Christus Health-Pine Street

Summary Statement of Deficiencies D0000 An onsite validation survey conducted 09/04/2024 to 09/09/2024 found the laboratory out of compliance with 42 CFR Part 493, Requirements for Laboratories for the following conditions of participation: D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; 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 testing records and confirmed in interview, the laboratory failed to verify the accuracy, at least twice annually, for 13 analytes reviewed in 2022 and 2023, to ensure accurate and reliable results. The findings included: 1. Review of the laboratory proficiency testing records for 2022 and 2023 included the following 13 non-regulated analytes that failed to achieve at least two satisfactory scores annually: 2022: Ammonia Procalcitonin Body Fluid Cholesterol 2023: Ammonia Body Fluid Cholesterol Body Fluid pH (quantitative) Urine Osmolality Body Fluid Chloride Body Fluid Sodium Body Fluid Urea Nitrogen Hemoglobin F, quantitative ACT (activated clotting time) CSF/Body Fluid Manual Cell Counts differentials: for Lymphocytes, Neutrophils, and Monocytes. Body Fluid Microscopy 2. Review of the laboratory proficiency testing policies did not include instructions to ensure that twice annual accuracy assessments for the non-regulated analytes were achieved. 3. In an interview on 9/4/2024 at 12:20 hours, in the conference room, general supervisor (GS) 3 confirmed that the laboratory did not have a mechanism in place to ensure a successful twice annual accuracy assessment Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- for non-regulated analytes, and that a successful twice annual accuracy had not been achieved for the above analytes. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions, review of patient test records and interview of facility personnel, the laboratory failed to ensure that patient specimens collected for Lactate testing were removed from cells within 15 minutes as specified by the manufacturer when using the Beckman DxC 600i, for records reviewed between January 1, 2024 and January 14, 2024. ( see D5311) D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, review of patient test records and interview of facility personnel,the laboratory failed to ensure patient specimens collected and tested for Lactate testing were removed from cells within 15 minutes of collection as specified by the the manufacturer when using the Beckman DxC 600i Chemistry analyzer. The laboratory tested and reported 142 patient specimens for Lactate between January 1, 2024 and January 14, 2024. 95 of 142 patient specimens tested and reported exceeded the 15 minute separation of cells from plasma as defined in the laboratory's own written procedure. The findings included: 1. A review of the laboratory's own written policy titled Lactate (LAC): Plasma (dated 05 /01/2009) found on page 2 under the heading storage and Stability: "Tubes of blood are to be kept closed at all times and in a vertical, stopper-up position. Keep samples on ice. Plasma should be physically separated from contact with cells within 15 minutes of sample collection and analyzed without delay." Further review found on page 2 in the section titled SPECIMEN REQUIREMENT: Lactic Acid/Lactate: "Collect: Gray Top (Sodium Fluoride/ Potassium Oxalate). Keep on Ice. Testing Sample: Plasma anticoagulated with sodium fluoride/potassium oxalate. Handling: Specimen shall be collected by the Lab Phlebotomy group or Nursing Staff. Specimen shall be transported on ice and brought to lab immediate for processing. Separate cells from plasma within 15 minutes of collection and process immediately without delay. Unacceptable Conditions: Sodium Heparin Plasma (Our Green Tops) is incompatible -- 2 of 18 -- with the method per B/C studies.... Refer to specific Procedure "Limitation and Interfering Substance Section and Procedure Notes sections below. Stability: 15 minutes on the cells if kept in ice." 2. Review of patient test records for Lactate between January 1, 2024 through January 14, 2024 found 95 specimens were received in the laboratory at 15 minutes or later from collection and thus, the plasma was not removed from the cells within the time required. 