Northern Cochise Community Hospital

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 review of the laboratory's policy and procedure manuals and interview with the Technical Consultant (TC-1), the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS-209, Laboratory Personnel Form presented for review during the survey has been serving as laboratory director since 12/2/2024. 2. The policy and procedure manual presented for review during the survey conducted on 3/11/25 was not approved, signed and dated by the current laboratory director. 3. The TC-1 interviewed on 3/11/25 at 9:15 AM confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 4. The laboratory performs patient testing under the specialties of Microbiology, Chemistry, Hematology and Immunohematology with an annual test volume of 172,033. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on lack of performance evaluation documentation from 2024 and interview with the Technical Consultant (TC-1), the technical consultant failed to evaluate and document the performance of six of six testing personnel, at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. The laboratory began utilizing the DxH 520 analyzer in March 2024 to perform CBC testing on patients as a backup method. 2. No semiannual competency evaluation documentation was presented for review for six of six testing personnel utilizing this analyzer. 3. The TC-1 on 3/11/25 at 9:30 AM confirmed the technical consultant failed to perform and document a semiannual competency evaluation as indicated above. 4. The laboratory performs patient testing under the specialty of Hematology with an annual test volume of 33,556. -- 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 review of Proficiency Testing (PT) reports for 2022 and 2023 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, Digoxin, under the specialty of Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 3rd event of 2022 for the regulated analyte, Digoxin, with a score of 60%. 2. The laboratory's PT performance was unsatisfactory for the 1st event of 2023 for the regulated analyte, Digoxin, with a score of 60%. 3. Unsatisfactory participation in the 3rd event of 2022 and 1st event of 2023 (two consecutive testing events) for the regulated analyte, Digoxin, constitutes an initial unsuccessful PT performance. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, Digoxin for the 3rd event of 2022 and 1st event of 2023 resulting in unsuccessful PT performance. See D2016 for findings. 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 lack of accuracy verification documentation for review and interview with the Technical Supervisor (TS-2), the laboratory failed to verify the accuracy of Body Fluid analysis testing at least twice annually during 2022. Findings include: 1. No documentation was presented for review during the survey conducted on August 29, 2023 to indicate the laboratory verified the accuracy of Body Fluid examinations at least twice annually during 2022. 2. The TS-2 interviewed at 11:40 AM confirmed the laboratory failed to verify the accuracy of the testing indicated above at least twice annually during 2022. 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 review of maintenance logs for the AU480 Chemistry Analyzers and interview with the Technical Consultant (TC-2), the laboratory failed to perform and document the weekly maintenance as required by the manufacturer. Findings include: 1. The laboratory performs testing on two separate AU480 Chemistry analyzers, referred to by the laboratory as AU480 #1 and AU480 #2. 2. Review of the AU480 Maintenance logs for AU480 #1 and AU480 #2 indicated the laboratory failed to document the weekly maintenance for one out of four weeks in August 2023, for each analyzer. 3. The AU480 weekly maintenance includes: Clean Sample Pre-Dilution Bottle, Perform a W2 and Perform a Photocal. 4. On August 29, 2023 at 1:37 PM, the TC-2 interviewed acknowledged the maintenance activities listed above were not performed and documented for the week listed above. 5. The laboratory's reported annual test volume for the specialty of Chemistry is 122,109. -- 2 of 6 -- 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 lack of calibration verification documentation for one of two AU480 chemistry analyzers and interview with the Technical Consultant (TC-2), the laboratory failed to perform and document calibration verification procedures at least once every 6 months during 2022 and 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory performed a calibration verification on the AU480 chemistry analyzer (system ID# 65355400) at least once every six months during 2022 and 2023, 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. 2. The TC-2 interviewed on August 29, 2023 at 1:33 PM confirmed the laboratory failed to perform calibration verification procedures on the chemistry analyzer indicated above during 2022 and 2023 (as of the survey date). 3. The laboratory's reported annual test volume in the specialty of Chemistry is 122,109. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation, lack of sterility documentation -- 3 of 6 -- and interview with the Technical Supervisor (TS-2), the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and failed to check each batch of media for sterility. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Bacteriology, with an annual approximate test volume of 3,193. 2. Review of plating media in use on the day of the survey, August 29, 2023, revealed the laboratory failed to check each batch of media for sterility and failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms prior to using the media for patient testing. QC and sterility documentation were missing for the following media: - Macconkey (MAC) media, lot# 703540, expiration date 9/26/23, received by the lab on 7/26/23 - Blood Agar (TSA w/ Sheep Blood), lot# 720640, expiration date 10/23/23, received by the lab on 8/25/23 - Columbia CNA agar w/ 5% Sheep Blood, lot# 703810, expiration date 9/20/23, received by the lab on 7/28/23 - Chocolate Agar, lot# 703605, expiration date 9/27/23, received by the lab on 7/26/23 3. The TS-2 interviewed on August 29, 2023 at 1:53 PM acknowledged the laboratory failed to check of each batch of media for its ability to support and/or inhibit growth and failed to check each batch of media for sterility. 4. The number of patient tests performed using the media indicated above could not be determined at the time of the survey. 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 blood bank temperature charts and interview with the Technical Supervisor (TS-2), the laboratory failed to perform and document quarterly inspections of the audible alarm system for the refrigerator and the freezer used to store blood and blood product storage. Findings include: 1. The laboratory performs patient testing in the specialty of Immunohematology with a reported annual test volume of 603. It is the policy of the laboratory to perform a "quarterly alarm evaluation check" for the refrigerator and the freezer used to store blood and blood products. 2. No documentation was presented for review from January 1, 2022 through August 29, 2023 to indicate the laboratory performed and documented audible alarm checks on a quarterly basis for the refrigerator and freezer which are used by the laboratory to store blood and blood products. 3. The TS-2 interviewed on August 29, 2023 at 2:35 PM confirmed the laboratory failed to perform and document audible alarm checks on a quarterly basis during the time period indicated above. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The -- 4 of 6 -- laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Review of 2021 and 2022 instrument comparisons for testing performed in the specialty of chemistry and hematology and interview with the technical consultant (TC-2), the laboratory failed to perform instrument comparisons for two of two chemistry analyzers and two of two hematology analyzers. Findings: 1. The laboratory utilizes the DXH900 and Coulter Ac-T Diff II analyzers to perform patient testing under the specialty of Hematology. 2. The laboratory utilizes two separate AU480 chemistry analyzers to perform patient testing under the specialty of Chemistry. 3. No evidence was presented for review from 2021 and 2022 to indicate the laboratory evaluated and defined the relationship between test results for the hematology analyzers and chemistry analyzers listed above. 4. Interview with the TC- 2 on August 29, 2023 at 12:45 PM confirmed the laboratory failed to perform instrument comparisons for the hematology and chemistry analyzers indicated above. 5. The laboratory results approximately 122,109 chemistry patient results and 50,034 hematology patient results annually. 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 review of Quality Assessment (QA) documentation, analytic test records, laboratory policies and procedures and interview with the Technical Supervisor (TS- 2), the laboratory's analytic QA policies and procedures failed to monitor, assess and, when indicated, correct problems identified with quality control, maintenance and alarm checks, calibration verification procedures, and comparison of instrumentation procedures. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of Quality Control (QC) and sterility records for testing performed in the specialty of Microbiology. See D5477 for findings. 2. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of weekly maintenance performance for the chemistry analyzers used by the laboratory for patient testing. See D5429 for findings. 3. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of quarterly audible alarm checks for the refrigerator and freezer used to store blood and blood products. See D5555 for findings. 4. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of instrument comparison records for testing performed in the specialties of Chemistry and Hematology. See D5775 for findings. 5. The TS-2 interviewed on August 29, 2023 at 3:00 PM confirmed the laboratory's QA processes at the time of the survey were not effective at monitoring, identifying and correcting problems associated with the analytic laboratory systems as indicated above. -- 5 of 6 -- D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of testing personnel competency records for individuals who perform Arterial Blood Gas (ABG) testing and interview with the technical consultant (TC-2), the procedures for evaluation of the competency of the staff failed to include a review of quality control records. Findings include: 1. Review of annual and 6-month competency records from 2022 and 2023 for five out of five testing personnel failed to include a review of quality control records. 