St Mary's Health

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 the laboratory's procedure, centrifuge user manual, and interview with the laboratory manager on 2/4/2025, the laboratory failed to follow their procedures reference and centrifuge urine at 400 relative centrifugal force (RCF) for urine sediment examinations. The findings include: 1. A review of the laboratory's procedure, Laboratory Urinalysis, stated "centrifuge tubes for 10 minutes at 3356 RPM" and contained a reference of "Urinalysis and Body Fluids" Strasinger and Di Lorenzo. 2. The reference "Urinalysis and Body Fluids" Strasinger and Di Lorenzo stated to centrifuge 10-15 ml of urine at RCF 400 for 5 minutes. 2. A review of the Horizon 642E centrifuge user manual listed a nominal RCF of 1600 +/- 90 identifying that the laboratory failed to centrifuge urine sediment samples per the laboratory's urinalysis procedure reference. 3. In interview with the laboratory manager on 2/4 /2025 at 10:17 am verified that the centrifuge setting was not following the laboratory's procedure reference. 4. The laboratory performs 2895 urine sediment examinations per year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 a Proficiency Testing (PT) desk review of graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 12/6/2022, the laboratory failed to successfully participate in PT for the analyte digoxin for one event in 2019 and two (2) consecutive testing events in 2020 and 2022. See D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 a proficiency testing (PT) desk review of graded PT results from the American Proficiency Institute (API) and an interview with the laboratory manager on 12/6/2022, the laboratory failed to achieve an overall score of satisfactory performance for two (2) consecutive testing events for the analyte digoxin in 2022. The findings include: 1. A PT desk review of graded PT results from API identified that the laboratory failed to achieve satisfactory results for the following analyte: Analyte Year Event Score Digoxin 2019 3 40% Digoxin 2020 1 0% Digoxin 2020 2 60% Digoxin 2022 2 40% Digoxin 2022 3 20% 2. A rolling review of the laboratory's graded PT results from API identified the subsequent occurrence of unsuccessful PT participation for the analyte digoxin in 2019 event three (40%), and in 2020 for events one (0%) and two (60%) for which the laboratory submitted an allegation of compliance (AOC) on 8/30/2020 which resulted in the reinstatement of testing of the analyte digoxin on 3/31/2021. 3. A PT desk review performed on 1/24/2023 identified the additional subsequent occurrence of unsuccessful PT participation for the analyte digoxin in 2022 for event two (40%) and event three (20%). 4. An interview with the laboratory manager on 12/6/2022 at 2:30 pm confirmed the PT failures for digoxin in 2019, 2020 and 2022. 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 a Proficiency Testing (PT) desk review of graded PT results from the American Proficiency Institute (API), the subsequent occurrence of unsuccessful participation for the analyte digoxin (event 3 in 2019, event 1 and 2 in 2020), the corresponding allegation of compliance (AOC) and evidence of compliance (EOC) which provided the basis for reinstatement of testing on 3/31/2021 for the analyte digoxin, the laboratory director failed to ensure the plan of remedial action, training, or technical assistance was successful from previous proficiency testing failures and sanction for the analyte digoxin to ensure that the laboratory maintained successful participation for the analyte digoxin for two (2) consecutive proficiency testing events in 2022. See D6092 D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies 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 direct observation and an interview with the laboratory manager on 12/7 /2022, the laboratory failed to calibrate five (5) pipettes used for laboratory testing. The findings include: 1. During the laboratory tour on 12/7/2022 a direct observation of five (5) pipettes identified that the laboratory failed to calibrate the Finnpipette II 0.5-10 ul, Finnpipette II 20- 200 ul, Finnpipette II 1000 ul, Finnpipette II 3 ml and ID- Tipmaster 12.5, 25, 30 ul pipettes since March 2021. 2. An interview with the laboratory manager on 12/7/2022 at 1:42 pm confirmed that the laboratory had no documentation of calibration for the five (5) pipettes. 3. The laboratory reports performing 198,658 tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the specialty of immunohematology. See D2162 D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte 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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from theAmerican Proficiency Institute (API) and telephone interview with the laboratory manager on 10 /13/2022, the laboratory failed to achieve a satisfactory score in two (2) of three (3) consecutive testing events in 2022 for the specialty of immunohematology. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve a satisfactory score of 100 percent for the analyte ABO group typing. Analyte Year Event Score ABO Group 2022 1 80% ABO Group 2022 2 0% 2. A telephone interview with the laboratory manager on 10/13/2022 at 1:01 pm confirmed the above findings. 3. The laboratory reports performing 145 ABO group typing tests annually -- 2 of 2 --

