OSAC 2021-S-0028, Standard for Use of Serological Testing Methods

Associated with Forensic Investigations

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OSAC 2021-S-0028

Standard for Use of 

Serological Testing 

Methods Associated with 

Forensic Investigations

Human Forensic Biology Subcommittee

Biology SAC

Organization of Scientific Area Committees (OSAC) for Forensic Science
 OSAC 2021-S-0028, Standard for Use of Serological Testing Methods

Associated with Forensic Investigations

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 OSAC 2021-S-0028, Standard for Use of Serological Testing Methods

Associated with Forensic Investigations

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Draft OSAC Proposed Standard

OSAC 2021-S-0028 Standard for Use 

of Serological Testing Methods 

Associated with Forensic

Investigations

Prepared by 

Human Forensic Biology Subcommittee

Version: 1.0

August 2021

Disclaimer:

This OSAC Proposed Standard was written by the Human Forensic Biology Subcommittee of the 

Organization of Scientific Area Committees (OSAC) for Forensic Science following a process that 

includes an open comment period. This Proposed Standard will be submitted to a standards developing 

organization and is subject to change.

There may be references in an OSAC Proposed Standard to other publications under development by 

OSAC. The information in the Proposed Standard, and underlying concepts and methodologies, may be 

used by the forensic-science community before the completion of such companion publications.

Any identification of commercial equipment, instruments, or materials in the Proposed Standard is not a 

recommendation or endorsement by the U.S. Government and does not imply that the equipment, 

instruments, or materials are necessarily the best available for the purpose.

To be placed on the OSAC Registry, certain types of standards first must be reviewed by a Scientific and 

Technical Review Panel (STRP). The STRP process is vital to OSAC’s mission of generating and 

recognizing scientifically sound standards for producing and interpreting forensic science results. The 

STRP shall provide critical and knowledgeable reviews of draft standards or of proposed revisions of 

standards previously published by standards developing organizations (SDOs) to ensure that the 

published methods that practitioners employ are scientifically valid, and the resulting claims are 

trustworthy.

The STRP panel will consist of an independent and diverse panel, including subject matter experts, 

human factors scientists, quality assurance personnel, and legal experts, which will be tasked with 

evaluating the proposed standard based on a comprehensive list of science-based criteria.

For more information about this important process, please visit our website 

at: https://www.nist.gov/topics/organization-scientific-area-committees-forensic-science/scientifictechnical-review-panels. 
 OSAC 2021-S-0028, Standard for Use of Serological Testing Methods

Associated with Forensic Investigations

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1 Keywords: serology, analysis, contamination prevention

2 Table of Contents

3 1 Scope 4

4 2 Normative References 4

5 3 Terms and Definitions 4

6 4 Requirements 6

7 4.1 4

8 4.2 Personnel 6

9 4.3 5

10 4.4 7

11 4.5 7

12 4.6 Reports 10

13

14
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15 1 Scope

16 This standard provides requirements for documented analytical procedures/protocols needed for 

17 the use of forensic serological methods to evaluate body fluids, stains, or residues associated 

18 with forensic investigations. 

19 This standard includes requirements for laboratory facilities and evidence control; use and 

20 monitoring of the analytical procedures; and reagents, chemicals, and equipment used for 

21 forensic serological testing. Also, requirements for personnel and training, equipment 

22 maintenance/calibration, report writing, and reviews are covered in this standard. 

23 2 Normative References

24 For dated references, only the edition cited applies. For undated references, the latest edition of 

25 the referenced document (including any amendments) applies.

26 ANSI/ASB Standard 077, First Edition 2020, Standard for the Developmental and Internal 

27 Validation of Forensic Serological Methods

28 ANSI/ASB Standard 110, Standards for Training in Forensic Serological Methods

29 3 Terms and Definitions

30 3.1

31 administrative review

32 An evaluation of the report and supporting documentation for consistency with laboratory 

33 policies and for editorial correctness.