2. The TC-2 interviewed on August 29, 2023 at 10:45 AM confirmed the procedures for the evaluation of competency of testing personnel who perform ABG testing failed to include a review of quality control records. 3. The laboratory began ABG testing on the Nova Prime Plus analyzer in August 2021. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies cited herein, the Condition: Laboratories Performing High Complexity Testing - Laboratory Director was not met. The laboratory director failed to ensure proficiency testing samples were tested as required under Subpart H of this part (see D2016 and D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a PT program for the regulated analyte, Digoxin. See D6076 for findings. -- 6 of 6 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2019 and 2020 for testing performed by the laboratory and interview with the facility personnel, the laboratory director failed to sign the PT attestation statements. Findings include: 1. The laboratory performs testing in the specialties of Microbiology, Chemistry, Hematology, and Immunohematology, with an approximate annual test volume of 125,204. 2. The PT attestation statement presented for review for the first event of 2019 for Coagulation lacked the director's signature. 3. The PT attestation statements presented for review for the second events of 2019 for Chemistry, Comprehensive Chemistry and Endocrinology (serum hCG) lacked the director's signature. 4. The PT attestation statements presented for review for the first event of 2020 for Hematology (Blood Cell Identification) and the third event of 2020 for Urine Drug Screens lacked the director's signature. 5. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on lack of instrument printouts for patient test results generated from the Opti CCA-TS2 blood gas analyzer and interview with the testing personnel, the laboratory failed to retain patient test records for at least 2 years. Findings include: 1. The laboratory began patient testing using the Opti CCA-TS2 blood gas analyzer on July 9, 2020. 2. No documentation was presented for review during the survey conducted on May 20, 2021 to indicate the laboratory retained patient test records (instrument printouts) from the Opti CCA-TS2 blood gas analyzer for testing that occurred from July 9, 2020 through the date of the survey. 3. The testing personnel acknowledged that patient test records from the Opti CCA-TS2 analyzer as indicated above were not being retained for at least 2 years. 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 severity and number of deficiencies cited for quality control practices identified during the survey conducted on May 20, 2021, it was determined that the laboratory failed to monitor the overall quality of the analytic systems and correct problems as specified in 493.1289 for patient testing performed by the laboratory in the specialties of Chemistry and Hematology. See D5401, D5421, D5437, D5445 and D5447 for findings. 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 lack of a written procedure manual for testing performed under the specialty of Chemistry and interview with the facility personnel, the laboratory failed to have a written procedure for performing Arterial Blood Gas (ABG) testing on the Opti CCA- TS2 analyzer. Findings include: 1. The laboratory began testing patient specimens on the Opti CCA-TS2 analyzer in July 2020. 2. No written, approved procedure manual was presented for review during the survey conducted on May 20, 2021 to indicate the laboratory had established procedures for testing performed on the Opti CCA-TS2 analyzer. 3. The facility personnel confirmed that the laboratory did not have an established written, approved procedure for the testing indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 8 -- 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 lack of performance specification documentation of the Opti CCA-TS2 blood gas instrument that was acquired by the laboratory on July 9, 2020 and interview with the testing personnel, the laboratory failed to provide documentation indicating verification of performance characteristics for the instrument including accuracy, precision, reportable range and reference range. Findings include: 1. The laboratory acquired the Opti CCA-TS2 blood gas analyzer on July 9, 2020. 2. During the survey conducted on 5/20/21, no documentation was presented for review to indicate the laboratory verified the manufacturer's performance characteristics of the Opti CCA-TS2 blood gas analyzer including accuracy, precision, reportable range and reference range, prior to patient testing. 3. During the survey, the testing personnel confirmed that approximately 254 patient tests had been performed on the Opti CCA- TS2 blood gas analyzer from July 9, 2020 through the date of the survey. 4. The testing personnel interviewed on 5/20/21 at approximately 11:30am stated that the laboratory received the new Opti CCA-TS2 blood gas analyzer by mail shipment, unboxed it, plugged it in and began using it for patient testing. 