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Zoning Resolution THE CITY OF NEW YORK CITY PLANNING COMMISSION Eric Adams, Mayor Daniel R. Garodnick, Chair 62-341 - Developments on land and platforms File generated by https://zr.planning.nyc.gov on 4/14/2024 62-341 - Developments on land and platforms † LAST AMENDED 12/6/2023 All #developments# on portions of a #zoning lot# landward of the #shoreline# or on #platforms# shall be subject to the height and setback provisions of this Section. However, when the seaward view from all points along the #shoreline# of a #zoning lot# is entirely obstructed by existing elevated roads, bridges or similar structures which are less than 50 feet above mean high water and within 200 feet of the #shoreline#, #developments# shall be exempt from the requirements of this Section. Height and setback regulations for #developments# on #piers# and #floating structures# are set forth in Sections 62-342 and 62-343. (a) For the purposes of applying the height and setback regulations of this Section, the following provisions shall apply: (1) #Street lines# For the purposes of paragraphs (c) and (d) of this Section and of paragraph (h) of Section 62-354, a #shore public walkway#, #visual corridor#, #upland connection# or #supplemental public access area# shall be considered a #street# and its boundary shall be treated as a #street line#. Any #visual corridor# or #upland connection# that measures at least 75 feet in width, or any #shore public walkway# or #supplemental public access area#, shall be considered a #wide street#. Any other #visual corridor# or #upland connection# shall be considered a #narrow street#. (2) #Initial setback distance# For the purposes of paragraph (c) of this Section, an #initial setback distance# shall be a horizontal distance measured for a depth of 15 feet from a #narrow# #street line# and 10 feet from a #wide# #street line#. However, an #initial setback distance# shall have a depth of 30 feet from the boundary of a #shore public walkway#. Wherever a #supplemental public access area# is provided as a widened #shore public walkway#, such widened area shall be included in the #initial setback distance#. (3) Measurement of height The height of all #buildings or other structures# on #waterfront blocks# shall be measured from the #base plane#, except where modified by the provisions of Article VI, Chapter 4. For #buildings# with pitched roofs, maximum #building# height shall be measured to the midpoint of such pitched roof, except for #buildings# subject to Section 23-631 (General provisions). (4) Permitted obstructions The obstructions permitted pursuant to Sections 23-62, inclusive, 24-51, 33-42 or 43-42 and, where applicable, Sections 64-331, 64-332 or 64-432, shall apply. In addition, the following regulations regarding permitted obstructions shall apply: (i) Within an #initial setback distance#, a dormer may exceed a maximum base height specified in Table A of this Section or penetrate a required setback area above a maximum base height specified in paragraph (d) of this Section, provided that such dormer complies with the provisions of paragraph (c)(1) of Section 23-623. (ii) A penthouse portion of a #building# shall be permitted to exceed the applicable maximum #building# height, specified in Table A, by not more than 40 feet, only if the gross area of any #story# within such portion has a #lot coverage# of at least 50 percent and not more than 85 percent of the highest #story# that is located entirely below the maximum #building# height. Such reduced #lot coverage# shall be achieved by one or more setbacks on each face of the penthouse portion, where at least one setback on each face has a depth of at least four feet and a width that, individually or in the aggregate, is equal to at least 10 percent of the width of such respective face. For the purposes of this paragraph, (a)(4)(ii), the penthouse portion shall have four faces, with each face being the side of the rectangle within which the outermost walls of the highest #story# located entirely below the maximum #building# height have been inscribed. The required setbacks shall be measured from the outermost walls of the #building# facing each penthouse portion face. Required setback areas may overlap. (iii) Wind energy systems Regulations governing wind energy systems are modified pursuant to this paragraph, (a)(4)(iii). In R6 through R10 Districts, #Commercial Districts#, other than C1 or C2 Districts mapped within R1 through R5 Districts and C4-1, C7 and C8-1 Districts, and #Manufacturing Districts#, other than M1-1 Districts, wind energy systems located on a roof of a #building# shall not exceed a height equivalent to 50 percent of the height of such portion of the #building# or 55 feet, whichever is less, as measured from the roof to the highest point of the wind turbine assembly. In C4-1, C7, C8-1 and M1-1 Districts, for #buildings# containing #commercial# or #community facility# #uses#, wind energy systems shall not exceed a height of 55 feet when located above a roof of the #building# as measured to the highest point of the wind turbine assembly. In all districts, no portion of a wind energy system may be closer than 10 feet to a #waterfront public access area# boundary or a #zoning# #lot line#. (b) Lower density districts R1 R2 R3 R4 R5 C3 C4-1 C7 C8-1 M1-1 In the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the underlying district height and setback regulations are applicable or modified as follows: (1) #Buildings# containing #residences# (i) In R1 and R2 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations shall not apply. In lieu thereof, no #building# containing #residences#, except for a #predominantly# #community facility building#, shall exceed a height of 35 feet. (ii) In R3, R4 and R5 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations for #buildings# containing #residences# shall apply, except for #predominantly# #community facility buildings#. (2) #Predominantly# #community facility buildings# The underlying height and setback regulations shall not apply. In lieu thereof, any portion of a #predominantly# #community facility building# that exceeds a height of 35 feet shall be set back at least 25 feet from a #front yard line# or #street line#, where applicable, and no portion of such #building# shall exceed a height of 60 feet. However, within a #large-scale community facility development#, for portions of a #building# that are located at least 100 feet from a #street line# and, on a #waterfront zoning lot#, 100 feet from a #waterfront yard#, the maximum height shall not exceed 100 feet. (3) #Buildings# containing #commercial# #uses# The underlying height and setback regulations for #commercial# #uses# are modified as follows: no #building# containing #commercial# #uses# shall exceed a height of 30 feet, except for #mixed buildings# as set forth in paragraph (b)(1) of this Section or #predominantly# #community facility buildings# as set forth in paragraph (b) (2) of this Section. (4) Other structures All structures other than #buildings# shall be limited to a height of 35 feet, except that in C4-1, C7, C8-1 and M1-1 Districts, freestanding wind energy systems shall be permitted to a height of 85 feet, as measured from the base plane to the highest point of the wind turbine assembly. (c) Medium and high density non-contextual districts R6 R7 R8 R9 R10 C1-6 C1-7 C1-8 C1-9 C2-6 C2-7 C2-8 C4-2 C4-3 C4-4 C4-5 C4-6 C4-7 C5 C6 C7 C8-2 C8-3 C8-4 M1-2 M1-3 M1-4 M1-5 M1-6 M2 M3 Except for medium and high density contextual districts listed in paragraph (d) of this Section, in the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the underlying height and setback regulations shall not apply. In lieu thereof, the height and setback regulations set forth in this Section shall apply. (1) Maximum base height Except for dormers permitted in accordance with paragraph (a)(4)(i) of this Section, the height of a #building or other structure# or portion thereof located within an #initial setback distance# may not exceed the maximum base height specified in Table A of this Section. (2) Maximum #building# height Except for penthouses permitted in accordance with paragraph (a)(4)(ii) of this Section, the height of a #building or other structure# or portion thereof may not exceed the maximum #building# height specified in Table A. (3) #Floor area# distribution #Zoning lots# with #buildings# that exceed the maximum base height listed in Table A shall have a minimum #floor area# coverage comprising at least 30 percent of the #lot area# at a height of 20 feet. For the purposes of determining this requirement, the #lot area# of #waterfront zoning lots# shall be deemed to be the area of the #zoning lot# landward of the #shoreline#. In the event the site plan involves construction on only a portion of the #zoning lot#, sufficient calculations shall be provided to show that such partial construction does not preclude compliance with the minimum #floor area# coverage requirements of this Section at the time the site is fully developed. (4) Maximum #residential# tower size Each #residential# #story# of a #building# located entirely above the maximum base height specified in Table A shall not exceed a gross area of 7,000 square feet on #zoning lots# less than 1.5 acres, and 8,100 square feet on larger #zoning lots#. On all #zoning lots#, dormers permitted within an #initial setback distance# in accordance with the provisions of paragraph (a)(4)(i) of this Section shall not be included in such gross area. (5) Maximum width of walls facing #shoreline# The maximum width of any #story# of a #building# that faces a #shoreline# and is entirely above the maximum base height specified in Table A shall not exceed 100 feet. Such width shall be measured by inscribing within a rectangle the outermost walls at the level of each #story# entirely above the maximum base height. Any side of such rectangle from which perpendicular lines may be drawn to a #shoreline#, regardless of any intervening structures, properties or #streets#, shall not exceed 100 feet. (See illustration). (6) Ground floor streetscape provisions For the purposes of this Section, "ground floor level" shall mean the floor of a #building#, the level of which is located within five feet of the finished level of the adjacent sidewalk. For #street walls# that are more than 50 feet in width and within 50 feet of a #waterfront public access area# or #street#, the following rules shall apply: (i) at least 50 percent of the width of such #street walls# shall be occupied by #floor area# at the ground floor level; and (ii) where such #street walls# do not contain windows with sill levels lower than four feet above the adjacent sidewalk for a continuous distance of at least 30 feet, such #street walls# shall be articulated with rustication or decorative grills, or screened with plant material, to a minimum height of four feet. Parking garages that occupy the ground floor frontage along any #street# or private drive which is also an #upland connection# shall be screened in accordance with the planting requirements of paragraph (a)(7)(iii) of Section 62-655. TABLE A HEIGHT AND SETBACK FOR ALL BUILDINGS AND OTHER STRUCTURES IN MEDIUM AND HIGH DENSITY NON-CONTEXTUAL DISTRICTS* Maximum Height (in feet) ------ * For #predominantly# #community facility buildings#, the applicable regulations shall be determined from Table B of this Section APPLICABLE HEIGHT AND SETBACK REGULATIONS FOR PREDOMINANTLY COMMUNITY FACILITY BUILDINGS (d) Medium and high density contextual districts R6A R6B R7A R7B R7D R7X R8A R8B R8X R9A R9X R10A C1-6A C1-7A C1-8A C1-8X C1-9A C2-6A C2-7A C2-7X C2-8A C4-2A C4-3A C4-4A C4-4L C4-5A C4-5D C4-5X C4-6A C4-7A C5-1A C5-2A C6-2A C6-3A C6-4A In the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the height and setback regulations of Section 23-662 shall apply. For #Commercial Districts#, the applicable #Residence District# within which such #Commercial District# is mapped, or the applicable residential equivalent set forth in the tables in Section 35-23 (Residential Bulk Regulations in Other C1 or C2 Districts or in C3, C4, C5 or C6 Districts) shall be used in applying such provisions. In addition, in all applicable districts, for #buildings# meeting the criteria set forth in paragraph (a) of Section 23-664 (Modified height and setback regulations for certain Inclusionary Housing buildings or affordable independent residences for seniors), the height and setback provisions of paragraph (b) of Section 23-664 shall apply. Separate maximum #building# heights are set forth in Sections 23-662 and 23-664 for #Quality Housing buildings# with #qualifying ground floors# and for those with #non-qualifying ground floors#. MAXIMUM WIDTH OF BUILDING WALL FACING SHORELINE (62-341d.1) DORMER (62-341d.2)
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Zoning Resolution THE CITY OF NEW YORK CITY PLANNING COMMISSION Eric Adams, Mayor Daniel R. Garodnick, Chair 62-341 - Developments on land and platforms File generated by https://zr.planning.nyc.gov on 4/14/2024 62-341 - Developments on land and platforms † LAST AMENDED 12/6/2023 All #developments# on portions of a #zoning lot# landward of the #shoreline# or on #platforms# shall be subject to the height and setback provisions of this Section. However, when the seaward view from all points along the #shoreline# of a #zoning lot# is entirely obstructed by existing elevated roads, bridges or similar structures which are less than 50 feet above mean high water and within 200 feet of the #shoreline#, #developments# shall be exempt from the requirements of this Section. Height and setback regulations for #developments# on #piers# and #floating structures# are set forth in Sections 62-342 and 62-343. (a) For the purposes of applying the height and setback regulations of this Section, the following provisions shall apply: (1) #Street lines# For the purposes of paragraphs (c) and (d) of this Section and of paragraph (h) of Section 62-354, a #shore public walkway#, #visual corridor#, #upland connection# or #supplemental public access area# shall be considered a #street# and its boundary shall be treated as a #street line#. Any #visual corridor# or #upland connection# that measures at least 75 feet in width, or any #shore public walkway# or #supplemental public access area#, shall be considered a #wide street#. Any other #visual corridor# or #upland connection# shall be considered a #narrow street#. (2) #Initial setback distance# For the purposes of paragraph (c) of this Section, an #initial setback distance# shall be a horizontal distance measured for a depth of 15 feet from a #narrow# #street line# and 10 feet from a #wide# #street line#. However, an #initial setback distance# shall have a depth of 30 feet from the boundary of a #shore public walkway#. Wherever a #supplemental public access area# is provided as a widened #shore public walkway#, such widened area shall be included in the #initial setback distance#. (3) Measurement of height The height of all #buildings or other structures# on #waterfront blocks# shall be measured from the #base plane#, except where modified by the provisions of Article VI, Chapter 4. For #buildings# with pitched roofs, maximum #building# height shall be measured to the midpoint of such pitched roof, except for #buildings# subject to Section 23-631 (General provisions). (4) Permitted obstructions The obstructions permitted pursuant to Sections 23-62, inclusive, 24-51, 33-42 or 43-42 and, where applicable, Sections 64-331, 64-332 or 64-432, shall apply. In addition, the following regulations regarding permitted obstructions shall apply: (i) Within an #initial setback distance#, a dormer may exceed a maximum base height specified in Table A of this Section or penetrate a required setback area above a maximum base height specified in paragraph (d) of this Section, provided that such dormer complies with the provisions of paragraph (c)(1) of Section 23-623. (ii) A penthouse portion of a #building# shall be permitted to exceed the applicable maximum #building# height, specified in Table A, by not more than 40 feet, only if the gross area of any #story# within such portion has a #lot coverage# of at least 50 percent and not more than 85 percent of the highest #story# that is located entirely below the maximum #building# height. Such reduced #lot coverage# shall be achieved by one or more setbacks on each face of the penthouse portion, where at least one setback on each face has a depth of at least four feet and a width that, individually or in the aggregate, is equal to at least 10 percent of the width of such respective face. For the purposes of this paragraph, (a)(4)(ii), the penthouse portion shall have four faces, with each face being the side of the rectangle within which the outermost walls of the highest #story# located entirely below the maximum #building# height have been inscribed. The required setbacks shall be measured from the outermost walls of the #building# facing each penthouse portion face. Required setback areas may overlap. (iii) Wind energy systems Regulations governing wind energy systems are modified pursuant to this paragraph, (a)(4)(iii). In R6 through R10 Districts, #Commercial Districts#, other than C1 or C2 Districts mapped within R1 through R5 Districts and C4-1, C7 and C8-1 Districts, and #Manufacturing Districts#, other than M1-1 Districts, wind energy systems located on a roof of a #building# shall not exceed a height equivalent to 50 percent of the height of such portion of the #building# or 55 feet, whichever is less, as measured from the roof to the highest point of the wind turbine assembly. In C4-1, C7, C8-1 and M1-1 Districts, for #buildings# containing #commercial# or #community facility# #uses#, wind energy systems shall not exceed a height of 55 feet when located above a roof of the #building# as measured to the highest point of the wind turbine assembly. In all districts, no portion of a wind energy system may be closer than 10 feet to a #waterfront public access area# boundary or a #zoning# #lot line#. (b) Lower density districts R1 R2 R3 R4 R5 C3 C4-1 C7 C8-1 M1-1 In the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the underlying district height and setback regulations are applicable or modified as follows: (1) #Buildings# containing #residences# (i) In R1 and R2 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations shall not apply. In lieu thereof, no #building# containing #residences#, except for a #predominantly# #community facility building#, shall exceed a height of 35 feet. (ii) In R3, R4 and R5 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations for #buildings# containing #residences# shall apply, except for #predominantly# #community facility buildings#. (2) #Predominantly# #community facility buildings# The underlying height and setback regulations shall not apply. In lieu thereof, any portion of a #predominantly# #community facility building# that exceeds a height of 35 feet shall be set back at least 25 feet from a #front yard line# or #street line#, where applicable, and no portion of such #building# shall exceed a height of 60 feet. However, within a #large-scale community facility development#, for portions of a #building# that are located at least 100 feet from a #street line# and, on a #waterfront zoning lot#, 100 feet from a #waterfront yard#, the maximum height shall not exceed 100 feet. (3) #Buildings# containing #commercial# #uses# The underlying height and setback regulations for #commercial# #uses# are modified as follows: no #building# containing #commercial# #uses# shall exceed a height of 30 feet, except for #mixed buildings# as set forth in paragraph (b)(1) of this Section or #predominantly# #community facility buildings# as set forth in paragraph (b) (2) of this Section. (4) Other structures All structures other than #buildings# s
hall be limited to a height of 35 feet, except that in C4-1, C7, C8-1 and M1-1 Districts, freestanding wind energy systems shall be permitted to a height of 85 feet, as measured from the base plane to the highest point of the wind turbine assembly.
