Lamb Healthcare Center

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted May 8, 2024, found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Review of policies and procedures, Transfusion Audits and interview of facility personnel found documentation was not audited by the director of nursing within 24 hours of the transfusion as defined in their own procedure for 9 of 9 patients receiving blood transfusions between March 1, 2024, and May 8, 2024. The findings included: 1. Review of the policy titled Blood and Blood Product Post Transfusion Audit Effective Date July 12, 2021) found on page 1 under the heading PROCEDURE: "1. Transfusion is ordered and performed by laboratory technologists. 2. All paperwork and E forms are filled out by laboratory technologists. 3. A sign out E-form is prepared for each unit of blood. 2. A two person sign out is performed by laboratory personnel and nurses, including either an R.N. or L.V.N., and laboratory personnel. Both nursing service and laboratory personnel must sign the e-form. 3. The nurse begins the transfusion and monitors the patient at the start, at 15 minutes, at 1 hour and at 2 hours. 4. At the completion of the transfusion and when all nursing forms are completed, a message is sent to the DON that a transfusion has been performed. 5. Each morning as either the DON or Assistant DON logs onto their computer a message is sent to them that a transfusion has occurred. 6. The message the DON receives, contains the Patient Demographics so at that time the DON will audit the transfusion nurses notes and vital signs, using the audit checklist within 24 hours of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the transfusion. 7. Those audit sheets will be monitored monthly by recording them in the QAPI minutes. Any problems with a transfusion can then be brought to medical staff attention." NOTE: directly quoted from procedure. 2. Review of Blood and Blood Product Transfusion Audit Checklist for 9 units transfused between March 1, 2024, and May 8, 2024, found: Audits were not reviewed within 24 hours for 9 patients. Patient 388529 - date of transfusion: 3.12.24, date/Time of Audit: 3.27.24 1639. 15 days had lapsed since transfusion. Patient 387260 - date of transfusion: (no date recorded), date/Time of Audit: 3.6.24 @ 1836. unknown number of days had lapsed since transfusion. Patient 388706 - date of transfusion: 3.16.2024, Date/Time of Audit: 3.27.24 @1712. 11 days had lapsed since transfusion. Patient 287260 - Date of Transfusion: 2.4.24, Date/Time of Audit: 3.6.24 @ 1905. 31 days had lapsed since transfusion. Patient 389585 - Date of Transfusion: 4.6.2024, Date/Time of Audit: 5.1.2024 @ 1630. 25 days had lapsed since transfusion. Patient 390216 - Date of Transfusion: 4.13.2024, Date/Time of Audit: 5.7.2024 @1327. 24 days had lapsed since transfusion. Patient 390216 - Date of Transfusion: 4.23.2024, Date/Time of Audit: 5.7.2024 @ 1131. 14 days had lapsed since transfusion. Patient 388238 - Date of Transfusion: (no date recorded), Date/Time of Audit: 3.20.2024 @ 1256. Unknown number of days had lapsed since transfusion. Patient 389849 - Date of Transfusion: 4.13.2024, Date/Time of Audit: 5.7.2024 @ 0959. 24 days had lapsed since transfusion. Further review of the Blood and Blood Product Transfusion Audit Checklist found documentation was incomplete or determined to not meet the defined requirements as defined in the Blood and Blood Products Administration policy for 5 of the 9 forms reviewed. Patient 388529 - Two nurse verification at bedside marked as not met. Patient education marked as not met. Patient 387260 - Consent form marked as not met. ID band and Blood Band on patient marked as not met. Two nurse verification at bedside marked as not met. Blood Transfusion Flowsheet utilized in CPSI marked as not met. 250 - ML Saline Flush available for use if reaction occurs marked as partially met. 15-minute vital signs marked as not met. Temperature increased marked as not met. Tachypnea change from baseline marked as not met. Systolic blood pressure decrease marked as not met. Patient 388706 - ID band and Blood Band on patient marked as partially met. Start of transfusion marked as not met. 15-minute check marked as not met' Q 1 hour Check marked as not met. Temperature increased marked as not met. Tachycardia marked as not met. Tachypnea change from baseline marked as not met. Systolic blood pressure decrease marked as not met. Patient 287260 - Consent form marked as not met. ID band and Blood Band on patient marked as not met. Two nurse verification at bedside marked as not met. Blood y-set marked as not met. 250 ml Saline Flush available for use marked as partially met. Blood Transfusion Flowsheet utilized in CPSI marked as not met. Start of Transfusion marked as