interview of 12/1/10 at 10:45 AM.

Please refer to A 355.

Based upon record review, observation and interview, the facility failed to evaluate the needs for 2 of 2 applicable patients from a sample of 33. ( PT #6 and PT # 21. Evidence includes the following:

During a walk-through tour on the 14- th floor on 12/2/10 at approximately 9:30 AM, PT #6 was observed lying in bed, rails up, with both wrists restrained. Patient was dependent on tube feedings, had an indwelling catheter and was semi conscious. Noted on the bedside table were 3 closed cans of Pulmocare feeding dated 12/2 and 3 other closed cans of Pulmocare of which 2 were dated 11/30 and 1 was not dated.

An interview with SP #10 was conducted on 12/2 at 10:40 AM. Staff was asked to provide evidence with the Intake & Output (I&O) documentation, that the patient had received the nutritional interventions as ordered for 11/30 since there were at least 2 unopened cans on the bedside.

Facility staff indicated the patient was not on I &O and could not verify the intake. SP #9 then found documentation in the medical record that the patient was actually on I & O although she was not aware of it before.

Review of the documented I &O revealed the following:
11/28/10 0700 hours- 1459 Intake was documented as "Parental 690" Output- 700
Intake was documented as "Tube 640"
11/28/10 1500 hours -2259 Intake was documented as " Parental 1" Output - No documentation
11/29/10 2300 hours - 0659 No documentation for either intake or output
11/29/10 0700 hours- 1459 Intake was documented as "Parental 51" Output- No documentation
11/29/10 1500 hours- 2259 Intake was documented as "Parental 101" Output- No documentation
11/29/10 2300 hours- 0659 Intake was documented as "Parental 1" Output - No documentation
11/30/10 0700 hours- 1459 Intake was documented as "Parental 52" Output - No documentation
11/30/10 1500 hours- 2259 Intake was documented as "Parental 1" Output - No documentation
11/30/10 2300 hours- 0659 Intake was documented as "Parental 1" Output - No documentation
12/01/10 0700 hours- 1459 Intake was documented as "Parental 1" Output - No documentation
12/01/10 1500 hours- 2259 Intake was documented as "Parental 1" Output - No documentation
12/01/10 2300 hours- 0659 Intake was documented as "Parental 51" Output - No documentation
12/02/10 0700 hours- 1459 Intake was documented as "Parental 50" Output - No documentation
12/02/10 1500 hours- 2259 Intake was documented as "Parental 101" Output - 850
Intake was documented as "Tube 460"
12/02/10 2300 hours- 0659 Intake was documented as "Parental 101" Output - 850
Intake was documented as "Tube 300" Output 300

Clarification of the medical record screen related to intake and output for PT #6 was requested of the clinical nursing staff. Staff was unable to explain the meaning of what was documented for intake, unable to explain what "Parental 1 or Parental 51 meant or why intake was not consistently recorded and tracked during the 12/2 interview. Nursing failed to supervise the intake and output of this patient who was medically and nutritionally compromised.

Review of the medical record for PT #6 noted that this patient was admitted on 10/26/10 with intact skin. A stage 2 decubitus ulcer was identified on 11/19/10. No photographs were taken as required by facility's policy until 11/30/10 when the ulcer had progressed to stage 3 measuring 7cm X 3 cm. Nursing documentation failed to assess the color, measurement, drainage and odor on 11/19/10 and 11/21/10. Nursing notes failed to adequately document the treatments. Nursing documented on 11/19/10, dressing on stage 2 ulcer on sacral area changed and on 11/21/10 sacral ulcer dressing intact. Nursing does not specify the type of dressing. The record showed a physician's order on 11/30/10 at 1711 for Anticoat ( an antimicrobial dressing) and Alleveyn dressing but it was not evident that the dressing was applied on that day.

Review of PT # 21, noted that the patient was admitted on 10/10/10 with skin intact. A stage 2 ulcer was identified on 11/17/10 measuring 8 cm X 3.5 cm. There was no physician's order for treatment for decubiti care until 6 days later on 11/23/10. There was no collaboration with dietary services as required by facility protocol following the skin breakdown until 11/30/10. Nursing failed to adequately document treatments. Nursing progress note on 12/1/10 at 0345 documents dressing to sacral ulcer changed. It is unclear what treatment was done.

Based on review of medical records and hospital policy, it was determined that the hospital failed to ensure that each patient ' s care plan was kept current in regards to pressure ulcers. This is evident in 3 of 4 records reviewed (PT # 20, PT # 21 and PT # 6).

Findings include:

During review of medical records and hospital policy conducted on 12/1/10 and 12/2/10 it was noted that nursing staff did not adhere to the hospital policy for skin integrity.

Review of PT # 20, admitted on 11/20/10 with stage 4 sacral ulcer of both buttocks and thighs measuring 38 cm X 38 cm that had black tissue and yellowish exudate. The staff failed to turn and position the patient Q2H as per physician ' s order from 11/26/10 at 1903 through 11/27/10 at 2200. There was a physician ' s order for wet to dry dressings on 11/21/10 at 0046. There was no documentation that wet to dry dressings were performed. The patient was transferred to a surgical floor on 11/30/10 and there was no specialty bed in place as of 12/3/10. The nursing care plan failed to address a plan of care for the sacral ulcer.

Review of PT # 21, noted that the patient was admitted on 10/10/10 with skin intact. A stage 2 ulcer was identified on 11/17/10 measuring 8cm X 3.5cm. There was no physician ' s order for treatment for decubiti care until 6 days later on 11/23/10. There was no collaboration with dietary services as required by facility policy following the skin breakdown until 11/30/10. Nursing failed to adequately document treatments. Nursing progress note on 12/1/10 at 0345 documents dressing to sacral ulcer changed. It is unclear what treatment was done.