28 of the 95 patient results reported on samples that exceeded the 15 minute time limit for separation follows: Patient: C00201R Collected: 01/01/24 - 0540 Received: 01/01/24 - 0630 Elapsed time: 50 minutes Patient: C00417S Collected: 01/01/24 - 0351 Received: 01/01/24 - 0639 Elapsed time: 168 minutes Patient: C00649R Collected: 01/02/24 - 1159 Received: 01 /02/24 - 1313 Elapsed time: 74 minutes Patient: C01141S Collected: 01/02/24 - 2050 Received: 01/02/24 - 2155 Elapsed time: 55 minutes Patient: C00866S Collected: 01 /03/24 - 1350 Received: 01/03/24 - 1413 Elapsed time: 23 minutes Patient: C011708 Collected: 01/03/24 - 2045 Received: 01/03/24 - 2112 Elapsed time: 27 minutes Patient: C00986S Collected: 01/04/24 - 1649 Received: 01/04/24 - 1739 Elapsed time: 50 minutes Patient: C01224R Collected: 01/04/24 - 2220 Received: 01/04/24 - 2255 Elapsed time: 35 minutes Patient: C00953S Collected: 01/05/24 - 1605 Received: 01 /05/24 - 1650 Elapsed time: minutes Patient: C01157S Collected: 01/05/24 - 2125 Received: 01/05/24 - 2252 Elapsed time: 87 minutes Patient: C00809T Collected: 01 /06/24 - 1514 Received: 01/06/24 - 1541 Elapsed time: 27 minutes Patient: C 00251S Collected: 01/06/24 - 0001 Received: 01/06/24 - 0039 Elapsed time: 38 minutes Patient: C00636S Collected: 01/07/24 - 1354 Received: 01/07/24 - 1434 Elapsed time: 40 minutes Patient: C00829S Collected: 01/07/24 - 1735 Received: 01/07/24 - 1852 Elapsed time: 77 minutes Patient: C00334S Collected: 01/08/24 -0133 Received: 01 /08/24 - 0252 Elapsed time: 89 minutes Patient: C00890S Collected:01/08/24 - 1243 Received: 01/08/24 - 1330 Elapsed time: 47 minutes Patient: C00234R Collected: 01 /09/24 - 0252 Received: 01/09/24 - 0322 Elapsed time: 30 minutes Patient: C00338S Collected: 01/09/24 - 0130 Received: 01/09/24 - 0221 Elapsed time: 51 minutes Patient: C00333R Collected: 01/10/24 - 0543 Received: 01/10/24 - 0627 Elapsed time: 44 minutes Patient: C01152 S Collected: 01/10/24 - 1925 Received: 01/10/24 - 2020 Elapsed time: 55 minutes Patient: C00994S Collected: 01/11/24 - 1425 Received: 01/11/24 - 1529 Elapsed time: 64 minutes Patient: C00254 Collected: 01/11 /24 - 0035 Received: 01/11/24 - 0058 Elapsed time: 23 minutes Patient: C01001S Collected: 01/12/24 - 1627 Received: 01/12/24 - 1757 Elapsed time: 90 minutes Patient: C01041S Collected: 01/12/24 - 1715 Received: 01/12/24 - 1737 Elapsed time: 21 minutes Patient: C00911S Collected: 01/13/24 - 2010 Received: 01/13/24 - 2038 Elapsed time: 28 minutes Patient: C01041S Collected: 01/13/24 - 2255 Received: 01 /13/24 - 2343 Elapsed time: 48 minutes Patient: C00416R Collected: 01/14/24 - 0450 Received: 01/14/24 - 0613 Elapsed time: 74 minutes Patient: C00742S Collected: 01 /14/24 - 1423 Received: 01/14/24 - 1502 Elapsed time: 39 minutes 3. During interview of the Compliance officer conducted September 5, 2024 at 11:14 AM, it was confirmed that patient specimens tested for Lactate were not always removed from cells within 15 minutes of collection. B. Based on review of laboratory policies and procedures, review of patient test records and interview of facility personnel,the laboratory failed to ensure patient specimens collected and tested for Ammonia testing were removed from cells within 10 minutes as specified by the the manufacturer when using the Beckman DxC 600i Chemistry analyzer. Receipt of 15 of 23 patients specimens tested and reported for Ammonia between January 1, 2024 and January 14, 2024 exceeded the 10 minute separation of plasma from cells as defined in their own written procedure. The findings included: 1. Review of the laboratory's own written policy titled Ammonia (AMM) (dated 05/09) found on page 2 under the heading Storage and Stability: "Tubes should be filled completely, mixed gently by inversion, placed on ice, centrifuged immediately for 10 minutes at an RCF of 1500G and -- 3 of 18 -- analyzed within 30 minutes." Further review found under SPECIMEN REQUIREMENT: AMMONIA/KEEP ON ICE "Collect: Green Top (Sodium Heparin Anticoagulated Plasma) on ice. Testing Sample: Sodium Heparin Plasma. Handling: Specimen shall be collected by the Lab Phlebotomy group or Nursing Staff. Specimen will be transported on ice and brought to lab immediate for processing. Specimen should be centrifuged within 10 minutes of collection. Notify Tech work department for processing ASAP. Unacceptable Conditions: Hemolyzed samples are not recommended because lysed red blood cells may elevate ammonia concentration in the sample. Lipemic samples greater than 1+ (visual turbidity) should be ultracentrifuged and the analysis performed on the infranate. Stability: 30 minutes, if specimen has remained tightly capped, stored in an upright position, and centrifuged within 10 minutes of collection." 