Summary Statement of Deficiencies 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 a record review and an interview with the laboratory manager on 6/23/2021, the laboratory failed to check each lot of prepared plated and liquid medium for its ability to support growth and/or inhibit growth before performing patient testing. The findings include: 1. A review of microbiology quality control (QC) records identified that the laboratory failed to perform and QC to show the ability of the prepared plated and liquid medium to support growth on MacConkey II Agar lot number 1131748 (BD BBL), Blood Agar, 5% Sheep Blood lot number 305635 (Remel), Fluid Thioglycol media lot number 1056319 (BD BBL), Lim Broth lot number 1078394 (BD BBL) and Enterococcosel Agar lot number 1091934 (BD BBL). 2. A review of microbiology QC records identified that the laboratory failed to perform and document QC to show the ability of the media to inhibit growth on selective media, MacConkey II Agar lot number 1131748 (BD BBL) and Enterococcosel Agar lot number 1091934 (BD BBL). 3. An interview with the laboratory manager on 6/23 /2021 at 8:50 am confirmed that the laboratory failed to perform and document QC on prepared plated and liquid medium. 4. The laboratory reports performing 2523 microbiology tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the following analytes; Albumin, Alkaline Phosphatase, ALT/SGPT, Amylase, AST/SGOT, Bilirubin(Total), Chloride, Cholesterol(Total), Creatine Kinase/CK, Creatinine, Glucose, LD/LDH, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid and Lithium. Refer to D2097 and D2119. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve an overall testing event score of satisfactory performance for 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 a proficiency testing desk review and the laboratory ' s graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Routine Chemistry. Findings: 1. The following analytes had a score of 0% for Event 1 of 2020: Albumin, Alkaline Phosphatase, ALT/SGPT, Amylase, AST/SGOT, Bilirubin (total), Calcium (total), Chloride, Cholesterol (total), Creatine Kinase/CK, Glucose, LD/LDH, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid. 2. The following analytes had a score of 60% for Event 2 of 2020: Albumin, Alkaline Phosphatase, ALT/SGPT Amylase, AST/SGOT, Bilirubin (total), Calcium (total), Chloride, Cholesterol (total), Creatine Kinase/CK, Glucose, LD/LDH, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Urea Nitrogen, and Uric Acid. D2119 TOXICOLOGY CFR(s): 493.845(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a proficiency testing desk review and the laboratory ' s graded results from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Toxicology. Findings: Analyte Year Event Score Lithium 2020 1 0% Lithium 2020 2 60% -- 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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Digoxin. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(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. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review and the laboratory ' s graded results from the American Proficiency Institute, the laboratory failed to achieve satisfactory performance in three consecutive testing events for Digoxin. This is a subsequent unsuccessful participation for the analyte Digoxin. Findings: Analyte Year Event Score Digoxin 2019 3 40% Digoxin 2020 1 0% Digoxin 2020 2 60% 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 deficiencies cited under the Laboratory Director's responsibilities at and continued unsuccessful performance in proficiency testing, the laboratory director failed to provide overall management and direction for the laboratory. See 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 a proficiency testing (PT) desk review and the laboratory's PT results from the American Proficiency Institute, the Laboratory Director failed to ensure that the laboratory maintained successful participation in proficiency testing for the analyte Digoxin. This constitutes a subsequent unsuccessful participation for the analyte Digoxin. Findings: Analyte Year Event Score Digoxin 2019 3 40% Digoxin 2020 1 0% Digoxin 2020 2 60% -- 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 proficiency testing (PT) desk review, the laboratory failed to successfully participate in proficiency testing for the analytes Free TY and Digoxin. Refer to D2107 and D2118 D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Free TY between 2019 and 2020. Findings: 1. A review of the API PT results from 2019 event 2 revealed the laboratory received a score of 0% for the analyte Free TY. 2. A review of the API PT results from 2020 event 1 revealed the laboratory received a score of 0% for the analyte Free TY. D2118 TOXICOLOGY CFR(s): 493.845(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 proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance in two out of three consecutive testing events for Digoxin in 2019 to 2020. Findings: 1. A review of the API PT results from 2019 event 3 revealed the laboratory received a score of 40% for the analyte Digoxin. 2. A review of the API PT results from 2020 event 1 revealed the laboratory received a score of 0% for the analyte Digoxin. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to document the alarm system for the refrigerator where blood products are stored as stated in the procedure manual from April 2018 through December 2018. Findings: 1. A review of the laboratory documents for blood bank revealed the laboratory failed to inspect and record the alarm system during August and November 2018. 2. A review of the laboratory's alarm system check procedure revealed the laboratory staff failed to follow the procedure to check the alarm system February, May, August, and November. 