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<url> https://zr.planning.nyc.gov/print/pdf/node/18958 </url> <text> Zoning Resolution THE CITY OF NEW YORK CITY PLANNING COMMISSION Eric Adams, Mayor Daniel R. Garodnick, Chair 62-341 - Developments on land and platforms File generated by https://zr.planning.nyc.gov on 4/14/2024 62-341 - Developments on land and platforms † LAST AMENDED 12/6/2023 All #developments# on portions of a #zoning lot# landward of the #shoreline# or on #platforms# shall be subject to the height and setback provisions of this Section. However, when the seaward view from all points along the #shoreline# of a #zoning lot# is entirely obstructed by existing elevated roads, bridges or similar structures which are less than 50 feet above mean high water and within 200 feet of the #shoreline#, #developments# shall be exempt from the requirements of this Section. Height and setback regulations for #developments# on #piers# and #floating structures# are set forth in Sections 62-342 and 62-343. (a) For the purposes of applying the height and setback regulations of this Section, the following provisions shall apply: (1) #Street lines# For the purposes of paragraphs (c) and (d) of this Section and of paragraph (h) of Section 62-354, a #shore public walkway#, #visual corridor#, #upland connection# or #supplemental public access area# shall be considered a #street# and its boundary shall be treated as a #street line#. Any #visual corridor# or #upland connection# that measures at least 75 feet in width, or any #shore public walkway# or #supplemental public access area#, shall be considered a #wide street#. Any other #visual corridor# or #upland connection# shall be considered a #narrow street#. (2) #Initial setback distance# For the purposes of paragraph (c) of this Section, an #initial setback distance# shall be a horizontal distance measured for a depth of 15 feet from a #narrow# #street line# and 10 feet from a #wide# #street line#. However, an #initial setback distance# shall have a depth of 30 feet from the boundary of a #shore public walkway#. Wherever a #supplemental public access area# is provided as a widened #shore public walkway#, such widened area shall be included in the #initial setback distance#. (3) Measurement of height The height of all #buildings or other structures# on #waterfront blocks# shall be measured from the #base plane#, except where modified by the provisions of Article VI, Chapter 4. For #buildings# with pitched roofs, maximum #building# height shall be measured to the midpoint of such pitched roof, except for #buildings# subject to Section 23-631 (General provisions). (4) Permitted obstructions The obstructions permitted pursuant to Sections 23-62, inclusive, 24-51, 33-42 or 43-42 and, where applicable, Sections 64-331, 64-332 or 64-432, shall apply. In addition, the following regulations regarding permitted obstructions shall apply: (i) Within an #initial setback distance#, a dormer may exceed a maximum base height specified in Table A of this Section or penetrate a required setback area above a maximum base height specified in paragraph (d) of this Section, provided that such dormer complies with the provisions of paragraph (c)(1) of Section 23-623. (ii) A penthouse portion of a #building# shall be permitted to exceed the applicable maximum #building# height, specified in Table A, by not more than 40 feet, only if the gross area of any #story# within such portion has a #lot coverage# of at least 50 percent and not more than 85 percent of the highest #story# that is located entirely below the maximum #building# height. Such reduced #lot coverage# shall be achieved by one or more setbacks on each face of the penthouse portion, where at least one setback on each face has a depth of at least four feet and a width that, individually or in the aggregate, is equal to at least 10 percent of the width of such respective face. For the purposes of this paragraph, (a)(4)(ii), the penthouse portion shall have four faces, with each face being the side of the rectangle within which the outermost walls of the highest #story# located entirely below the maximum #building# height have been inscribed. The required setbacks shall be measured from the outermost walls of the #building# facing each penthouse portion face. Required setback areas may overlap. (iii) Wind energy systems Regulations governing wind energy systems are modified pursuant to this paragraph, (a)(4)(iii). In R6 through R10 Districts, #Commercial Districts#, other than C1 or C2 Districts mapped within R1 through R5 Districts and C4-1, C7 and C8-1 Districts, and #Manufacturing Districts#, other than M1-1 Districts, wind energy systems located on a roof of a #building# shall not exceed a height equivalent to 50 percent of the height of such portion of the #building# or 55 feet, whichever is less, as measured from the roof to the highest point of the wind turbine assembly. In C4-1, C7, C8-1 and M1-1 Districts, for #buildings# containing #commercial# or #community facility# #uses#, wind energy systems shall not exceed a height of 55 feet when located above a roof of the #building# as measured to the highest point of the wind turbine assembly. In all districts, no portion of a wind energy system may be closer than 10 feet to a #waterfront public access area# boundary or a #zoning# #lot line#. (b) Lower density districts R1 R2 R3 R4 R5 C3 C4-1 C7 C8-1 M1-1 In the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the underlying district height and setback regulations are applicable or modified as follows: (1) #Buildings# containing #residences# (i) In R1 and R2 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations shall not apply. In lieu thereof, no #building# containing #residences#, except for a #predominantly# #community facility building#, shall exceed a height of 35 feet. (ii) In R3, R4 and R5 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations for #buildings# containing #residences# shall apply, except for #predominantly# #community facility buildings#. (2) #Predominantly# #community facility buildings# The underlying height and setback regulations shall not apply. In lieu thereof, any portion of a #predominantly# #community facility building# that exceeds a height of 35 feet shall be set back at least 25 feet from a #front yard line# or #street line#, where applicable, and no portion of such #building# shall exceed a height of 60 feet. However, within a #large-scale community facility development#, for portions of a #building# that are located at least 100 feet from a #street line# and, on a #waterfront zoning lot#, 100 feet from a #waterfront yard#, the maximum height shall not exceed 100 feet. (3) #Buildings# containing #commercial# #uses# The underlying height and setback regulations for #commercial# #uses# are modified as follows: no #building# containing #commercial# #uses# shall exceed a height of 30 feet, except for #mixed buildings# as set forth in paragraph (b)(1) of this Section or #predominantly# #community facility buildings# as set forth in paragraph (b) (2) of this Section. (4) Other structures All structures other than #buildings# s<cursor_is_here> </text>
[ { "content": "<url>\nhttps://zr.planning.nyc.gov/print/pdf/node/18958\n</url>\n<text>\nZoning Resolution\n\nTHE CITY OF NEW YORK\n\nCITY PLANNING COMMISSION\n\nEric Adams, Mayor\n\nDaniel R. Garodnick, Chair\n\n62-341 - Developments on land and platforms\n\nFile generated by https://zr.planning.nyc.gov on 4/14/2024\n\n62-341 - Developments on land and platforms\n\n†\n\nLAST AMENDED 12/6/2023\n\nAll #developments# on portions of a #zoning lot# landward of the #shoreline# or on #platforms# shall be subject to the height and setback provisions of this Section. However, when the seaward view from all points along the #shoreline# of a #zoning lot# is entirely obstructed by existing elevated roads, bridges or similar structures which are less than 50 feet above mean high water and within 200 feet of the #shoreline#, #developments# shall be exempt from the requirements of this Section. Height and setback regulations for #developments# on #piers# and #floating structures# are set forth in Sections 62-342 and 62-343.\n\n(a) For the purposes of applying the height and setback regulations of this Section, the following provisions shall apply:\n(1) #Street lines#\n\nFor the purposes of paragraphs (c) and (d) of this Section and of paragraph (h) of Section 62-354, a #shore public walkway#, #visual corridor#, #upland connection# or #supplemental public access area# shall be considered a #street# and its boundary shall be treated as a #street line#. Any #visual corridor# or #upland connection# that measures at least 75 feet in width, or any #shore public walkway# or #supplemental public access area#, shall be considered a #wide street#. Any other #visual corridor# or #upland connection# shall be considered a #narrow street#.\n\n(2) #Initial setback distance#\n\nFor the purposes of paragraph (c) of this Section, an #initial setback distance# shall be a horizontal distance measured for a depth of 15 feet from a #narrow# #street line# and 10 feet from a #wide# #street line#. However, an #initial setback distance# shall have a depth of 30 feet from the boundary of a #shore public walkway#. Wherever a #supplemental public access area# is provided as a widened #shore public walkway#, such widened area shall be included in the #initial setback distance#.\n\n(3) Measurement of height\n\nThe height of all #buildings or other structures# on #waterfront blocks# shall be measured from the #base plane#, except where modified by the provisions of Article VI, Chapter 4. For #buildings# with pitched roofs, maximum #building# height shall be measured to the midpoint of such pitched roof, except for #buildings# subject to Section 23-631 (General provisions).\n\n(4) Permitted obstructions\n\nThe obstructions permitted pursuant to Sections 23-62, inclusive, 24-51, 33-42 or 43-42 and, where applicable, Sections 64-331, 64-332 or 64-432, shall apply. In addition, the following regulations regarding permitted obstructions shall apply:\n\n(i) Within an #initial setback distance#, a dormer may exceed a maximum base height specified in Table A of this Section or penetrate a required setback area above a maximum base height specified in paragraph (d) of this Section, provided that such dormer complies with the provisions of paragraph (c)(1) of Section 23-623.\n(ii) A penthouse portion of a #building# shall be permitted to exceed the applicable maximum #building# height, specified in Table A, by not more than 40 feet, only if the gross area of any #story# within such portion has a #lot coverage# of at least 50 percent and not more than 85 percent of the highest #story# that is located entirely below the maximum #building# height. Such reduced #lot coverage# shall be achieved by one or more setbacks on each face of the penthouse portion, where at least one setback on each face has a depth of at least four feet and a width that, individually or in the aggregate, is equal to at least 10 percent of the width of such respective face. For the purposes of this paragraph, (a)(4)(ii), the penthouse portion shall have four faces, with each face being the side of the rectangle within which the outermost walls of the highest #story# located entirely below the maximum #building# height have been inscribed. The required setbacks shall be measured from the outermost walls of the #building# facing each penthouse portion face. Required setback areas may overlap.\n\n(iii) Wind energy systems\n\nRegulations governing wind energy systems are modified pursuant to this paragraph, (a)(4)(iii).\n\nIn R6 through R10 Districts, #Commercial Districts#, other than C1 or C2 Districts mapped within R1 through R5 Districts and C4-1, C7 and C8-1 Districts, and #Manufacturing Districts#, other than M1-1 Districts, wind energy systems located on a roof of a #building# shall not exceed a height equivalent to 50 percent of the height of such portion of the #building# or 55 feet, whichever is less, as measured from the roof to the highest point of the wind turbine assembly.\n\nIn C4-1, C7, C8-1 and M1-1 Districts, for #buildings# containing #commercial# or #community facility# #uses#, wind energy systems shall not exceed a height of 55 feet when located above a roof of the #building# as measured to the highest point of the wind turbine assembly.\n\nIn all districts, no portion of a wind energy system may be closer than 10 feet to a #waterfront public access area# boundary or a #zoning# #lot line#.\n\n(b) Lower density districts\n\nR1 R2 R3 R4 R5 C3 C4-1 C7 C8-1 M1-1\n\nIn the districts indicated, and in C1 and C2 Districts mapped within such #Residence Districts#, the underlying district height and setback regulations are applicable or modified as follows:\n\n(1) #Buildings# containing #residences#\n\n(i) In R1 and R2 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations shall not apply. In lieu thereof, no #building# containing #residences#, except for a #predominantly# #community facility building#, shall exceed a height of 35 feet.\n(ii) In R3, R4 and R5 Districts, and in #Commercial Districts# governed by the #bulk# regulations of such #Residence Districts#, the underlying height and setback regulations for #buildings# containing #residences# shall apply, except for #predominantly# #community facility buildings#.\n\n(2) #Predominantly# #community facility buildings#\n\nThe underlying height and setback regulations shall not apply. In lieu thereof, any portion of a #predominantly#\n\n#community facility building# that exceeds a height of 35 feet shall be set back at least 25 feet from a #front yard line# or #street line#, where applicable, and no portion of such #building# shall exceed a height of 60 feet. However, within a #large-scale community facility development#, for portions of a #building# that are located at least 100 feet from a #street line# and, on a #waterfront zoning lot#, 100 feet from a #waterfront yard#, the maximum height shall not exceed 100 feet.\n\n(3) #Buildings# containing #commercial# #uses#\n\nThe underlying height and setback regulations for #commercial# #uses# are modified as follows: no #building# containing #commercial# #uses# shall exceed a height of 30 feet, except for #mixed buildings# as set forth in paragraph (b)(1) of this Section or #predominantly# #community facility buildings# as set forth in paragraph (b) (2) of this Section.\n\n(4) Other structures\n\nAll structures other than #buildings# s<cursor_is_here>\n</text>\n", "role": "user" }, { "content": "hall be limited to a height of 35 feet, except that in C4-1, C7, C8-1 and M1-1 Districts, freestanding wind energy systems shall be permitted to a height of 85 feet, as measured from the base plane to the highest point of the wind turbine assembly.", "role": "assistant" } ]
