Saint Francis Lab-Sand Springs Urgent Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/08,09/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and technical consultant at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant, the laboratory failed to have a written policy to assess the competency of the technical consultant, based on the position responsibilities listed in Subpart M, for one of one person. Findings include: (1) On 05/08/2025, a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant based on the position responsibilities, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of September 2023 through the current date identified, although competencies, based on position responsibilities, had been performed for one of one person listed as the technical consultant on 04/04/2024 and 04/04/2025, the assessment policy was not available for review; (3) The findings were reviewed with the technical consultant who stated on 05/08/2025 at 09:16 am, a written policy was not available, although competencies had been performed for the position as stated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the Cepheid GeneXpert Xpress analyzer during the review period of February 2024 through the current date. Findings include: (1) On 05/08/2025 at 12:00 pm, the technical consultant stated the laboratory performed SARS-CoV-2, Influenza A and B, and RSV (Respiratory syncytial virus) testing using the Cepheid GeneXpert Xpress analyzer; (2) A review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Weekly: (i) Power down the GeneXpert Instrument and Computer (ii) Clean fan prefilter (b) Monthly: (i) Archive tests (ii) Purge tests (c) Quarterly: (i) Clean plunger rod and cartridge bays (ii) Clean instrument surfaces (iii) Replace fan filters (iv) Replace fan prefilters (3) A review of maintenance records from February 2024 through the current date identified weekly, monthly, and quarterly maintenance had not been documented as performed as follows: (a) Weekly: (i) Between 03/22 /2024 and 04/04/2024 (ii) Between 04/19/2024 and 05/03/2024 (iii) Between 05/03 /2024 and 05/17/2024 (iv) Between 05/17/2024 and 05/26/2024 (v) Between 06/25 /2025 and 07/07/2025 (vi) Between 07/15/2024 and 08/01/2024 - Fan prefilter cleaning not performed (vii) Between 08/08/2025 and 08/18/2025 (viii) Between 10/05 /2024 and 10/14/2024 (ix) Between 11/01/2024 and 11/11/2024 (b) Monthly: (i) Between 03/09/2024 and 05/12/2024 - Archive Tests not performed (ii) Between 05/31 /2024 and 09/09/2024 - Archive Tests not performed (iii) Prior to 09/09/2024 - Purge Tests not performed (iv) Between 09/09/2024 and 11/01/2024 - Archive Tests not performed (v) Between 09/09/2024 and 02/01/2025 - Purge Tests not performed (vi) Between 12/31/2024 and 02/01/2025 - Archive Tests not performed (c) Quarterly: (i) Prior to 08/16/2024 - Clean Plunger rod and cartridge bays not performed (ii) Prior to 08/16/2024 - Clean Instrument Surfaces not performed (iii) Prior to 09/09/2024 - Replace fan filters not performed vii) Prior to 09/09/2024 - Replace fan prefilters not performed (4) Interview with the technical consultant on 05/08/2025 at 02:40 pm confirmed the maintenance procedures had not been documented as performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/13/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 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 a review of records and interview with the technical consultant, the laboratory failed to ensure the reportable range had been utilized for two of four analytes reviewed. Findings include: (1) On 09/13/2023 at 09:25 am, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Beckman Coulter DxH 520 hematology analyzer beginning 05/15/2023; (2) A review of performance specification records identified the reportable ranges had been demonstrated by the laboratory as follows: (a) Hemoglobin: 0.00 - 19.31 g/dL (b) Platelet: 0.1 - 1846.6 (x10^3 cells/ L) (3) A review of the manual titled, "Manufacturer's Instructions for Use - DxH 520 Published Version: v2" in Chapter 1, section 1-23 titled "System Overview Performance" defined the reportable range as follows: (a) Hemoglobin: 0.20 - 25.0 g/dL (b) Platelet: 7.0-2000 (x10^3 cells/ L) (4) Interview with the technical consultant on 09/13/2023 at 02:18 pm, confirmed the laboratory was using the manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory. 