Review of PT #6 noted that this patient was admitted on 10/26/10 with intact skin. A stage 2 decubitus ulcer was identified on 11/19/10. No photographs were taken as required by facility ' s policy until 11/30/10 when the ulcer had progressed to stage 3 measuring 7cm X 3 cm. Nursing documentation failed to assess the color, measurement, drainage and odor on 11/19/10 and 11/21/10. Nursing notes failed to adequately document the treatments. Nursing documented on 11/19/10, dressing on stage 2 ulcer on sacral area changed and on 11/21/10 sacral ulcer dressing intact. Nursing does not specify the type of dressing. There was a physician ' s order on 11/30/10 at 1711 for Anticoat and Alleveyn dressing,. There was no evidence that the dressing was applied on that day.

Based on medical record review , review of policies and interviews, it was determined that the facility failed to meet the Condition of Participation for Medical Records as evidenced by:

1. Failing to ensure that medical records were accessible. (See A 438).

2. Failing to ensure that medical records were legible, complete and timed. (See A 450).

3. Failing to provide evidence that consultative evaluations and other appropriate findings were in the medical records. ( See A 464).

4. Failing to ensure that medical records contained all necessary information to monitor the condition of the patient. (See A 467).

Based upon medical record review, review of facility documents, observations and interviews, the facility failed to ensure and provide evidence that medical records were accessible and complete. Evidence includes the following:

Review of a document "What's On Line- Network Wide" listed documents of the medical record that were in the electronic format. Documents listed that were not in the electronic format included cardiology results, consents, some flow sheets, psychiatric progress notes and restraint documentation.

On 12/2 on the 14- th floor while accompanied by facility staff, interviews were conducted by 2 survey staff. SP #10 was asked to find medical record documents for PT #6. While navigating the electronic record, SP #10 first stated that the patient was not on Intake & Output and unable to demonstrate where in the record the necessary documentation was recorded to support the nutritional and skin care needs of the patient. Other facility staff in the room provided suggestions to SP #10 as to where to try for the needed information.

When an Intake & Output screen was seen in the electronic record, SP #10 was not aware of this intervention. Medical information needed to monitor and provide care for the patient was not accessible in the medical record.

On 12/3/10 at 8:35 AM, information about the electronic medical record was discussed with SP #9 while in the presence of SP#8 and other facility staff. Staff was asked to explain how a clinician can review all necessary information pertaining to any patient without choosing separate panels for each area of the record or how clinician's are to review other clinicians assessment information in order to summarize care needs for any patient. When asked if all information necessary for a holistic view is possible with the electronic medical record system as it is now for any patient, the response was "no".

Based on review of medical records, it was determined that the facility failed to ensure the medical record entries were legible, completed or timed for 15 of 25 sampled patients. Evidence includes the following:

The facility failed to ensure Interdisciplinary Integrated Restraint Records were legible for 2 of 4 sampled patients. ( PT #6 and PT #7). Evidence includes the following:

Review of the Medical Record for PT #6 noted the date on the Interdisciplinary Integrated Restraint Record of 10/31/10 had been written over/altered.

Review of the Medical Record for PT #7 noted the date on the Interdisciplinary Integrated Restraint Record of 11/14, 11/19 and 11/24 all had been written over/altered.

The facility failed to ensure that medical records were complete for 5 of 5 sampled patients.
( PT # 5, PT #6, PT #7, PT #9 and PT #12).

Review of the Medical Record for PT #6 revealed the document to be incomplete. In section V of the Interdisciplinary Integrated Restraint Record dated 10/30/10 , the section that indicated whether or not an explanation was provided to the patient and/or significant other relative to the risks associated with the use of physical restraints was blank.

Review of the Medical Record for PT #7 revealed the document to be incomplete. In section V of the Interdisciplinary Integrated Restraint Record dated 11/25, 11/28 and 11/29/10, the section that indicated whether or not an explanation was provided to the patient and/or significant other relative to the risks associated with the use of physical restraints was left blank.

During review of medical records conducted on 11/30/10, it was noted that the Post-Anesthesia Evaluation form for general anesthesia has a check list of categories in which the practitioner drew a consecutive line through the check list to indicate that there was no sequela. This checklist does not provide clarity, completeness and lacks objective clinical information. This was noted in review of: PT # 5 for 2/10, 3/2 and 3/24/10; review of PT # 9 for 10/12/07; and review of PT # 12 for 2/23/07.

Also, for PT # 12 the Pre-Anesthesia evaluation, form HLM 202 was not complete. The section to notate that the anesthesia was discussed with the patient was left blank.

During review of medical records, conducted on 11/29/10 and 11/30/10, it was noted that there was insufficient documentation in the echocardiogram reports. Specifically, the indication for the echocardiogram report was not populated from the required field in the orders onto the reports. This was evident in 7 of 14 medical records reviewed (PT # 13, PT #14, PT #15, PT #16, PT #17, PT #18 and PT #19.

Interview with SP #16, Senior Associate Executive Director for Information Technology, on 11/30/10 at 10 am confirmed that the indication for the echocardiogram report is a required field in the order sheet, but for 5 MR ' s reviewed on 11/29/10-11/30/10, there was no indication listed on the echocardiogram report. (PT # 15, PT #16, PT #17, PT #18 and PT #19).

The facility failed to ensure that all medical entries on the Interdisciplinary Integrated Restraint Record were timed for 4 of 4 sampled patients.(PT #5, PT #6, PT #7 and PT #8). Evidence includes the following:

Medical Record review for PT #5 revealed the physician failed to record the time of the signature entered into the medical record on the Interdisciplinary Integrated Restraint Record dated 1/30/10, the time the patient was admitted to another unit on the anesthesia record for 2/24/10 and the time of the signature of the anesthesiologist on the pre-anesthesia evaluation dated 3/23/10.

