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How Are We Doing So Far?
               g

   Glenda M. Payne RN, MS, CNN
      ESRD Technical Advisor
       CMS, Dallas & Atlanta


                                 1
Objective: To Answer
  j
These Questions:




What can we do to be sure our
 facility is in compliance with
 the new rules of the game?
                                  2
What’s Expected
        Expected…
Subpart A: General
1. Compliance with Federal State & local
  laws and regulations


Subpart B: Patient Safety
2.   Infection control
3.   Water and dialysate quality
4.   Reuse of hemodialyzers
5.   Physical environment
                                      3
Subpart C: Patient Care
6. P ti t ’ i ht
6 Patients’ rights
7. Patient assessment
8. Patient plan of care
9. Care at home
10. QAPI
11.
11 Special purpose dialysis
   facilities
12. Laboratory services
                              4
Subpart D:
   p
Administration

13. Personnel qualifications
14. Responsibilities of
    the medical director
15. Medical records
16. Governance


                               5
So,
So How ARE We Doing?

• From October 14, 2008 to
  February 12, 2009
         y    ,
• 298 ESRD surveys done (or
  “uploaded”) nationally
   uploaded )
• 53 Condition Level Findings
  • 31 Facilities (from 1 to 4 CfC each)


                                       6
Conditions Not Met
• Infection Control (17)
• Governance (10)           • Medical Records
• QAPI (6)                    (2)
• Responsibilities of the   • Laboratory (1)
  Medical Director (5)      • Patient
• Water & Dialysate           Assessment (1)
  Quality (5)               • Personnel Quals (1)
• Physical Environment      • Reuse (1)
  (3)                       • Plan of Care (1)

                                            7
Top Ten Citations: US
10. V143: IC: Aseptic technique for
    meds (22)
 9. V504 A
 9 V504: Assess B/P & fl id mgmt
                        fluid     t
    needs (22)
 8.
 8 V403: PE: equipment maintenance;
    follow DFU (23)
 7. V506: Immunization/ med hx (23)
                                 ( )
 6. V715: MD resp: all adhere to P&P
    (26)

                                       8
Top Ten Citations: US
5. V115: IC: Wear Gowns/PPE (26)
4. V116: IC: Items taken to station
   D/D/D (26)
3. V117: IC: Clean/dirty areas, med
   prep area, no common carts (27)
        area
2. V113: IC: Wear gloves/ hand
   hygiene (35)
    yg     ( )
1. V122: IC: Clean, disinfect surfaces,
   equipment (38)

                                          9
Infection Control
           Citations
• All 29 tags have been cited
• Most frequent cited Condition (17X)
• SIX of the top 10 most frequently cited
  tags are “IC”
# 11 and #12 are also IC:
11: Handling infectious waste (21X)
12: HBV-vaccinate patients and staff (21X)
The most frequently cited QAPI indicator
  cited is # 16: IC: trend/plan/act (20X)


                                             10
IC=Infection Control

            All about
            • HANDS
            • Supplies
            • M d
              Meds
               • Saline
               • Heparin
            • PPE
                           11
“Hey-Hey”
“Hey Hey”
• “Observe Care”
• Pay attention to your practice and to
  that of your co-workers colleagues,
               co-workers, colleagues
  teammates, patient care techs,
  doctors, nurses, social workers, and
  dietitians
• Call them on hand washing and glove
  use
• Pay attention to cleaning all
  surfaces: counters, tables, chairs,
  machines, jugs, etc.
  machines jugs etc
                                     12
Top 10 Citations: TX
     p
       25 surveys
10. V515: PA: Eval current physical
    activity level & voc/phys. rehab (4X)
 9. V545: POC: Effective nutritional
 9 V545 POC Eff ti           t iti  l
    status (4X)
 8.
 8 V511: PA: Dialysis access type &
    maintenance (4X)
 7. V508: PA: Access renal bone
    disease (4X)
 6. V505: PA: Assess lab profile (4X)