Identification of the Types of Pre-analytical Errors in the Clinical Chemistry Laboratory from Jan-2012 to Dec-2012 at Jinnah Hospital, Pathology Department Jahangir Sultan, Tariq Afzal, Kokab Jabeen ABSTRACT Objective: To evaluate the leading causes of preanalytical errors in a clinical chemistry laboratory. Methods: A retrospective analysis of the results obtained from the clinical chemistry laboratory for errors in the pre-analytical phase has been carried out to summarize data regarding the frequency of the main factors affecting the pre-analytical quality of results. Laboratory personnel were asked to register rejections, and causes for rejection of ward as well as out-patient samples collected in INTRODUCTION Modern day diagnosis is heavily dependent upon reliable laboratory data. It is therefore pertinent to ensure credibility of the results emanating from the clinical laboratories. Remarkable advances in automation, sample collection, transport, and dispatch of reports have led to a drastic improvement in the performance of these laboratories. But there is long path to tread before we achieve 100% accuracy and precision. Errors arising during sample processing are classified into pre-analytical, analytical, and postanalytical, depending upon their source and time of presentation respectively. The pre-and post-analytical phases of the process account for 93% of errors. 1 The pre-analytical phase comprises all of the processes Corresponding Author Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College, Pakistan E-mail: [email protected] A.P.M.C Vol: 7 No. 1 January-June 2013 Lahore, the laboratory. Results: Of the 1,54,554 tubes received during the data collection period, 2505 samples were found unsuitable for further processing. This accounted for 1.52% of all samples collected in the laboratory. Rejections arose as a result of the following reasons: 0.48 % were rejected due to hemolysis; 0.92 % were specimens without proper requisition slips; and 0.14 % had insufficient sample quantity. Conclusion: Of all the samples received in the lab, the overall percentage of rejection is 1.62%. occurring before the sample is processed in the auto analyzer. 2 These include inappropriate tests that have been ordered, improper sample collection, transport delays, and illegible handwriting on requisition slips. 3,4 Although these areas are beyond the jurisdiction of the clinical laboratory per se, the credibility of 5,6,7 The labs have to bear the burden of the inconsistencies or the labs is at stake due to these errors. incorrect reporting that can ensue because of these preanalytical errors. 8,9 The goal of the present paper is to enumerate and analyze the prevalence of different pre-analytical errors that surfaced during sample processing in the clinical biochemistry department during a 1-year period. Jinnah Hospital is a tertiary care super specialty center in Lahore specializing in cardiology, cardiothoracic surgery, neurology, neurosurgery, gastroenterology, gastro surgery, and psychiatry. Jinnah Hospital is a teaching hospital as well. With 1416 students studying to be doctors at Allama Iqbal Medical College and learning practical procedures at Jinnah Hospital, over 7,000 doctors have graduated from here over the last ten years. It is a 1250-bed hospital offering specialized medical and surgical treatment to about an average of patients 700,000 visit the Out-Patient and Emergency Department every year, where 70% of the treatment is given completely free. Every year more than 1,500,000 tests are carried out in Pathology Laboratory The clinical biochemistry department is equipped with a state-of-the-art autoanalyzer with ISE– Beckman Coulter CX9PRO Clinical System (Hamburg, Germany), electrolyte Plus analyzer– Na/K/Cl,ABG Nova biochemical Analyser, and other ancillaries for sample processing. Inpatient phlebotomies are performed by clinical department staff, whereas blood specimens from outpatients are collected on site at a centralized collection center by laboratory personnel. The samples are delivered to the lab by the paramedical staff from the wards and laboratory support staff from the OPD respectively. REVIEW OF THE LITERATURE ON LABORATORY ERRORS | Sector of the laboratory | Lapworth and Teal.12 | Goldschmidt and Lent. 11 | M.Pleban.15 | Plebani and Carro.16 | Stahl M et al.14 | Jahangir Kokab and Tariq | Ranjan and Binita.17 | |---|---|---|---|---|---|---|---| | Sector of the laboratory | Clinical chemistry | Whole laboratory | Primary care. | Stat laboratory | Whole laboratory | Clinical chemistry | Clinical chemistry | | Data collection period | 1 year | 6 year | 6 month | 6 month | 3 year | 1 year | 1 year | | No of Patients | 997000 | ND | 160714 | ND | ND | 154554 | 96328 | | No of errors | 120 | 123 | 180 | 189 | 4135 | 2505 | 736 | | Frequency | | | | 0.47 % of patients | 0.61% of patients | 1. 6% of patients | 1.5 %.of patients | | Pre-analytical phase | 31.6% | 53% | 55% | 55.65 | 68.2% | 0.05% | | MATERIALS AND METHODS A total of 1,54554 samples from the outpatient department and in-house patients were received by our clinical chemistry laboratory during the period from January 2012 to December 2012. Out of these, 97,185 samples were collected from the patients admitted in the wards and 57,369 samples were collected in the outpatient department. The samples are collected using evacuated tubes (vacutainers evacuated tubes from BD (Franklin Lakes, NJ). The lab provides routine and reference testing in biochemistry. Upon receiving the samples, the lab supervisor visually detects any problems. When an error occurs, entries are made in the problem notification log book. The data generated is reviewed on a weekly basis. The data collection procedure involved review of blood samples received from the inpatient as well as outpatient departments. Venous blood samples are considered unsuitable according to the following accepted criteria: inappropriate volume, wrong or missing patient identification, inappropriate container, visible hemolysis after centrifugation, and lipemic samples. The pre-analytical variables evaluated included all the criteria mentioned above for sample rejection as well as incomplete/incorrect patient details and illegible handwriting. RESULTS We will first discuss the findings of the routine samples obtained from the inpatients in our hospital. Out of the 97,185 blood collection tubes screened over a period of 1 year, pre-analytical errors were observed in 1626 samples, which is approximately 1.6 % of the total number of samples received. The distribution of the different types of errors was then calculated (Table 1). The majority of the rejected samples were hemolyzed. Hemolysis was responsible for rejection of 692 samples, which accounts for 0.71% of the total number of samples received during this period. The amount of blood was insufficient for complete analysis in 0.15 % (i.e., 144out of the 97,185samples). A total of 687 samples were accompanied by inappropriate slips (i.e., wrong requisition slip, without requisition slip, central registration number ward not mentioned). This comprised approximately 0.70 % of all the samples received by the laboratory. Out of these 203 samples, laboratory personnel managed to ascertain correct patient data in 153 cases, and hence reporting was completed successfully for these patients. Fifty samples could not be processed even after elaborate and painstaking efforts by the laboratory staff. Gross lipemia led to rejection of 103samples (0.10 %). Similarly, we evaluated the slips obtained from the outpatient department. A total of 57,369 samples were received for processing from our OPD. Out of these, the number of pre-analytical errors documented was 879. This constitutes an error rate of 1.5 %. The distribution of the various pre-analytical variables is depicted in (Table 2). The most frequent error encountered during processing was sample with insufficient information (wrong vial/wrong slip). This constitutes an error rate of 1.28% this led to rejection of 738 samples out 57369 samples. The insufficient volume with an incidence of 0.13 %. Hemolysis, which constituted the most frequent pre-analytical error observed during sample processing of admitted patients, contributed to the rejection of 0.09 % of the samples in OPD as compared to 0.71% in the previous case. Table-1 Frequency of the Different Preanalytical Errors Observed in a Total of 97,185 Routine Inpatient Samples | 01 | Insufficient volume | |---|---| | 02 | Hemolysis | | 03 | Sample with insufficient information (wrong vial/wrong slip) | | 04 | Lipemic samples | Table-2 Preanalytical Errors Observed in a Total of 57,369 Outpatient Samples | 01 | Insufficient volume | 75(0.13 %) | |---|---|---| | 02 | Hemolysis | 55(0.09 %) | | 03 | Sample with insufficient information (wrong vial/wrong slip) | 738(1.28 %) | | 04 | Lipemic samples | 11(0.019%) | DISCUSSION Advances in science and technology have led to many path-breaking innovations that have transformed laboratory diagnostics from manual, cumbersome testing methods to fully automated science, ensuring accuracy and speed. 1, 2 However, the laboratory cannot function in isolation. It is dependent upon other departments; mainly the clinical division for properly filled requisition slips and samples for analysis. 1, 2Mounting evidence indicates that reliability cannot be achieved in a clinical laboratory through the mere promotion of accuracy in the analytical phase of the testing process. 3 It is evident that the majority of all errors in the total testing processing are of pre-analytical origin, i.e. they occur before the sample arrives in the laboratory and the phase after the sample is analyzed (post-analytical) are equally important. 4 The pre-analytical phase is riddled with many shortcomings ranging from lax attitude about filling the requisition slips to the staff's lack of education about ideal phlebotomy procedures. The health care system must be more diligent in applying scientific knowledge to reduce the errors in this phase. This is imperative to curtail the dent on laboratory services that arise due to human errors. There has been varied information on the error rate within the whole lab testing procedure (0.1% to 9.3%). Plebani and Carraro observed in their paper that the great majority of errors result from problems in the pre-analytical or post-analytical phases. 5 Pre-analytical errors are largely attributable to human mistakes and the majority of these errors are preventable. 15 This is understandable, since the preanalytical phase involves much more human handling, compared to the analytical and post-analytical phases. 6 Hemolysis accounted for the majority of rejections in our study. The introduction of vacuum tubes along with the closed system of blood collection has made blood collection efficient and easy. But lack of staff training engaged in phlebotomy is an impediment for expediting sample collection and transport. Hemolysis of samples occurs when blood is forced through a fine needle, shaking the tubes vigorously, and centrifuging the sample specimens before clotting is complete. 7 Red top vacutainers without any anticoagulant should not be shaken after the sample has been collected, and vacutainers for plasma should be gently inverted a few times so the anticoagulant mixes with the blood. Freezing and thawing of blood specimens may cause massive hemolysis. In a study by Jay and colleagues, the majority of hemolyzed samples (>95%) could be attributed to in vitro processes resulting from incorrect sampling procedure or transportation. 8 Hemolysis leads to the extravasation of intracellular contents into the plasma, leading to false high values of potassium and intracellular enzymes such as SGOT and LDH. It also leads to a prolongated turn around time (TAT) due to the need for fresh samples for processing the request. 9 The frequency of hemolysis was more in the samples that were collected from the admitted patients as compared to the patients attending the OPDs (0.71% as compared to 0.09 %). One plausible explanation for this phenomenon could be the systematic blood collection technique followed by the laboratory staff in the OPD. 10 As a part of our endeavor to achieve accreditation for our laboratory services; we carry out regular in-house training sessions for our technicians to familiarize them with the standard protocols for sample processing. For this purpose, we have developed standard operating procedures (SOPs) for the different steps involved in ideal laboratory operations and ethics. Such training has facilitated in the adoption of ideal phlebotomy practices by our laboratory personnel. The samples are thereby transported to our laboratory from the collection center by our staff following the basic precautions that must be adhered to during transportation. There is an urgent need to instill awareness about the intricacies of a seemingly "easy and basic" activity that forms the mainstay of laboratory services - phlebotomy among the staff engaged in sample collection in our hospitals to reduce inadvertent hemolysis. 11 Another factor leading to rejection of blood samples in Our study was insufficient blood volume. Every analytical process requires a fixed volume of serum/plasma for analysis. The main reasons behind this anomaly are ignorance of the phlebotomists, difficult sampling as in pediatric patients, patients with chronic, debilitating diseases, and patients on chemotherapy whose thin veins are difficult to localize. Insufficient sample volume constituted the most frequent cause of test rejection in the samples collected in the OPD (1.28%). 12 Inpatient sampling with a frequency of 0.15 % for inadequate volume only. The difference is striking. This may be attributed to a number of factors. We have a centralized collection center where samples for clinical biochemistry, hematology, microbiology, and gastroenterology are collected simultaneously. 13 Due to the paucity of man power; the ratio of patients to phlebotomists is disproportionate, making sample collection difficult. This may hamper proper sample collection, leading to inadequate collection. The collection is carried out during fixed hours. Hence, this patient load combined with shortage of time may adversely affect proper sample collection in the OPD setting. Difficult sampling and patient non-compliance further aggravates this problem. Nevertheless, it is mandatory for the laboratory staff to practice a certain basic level of workmanship and skillful phlebotomy techniques to reduce such errors to a minimum. 14 A total of 0.70 % samples in the wards were accompanied by inappropriate requisition slips. The same figure for OPD samples was1.28 %. It has been observed that the clinicians often send incomplete slips with the samples. This could be due to excessive patient load or lack of awareness regarding patient information. Modern day diagnostics is not merely sample processing and preparation of reports. The laboratories are actively involved in disseminating information about critical results to clinicians so corrective measures can be initiated at the earliest. Incomplete/wrong patient information makes the practice redundant. Our laboratory staff could arrange the correct information about some of the patients admitted in the wards through their painstaking efforts. This leads to loss of precious time and is a laborintensive activity. The same protocol could not be followed for the OPD patients as it was virtually impossible to ascertain the patient/test information from either the clinicians or the patients. We followed a different protocol for these patients. The requisition slips, with an appropriate note citing reasons for sample rejection, were dispatched to the OPD for the clinicians' knowledge. Those tests were repeated with fresh samples and new requisition slips as and when the patients revisited the hospital for checkup. This is definitely inconvenient for patients, who have to undergo the same process of registration and consequent sampling. Such errors can be completely wiped out by persistence by the laboratories for complete information and sincere efforts by the clinicians to provide the same. This will facilitate speedy sample processing and report dispatch to the patients to initiate therapeutic interventions at the earliest. 