2. Review of patient test records found the laboratory tested and reported 23 patient specimens for Lactate between January 1, 2024 through January 14, 2024. Of the 23 patient results reported, 15 specimens were received in the laboratory at 10 minutes or later from collection and thus, the plasma was not removed from the cells within the time required as follows. Patient: C00125R Collected: 01/01/24 - 0021 Received: 01/01/24 - 0211 Elapsed time: 50 minutes Patient: C00202R Collected: 01/01/24 - 0540 Received: 01/01/24 - 0625 Elapsed time: 45 minutes Patient: C00309S Collected: 01/01/24 - 0305 Received: 01/01/24 - 0317 Elapsed time: 12 minutes Patient: C00628S Collected: 01/01/24 - 1144 Received: 01/01/24 - 1155 Elapsed time: 11 minutes Patient: C00816S Collected: 01 /01/24 - 1608 Received: 01/01/24 - 1626 Elapsed time: 18 minutes Patient: C00127R Collected: 01/02/24 - 0301 Received: 01/02/24 - 0314 Elapsed time: 13 minutes Patient: C00159R Collected: 01/02/24 - 0218 Received: 01/02/24 0230 Elapsed time: 12 minutes Patient: C00130R Collected: 01/03/24 - 0137 Received: 01/03/24 - 0215 Elapsed time: 43 minutes Patient: C00133R Collected: 01/04/24 - 0350 Received: 01 /04/24 - 0411 Elapsed time: 21 minutes Patient: C00874R Collected: 01/04/24 - 1355 Received: 01/04/24 - 1422 Elapsed time: 27 minutes Patient: COO394R Collected: 01 /06/24 - 0745 Received: 01/06/24 0818 Elapsed time: 33 minutes Patient: C00045R Collected: 01/07/24 - 0300 Received: 01/07/24 - 0317 Elapsed time: 17 minutes Patient: C00098R Collected: 01/07/24 - 0047 Received: 01/07/24 0234 Elapsed time: 144 minutes Patient: C00961S Collected: 01/09/24 - 1450 Received: 01/09/24 - 1504 Elapsed time: 13 minutes Patient: C01039S Collected: 01/12/24 - 1715 Received: 01 /12/24 - 1337 Elapsed time:22 minutes 3. During interview of the Compliance officer conducted September 5, 2024 at 11:14 AM, it was confirmed that patient specimens tested for Ammonia were not always removed from cells within 10 minutes of collection. 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 the review of laboratory Individual Quality Control Plan (IQCP), laboratory policy, laboratory quality control (QC) records, patient test records and interviews, the laboratory failed to meet the applicable analytic system requirements to monitor and -- 4 of 18 -- evaluate the overall quality of the analytc system to identify and correct problems for records reviewed in 2023 and 2024. The findings included: 1. The laboratory failed to follow its quality control plan to perform weekly external for GN ID and GP ID Cards used in the identification of gram negative and gram positive bacteria isolated from culture in microbiology for 15 of 17 weeks reviewed in January 2024 through April 2024. (See D5401 I) 2. The laboratory failed to follow its quality control plan for the testing of external QC every 31 days for three of three kit tests used in microbiology patient testing for records reviewed from May 2023 to April 2024. (See D5401 II) 3. The laboratory failed to perform and document quality control procedures for 24 of 24 months when testing patient specimens for Activated Clotting Time (ACT) using the Hemochron Whole Blood Coagulation System. (See D5445) 4. The laboratory failed to test at least two levels of Hematology quality control materials when testing 169 patient specimens for Complete Blood Counts (CBC) using the Sysmex XN-10 and XN-450 between August 11- 12, 2023. (See D5447) 5. The laboratory failed to define the acceptability criteria accurately for analytes in each lot for five of five BIO RAD quality controls used to ensure the quality of results in Chemistry and Immunology between January 1, 2024 and May 31, 2024. (See D5469) 6. The laboratory failed to ensure QC was acceptable every 8 hours of operation that prothrombin time (PT) patient testing was performed on the Sysmex CS-2500 coagulation analyzer, for records reviewed in January 2023 and February 2023. (See D5481) 7. The laboratory failed to test body fluid QC in duplicates for 40 of 40 days where patient testing occurred for records reviewed in March, November, and