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, laboratory maintenance records, and interview with the technical consultant, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures during the review period of 06/01/2023 through 08/31/2023. Findings include: (1) On 09/13/2023 at 09:25 am, the technical consultant stated CBC (Complete Blood Count) testing was performed using the Beckman Coulter DxH 520 hematology analyzer beginning 05/15/2023; (2) A review of the manual titled, "Manufacturer's Instructions for Use - DxH 520 Published Version: v2" Chapter 12, section 12-1 stated the following required maintenance procedures: (a) "Performing a bleach cycle every 1000 cycles or monthly, whichever comes first"; (b) "Cleaning the WBC bath filter monthly". (3) A review of maintenance logs from 06/01/2023 through 08/31/2023 identified no documentation monthly maintenance had been performed as follows: (a) Bleach Cycle (i) Not documented as performed until 07/05/2023 (ii) Not documented as performed after 07/14/2023 (b) Cleaning WBC Bath Filter (i) Not documented as performed until 08/15/2023 (4) The records were reviewed with the technical consultant who stated on 09/13/2023 at 11:57 am, monthly maintenance had not been documented as performed as shown above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the technical consultant, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for two of two function checks performed during the review period of January 2022 through the current date. Finding include: (1) On 09/13/2023 at 09:30 am, the technical consultant stated the following: (a) Urine sediment examinations were performed; (b) The specimens were processed in the Cardinal Health Benchtop 6V centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) A review of the centrifuge function check policy titled, "Function Check Procedure" stated the following: (a) "To ensure the centrifuge is functioning properly in an acceptable standardized manner, its speed and timer is be checked annually"; (b) " Acceptable Speed Cardinal Health Benchtop 6V - 1500 rpm +/-100". (3) A review of centrifuge function check records during 2022 through the -- 2 of 3 -- current date identified the centrifuge speed had not been checked at the speed urines were processed for two of two checks performed as follows: (a) 06/28/2022 - The speed had been checked at 1705 rpm; (b) 06/23/2023 - the speed had been checked at 1705 rpm. (4) The records were reviewed with the technical consultant who stated on 09/13/2023 at 02:10 pm, the laboratory had not followed their policy. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to verify the stated value of control materials before they were put into use for nine of nine lot numbers used during the review period of 06/01/2023 through the current date. Findings include: (1) On 09/13/2023 at 09:25 am, the technical consultant stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Beckman Coulter DxH 520 hematology analyzer beginning 05/15/2023; (b) Three levels of QC (quality control) materials were tested each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of records for nine control lot numbers identified no evidence the provided ranges were verified before the lot numbers were put into use for nine of nine lot numbers as follows: (a) Low control lot #352314811, Normal control lot #362314812, and High control lot #372314813 used from 06/01/2023 through 06/30/2023; (b) Low control lot #352314911, Normal control lot #362314912, and High control lot #372314913 used from 07/03/2023 through 07/31/2023; (c) Low control lot #352315011, Normal control lot #362315012, and High control lot #372315013 put into use on 08/01/2023 and currently in use. (3) The findings were reviewed with the technical consultant who stated on 09/13/2023 at 11:57 am the manufacturer's ranges had not been verified before the above lot numbers had been put into use. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/20/2021. The findings were reviewed with the laboratory director and technical consultant during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1403; D6000: Laboratory Director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 1 of 10 patient specimens. Findings include: (1) On 08/20/2021 at 10:55 am, the laboratory director stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument (i) Abbott ID Now - qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "ID NOW COVID- 19" which stated, "For best performance, direct nasal, throat or nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, and to maintain best performance, it is highly recommended the nasal, throat or nasopharyngeal swab is placed in a clean, unused tube labeled with patient information, and capped tightly at room temperature (15-30C) for up to one (1) hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than one (1) hour delay occurs, dispose of sample. A new sample must be collected