                                       13
Top 10 Citations: TX
5. V502: PA: Assess current health
   status inc co-morbids (4X)
4. V507: PA: Assess anemia (4X)
4 V507 PA A               i
3. V544: POC: Achieve adequate
   clearance (4 X)
2. V504: PA: Assess B/P & fluid
   management needs ( )
         g             (5X)
1. V715: MD resp: ensure all adhere to
   P&P (7X)

                                     14
So, No Infection Control
  ,
    Issues in Texas?
Not exactly…
27 way “tie” for #3 actually
      y                    y
All 27 have been cited 4 X – 3 are IC:
• V122: Clean & disinfect surfaces
• V117: Clean/dirty areas, med prep
  area, no common med carts
       ,
• V120: Transducer protectors not
  wetted/changed
                                         15
What About Other
          Areas?
• 62 of the 92      • V196: primary tag
                      for problems in
  tags for Water      ch/chl monitoring
  & Dialysate       • V250: handheld
  Quality have        checks of machine
  been cited          pH/conductivity
                    • V191: checking
• #1 is this area     softener at end of
  = four way tie,     the day
  each with 12
      h ith         • V260 water staff
                      V260:     t   t ff
  citations:          training/audits


                                       16
Problems in Ch/Chl
         Testing
• Policy = practice;
• Policy matches test method in
  use
• Staff trained and competent
• Hey-Hey



                                  17
V196: Zero ≠ Zero

• Just because the label says “0”
  does not mean the strip will
  read to zero
• Strips only read to the lowest
  NUMBER on the range: 0 =  0.5
  only reads to less than 0.5
•CCritical that strips/ reagents be
                      /
  sensitive “enough” to detect
  unsafe levels
                                  18
Residual Chlorine Test Strips


                  Test strips used
                   to test for the
                     absence of
                       BLEACH

                NOT sensitive enough
                  to use to test for
                     chloramine
                                     19
V250: Verifying Machine
           y g
       Function
For hand-held verification:
• Maintain your equipment
            y     q p
• Use in-date standards
• Be sure staff know “why” they
                       why
  are doing the test and
  understand the allowable
  variation between the machine/
  handheld results
                               20
V191: Softener Testing

• AAMI RD 52 states to do this
  testing “at the end of the
        g
  treatment day”
• This means when the last
  treatment is finished



                                 21
V260: Training for Water
              g
       & Dialysate
• Mandatory
• Must cover quality testing, risks and
  hazards of i
  h    d    f improperly prepared
                      l          d
  concentrate, bacterial issues
• Operators trained in use of equipment
• Specific to functions performed
• Periodic audits of operator’s
                     operator s
  compliance
• Ongoing training to maintain
    g    g        g
  knowledge and skills
                                      22
Let’s Go Back to the Top 10:
        What is NOT IC?

10. V143: IC: Aseptic technique for
    meds (22)
 9. V504 A
 9 V504: Assess B/P & fl id mgmt
                        fluid     t
    needs (22)
 8.
 8 V403: PE: equipment maintenance;
    follow DFU (23)
 7. V506: Immunization/ med hx (23)
                                ( )
 6. V715: MD resp: all adhere to P&P
    (26)

                                   23
Patient Assessment: #9: V504:
     Assess B/P and fluid
  management needs (22 X)
Why would this be cited?
• Review of flow sheets = no evidence B/P
   is being monitored
          g
• Post weight does not = goal and no
   comment is made
• Fluid removed and weights do not match
   and no comment is made
Note: Surveyors are being taught
  to look at flow sheets for the
  implementation of the
  assessment-based plan of care
                     p
                                        24
# 7. V506: Immunization/
   Medication Hx (23 X)
• “Immunization history should
   Immunization history”
  include whether the patient has
  received standard immunizations
  (pneumococcal, hepatitis, and
  influenza), and has been screened
  for tuberculosis.
  f t b       l i
• The immunization record is expected
  include at least the patient’s
  immunization history as of the
  effective date of this regulation.
                                   25
# 7. V506: Immunization/
     Medication Hx (23)

CDC recommends all dialysis patients:
• Be tested at least once for baseline
  tuberculin skin test results (TST) and
  re-screened if TB exposure is
  detected. Chest x-rays may be used
                        y    y
  as an option.
• Be offered influenza and
  pneumococcal vaccine and th t th i
                 l     i     d that their
  immunization history be tracked.

