| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 01D0300027 | (X3) Date Survey Completed 07/28/2021 |
| Name of Provider or Supplier Bibb Medical Center | Street Address, City, State 208 Pierson Avenue, Centreville, AL | |
| For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency. | ||
| (X4) ID Prefix Tag | Summary Statement of Deficiencies |
| D2006 | TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing records and an interview with the General Supervisor, the laboratory failed to test the proficiency testing samples in the same manner as it tested patient specimens. This was noted on three out of eight 2018 - 2021 Chemistry - Core Proficiency Testing Events. The findings include: 1. A review of Proficiency Testing records revealed proficiency samples were performed twice before results were submitted to API. The samples were repeated, although they did not meet a repeat criteria. The following events had samples repeated: a) Chemistry - Core 2nd Event 2020: On 05/21/2020 the analytes were run on the UniCel DxC 600 used for patient testing (these were the results submitted to API) and a second run was performed on the UniCel DxC 600 (currently being validated). The API event cut off date was 06/01/2020. b) Chemistry - Core 3rd Event 2020: On 08/29/2020 the analytes were run on the UniCel DxC 600 used for patient testing (these were the results submitted to API) and on 09/09/2020 a second run was performed on the UniCel DxC 600 (currently being validated). The API event cut off date was 09/16/2020. c) Chemistry - Core 1st Event 2021: Amylase was out of reagent for UniCel DxC 600 used for patient testing, but the Amylase was run on the UniCel DxC 600 (currently being validated but not put in use for patient testing) and submitted to API. 2. During an interview on 07/27/2021 at 02:30 PM, the General Supervisor stated they were trying to validate the second UniCel DxC 600 and the instrument is currently not live for patient testing. |
| D2127 | HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the review of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with the General Supervisor, the surveyor determined the laboratory failed to submit proficiency testing results by the submission deadlines for Hematology/Coagulation testing for Event #1 2020. The laboratory scored zero percent (0%) for this event, due to the failure to timely submit the results. The findings include: 1. A review of the PT records revealed the due date to submit API proficiency testing results for the 1st Event 2020 was 03/27/2020. The label printed by the lab was dated 03/26/2020 on the package, but the package was post marked 03/29/2020 by the Post Office. 2. During an interview on 07/27/2021 at 1:30 PM, the General Supervisor stated the package was dropped off in a drop box on 03/26/2020 and later learned that items dropped in the drop box are not stamped by the Post Office. They go to the main office in Birmingham and would sit for several days due to COVID, resulting in this event being post marked on 03/29/2020. |
| D5407 | PROCEDURE MANUAL CFR(s): 493.1251(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 a review of the Individualized Quality Control Plan (IQCP) for MedTox and an interview with the General Supervisor, the Laboratory Director failed to approve the IQCP before used. The findings include: 1. A review of the IQCP revealed the Technical Supervisor signed the IQCP on 11/05/2019. 2. During an interview on 07/27/2021 at 03:15 PM, the General Supervisor stated they thought since the Technical Supervisor was a pathologist it had to be sign by them. |
| 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 a review of the iStat calibration verification records and an interview with Testing Personnel #7, the laboratory failed to perform calibrations verifications at least every six months as per CLIA regulations. This was noted on one out of four calibration verifications reviewed for 2019 - 2021. The findings include: 1. A review of the iStat records revealed no calibration verification in December of 2019. The previous calibration verification was performed on 07/12/2019 and the next calibration verification was performed on 06/28/2020. 2. During an interview at 1:45 PM on 07/28/2021, Testing Personnel #7 confirmed the laboratory did not performed calibration verification in December 2019. |
| 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 a review of the 2021 Chemistry quality control (QC) records for the Access 2 and an interview with the General Supervisor, the laboratory failed to ensure at least two levels of quality control were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted one day out of 3 months reviewed February 2019, September 2020, and March 2021 by the surveyor. The findings include: 1. A review of the QC records for the Access 2 analyzer revealed on 03/20/2021: a) Low control was run at 10:06 AM and within acceptable limits b) High control was not run on 03/20/2021 2. During an interview on 07/28/2021 at 2:00 PM, the General Supervisor confirmed the high control was not run on 03/20/2021. It was also confirmed one patient was run at 12:46 PM that day. |
| D5781 | CORRECTIVE ACTIONS CFR(s): 493.1282(b)(1) (b) The laboratory must document all corrective actions taken, including actions taken when any of the following occur: (b)(1) Test systems do not meet the laboratory's verified or established performance specifications, as determined in §493.1253(b), which include but are not limited to-- (b)(1)(i) Equipment or methodologies that perform outside of established operating parameters or performance specifications; (b)(1)(ii) Patient test values that are outside of the laboratory's reportable range of test results for the test system; and (b)(1)(iii) When the laboratory determines that the reference intervals (normal values) for a test procedure are inappropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of temperature logs and an interview with the General Supervisor, the laboratory failed to document corrective action when temperatures were not within acceptable limits. This was noted 18 days reviewed from January 2019 to June 2021. The findings include: 1. A review of temperature logs revealed the following days were outside of established range without corrective action documented: a) Refrigerator #1 (2 - 8 degrees Celsius) 1) 04/09/2020 - 8.5 degrees Celsius 2) 04/10/2020 - 8.6 degrees Celsius 3) 04/11/2020 - 8.1 degrees Celsius 4) 04/13/2020 - 8.3 degrees Celsius 5) 04/14/2020 - 8.5 degrees Celsius 6) 04/21/2020 - 8.1 degrees Celsius 7) 04/22/2020 - 8.1 degrees Celsius b) Refrigerator #2 (2 - 8 degrees Celsius) 1) 01/21/2020 - 8.1 degrees Celsius 2) 04/13/2020 - 8.2 degrees Celsius 3) 04/14/2020 - 9.0 degrees Celsius 4) 04/24/2020 - 8.1 degrees Celsius c) Freezer (< -20 degrees Celsius) 1) 06/10/2020 to 06/16/2020 range between -19 and -18 degrees Celsius 3. During an interview on 07/28/2021 at 12:30 PM, the General Supervisor stated corrective action should have been documented when temperatures were recorded outside of established ranges and confirmed the above dated did not have corrective action documented. |