Wilson Medical Center

Summary Statement of Deficiencies 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 review of instrument type and test settings, lack of reagent lot evaluation data, manufacturer's instructions, patient testing volumes and interview with general supervisor (GS) #1, the laboratory failed to follow manufacturer's instruction on reagent lot changes for both RecombiPlasTin 2G for prothrombin time (PT) and SynthASil reagent for partial thromboplastin time (PTT) prior to use for patient testing. Findings: 1. Prothrombin time (PT) and partial prothrombin time (PTT) testing are performed on the ACL Elite coagulation analyzer from Instrumentation Laboratory/Werfen. 2. ACL Elite coagulation analyzer instrument setting for PT testing showed RecombiPlasTin 2G reagent lot #N1127253, expiration 12/31/24. Mean normal patient (MNPT) was set at 11.1 seconds, and ISI value set at 1.04. 3. The surveyor requested documentation for the MNPT value determination used to calculate the international normalized ratio (INR) and the patient normal range values. No documentation was provided at the time of survey. 4. Manufacturer's instructions for RecombiPlasTin 2G contained under: a. Instrument/test procedures: "Enter the ISI value from the insert and establish the Mean of the PT Normal Range with each new lot. b. Expected values: "Due to many variables which may affect clotting time, each laboratory should verify its own normal range. 5. Lot #N1127253 was placed into use on 11/1/23 with 181 patient test results reported from 11/1/23 to 3/5/24. 6. ACL Elite instrument setting for PTT testing showed SynthASil reagent lot #N0431123, expiration 5/31/25. 7. Request was made to review the SynthASil reagent lot #N0431123 evaluation for normal values. No data was made available at the time 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 2 -- survey. 8. Manufacturer's instructions for SynthASil under expected values stated: "Due to many variables which may affect clotting times, each laboratory should establish its own normal range." 9. SynthASil reagent lot #N0431123 was placed into use on 11/1/23 with 106 patient results reported from 11/1/23 to 3/5/24. 10. Interview with GS#1 3/5/24 at 12:15 p.m. confirmed, the laboratory failed to follow manufacturer's instruction on reagent lot changes for both RecombiPlasTin 2G for prothrombin time (PT) and SynthASil reagent for partial thromboplastin time (PTT) prior to use for patient testing. -- 2 of 2 --

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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Endocrinology for the regulated analyte: 0585 Thyroid-Stimulating Hormone (TSH) for two out of three consecutive testing events. (Refer to D2107) D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) records from the CMS report 0155D and phone interview, the laboratory failed to achieve satisfactory performance in PT for the regulated analyte 0585 Thyroid-Stimulating Hormone (TSH) for two out of three consecutive testing events. Findings: 1. A review of proficiency testing records from the PT provider American Proficiency Institute (API) Proficiency Testing for the regulated analyte 0585 TSH revealed the following performance scores for the periods indicated: 2. Third testing event, 2022 revealed a score 0% 3. Second testing event, 2023 revealed a score of 40% 4. Phone interview on July 5 2023 at 3:00 p.m. confirmed, the laboratory failed to achieve satisfactory performance in PT for the regulatd analyte 0585 TSH for two out of three consecutive testing events. -- 2 of 2 --

Summary Statement of Deficiencies 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 failure to follow written procedures, availability of procedures with required information, testing performed prior to approved procedures, lack of the establishment of normal ranges during verification of performance, and interview with technical consultant (TC) #3, the laboratory failed to follow the Individual Quality Control Plan (IQCP) for arterial blood gas quality control (refer to D5401); failed to have procedures for patient preparation and identification, reportable range, control procedures, reference intervals (normal values), and protocol for notification and instruction for entering results in the patient record for pH, pCO2, and pO2 performed on the Abbott i-STAT analyzer (refer to D5405); failed to have written approved procedures for i-STAT testing and IQCP for pH, pCO2, and pO2 before patient testing (refer to D5407); and failed to define the patient normal values for pH, pCO2 and pO2 before patient testing (refer to D5421). