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Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/18,19,20/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and the technical consultant at the conclusion of the survey. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, nursing policy, and interview with the laboratory manager, the facility failed to ensure written policies were followed for preventing transfusion reactions for four of four units of packed red-blood cells transfused. Findings include: (1) On 02/19/2025 at 11:55 am, the laboratory manager stated blood transfusions were performed by nursing staff; (2) A review of the hospital policy titled, "Blood Administration and Blood Component Administration" stated: (a) "Vital signs are taken immediately prior to infusing the blood" (b) "Every 15 minutes for four times, then" (c) "Every hour for the remainder of the transfusion." (3) A review of transfusion records for four units transfused, identified the policy had not been followed for four of four units as follows: (a) Unit #W091024426357 - The transfusion started on 01/27/2025 at 09:04 pm and ended at 11:30 pm. The 15 minute vital signs had not been taken as follows; (i) Between 09:19 pm and 09:49 pm. (b) Unit #W091025107315 - The transfusion started on 01/27/2025 at 11:58 pm and ended at 02:20 am. The 15 minute vital signs had not been taken as follows; (i) Between 12:15 am and 12:45 am. (c) Unit #W091024422261 - The transfusion started on 12/08/2024 at 01:50 am and ended at 03:30 am. The 15 minute vital signs had not 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 -- been taken as follows; (i) Between 02:00 am and 02:30 am. (d) Unit #W091024423754 - The transfusion started on 01/03/2025 at 03:10 am and ended at 06:60 am. The 15 minute vital signs had not been taken as follows; (i) Between 03:25 am and 03:55 am. (4) The records were reviewed with the laboratory manager who stated on 02/19/2024 at 11:55 am, the vital signs had not been documented according to policy. 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 observation and interview with the laboratory manager, the laboratory failed to label 24 of 24 aliquots of Bio-Rad Liquichek Specialty Immunoassay Control with the expiration date, and lot number of the contents. Findings include: (1) On 2/18 /2025 at 11:35 am, the laboratory manager stated that the laboratory performed parathyroid hormone testing on the Ortho Vitros 7600 analyzer; (2) Observation on 02 /18/2025 at 11:35 am identified a Styrofoam test tube flat with 1 ml sample cups and lids inside the Thermo Freezer; (3) Interview with the laboratory manager identified the cups contained frozen aliquots of Bio-Rad Liquichek Specialty Immunoassay Control materials; (4) A review of the product package insert stated, "once thawed, opened, and stored in tightly capped aliquot vials at -20 to -70 degrees Celsius, this product will be stable as follows: All analytes: 30 days"; (5) The findings were reviewed with the laboratory manager who on 02/18/2025 at 11:35 am stated the aliquots had not been labeled with the contents, expiration date, and lot number. 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 a review of records and interview with the laboratory manager and technical consultant, the laboratory failed to ensure reagents had not exceeded their expiration date for 2 of 62 days of patient testing. Findings include: (1) On 02/20/2025 at 09:50, the laboratory manager stated Crossmatch testing was performed in the laboratory which included ABO/Rh typing and antibody screening using the Ortho tube method; (2) On 02/20/2025, A review of quality control and patient testing records for testing performed from 01/01/2024 through 12/31/2024 identified expired Affirmagen and Coombs reagents had been used two of 62 days of testing reviewed as follows: (a) Ortho Affirmagen, lot #A770, expiration date 03/05/2024 with patient testing performed on 03/07/2024; (b) Ortho Coombs reagent, lot #K931, expiration date 01/30 -- 2 of 4 -- /2024 with patient testing performed on 02/01/2024. (4) This was reviewed with the technical consultant who stated on 02/20/2025 at 12:05 expired reagents had been used as indicated above. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the general supervisor, the laboratory failed to comply with 21 CFR 606.160(b)(3)(v). The laboratory failed to ensure that emergency release of blood forms had been signed by the physician for four of five emergency releases reviewed. Findings include: (1) On 02/19/2025 at 9:00 am, the general supervisor stated the laboratory maintained units of (PRBC's) packed red blood cells. The units were to be used for patient transfusions; (2) On 02/19/2025 a review of the form titled, "Emergency Transfusion Request and Release" required an Emergency Transfusion Request and Release form be completed which stated, "As per an emergency request based upon (a) the stated allowable time before issuance for pre-transfusion testing, (b) the availibility of a patient's blood sample". The form included a space for the medical provider's signature; (3) A review of documentation of emergency issue identified the following for four of five patient records: (a) One unit of O negative packed red blood cells had been released to a patient on 01/03/2025. The "Emergency Transfusion Request and Release" form appeared to be signed by a mid-level provider and not a physician; (b) One unit of O negative packed red blood cells had been released to a patient on 12/10/2023. The "Emergency Transfusion Request and Release" form appeared to be signed by a mid- level provider and not a physician; (c) One unit of O positive packed red blood cells had been released to a patient on 02/01/2024. The "Emergency Transfusion Request and Release" form appeared to be signed by a mid-level provider and not a physician; (d) One unit of O negative packed red blood cells had been released to a patient on 11 /22/2024. The "Emergency Transfusion Request and Release" form appeared to be signed by a mid-level provider and not a physician; (4) The documentation was reviewed with the laboratory manager who stated on 02/19/2025 at 9:00 am, the emergency releases had not been signed by a physician. 