15, 16 Lipemia accounted for rejection of 0.10 % and 0.019 % of the samples in the inpatient and outpatient departments respectively. Lipemic samples can arise due to collection after heavy meals or the presence of some metabolic disorder (hyperlipoproteinemias). This can be avoided by sample collection, preferably after an overnight fast. If the patient has a metabolic disorder, the same must be mentioned in the requisition slip. Lipemia interferes with optical reading by the instrument and can affect interpretation of electrolyte values. A higher incidence of lipemia in OPD patients may be due to non-dissemination of information regarding prior preparation to the patients by the clinicians as well as non-compliance and/or miscomprehension of preparation rules by the patients. Hence, many patients give samples in non-fasting states leading to erroneous reporting. It is the responsibility of the clinicians and the phlebotomists to ensure that proper patient preparation is instituted before sample collection. 17 These data are comparable to those provided by other investigators, which confirm that problems directly related to specimen collection are the main cause of pre-analytic errors, especially hemolyzed, clotted, insufficient, and incorrect samples. 16, 17 With the exclusive use of vacutainers, the frequency of errors found in our study is 1.62 %. It is clear from the above discussion that incorrect phlebotomy practices are the main reason behind pre-analytical errors. The reason for incorrect phlebotomy practice includes lack of awareness or possibly a heavy workload. This is the reason phlebotomy has been considered a separate area of improvement for medical technicians in developed Countries. Those of us in developing nations must adopt a similar approach toward phlebotomy and initiate steps for the inculcation of ideal phlebotomy practices among health care workers. 17, 18 CONCLUSIONS The concept of total quality management encompasses all the steps involved in sample processing, beginning from test ordering to the final interpretation of results by the clinicians to reduce or eliminate the errors that may arise during the various steps. The promotion of ideal phlebotomy practices and sample transport procedures is a pre-requisite for the efficacy of Laboratory functioning. The dependence on accurate laboratory results for diagnostics makes it mandatory for labs to ensure accountability and accuracy of results to negate incorrect diagnosis as a consequence of faulty reporting. A practice of keeping a record of the errors at all stages of analysis and then devising corrective strategies for their prevention can gradually free a laboratory from such errors. Errors in the laboratory can lead to inaccurate reports dispatched to clinicians, affecting health care services greatly. Ensuring the credibility of results is of utmost importance. While many clinicians probably believe that most errors in the laboratory are analytical, there are data showing that the pre-analytical and postanalytical phases are the greatest contributors to laboratory mistakes. Though it is impossible to completely eliminate errors, it is possible to reduce them. We conclude that training of phlebotomists and technicians, bar coding of samples, implementation of a LIS, adoption of standardized procedures along with participation in external quality assessment programs and accreditation schemes can help to reduce laboratory errors to a minimum. To attain this goal, we first implemented a continued education program, financed by our Regional Health Service and focused in Primary Care Nurses. REFERENCES 1. Ranjna Chawla, PhD, Binita Goswami, MD, DNB, Devika Tayal, MD, V Mallika, MD.Identification of the Types of Preanalytical Errors in the Clinical Chemistry Laboratory: 1Year Study at G.B. Pant Hospital. LAB MED. 2010; 41: 89-92. 2. Plebani M, Carraro P. The detection and prevention of errors in laboratory medicine Ann Clin Biochem. 2010; 47: 101-110. 3. Robert Hawkins Managing the Pre- and Postanalytical Phases of the Total Testing Process. Ann Lab Med. 2012; 32: 5-16. 4. Mai M,H. Mansour, Hassan M. E, Azzazy, Steven C. Correction Factors for Estimating Potassium Concentrations in Samples With In Vitro Hemolysis.Clin Chem. 2010; 46: 306–307. 5. Characterization and mathematical correction of hemolysis interference in selected Hitachi 717 assays. Arch Pathol Lab Med. 2010; 133:960–966. 6. Jones BA, Calam RR, Howanitz PJ Chemistry specimen acceptability: A College of American Pathologists Q-Probes study of 453 laboratories. Arch Pathol Lab Med. 2011; 121:19–26. 7. Romero A, Munoz M, Ramos JR, et al. Identification of preanalytical mistakes in the stat section of the clinical laboratory. Clin Chem Lab Med. 2010; 43:974–975. 8. Jones BA, Meier F, Howanitz PJ .Complete blood count specimen acceptability: A College of American Pathologists Q-Probes study of 703 laboratories. Arch Pathol Lab Med. 2012; 119: 203–208. 9. Fidler JR. Task analysis revisited: Refining the phlebotomy technician scope of practice and assessing longitudinal change in competencies. Eval Health Prof. 2007; 30:150–169. 10. Lippi G, Blanckaert N, Bonini P, et al. Causes, consequences, detection and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2011; 47:143– 153. 11. Goldschmit HMJ, Lent RW. Gross errors and work flow analysis in the clinical laboratory. Klin Biochem Metab 2010; 3:131-140. 12. Lapworth R, Teal TK. Laboratory blunders revisited. Ann C Biochem 2010; 31:78-84. 13. Plebani M, Carraro P. Mistakes in a stat laboratory: type frequency. Clin Chem 2009; 43: 1348-1351. 14. Stahl M, Lund ED, Brandslund I. Reasons for a laboratory's inability to report results for requested analytical tests. Clin Chem 2012; 44:2195-2197. 15. Nutting PA, Main DS, Fischer PM, Stull TM, Pontious M, Seifert M, et al. Problems in laboratory testing in primary care. JAMA 2006; 275:635-639. 16. M. Pleban The detection and prevention of errors in laboratory medicin Ann Clin Biochem, 2010; 47: 101 - 110. 17. Ranjan and Binita. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. JAMA 2011; 280: 550-558. 18. Romero and Cobos. The need for an outcomes research agenda for clinical laboratory testing. JAMA 2010; 280: 565-566. AUTHORS Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College Lahore, Pakistan Dr. Tariq Afzal Assistant Professor Pathology Sargodha Medical College, Sargodha, Pakistan Dr. Kokab Jabeen Assistant Professor Pathology Microbiology section Continental Medical College, Lahore, Pakistan Submitted for Publication: 27-03-2013 Accepted for Publication: 03-10-2013 After minor revisions
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Identification of the Types of Pre-analytical Errors in the Clinical Chemistry Laboratory from Jan-2012 to Dec-2012 at Jinnah Hospital, Pathology Department Jahangir Sultan, Tariq Afzal, Kokab Jabeen ABSTRACT Objective: To evaluate the leading causes of preanalytical errors in a clinical chemistry laboratory. Methods: A retrospective analysis of the results obtained from the clinical chemistry laboratory for errors in the pre-analytical phase has been carried out to summarize data regarding the frequency of the main factors affecting the pre-analytical quality of results. Laboratory personnel were asked to register rejections, and causes for rejection of ward as well as out-patient samples collected in INTRODUCTION Modern day diagnosis is heavily dependent upon reliable laboratory data. It is therefore pertinent to ensure credibility of the results emanating from the clinical laboratories. Remarkable advances in automation, sample collection, transport, and dispatch of reports have led to a drastic improvement in the performance of these laboratories. But there is long path to tread before we achieve 100% accuracy and precision. Errors arising during sample processing are classified into pre-analytical, analytical, and postanalytical, depending upon their source and time of presentation respectively. The pre-and post-analytical phases of the process account for 93% of errors. 1 The pre-analytical phase comprises all of the processes Corresponding Author Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College, Pakistan E-mail: [email protected] A.P.M.C Vol: 7 No. 1 January-June 2013 Lahore, the laboratory. Results: Of the 1,54,554 tubes received during the data collection period, 2505 samples were found unsuitable for further processing. This accounted for 1.52% of all samples collected in the laboratory. Rejections arose as a result of the following reasons: 0.48 % were rejected due to hemolysis; 0.92 % were specimens without proper requisition slips; and 0.14 % had insufficient sample quantity. Conclusion: Of all the samples received in the lab, the overall percentage of rejection is 1.62%. occurring before the sample is processed in the auto analyzer. 2 These include inappropriate tests that have been ordered, improper sample collection, transport delays, and illegible handwriting on requisition slips. 3,4 Although these areas are beyond the jurisdiction of the clinical laboratory per se, the credibility of 5,6,7 The labs have to bear the burden of the inconsistencies or the labs is at stake due to these errors. incorrect reporting that can ensue because of these preanalytical errors. 8,9 The goal of the present paper is to enumerate and analyze the prevalence of different pre-analytical errors that surfaced during sample processing in the clinical biochemistry department during a 1-year period. Jinnah Hospital is a tertiary care super specialty center in Lahore specializing in cardiology, cardiothoracic surgery, neurology, neurosurgery, gastroenterology, gastro surgery, and psychiatry. Jinnah Hospital is a teaching hospital as well. With 1416 students studying to be doctors at Allama Iqbal Medical College and learning practical procedures at Jinnah Hospital, over 7,000 doctors have graduated from here over the last ten years. It is a 1250-bed hospital offering specialized medical and surgical treatment to about an average of patients 700,000 visit the Out-Patient and Emergency Department every year, where 70% of the treatment is given completely free. Every year more than 1,500,000 tests are carried out in Pathology Laboratory The clinical biochemistry department is equipped with a state-of-the-art autoanalyzer with ISE– Beckman Coulter CX9PRO Clinical System (Hamburg, Germany), electrolyte Plus analyzer– Na/K/Cl,ABG Nova biochemical Analyser, and other ancillaries for sample processing. Inpatient phlebotomies are performed by clinical department staff, whereas blood specimens from outpatients are collected on site at a centralized collection center by laboratory personnel. The samples are delivered to the lab by the paramedical staff from the wards and laboratory support staff from the OPD respectively. REVIEW OF THE LITERATURE ON LABORATORY ERRORS | Sector of the laboratory | Lapworth and Teal.12 | Goldschmidt and Lent. 11 | M.Pleban.15 | Plebani and Carro.16 | Stahl M et al.14 | Jahangir Kokab and Tariq | Ranjan and Binita.17 | |---|---|---|---|---|---|---|---| | Sector of the laboratory | Clinical chemistry | Whole laboratory | Primary care. | Stat laboratory | Whole laboratory | Clinical chemistry | Clinical chemistry | | Data collection period | 1 year | 6 year | 6 month | 6 month | 3 year | 1 year | 1 year | | No of Patients | 997000 | ND | 160714 | ND | ND | 154554 | 96328 | | No of errors | 120 | 123 | 180 | 189 | 4135 | 2505 | 736 | | Frequency | | | | 0.47 % of patients | 0.61% of patients | 1. 6% of patients | 1.5 %.of patients | | Pre-analytical phase | 31.6% | 53% | 55% | 55.65 | 68.2% | 0.05% | | MATERIALS AND METHODS A total of 1,54554 samples from the outpatient department and in-house patients were received by our clinical chemistry laboratory during the period from January 2012 to December 2012. Out of these, 97,185 samples were collected from the patients admitted in the wards and 57,369 samples were collected in the outpatient department. The samples are collected using evacuated tubes (vacutainers evacuated tubes from BD (Franklin Lakes, NJ). The lab provides routine and reference testing in biochemistry. Upon receiving the samples, the lab supervisor visually detects any problems. When an error occurs, entries are made in the problem notification log book. The data generated is reviewed on a weekly basis. The data collection procedure involved review of blood samples received from the inpatient as well as outpatient departments. Venous blood samples are considered unsuitable according to the following accepted criteria: inappropriate volume, wrong or missing patient identification, inappropriate container, visible hemolysis after centrifugation, and lipemic samples. The pre-analytical variables evaluated included all the criteria mentioned above for sample rejection as well as incomplete/incorrect patient details and illegible handwriting. RESULTS We will first discuss the findings of the routine samples obtained from the inpatients in our hospital. Out of the 97,185 blood collection tubes screened over a period of 1 year, pre-analytical errors were observed in 1626 samples, which is approximately 1.6 % of the total number of samples received. The distribution of the different types of errors was then calculated (Table 1). The majority of the rejected samples were hemolyzed. Hemolysis was responsible for rejection of 692 samples, which accounts for 0.71% of the total number of samples received during this period. The amount of blood was insufficient for complete analysis in 0.15 % (i.e., 144out of the 97,185samples). A total of 687 samples were accompanied by inappropriate slips (i.e., wrong requisition slip, without requisition slip, central registration number ward not mentioned). This comprised approximately 0.70 % of all the samples received by the laboratory. Out of these 203 samples, laboratory personnel managed to ascertain correct patient data in 153 cases, and hence reporting was completed successfully for these patients. Fifty samples could not be processed even after elaborate and painstaking efforts by the laboratory staff. Gross lipemia led to rejection of 103samples (0.10 %). Similarly, we evaluated the slips obtained from the outpatient department. A total of 57,369 samples were received for processing from our OPD. Out of these, the number of pre-analytical errors documented was 879. This constitutes an error rate of 1.5 %. The distribution of the various pre-analytical variables is depicted in (Table 2). The most frequent error encountered during processing was sample with insufficient information (wrong vial/wrong slip). This constitutes an error rate of 1.28% this led to rejection of 738 samples out 57369 samples. The insufficient volume with an incidence of 0.13 %. Hemolysis, which constituted the most frequent pre-analytical error observed during sample processing of admitted patients, contributed to the rejection of 0.09 % of the samples in OPD as compared to 0.71% in the previous case. Table-1 Frequency of the Different Preanalytical Errors Observed in a Total of 97,185 Routine Inpatient Samples | 01 | Insufficient volume | |---|---| | 02 | Hemolysis | | 03 | Sample with insufficient information (wrong vial/wrong slip) | | 04 | Lipemic samples | Table-2 Preanalytical Errors Observed in a Total of 57,369 Outpatient Samples | 01 | Insufficient volume | 75(0.13 %) | |---|---|---| | 02 | Hemolysis | 55(0.09 %) | | 03 | Sample with insufficient information (wrong vial/wrong slip) | 738(1.28 %) | | 04 | Lipemic samples | 11(0.019%) | DISCUSSION Advances in science and technology have led to many path-breaking innovations that have transformed laboratory diagnostics from manual, cumbersome testing methods to fully automated science, ensuring accuracy and speed. 