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- examining specimens. This STANDARD is not met as evidenced by: Based on the review of the "Individual Quality Control Plan Summary Report iSTAT CG4+", quality control (QC) records, patient test logs, procedure "Comparison of Past Blood Bank Records", blood bank test logs and interview with testing personnel (TP) #10, and General Supervisor (GS) #2, the laboratory failed to have written, approved procedures followed by laboratory personnel for CG4+ quality control test intervals and blood bank historical record review. Findings: 1. Review of the" Individual Quality Control Plan Summary Report iSTAT CG4+" signed by the LD on 10/23 /2020 revealed: a. The Individual Quality Control Plan(IQCP) control interval was stated as "2 external controls will be ran with every new box, lot number and/or shipment or 30 days." b. Review of QC records revealed last daily QC was performed 9/29/2020. c. QC records after daily QC ceased revealed 2 levels of QC for the following performance dates: 11/10/2020, 11/12/2020, 12/11/2020, 1/12/2021, 2/15 /2021, 5/7/2021, 6/7/2021, 8/5/2021, 9/16/2021, 10/18/2021, 11/23/2021 and 3/1 /2022. 2. Review of patient test logs revealed 62 of 191 patient results for pH, pCO2 and pO2 were released without QC performed as required by the IQCP. 3. Review of the procedure "Comparison of Past Blood Bank Records" revealed under bullet point # 3, "The Blood Bank Technologist will initial the Blood Bank requisition noting that records were reviewed." 4. The surveyor asked where blood bank history checks are recorded. GS #2 stated they were recorded on the patient test log. 5. Review of the patient test log from 12/21/2021 to 3/8/20222 found 11 of 16 patient records failed to have documentation of a historical record review. 6. Interview with TP #10 on 3/8 /2022 at 11:15 a.m. and GS #2 on 3/8/2022 at 2:30 p.m. confirmed, the laboratory failed to have written, approved procedures followed by laboratory personnel for CG4+ quality control test intervals and blood bank historical record review. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based upon a review of the laboratory procedures and interview with technical consultant (TC) #3, the laboratory failed to define by written procedure: patient preparation and identification, reportable range, control procedures, reference intervals (normal values), protocol for notification and instruction for entering results in the patient record, and course of action when the testing system becomes inoperable for pH, pCO2, and pO2 performed on the Abbott i-STAT analyzer. Findings: 1. The test procedure for pH, pCO2, and pO2 performed on the Abbott i-STAT analyzer was requested for review. The laboratory provided a printed copy of the Abbott procedure manual for the i-STAT 1 System. The following information was not included: a. Requirements for patient preparation and identification. b. Reportable range (AMR) for pH, pCO2 and pO2 as determined by the laboratory. c. Control procedures that included which control to be used (identity), number and frequency of testing as required by the IQCP. d. Reference or normal values as determined by the laboratory. e. Protocols for entering results in the patient's record, including panic or alert values. -- 2 of 6 -- f. Course of action for when the test system becomes inoperable. 2. Interview with TC #3 on 3/8/22 at 11:30 a.m. confirmed, the laboratory failed to define by written procedure: patient preparation and identification, reportable range, control procedures, reference intervals (normal values), protocol for notification and instruction for entering results in the patient record, and course of action when the testing system becomes inoperable for pH, pCO2, and pO2 performed on the Abbott i-STAT analyzer. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on the laboratory director's signature date for the two of two procedures provided, patient test data, quality control (QC) data, and interview with TC #3, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Review of the document "Procedure Manual for the i-STAT 1 System" revealed the procedure was signed by the laboratory director (LD) on 3/7/2022. 2. Review of patient test logs revealed patient testing began 9/7/2020. A total of 191 patient results for pH, pCO2, and pO2 were reported 9/7/2020 to 3/7/2022. 3. Review of the" Individual Quality Control Plan Summary Report iSTAT CG4+" revealed the procedure was signed by the LD on 10 /23/2020. a. The Individual Quality Control Plan(IQCP) control interval was stated as "2 external controls will be ran with every new box, lot number and/or shipment or 30 days." b. Review of QC data revealed performance of daily QC ceased on 9/29/2020 with the next QC performed on 11/10/2020. 4. Interview with TC #3 on 3/8/2022 confirmed, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. 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 the review of the performance verification of the Abbott i-STAT analyzer, and interview with TC #3, the laboratory failed to define the patient normal values for the Abbott iSTAT analyzer prior to reporting patient test results. Findings: 1. Request was made to review the performance verifications for the Abbott iSTAT analyzer serial number 416842 used to perform pH, pCO2, and pO2 testing. 2. Review of the performance verification, signed the LD 10/12/2022 revealed no normal range values. No acceptability of the manufacturer's stated normal ranges statement was present. 3. Review of patient test logs revealed patient testing began 9/7/2020. This was prior to -- 3 of 6 -- the LD approval date on the verification study. A total of 191 patient results for pH, pCO2, and pO2 were reported 9/7/2020 to 3/7/2022 for 3 of 3 analytes. 