Memorial Hospital Of Carbon County

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the technical supervisor and general supervisor's competency assessment had been completed for 2 of 2 years (2022, 2023) reviewed. The findings were: 1. Review of the personnel file of the technical and general supervisor showed no evidence a competency assessment had been completed in 2022 or 2023. 2. Interview with the technical/general supervisor on 10/8/24 at 3 PM confirmed a competency assessment had not been completed. 3. Review of the "Personnel Competency and Records" policy showed "...G. The performance of section directors/technical supervisors, general supervisors, and technical consultants is assessed and satisfactory. NOTE: All responsibilities of the section directors...must be delegated by the laboratory director in writing. Unsatisfactory performance must be addressed in a

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing records, review of the CMS (Center for Medicare and Medicaid Services) 209 Laboratory Personnel Report, and staff interview, the laboratory failed to include the respiratory therapists in the rotation of personnel performing blood gas (pH, partial pressure of oxygen, partial pressure of carbon dioxide) testing for 3 of 3 proficiency testing events reviewed from September 2021 through September 2022. The laboratory performed approximately 365 patient blood gases per year. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report dated 9/19/22 showed 4 respiratory therapists were listed as testing personnel performing moderate complexity testing. 2. Review of the 3 American Proficiency Institute Chemistry Core Proficiency testing events from September 2021 through September 2022 showed the blood gas section of the events was performed by laboratory personnel which did not include the respiratory therapists. 3. Interview with the technical supervisor and the respiratory therapist supervisor on 9/27/22 at 3: 47 PM revealed blood gas testing was shared between the respiratory therapists and the laboratory staff using the Abbott iSTAT analyzer. 4. Interview with the laboratory director on 9/27/22 at 3:56 PM confirmed the respiratory therapists had not participated in the proficiency testing events. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel files, review of the CMS (Center for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the technical supervisor failed to complete competency assessment for 4 of 4 respiratory therapists (RT #1, RT #2, RT #3, RT #4) as required for 2 of 2 years reviewed (2021, 2022). The findings were: 1. Review of the laboratory's personnel files showed the following concerns: a. Review of the personnel file for RT #1 showed an initial competency assessment was completed in March 2021 and a 6-month competency assessment in October 2021. There was no evidence an annual competency assessment had been completed. b. Review of the personnel file for RT #2 showed the RT had been trained on the Abbott iSTAT analyzer in July 2020 and a 6-month competency assessment had been completed in October 2021. There was no evidence an annual competency assessment had been completed. c. Review of the personnel file for RT #3 showed an initial competency assessment had been completed on 1/4/22. There was no evidence a 6- month competency assessment had been completed. d. Review of the personnel file for RT #4 showed an initial competency assessment had been completed in March 2021 and a 6-month competency assessment had been completed in December 2021. There was no evidence an annual competency assessment had been completed. 2. Interview with the technical supervisor on 9/27/22 at 3:15 PM revealed the respiratory therapists had started performing blood gas patient testing in May of 2021 using the Abbott iSTAT instrument. In addition, the technical supervisor confirmed the competency assessments had not been completed as required. 3. Review of the Personnel Competency and Records policy showed "...For nonwaived testing: During the first year of an individual's duties, competency must be assessed at least semiannually. After an individual has performed his/her duties for one year, competency must be assessed at least annually..." 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 review of the laboratory's test menu, lack of documentation, and staff interview, the laboratory failed to at least twice annually verify the accuracy of the C- reactive protein (CRP) analyte for 13 months of testing reviewed. The laboratory performed approximately 534 CRP patient tests annually. The findings were: 1. Review of the laboratory's test menu showed the laboratory performed CRP testing. 2. Review of the laboratory's records showed no evidence the analyte of CRP had been verified for accuracy at least twice annually. 3. Interview with the laboratory director on 9/27/22 at 2:21 PM confirmed the laboratory had not verified the accuracy of the CRP analyte as required. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) -- 2 of 5 -- 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 review of calibration verification records, lack of documentation and staff interview, the laboratory failed to verify the reportable range at least every 6 months using testing materials with values at the zero or minimal level, the mid-level, and the upper-level of the reportable range for Troponin I, enzymatic carbon dioxide (CO2), alcohol, ammonia, iron, uric acid, urine total protein, urine creatinine, free thyroxine (FT4), vitamin B-12, total bilirubin, direct bilirubin, prostatic-specific antigen (PSA), creatinine kinase-MB (CKMB), hemoglobin A1C, beta-human chorionic gonadotropin (BhCG), alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), creatinine kinase (CK), and lipase on the Roche Cobas 6000. In addition, the laboratory failed to verify the reportable range for blood gases (pH, partial pressure of oxygen, partial pressure of carbon dioxide) analyzed on the Abbott iSTAT instrument for 2 of 2 years of testing (2021, 2022). The laboratory performed approximately 32,787 tests on the Roche Cobas analyzer and 365 blood gases on the Abbott iSTAT analyzer annually. The findings were: 1. Review of the laboratory's records showed a calibration verification study had not been completed on the Abbott iSTAT instrument for the analytes of pH, partial pressure of oxygen, partial pressure of carbon dioxide) since the implementation of the instrument in May 2021. 2. Review of the laboratory's records showed the following concerns related to the Roche 6000 analyzer: a. CO2, alcohol, ammonia, iron, uric acid, urine total protein, urine creatinine, total bilirubin and direct bilirubin was missing the 2021 calibration verification studies. b. The last completed calibration verification studies for Troponin I, BhCG, and Vitamin B-12 were completed in November 2021. c. A calibration verification study was completed for FT4 and CKMB in January 2021 and January 2022. d. The last completed calibration verification study for PSA was completed on 1/13/22. e. The last completed calibration verification study for hemoglobin A1C was completed on 12/3/21. f. The last completed calibration verification study for ALP, ALT, amylase, AST, CK and lipase was completed on 12/3/21. 3. Interview with the technical supervisor (TS) on 9 /28/22 at 10:21 AM revealed the laboratory did not have a system in place to ensure the calibration verification studies were completed as required. In addition, the TS confirmed calibration verification studies on the Abbott iSTAT instrument had not -- 3 of 5 -- been completed. 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 review of patient testing records, review of quality control (QC) records, lack of documentation, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the laboratory failed to perform two levels of control once a month, with a new shipment, or with a new lot number for 3 of 5 months of testing reviewed (May 2022 through July 2022) for patient blood gas (pH, partial pressure of carbon dioxide, partial pressure of oxygen) testing using the Abbott iSTAT instrument. This failure affected 9 patient samples (#3437475, #3440101, #3437077, #3436401, #3436678, #3436549, #3435724, #3436390, #3435537). The findings were: 1. Review of patient testing records showed the following concerns: a. Blood gases were performed on patient #3437077 on 5/27/22; #3436401 on 5/15/22; #3436678 on 5/20/22; #3436549 on 5/19/22; #3436390 on 5/14/22 at 3:11 PM and at 4:54 PM; #3440101 on 7/27/22 and 7/28/22; using reagent lot number 23D213390243. Review of the QC records showed QC was performed on 5/6/22; however, the analyte of partial pressure of carbon dioxide (pCO2) on the level 1 control was outside of the acceptable QC range. There was no evidence the failure of pCO2 was investigated. b. Blood gases were performed on patient #3435537 on 5/1 /22; #3435724 on 5/4/22; and #3437475 on 6/5/22 using reagent lot number 230212920243. Review of the QC records showed QC had not been performed on the lot number until 6/7/22. 2. Review of the IQCP, last reviewed on 8/10/22, showed external QC must be performed with each new lot number or shipment or every 30 days. 3. Review of a QC variance form dated 7/18/22 showed the failure of the pCO2 analyte on 5/6/22 had been noted; however no