not met. 15-minute check not documented. Q1 hour check not documented. Temperature increased not documented. Tachycardia not documented. Tachypnea change from baseline not documented. Systolic blood pressure decrease not documented. transfusion reaction educated not documented. Patient 389849 - Consent form marked as not met. ID band and Blood Band on patient marked as not met. Blood y-set marked as not met. 250 ml Saline Flush available for use marked as partially met. Blood Transfusion Flowsheet utilized in CPSI marked as not met. Temperature increased not documented. Tachycardia not documented. Tachypnea change from baseline not documented. Systolic blood pressure decrease not documented. transfusion reaction educated not documented. 3. During interview of the Director of Nursing conducted May 8, 2024, at 2:48 PM, she confirmed that Blood transfusion Audits were not being evaluated within 24 hours of the transfusion as defined in their own policy. She went on to clarify that if the forms were marked as "not met" this indicated that the information was not documented by nursing staff in the computer system. When asked if there was another means of documenting vital -- 2 of 4 -- signs she stated there was not. Further interview of the director of nursing at 2:54 PM she confirmed that she was too busy to complete the audits within the 24-hour period, and if transfusion occurred during the weekend, it would not be done because she wasn't there. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and staff interview, the laboratory failed to have documentation of performing twice annual accuracy assessments in 2023 for one of one non-regulated analyte tested on the Diesse Mini Cube analyzer. Findings include: 1. A review of the laboratory's records revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for the non- regulated analyte Erythrocyte Sedimentation Rate (ESR) tested on the Diesse Mini Cube analyzer in 2023. 2. A review of the laboratory's test records revealed the laboratory performed a total of 218 ESR tests in 2023. 3. In an interview on 5/8/24 at 9:45 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observation, a review of patient test records, and staff interview, the laboratory failed to ensure four of twenty-eight patient tubes had not exceeded their expiration dates prior to using them for patient testing on May 7, 2024. Findings include: 1. Surveyor observation of the specimen storage refrigerator in the laboratory on 5/8/24 at 11:35 a.m. revealed 28 lavender top patient specimen tubes had been used for testing on 5/7/24. 2. Further observation of the 28 lavender top patient specimen tubes revealed the following 4 tubes had exceeded their expiration date: Patient ID: 390830 Vacuette ref # 454209 Lot: B2207343 Exp: 10/31/23 Patient ID: 390831 Vacuette ref # 454209 Lot: B2207343 Exp: 10/31/23 Patient ID: 390832 Vacuette ref # 454209 Lot: B2207343 Exp: 10/31/23 Patient ID: 390833 Vacuette ref # 454209 Lot: B2207343 Exp: 10/31/23 3. A review of patient test records confirmed the 4 expired patient specimen tubes were used for Complete Blood Count (CBC) testing and values were resulted on 5/7/24. 4. In an interview on 5/8/24 at 11:35 a.m. in the conference room, after review of the records, the technical consultant confirmed the above findings. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not -- 3 of 4 -- limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of laboratory policy, employee competency assessment records, and interview with the Laboratory Manager, the laboratory failed to assess problem solving skills on one of eleven testing personnel for the 2024 annual competency. The findings included: 1. Based on review of the laboratory's policy, "Competency and CLIA Competency Assessment", stated the following: "Competency is ability of personnel to apply their skill, knowledge, and experience to perform their laboratory duties correctly. Competency assessment is used to ensure that the laboratory personnel are fulfilling their duties as required by federal regulation." 2. Based on review of the competency assessment documentation for Testing Person 3 (as listed on the CMS-209 laboratory personnel report), the problem-solving quiz for hematology was blank and not completed. The quiz contained questions to assess problem solving skills in hematology, chemistry, microbiology,urinalysis, and immunohematology. 3. In an interview at 10:07 hours on 5/8/2024, the Laboratory Manager confirmed the assessment of problem-solving skills competency requirements were met by giving testing personnel quizzes and that Testing Person 3 had not completed the hematology competency quiz. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on August 5, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve successful performance in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- two of three consecutive testing events for the specialty Immunohematology for the analyte Compatibility, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve successful performance in two of three consecutive testing events in 2021 for the specialty Immunohematology for the analyte Compatibility, resulting in unsuccessful performance. The findings included: Based on review of the American Proficiency Institute evaluation reports from the first and third events of 2021, the laboratory receive the following scores: 1) First event 2021, Compatibility Testing - score of 60 percent 2) Third event of 2021, Compatibility Testing - score of 80 percent. For Compatibility testing, the laboratory must score 100 percent for successful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for two of three consecutive testing events in 2021 for the specialty Immunohematology for the analyte Compatibility, resulting in unsuccessful performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for two of three consecutive testing events in 2021 for the specialty Immunohematology for the analyte Compatibility, resulting in unsuccessful performance. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: I. Based on review of manufacturer's instructions, laboratory's procedures, Mean Normal Prothrombin Time (MNPT) study, and interview, the laboratory failed to verify the reference interval for Prothrombin Time (PT) tested on the ACL Elite for 11 of 11 months reviewed. Findings follow. A. Review of the ACL Hemostasis Systems Performance Verification Manual, Revision A August 28 2012, under Normal Reference Interval Chapter 8, stated, Establishing a Normal Reference Interval "Summary and Explanation The interpretation of clinical laboratory data is a comparative decision-making process. For this process to occur, reference intervals are needed for all test systems. Since all results will be compared to the reference interval, it is crucial that it be done correctly. For the purpose of this method, we will use the following definitions: Reference Range... refers to the entire range of values, i. e.., ALL the values collected in the study. Reference Interval.... refers to the 95% confidence limits of the Reference Range (ie. the mean +/- 2SD)... Record the data on the worksheet provided. Determine the mean, standard deviation (SD) and range once the data has been collected. The range is usually defined as the mean +/- 2 SD. For non-Gaussuan distributions, such as PT, a geometric mean is recommended... Expected Values The original laboratory's reported 95% reference limits may be considered valid for use in the secondary lab if no more than 2 of the 20 tested Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- subjects' values fall outside those original reported limits and pre-testing criteria are met. If 3 or more results fall outside the original range, 20 new subjects must be obtained and the testing repeated (you cannot just add an additional 3 samples)." B. Revew of the laboratory's policies and procedures found in the Coagulation & Serology Procedures Manual under the coagulation QC tab showed a copy of the above procedure in the procedure titled Reference Interval / Normal Reference Range mean normal PT. C. Review of the laboratory's established reference interval from 2012 showed the PT normal range to be 9.4 - 12.2 seconds. D. Review of the current Mean SD Calculation for Normal Range Study from 04/15/2021 - 04/29/2021 showed for the Reagent Lot N0504540, expiration 05/31/2022 had a geometric mean of 11.6 and 2SD of 1.5 with a range of 10.1 - 13.1 seconds. Five values were outside the established 9.4 - 12.2 seconds with sample numbers Female 1 at 12.8, Female 2 at 12.5, Female 3 at 12.6, Female 6 at 12.3, and Female 8 at 12.3. E. Interview with Technical Consultant #2 as listed on the CMS 209, on May 2, 2022 at 1500 hours via phone call confirmed the verification studies for the reference interval for Lot N0504540 had 5 values outside the established reference interval of 9.4-12.2 seconds. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the calibration verification, and interview, the laboratory failed to perform calibration verification every six months for D-Dimer performed on the Alere Triage for two of two events for the duration of 12 months reviewed. Findings follow. A. Review of the calibration verifications performed for D-Dimer from April 2021 - March 2022 showed none performed. Calibration verifications were requested but not provided. B. Interview with Technical Consultant #2 on April 14, 2022 at 1555 hours in the conference room confirmed they stopped performing calibration verifications for D-Dimer. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) -- 2 of 3 -- (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on review of quality control results and interview, the laboratory failed to monitor over time the accuracy and precision of the test system for D-Dimer performed on the Triage Meter using the Triage Control Total 5 for 1 of 1 years reviewed. Findings follow. A. Review of quality control results from April 2021 - March 2022 showed mean and standard deviation (SD) were not calculated for the D- Dimer quality control results. B. Interview with the Technical Consultant on April 14, 2022 at 1550 hours in the conference room confirmed statistical analysis was not performed on the D-Dimer quality control results. II. Based on review of quality control results and interview, the laboratory failed to monitor over time the accuracy and precision of blood gases performed on the Instrumentation Laboratory GEM Premier 3500 using Instrumentation Laboratory Contril 7 for 1 of 1 years reviewed. Findings follow. A. Review of quality control results from April 2021- March 2022 showed mean and standard deviation (SD) were not calculated for the blood gas quality control results. B. Interview with Testing Personnel #7 listed on the CMS 209 on April 13, 2022 at 1545 hours in the respiratory therapy room confirmed statistical analysis was not performed on the blood gas quality control results. -- 3 of 3 --

Summary Statement of Deficiencies D3017 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(a) Arrangement for services. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, transfusion services agreements, and confirmed in interview, the laboratory failed to have a reviewed and approved arrangement for transfusion services agreement for Fresh frozen plasma and antibody identification services. The findings included: 1. Review of the laboratory's own procedure titled Fresh Frozen Plasma found a handwritten note on page 1 under PRINCIPLE - "Fax order for thawed plasma to 806-723-7225(Covenant) BC." Further review found on page 1 under PROCEDURE step 3. - "The patient is typed and Covenant Blood Bank (806)725-4256) is called to obtain the correct unit, ask that the plasma be sent thawed." 2. The transfusion services agreement for United Blood Services (UBS) and the Affiliation agreement (with Covenant Health System)were reviewed and found no agreement regarding the provision of thawed fresh frozen plasma. 3. Interview of the General Supervisor conducted on June 27, 2018 at 10:07 AM confirmed that the laboratory would obtain thawed fresh frozen plasma from Covenant Hospital if the need arose. She went on to confirm that the affiliation agreement did not define what transfusion services would be provided . D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Review of patient test records and interview of the general supervisor found that testing personnel failed to complete patient test records for waived and non-waived manual test kits. Findings Included: 1. Review of the Serology/ Manual Test logs (6 pages) for June and July of 2017 found that testing personnel failed to record lot numbers and expiration dates for 8 of 8 test kits used and 4 of 4 controls. In the two month period, testing personnel failed to document lot number of test kits and controls on logs as follows: ANA Kit - 5 of 6 pages had no documentation of lot used with expiration date. ESR Control - 6 of 6 pages had no documentation of lot used with expiration date. hCG Serum Control - 6 of 6 pages had no documentation of lot used with expiration date. Microalbumin - 5 of 6 pages had no documentation of lot used with expiration date. AmniSure kit - 6 of 6 pages had no documentation of lot used with expiration date. hCG kit - 6 of 6 pages had no documentation of lot used with expiration date. HIV kit - 5 of 6 pages had no documentation of lot used with expiration date. Mono kit - 6 of 6 pages had no documentation of lot used with expiration date. ESR Pipettes - 6 of 6 pages had no documentation of lot used with expiration date. hCG Urine Control - 6 of 6 pages had no documentation of lot used with expiration date. HIV Control - 6 of 6 pages had no documentation of lot used with expiration date. RF Kit - 5 of 6 pages had no documentation of lot used with expiration date. 2. Interview of the General Supervisor conducted on June 27, 2018 at 3:40 PM confirmed that testing personnel did not complete the test records to include the lot number and expiration dates as required. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Review of policies and procedures, contractual agreements and interview of facility personnel found that the laboratory director failed to ensure that the laboratory had an agreement to provide all transfusion services required by the laboratory. (see D 3017) -- 2 of 2 --