34

35 3.2

36 analytical procedure

37 An orderly step-by-step process designed to provide reproducible, accurate results.

38

39 3.3

40 confirmatory test

41 A test that is specific for a biological material or substance of interest and that is used for the 

42 conclusive identification of a biological fluid; this usually refers to a serological or microscopic 

43 test for detection of a particular biological fluid (e.g., blood or semen). 

44

45 3.4

46 contamination

47 Exogenous DNA or other biological material in a DNA sample, PCR reaction, or item of 

48 evidence; the exogenous DNA or biological material could be present before the sample is 

49 collected, or introduced during collection or testing of the sample.

50

51 3.5

52 controls

53 Samples of known types, run in parallel with experimental reference, or evidence samples that 

54 are used to demonstrate that a procedure is working correctly. 

55
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56 3.6

57 inconclusive

58 A statement provided as the conclusion when testing results are insufficient or lacking in quality 

59 and/or quality, as defined by the laboratory, for comparison purposes; the data are inadequate to 

60 draw any meaningful conclusions. 

61

62 3.7

63 material modification

64 An alteration of an existing procedure that may have consequential effect(s) on results.

65

66 3.8

67 performance check

68 In general, a quality assurance measure to assess the functionality of laboratory instruments and 

69 equipment that affect the accuracy and/or validity of forensic sample analysis. 

70

71 3.9

72 presumptive test

73 A screening test that indicates the presence of a material of interest although the test result does 

74 not constitute the identification of that material. A negative presumptive test indicates that the 

75 material of interest was not detected; it is not confirmation of its absence. 

76

77 3.10

78 serology

79 The detection, characterization, identification, and/or typing of body tissues and fluids, either in 

80 native form or as stains or residues left at a crime scene using physical methods (normal and 

81 enhanced lighting), biochemical assays, and/or microscopy. This definition applies to current 

82 biology laboratory practices, which may be followed by DNA testing. 

83

84 3.11

85 standard operating procedure

86 A series of instructions to be followed in performing a specified task or under specific 

87 circumstances.

88

89 3.12

90 technical management

91 Personnel, as defined by the laboratory, who have serological technical responsibility of the 

92 laboratory operations. 

93

94 3.13

95 technical review

96 A qualified second party's evaluation of reports, notes, data, and other documentation to ensure 

97 there is appropriate and sufficient support for the actions, results, conclusions, opinions, and 

98 interpretations. 
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99 4 Requirements

100 4.1 Facilities and Evidence Control

101

102 4.1.1 General

103

104 The laboratory shall have facilities designed to ensure the integrity of all evidence where the 

105 serological testing procedures are performed within the laboratory.

106 4.1.2 Access to Facilities

107

108 Access to the laboratory shall be controlled and limited in a manner to prevent access by 

109 unauthorized personnel. All exterior entrance/exit points require security control. The 

110 distribution of all keys, combinations, or other access control mechanism(s) shall be documented 

111 and limited to the personnel designated by laboratory management.

112

113 4.1.3 Maintenance of Facilities

114

115 The laboratory shall have and follow written analytical procedures for cleaning and 

116 decontaminating facilities to ensure the integrity of all evidence where analytical procedures are 

117 being performed by the laboratory. 

118

119 4.2 Personnel

120 4.2.1 Technical Management

121

122 The laboratory or multi-laboratory system shall have designated personnel who is responsible for 

123 the implementation and annual review of analytical procedures for forensic serological methods 

124 performed by the laboratory. Additionally, the designated personnel shall authorize, in written 

125 form, the successful completion of training by an analyst. This documented authorization shall 

126 extend to personnel that perform technical reviews.

