Texas County Memorial Hospital

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Siemens Healthineers RAPIDPoint 500 system operator's guide, arterial blood gas (ABG) laboratory temperature logs for 2025 to date August 18, 2026, and patient results and interview with the testing personnel (TP) #11, the laboratory failed to ensure the room temperature and humidity was monitored and documented as required by the manufacturer for 18 of 595 days. Findings: 1. Review of the Siemens Healthineers RAPIDPoint 500 system operator's guide states "ambient operating temperature 15-30 degrees Celsius, and ambient operating relative humidity 5-85% noncondensing'. 2. Review of the ABG laboratory temperature logs where the Siemens Healthineers RAPIDPoint 500 is located showed no documentation of room temperature for 18 of 595 days in 2025 to date August 18, 2026. 3. Review of the ABG laboratory temperature logs where the Siemens Healthineers RAPIDPoint 500 is located showed no documentation of humidity for 18 of 595 days in 2025 to date August 18, 2026. 4. Review of patient results showed the ABG laboratory performs approximately 477 ABG patient tests per year. 5. Interview with the TP #11 on August 18, 2026 at 2:00 PM confirmed the laboratory failed to ensure the room temperature and humidity was monitored and documented as required by the manufacturer for 18 days. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: A.) Based on review of the HemosIL D-Dimer HS 500 Controls package insert, observation of open HemosIL D-Dimer HS 500 Control vials, review of HemosIL Q.F. A Thrombin (Bovine) package insert, observation of an open HemosIL Q.F.A Thrombin (Bovine) vial, review of patient results, and interview with the general supervisor (GS) #2, the laboratory failed to document correct expiration dates on open d-dimer control vials and on an open thrombin vial. Findings: 1. Review of the HemosIL D-Dimer HS 500 Controls package insert states "up to 5 days when controls are on-board for 1 hour each time, twice daily and the vials are returned well capped to 2-8C between sessions." 2. Observation of open HemosIL D-Dimer HS 500 Controls level one and level 3 vials lot # B37786 showed an open date of August 13, 2026, and expiration date of September 14, 2026. 3. Review of HemosIL Q.F.A Thrombin (Bovine) package insert states "Stability after reconstitution: 7 days at 2-8C in closed original vials." 4. Observation of an open HemosIL Q.F.A Thrombin (Bovine) vial lot # M158382 showed an open date of August 14 and no expiration date. 5. Review of patient results showed the laboratory performs approximately 468 d-dimer tests and 28 fibrinogen tests per year. 6. Interview with the GS #2 on August 18, 2026, at 1:00 PM confirmed the laboratory failed to document correct expiration dates on open d-dimer control vials and on a thrombin vial. 52867 B.) Based on review of the Abbott i-STAT CG8+ Cartridge package insert, and Abbott i-STAT CG8+ Cartridge box, observation of i-STAT testing area and interview with the general supervisor (GS) #2, the laboratory failed to document revised expiration dates on one of one i-STAT CG8+ cartridge. Findings: 1. Review of the Abbott i-STAT CG8+ Cartridge package insert states "Storage Conditions: Refrigerated at 2-8C (35- 46F) until expiration date. Room Temperature at 18-30C (64-86F). Cartridges may be stored at room temperature for the time frame indicated on the cartridge box". 2. Review of the Abbott i-STAT CG8+ Cartridge box showed "Store at room temperature for 14 days". 3. Observation of Abbott i-STAT testing area in the main laboratory showed one i-STAT CG8+ cartridge Lot H26066 exp 09/03/2026 stored at room temperature with no revised expiration date on package. 4. Interview with the GS #2 on August 18, 2026 at 1:30 PM confirmed the laboratory failed to document revised expiration dates on one i-STAT CG8+ cartridge. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation of laboratory supplies during the laboratory tour, review of -- 2 of 4 -- patient results and interview with the general supervisor (GS) #1, the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. Findings: 1. Observation of laboratory supplies during the laboratory tour on August 18, 2026 showed the following still in use: 1 box of Vitros Immunodiagnostic Total Triiodothyronine (T3) II Calibrator Lot 0390 exp 07/27/2026 1 each of Remel Potassium Hydroxide (KOH) Lot 231606 exp 08/05/2026 2. Review of patient results showed the laboratory performs approximately 215 Total T3 and 2 KOH patient tests annually. 3. Interview with the GS #1 on August 18, 2026, at 1:00 PM confirmed the laboratory failed to ensure laboratory supplies were not used when they had exceeded their expiration date. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 2025, and to date August 18, 2026 Vitros XT 7600 chemistry calibration records and interview with the general supervisor (GS) #1, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range in 2025 and date August 18, 2026 for 1 of 64 analytes. Findings: 1. Review of the Vitros XT 7600 chemistry analyzer calibration records for 2025 and to date August 18, 2026 showed no calibration every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for hemoglobin A1C. 2. The laboratory performs 5,323 hemoglobin A1C chemistry patient tests annually. 