1, 2 However, the laboratory cannot function in isolation. It is dependent upon other departments; mainly the clinical division for properly filled requisition slips and samples for analysis. 1, 2Mounting evidence indicates that reliability cannot be achieved in a clinical laboratory through the mere promotion of accuracy in the analytical phase of the testing process. 3 It is evident that the majority of all errors in the total testing processing are of pre-analytical origin, i.e. they occur before the sample arrives in the laboratory and the phase after the sample is analyzed (post-analytical) are equally important. 4 The pre-analytical phase is riddled with many shortcomings ranging from lax attitude about filling the requisition slips to the staff's lack of education about ideal phlebotomy procedures. The health care system must be more diligent in applying scientific knowledge to reduce the errors in this phase. This is imperative to curtail the dent on laboratory services that arise due to human errors. There has been varied information on the error rate within the whole lab testing procedure (0.1% to 9.3%). Plebani and Carraro observed in their paper that the great majority of errors result from problems in the pre-analytical or post-analytical phases. 5 Pre-analytical errors are largely attributable to human mistakes and the majority of these errors are preventable. 15 This is understandable, since the preanalytical phase involves much more human handling, compared to the analytical and post-analytical phases. 6 Hemolysis accounted for the majority of rejections in our study. The introduction of vacuum tubes along with the closed system of blood collection has made blood collection efficient and easy. But lack of staff training engaged in phlebotomy is an impediment for expediting sample collection and transport. Hemolysis of samples occurs when blood is forced through a fine needle, shaking the tubes vigorously, and centrifuging the sample specimens before clotting is complete. 7 Red top vacutainers without any anticoagulant should not be shaken after the sample has been collected, and vacutainers for plasma should be gently inverted a few times so the anticoagulant mixes with the blood. Freezing and thawing of blood specimens may cause massive hemolysis. In a study by Jay and colleagues, the majority of hemolyzed samples (>95%) could be attributed to in vitro processes resulting from incorrect sampling procedure or transportation. 8 Hemolysis leads to the extravasation of intracellular contents into the plasma, leading to false high values of potassium and intracellular enzymes such as SGOT and LDH. It also leads to a prolongated turn around time (TAT) due to the need for fresh samples for processing the request. 9 The frequency of hemolysis was more in the samples that were collected from the admitted patients as compared to the patients attending the OPDs (0.71% as compared to 0.09 %). One plausible explanation for this phenomenon could be the systematic blood collection technique followed by the laboratory staff in the OPD. 10 As a part of our endeavor to achieve accreditation for our laboratory services; we carry out regular in-house training sessions for our technicians to familiarize them with the standard protocols for sample processing. For this purpose, we have developed standard operating procedures (SOPs) for the different steps involved in ideal laboratory operations and ethics. Such training has facilitated in the adoption of ideal phlebotomy practices by our laboratory personnel. The samples are thereby transported to our laboratory from the collection center by our staff following the basic precautions that must be adhered to during transportation. There is an urgent need to instill awareness about the intricacies of a seemingly "easy and basic" activity that forms the mainstay of laboratory services - phlebotomy among the staff engaged in sample collection in our hospitals to reduce inadvertent hemolysis. 11 Another factor leading to rejection of blood samples in Our study was insufficient blood volume. Every analytical process requires a fixed volume of serum/plasma for analysis. The main reasons behind this anomaly are ignorance of the phlebotomists, difficult sampling as in pediatric patients, patients with chroni
c, debilitating diseases, and patients on chemotherapy whose thin veins are difficult to localize.
Insufficient sample volume constituted the most frequent cause of test rejection in the samples collected in the OPD (1.28%). 12 Inpatient sampling with a frequency of 0.15 % for inadequate volume only. The difference is striking. This may be attributed to a number of factors. We have a centralized collection center where samples for clinical biochemistry, hematology, microbiology, and gastroenterology are collected simultaneously. 13 Due to the paucity of man power; the ratio of patients to phlebotomists is disproportionate, making sample collection difficult. This may hamper proper sample collection, leading to inadequate collection. The collection is carried out during fixed hours. Hence, this patient load combined with shortage of time may adversely affect proper sample collection in the OPD setting. Difficult sampling and patient non-compliance further aggravates this problem. Nevertheless, it is mandatory for the laboratory staff to practice a certain basic level of workmanship and skillful phlebotomy techniques to reduce such errors to a minimum. 14 A total of 0.70 % samples in the wards were accompanied by inappropriate requisition slips. The same figure for OPD samples was1.28 %. It has been observed that the clinicians often send incomplete slips with the samples. This could be due to excessive patient load or lack of awareness regarding patient information. Modern day diagnostics is not merely sample processing and preparation of reports. The laboratories are actively involved in disseminating information about critical results to clinicians so corrective measures can be initiated at the earliest. Incomplete/wrong patient information makes the practice redundant. Our laboratory staff could arrange the correct information about some of the patients admitted in the wards through their painstaking efforts. This leads to loss of precious time and is a laborintensive activity. The same protocol could not be followed for the OPD patients as it was virtually impossible to ascertain the patient/test information from either the clinicians or the patients. We followed a different protocol for these patients. The requisition slips, with an appropriate note citing reasons for sample rejection, were dispatched to the OPD for the clinicians' knowledge. Those tests were repeated with fresh samples and new requisition slips as and when the patients revisited the hospital for checkup. This is definitely inconvenient for patients, who have to undergo the same process of registration and consequent sampling. Such errors can be completely wiped out by persistence by the laboratories for complete information and sincere efforts by the clinicians to provide the same. This will facilitate speedy sample processing and report dispatch to the patients to initiate therapeutic interventions at the earliest. 15, 16 Lipemia accounted for rejection of 0.10 % and 0.019 % of the samples in the inpatient and outpatient departments respectively. Lipemic samples can arise due to collection after heavy meals or the presence of some metabolic disorder (hyperlipoproteinemias). This can be avoided by sample collection, preferably after an overnight fast. If the patient has a metabolic disorder, the same must be mentioned in the requisition slip. Lipemia interferes with optical reading by the instrument and can affect interpretation of electrolyte values. A higher incidence of lipemia in OPD patients may be due to non-dissemination of information regarding prior preparation to the patients by the clinicians as well as non-compliance and/or miscomprehension of preparation rules by the patients. Hence, many patients give samples in non-fasting states leading to erroneous reporting. It is the responsibility of the clinicians and the phlebotomists to ensure that proper patient preparation is instituted before sample collection. 17 These data are comparable to those provided by other investigators, which confirm that problems directly related to specimen collection are the main cause of pre-analytic errors, especially hemolyzed, clotted, insufficient, and incorrect samples. 16, 17 With the exclusive use of vacutainers, the frequency of errors found in our study is 1.62 %. It is clear from the above discussion that incorrect phlebotomy practices are the main reason behind pre-analytical errors. The reason for incorrect phlebotomy practice includes lack of awareness or possibly a heavy workload. This is the reason phlebotomy has been considered a separate area of improvement for medical technicians in developed Countries. Those of us in developing nations must adopt a similar approach toward phlebotomy and initiate steps for the inculcation of ideal phlebotomy practices among health care workers. 17, 18 CONCLUSIONS The concept of total quality management encompasses all the steps involved in sample processing, beginning from test ordering to the final interpretation of results by the clinicians to reduce or eliminate the errors that may arise during the various steps. The promotion of ideal phlebotomy practices and sample transport procedures is a pre-requisite for the efficacy of Laboratory functioning. The dependence on accurate laboratory results for diagnostics makes it mandatory for labs to ensure accountability and accuracy of results to negate incorrect diagnosis as a consequence of faulty reporting. A practice of keeping a record of the errors at all stages of analysis and then devising corrective strategies for their prevention can gradually free a laboratory from such errors. Errors in the laboratory can lead to inaccurate reports dispatched to clinicians, affecting health care services greatly. Ensuring the credibility of results is of utmost importance. While many clinicians probably believe that most errors in the laboratory are analytical, there are data showing that the pre-analytical and postanalytical phases are the greatest contributors to laboratory mistakes. Though it is impossible to completely eliminate errors, it is possible to reduce them. We conclude that training of phlebotomists and technicians, bar coding of samples, implementation of a LIS, adoption of standardized procedures along with participation in external quality assessment programs and accreditation schemes can help to reduce laboratory errors to a minimum. To attain this goal, we first implemented a continued education program, financed by our Regional Health Service and focused in Primary Care Nurses. REFERENCES 1. Ranjna Chawla, PhD, Binita Goswami, MD, DNB, Devika Tayal, MD, V Mallika, MD.Identification of the Types of Preanalytical Errors in the Clinical Chemistry Laboratory: 1Year Study at G.B. Pant Hospital. LAB MED. 2010; 41: 89-92. 2. Plebani M, Carraro P. The detection and prevention of errors in laboratory medicine Ann Clin Biochem. 2010; 47: 101-110. 3. Robert Hawkins Managing the Pre- and Postanalytical Phases of the Total Testing Process. Ann Lab Med. 2012; 32: 5-16. 4. Mai M,H. Mansour, Hassan M. E, Azzazy, Steven C. Correction Factors for Estimating Potassium Concentrations in Samples With In Vitro Hemolysis.Clin Chem. 2010; 46: 306–307. 5. Characterization and mathematical correction of hemolysis interference in selected Hitachi 717 assays. Arch Pathol Lab Med. 2010; 133:960–966. 6. Jones BA, Calam RR, Howanitz PJ Chemistry specimen acceptability: A College of American Pathologists Q-Probes study of 453 laboratories. Arch Pathol Lab Med. 2011; 121:19–26. 7. Romero A, Munoz M, Ramos JR, et al. Identification of preanalytical mistakes in the stat section of the clinical laboratory. Clin Chem Lab Med. 2010; 43:974–975. 8. Jones BA, Meier F, Howanitz PJ .Complete blood count specimen acceptability: A College of American Pathologists Q-Probes study of 703 laboratories. Arch Pathol Lab Med. 2012; 119: 203–208. 9. Fidler JR. Task analysis revisited: Refining the phlebotomy technician scope of practice and assessing longitudinal change in competencies. Eval Health Prof. 2007; 30:150–169. 10. Lippi G, Blanckaert N, Bonini P, et al. Causes, consequences, detection and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2011; 47:143– 153. 11. Goldschmit HMJ, Lent RW. Gross errors and work flow analysis in the clinical laboratory. Klin Biochem Metab 2010; 3:131-140. 12. Lapworth R, Teal TK. Laboratory blunders revisited. Ann C Biochem 2010; 31:78-84. 13. Plebani M, Carraro P. Mistakes in a stat laboratory: type frequency. Clin Chem 2009; 43: 1348-1351. 14. Stahl M, Lund ED, Brandslund I. Reasons for a laboratory's inability to report results for requested analytical tests. Clin Chem 2012; 44:2195-2197. 15. Nutting PA, Main DS, Fischer PM, Stull TM, Pontious M, Seifert M, et al. Problems in laboratory testing in primary care. JAMA 2006; 275:635-639. 16. M. Pleban The detection and prevention of errors in laboratory medicin Ann Clin Biochem, 2010; 47: 101 - 110. 17. Ranjan and Binita. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. JAMA 2011; 280: 550-558. 18. Romero and Cobos. The need for an outcomes research agenda for clinical laboratory testing. JAMA 2010; 280: 565-566. AUTHORS Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College Lahore, Pakistan Dr. Tariq Afzal Assistant Professor Pathology Sargodha Medical College, Sargodha, Pakistan Dr. Kokab Jabeen Assistant Professor Pathology Microbiology section Continental Medical College, Lahore, Pakistan Submitted for Publication: 27-03-2013 Accepted for Publication: 03-10-2013 After minor revisions
