Smp Health St Andrew's

Summary Statement of Deficiencies 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 observation, staff interview, and policy review, the laboratory failed to verify the manufacturer's performance characteristics for 1 of 1 new endocrinology test method (serum pregnancy) in 2023 before reporting patient results. The laboratory performed 47 patient tests with the new test kit since implementation on 05/13/23. Findings include: 1. Observation of the laboratory at 09:15 a.m. on 06/04/24 showed a Cardinal Health hCG (human chorionic gonadotropin) Combo Rapid Test available for patient pregnancy testing. 2. Upon request on 06/04/24, the laboratory failed to provide evidence of verification of performance characteristics for the new serum pregnancy testing method (Cardinal Health hCG Combo Rapid Test). 3. During interview at 3:55 p.m. on 06/04/24, a general supervisor (#1) confirmed the laboratory began patient testing using a new serum pregnancy test kit (Cardinal Health hCG Combo Rapid Test) on 05/13/23, and the laboratory did not verify the manufacturer's performance characteristics before patient testing began. 4. Reviewed on 06/04/24, the undated policy "Method Verification," stated, "Purpose: The laboratory must have written protocol and documentation for the validation of each method, which verifies patient correlation, accuracy, precision, reportable range, and reference range for each 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 -- new unmodified, moderate complexity test that the laboratory performs. The verification process helps to assure that the test . . . is performing as the manufacturer intended. . . ." 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 record review, staff interview, and policy review, the laboratory failed to perform a positive and negative control each day of patient testing for serum pregnancy tests for 4 of 5 patient testing days (04/03, 04/09, 04/30, and 05/23) in April-May 2024. The laboratory performed five serum pregnancy tests on days with no quality control (QC) performance in April-May 2024. Findings include: 1. Reviewed on 06/04/24, the patient testing records for serum pregnancy indicated performance of patient testing using the Cardinal Health hCG (human chorionic gonadotropin) Combo Rapid Test on the following days in April-May 2024: - 04/03 one patient test, - 04/09 one patient test, - 04/29 one patient test, - 04/30 two patient tests, and - 05/23 one patient test. 2. Reviewed on 06/04/24, the April-May 2024 QC records for serum pregnancy failed to include evidence of the performance of positive and negative controls on the following patient testing days: 04/03, 04/09, 04/30, and 05/23. 3. During interview at 3:55 p.m. on 06/04/24, a general supervisor (#1) confirmed the laboratory failed to perform QC each day of patient testing for serum pregnancy using the Cardinal Health hCG Combo Rapid Test. 4. Reviewed on 06/04 /24, the policy "General Quality Control (Includes Proficiency Test Policy)," revised 01/20/24, stated, "Characteristics of a good control Quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results. . . . Quality control material is usually run at the beginning of each shift . . . Quantitative/Qualitative QC Qualitative testing, [sic] is usually performed to determine the presence of a specific substance . . . Examples are pregnancy and Strep tests. The results are reported out as positive or negative. . . ." 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 record review, staff interview, and policy/procedure review, the laboratory -- 2 of 3 -- failed to include the units of measure for 2 of 2 random urine microscopic and prostate specific antigen (PSA) patient reports reviewed (Patients #15139 and #32243). The laboratory reported approximately 250 urine microscopic and 100 PSA patient test results since the start of a new electronic record system March 4, 2024. Findings include: 1. Reviewed on 06/04/24, the following random patient reports failed to include the units of measure: - Patient #15139 on 05/31/24 for PSA and - Patient #32243 on 06/06/24 for white blood cell and red blood cell quantified results. 2. During interview at 4:55 p.m. on 06/04/24, a general supervisor (#1) stated the laboratory began using a new electronic record system March 4, 2024 and confirmed the patient reports for PSA and urine microscopic results failed to include the units of measure. 3. Review of the following undated policies/procedures occurred on 06/04 /24: - "Microscopic Results Reporting," stated, ". . . Casts: Enumerate on low power. . . . RBC and WBC: Enumerate the average number/HPF [high power field] . . ." - "Prostate Specific Antigen ST AIA-PACK PA," stated, ". . . Calculation of Results . . . All the AIA Systems read the rate of fluorescence produced by the reaction and automatically convert the rate to Prostate Specific Antigen concentration in ng/mL [nanograms per milliliter]." 4. Reviewed on 06/04/24, the laboratory's general policy manual failed to include a policy defining the elements required for patient test reports. -- 3 of 3 --

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 American Proficiency Institute proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte thyroid stimulating hormone (TSH) for two consecutive events in 2023 (Events 1 and 2), resulting in unsuccessful performance. (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 proficiency testing record review and staff interview, the laboratory failed to achieve satisfactory performance in proficiency testing for the analyte thyroid stimulating hormone (TSH) in two consecutive events in 2023 (Events 1 and 2), resulting in unsuccessful performance. Findings include: 1. Review of 2023 American Proficiency Institute (API) proficiency testing reports on 06/29/23 for the analyte TSH revealed the following results: Event 1-2023 - 60% Sample Lab Results Acceptable Range #01 2.35 2.45 - 3.83 #02 0.20 0.22 - 0.36 #03 8.34 6.93 - 10.44 #04 3.06 2.49 - 3.93 #05 6.45 5.13 - 7.94 Event 2-2023 - 40% Sample Lab Results Acceptable Range #06 2.88 2.39 - 3.51 #07 7.77 4.86 - 7.14 #08 3.33 1.16 - 1.73 #09 5.51 6.19 - 8.85 Sample Lab Results Acceptable Range #10 4.53 4.19 - 6.21 The subspecialty of endocrinology requires a score of 80% or greater for satisfactory performance. 2. During a telephone interview at 10:50 a.m. on 06/29/23, the laboratory supervisor (#1) confirmed the laboratory had scored 60% in Event 1 and 40% in Event 2 in 2023 for TSH. -- 2 of 2 --