December 2023. (See D5543) 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: I. Based on review of the laboratory Individual Quality Control Plan (IQCP) for the VITEK 2 Systems, quality control records, patient test records, and confirmed in interview, the laboratory failed to perform 15 of 17 weekly quality control for GN ID and GP ID Cards used in the identification of gram negative and gram positive bacteria isolated from culture for records reviewed in January 2024 through April 2024. The findings included: 1. Review of the laboratory IQCP, section "Quality Control Plan" for the VITEK 2 System included the following quality control frequency for the GN ID and GP ID cards, approved by the laboratory director 9/19 /2023: " ... Two levels of external controls or knowns performed with each lot /shipment and weekly thereafter" 2. Review of the microbiology form titled "Microbiology Vitek QC Log" included the following dates of QC for the GPID and the GNID: In January 2024 the GNID QC was performed and acceptable on 1/22 /2024. QC for the GPID was performed and acceptable on 1/23/2024 and 1/29/2024. During the period from 1/1/2024 and 1/23/2024, where weekly QC was not performed, 20 patients had bacterial ID's performed on the Vitek to include the following five patients: WD0007547748, WD0007548670, WD0007556582, WD0007525264, WD0007578834. In March 2024, the next acceptable QC was performed on 3/22/2024 for the GPID and GNID. During the period from 1/30/2024, seven days after the initial QC, to 3/22/2024 included 45 patients with bacterial ID's -- 5 of 18 -- performed on the Vitek to include the following five patients: WD0007624224, WD0007639073, WD0007644933, WD0007654346, WD0007612112. In April 2024, no weekly quality control was performed for the Vitek Bacterial GNID and GPID cards. During the period from 3/29/2024, seven days after the initial QC, to 4/30/2024 included 12 patients with bacterial ID's performed on the Vitek to include the following five patients: WD0007745508, WD0007731771, WD0007764632, WD0007764913, WD000778251. 3. In an interview on 9/5/2024 at 09:55 hours, in the conference room, the general supervisor (GS)1 confirmed that weekly QC had not been performed on the vitek for the GNID and GPID cards. II. Based on review of laboratory Individualized Quality Control Plans (IQCP), quality control (QC) records, patient test records, and confirmed in interview, the laboratory failed to follow its quality control plan for the testing of external QC every 31 days for three of three kit tests used in microbiology patient testing for records reviewed from May 2023 to April 2024. The findings included: 1.A. Review of the laboratory IQCP for the "ImmunoCard STAT Giardia/Cryptosporidium Kit Rapid", signed by the laboratory director 1/5/2024, included the following instructions under section "Quality Control Plan": "Two levels of external controls or known's [sic] performed with each lot /shipment and every 31 days thereafter." 1.B Review of the laboratory IQCP for the "Leuko EZ Vue" for stool lactoferrin testing, signed by the laboratory director on 12 /30/2015, included the following instructions under section "Quality Control Plan": "Two levels of external controls or known's [sic] performed with each lot/shipment and every 31 days thereafter." 1.C. Review of the laboratory IQCP for the MRSA Screen PBP2a, signed by the laboratory director on 02/12/2016, included the following instructions under the section "Quality Control Plan": "Two levels of external controls or known's [sic] performed with each lot/shipment and every 31 days thereafter." 2. Review of the microbiology QC forms, and patient testing, from May 2023 to April 2024 identified six months where QC intervals exceeded 31 days, and patients tested during these lapses. In May 2023, the ImmunoCard STAT Giardia /Cryptosporidium and Leuko EZ view kits QC was conducted on 5/6/2023 with the next acceptable QC performed on 6/26/2023. During the period from 6/6/2023 (31 days after the initial QC) until the next acceptable QC on 6/26/2023, the following 25 patients were tested: Date Patient Accession Test Performed 06/07/2023 23: M0036951R Stool Lactoferrin 06/07/2023 23:M0036993R Stool Lactoferrin 06/07 /2023 23:M0036951R Giardia/Cryptosporidium 06/09/2023 23:M0037393S Stool Lactoferrin 06/09/2023 23:M0037363S Giardia/Cryptosporidium 