127

128 4.2.2 Training of Personnel

129

130 Personnel shall have the education, training, and experience commensurate with the 

131 responsibilities, duties, and skills necessary to perform the analytical procedures performed by 

132 the laboratory, as defined by the laboratory. All serology laboratory personnel shall receive 

133 training and successfully complete a competency test prior to performing any analytical 

134 procedure or following material modification(s) to an analytical procedure performed by the 

135 laboratory. All forensic laboratory personnel that will perform technical review shall meet the 

136 minimum education requirements and receive training per laboratory protocol as well as 

137 demonstrate competency as a technical reviewer prior to performing technical review of 

138 serological data and/or reports. Previously qualified serology analysts shall demonstrate 

139 competency prior to performing technical reviews. 

140

141 4.2.3 Personnel records
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142

143 The laboratory shall have and follow an internal document retention policy that includes, but is 

144 not limited to, documents associated with education, training, competency and proficiency 

145 testing, and continuing education for all personnel involved in the analytical testing performed 

146 by the laboratory. 

147

148 4.3 Analytical Procedures 

149 4.3.1 General

150

151 The laboratory shall have and follow written analytical procedures for each serological method 

152 used by the laboratory. The analytical procedures shall be based upon validation studies and 

153 scientific literature. 

154

155 4.3.2 Content

156

157 Laboratory procedure(s) shall include the following information as they apply to the analytical 

158 procedures performed by the laboratory:

159

160 a) Classification of the testing method as either a presumptive or confirmatory test;

161

162 b) Safety measures to be taken throughout the testing process, including the use of personal 

163 protective equipment;

164

165 c) Contamination prevention measures to be taken throughout the testing process. At a 

166 minimum, decontamination/cleaning and evidence handling analytical procedures to

167 prevent the potential indirect transfer of cellular materials onto items of evidence;

168

169 d) Equipment, materials, reagents, and chemicals used in evidence testing and sample 

170 collection;

171

172 e) Preparation, labeling, storage, and quality control testing of reagents and chemicals used 

173 in testing;

174

175 f) Testing procedures;

176

177 g) Order in which evidence within a single case is tested;

178

179 h) Requirements for rare circumstances when deviating from written analytical procedures, 

180 including technical management involvement;

181

182 i) Recording of examination notes;

183

184 j) Interpretation of test results;

185
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186 k) Define/identify limitations, such as potential false positive, false negative test results, and 

187 inconclusive results;

188

189 l) Sample collection and preservation for potential DNA analysis; and

190

191 m) Reporting results.

192

193 4.3.3 Monitoring of Analytical Procedures

194

195 The laboratory shall have a documented procedure for monitoring the performance of its 

196 analytical procedures. The procedure shall define:

197

198 a) Positive and negative control samples used in monitoring;

199

200 b) The frequency at which the monitoring is performed (e.g., concurrently with testing, 

201 daily, before use);

202

203 c) Successful performance of the positive and negative controls; and

204

205 d) Actions to be taken in the event of the unsuccessful performance of a control.

206

207 4.3.4 Approval of Analytical Procedures

208

209 All analytical procedures shall be approved by the technical management, as applicable, prior to 

210 implementation by the laboratory.

211

212 4.3.5 Revisions to Analytical Procedures

213

214 Any revision to an analytical procedure shall be approved by the technical management required 

215 by laboratory policy, prior to implementation by the laboratory. Staff notification of this change 

216 shall be documented.

217

218 4.3.6 Deviation of Analytical Procedures

219

220 Any deviation made to a validated analytical procedure shall be documented. The performance 

221 of a deviation to any analytical procedure shall be evaluated prior to use on evidence. The 

222 evaluation shall be accomplished by comparison to the original analytical procedure using 

223 similar samples. The deviation shall be approved by technical management required by 

224 laboratory policy, prior to use on evidence. Staff notification, training, and competency testing of 

225 this deviation shall be documented. 

226

227 4.3.7 Review of Analytical Procedures

228

229 The laboratory’s standard operating procedures shall be reviewed annually by technical 

230 management and the review shall be documented. 