Medical Record review for PT #6 revealed the physician failed to record the time of the signature entered into the medical record on the Interdisciplinary Integrated Restraint Record dated 10/30; 10/31, 11/1 and 11/23 through 12/2/10.

Medical Record review for PT #7 revealed the physician failed to record the time of the signature entered into the medical record on the Interdisciplinary Integrated Restraint Record dated 11/14, 11/15, 11/17 and 11/19 through 12/3/10.

Medical Record review for PT #8 revealed the physician failed to record the time of the signature entered into the medical record on the Interdisciplinary Integrated Restraint Record dated 11/26 through 12/2/10.

During an interview with SP#9 on 12/3/10 at 8:35 AM in the presence of other clinical staff, explanation was provided that all medical entries are to be dated and timed. Nursing stated that the time recorded on the restraint form was the time of the physician's signature. When asked to validate that a time entered onto the form compared with the physicians signature or the nurse notating the order, clinical staff confirmed the time was written by nursing and not the physician.

During review of medical records on 11/30/10, it was noted that post anesthesia evaluations were not timed. This was noted in 4 of 6 sampled patients (PT # 9, PT #10, PT #11 and PT #12).

For PT #9, the Post-Anesthesia Evaluation Form for general anesthesia on 10/12/07 was not timed. For PT # 10, the Post-Procedure Assessment for conscious sedation on 8/10/10 was not dated and timed. For PT #11, the Post-Procedure Assessment for conscious sedation on 9/8/10 was not timed. For PT #12, the Post-Anesthesia Evaluation Form for general anesthesia on 2/23/07 was not timed.

Based on review of medical records and hospital policies and confirmed by interview, it was determined that outpatient records did not document the results of appropriate findings by clinical staff involved in the care of the patient. This was evident in 3 of 8 outpatient records reviewed for follow-up of echocardiograms for PT # 3, PT #14, PT #22 and 1 of 2 outpatient records reviewed for follow-up of MRI ' s for PT #23.

Findings include:

During review of medical records, conducted on 11/29/10 and 11/30/10, there was no evidence that the results of echocardiograms and an MRI were known by the providers. For patients with PT #3, PT #14, and PT #22, it was noted that patients had visits for medical follow-ups, but there was no indication that test results were known by the providers during patient visits. Interview with SP #6, Director of Clinical Services for Medicine, on November 30, 2010 at 10 am confirmed that for the echocardiograms PT # 14 and PT #22 reviewed on November 30, 2010 at 10 am, providers were unaware of the results.

Review of PT #3 on 11/29/10 noted that an outpatient dobutamine stress echocardiogram was read by the cardiologist on 10/15/10. At the next Medicine clinic visit on 10/26/10, there was no mention of the echocardiogram in the visit note.

Review of PT # 14 on 11/30/10 noted that an outpatient 2D echocardiogram was read by the cardiologist on 9/7/10. At the next Medicine clinic visit on 11/24/10, there was no mention of the echocardiogram in the visit note.

Review of PT #22 on 11/30/10 noted that an outpatient 2D echocardiogram was read by the cardiologist on 8/21/10. At the next Medicine clinic visit on 11/12/10, there was no mention of the echocardiogram in the visit note.

Interview with SP # 16, Senior Associate Executive Director for Information Technology, 11/29/10 at 10 AM noted that the hospital's electronic health record system does not currently have the capability for a reminder system to notify the physicians who order echocardiograms that the test has been done and/ or was normal/ abnormal.

Review of PT #23 on 12/2/10 noted that this 17 year old patient had an outpatient MRA brain on 9/13/10. There has been no clinic visit since, and no appointment has been made for follow-up of the MRA. Also, the MD who ordered the test on 8/12/10 did not enter an assessment note regarding this patient encounter, but had entered only that the indication for the study was for right forehead headache. The study showed that "the less likely possibility of tiny cerebral aneurysm cannot be excluded on the basis of this study alone; clinical correlation is suggested" .

During review of medical records and hospital policy, conducted on 12/1/10 and 12/2/10, it was noted that the results of MRI's were not promptly filed in the MR so that health care staff involved in the patient's care can access this information in order to monitor the patient's condition and provide appropriate care. Specifically, staff failed to meet the required
turnaround time for completion of MRI's. This was evident in 3 of 8 medical records reviewed for follow-up of MRI's (PT # 24, PT #25 and PT #26).

Findings include:

Review of PT #24 on 12/1/10 noted a brain MRI was read in 48 hours that is over the 24 hour required time frame. Policy titled "Completion of Radiological Procedures" requires that there is a 24 hour time frame from completion of an MRI procedure to approval of the report. A brain MRI was done by the radiology technician on 9/25/09 at 2014. The test was read by the radiologist on 9/27/09 at 2153.

The medical record for PT #25 noted that a brain MRI was read in 48 hours. The test was done as an inpatient on 9/5/10 at 1355, and read by the radiologist on 9/7/10 at 1222.

The medical record review for PT #26 noted that a brain MRI was read in 40 hours. The test was done as an inpatient on 10/19/10 at 2003, and read by the radiologist on 10/21/10 at 1313.

During review of medical records and hospital policy, conducted on 12/2/10, it was noted that attending physicians did not co-sign residents' notes in the required time frame. This is evident in 4 medical records (PT #26, PT #27, PT #28 and PT #24).

Review of the medical record for PT #26 noted that the attending co-signed the resident's notes in 2 to 3 days that is over the requirement to co-sign daily. Policy titled "Assessment and Reassessment of Patients" requires progress notes to be signed daily including attending signature. The resident (PGY1) signed a progress note on 10/20/09 at 2202, and the attending co-signed the note on 10/23/09 at 1940. In another note, the resident (PGY1) signed a progress note on 10/21/09 at 2027, and the attending co-signed the note on 10/23/09 at 1951.