                                       26
Medication history
• Should include a review of the
  patient’s allergies and of all
  medications including over the
                          over-the-
  counter medications and
  supplements that the patient is
     pp                  p
  taking.
• The assessment should demonstrate
  that ll
  th t all current medications were
                 t    di ti
  reviewed for possible adverse
  effects/interactions and continued
  need.
                                   27
Another Word about PA/POC*
Here is our REAL opportunity to
 CHANGE the way care is
 delivered!
Here is our REAL opportunity to
 INCREASE patient involvement
 and INDEPENDENCE = improved
 satisfaction & better working
 conditions for everyone!
*Remember, th T
*R       b   the Top 10 in TX!
                        i
                              28
Time for Change!
• Expectation that all facilities are
  in the process of converting all
  patients to the new system of
  planning and evaluating care—all
  p
  patients converted to this system
                                y
  by 10/14/2009
• STCP and LTCP are so yesterday!
                         y          y
• PA and POC: the way for the
  future
                                   29
Correlation of PA & POC
           PA                        POC
Current health status       Incorporated into all
                                 p
(V502)                      POC tags
Lab profile (V505)
Medication/immunization
history (V506)
Appropriateness of dialysis Provide adequate
prescription (V503)         clearance (V544)
BP/fluid management         Manage volume status
needs (V504)                (V543)
Assess anemia (V507)        Manage anemia (V547)
                            Home pt ESA (V548)
                            ESA response (V549)
Assess renal bone disease   Manage mineral          30
(V508)                      metabolism (V546)
PA                             POC
Nutritional status (V509)
N t iti   l t t                 Effective nutritional status
                                Eff ti      t iti   l t t
                                (V545)
Psychosocial needs (V510)
  y                 (   )       Psychosocial
                                  y
Evaluate family support         counseling/referrals/
(V514)                          assessment tool (V552)
Access type/maintenance         VA monitor/referral (V550)
(V511)                          Monitor/prevent failure
                                (V551)
Evaluate for
E l t f self/home care
             lf/h               Home dialysis plan (V553)
                                H    di l i    l
(V512)
Transplantation referral
     p                          Transplantation status: plan
                                     p                  p
(V513)                          or why not (V554)
Evaluate current physical       Rehab status addressed
activity level & voc/physical   (V555)
rehab (V515)
                                                       31
How Is This Supposed to Work?
               pp
• PA: identifies intradialytic weight gains
  (IDWG) of greater than 12
  pounds/treatment
• POC:
  • IDT members (all) to work with patient on
    risks of excessive fluid gains and (RD) on
    ways to handle thirst
  • Agree to a goal for IDWG to be reduced by
    10% each week until goal of no greater than
    5 pounds is reached
  • Monitor IDWG each treatment. Praise
    positive actions (RN, PCT)
  • If IDWG remains at same levels at end of
    one month, review and revise POC           32
PA/POC

Everyone has one year to comply
 with these two Conditions
About ½ of your patients should
 now be on the new system
“Monitor, recognize and address”
Make thi
M k this work worthwhile—it i
              k    th hil   it is
 not about paper or the form!