231

232 4.3.8 Records of Testing
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233

234 The laboratory shall have and follow written procedures for documenting and maintaining case 

235 notes for all serological testing performed to support the reported conclusions. The laboratory 

236 shall maintain all analytical documentation generated by personnel related to the testing. The 

237 records shall be sufficient so that another qualified individual can evaluate what was tested and 

238 interpret the test results.

239

240 4.4 Reagents and Chemicals 

241 4.4.1 General

242

243 The laboratory’s analytical procedures shall specify the reagents and chemicals that are 

244 acceptable for use in each test performed. The analytical procedures shall define, as appropriate:

245

246 a) Formulation of prepared reagents;

247

248 b) Labeling of reagents;

249

250 c) Storage conditions;

251

252 d) Expiration date to be used for reagents and chemicals;

253

254 e) Quality assurance procedures for evaluation of reagents and chemicals prior to use;

255

256 f) Documentation of reagents and chemicals used in testing; and

257 g) Documentation of successful performance of reagents and chemicals prior to use in 

258 testing.

259

260 4.5 Equipment Used in Testing 

261 4.5.1 General

262

263 The laboratory shall use equipment suitable for the testing methods employed. The laboratory’s 

264 analytical procedures shall specify the equipment used in testing. 

265

266 4.5.2 Equipment Maintenance and Calibration

267

268 The laboratory shall have a documented program for proper maintenance and calibration for 

269 equipment. The program shall define and require the following:

270

271 a) The schedule for the maintenance and calibration of equipment used in testing; 

272

273 b) That performance checks be performed prior to use in testing; and

274

275 c) Labeling of equipment that is out of service.

276
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277 4.5.3 Records of Equipment Maintenance and Calibration

278

279 The laboratory shall retain records of maintenance and calibration that include repair, service, 

280 and performance checks for all equipment that would affect the outcome of the testing being 

281 performed. 

282

283 4.6 Reports

284 4.6.1 General

285 The laboratory shall have documented procedures that address case notes, report writing, as well 

286 as technical and administrative review of reports. The procedure/protocol for releasing reports 

287 and supporting documentation shall be included in the procedure(s). Includes items received, but 

288 no work done.

289

290 4.6.2 Content

291

292 Casework reports shall include the following elements:

293

294 a) Case identifier;

295

296 b) Description of the evidence examined;

297

298 c) Description of the analytical testing performed;

299

300 d) Results and/or conclusions, for each evidence item tested, including the reason for an 

301 inconclusive result;

302

303 e) Date of the report;

304

305 f) Disposition of evidence; and

306

307 g) A signature and title, or equivalent identification, of the person accepting responsibility 

308 for the content of the report.

309

310 4.6.3 Technical Review of Reports and Case Records

311 Prior to release of the report and associated case notes, the laboratory shall conduct and 

312 document a technical review of the documents to ensure conclusions and supporting test results 

313 are reasonable and within the constraints of scientific knowledge. The review shall be performed 

314 by personnel who are proficient in the analytical procedure being reviewed or those that are only 

315 qualified to perform technical reviews (as outlined in 4.2.2). The technical review shall include:

316

317 a) A review of all records, including notes, worksheets, and photographs, that support the 

318 reported results and/or conclusions.

319
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320 b) Reviewer ensures appropriate controls were tested and documented in case file.

321

322 c) A review of the case records to verify that the reported results and/or conclusions are 

323 supported by the data.

324

325 4.6.4 Administrative Review

326

327 Prior to the release of a report and associated case records, the laboratory shall conduct and 

328 document an administrative review for consistency with laboratory policies and for editorial 

329 correctness. The administrative review shall include the following elements, any or all of which 

330 may also be included within the technical review:

331

332 a) A review of the case file and final report for editorial correctness and that information 

333 specified in Standard 4.6.2 is complete and accurate;

334

335 b) A review of the chain of custody for completeness and accuracy; and

336

337 c) A review of the disposition of evidence;

338