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<url> http://apmc.com.pk/Download/APMC/apmc_v7n1/19-%20Identification%20of%20the%20Types%20of%20Pre-analytical%20Errors%20in%20the%20Clinical%20Chemistry%20Laboratory%20from%20Jan-2012%20to%20Dec-2012%20at%20Jinnah%20Hospital%2C%20Pathology%20Department.doc.pdf </url> <text> Identification of the Types of Pre-analytical Errors in the Clinical Chemistry Laboratory from Jan-2012 to Dec-2012 at Jinnah Hospital, Pathology Department Jahangir Sultan, Tariq Afzal, Kokab Jabeen ABSTRACT Objective: To evaluate the leading causes of preanalytical errors in a clinical chemistry laboratory. Methods: A retrospective analysis of the results obtained from the clinical chemistry laboratory for errors in the pre-analytical phase has been carried out to summarize data regarding the frequency of the main factors affecting the pre-analytical quality of results. Laboratory personnel were asked to register rejections, and causes for rejection of ward as well as out-patient samples collected in INTRODUCTION Modern day diagnosis is heavily dependent upon reliable laboratory data. It is therefore pertinent to ensure credibility of the results emanating from the clinical laboratories. Remarkable advances in automation, sample collection, transport, and dispatch of reports have led to a drastic improvement in the performance of these laboratories. But there is long path to tread before we achieve 100% accuracy and precision. Errors arising during sample processing are classified into pre-analytical, analytical, and postanalytical, depending upon their source and time of presentation respectively. The pre-and post-analytical phases of the process account for 93% of errors. 1 The pre-analytical phase comprises all of the processes Corresponding Author Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College, Pakistan E-mail: [email protected] A.P.M.C Vol: 7 No. 1 January-June 2013 Lahore, the laboratory. Results: Of the 1,54,554 tubes received during the data collection period, 2505 samples were found unsuitable for further processing. This accounted for 1.52% of all samples collected in the laboratory. Rejections arose as a result of the following reasons: 0.48 % were rejected due to hemolysis; 0.92 % were specimens without proper requisition slips; and 0.14 % had insufficient sample quantity. Conclusion: Of all the samples received in the lab, the overall percentage of rejection is 1.62%. occurring before the sample is processed in the auto analyzer. 2 These include inappropriate tests that have been ordered, improper sample collection, transport delays, and illegible handwriting on requisition slips. 3,4 Although these areas are beyond the jurisdiction of the clinical laboratory per se, the credibility of 5,6,7 The labs have to bear the burden of the inconsistencies or the labs is at stake due to these errors. incorrect reporting that can ensue because of these preanalytical errors. 8,9 The goal of the present paper is to enumerate and analyze the prevalence of different pre-analytical errors that surfaced during sample processing in the clinical biochemistry department during a 1-year period. Jinnah Hospital is a tertiary care super specialty center in Lahore specializing in cardiology, cardiothoracic surgery, neurology, neurosurgery, gastroenterology, gastro surgery, and psychiatry. Jinnah Hospital is a teaching hospital as well. With 1416 students studying to be doctors at Allama Iqbal Medical College and learning practical procedures at Jinnah Hospital, over 7,000 doctors have graduated from here over the last ten years. It is a 1250-bed hospital offering specialized medical and surgical treatment to about an average of patients 700,000 visit the Out-Patient and Emergency Department every year, where 70% of the treatment is given completely free. Every year more than 1,500,000 tests are carried out in Pathology Laboratory The clinical biochemistry department is equipped with a state-of-the-art autoanalyzer with ISE– Beckman Coulter CX9PRO Clinical System (Hamburg, Germany), electrolyte Plus analyzer– Na/K/Cl,ABG Nova biochemical Analyser, and other ancillaries for sample processing. Inpatient phlebotomies are performed by clinical department staff, whereas blood specimens from outpatients are collected on site at a centralized collection center by laboratory personnel. The samples are delivered to the lab by the paramedical staff from the wards and laboratory support staff from the OPD respectively. REVIEW OF THE LITERATURE ON LABORATORY ERRORS | Sector of the laboratory | Lapworth and Teal.12 | Goldschmidt and Lent. 11 | M.Pleban.15 | Plebani and Carro.16 | Stahl M et al.14 | Jahangir Kokab and Tariq | Ranjan and Binita.17 | |---|---|---|---|---|---|---|---| | Sector of the laboratory | Clinical chemistry | Whole laboratory | Primary care. | Stat laboratory | Whole laboratory | Clinical chemistry | Clinical chemistry | | Data collection period | 1 year | 6 year | 6 month | 6 month | 3 year | 1 year | 1 year | | No of Patients | 997000 | ND | 160714 | ND | ND | 154554 | 96328 | | No of errors | 120 | 123 | 180 | 189 | 4135 | 2505 | 736 | | Frequency | | | | 0.47 % of patients | 0.61% of patients | 1. 6% of patients | 1.5 %.of patients | | Pre-analytical phase | 31.6% | 53% | 55% | 55.65 | 68.2% | 0.05% | | MATERIALS AND METHODS A total of 1,54554 samples from the outpatient department and in-house patients were received by our clinical chemistry laboratory during the period from January 2012 to December 2012. Out of these, 97,185 samples were collected from the patients admitted in the wards and 57,369 samples were collected in the outpatient department. The samples are collected using evacuated tubes (vacutainers evacuated tubes from BD (Franklin Lakes, NJ). The lab provides routine and reference testing in biochemistry. Upon receiving the samples, the lab supervisor visually detects any problems. When an error occurs, entries are made in the problem notification log book. The data generated is reviewed on a weekly basis. The data collection procedure involved review of blood samples received from the inpatient as well as outpatient departments. Venous blood samples are considered unsuitable according to the following accepted criteria: inappropriate volume, wrong or missing patient identification, inappropriate container, visible hemolysis after centrifugation, and lipemic samples. The pre-analytical variables evaluated included all the criteria mentioned above for sample rejection as well as incomplete/incorrect patient details and illegible handwriting. RESULTS We will first discuss the findings of the routine samples obtained from the inpatients in our hospital. Out of the 97,185 blood collection tubes screened over a period of 1 year, pre-analytical errors were observed in 1626 samples, which is approximately 1.6 % of the total number of samples received. The distribution of the different types of errors was then calculated (Table 1). The majority of the rejected samples were hemolyzed. Hemolysis was responsible for rejection of 692 samples, which accounts for 0.71% of the total number of samples received during this period. The amount of blood was insufficient for complete analysis in 0.15 % (i.e., 144out of the 97,185samples). A total of 687 samples were accompanied by inappropriate slips (i.e., wrong requisition slip, without requisition slip, central registration number ward not mentioned). This comprised approximately 0.70 % of all the samples received by the laboratory. Out of these 203 samples, laboratory personnel managed to ascertain correct patient data in 153 cases, and hence reporting was completed successfully for these patients. Fifty samples could not be processed even after elaborate and painstaking efforts by the laboratory staff. Gross lipemia led to rejection of 103samples (0.10 %). Similarly, we evaluated the slips obtained from the outpatient department. A total of 57,369 samples were received for processing from our OPD. Out of these, the number of pre-analytical errors documented was 879. This constitutes an error rate of 1.5 %. The distribution of the various pre-analytical variables is depicted in (Table 2). The most frequent error encountered during processing was sample with insufficient information (wrong vial/wrong slip). This constitutes an error rate of 1.28% this led to rejection of 738 samples out 57369 samples. The insufficient volume with an incidence of 0.13 %. Hemolysis, which constituted the most frequent pre-analytical error observed during sample processing of admitted patients, contributed to the rejection of 0.09 % of the samples in OPD as compared to 0.71% in the previous case. Table-1 Frequency of the Different Preanalytical Errors Observed in a Total of 97,185 Routine Inpatient Samples | 01 | Insufficient volume | |---|---| | 02 | Hemolysis | | 03 | Sample with insufficient information (wrong vial/wrong slip) | | 04 | Lipemic samples | Table-2 Preanalytical Errors Observed in a Total of 57,369 Outpatient Samples | 01 | Insufficient volume | 75(0.13 %) | |---|---|---| | 02 | Hemolysis | 55(0.09 %) | | 03 | Sample with insufficient information (wrong vial/wrong slip) | 738(1.28 %) | | 04 | Lipemic samples | 11(0.019%) | DISCUSSION Advances in science and technology have led to many path-breaking innovations that have transformed laboratory diagnostics from manual, cumbersome testing methods to fully automated science, ensuring accuracy and speed. 1, 2 However, the laboratory cannot function in isolation. It is dependent upon other departments; mainly the clinical division for properly filled requisition slips and samples for analysis. 1, 2Mounting evidence indicates that reliability cannot be achieved in a clinical laboratory through the mere promotion of accuracy in the analytical phase of the testing process. 3 It is evident that the majority of all errors in the total testing processing are of pre-analytical origin, i.e. they occur before the sample arrives in the laboratory and the phase after the sample is analyzed (post-analytical) are equally important. 4 The pre-analytical phase is riddled with many shortcomings ranging from lax attitude about filling the requisition slips to the staff's lack of education about ideal phlebotomy procedures. The health care system must be more diligent in applying scientific knowledge to reduce the errors in this phase. This is imperative to curtail the dent on laboratory services that arise due to human errors. There has been varied information on the error rate within the whole lab testing procedure (0.1% to 9.3%). Plebani and Carraro observed in their paper that the great majority of errors result from problems in the pre-analytical or post-analytical phases. 5 Pre-analytical errors are largely attributable to human mistakes and the majority of these errors are preventable. 15 This is understandable, since the preanalytical phase involves much more human handling, compared to the analytical and post-analytical phases. 6 Hemolysis accounted for the majority of rejections in our study. The introduction of vacuum tubes along with the closed system of blood collection has made blood collection efficient and easy. But lack of staff training engaged in phlebotomy is an impediment for expediting sample collection and transport. Hemolysis of samples occurs when blood is forced through a fine needle, shaking the tubes vigorously, and centrifuging the sample specimens before clotting is complete. 7 Red top vacutainers without any anticoagulant should not be shaken after the sample has been collected, and vacutainers for plasma should be gently inverted a few times so the anticoagulant mixes with the blood. Freezing and thawing of blood specimens may cause massive hemolysis. In a study by Jay and colleagues, the majority of hemolyzed samples (>95%) could be attributed to in vitro processes resulting from incorrect sampling procedure or transportation. 8 Hemolysis leads to the extravasation of intracellular contents into the plasma, leading to false high values of potassium and intracellular enzymes such as SGOT and LDH. It also leads to a prolongated turn around time (TAT) due to the need for fresh samples for processing the request. 9 The frequency of hemolysis was more in the samples that were collected from the admitted patients as compared to the patients attending the OPDs (0.71% as compared to 0.09 %). One plausible explanation for this phenomenon could be the systematic blood collection technique followed by the laboratory staff in the OPD. 10 As a part of our endeavor to achieve accreditation for our laboratory services; we carry out regular in-house training sessions for our technicians to familiarize them with the standard protocols for sample processing. For this purpose, we have developed standard operating procedures (SOPs) for the different steps involved in ideal laboratory operations and ethics. Such training has facilitated in the adoption of ideal phlebotomy practices by our laboratory personnel. The samples are thereby transported to our laboratory from the collection center by our staff following the basic precautions that must be adhered to during transportation. There is an urgent need to instill awareness about the intricacies of a seemingly "easy and basic" activity that forms the mainstay of laboratory services - phlebotomy among the staff engaged in sample collection in our hospitals to reduce inadvertent hemolysis. 11 Another factor leading to rejection of blood samples in Our study was insufficient blood volume. Every analytical process requires a fixed volume of serum/plasma for analysis. The main reasons behind this anomaly are ignorance of the phlebotomists, difficult sampling as in pediatric patients, patients with chroni<cursor_is_here> Insufficient sample volume constituted the most frequent cause of test rejection in the samples collected in the OPD (1.28%). 12 Inpatient sampling with a frequency of 0.15 % for inadequate volume only. The difference is striking. This may be attributed to a number of factors. We have a centralized collection center where samples for clinical biochemistry, hematology, microbiology, and gastroenterology are collected simultaneously. 13 Due to the paucity of man power; the ratio of patients to phlebotomists is disproportionate, making sample collection difficult. This may hamper proper sample collection, leading to inadequate collection. The collection is carried out during fixed hours. Hence, this patient load combined with shortage of time may adversely affect proper sample collection in the OPD setting. Difficult sampling and patient non-compliance further aggravates this problem. Nevertheless, it is mandatory for the laboratory staff to practice a certain basic level of workmanship and skillful phlebotomy techniques to reduce such errors to a minimum. 14 A total of 0.70 % samples in the wards were accompanied by inappropriate requisition slips. The same figure for OPD samples was1.28 %. It has been observed that the clinicians often send incomplete slips with the samples. This could be due to excessive patient load or lack of awareness regarding patient information. Modern day diagnostics is not merely sample processing and preparation of reports. The laboratories are actively involved in disseminating information about critical results to clinicians so corrective measures can be initiated at the earliest. Incomplete/wrong patient information makes the practice redundant. Our laboratory staff could arrange the correct information about some of the patients admitted in the wards through their painstaking efforts. This leads to loss of precious time and is a laborintensive activity. The same protocol could not be followed for the OPD patients as it was virtually impossible to ascertain the patient/test information from either the clinicians or the patients. We followed a different protocol for these patients. The requisition slips, with an appropriate note citing reasons for sample rejection, were dispatched to the OPD for the clinicians' knowledge. Those tests were repeated with fresh samples and new requisition slips as and when the patients revisited the hospital for checkup. This is definitely inconvenient for patients, who have to undergo the same process of registration and consequent sampling. Such errors can be completely wiped out by persistence by the laboratories for complete information and sincere efforts by the clinicians to provide the same. This will facilitate speedy sample processing and report dispatch to the patients to initiate therapeutic interventions at the earliest. 