Review of the medical record PT # 27 noted that the attending co-signed the resident's note in 2 days. The resident (PGY1) signed a progress note on 11/7/09 at 1110, and the attending co-signed the note on 11/9/09 at 1504.

Review of the medical record PT # 28 noted that the attending co-signed the resident's note in 6 days. The resident (PGY1) signed a discharge summary on 11/23/10 at 1804, and the attending co-signed the note on 11/29/10 at 1026.

Review of the medical record PT # 24 noted that the attending co-signed the resident's note in 2 days. The resident (PGY1) signed a discharge summary on 9/26/09 at 0736, and the attending co-signed the note on 9/28/09 at 0916.

Based on staff interview and review of records, it was determined that the director of the food and dietetic services failed to take responsibility for the daily management of the dietary services.

Findings include:

Interview with SP #38, Director of Food and Nutrition Services on 11/29/10 at 11:30AM and review of records, revealed that food served to patients is delivered from Kings County Cook Chill facility to Harlem Hospital between the hours of 9:00PM -12:00 AM for the next day meal service. The cook chill food is delivered to the kitchen and placed in the walk- in refrigerator by the truck driver accompanied by hospital police. The food is delivered to the facility outside of the food service department operational hours and there is no food service personnel assigned to receive the food at night.

Review of the dispatch/delivery temperature sheets indicates that food temperature is not recorded and that only the truck temperature at dispatch time, truck temperature at arrival time and receiving refrigerator temperature at location is recorded. It was noted that a copy of the dispatch/delivery temperature is not left at the facility on the day of the delivery. The dispatch /delivery temperature is sent to the food service department at the end of the week from the cook chill plant.

The temperature of the cook chill food delivered to the facility at night is not taken to ensure that the food is safe to be used for the next day meal. The ambient air temperature of the truck is taken, not the actual temperature of the food.

16628

Based upon observations, interviews and review of the facility's policy and procedures and other facility documents, it was determined that the facility failed to be constructed, arranged and maintained to ensure the safety of patients. Therefore the accumulative effect of the Hospital Regulation standard level deficiencies as well as the Life Safety Code deficiencies is that the Condition of Participation for Physical Environment is not met as evidenced by:

1. Failing to maintain the physical plant to assure patient safety and well-being. ( See A 701).

2. Failing to maintain supplies and equipment. ( See A 724).

3. Failing to meet LSC standards. ( See K20, K21, K22, K25, K29, K33, K34, K38, K45, K46, K50, K52, K62, K72, K75, K76, K144 and K 145).

16628

Based on observations, record review, and interview during tours of the facility between 11/29/10 through 12/3/10 the hospital did not ensure that the condition of the physical plant and overall hospital environment was developed and maintained in a manner to ensure the safety and well being of patients.

Findings include:

During a tour of the Operating Room suite (OR) on the morning of 11/29/10 the following environmental deficiencies were identified:

1. Interview with facility staff indicated that the hospital uses the American Institute of Architects (AIA) industry standard for humidity and temperature control. For humidity the range is 30-60%. Temperature and humidity circular chart records for the week of October 22-29, 2010 showed humidity greater than 60 % in ORs 1,3,4, 5, 10, 11 and 12 from Monday through Thursday i.e., October 25 -28, 2010. (ORs 6, 8 and 13 are not currently in use) The temperature and humidity recording device in OR # 2 was not functioning properly in that it was not recording humidity. The circular chart for OR # 7 was blank showing that no temperature or humidity data was recorded. Circular charts are removed each week and replaced. Although the recording devices in OR # 2 and # 7 were not recording data appropriately no action was taken to repair them. The circular chart for OR # 10 for the week of 11/19-11/26/10 was blank indicating that no data recorded that week. Documentation for calibration of the temperature and humidity recorders was requested but not provided.

2. During the tour of the OR suite the door to the housekeeping closet was opened and two staff members, whose job it is to clean the ORs between cases, were observed sitting on chairs inside the closet.
3. Overhead HVAC supply ventilation vents, in the ORs throughout, were noted painted over restricting air flow.

4. In OR # 1 two bean bags, in a metal cabinet, used for positioning patients on the operating table, were noted soiled. The bean bags prevented closure of the cabinet doors. The door handles were tied together with gauze.

5. The exhaust vent in OR # 3 was noted soiled and dust laden.

6. The ceiling mounted stainless steel medical gas and electrical receptacle columns were noted soiled with a splatter pattern.

7. The wall of the ORs were noted tiled with grout being used between the tiles. The exposed grout was noted cracked and broken The grout between the tiles is not easily washable and the cracks and crevices may retain dirt and bacteria.



During a tour of Central Sterile Supply on the afternoon of 11/29/10 the following environmental deficiencies were identified:

1. The air flow in the clean work room was negative rather than positive as required.

2. The HVAC exhaust vents (in the prep and pack area) were dust laden.


During a tour of the 18-th floor mechanical room on the afternoon 12/2/10 and the morning of 12/3/10 the following environmental deficiencies were identified:

1. On the afternoon of 12/2/10 the corridor outside the 18-th floor mechanical room was noted flooded.

2. A return visit was made to the 18-th floor mechanical room on the morning of 12/3/10. Some residual water from the previous day was noted on the floor in the corridor just outside the mechanical room. The bottom 12" of the sheetrock walls were noted warped and the floor was noted pitted suggesting an ongoing problem with flooding in this area. Concurrent interview with SP #15, confirmed that there has been flooding in this area from the roof above. The 18-th floor mechanical room is located directly above the 17-th floor Pediatric Intensive Care Unit (PICU) where flooding was noted on the afternoon of 12/1/10.

3. Pooled water was noted on the floor inside the mechanical room. Concurrent interview with SP #15 indicated that the evaporator coils of the heating, ventilation and air conditioning (HVAC) unit leak and are in need of replacement.