Summary Statement of Deficiencies D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on observation, staff interview, record review, and policy review, the general supervisor failed to ensure safe laboratory operations for 1 of 1 refrigerator alarm system (blood product refrigerator). Findings include: 1. Observation of the laboratory at 3:00 p.m. on 12/09/20 showed the laboratory had installed a new blood product refrigerator. 2. During interview at 3:00 p.m. on 12/09/20, a general supervisor (#1) stated the laboratory had installed a new blood bank refrigerator and alarm system on 02/26/20, but the laboratory had not checked the new blood bank refrigerator's alarm system since installation. General Supervisor #1 confirmed the laboratory should check the blood bank refrigerator alarm system and stated the laboratory had not developed a procedure for checking the new alarm system. 3. Review of the 2020 blood bank maintenance records at 4:15 p.m. on 12/09/20 indicated the laboratory had not checked the blood product refrigerator alarm system since installation on 02/26/20 (approximately nine months). 4. Reviewed at 4:55 p.m. on 12/09/20, the undated policy "Alarm Check (Blood Bank Refrigerator)," stated, "Principle To ensure proper function of blood bank audio alarm as well as the accuracy of the sensors which monitor temperature and trigger the alarm. . . ." This policy did not include the frequency for checking the alarm system. 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 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 record review, staff interview, and policy review, the laboratory failed to ensure the laboratory director signed the attestation statements for 11 of 15 (1-2017 immunohematology; 2-2017 core chemistry, hematology, immunohematology; 3- 2017 core chemistry, hematology, microbiology, immunohematology; 1-2018 core chemistry, hematology, and microbiology) proficiency testing events reviewed from January 2017 through March 2018. Findings include: 1. Reviewed at 1:40 p.m. on 04 /10/18, the January 2017 through March 2018 proficiency testing records lacked evidence the laboratory director or qualified designee signed the proficiency testing attestation statements for the following eleven events: 1-2017 immunohematology; 2- 2017 core chemistry, hematology, immunohematology; 3-2017 core chemistry, hematology, microbiology, immunohematology; 1-2018 core chemistry, hematology, and microbiology. 2. During an interview at 4:10 p.m. on 04/10/18, the laboratory supervisor (#1) confirmed the laboratory director or qualified designee had not signed the eleven proficiency testing attestation statements listed above. 3. Reviewed at 11: 15 a.m. on 04/11/18, the undated policy "General Quality Control (Includes Proficiency Testing Policy)," failed to include a requirement for the laboratory director or qualified designee to sign the proficiency testing attestation statements. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- 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 record review, staff interview, and policy review, the laboratory failed to verify the reportable range for 2 of 4 urine chemistry analytes (creatinine and sodium) on the new Ortho Vitros 4600 chemistry analyzer in 2016. The laboratory performed approximately 245 urine creatinine patient tests since implementation on 10/01/16 and 4 urine sodium patient tests since implementation on 02/02/17. Findings include: 1. Reviewed at 7:05 a.m. on 04/11/18, the laboratory's 2016 performance specification verification records for the new Ortho Vitros 4600 chemistry analyzer lacked evidence the laboratory verified the reportable range for urine creatinine and urine sodium. 2. During interview at approximately 9:45 a.m. on 04/11/18, the laboratory supervisor (#1) confirmed the laboratory performed patient testing for urine creatinine and urine sodium on the Ortho Vitros 4600 chemistry analyzer and had not verified the reportable range. 3. Reviewed at approximately 12:15 p.m. on 04/11/18, the undated policy "Method Verification," stated, ". . . Reprotable [sic] Range (Linearity) The laboratory is responsible for verifying the reportable range of patient test results of each test system. . . ." 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 record review and staff interview, the laboratory failed to verify calibration for 1 of 1 Ortho Vitros 4600 analytes (chloride) calibrated with less than three calibrators at least once every six months in 2017. Findings include: 1. Reviewed at -- 2 of 3 -- approximately 7:30 a.m. on 04/11/18, the Ortho Vitros 4600 calibration records indicated the laboratory used two standards to calibrate chloride. 2. Reviewed the morning of 04/11/18, the 2017 calibration verification records lacked evidence the laboratory verified calibration for chloride in 2017. 3. Upon request on 04/11/18, the laboratory failed to provide evidence of calibration verification for chloride in 2017. 4. During interview at approximately 8:30 a.m. on 04/11/18, the laboratory supervisor (#1) stated the laboratory used two standards for calibration of chloride and confirmed the laboratory had not verified calibration of chloride in 2017. 5. Upon request on 04 /11/18, the laboratory did not provide a policy regarding calibration verification requirements. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the technical consultant failed to include the Biosite Triage Meter analyzer in the annual competency evaluation for 1 of 2 sampled testing personnel (#1) in 2017. Findings include: 1. Reviewed at 4:30 p.m. on 04/10/18, the 2017 competency evaluation records for Testing Personnel #1 lacked evidence of a completed competency evaluation for the BiositeTriage Meter analyzer. 2. During an interview at 9:45 a.m. on 04/11/18, the laboratory supervisor (#1) confirmed the competency evaluation for Testing Personnel #1 in 2017 did not include the Biosite Triage Meter analyzer. 3. Reviewed at 11:15 a. m. on 04/11/18, the policy "Laboratory Job Descriptions," revised 8/06/08, stated, ". . . Job Title: Technical Supervisor . . . Responsibilities . . . 9. Evaluating and documenting the performance of individuals responsible for high complexity testing . . . evaluations must be performed at least annually . . ." -- 3 of 3 --