15, 16 Lipemia accounted for rejection of 0.10 % and 0.019 % of the samples in the inpatient and outpatient departments respectively. Lipemic samples can arise due to collection after heavy meals or the presence of some metabolic disorder (hyperlipoproteinemias). This can be avoided by sample collection, preferably after an overnight fast. If the patient has a metabolic disorder, the same must be mentioned in the requisition slip. Lipemia interferes with optical reading by the instrument and can affect interpretation of electrolyte values. A higher incidence of lipemia in OPD patients may be due to non-dissemination of information regarding prior preparation to the patients by the clinicians as well as non-compliance and/or miscomprehension of preparation rules by the patients. Hence, many patients give samples in non-fasting states leading to erroneous reporting. It is the responsibility of the clinicians and the phlebotomists to ensure that proper patient preparation is instituted before sample collection. 17 These data are comparable to those provided by other investigators, which confirm that problems directly related to specimen collection are the main cause of pre-analytic errors, especially hemolyzed, clotted, insufficient, and incorrect samples. 16, 17 With the exclusive use of vacutainers, the frequency of errors found in our study is 1.62 %. It is clear from the above discussion that incorrect phlebotomy practices are the main reason behind pre-analytical errors. The reason for incorrect phlebotomy practice includes lack of awareness or possibly a heavy workload. This is the reason phlebotomy has been considered a separate area of improvement for medical technicians in developed Countries. Those of us in developing nations must adopt a similar approach toward phlebotomy and initiate steps for the inculcation of ideal phlebotomy practices among health care workers. 17, 18 CONCLUSIONS The concept of total quality management encompasses all the steps involved in sample processing, beginning from test ordering to the final interpretation of results by the clinicians to reduce or eliminate the errors that may arise during the various steps. The promotion of ideal phlebotomy practices and sample transport procedures is a pre-requisite for the efficacy of Laboratory functioning. The dependence on accurate laboratory results for diagnostics makes it mandatory for labs to ensure accountability and accuracy of results to negate incorrect diagnosis as a consequence of faulty reporting. A practice of keeping a record of the errors at all stages of analysis and then devising corrective strategies for their prevention can gradually free a laboratory from such errors. Errors in the laboratory can lead to inaccurate reports dispatched to clinicians, affecting health care services greatly. Ensuring the credibility of results is of utmost importance. While many clinicians probably believe that most errors in the laboratory are analytical, there are data showing that the pre-analytical and postanalytical phases are the greatest contributors to laboratory mistakes. Though it is impossible to completely eliminate errors, it is possible to reduce them. We conclude that training of phlebotomists and technicians, bar coding of samples, implementation of a LIS, adoption of standardized procedures along with participation in external quality assessment programs and accreditation schemes can help to reduce laboratory errors to a minimum. To attain this goal, we first implemented a continued education program, financed by our Regional Health Service and focused in Primary Care Nurses. REFERENCES 1. Ranjna Chawla, PhD, Binita Goswami, MD, DNB, Devika Tayal, MD, V Mallika, MD.Identification of the Types of Preanalytical Errors in the Clinical Chemistry Laboratory: 1Year Study at G.B. Pant Hospital. LAB MED. 2010; 41: 89-92. 2. Plebani M, Carraro P. The detection and prevention of errors in laboratory medicine Ann Clin Biochem. 2010; 47: 101-110. 3. Robert Hawkins Managing the Pre- and Postanalytical Phases of the Total Testing Process. Ann Lab Med. 2012; 32: 5-16. 4. Mai M,H. Mansour, Hassan M. E, Azzazy, Steven C. Correction Factors for Estimating Potassium Concentrations in Samples With In Vitro Hemolysis.Clin Chem. 2010; 46: 306–307. 5. Characterization and mathematical correction of hemolysis interference in selected Hitachi 717 assays. Arch Pathol Lab Med. 2010; 133:960–966. 6. Jones BA, Calam RR, Howanitz PJ Chemistry specimen acceptability: A College of American Pathologists Q-Probes study of 453 laboratories. Arch Pathol Lab Med. 2011; 121:19–26. 7. Romero A, Munoz M, Ramos JR, et al. Identification of preanalytical mistakes in the stat section of the clinical laboratory. Clin Chem Lab Med. 2010; 43:974–975. 8. Jones BA, Meier F, Howanitz PJ .Complete blood count specimen acceptability: A College of American Pathologists Q-Probes study of 703 laboratories. Arch Pathol Lab Med. 2012; 119: 203–208. 9. Fidler JR. Task analysis revisited: Refining the phlebotomy technician scope of practice and assessing longitudinal change in competencies. Eval Health Prof. 2007; 30:150–169. 10. Lippi G, Blanckaert N, Bonini P, et al. Causes, consequences, detection and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2011; 47:143– 153. 11. Goldschmit HMJ, Lent RW. Gross errors and work flow analysis in the clinical laboratory. Klin Biochem Metab 2010; 3:131-140. 12. Lapworth R, Teal TK. Laboratory blunders revisited. Ann C Biochem 2010; 31:78-84. 13. Plebani M, Carraro P. Mistakes in a stat laboratory: type frequency. Clin Chem 2009; 43: 1348-1351. 14. Stahl M, Lund ED, Brandslund I. Reasons for a laboratory's inability to report results for requested analytical tests. Clin Chem 2012; 44:2195-2197. 15. Nutting PA, Main DS, Fischer PM, Stull TM, Pontious M, Seifert M, et al. Problems in laboratory testing in primary care. JAMA 2006; 275:635-639. 16. M. Pleban The detection and prevention of errors in laboratory medicin Ann Clin Biochem, 2010; 47: 101 - 110. 17. Ranjan and Binita. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. JAMA 2011; 280: 550-558. 18. Romero and Cobos. The need for an outcomes research agenda for clinical laboratory testing. JAMA 2010; 280: 565-566. AUTHORS Dr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College Lahore, Pakistan Dr. Tariq Afzal Assistant Professor Pathology Sargodha Medical College, Sargodha, Pakistan Dr. Kokab Jabeen Assistant Professor Pathology Microbiology section Continental Medical College, Lahore, Pakistan Submitted for Publication: 27-03-2013 Accepted for Publication: 03-10-2013 After minor revisions </text>
[ { "content": "<url>\nhttp://apmc.com.pk/Download/APMC/apmc_v7n1/19-%20Identification%20of%20the%20Types%20of%20Pre-analytical%20Errors%20in%20the%20Clinical%20Chemistry%20Laboratory%20from%20Jan-2012%20to%20Dec-2012%20at%20Jinnah%20Hospital%2C%20Pathology%20Department.doc.pdf\n</url>\n<text>\nIdentification of the Types of Pre-analytical Errors in the Clinical Chemistry Laboratory from Jan-2012 to Dec-2012 at Jinnah Hospital, Pathology Department\n\nJahangir Sultan, Tariq Afzal, Kokab Jabeen\n\nABSTRACT\n\nObjective: To evaluate the leading causes of preanalytical errors in a clinical chemistry laboratory. Methods: A retrospective analysis of the results obtained from the clinical chemistry laboratory for errors in the pre-analytical phase has been carried out to summarize data regarding the frequency of the main factors affecting the pre-analytical quality of results. Laboratory personnel were asked to register rejections, and causes for rejection of ward as well as out-patient samples collected in\n\nINTRODUCTION\n\nModern day diagnosis is heavily dependent upon reliable laboratory data. It is therefore pertinent to ensure credibility of the results emanating from the clinical laboratories. Remarkable advances in automation, sample collection, transport, and dispatch of reports have led to a drastic improvement in the performance of these laboratories. But there is long path to tread before we achieve 100% accuracy and precision. Errors arising during sample processing are classified into pre-analytical, analytical, and postanalytical, depending upon their source and time of presentation respectively. The pre-and post-analytical phases of the process account for 93% of errors. 1 The pre-analytical phase comprises all of the processes\n\nCorresponding Author\n\nDr. Jahangir Sultan\nAssistant Professor Pathology\n\nChemical Section\n\nContinental Medical\n\nCollege,\n\nPakistan\nE-mail: [email protected]\n\nA.P.M.C Vol: 7 No. 1 January-June 2013\n\nLahore, the laboratory. Results: Of the 1,54,554 tubes received during the data collection period, 2505 samples were found unsuitable for further processing. This accounted for 1.52% of all samples collected in the laboratory. Rejections arose as a result of the following reasons: 0.48 % were rejected due to hemolysis; 0.92 % were specimens without proper requisition slips; and 0.14 % had insufficient sample quantity. Conclusion: Of all the samples received in the lab, the overall percentage of rejection is 1.62%.\n\noccurring before the sample is processed in the auto analyzer. 2 These include inappropriate tests that have been ordered, improper sample collection, transport delays, and illegible handwriting on requisition slips. 3,4 Although these areas are beyond the jurisdiction of the clinical laboratory per se, the credibility of 5,6,7 The labs have to bear the burden of the inconsistencies or the labs is at stake due to these errors. incorrect reporting that can ensue because of these preanalytical errors. 8,9\n\nThe goal of the present paper is to enumerate and analyze the prevalence of different pre-analytical errors that surfaced during sample processing in the clinical biochemistry department during a 1-year period.\n\nJinnah Hospital is a tertiary care super specialty center in Lahore specializing in cardiology, cardiothoracic surgery, neurology, neurosurgery, gastroenterology, gastro surgery, and psychiatry. Jinnah Hospital is a teaching hospital as well. With 1416 students studying to be doctors at Allama Iqbal Medical College and learning practical procedures at Jinnah Hospital, over 7,000 doctors have graduated from here over the last ten years.\n\nIt is a 1250-bed hospital offering specialized medical and surgical treatment to about an average of patients 700,000 visit the Out-Patient and Emergency Department every year, where 70% of the treatment is given completely free. Every year more than 1,500,000 tests are carried out in Pathology Laboratory\n\nThe clinical biochemistry department is equipped with a state-of-the-art autoanalyzer with ISE– Beckman Coulter CX9PRO Clinical System (Hamburg, Germany), electrolyte Plus analyzer–\n\nNa/K/Cl,ABG Nova biochemical Analyser, and other ancillaries for sample processing. Inpatient phlebotomies are performed by clinical department staff, whereas blood specimens from outpatients are collected on site at a centralized collection center by laboratory personnel. The samples are delivered to the lab by the paramedical staff from the wards and laboratory support staff from the OPD respectively.\n\nREVIEW OF THE LITERATURE ON LABORATORY ERRORS\n\n| Sector of the laboratory | Lapworth and Teal.12 | Goldschmidt and Lent. 11 | M.Pleban.15 | Plebani and Carro.16 | Stahl M et al.14 | Jahangir Kokab and Tariq | Ranjan and Binita.17 |\n|---|---|---|---|---|---|---|---|\n| Sector of the laboratory | Clinical chemistry | Whole laboratory | Primary care. | Stat laboratory | Whole laboratory | Clinical chemistry | Clinical chemistry |\n| Data collection period | 1 year | 6 year | 6 month | 6 month | 3 year | 1 year | 1 year |\n| No of Patients | 997000 | ND | 160714 | ND | ND | 154554 | 96328 |\n| No of errors | 120 | 123 | 180 | 189 | 4135 | 2505 | 736 |\n| Frequency | | | | 0.47 % of patients | 0.61% of patients | 1. 6% of patients | 1.5 %.of patients |\n| Pre-analytical phase | 31.6% | 53% | 55% | 55.65 | 68.2% | 0.05% | |\n\nMATERIALS AND METHODS\n\nA total of 1,54554 samples from the outpatient department and in-house patients were received by our clinical chemistry laboratory during the period from January 2012 to December 2012. Out of these, 97,185 samples were collected from the patients admitted in the wards and 57,369 samples were collected in the outpatient department. The samples are collected using evacuated tubes (vacutainers evacuated tubes from BD (Franklin Lakes, NJ). The lab provides routine and reference testing in biochemistry. Upon receiving the samples, the lab supervisor visually detects any problems. When an error occurs, entries are made in the problem notification log book. The data generated is reviewed on a weekly basis. The data collection procedure involved review of blood samples received from the inpatient as well as outpatient departments. Venous blood samples are considered unsuitable according to the following accepted criteria: inappropriate volume, wrong or missing patient identification, inappropriate container, visible hemolysis after centrifugation, and lipemic samples. The pre-analytical variables evaluated included all the criteria mentioned above for sample rejection as well as incomplete/incorrect patient details and illegible handwriting.\n\nRESULTS\n\nWe will first discuss the findings of the routine samples obtained from the inpatients in our hospital. Out of the 97,185 blood collection tubes screened over a period of 1 year, pre-analytical errors were observed in 1626 samples, which is approximately 1.6 % of the total number of samples received. The distribution of the different types of errors was then calculated (Table\n\n1). The majority of the rejected samples were hemolyzed. Hemolysis was responsible for rejection of 692 samples, which accounts for 0.71% of the total number of samples received during this period. The amount of blood was insufficient for complete analysis in 0.15 % (i.e., 144out of the 97,185samples).\n\nA total of 687 samples were accompanied by inappropriate slips (i.e., wrong requisition slip, without requisition slip, central registration number ward not mentioned). This comprised approximately 0.70 % of all the samples received by the laboratory. Out of these 203 samples, laboratory personnel managed to ascertain correct patient data in 153 cases, and hence reporting was completed successfully for these patients. Fifty samples could not be processed even after elaborate and painstaking efforts by the laboratory staff. Gross lipemia led to rejection of 103samples (0.10 %).