3. An interview on February 28, 2019 at 1:45 PM, with the laboratory manager, confirmed the laboratory staff failed to follow the procedure to perform and record the blood storage refrigerator alarm system. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Based on the Tosoh AIA-360 prostate-specific antigen (PSA) reagent instructions, patient test report review, and an interview with the laboratory manager, the laboratory failed to follow the Tosoh manufacturer's instructions to include the test method for PSA on the patient's test reports from the dates reviewed in November 2018. Findings: 1. A review of the Tosoh AIA-360 PSA reagent instruction sheet revealed the laboratory failed to include the identity of the PSA assay to physicians for patient's PSA test results. 2. A review of patient #C00021R final test report on November 2018, revealed the report failed to include the identity of the PSA assay used as required by the manufacturer. 3. The laboratory performs approximately 735 PSA tests per year. 4. An interview on February 28, 2019 at 11:10 AM, with the laboratory manager, confirmed the identity of the PSA assay was not included on patient test reports. 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 an observation, a record review, and an interview with the laboratory manager, the laboratory failed to perform and document calibration verification procedures for blood gas analytes performed on the I-Stat since the last survey on August 16, 2017. Findings: 1. An observation on February 28, 2019 at 1:00 PM, revealed an I-Stat in use for the performance of blood gases. The laboratory tests approximately 150 a year. 2. A review of documents revealed the laboratory failed to perform and document calibration verification procedures for blood gases performed on the I-Stat since the last survey. 3. An interview on February 28, 2019 at 1:20 PM, with the laboratory manager, confirmed the laboratory failed to perform and document calibration verification activities for the blood gases. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures -- 2 of 4 -- that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to establish the number, type, and frequency of quality control testing materials used to monitor and detect immediate errors in blood gases performed on the I-Stat since the last survey on August 16, 2017. Findings: 1. A review of the laboratory's Individualized Quality Control Plan (IQCP) for blood gases performed on the I-Stat revealed the laboratory failed to identify the number, type, and frequency of quality control testing materials used to monitor the performance of the tests over time. 2. An interview on February 28, 2019 at 1:00 PM, with the laboratory manager, confirmed the laboratory failed to establish and identify the number, type, and frequency of quality control testing materials for blood gases in the IQCP. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on records review and an interview with the laboratory manager, the laboratory failed to check for a positive and negative reaction on each substrate of the gram- negative identification panel with each new lot number or shipment for the quality control performed in December 2018. Findings: 1. The laboratory performs approximately 2000 bacteriology cultures per year. 2. A review of quality control results in December 2018 for a new lot of Microscan gram-negative panels revealed the Cf8 and nitrate failed to show a positive and negative reaction for all organisms tested on the test system. 3. An interview on February 28, 2019 at 12:45 PM, with the laboratory manager, confirmed the two substrates were missing both a positive and negative reaction. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time -- 3 of 4 -- of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on patient record reviews, proficiency testing (PT) records, and an interview with the laboratory manager, the laboratory failed to record the dates and all the tests performed for microbiology culture specimens to include culture set-up on media, colony description and morphology, and the personnel who performed the testing from the period reviewed between June 2018 to February 2019. Findings: 1. A review of the American Proficiency Institute bacteriology PT worksheets from June 2018, revealed the laboratory failed to document the testing for microbiology culture procedures which include: a. the type of media used; b. the colony description, quantitation, and morphology; c. the individual performing each step of testing from streaking of the plate to final reporting; 2. The laboratory performs approximately 2000 microbiology cultures per year. 3. A review of patient test records in February 20, 2019, revealed the laboratory failed to identify the dates, testing personnel, and all steps of bacteriology tests performed on a throat culture. 4. An interview on February 28, 2019 at 12:45 PM, with the laboratory manager, confirmed the laboratory failed to document all steps of bacteriology tests performed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the laboratory manager, the final patient test reports failed to include the test report dates and the zip code of the laboratory which performed the test since the last survey on August 16, 2017. Findings: 1. A review of three patient test reports from June 2018, revealed the patient laboratory reports failed to include the date the test results were generated and failed to include the zip code of the laboratory. 2. An interview on February 28, 2019 at 11:10 AM, with the laboratory manager, confirmed the test report date and the zip code were not included on the patient's test report. -- 4 of 4 --