06/11/2023 23: M0037850R Stool Lactoferrin 06/11/2023 23:M0037850R Giardia/Cryptosporidium 06/12/2023 23:M0038138R Giardia/Cryptosporidium 06/13/2023 23:M0037755R Stool Lactoferrin 06/13/2023 23:M0038181S Stool Lactoferrin 06/13/2023 23: M0038195R Stool Lactoferrin 06/13/2023 23:M0038181S Giardia/Cryptosporidium 06/13/2023 23:M0038195R Giardia/Cryptosporidium 06/14/2023 23:M0038457S Stool Lactoferrin 06/14/2023 23:M0038472S Giardia/Cryptosporidium 06/17/2023 23: M0038981R Stool Lactoferrin 06/17/2023 23:M0038981R Giardia/Cryptosporidium 06/18/2023 23:M0039078S Stool Lactoferrin 06/18/2023 23:M0039107S Stool Lactoferrin 06/19/2023 23:M0039105R Giardia/Cryptosporidium 06/20/2023 23: M0039378R Stool Lactoferrin 06/20/2023 23:M0039378R Giardia/Cryptosporidium 06/22/2023 23:M0039663R Stool Lactoferrin 06/22/2023 23:M0039663R Giardia /Cryptosporidium 06/23/2023 23:M0039714R Stool Lactoferrin 06/23/2023 23: M0039891R Stool Lactoferrin 06/23/2023 23:M0039714R Giardia/Cryptosporidium 06/24/2023 23:M0040081R Stool Lactoferrin 06/24/2023 23:M0040081R Giardia /Cryptosporidium In July 2023, the Leuko EZ Vue QC was performed on 7/5/2023 with the next acceptable QC performed on 8/7/2023. During the period from 8/5/2023 (31 days after the initial QC) until the next acceptable QC on 8/7/2023, the following patient was tested. Date Patient Accession Test Performed 08/06/2023 23: -- 6 of 18 -- M0047725R Stool Lactoferrin In August 2023, the ImmunoCard STAT Giardia /Cryptosporidium and Leuko EZ view kits QC was conducted on 8/7/2023 with the next acceptable QC performed on 9/23/2023. During the period from 9/7/2023 (31 days after the initial QC) until the next acceptable QC on 9/23/2023, the following 10 patients were tested: Date Patient Accession Test Performed 09/07/2023 23: M0054080S Stool Lactoferrin 09/08/2023 23:M0054423R Stool Lactoferrin 09/13 /2023 23:M0055402R Giardia/Cryptosporidium 09/14/2023 23:M0055569R Stool Lactoferrin 09/14/2023 23:M0055629S Stool Lactoferrin 09/14/2023 23:M0055569R Giardia/Cryptosporidium 09/15/2023 23:M0055716R Stool Lactoferrin 09/15/2023 23:M0055716R Giardia/Cryptosporidium 09/16/2023 23:M0055905R Stool Lactoferrin 09/17/2023 23:M0056155S Stool Lactoferrin In September 2023 the ImmunoCard STAT Giardia/Cryptosporidium QC was conducted on 9/23/2023 with the next acceptable QC performed on 12/16/2023. During the period from 10/24/2023 (31 days after the initial QC) until the next acceptable QC on 12/16/2023, the following 5 patients were tested. Date Patient Accession Test Performed 12/04/2023 23:M0069641S Giardia/Cryptosporidium 12/06/2023 23:M0071172R Giardia /Cryptosporidium 12/11/2023 23:M0072036R Giardia/Cryptosporidium 12/11/2023 23:M0072211R Giardia/Cryptosporidium 12/13/2023 23:M0072547R Giardia /Cryptosporidium In October 2023, the Leuko View kit QC was conducted on 10/06 /2023 with the next acceptable QC performed on 11/16/2024. During the period from 11/06/2023 (31 days after the initial QC) until the next acceptable QC on 11/16/2024, the following four patients were tested: Date Patient Accession Test Performed 11/07 /2023 23:M0064159S Stool Lactoferrin 11/10/2023 23:M0066059R Stool Lactoferrin 11/12/2023 23:M0066350R Stool Lactoferrin 11/15/2023 23:M0067191S Stool Lactoferrin In February 2024 the ImmunoCard STAT Giardia/Cryptosporidium and Leuko EZ, and PBP2 MRSA QC was conducted on 2/03/2024 with the next acceptable QC performed on 03/15/2024. During the period from 03/05/2024 (31 days after the initial QC) until the next acceptable QC on 03/15/2024, the following 11 patients were tested: Date Patient Accession Test Performed 03/08/2024 24: M0012730R MRSA PBP2a 03/10/2024 24:M0013546R Stool Lactoferrin 03/10/2024 24:M0013546R Giardia/Cryptosporidium 03/11/2024 24:M0013641S Stool Lactoferrin 03/11/2024 24:M0013711R Stool Lactoferrin 03/11/2024 24:M0013727R Stool Lactoferrin 03/11/2024 24:M0013711R Giardia/Cryptosporidium 03/12/2024 24:M0013884R Stool Lactoferrin 03/12/2024 24:M0014032S Stool Lactoferrin 03/13 /2024 24:M0014077R Stool Lactoferrin 03/13/2024 24:M0014156R Giardia /Cryptosporidium 3. In an interview on 9/5/2024 at 15:25, in microbiology, the general supervisor (GS)1 confirmed that monthly QC had not been performed on a monthly, 31-day, cycle and patient testing had occurred when QC exceeded the 31 days. 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)