                                33
#8: V403: PE: equipment
maintenance; follow DFU (23 X)

Equipment R
E i     t Repair & M i t
              i    Maintenance




    *DFU= Directions for use
     DFU=
                               34
#6: V715: MD resp: all
    adhere to P&P (26 X)

Admission policies
• Orders
• Baseline H&P
•NNursing assessment prior t 1st
       i           t i to
  treatment
• “Adhere to P&P”


                                   35
Achieving Compliance

Learn about the new
 regulations:
•   Read the Federal Register
•   Read the Interpretative Guidance
                  p
•   Attend meetings (like this one!)
•   Discuss with your peers
                 y    p
•   Ask questions!

      ESRDsurvey@cms.hhs.gov           36
Achieving Compliance
Then:
• Evaluate current practice and
  compare to new requirements
• Implement policy changes as
  needed
• Educate staff to new policy and
  new regulation
• Audit practice for compliance
•RRepeat, repeat, repeat…
        t       t       t
                                    37
Q
Questions?



 ESRDsurvey@cms.hhs.gov   38
39

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Lessons At This Point C Megulations

  • 1. How Are We Doing So Far? g Glenda M. Payne RN, MS, CNN ESRD Technical Advisor CMS, Dallas & Atlanta 1
  • 2. Objective: To Answer j These Questions: What can we do to be sure our facility is in compliance with the new rules of the game? 2
  • 3. What’s Expected Expected… Subpart A: General 1. Compliance with Federal State & local laws and regulations Subpart B: Patient Safety 2. Infection control 3. Water and dialysate quality 4. Reuse of hemodialyzers 5. Physical environment 3
  • 4. Subpart C: Patient Care 6. P ti t ’ i ht 6 Patients’ rights 7. Patient assessment 8. Patient plan of care 9. Care at home 10. QAPI 11. 11 Special purpose dialysis facilities 12. Laboratory services 4
  • 5. Subpart D: p Administration 13. Personnel qualifications 14. Responsibilities of the medical director 15. Medical records 16. Governance 5
  • 6. So, So How ARE We Doing? • From October 14, 2008 to February 12, 2009 y , • 298 ESRD surveys done (or “uploaded”) nationally uploaded ) • 53 Condition Level Findings • 31 Facilities (from 1 to 4 CfC each) 6
  • 7. Conditions Not Met • Infection Control (17) • Governance (10) • Medical Records • QAPI (6) (2) • Responsibilities of the • Laboratory (1) Medical Director (5) • Patient • Water & Dialysate Assessment (1) Quality (5) • Personnel Quals (1) • Physical Environment • Reuse (1) (3) • Plan of Care (1) 7
  • 8. Top Ten Citations: US 10. V143: IC: Aseptic technique for meds (22) 9. V504 A 9 V504: Assess B/P & fl id mgmt fluid t needs (22) 8. 8 V403: PE: equipment maintenance; follow DFU (23) 7. V506: Immunization/ med hx (23) ( ) 6. V715: MD resp: all adhere to P&P (26) 8
  • 9. Top Ten Citations: US 5. V115: IC: Wear Gowns/PPE (26) 4. V116: IC: Items taken to station D/D/D (26) 3. V117: IC: Clean/dirty areas, med prep area, no common carts (27) area 2. V113: IC: Wear gloves/ hand hygiene (35) yg ( ) 1. V122: IC: Clean, disinfect surfaces, equipment (38) 9
  • 10. Infection Control Citations • All 29 tags have been cited • Most frequent cited Condition (17X) • SIX of the top 10 most frequently cited tags are “IC” # 11 and #12 are also IC: 11: Handling infectious waste (21X) 12: HBV-vaccinate patients and staff (21X) The most frequently cited QAPI indicator cited is # 16: IC: trend/plan/act (20X) 10
  • 11. IC=Infection Control All about • HANDS • Supplies • M d Meds • Saline • Heparin • PPE 11
  • 12. “Hey-Hey” “Hey Hey” • “Observe Care” • Pay attention to your practice and to that of your co-workers colleagues, co-workers, colleagues teammates, patient care techs, doctors, nurses, social workers, and dietitians • Call them on hand washing and glove use • Pay attention to cleaning all surfaces: counters, tables, chairs, machines, jugs, etc. machines jugs etc 12