5. The testing personnel confirmed that the laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the Opti CCA-TS2 blood gas analyzer prior to patient testing. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration records for the AcT 5 Diff hematology analyzer and interview with the facility personnel, the laboratory failed to perform and document calibration procedures as required. Findings include: 1. The laboratory utilized the AcT 5 Diff hematology analyzer during 2019 to perform patient testing. The laboratory's approximate annual test volume in the specialty of Hematology is 34,740. 2. No documentation was presented for review during the survey conducted on May 20, 2021 to indicate the laboratory performed and documented calibration procedures -- 3 of 8 -- every 6 months during 2018 and 2019 as required by the manufacturer for the analyzer indicated above. 3. The calibration records for the AcT 5 Diff analyzer reviewed during the survey indicated the laboratory performed a calibration on 5/16 /2018 and the calibration was not performed again until 11/26/19. 4. The facility personnel confirmed that the laboratory failed to perform a calibration every six months on the AcT 5 Diff analyzer during 2018 and 2019. 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. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation for review and interview with the facility personnel, (A) the laboratory failed to perform QC on the Medtox analyzer as required and (B) the laboratory failed to perform and document control procedures for Blood Gas testing using the number and frequency required by the laboratory. Findings include: A1. The laboratory utilizes the Medtox Urine Drug Screen analyzer for patient testing. The laboratory's approximate annual test volume in the sub- specialty of Toxicology is 1,096. A2. At the time of the survey conducted on May 20, 2021, the laboratory's procedure for QC on the Medtox analyzer consisted of performing an external QC material (positive and negative) monthly or prior to using each new lot of test devices. A3. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. A4. At the time of the survey it was determined that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for this test kit. A5. The facility personnel confirmed that the laboratory did not perform and document controls as required since January 1, 2016 and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for testing performed on the Medtox Urine Drug Screen Analyzer. A6. The number of patients tested during the time period indicated above could not be determined at the time of the survey. B1. The laboratory performs patient blood gas testing on the Opti CCA-TS2 analyzer under the specialty of Chemistry, with an approximate annual test volume of 888. B2. The laboratory policy titled, "Arterial Blood Gas Quality Assurance Policy" presented for review during the survey conducted on May 20, 2021 indicates the laboratory must perform one level of liquid Opti Check controls every eight hours on patient testing days (and through the night as needed). These will include alternating high and low levels". In addition, the laboratory performs a Standard Reference Cassette (SRC) control twice daily, at 7:00am and 3:00pm. The SRC control is one cassette containing 3 levels of control (high, normal and low). B3. The laboratory failed to perform one level of the Opti Check control every eight hours on patient testing days as evidenced by review of the laboratory's quality control records for 12/02/20. On 12 /02/20, the laboratory performed the Opti Check Level 3 control (Lot# 0379) at 07: 30am. No documentation of the Opti Check Level 1 control performance was -- 4 of 8 -- presented for review for the remainder of the day on 12/02/20. B4. Approximately 2 patients were tested using the Opti CCA-TS2 blood gas analyzer on 12/02/20. B5. The facility personnel acknowledged that the laboratory failed to perform two levels of Opti Check controls on 12/02/20, as indicated above. . 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 patient test reports, review of quality control (QC) policies and records for Thyroid Stimulating Hormone (TSH) testing performed on the Architect i- 1000 analyzer and interview with the facility personnel, the laboratory failed to perform two control materials of different concentrations each day patient testing occurred. Findings include: 1. The laboratory performs patient testing in the sub- specialties of Routine Chemistry and Endocrinology, with an approximate annual test volume of 84,976. 2. The laboratory's policy titled, "Correct Quality Control Material" states, "Run Level 1 & 3 per day of use for the following analytes....TSH." 3. The QC documentation presented for review for TSH from the testing date of 2/01/2021 indicated the laboratory only performed the QC for Level 1 (performed at 11:46am). The laboratory failed to produce evidence that QC for Level 3 was performed on 2/01 /21. 4. The laboratory confirmed that one patient (patient# 4434018) was tested for TSH on 2/01/2021. 5. The facility personnel confirmed that the laboratory failed to successfully perform 2 levels of quality control for TSH, as indicated above, prior to reporting patients' test results on each date of patient testing. 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 review of Quality Assessment (QA) documentation, analytic test records, laboratory policies and procedures and interview with the laboratory personnel, the laboratory's established QA policies and procedures failed to monitor, assess and, when indicated, correct problems identified with quality control, establishment of performance verification, and calibration verification. Findings include: 1. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of Quality Control (QC) records for testing performed in the specialty of Chemistry. See D5445 (A) and (B) and D5447 for findings. 2. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of verification of performance -- 5 of 8 -- characteristics for the instrumentation used for blood gas testing. See D5421 for findings. 3. No QA documentation was presented for review during the survey to indicate the laboratory monitored, assessed and, when indicated, corrected problems identified with a lack of calibration verification records for testing performed in the specialty of Hematology. See D5437 for findings. 4. The facility personnel confirmed that the laboratory's QA processes at the time of the survey conducted on May 20, 2021 were not effective at monitoring, identifying and correcting problems associated with the analytic laboratory systems. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test results maintained in the electronic health record (EHR) system, review of the laboratory form used to record patient test results and interview with the testing personnel, the laboratory failed to accurately report the Arterial Blood Gas (ABG) test result for one patient. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) testing, with an approximate annual test volume of 888. It is the practice of the laboratory to manually document the ABG test results onto the laboratory's 'Cardiopulmonary ABG Log' and then to manually enter the test results into the EHR (Electronic Health Record) for each patient tested. 2. Review of ABG test results for the analyte, PaCO2, in the EHR for patient #4441037 performed on 4/25/21 at 11:32am indicated the test result for PaCO2 as 45.5 mmHg, however the laboratory form used to record the test result indicated the PaCO2 test result as 45.7 mmHg. 3. No

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 lack of verification documentation and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed in the specialty of Hematology, at least twice annually during 2016 and 2017. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing on the Coulter HMX analyzer under the specialty of Hematology, with an approximate annual test volume of 35,750. It is the practice of the lab to perform a manual WBC differential if the sample meets the criteria as established in laboratory policy. 2. The laboratory is enrolled in proficiency testing (PT) for the automated WBC differential portion of the CBC, which it uses as the primary test method. 3. No documentation was presented for review during the survey conducted on July 24, 2018 to indicate the laboratory verified the accuracy of manual WBC differentials at least twice annually during 2016 and 2017. 4. The facility personnel confirmed that the laboratory failed to verify the accuracy of the manual WBC Differentials. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of coagulation test records, review of the manufacturer's package insert for coagulation reagents and interview with the facility personnel, the laboratory failed to use the correct International Sensitivity Index (ISI) value for each lot of thromboplastin reagent used on the analyzer. Findings include: 1. The laboratory performs patient testing on the ACL-Elite coagulation analyzer. The analyzer uses a reagent called "Recombiplastin 2G". 2. The ISI value contained in manufacturer's package insert from the Recombiplastin 2G reagent must be correctly programmed into the analyzer for each new lot of reagent used on the analyzer, to ensure the correct ISI value is used in the calculation of the International Normalized Ratio (INR). 3. Direct inspection of the Recombiplastin 2G reagent data entered into the analyzer at the time of the survey conducted on July 24, 2018 revealed the following: Lot# N0378719, expiration date 03/2019, ISI = 1.04. 4. Direct inspection of the manufacturer's package insert for the Recombiplastin reagent used on the analyzer at the time of the survey revealed the following information: Lot# N0285578, expiration date 02/2020, ISI = 1.01. 5. It is the practice of the laboratory to use a "Coagulation Worksheet" to document daily controls. The worksheet contains information specific to the Lot number, expiration date and ISI value for all reagents/controls currently used on the analyzer. The facility personnel stated that the information contained on the worksheet is updated by the laboratory whenever a new lot of control/reagent is put into use. 6. The Coagulation Worksheet presented for review during the survey failed to contain updated information with regard to the Recombiplastin 2G reagent, including lot#, expiration date and ISI value. 7. The testing personnel interviewed during the survey stated that a new lot of Recombiplastin (Lot# N0285578, exp. date 02/2020, ISI = 1.01) was put into use on the analyzer approximately in the beginning of July 2018, but the new lot information, including the ISI value, was not updated in the analyzer or on the Coagulation Worksheet. 