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on qualify control records reviewed as documentation of

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on direct observation on 11/10/2020 at approximately 8:10 A.M., procedure manual review and interview with staff, the laboratory failed to follow the laboratory procedure to positively identify blood product recipients. See D3023. . D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: . Based on direct observation, procedure manual review, and interview with staff, the laboratory failed to follow their procedure to ensure positive identification of a blood product recipient for 1 of 1- 3 unit crossmatch awaiting transfusion on 11/10/2020. Findings include: 1. During direct observation at approximately 8:00 A.M. on 11/10 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 -- /2020, segregated units of blood were observed to be crossmatched and awaiting possible transfusion for patient MR130018/ accession number 3405749. The 3 units of packed red blood cells included a blood bank arm band bracelet attached to the unit of packed red blood cells. 2. The patient's specimen for cross match observed did not include the green sticker labeled from the armband; rather the laboratory printer generated label. 3. Blood Bank procedure manual review included instructions for the blood bank arm band bracelet to be attached to the patient and for removing the top sticker to be placed on the specimen collected from the patient at the time of collection. The removable sticker from the armband contained the identical information as was pressure copied on to the arm band bracelet to ensure the specimen undoubtedly belonged to the banded patient and to the specimen used for crossmatching. 4. In an interview with staff conducted on 11/10/2020 at approximately 8:10 A.M., staff stated the procedure was not followed due to the patient being an outpatient and outpatient's could not be trusted to keep the arm band bracelet on when outside of the hospital. Without the positive and continuous identification of the patient to the specimen and units crossmatched the chain of the identification process could not be maintained. . D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of