for testing."; (3) The surveyor reviewed 10 test reports for patients tested on 08/19/20201 and identified the following: (a) Patient Report #3 - Specimen Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- collection date and time (08/19/20201 at 11:35 am) and the result date and time (08/19 /2021 at 01:38 pm); (4) The surveyor was not able to determine if the results had been interpreted within the one (1) hour after collection since the time between the specimen collection date and time and the result date and time was was 2 hours and 3 minutes; (5) The surveyor reviewed the records with the laboratory director. The laboratory director stated on 08/20/2021 at 12:25 pm the laboratory could not prove the results had been interpreted within one (1) hour after collection as indicated above. 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: Based on a review of records, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for verifying automated differential flags for 6 of 6 patient reports. Findings include: (1) On 08/20/2021 at 10:55 am, the laboratory director stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Cell Dyn Emerald analyzer; (2) The surveyor reviewed the manufacturer's operator's manual for information regarding flagged results. The following was identified: (a) For L1, L2, and L3 flags the instructions stated, "Check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results and verify the WBC count." (3) The surveyor asked the laboratory director if the laboratory had a written policy for addressing the flags. The laboratory director stated on 08/20/2021 at 03:35 pm it was the laboratory's policy to review a stained smear when automated differential flags were obtained; (4) The surveyor then reviewed patient records and identified that for 6 of 6 records reviewed, the laboratory had not verified the results when automated differential flags were obtained as follows: (a) L1 flag obtained on a patient sample tested on 05/30/2021 at 01:00 pm (b) L3 flag obtained on a patient sample tested on 06/09/2021 at 04:10 pm (c) L3 flag obtained on a patient sample tested on 06/18/2021 at 08:01 pm (d) L3 flag obtained on a patient sample tested on 06/20/2021 at 12:56 pm (e) L3 flag obtained on a patient sample tested on 07/11/2021 at 11:37 am (f) L2, L3 flags obtained on a patient sample tested on 07/28/2021 at 08:21 pm (5) The findings were reviewed with the laboratory director who stated on 08/20/2021 at 03:25 pm, the laboratory had performed a smear but not documented the findings. 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 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to demonstrate the performance specifications for one of one new test method; and failed to ensure the demonstrated reportable ranges were utilized for one of one new test method Findings include: ASI COLOR MONO II TEST (1) On 08/20/2021 at 10:55 am, the laboratory director stated to the surveyor that qualitative mononucleosis testing was performed using the ASI Color Mono II test kit (a non- waived test kit) beginning 07/16/2021; (2) The surveyor asked the laboratory director if the performance specifications (accuracy, precision) had been demonstrated before the test kit had been put into use for patient testing. On 08/20/2021 at 02:10 pm the laboratory director stated the performance specifications had not been demonstrated before patient testing; (3) The following were examples of patient mononucleosis testing performed when the performance specifications had not been demonstrated prior to putting into use for patient testing: (a) Patient #1 - Testing performed on 07/16 /2021 (b) Patient #2 - Testing performed on 07/18/2021 (c) Patient #3 - Testing performed on 07/31/2021 (d) Patient #4 - Testing performed on 08/09/2021 iSTAT CHEM8+ CARTRIDGE (1) On 08/20/2021 at 10:45 am, the laboratory director stated to the surveyor the iSTAT 1 analyzer (serial number 399311), using the Chem 8+ cartridge (included the analytes Sodium, Potassium, Ionized Calcium, Total CO2, Creatinine, BUN, Chloride, and Glucose), was available for patient testing on 03/02 /2020; (2) The surveyor reviewed the performance specification records for the test system. The reportable ranges were verified as follows: (a) Sodium (i) The laboratory verified 103-173 mmol/L (ii) The manufacturer's reportable range was 100-180 mmol /L (b) Potassium (i) The laboratory verified 2.3-7.8 mmol/L (ii) The manufacturer's reportable range was 2.0-9.0 mmol/L (c) Ionized Calcium (i) The laboratory verified 0.34-2.34 mmol/L (ii) The manufacturer's reportable range was 0.25-2.50 mmol/L (d) Total CO2 (i) The laboratory verified 12-41 mmol/L (ii) The