\n\nSimilarly, we evaluated the slips obtained from the outpatient department. A total of 57,369 samples were received for processing from our OPD. Out of these, the number of pre-analytical errors documented was 879. This constitutes an error rate of 1.5 %. The distribution of the various pre-analytical variables is depicted in (Table 2). The most frequent error encountered during processing was sample with insufficient information (wrong vial/wrong slip). This constitutes an error rate of 1.28% this led to rejection of 738 samples out 57369 samples. The insufficient volume with an incidence of 0.13 %. Hemolysis, which constituted the most frequent pre-analytical error observed during sample processing of admitted patients, contributed to the rejection of 0.09 % of the samples in OPD as compared to 0.71% in the previous case.\n\nTable-1 Frequency of the Different Preanalytical Errors Observed in a Total of 97,185 Routine Inpatient Samples\n\n| 01 | Insufficient volume |\n|---|---|\n| 02 | Hemolysis |\n| 03 | Sample with insufficient information (wrong vial/wrong slip) |\n| 04 | Lipemic samples |\n\nTable-2 Preanalytical Errors Observed in a Total of 57,369 Outpatient Samples\n\n| 01 | Insufficient volume | 75(0.13 %) |\n|---|---|---|\n| 02 | Hemolysis | 55(0.09 %) |\n| 03 | Sample with insufficient information (wrong vial/wrong slip) | 738(1.28 %) |\n| 04 | Lipemic samples | 11(0.019%) |\n\nDISCUSSION\n\nAdvances in science and technology have led to many path-breaking innovations that have transformed laboratory diagnostics from manual, cumbersome testing methods to fully automated science, ensuring accuracy and speed. 1, 2 However, the laboratory cannot function in isolation. It is dependent upon other departments; mainly the clinical division for properly filled requisition slips and samples for analysis. 1, 2Mounting evidence indicates that reliability cannot be achieved in a clinical laboratory through the mere promotion of accuracy in the analytical phase of the testing process. 3\n\nIt is evident that the majority of all errors in the total testing processing are of pre-analytical origin, i.e. they occur before the sample arrives in the laboratory and the phase after the sample is analyzed (post-analytical) are equally important. 4 The pre-analytical phase is riddled with many shortcomings ranging from lax attitude about filling the requisition slips to the staff's lack of education about ideal phlebotomy procedures. The health care system must be more diligent in applying scientific knowledge to reduce the errors in this phase. This is imperative to curtail the dent on laboratory services that arise due to human errors.\n\nThere has been varied information on the error rate within the whole lab testing procedure (0.1% to 9.3%). Plebani and Carraro observed in their paper that the great majority of errors result from problems in the pre-analytical or post-analytical phases. 5\n\nPre-analytical errors are largely attributable to human mistakes and the majority of these errors are preventable. 15 This is understandable, since the preanalytical phase involves much more human handling, compared to the analytical and post-analytical phases. 6 Hemolysis accounted for the majority of rejections in our study. The introduction of vacuum tubes along\n\nwith the closed system of blood collection has made blood collection efficient and easy. But lack of staff training engaged in phlebotomy is an impediment for expediting sample collection and transport. Hemolysis of samples occurs when blood is forced through a fine needle, shaking the tubes vigorously, and centrifuging the sample specimens before clotting is complete. 7 Red top vacutainers without any anticoagulant should not be shaken after the sample has been collected, and vacutainers for plasma should be gently inverted a few times so the anticoagulant mixes with the blood.\n\nFreezing and thawing of blood specimens may cause massive hemolysis. In a study by Jay and colleagues, the majority of hemolyzed samples (>95%) could be attributed to in vitro processes resulting from incorrect sampling procedure or transportation. 8 Hemolysis leads to the extravasation of intracellular contents into the plasma, leading to false high values of potassium and intracellular enzymes such as SGOT and LDH. It also leads to a prolongated turn around time (TAT) due to the need for fresh samples for processing the request. 9 The frequency of hemolysis was more in the samples that were collected from the admitted patients as compared to the patients attending the OPDs (0.71% as compared to 0.09 %). One plausible explanation for this phenomenon could be the systematic blood collection technique followed by the laboratory staff in the OPD. 10 As a part of our endeavor to achieve accreditation for our laboratory services; we carry out regular in-house training sessions for our technicians to familiarize them with the standard protocols for sample processing. For this purpose, we have developed standard operating procedures (SOPs) for the different steps involved in ideal laboratory operations and ethics. Such training has facilitated in the adoption of ideal phlebotomy practices by our laboratory personnel. The samples are thereby transported to our laboratory from the collection center by our staff following the basic precautions that must be adhered to during transportation. There is an urgent need to instill awareness about the intricacies of a seemingly \"easy and basic\" activity that forms the mainstay of laboratory services - phlebotomy among the staff engaged in sample collection in our hospitals to reduce inadvertent hemolysis. 11\n\nAnother factor leading to rejection of blood samples in Our study was insufficient blood volume. Every analytical process requires a fixed volume of serum/plasma for analysis. The main reasons behind this anomaly are ignorance of the phlebotomists, difficult sampling as in pediatric patients, patients with chroni<cursor_is_here> Insufficient sample volume constituted the most frequent cause of test rejection in the samples collected in the OPD (1.28%). 12\n\nInpatient sampling with a frequency of 0.15 % for inadequate volume only. The difference is striking. This may be attributed to a number of factors. We have a centralized collection center where samples for clinical biochemistry, hematology, microbiology, and gastroenterology are collected simultaneously. 13 Due to the paucity of man power; the ratio of patients to phlebotomists is disproportionate, making sample collection difficult. This may hamper proper sample collection, leading to inadequate collection. The collection is carried out during fixed hours. Hence, this patient load combined with shortage of time may adversely affect proper sample collection in the OPD setting. Difficult sampling and patient non-compliance further aggravates this problem. Nevertheless, it is mandatory for the laboratory staff to practice a certain basic level of workmanship and skillful phlebotomy techniques to reduce such errors to a minimum. 14\n\nA total of 0.70 % samples in the wards were accompanied by inappropriate requisition slips. The same figure for OPD samples was1.28 %. It has been observed that the clinicians often send incomplete slips with the samples. This could be due to excessive patient load or lack of awareness regarding patient information. Modern day diagnostics is not merely sample processing and preparation of reports. The laboratories are actively involved in disseminating information about critical results to clinicians so corrective measures can be initiated at the earliest. Incomplete/wrong patient information makes the practice redundant. Our laboratory staff could arrange the correct information about some of the patients admitted in the wards through their painstaking efforts. This leads to loss of precious time and is a laborintensive activity. The same protocol could not be followed for the OPD patients as it was virtually impossible to ascertain the patient/test information from either the clinicians or the patients. We followed a different protocol for these patients. The requisition slips, with an appropriate note citing reasons for\n\nsample rejection, were dispatched to the OPD for the clinicians' knowledge. Those tests were repeated with fresh samples and new requisition slips as and when the patients revisited the hospital for checkup. This is definitely inconvenient for patients, who have to undergo the same process of registration and consequent sampling. Such errors can be completely wiped out by persistence by the laboratories for complete information and sincere efforts by the clinicians to provide the same. This will facilitate speedy sample processing and report dispatch to the patients to initiate therapeutic interventions at the earliest. 15, 16\n\nLipemia accounted for rejection of 0.10 % and 0.019 % of the samples in the inpatient and outpatient departments respectively. Lipemic samples can arise due to collection after heavy meals or the presence of some metabolic disorder (hyperlipoproteinemias). This can be avoided by sample collection, preferably after an overnight fast. If the patient has a metabolic disorder, the same must be mentioned in the requisition slip. Lipemia interferes with optical reading by the instrument and can affect interpretation of electrolyte values. A higher incidence of lipemia in OPD patients may be due to non-dissemination of information regarding prior preparation to the patients by the clinicians as well as non-compliance and/or miscomprehension of preparation rules by the patients. Hence, many patients give samples in non-fasting states leading to erroneous reporting. It is the responsibility of the clinicians and the phlebotomists to ensure that proper patient preparation is instituted before sample collection. 17\n\nThese data are comparable to those provided by other investigators, which confirm that problems directly related to specimen collection are the main cause of pre-analytic errors, especially hemolyzed, clotted, insufficient, and incorrect samples. 16, 17\n\nWith the exclusive use of vacutainers, the frequency of errors found in our study is 1.62 %. It is clear from the above discussion that incorrect phlebotomy practices are the main reason behind pre-analytical errors. The reason for incorrect phlebotomy practice includes lack of awareness or possibly a heavy workload. This is the reason phlebotomy has been considered a separate area of improvement for medical technicians in developed Countries. Those of us in developing nations must adopt a similar approach toward phlebotomy and initiate steps for the inculcation of ideal phlebotomy practices among health care workers. 17, 18\n\nCONCLUSIONS\n\nThe concept of total quality management encompasses all the steps involved in sample processing, beginning from test ordering to the final interpretation of results by the clinicians to reduce or eliminate the errors that may arise during the various steps. The promotion of ideal phlebotomy practices and sample transport procedures is a pre-requisite for the efficacy of\n\nLaboratory functioning. The dependence on accurate laboratory results for diagnostics makes it mandatory for labs to ensure accountability and accuracy of results to negate incorrect diagnosis as a consequence of faulty reporting. A practice of keeping a record of the errors at all stages of analysis and then devising corrective strategies for their prevention can gradually free a laboratory from such errors.\n\nErrors in the laboratory can lead to inaccurate reports dispatched to clinicians, affecting health care services greatly. Ensuring the credibility of results is of utmost importance. While many clinicians probably believe that most errors in the laboratory are analytical, there are data showing that the pre-analytical and postanalytical phases are the greatest contributors to laboratory mistakes.\n\nThough it is impossible to completely eliminate errors, it is possible to reduce them. We conclude that training of phlebotomists and technicians, bar coding of samples, implementation of a LIS, adoption of standardized procedures along with participation in external quality assessment programs and accreditation schemes can help to reduce laboratory errors to a minimum.\n\nTo attain this goal, we first implemented a continued education program, financed by our Regional Health Service and focused in Primary Care Nurses.\n\nREFERENCES\n\n1. Ranjna Chawla, PhD, Binita Goswami, MD, DNB, Devika Tayal, MD, V Mallika, MD.Identification of the Types of Preanalytical Errors in the Clinical Chemistry Laboratory: 1Year Study at G.B. Pant Hospital. LAB MED. 2010; 41: 89-92.\n\n2. Plebani M, Carraro P. The detection and prevention of errors in laboratory medicine Ann Clin Biochem. 2010; 47: 101-110.\n3. Robert Hawkins Managing the Pre- and Postanalytical Phases of the Total Testing Process. Ann Lab Med. 2012; 32: 5-16.\n4. Mai M,H. Mansour, Hassan M. E, Azzazy, Steven C. Correction Factors for Estimating Potassium Concentrations in Samples With In Vitro Hemolysis.Clin Chem. 2010; 46: 306–307.\n5. Characterization and mathematical correction of hemolysis interference in selected Hitachi 717 assays. Arch Pathol Lab Med. 2010; 133:960–966.\n6. Jones BA, Calam RR, Howanitz PJ Chemistry specimen acceptability: A College of American Pathologists Q-Probes study of 453 laboratories. Arch Pathol Lab Med. 2011; 121:19–26.\n7. Romero A, Munoz M, Ramos JR, et al. Identification of preanalytical mistakes in the stat section of the clinical laboratory. Clin Chem Lab Med. 2010; 43:974–975.\n8. Jones BA, Meier F, Howanitz PJ .Complete blood count specimen acceptability: A College of American Pathologists Q-Probes study of 703 laboratories. Arch Pathol Lab Med. 2012; 119: 203–208.\n9. Fidler JR. Task analysis revisited: Refining the phlebotomy technician scope of practice and assessing longitudinal change in competencies. Eval Health Prof. 2007; 30:150–169.\n10. Lippi G, Blanckaert N, Bonini P, et al. Causes, consequences, detection and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2011; 47:143– 153.\n11. Goldschmit HMJ, Lent RW. Gross errors and work flow analysis in the clinical laboratory. Klin Biochem Metab 2010; 3:131-140.\n12. Lapworth R, Teal TK. Laboratory blunders revisited. Ann C Biochem 2010; 31:78-84.\n13. Plebani M, Carraro P. Mistakes in a stat laboratory: type frequency. Clin Chem 2009; 43: 1348-1351.\n14. Stahl M, Lund ED, Brandslund I. Reasons for a laboratory's inability to report results for\nrequested analytical tests. Clin Chem 2012; 44:2195-2197.\n15. Nutting PA, Main DS, Fischer PM, Stull TM, Pontious M, Seifert M, et al. Problems in laboratory testing in primary care. JAMA 2006; 275:635-639.\n16. M. Pleban The detection and prevention of errors in laboratory medicin Ann Clin Biochem, 2010; 47: 101 - 110.\n17. Ranjan and Binita. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. JAMA 2011; 280: 550-558.\n18. Romero and Cobos. The need for an outcomes research agenda for clinical laboratory testing. JAMA 2010; 280: 565-566.\n\nAUTHORS\n\nDr. Jahangir Sultan Assistant Professor Pathology Chemical Section Continental Medical College Lahore, Pakistan\n\nDr. Tariq Afzal\n\nAssistant Professor Pathology Sargodha Medical College, Sargodha, Pakistan\n\nDr. Kokab Jabeen\n\nAssistant Professor Pathology Microbiology section Continental Medical College, Lahore, Pakistan\n\nSubmitted for Publication: 27-03-2013\n\nAccepted for Publication: 03-10-2013\n\nAfter minor revisions\n</text>\n", "role": "user" }, { "content": "c, debilitating diseases, and patients on chemotherapy whose thin veins are difficult to localize.", "role": "assistant" } ]
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