  • 13. Top 10 Citations: TX p 25 surveys 10. V515: PA: Eval current physical activity level & voc/phys. rehab (4X) 9. V545: POC: Effective nutritional 9 V545 POC Eff ti t iti l status (4X) 8. 8 V511: PA: Dialysis access type & maintenance (4X) 7. V508: PA: Access renal bone disease (4X) 6. V505: PA: Assess lab profile (4X) 13
  • 14. Top 10 Citations: TX 5. V502: PA: Assess current health status inc co-morbids (4X) 4. V507: PA: Assess anemia (4X) 4 V507 PA A i 3. V544: POC: Achieve adequate clearance (4 X) 2. V504: PA: Assess B/P & fluid management needs ( ) g (5X) 1. V715: MD resp: ensure all adhere to P&P (7X) 14
  • 15. So, No Infection Control , Issues in Texas? Not exactly… 27 way “tie” for #3 actually y y All 27 have been cited 4 X – 3 are IC: • V122: Clean & disinfect surfaces • V117: Clean/dirty areas, med prep area, no common med carts , • V120: Transducer protectors not wetted/changed 15
  • 16. What About Other Areas? • 62 of the 92 • V196: primary tag for problems in tags for Water ch/chl monitoring & Dialysate • V250: handheld Quality have checks of machine been cited pH/conductivity • V191: checking • #1 is this area softener at end of = four way tie, the day each with 12 h ith • V260 water staff V260: t t ff citations: training/audits 16
  • 17. Problems in Ch/Chl Testing • Policy = practice; • Policy matches test method in use • Staff trained and competent • Hey-Hey 17
  • 18. V196: Zero ≠ Zero • Just because the label says “0” does not mean the strip will read to zero • Strips only read to the lowest NUMBER on the range: 0 = 0.5 only reads to less than 0.5 •CCritical that strips/ reagents be / sensitive “enough” to detect unsafe levels 18
  • 19. Residual Chlorine Test Strips Test strips used to test for the absence of BLEACH NOT sensitive enough to use to test for chloramine 19
  • 20. V250: Verifying Machine y g Function For hand-held verification: • Maintain your equipment y q p • Use in-date standards • Be sure staff know “why” they why are doing the test and understand the allowable variation between the machine/ handheld results 20
  • 21. V191: Softener Testing • AAMI RD 52 states to do this testing “at the end of the g treatment day” • This means when the last treatment is finished 21
  • 22. V260: Training for Water g & Dialysate • Mandatory • Must cover quality testing, risks and hazards of i h d f improperly prepared l d concentrate, bacterial issues • Operators trained in use of equipment • Specific to functions performed • Periodic audits of operator’s operator s compliance • Ongoing training to maintain g g g knowledge and skills 22
  • 23. Let’s Go Back to the Top 10: What is NOT IC? 10. V143: IC: Aseptic technique for meds (22) 9. V504 A 9 V504: Assess B/P & fl id mgmt fluid t needs (22) 8. 8 V403: PE: equipment maintenance; follow DFU (23) 7. V506: Immunization/ med hx (23) ( ) 6. V715: MD resp: all adhere to P&P (26) 23
  • 24. Patient Assessment: #9: V504: Assess B/P and fluid management needs (22 X) Why would this be cited? • Review of flow sheets = no evidence B/P is being monitored g • Post weight does not = goal and no comment is made • Fluid removed and weights do not match and no comment is made Note: Surveyors are being taught to look at flow sheets for the implementation of the assessment-based plan of care p 24
  • 25. # 7. V506: Immunization/ Medication Hx (23 X) • “Immunization history should Immunization history” include whether the patient has received standard immunizations (pneumococcal, hepatitis, and influenza), and has been screened for tuberculosis. f t b l i • The immunization record is expected include at least the patient’s immunization history as of the effective date of this regulation. 25