manufacturer's reportable range was 5-50 mmol/L (e) Creatinine (i) The laboratory verified 0.3-15.4 mg/dL (ii) The manufacturer's reportable range was 0.2-20.0 mg/dL (f) Chloride (i) The laboratory verified 62-123 mmol/L (ii) The manufacturer's reportable range was 65-140 mmol/L (g) Glucose (i) The laboratory verified 27-600 mg/dL (ii) The manufacturer's reportable range was 20-700 mg/dL (3) The surveyor reviewed the performance specification with the laboratory director and asked if there was documentation to prove the laboratory was utilizing the reportable ranges that had been demonstrated by the laboratory; (4) On 08/20/2021 at 02:35 pm, the laboratory director stated the laboratory was using the manufacturer's reportable ranges instead of the reportable ranges that had been demonstrated by the laboratory. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the laboratory director the laboratory failed to follow written quality control policies for 1 of 22 months. Findings include: (1) On 08/20/2021 at 10:45 am, the laboratory director stated the following to the surveyor: (a) Troponin I testing was performed in the laboratory using the cTnl cartridge and the iSTAT1 analyzer (serial number 399311); (b) BNP (Brain Natriuretic Peptide) testing was performed in the laboratory using the BNP cartridge and iSTAT analyzer (serial number 399311); (c) PT/INR (Prothrombin Time/International Normalized Ratio) testing was performed in the laboratory using the PT/INR cartridge and the iSTAT analyzer (serial number 399311). (d) An IQCP (Individualized Quality Control Plan) had been developed for the above test systems. (2) The surveyor reviewed the IQCP that had been developed for the test system. The QCP (Quality Control Plan) portion of the IQCP required 2 levels of external quality control materials be tested once every 30 days; (3) The surveyor reviewed QC (quality control) records for 22 months (October 2019 through July 2021) and identified the laboratory failed to follow the written QCP of performing quality control testing every 30 days. Quality control testing had not been performed as follows: (a) Troponin I (i) Between 10/19/2019 and 12/15/2019 (b) BNP (i) Between 10/19/2019 and 12/05/2019 (c) PT/INR (i) Between 10/22/2019 and 12/05/2019 (4) The findings were reviewed with the laboratory director who stated on 08/20/2021 at 02:45 pm, the laboratory had not performed quality control testing as required by the QCP. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, written policies, and interview with the laboratory director, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to follow the manufacturer's instructions for verifying automated differential flags for 6 of 6 patient reports. Refer to D5411; (b) The laboratory failed to demonstrate the performance specifications for one of one new test method; and failed to ensure the demonstrated reportable ranges were utilized for one of one new test method. Refer to D5421; (c) The laboratory failed to follow written quality control policies for 1 of 22 months. Refer to D5445. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: -- 4 of 5 -- Based on a review of records and interview with the laboratory director, the laboratory director failed to provide overall management and direction for moderate complexity testing. Findings include: (1) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Findings include: (1) The laboratory director failed to ensure the performance specifications had been demonstrated for 1 of 1 new test methods. Refer to D5421. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An initial survey was performed on 07/29/19 The findings were reviewed with technical consultant #2 and the laboratory technical services manager during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with technical consultant #2, the laboratory failed to have a written technical consultant and clinical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed personnel records for competency assessments performed during 2018 and 2019. There was no evidence competencies had been performed for the technical consultants and clinical consultant, based on their job responsibilities; (2) Surveyor #2 asked technical consultant #2 if a written policy to evaluate the technical consultant and clinical consultant based on job responsibilities was available. Technical consultant #2 stated a policy to evaluate the technical consultant and clinical consultant based on job responsibilities had not been written; and competencies had not been performed. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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)