3. Interview with the GS #1 on August 18, 2026 at 11:00 AM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for hemoglobin A1C. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the -- 3 of 4 -- manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of June 2026 to date August 18, 2026 Vitros XT 7600 chemistry analyzer quality control (QC), patient results and interview with the general supervisor (GS) #1, the laboratory failed to ensure QC was acceptable before reporting patients results for the analyte direct bilirubin for 61 of 79 days. Findings: 1. Review of June 2026 to date August 18, 2026 Vitros XT 7600 chemistry QC showed the laboratory could not provide documentation for direct bilirubin QC from June 5, 2026 through July 31, 2026, could not provide QC for August 2, 2026 through August 6, 2026 and could not provide QC for August 13, 2026 through August 16, 2026. 2. The laboratory performed approximately 13 direct bilirubin tests from June 2026 to date August 18, 2026. 3. Interview with the GS #1 on August 18, 2026 at 1:30 PM confirmed the laboratory failed to ensure QC was acceptable before reporting direct bilirubin patient results. -- 4 of 4 --

Summary Statement of Deficiencies 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 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2023 and 2024 and interview with the general supervisor (GS) #1 on July 1, 2024 at 9:45 AM , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in two out of three consecutive testing events for the analyte sodium (NA). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in 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 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2023 and 2024 and interview with the general supervisor (GS) #1, the laboratory failed to achieve satisfactory performance for sodium (NA) in two out of three consecutive testing events Findings: 1. Review of the chemistry PT results for the third event of 2023 showed the laboratory obtained an unsatisfactory score of 60 percent for the analyte sodium (NA). 2. Review of the chemistry PT results for the second event of 2024 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte sodium (NA). 3. Interview with the general supervisor (GS) #1 on July 1, 2024 at 9:45 AM confirmed the laboratory failed to achieve satisfactory performance for sodium (NA) in two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An recertification survey was completed on April 1, 2024. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1100 Condition: Facility Administration 42 C.F.R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1441 Condition: Laboratory Director D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of laboratory temperature logs and interview, the laboratory failed to ensure protection from biological hazards for laboratory and hospital personnel (Refer to D3011). D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- This STANDARD is not met as evidenced by: Based on review of laboratory temperature logs and interview with the general supervisor (GS) #2, the laboratory failed to ensure protection from biological hazards for laboratory and hospital personnel. Findings: 1. Review of refrigerator temperature log for March 2023 and April 2023 stated "Cafeteria walk-in stored reagents when our fridge was down". 2. During interview GS #2 stated, "Yes, Vitros chemistry reagents were stored in fridge in the cafeteria." 3. Interview with GS #2 on March 26, 2024 at 1: 30 PM confirmed the laboratory failed to ensure protection from biohazardous materials for laboratory and hospital personnel. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, patient reports, patient charts, correlation studies, Vitros 5600 chemistry quality control (QC), laboratory package inserts, RPR QC and maintenance logs, observation of microbiology rooms, review of temperature and humidity logs, review of the BacT/Alert blood culture analyzer and the Vitek 2 Compact microbiology analyzer manufacturer's instructions, observation of the Ortho Diagnostics Vitros 5600 chemistry analyzer, review of the Vitros 5600 alarm log and manufacturer's guidelines, observation of laboratory refrigerators and freezers, review of the performance verification procedures, calibration records, review of individualized quality control plans (IQCP), ESR QC, iStat QC, Biofire QC, lack of BBL catalase and BBL oxidase reagent QC, review of agar plates and broth media, gram stain QC, antimicrobial susceptibility testing (AST) records, d-dimer QC, instrument comparisons, review of blood bank history and worksheet logs, Community Blood Center of the Ozarks immunohematology consultation reports, lack of