4. Water was also noted pooled around two floor pumps used for the reverse osmosis (RO) filtration system. Interview with SP #15, indicated that occasionally the RO needs to "drain down". As there is no drain in the floor, when the RO is drained down, it drains directly onto the floor of the mechanical room.

Based on review of ventilation records on the morning of 12/3/10 the hospital did not ensure that it's HVAC system and monitoring equipment is maintained to assure the safety and well being of patients:

Findings:

1. Temperature and humidity circular recording charts showed humidity in the burn unit greater than 90% on 10/27/10.

2. Humidity was not recorded on the circular recording chart for birthing room 4170 the week of 11/19- 11/26/10.

3. During the week of 11/19-11/26/10 the temperature in the adult intensive care unit (AICU) was at or greater than 80 degrees Fahrenheit. Humidity was greater than 70% 11/22 and 11/23/2010.

4. The circular charts for the adult emergency department (ED) for the week of 11/19-11/26/10 showed that five out of seven days had not been recorded.

5. Documentation for calibration of the temperature and humidity recorders was requested but not provided






21204


Emergency Department ED:

1. On the morning of 11/29/10, during a tour of the Adult Emergency Department (ED), it was found that the nursing call bells were not working in all the patients ' private rooms (four rooms); the patients ' treatment cubicles (10 cubicles) and 6 rooms in the urgent care area.

2. On 11/29/10 at approximately 11:15 AM, the Nurse Supervisor of the Adult ED, SP #14, was asked to activate the nursing call bell in isolation room# 14. The call bell did not work. Then, the Nurse Supervisor was asked to check the nursing call bells in all the private rooms and patients ' treatment cubicles. None of these rooms or cubicles had working call bells.

3. On the morning of 11/29/10, the patients in room 11 and 12 were asked what they would do if they need help or assistance. Each patient said " I do not know " , and when asked whether they received any kind of orientation to the room or what to do if help was needed, each one of them said " I did not get any orientation to the room " and they did not know what to do if assistance was needed.

4. During an interview with the Associate Director of Facilities Management, SP #15 stated that the call bell system in the hospital is checked every morning by the nurses and checked every month by an outside contractor called Naztech.

5. The hospital provided their documented evidence of checking or testing the nurse call system in the ED. Evidence noted that SP #29 conducted the audit in the Adult Emergency Room on 11/3/10 there were no call bells working in 3 of the 9 areas tested ( #2, #3 and #7) nor were call lights over the doors working and this had been reported to SP # 4. Audits were repeated on 11/12, 11/14, 11/23, 11/25 and 11/28 with the same areas ( #2, #3 and #7 still identified as non working. On 11/29/10, another audit as conducted and identified areas #1 - 14 and "F", "E" "D" and "C" also with non working call lights and over door working lights. Audits were also done in the triage areas that noted areas 107, 108, 110, and bathrooms also failed to have properly working lights and or call bells. The facility was aware of the non-working equipment as reported.

6. On the afternoon of 11/29/10, during a tour of the Pediatric Emergency Department, it was observed that none of the patients ' treatment rooms or cubicles had any mechanism in place to call for assistance in the event that the patient needed help or assistance.

7. The patient bathrooms of the Adult ED and the bathrooms of the waiting area of the Adult ED were found to be not functioning on the morning of 11/29/10. Additionally, the nursing call buttons were mounted approximately four feet above the floor in bathrooms in the waiting area. Therefore, those call bells in the referenced bathrooms were not accessible to patients who might collapse on the floor.

8. The electrical outlet in front of the nursing station of the Adult ED was found to have exposed electrical wiring and not covered or secured. This finding carries a potential risk and safety hazard.

9. On 11/29/10 at 11:00 AM, a fan was observed in the corridor in front of the nursing station. That fan was noted to be dirty, dust laden and blowing air directly toward the nursing station.

10. Two patients were observed on stretchers being treated on the corridor outside room F and room E in the Adult ED. It should be noted that the clear width of the corridor after the stretchers was less than 4 feet.


11. On the morning of 11/29/10, the floor of the trauma room was observed to be very dirty with multiple black stains and many caps of vials and syringes. Also, there was a dirty pair of scissors in the hand-washing sink of the trauma room. The above finding was in the presence of the Nurse Supervisor and the ED Administrator SP # 4 who acknowledged the finding.

Psychiatric Unit
On 11/30/10, during a tour of the inpatient Psychiatric Unit, the following findings were identified:

1. The piano hinges of the cupboards in all the patient rooms did not extend to the top of the cupboards, leaving 2 inches of space and presenting a looping hazard for the psychiatric patients in the unit.

2. The paper towel dispenser of bathroom # 10-138 was noted to be broken and had sharp edges that could be used by patients to harm themselves or others.

3. Three screws on the side of the night stand in patient room#10-146 were observed to be protruding, loose and not secured which present patient safety hazard.

4. There were four protruding screws above the hand-wash sink in room 10-133. They were not mounted flush to the surface and were not safety screws. This presents a patient safety hazard.

5. Shower room # 10-134 was noted to be divided into three small rooms; the middle room did not have a door which presents a privacy and patient rights concern. The doors of the other two rooms did not have piano hinges; instead they had regular hinges that present a loop-able risk.

6. There were two screws that were observed to be protruding few millimeters on the surface of the wall next to the hand-washing sink just outside of shower room # 1-134 A. Additionally, there were four screws that were used to affix a sign that said " Hand Washing Technique " above the hand-washing sink that were protruding few millimeters above the surface of the wall. They were not safety screws. This presents a potential risk to patient safety.

7. Room # 10- 149, (the activity storage room) was observed to have exposed electrical wiring and a temporary light bulb attached to the wiring and hanging from the ceiling. This presents a fire and safety risk. Also, two ceiling tiles were noted to be missing from the ceiling of room 10- 149.