  • 26. # 7. V506: Immunization/ Medication Hx (23) CDC recommends all dialysis patients: • Be tested at least once for baseline tuberculin skin test results (TST) and re-screened if TB exposure is detected. Chest x-rays may be used y y as an option. • Be offered influenza and pneumococcal vaccine and th t th i l i d that their immunization history be tracked. 26
  • 27. Medication history • Should include a review of the patient’s allergies and of all medications including over the over-the- counter medications and supplements that the patient is pp p taking. • The assessment should demonstrate that ll th t all current medications were t di ti reviewed for possible adverse effects/interactions and continued need. 27
  • 28. Another Word about PA/POC* Here is our REAL opportunity to CHANGE the way care is delivered! Here is our REAL opportunity to INCREASE patient involvement and INDEPENDENCE = improved satisfaction & better working conditions for everyone! *Remember, th T *R b the Top 10 in TX! i 28
  • 29. Time for Change! • Expectation that all facilities are in the process of converting all patients to the new system of planning and evaluating care—all p patients converted to this system y by 10/14/2009 • STCP and LTCP are so yesterday! y y • PA and POC: the way for the future 29
  • 30. Correlation of PA & POC PA POC Current health status Incorporated into all p (V502) POC tags Lab profile (V505) Medication/immunization history (V506) Appropriateness of dialysis Provide adequate prescription (V503) clearance (V544) BP/fluid management Manage volume status needs (V504) (V543) Assess anemia (V507) Manage anemia (V547) Home pt ESA (V548) ESA response (V549) Assess renal bone disease Manage mineral 30 (V508) metabolism (V546)
  • 31. PA POC Nutritional status (V509) N t iti l t t Effective nutritional status Eff ti t iti l t t (V545) Psychosocial needs (V510) y ( ) Psychosocial y Evaluate family support counseling/referrals/ (V514) assessment tool (V552) Access type/maintenance VA monitor/referral (V550) (V511) Monitor/prevent failure (V551) Evaluate for E l t f self/home care lf/h Home dialysis plan (V553) H di l i l (V512) Transplantation referral p Transplantation status: plan p p (V513) or why not (V554) Evaluate current physical Rehab status addressed activity level & voc/physical (V555) rehab (V515) 31
  • 32. How Is This Supposed to Work? pp • PA: identifies intradialytic weight gains (IDWG) of greater than 12 pounds/treatment • POC: • IDT members (all) to work with patient on risks of excessive fluid gains and (RD) on ways to handle thirst • Agree to a goal for IDWG to be reduced by 10% each week until goal of no greater than 5 pounds is reached • Monitor IDWG each treatment. Praise positive actions (RN, PCT) • If IDWG remains at same levels at end of one month, review and revise POC 32
  • 33. PA/POC Everyone has one year to comply with these two Conditions About ½ of your patients should now be on the new system “Monitor, recognize and address” Make thi M k this work worthwhile—it i k th hil it is not about paper or the form! 33
  • 34. #8: V403: PE: equipment maintenance; follow DFU (23 X) Equipment R E i t Repair & M i t i Maintenance *DFU= Directions for use DFU= 34
  • 35. #6: V715: MD resp: all adhere to P&P (26 X) Admission policies • Orders • Baseline H&P •NNursing assessment prior t 1st i t i to treatment • “Adhere to P&P” 35
  • 36. Achieving Compliance Learn about the new regulations: • Read the Federal Register • Read the Interpretative Guidance p • Attend meetings (like this one!) • Discuss with your peers y p • Ask questions! ESRDsurvey@cms.hhs.gov 36
  • 37. Achieving Compliance Then: • Evaluate current practice and compare to new requirements • Implement policy changes as needed • Educate staff to new policy and new regulation • Audit practice for compliance •RRepeat, repeat, repeat… t t t 37
  • 39. 39