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of blood bank procedures, Community Blood Center of the Ozarks (CBCO) patient reports, blood bank patient file cards, and interview with the technical supervisor (TS) #2, the laboratory failed to follow procedure for cross match of blood products. Findings: 1. Review of "Cross-Match Procedure and Antibody Screen (Indirect Coombs)" procedure states, "If there is not already a file card on patient, fill one out including full name, date of birth, medical record #, group/type and AB screen results, with today's date and your initials. Also include the number and type of any compatible/incompatible units. File alphabetically." 2. Review of CBCO patient reports showed an immunohematology consultation report for patient AA for a positive antibody screen and an Anti- M antibody identified on July 12, 2021. 3. Review of blood bank patient file cards showed no file card for patient AA. 4. Interview with the TS # 2 on July 6, 2022 at 10:00 AM confirmed the laboratory failed to follow procedure for cross match of blood products by not documenting patient results on a patient file card. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Sysmex XN-550 hematology analyzer and interview with the technical supervisor (TS) #2, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance specifications for the Sysmex XN-550 hematology analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: red blood cell (RBC), hemoglobin, hematocrit, platelet, white blood cell (WBC) and differential prior to the beginning of patient testing in May 2020. 2. Interview with the TS #2 on July 6, 2022 at 10:30 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. 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 2020, 2021, and to date July 6, 2022 calibration records for the Ortho Diagnostics Vitros 5600 chemistry analyzer and interview with the technical supervisor (TS) #2, the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range. Findings: 1. Review of Vitros 5600 calibration records for 2020, 2021, and to date July 6, 2022 showed no calibration every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for the analytes: total iron-binding capacity (TIBC), -- 2 of 4 -- vitamin D, vitamin B12 and procalcitonin. 2. Interview with the TS #2 on July 6, 2022 at 10:00 AM confirmed the laboratory failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for TIBC, vitamin D, vitamin B12 and procalcitonin. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of procedures, chemistry control package inserts, Vitros 5600 quality control (QC) and interview with technical supervisor (TS) #2, the laboratory failed to follow procedure and ensure two levels of chemistry QC were performed each day. Findings: 1. Review of "Quality Control Program-Chemistry" procedure states "Two levels of control must be run each day". 2. Review of MAS Omni CORE liquid assayed chemistry controls package insert for showed level 1 total bilirubin range is . 89-1.37. 3. Review of total bilirubin QC showed on June 22, June 23 and June 24 level 1 QC was not within acceptable limits. 4. Interview with the TS #2 on July 6, 2022 at 11:00 AM confirmed the laboratory failed to follow procedure and ensure two levels of acceptable QC was performed each day for total bilirubin testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the blood bank procedure manual, blood bank alarm test log, and interview with the technical supervisor (TS) #2, the laboratory failed to perform refrigerator alarm inspections according to the laboratory's established procedure. Findings: 1. Review of blood bank procedure "Testing Blood Bank Refrigerator Alarms" states, "There are two alarm systems connected to blood bank refrigerators. These must both be tested quarterly. Results should be documented on chart posted in blood bank." 2. Review of blood bank alarm test log showed refrigerator alarm inspections for 2020, 2021 and to date July 6, 2022 were not performed quarterly according to procedure. 3. Interview with the TS #2 on July 6, 2022 at 10:00 AM confirmed, the laboratory failed to perform blood bank refrigerator alarm inspections according to the laboratory's established procedure. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of ACL Elite analyzer quality control (QC) and interview with technical supervisor (TS) #2, the TS failed to ensure prothrombin time (PT), partial thromboplastin time (PTT) QC program was appropriate for the testing performed. Findings: 1. Review of the PT, PTT QC showed no documentation could be provided for time and data points for QC from January 2020 to June 30, 2022. 2. Interview with the TS #2 on July 6, 2022 at 11:00 AM confirmed the TS failed to ensure PT and PTT QC was stored and retrievable for review. -- 4 of 4 --

Summary Statement of Deficiencies 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 review of proficiency and correlation records and interview with the general supervisor on April 3, 2018 at 2:00 PM, the laboratory failed to document and verify accuracy of the non regulated analyte, deoxyhemoglobin, twice annually for 2016 and 2017. 38475 Based on review of laboratories non regulated chemistry verification of accuracy and interview with the general supervisor on April 3, 2018 at 2:00 PM confirmed the laboratory failed to document and verify accuracy of the non regulated analyte Lipase twice annually in 2017. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)