On the afternoon of 11/30/10, during a tour of the North Side of the Psychiatric unit, the followings issues were identified:

8. The commode in the patient bathroom in the dining area was clogged with dirty paper towels, was full of feces, smelled very bad, looked very dirty and had not been cleaned for a long time.

9. The multipurpose room of the North Side of the Psychiatric unit was found to be missing one ceiling tile above the door 10 -107 B.

10. Restroom # 10-108 A had two screws that were not of the safety type, and were protruding above the surface of the wall. This presents a potential risk to patient safety.

11. The magnate plate that holds the smoke doors to the wall next to room 10-129 was found to be unsecured, loose and needing repair.

12. The metal access door next to the hand washing sink in room # 10-121 C was noted to be loose and one of its edges was bent and pointing above the surface of the wall, that needed to be secured for patient safety.

13. The cover for the sprinkler head in the activity storage room #10-126 was noted to be missing.

14. The doors of the two shower rooms in room #10-123 did not have piano hinges; instead they had regular hinges, which present a loop-able risk for the psychiatric patients.

Pediatric Intensive Care Unit (PICU):

1. On 12/1/10 at approximately 3:15 pm, during a walk-through tour of the Pediatric Intensive Care Unit (PICU) on the 17-th floor the following issue was identified:
A water flood was observed on the area of the nursing station and there was an active leakage of water dripping from the ceiling around the light fixture, the nurses were using basins and other plastic containers to collect the water. Also, there were many Chux on the floor around the containers that were saturated with water.

Also, there were two other locations of water floods on corridors outside the PICU; one of them was in front of the exit door 17 F.

During interview with the Head Nurse of the PICU SP #20, the Director of PICU, SP #21 and the Chief of Pediatrics, SP # 46, all stated that the water leakage is an ongoing problem and that they had this problem for years, and that they have complained to the administration many times, but the problem was never corrected. This observation and interview was made while accompanied by facility staff persons SP #22, Supervisor of Mechanics who acknowledged the problem and said the water is coming from 19th floor - (the roof), to the 18th floor to the 17th floor.

Radiology:

1. During a tour of the radiology area on 12/2/2010 at approximately 11:30 AM, it was noted that the buttons of the call bells in two patient bathrooms, did not have a sound indicator or annunciation, and they were mounted at > 3 feet above the floor and did not have a string or cord that make them reachable to the patients who might be on the floor.

2. The waiting area of the radiology did not have illuminated exit signs to direct patients and staff to the exits in the event of fire or smoke conditions. That area had paper exit signs that were not illuminated and would not be readily visible in the event of smoke condition.

3. On 12/3/2010 during a tour of the CT scan trailer next to the emergency room, the followings were identified:
- No illuminated exit signs were provided in the exit passageway of the CT scan trailer.
- No illuminated exit signs were provided in the CT scan trailer to direct the patient and staff to the exit door in the event of fire or smoke condition.
- There was no radiology permit mounted or available for the CT scan and there was no documented evidence available to indicate that that CT scan trailer was approved for use by the New York State Department of Health.
- There was no soiled, clean utility room, or janitor closet to serve the CT scan trailer.
- The echo suite did not have exit signs to guide patients and the staff to the exit doors and way especially in the fire or smoke conditions.

Maternity Department:

1. On 12/3/2010, at 11:45 AM, the nursing call bell in room 4146 of the Maternity Department was tested by the Head Nurse, SP #23 and there was no audio signal produced, the state surveyor and the facility persons waited for 4 - 5 minutes, but no one from the hospital staff came to the room to check the bathroom.

Catheterization Lab:

1. On 12/3/2010, at approximately 12:15 PM, the soiled utility room of the Catheterization Lab, was noted not to have a hand washing sink as required for this type of room.


Coronary Care Unit

1. On 12/2/10 at 10:30 AM., during a walk-through of the Coronary Care Unit clean utility room, the metal cabinet shelves were found to be rusty and poorly maintained. Intravenous solution bags were stored in the cabinet and some of the bags were in direct contact to the rusty spots. This observation was made in the presence of facility staff.

Based upon observations, the facility failed to maintain equipment in an acceptable level of quality. Evidence includes the following:

During a walkthrough tour on the 14-th floor on 12/2/10 at 9:30 AM, a staff person was noted to be cleaning down an unoccupied patient care unit in 14-137. While in the presence of facility staff, the outer material in center of the mattress was noted to have a large oval shaped tear approximately 6 inches in length and 4 inches in diameter. The outer covering left the inner material open and exposed to possible infectious material. Please refer to A 0749.

Noted in bedside area 14-138 during the same walk through tour was a bedside table missing the bottom drawer. The facility failed to provide equipment acceptable to meet the needs of patients.






08202

Based on observations and interviews conducted from 11/30/10 through 12/02/10, it was observed that the facility failed to ensure that all equipments are fully functional and operable during an emergency situation..

The findings include:

During a walk-through of the Pediatric Emergency Department area on 11/30/10 at 10:30 AM. it was observed that the following rooms did not have the suction set hooked up to the wall suction functional and ready in case of an emergency.

Area - B which is an asthma bay area consists of 2 wall suction set ups. Both of them were not ready and functional. The suction equipment did not have the tubing, collection container and the suction catheter hocked up to the wall unit.

Area - C This area had one wall suction set. The suction equipment did not have the tubing, collection container and the suction catheter hocked up to the wall unit.

Examination RM #1 had one wall suction set and the suction equipment did not have the tubing, collection container and the suction catheter hocked up to the wall unit.

Examination RM #2 had one wall suction set and the suction equipment did not have the tubing, collection container and the suction catheter hocked up to the wall unit.

These observations were all made in the presence of the Assistant Executive Director of Quality Management, SP # 39.