8. The laboratory failed to document the exact date in which the Recombiplastin reagent (Lot# N0285578, exp. date 02 /2020, ISI = 1.01) was put into use for patient testing on the ACL-Elite analyzer. 9. The number of patients tested using the incorrect ISI value could not be determined at the time of the survey. 10. The facility personnel confirmed that the laboratory failed to update the ISI value in the analyzer for the current lot of Recombiplastin 2G reagent used at the time of the survey, failed to document the exact date the current lot of Recombiplastin 2G reagent was put into use for patient testing, and failed to update the Coagulation Worksheet with the current reagent information. 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. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) documentation and interview with the facility personnel, the laboratory failed to perform and document control procedures using the number and frequency as required. Findings include: 1. The laboratory performs -- 2 of 5 -- serum hCG testing using a Quick Vue serum pregnancy test kit under the sub- specialty of Endocrinology, with an approximate annual test volume of 1,951. On the date of the survey, July 24, 2018, the laboratory's quality control procedure consisted of performing two levels of external control material, once each month and/or each new lot of test kit. 2. No QC documentation was provided for review during the survey to indicate the laboratory performed two levels of control material of different concentrations, each day of patient testing as required since January 1, 2016. 3. During the survey, review of QC records from 2016 through the date of the survey indicated the laboratory performed and documented QC with the number and frequency described above, and as of January 1, 2016, the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for this test kit. 4. The facility personnel confirmed that the laboratory did not perform and document controls as required since January 1, 2016 and confirmed that the laboratory had not implemented an Individualized Quality Control Plan (IQCP) for testing performed on the Quick Vue serum pregnancy test. 5. The number of patients tested during the time period indicated above could not be determined at the time of the survey. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation, review of the laboratory's QC procedures and interview with the facility personnel, the laboratory failed to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Bacteriology, with an annual approximate test volume of 1,547. 2. The laboratory utilizes the following media for patient testing: TSA, CNA, MAC, CHOC, THIO and Martin-Lewis. 3. No QC documentation was presented for review on the day of the survey, July 24, 2018, to indicate the laboratory checked each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms prior to using the media for patient testing. 4. The facility personnel confirmed that the laboratory was performing a visual check of each batch of media but was not checking each batch of media for its ability to support and/or inhibit growth. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with the testing personnel, -- 3 of 5 -- the laboratory failed to document gram stains for positive and negative reactivity using control organisms each week of use. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Bacteriology with an approximate annual test volume of 1,547. It is the practice of the laboratory to perform gram stains on patient specimens if warranted, as outlined in laboratory policy. 2. During the survey conducted on July 24, 2018, review of the laboratory's Gram Stain Quality Control (QC) Log from 2017 indicated the laboratory last performed and documented the acceptability of the gram stain using a positive and negative organism on July 21, 2017. 3. The facility personnel confirmed that the laboratory failed to document the acceptability of the gram stain using a positive and negative organism since July 21, 2017. 4. The number of patient tested since that time could not be determined at the time of the survey. 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 review of Quality Assessment (QA) documentation and interview with the facility personnel, the laboratory failed to have written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems. Findings include: 1. No documentation was presented for review during the survey to indicate the laboratory monitored or identified problems with analytic activities, including but not limited to, quality control procedures for the Quick Vue serum pregnancy test, See D5445 for findings; quality control procedures for the Gram Stain, see D5503 for findings; quality control procedures for media used in bacteriology testing, see D5477 for findings; and test system failures identified with Coagulation testing, see D5411 for findings. 2. The facility personnel confirmed that the laboratory did not have a system in place at the time of the survey to monitor specific areas of the analytic systems as indicated above. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of