4. Interview with TC #3 on 3/8/2022 at 11:30 a.m. confirmed, the laboratory failed to define the patient normal values for the Abbott iSTAT analyzer prior to reporting patient test results. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The laboratory failed to have a qualified technical consultant for competency evaluation of blood gas testing personnel (refer to D6035); the technical consultant failed to ensure acceptable levels of analytic performance were maintained (refer to D6042); and the technical consultant failed evaluate and document competency on five of eleven moderate complexity testing personnel for 2021 (refer to D6046). D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be -- 4 of 6 -- qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on the review of competency documents for laboratory personnel who performed arterial blood gas testing, educational documentation for TP #10, and interview, the laboratory failed to have a qualified technical consultant performing competency assessment of moderate complexity testing personnel. Findings; 1. Review of competency documents for four of nine arterial blood gas TP revealed the initial training competencies were signed by TP #10. 2. Review of the educational documents of TP #10 revealed an Associate in Applied Science in Respiratory Care degree. 3. Interview with TP #10 on 3/8/2022 at 11:15 a.m. confirmed, the laboratory failed to have a qualified technical consultant performing competency assessment of moderate complexity testing personnel. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) 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 upon review of IQCP procedure, QC documents, patient test logs, and interview with TC #3, the TC failed to ensure acceptable levels of analytic performance were maintained on the Abbott i-STAT analyzer for three of three analytes. Findings: 1. The Individual Quality Control Plan (IQCP) control interval was stated as "2 external controls will be ran with every new box, lot number and/or shipment or 30 days." 2. Review of i-STAT QC records for 9/4/2020 through 3/1 /2022 for pH, pCO2 and pO2 revealed: a. The last daily QC was performed 9/29 /2020. b. QC records after daily QC ceased revealed 2 levels of QC for the following performance dates: 11/10/2020, 11/12/2020, 12/11/2020, 1/12/2021, 2/15/2021, 5/7 /2021, 6/7/2021, 8/5/2021, 9/16/2021, 10/18/2021, 11/23/2021 and 3/1/2022. c. No documentation of review or

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) results and interview with the technical supervisor #1 the laboratory failed to evaluate and document any unsatisfactory PT analyte or test performance. Findings: 1. Review of blood gas PT in 2017 showed event 3 pH was 80% with no evaluation documented. 2. Review of blood gas PT in 2017 showed event 3 pO2 was 80% with no evaluation documented. 3. Interview with the technical supervisor #1 on September 21, 2018 at 11:00 AM confirmed the laboratory failed to evaluate and document 80% blood gas scores in 2017. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This CONDITION is not met as evidenced by: Based on review of procedure manual, quality control records and interview the laboratory failed to meet the condition: Analytic systems. The laboratory failed to follow procedure manual for blood bank quality control (refer to D5401); failed to follow manufacturer's instructions for ISI value (refer to D5411); failed to calibrate pipettes (refer to D5429); failed to perform sodium, potassium and chloride calibration (refer to D5439); failed to perform quality control each day of testing for Mycoplasma (refer to D5449) and failed to perform blood gas control material every 8 hours of patient testing (refer to D5537) 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 procedures, blood bank quality control (QC) and interview with the technical supervisor #1 the laboratory failed to follow blood bank QC procedure. Findings: 1. Review of blood bank procedure shows "the individual performing blood bank testing on patients will perform the quality control if it has not already been performed for that day." 2. On May 5, 2018, two units of blood were cross matched and no QC was completed. 3. On August 20, 2018 two units of blood were cross matched and no QC was completed. 4. On September 19, 2018 two units of blood were cross matched and no QC was completed. 5. Interview with the technical supervisor #1 on September 21, 2018 at 11:00 AM confirmed the laboratory failed to follow blood bank QC procedure. 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 review of prothrombin time (PT) RecombiPlasTin2G package insert for lot # N0972299, ACL Elite instrument and interview with the technical supervisor #1 the laboratory failed to follow the manufacturer's instructions for ISI value. Findings: 1. Review of the package insert for lot #N097229 defines the ISI at 1.06. 2. Review of the instrument shows the ISI is 1.03. 3. Interview with the technical supervisor #1 on September 21, 2018 at 11:00 AM confirmed the laboratory failed to follow the manufacturer's instructions for the ISI value. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 6 -- 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 review of Prothrombin time (PT) and Partial thromboplastin time (PTT) quality control (QC) and interview with technical supervisor #1 the laboratory failed to define acceptable QC ranges. Findings: 1. Placed on a piece of paper attached to the front of the instrument PT level 1 Control range 10-13 and PT level 3 control range 31.3-46.9. 2. Package insert for lot #N1073419 and N0771137 in use PT level 1 control range 9.6-12.6 and PT level 3 control range 26.6-39.8. 3. Placed on a piece of paper attached to the front of the instrument PTT level 1 control range 23.1-31.1 and level 3 control range 45.7-61.9. 4. Package insert for lot #N1073419 and N0771137 in use PTT level 1 control range 23.2-31.2 and level 3 range 48.5-65.6. 5. Interview with the technical supervisor #1 on September 21, 2018 at 11:00 AM confirmed the laboratory failed to define acceptable QC ranges for PT and PTT. 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 observation of MLA pipettes and interview with technical supervisor #1 on September 21, 2018 at 11:30 AM confirmed the laboratory failed to calibrate two MLA pipettes in 2017 to date. 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 -- 3 of 6 -- 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 chemistry calibration and interview with the technical supervisor #1 on September 21, 2018 at 11:30 AM confirmed the laboratory failed to perform calibration including a minimal ( or zero) value, a mid-point value and a maximum value near the upper limit on sodium, potassium and chloride every six months for 2017 to date D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Immunocard Mycoplasma test and interview with the technical supervisor #1 on September 21, 2018 at 11:30 AM confirmed the laboratory failed to perform a positive and negative control each day of patient testing D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood gas quality control (QC) and interview with testing personnel #3 the laboratory failed to test one sample of control material each 8 hours of patient testing using a combination of control materials that include both low and high values on each day of testing. Findings: 1. Review of blood gas patients showed since May 1, 2018 to date 75 patients were reported out. Review of blood gas QC showed controls were performed 3 times in 2018. 2. Interview with testing personnel #3 on September 21, 2018 confirmed the laboratory failed to test one sample of control material each 8 hours of patient testing using a combination of control materials that include both low and high values on each day of testing. 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 -- 4 of 6 -- with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of procedures, quality control program, calibration and interviews the director failed to provide overall management and direction: failed to maintain quality control program (refer to D6093); failed to ensure the establishment and maintenance of acceptable levels of analytical performance (refer to D6095) and failed to ensure that an approved procedure manual is available (D6106). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of blood bank quality control, blood gas quality control (QC), protime QC and interview with the technical supervisor #1 and testing personnel #3 the laboratory director failed to ensure QC is maintained to assure the quality of laboratory services provided. Findings: 1. Review of blood bank procedure shows "the individual performing blood bank testing on patients will perform the quality control if it has not already been performed for that day." On May 5, 2018, two units of blood were cross matched and no QC was completed. On August 20, 2018 two units of blood were cross matched and no QC was completed. On September 19, 2018 two units of blood were cross matched and no QC was completed. 2. Blood gas QC material must be performed each 8 hours of patient testing using a combination of control materials that include both low and high values on each day of testing Review of blood gas patients showed since May 1, 2018 to date 75 patients were reported out. Review of blood gas QC showed controls were performed 3 times in 2018. 3. Prothrombin time ISI is 1.03 in ACL Elite and package insert for lot number in use N0972299 ISI is 1.06. 4. Interview with technical supervisor #1 and testing personnel #1 on September 21, 2018 at 11:30 AM confirmed the laboratory director failed to ensure QC was maintained. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on review of blood bank, Prothrombin time (PT), partial thromboplastin time (PTT), blood gas and interview with technical supervisor #1 confirmed the laboratory director failed to ensure acceptable levels of analytical performance for blood bank, PT, PTT and blood gas D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) -- 5 of 6 -- The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of blood gas procedure and interview with the technical supervisor #1 on September 21, 2018 at 11:30 AM confirmed the laboratory director failed to ensure that an approved blood gas procedure manual is available to all personnel. -- 6 of 6 --