Based upon observations, staff interviews, review of policies and procedures, medical record reviews and document reviews conducted from 12/01/10 to 12/03/10, it was determined that the hospital failed to protect the patient population by not placing patients with suspected tuberculosis in airborne isolation rooms.

The hospital's failure to implement the appropriate infection control interventions in order to prevent and control management of infections and communicable diseases showed a lack of compliance with the Condition of Participation at 42 CFR 482.42 Infection Control. As a result, these deficient practices posed an immediate and serious threat to patients.

A plan of correction was required before the immediate jeopardy determination could be lifted. The determination was made on 12/03/10 at 4:15 PM, and the immediacy was corrected on 12/03/10 at 7:10 PM, at which point an acceptable plan of correction was received.

An associated deficient practice still remains at the condition level for the same Condition of Participation at 42 CFR 482.42 Infection Control.


This Deficient Practice was evidenced for sampled PT #4.

The findings include:

1. PT #4 is a 50 year old male who came to the emergency department on 11/29/10.

a. ED triage Assessment dated 11/29/10 at 1436 states the following::

Chief complaint: "Still having pain in my hemorrhoids, coughing".

Vital signs:
BP: 93/66
HR: 127
RR 18
Temp: 100.1 (oral).

TB alert:
Cough: Yes.
Fever: Yes.
Night sweats: Yes.
Weight loss: Yes.

SARS (Severe Acute Respiratory Syndrome) alert:
Fever: Yes.
Cough:Yes.
Travel Hx: none.

b. Medical admitting resident's assessment note dated 11/29/10 at 1858 states,

Middle aged male from Honduras, recently diagnosed with HIV, who presented with general feeling of being unwell, weakness and dry cough for the past two months. Review of investigations showed hyponatremia, CT of the abdomen showing lymphadenopathy, and (+) Hep B cAb (Hepatitis B core Antibody), (+) RPR (rapid plasma reagin). HIV with possible lymphoma.

TB alert:
Fever: Yes.
Cough: Yes.
Night sweats: Yes.
Weight loss: Yes.

Primary diagnoses:
Human immunodeficiency virus disease. External hemorrhoids without mention of complication.

Plan:
To Admit
ID (Infectious Disease) consult.
R/O PTB (Pulmonary Tuberculosis) with airborne isolation.

c. Infectious Disease Consult note dated 12/01/10 at 0945 states:

"50 year old man originally from Honduras with history of newly diagnosed HIV in October 2010 was admitted on the medical floor on 11/30/2010 with impression of CAP (community acquired pneumonia) and also being treated for PCP.

He presented to the ER with a 2 month history of cough productive , generalized weakness, subjective fever, night sweats and chills and rigors for past few weeks. His ET (excessive tolerance) also reduced to less than a block from 30 blocks limited by SOB.

Reports loosing 48 lbs weight in less than 3 months period of time".

Impression:
AIDS
PCP/CAP
R/O pulmonary TB
Oral thrush



A review of the Harlem Hospital Center procedure manual titled Tuberculosis: Preventing the Transmission of - Effective as of March 15, 2001 states:

Purpose:
To offer guidelines for the appropriate management of suspected and diagnosed patients with tuberculosis and reduce the risk of exposure to staff and persons visiting our network.

Policy:
It is the policy that patients with known or suspected Tuberculosis will be screened to enable early intervention and reduction of the risk of transmission.

Inpatients:
All inpatients with suspected or confirmed tuberculosis should be admitted to airborne isolation rooms and evaluated by a physician knowledgeable about tuberculosis.

On 12/02/10 at approximately 8:30 AM., while reviewing the daily isolation list with the infection control Senior Associate Director SP #11 on the 12-floor it was observed that Room 135 was a four bedded room. The room was occupied by four patients including PT #4. PT #4's diagnoses included R/O Pulmonary Tuberculosis with Airborne isolation.

The other three patients in room 135 were PT #29- Diagnoses of End Stage Renal Disease, Diabetes Mellitus, PT #30- Diagnoses of Hypertension, Diabetes Mellitus and Chronic Alcoholic Abuse and PT #31- Diagnoses of Ulcerative Colitis.

An interview with the infection control Senior Associate Director on 12/02/10 at approximately 8:40 AM, revealed that this patient with the given diagnoses of R/O should not have been placed in a four - bed room with three other patients. She did not know how this could have happened.

During an interview with the charge nurse SP#12 on the 12 th floor, he acknowledged that PT #4 who is being ruled out for pulmonary TB should have been placed in a negative pressure single room. Upon arrival to the floor he also stated that he is working on moving this patient to room 146 which is a single room equipped with negative pressure.

Since his admission this patient was maintained in a four bedded room with three other patients since his arrival to the floor on 11/30/10. On 12/02/10 at 1:00 PM, PT #4 was finally moved to room 146 a negative pressure room .

When the surveyor's findings were brought to the Medical Director, SP # 13, he acknowledge that there was very serious break in infection control practice. Effective 12/3/10 the following procedures were made by the Medical Director:

When a diagnosis of R/O TB is made the admitting resident will immediately notify the unit's Head Nurse to place the patient on airborne isolation and write an order to that effect.

If a negative pressure isolation room or filter are not available the patient will be moved to a single bed room with a HEPA filter.

If such a room or filter are not available, arrangements will be made to transfer the patient to another facility.

Based upon observation and interview, the hospital failed to maintain a system to mitigate risk of infections and communicable disease. Evidence includes the following:

During a walk- through tour of the Pediatric Urgent Care area on 11/29/10 at approximately 2:00 PM, on the left side of the corridor an electrical appliance was noted with 2 plastic-like hoses, one of which was blowing cold air. One hose was affixed to the unit by duck tape- a material that is unable to be effectively cleaned to prevent the spread of hospital infections and communicable diseases. This observation was made while accompanied by facility staff. When asked how the unit is cleaned, SP #7 indicated that housekeeping is expected to wipe the unit down but was unable to discuss how the tape could be cleaned and confirmed the material in the duct tape would not be able to be properly cleaned.

During a walk- through tour on the 14 th floor at 9:30 AM on 12/2/10, the bed in room 14-137 was being cleaned by facility staff. When questioned, the staff person indicated the solution s/he had in the container was Virex ( a disinfectant cleaner). Observation of the bottle noted a clear-like liquid inside the container with the markings on the outside of the container that read "Barney's of New York". Further questioning of the staff person confirmed that the container should have had the applicable label of the solution being used. This observation was made while accompanied by facility staff.


21204


On the morning of 11/29/10, the soiled utility room of the Adult ED was found to have a positive air flow instead of negative air flow that is required for this type of room. The soiled utility room was observed to be cluttered and the hand - washing sink was covered with and obstructed by three instrument containers. This finding carries infection control concern.

The medication room # 138-ED was found to be very stuffy, hot and did not have a positive air flow as is required for this type of room.

On the afternoon of 11/29/10, the Hepa Filter in the isolation room of the pediatric ED was found to be very filthy and had a layer of black greasy dirt. This finding was acknowledged by the Head Nurse of the pediatric ED and the Associate Director of Facilities Management.
The above findings were acknowledged by the SP #25, Director of Facility Management who was escorting the state surveyor.

Acute Hemodialysis

Based on document review and staff interview, the hospital failed to maintain the portable reverse osmosis (RO) machines as per the facility's policy and procedure and per the manufacturer's recommendation to ensure the patients safety and wellbeing.

Findings include:

On the afternoon of 11/30/2010, review of the hemodialysis records revealed the following:

1- There was no documented evidence to ensure that the staff changed the carbon filters of the portable Reverse Osmosis (RO). The carbon filters remove chlorine and chloramine from the water to prepare the dialysate. RO is required to be changed periodically by the manufacturer ' s recommendation and the hospital policy.

During an interview with the Senior Biomedical Technician SP #25 and the Head Nurse of the Dialysis SP #26, they stated that the carbon filter must be changed after each patient treatment. Also, they acknowledged that the changes of carbon filters have never been documented.

2- There was no documented evidence that the staff tested for the conductivity and the pH of the dialysate before each patient treatment using an independent meter as required.

3- The facility did not take corrective action in a timely manner to fix the problems of water cultures that were outside the range of acceptable limits. Examples included but were not limited to: - On 9/1/10, the monthly water cultures of the RO #4 were higher than the maximum allowable limit of the endotoxins. (LAL result was 1.75 EU/ml vs. LAL limit of 1 EU/ml). The culture was repeated on 9/28/10 and the result was even higher (LAL was 10.0 EU/ml), then repeated again on 10/8/10 and the result then was within the acceptable range. Therefore, RO # 4 was used for patient dialysis in the period from 9/1/10 to 10/8/10; when it was contaminated and not good for patient use. During that period of time, the proper corrective action of excluding RO # 4 from being use for patient dialysis was not taken on timely manner.

- on 10/27/10 the monthly water cultures of the RO #6 was higher than the maximum allowable limit for the LAL " 1.85 EU/ml, and was repeated on 11/9/10, the culture then was higher than the hospital action limit for the colony count. It was 142 (the hospital action level is 50 cfu), then the culture was repeated again on 11/24/10, and the result was again higher than the maximum allowable limit for the LAL, (LAL was >10 EU/ml). Therefore, RO # 6 was used for patient dialysis at the period from 10/9/10 to 11/24/10, when it was contaminated and not good for use during that period of time. The proper corrective action of excluding RO # 4 from being use for patient dialysis was not taken on timely manner.

The above findings were identified and were brought to the attention of the facility staff persons SP #26, Head Nurse of Dialysis, The Chief of Nephrology, SP # 48, and The Medical Director of Dialysis, SP #47, who acknowledged them.

Based on staff interviews conducted it was determined that surgical privileges was not delineated for all practitioners performing surgery in accordance with the competencies of each practitioners.

Findings include:

Based on interview with SP #17, ADN - OR, conducted on 11/29/10 and SP #18, Interim Director of Surgery, conducted on 11/30/10, staff stated that the list of practitioners whose surgical privileges have been terminated or suspended is kept in the medical staff office and not in the Operating Room suite/area .

Based upon observation while accompanied by facility staff, the facility failed to ensure that high standards of surgical care was afforded to patients. Specifically, the facility had failed to remove outdated surgical supplies.

Evidence includes the following:

While accompanied by facility staff on 11/29/10 a tour of the Operating Suite was conducted. Seven (7) outdated Povidine Iodine B- EZ scrub were observed, five (5) with the expiration date 10/2010 and two (2) with the expiration date 3/2010.

Based on staff interview conducted, the organization of Anesthesia services was not appropriate for the scope of services offered.

Findings include:

Based on interview of SP #27, M.D. , Director of Anesthesia, conducted on 12/2/10, it was determined that the organization of Anesthesia services was not appropriate for the scope of services offered . The Director of Anesthesia did not demonstrate oversight over the Emergency Department and the Endoscopy suite. Practitioners administering anesthesia in the Emergency Department and Endoscopy suite are granted privilege by the Director of Medicine.

Based on 2 of 4 medical records reviewed it was determined that the hospital failed to ensure that a post anesthesia evaluation was completed for each patient which reflect current standards of anesthesia care. (PT # 9 and PT #12).

Findings include:

Review of PT #9 and PT #12 on 12/1/10 it was evident that the post anesthesia assessments were inadequate. The post anesthesia assessments failed to note the time of assessment, patients' cardiopulmonary status and levels of consciousness as well as other clinical indicators of the status of the patient's recovery from anesthesia.