Jasper General Hospital

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 review of the Blood Bank Procedure Manual, the Retyping Log from 7/26 /18 through 11/9/20, and transfusion records from 2/1/19 through 2/13/21, the laboratory failed to follow its policy for confirmation of ABO Group and Rh Type for donor units of packed red blood cells (PRBC) for six units released for transfusion for three patients during this time frame. Findings include: Review of the Blood Bank Procedure Manual revealed the policy for confirmation of ABO Group and Rh Type states, "Each unit of blood that is received at Jasper General Hospital is immediately retyped to confirm the ABO and Rh of that unit." Review of the Retyping Log from 7 /26/18 through 11/9/20 and transfusion records from 2/1/19 through 2/13/21 revealed no documentation of retyping of six units released for transfusion for the following three patients: Patient #10000036 - Unit #W0671-19-032544-005 released for transfusion on 6/24/19 and Unit #W0671-19-036413-000 released for transfusion on 6 /25/19. Patient #3167 - Units #W0691-19-138394-000 and #W0691-19-123593-000 released for transfusion on 10/3/19. Patient #7003453 - Unit #W0691-19-140865-005 released for transfusion on 10/30/19 and Unit #W0691-19-144899-00W released for transfusion on 10/31/19. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the 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 -- 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: 1. Based on review of verification of performance specifications performed on the EPOC Blood Analysis system for blood gases on 11/14/18 and calibration verification records from 2/20/20 through 2/19/21, the laboratory failed to perform calibration verification on the EPOC Blood Analysis system at least every six months from 11/14 /18 until 2/20/20. Findings include: Review of verification of performance specifications performed on the EPOC Blood Analysis system for blood gases revealed calibration verification was performed at installation on 11/14/18. Review of calibration verification records from 2/20/20 through 2/19/21 revealed calibration verification was performed on blood gas testing on the EPOC Blood Analysis system on 2/20/20, 8/16/20, and 2/19/21. There was no documentation of performance of calibration verification from 11/14/18 until 2/20/20. Blood gas testing for pH, pCO2, and pO2 were performed on the EPOC system from May 2019, when the calibration verification was due, until 2/20/20 on the following four patients: Patient #6091 performed on 7/16/19. Patient #10088 performed on 9/12/19. Patient #12822 performed on 10/20/19. Patient #15026 performed on 11/21/19. 2. Based on review of calibration verification records for the TOSOH AIA-900 Immunoassay System since the last survey on 10/11/18 and confirmation by the technical consultant, the laboratory failed to perform calibration verification for prostate specific antigen (PSA) and ferritin tests, which have only two calibrators, at least every six months. Findings include: Review of calibration verification records for the TOSOH AIA-900 Immunoassay System since 10/11/18 revealed no documentation of performance of calibration verification for the PSA test since 2/28/20 and for the ferritin test since 8 /10/19. The technical consultant confirmed calibration verification has not been performed since those dates. 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 -- 2 of 3 -- 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: 1. Based on review of blood bank refrigerator continuous-monitoring temperature recorder graphs, blood bank refrigerator temperature logs, and transfusion records from 2/1/19 through 12/24/20, the laboratory failed to ensure blood for transfusion was stored under appropriate conditions for three weeks during this time frame, when six units of packed red blood cells (PRBC) were stored for transfusion and the seven- day graphs used during this time frame were not dated. Findings include: Review of blood bank refrigerator continuous-monitoring temperature recorder graphs from 10 /12/18 through 12/24/20 revealed there were no dated graphs from 4/13/19 through 2 /26/20. Review of transfusion records from 2/1/19 through 12/24/20 revealed six units of PRBC were transfused during this time frame to the following three patients: Patient #10000036 - 1 unit released from the laboratory for transfusion on 6/24/19 at 15:43 and 1 unit released for transfusion on 6/25/19 at 10:43. Patient #3167 - 1 unit released for transfusion on 10/3/19 at 16:32 and 1 unit released for transfusion on 10/3 /19 at 21:21. Patient #7003453 - 1 unit released for transfusion on 10/30/19 at 16:10 and 1 unit released for transfusion on 10/31/19 at 09:05. Review of the blood bank refrigerator temperature logs from 2/1/19 through 12/24/20 revealed the temperature of the blood bank refrigerator was manually recorded on the logs only once per day, which does not ensure continuous storage under appropriate conditions. 2. Based on review of blood bank refrigerator alarm checks since the last survey, 10/11/18, through 12/17/20 and the Blood Bank Procedure Manual, the laboratory failed to follow its established policy for semi-annual alarm checks to ensure blood and blood products were stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. Findings include: Review of the Blood Bank Procedure Manual revealed the Blood Bank Refrigerator Preventive Maintenance policy states the refrigerator alarm is checked semi-annually for high and low temperatures. Review of blood bank refrigerator alarm checks from 10/11/18 through 12/17/20 revealed no documentation of performance of blood bank refrigerator alarm checks from 10/11/18 until 3/2/20. -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/25/20, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts COMPATIBILITY TESTING: Year 2019 3rd Event 80% Year 2020 2nd Event 80% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the 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 -- analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/25/20, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Association of Bioanalysts COMPATIBILITY TESTING: Year 2019 3rd Event 80% Year 2020 2nd Event 80% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --