Jackson Medical Center

CLIA Laboratory Citation Details

5
Total Citations
27
Total Deficiencyies
24
Unique D-Tags
CMS Certification Number 01D0305356
Address 220 Hospital Drive, Jackson, AL, 36545
City Jackson
State AL
Zip Code36545
Phone(251) 246-9021

Citation History (5 surveys)

Survey - April 23, 2025

Survey Type: Standard

Survey Event ID: IPF311

Deficiency Tags: D5415 D5417 D5429 D5447

Summary:

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations during the laboratory tour, reviews of the package insert for the Hematology Quality Controls (QC) and Triage test cartridges, and an interview with the General Supervisor (GS), the laboratory staff failed to: (1) write the new expiration dates on the three levels of the Complete Blood Count (CBC) and Retic QC vials currently in use; and (2) record the new expiration for Triage D-Dimer cartridges when transferred from the refrigerator to room temperature for patient testing. The findings include: 1. During the laboratory tour on 04-22-2025 at approximately 8:16 AM the surveyor observed the three levels of the CBC and Retic Controls in use. The testing personnel had failed to record the new expiration date after the vials were opened. 2. As the laboratory tour continued, the surveyor observed room temperature D-Dimer test cartridge pouches with "04/18/25", the date when the packages were removed from the refrigerator. The testing personnel failed to record the new expiration date for test cartridges stored at room temperature. 3. A review of package inserts for the Hematology Controls and the Triage D-Dimer cartridges revealed the following: A) Hematology CBC and Retic QC - stable for 16 open vial days B) Triage Test Cartridges: Storage and Handling Requirements, "Once removed from refrigeration, the pouched Test Device is stable up to 14 days at room temperature..." 4. GS confirmed the above findings during the Day 2 exit conference on 04-23-2025 at 2:48 PM. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observations of the Beckman Coulter Bicarbonate Calibrator (BCBC) bottles, an interview with the General Supervisor (GS) and a review of Instructions for Use (IFU), the surveyor determined the laboratory had utilized expired calibrators prior to patient testing. The surveyor noted two of the two levels of calibrators were utilized for 27 days after expiration. The findings include: 1. During the Chemistry laboratory tour with the GS at approximately 8:21 AM, the surveyor observed the BCBC, Levels 1 and 2, Lot number 2763 with a manufacturer's expiration date of 08- 11-2025, and open date 02-25-2025. The new expiration date upon opening was not written on the bottles. 2. During the tour, a discussion about the BCBC open stability requirement prompted the GS to show the surveyor a posted reminder (30-day expiration after opening) attached to the analyzer. However, the testing personnel had failed to follow the requirement and record the new open expiration date. 3. A review of the BCBC IFU verified the 30-day open stability requirement. The laboratory utilized the BCBC, Lot number 2763 for 27 days after the calibrators had expired on 03-27-2025 until the date of the current survey on 04-22-2025. 4. The GS confirmed the above findings during the Day 2 exit conference on 04-23-2025 at 2:48 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Chemistry maintenance records, the Policy and Procedure Manuals (PPM) for Beckman Coulter AU 700 and Access 2 and an interview with the General Supervisor (GS), the laboratory failed to provide documentation of the Annual Preventive Maintenance (APM). The surveyor noted one of the two APM for the two analyzers had no documentation from 2023-2024 The findings include: 1. A review of the 2023-2024 Chemistry maintenance records for the Beckman Coulter AU 700 and Access 2 analyzers revealed no documentation for the 2023 APM. 2. A review of the PPM for the Beckman Coulter AU 700 and Access 2 revealed the laboratory's policy required an annual maintenance performed. 3. During an interview on 04-23-2025 at 2:48 PM, the GS confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on reviews of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) Quality Control (QC) logs, the ACL Elite analyzer patient result logs, and an interview with the General Supervisor (GS), the laboratory failed to ensure two levels of QC were performed and documented before patient testing. The surveyor noted no QC was performed on one day of patient testing in July 2023. The findings include: 1. A review of the PT and APTT QC logs revealed the laboratory failed to perform the required QC prior to patient testing on 07-01-2023. One patient testing was performed. 2. During an interview on 04-23-2025 at 2:48 PM, the GS confirmed the above findings. -- 3 of 3 --

πŸ”’ Unlock Deficiency Summary

Get full access to the detailed deficiency summary for this facility

One-time payment β€’ Lifetime access

Survey - February 20, 2025

Survey Type: Special

Survey Event ID: V7YO11

Deficiency Tags: D0000 D2016 D2162 D6000 D6016

Summary:

Summary Statement of Deficiencies D0000 The following deficiencies are a result of an off-site desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director . 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for ABO Group Testing, analytes in the specialty of Immunohematology. The laboratory failed two out of three API PT events in 2024, resulting in initial unsuccessful proficiency testing performance. Refer to D2162. . D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) (f) 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 100%) in proficiency testing for ABO Group Testing. The laboratory failed two out of three PT events in 2024, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for ABO Group Testing in two out of three API PT events, as follows: A) 2024 Immunohematology / ABO Group--Event #1: 80% B) 2024 Immunohematology / ABO Group--Event #3: 60% 2. A review of the laboratory's proficiency testing results from API confirmed the above findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports -- 2 of 3 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for ABO Group Testing in two out of three 2024 API PT events. Refer to D2162. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

πŸ”’ Unlock Deficiency Summary

Get full access to the detailed deficiency summary for this facility

One-time payment β€’ Lifetime access

Survey - June 7, 2023

Survey Type: Standard

Survey Event ID: 08V511

Deficiency Tags: D2089 D5217 D5439 D6053 D6054

Summary:

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with the General Supervisor, the laboratory failed to participate in Proficiency Testing for Routine Chemistry. This was noted for one out of four Chemistry events reviewed from November 2021 to the date of the current survey, 6/7/2023. The findings include: 1. A review of American Proficiency Institute PT records revealed the laboratory scored 0% on all analytes for 2023 Chemistry 1st due to failure to submit results within the time frame established by the PT provider. No documentation of additional accuracy verification was available for review. 2. During an interview on 6 /6/2023 at 2:00 PM, the General Supervisor confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of Beckman Coulter Access 2 validation records, a review of American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the General Supervisor, the laboratory failed to verify the accuracy of Vitamin B12 and Folate at least twice annually. This was noted for one out of one Chemistry Proficiency Testing events reviewed since the implementation of these analytes. The findings include: 1. A review of validation records revealed the laboratory added Vitamin D, Vitamin B12, Folate, and Parathyroid Hormone (PTH) to the testing menu of the Beckman Coulter Access 2 as of 11/30/2022. 2. A review of API records revealed Vitamin D and PTH were added to the laboratory's PT menu, however, Vitamin B12 and Folate were not added. 3. During an interview on 6/6/2023 at 2:00 PM, the General Supervisor confirmed Vitamin B12 and Folate were not added to the 2023 PT order, and the laboratory had not implemented another mechanism to verify semi-annually the accuracy of these non-regulated Chemistry analytes. 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 OPTI CCA-TS2 Calibration Verification records, a review of RNA Medical CVC 123 Calibration Verification Controls package insert, and an interview with the General Supervisor, the laboratory failed to perform Calibration Verification procedures according to manufacturer's instructions. This was noted for three out of three calibration verifications reviewed. The findings include: 1. A review of OPTI CCA-TS2 Calibration Verification records revealed one run of five levels of CVC 123 controls for pH, pCO2, and pO2 on 6/8/2022, 6/29/2022, and 1/12/2023. 2. A review of the CVC 123 Calibration Verification Controls package insert revealed the following: "...Repeat steps 2 through 5 for the remaining ampoules of Level 1 until -- 2 of 3 -- three replicates are completed...Test Levels 2, 3, 4, and 5 the same way..." 3. During an interview on 6/7/2023 at 11:30 AM, the General Supervisor confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the General Supervisor, the Technical Consultant failed to evaluate competency for Testing Personnel at least semiannually within the first year of patient testing. This was noted for one out of two new Testing Personnel that would be eligible to have a semiannual competency assessment performed since the date of the previous survey (11/21/21). The findings include: 1. A review of Personnel records for Testing Personnel #6 revealed only documentation of initial training, dated 10/3/2022. There was no record of the semiannual competency assessment due the first half of 2023 for Testing Personnel #6. 2. During an interview on 6/6/2023 at 12:00 PM, the General Supervisor confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with the General Supervisor (also Testing Personnel #7), the Technical Consultant failed to perform and document the annual competency for one out of three Testing Personnel previously qualified during the last survey (11/21/21). The findings include: 1. A review of Personnel records for Testing Personnel #7 (also the General Supervisor) revealed no documentation of the 2022 annual competency assessment. The laboratory only provided the most recent competency evalulation, dated 6/5/2023. 2. During an interview on 6/6/2023 at 12:00 PM, the General Supervisor confirmed the above findings. -- 3 of 3 --

πŸ”’ Unlock Deficiency Summary

Get full access to the detailed deficiency summary for this facility

One-time payment β€’ Lifetime access

Survey - November 3, 2021

Survey Type: Standard

Survey Event ID: 7ZB711

Deficiency Tags: D2000 D5217 D5439 D5447 D6103

Summary:

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification and an interview with the General Supervisor, the laboratory failed to enroll in a proficiency testing (PT) program for Chemistry - Endocrinology Human Chorionic Gonadotropin (hCG) (this is a regulated moderate-complexity test). This was noted from the previous survey (January 2019) to the current survey (November 2021). The findings include: 1. A review of the Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification revealed the test menu included Human Chorionic Gonadotropin (hCG) performed on the Beckman Coulter Access II analyzer. 2. During an interview on 11 /02/2021 at 02:20 PM, the General Supervisor confirmed the laboratory was not enrolled in PT for hCG; patient testing was performed, starting in 2019 thru November 2021. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the Laboratory Director, the laboratory failed to verify the accuracy of Urine Sediment, Vaginal Wet Prep, Vaginal Wet Prep KOH (potassium hydroxide), and direct antiglobulin test (DAT) at least twice annually. This was noted from the previous survey in 2019 thru November 2021. The findings include: 1. A review of the Urine Sediment records, Vaginal Wet Prep records, Vaginal Wet Prep KOH records, and DAT records revealed a lack of accuracy verification performed at least twice annually. 2. During an interview on 11/02/2021 at 2:20 PM, the General Supervisor confirmed the above test did not have accuracy verification at least twice annually from the previous survey in 2019 thru November 2021. 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 OPTI CCA-TS2 Blood Gas calibration verification records and an interview with the General Supervisor, the laboratory failed to perform calibrations verifications at least every six months as per CLIA regulations. The laboratory missed performing one of three calibration verifications due during the review period of 06/19/2020 (installation of the instrument) thru November 2021. The findings include: 1. A review of the OPTI CCA-TS2 Blood Gas calibration verification records revealed no calibration verification in July of 2021. The previous calibration verifications were performed on 06/19/2020 and 01/11/2021. 2. During an interview on 11/02/2021 at 4:00 PM, the General Supervisor confirmed the laboratory had not performed calibration verification since 01/11/2021. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) -- 2 of 4 -- 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 Chemistry quality control (QC) records for the Access 2 analyzer, Coagulation QC for the ACL Elite analyzer, 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 two days out of 6 months reviewed from March 2019 to August 2021 for Coagulation. For Chemistry this was noted ten days out of 5 months reviewed from March 2019 to September 2021. The findings include: 1. A review of the QC records for the Access 2 analyzer revealed the following: a) Free Thyroxine (FRT4) i) 10/28/2019 (6 patients run) and 10/31/2019 (4 patients run); Level 1 control was not run ii) 01/20/2020 (4 patients run), 01/21/2020 (2 patients run), 01/28/2020 (1 patient run), and 01/31/2020 (2 patients run); Level 1 was not run (except 01/28/2020 when Level 1 was unacceptable) iii) 09/09/2021 (1 patient run); Level 2 was unacceptable b) Human Chorionic Gonadotropin (hCG) i) 10/12/2019 (1 patient run); Level 1 was not run ii) 01/22/2020 (1 patient run); Level 1 was not run c) Prostate- Specific Antigen (PSA) i) 10/28/2019 (4 patients run); Level 1 was not run ii) 01/20 /2020 (1 patient run), 01/21/2020 (2 patients run), 01/28/2020 (3 patients run), and 01 /31/2020 (3 patients run); Level 1 was not run (except 01/28/2020 when Level 1 was unacceptable) iii) 09/04/2021 (1 patient run); Level 2 was unacceptable d) Thyroid- Stimulating Hormone (TSH) i) 01/20/2020 (11 patients run), 01/21/2020 (9 patients run), 01/28/2020 (15 patients run), and 01/31/2020 (7 patients run) Level 1 was not run (except 01/28/2020 Level 1 was unacceptable). 2. A review of the QC records for ACL Elite analyzer revealed the following: a) 03/24/2019-Partial thromboplastin time (PTT) Level 1 was unacceptable (two patients run) b) 08/07/2021-Partial thromboplastin time (PTT) Level 1 was unacceptable (one patient run). 2. During an interview on 11/03/2021 at 11:35 AM, the General Supervisor confirmed the above findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a review of personnel records and interview with the General Supervisor, the Laboratory Director failed to ensure semi-annual and annual competency evaluations assessed the six specific skills required by CLIA for testing personnel in the laboratory. This was noted on eight of eight Testing Personnel (TP) listed on the CMS-209 Form. The findings include: 1. A review of personnel records revealed -- 3 of 4 -- competency for laboratory testing personnel was assessed using the "Position Description / Performance Evaluation". This form was a general Human Resources assessment form; there was no semi-annual and annual competency evaluation of skills required by CLIA for testing personnel for each testing system used in the laboratory. The 6 skills required by CLIA are the following: a) direct observation of routine patient test performance, b) monitoring the recording and reporting of test results, c) review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records, d) direct observation of performance of instrument maintenance and function checks, e) assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples, and f) assessment of problem solving skills. 2. During an interview on 11/02/2021 at 12:45 AM, the General Supervisor confirmed the above findings. -- 4 of 4 --

πŸ”’ Unlock Deficiency Summary

Get full access to the detailed deficiency summary for this facility

One-time payment β€’ Lifetime access

Survey - June 6, 2018

Survey Type: Standard

Survey Event ID: I61W13

Deficiency Tags: D5413 D5437 D5555 D5791 D6083 D6093 D6094 D6095

Summary:

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --

πŸ”’ Unlock Deficiency Summary

Get full access to the detailed deficiency summary for this facility

One-time payment β€’ Lifetime access