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 a review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for one of six chemistry core proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 02/18/2025, a review of 2023 and 2024 proficiency testing events identified an attestation statement that had been signed after -- 3 of 4 -- the graded evaluation was completed by the proficiency testing program for one of six chemistry core events reviewed: (a) Third Chemistry Core Event 2023 - The graded evaluation was completed on 09/28/2023 and the attestation statement had not been signed by the laboratory director until 10/14/2023. (2) The records were reviewed with the laboratory manager who stated on 02/18/2025 at 01:10 pm the attestation statements had not been signed timely as stated above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/18,19,20/2023 The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and technical consultant #2 at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the laboratory manager and technical consultant #2, the laboratory failed to have a written policy to assess the competency of the general supervisors, based on the position responsibilities as listed in Subpart M, for six of six persons serving as general supervisor. Findings include: (1) On 04/18/2023 a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the general supervisors, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of June 2021 through the current date identified competencies, based on job responsibilities, had not been performed for six of six persons listed as general supervisor on Form CMS-209; (3) The findings were reviewed with the laboratory manager and technical consultant #2. Both stated on 04/18/2023 at 02:49 pm a policy had not been written and competencies had not been performed for the general supervisors. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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 -- The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, review of written policies, and interview with the laboratory manager, the laboratory failed to have policies to ensure positive identification of one of one peripheral blood smear slide for manual differential testing. Findings include: (1) On 04/18/2023 at 11:35 am, the laboratory manager stated manual differential testing was performed in the laboratory; (2) On 4/20/2023 at 09:20 am, observation of the Hematology area of the laboratory identified an unlabeled slide of a peripheral blood smear for manual differential testing on the counter waiting to be stained with Wright's stain; (3) A review of policies identified the following: (a) The policy titled, "Manual Differential Policy" did not provide guidance on labeling slides; (b) The policy titled, "Specimen Labeling" stated, "After specimens have been drawn they must be properly labeled" but did not specifically address labeling slides. (4) Interview with the laboratory manager on 04/18/2023 at 09:30 am confirmed the peripheral blood slide had not been labeled with the patient identification and the laboratory polices did not address labeling slides. 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 a review of records and interview with the laboratory manager and technical consultant #2, the laboratory failed to utilize the demonstrated reportable ranges for one of one new test method introduced into the laboratory in June 2022. Findings include: (1) On 04/11/2023 at 11:40 am, the laboratory manager stated the laboratory began using the ACL Elite analyzer to perform PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing on 06 /27/2022; (2) A review of the performance specification records for the analyzer identified the laboratory had demonstrated the following reportable ranges: (a) PT - 9.8-124.0 (b) PTT - 18.9-165.0 (3) Interview with the laboratory manager and technical consultant #2 on 04/18/2023 at 04:00 pm confirmed the laboratory was not using the lower limit of the reportable ranges that had been demonstrated as follows: (a) PT - The laboratory was using the manufacturer's reportable range of 8.0-115; (a) PTT - The laboratory was using the manufacturer's reportable range of 5.5-113. D5439 CALIBRATION AND CALIBRATION VERIFICATION -- 2 of 5 -- 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 records and interview with the laboratory manager and technical consultant #2, the laboratory failed to perform calibration verification procedures at least once every six months for one of three test systems (D-dimer testing) reviewed from January 2022 through the current date; and failed to ensure identical materials were not utilized to perform calibration verification and QC (quality control) procedures for one of three test systems (Troponin I testing) reviewed from 09/14 /2021 through 03/29/2023. Findings include: D-DIMER (1) On 04/18/2023 at 11:20 am, the laboratory manager stated the laboratory performed D-dimer testing using the Biosite Triage Meter Pro analyzer; (2) On 04/19/2023 a review of records from January 2022 through the current date identified no evidence calibration verification had been performed during the review period; (3) The records were reviewed with the laboratory manager and technical consultant #2. Both stated on 04/19/2023 at 12:08 pm, calibration verification procedures had not been performed at least once every six months. TROPONIN I (1) On 04/18/2023 at 11:25 am, the laboratory manager stated the laboratory performed Troponin I testing using the iSTAT 1 analyzer and the cTnI cartridge; (2) On 04/19/2023 a review of records from 09/14/2021 through 03/29/2023 identified the following: (a) 09/14/2021 (i) Calibration verification had been performed using cTnI Calibration Verification Control Set (level 1 lot #471129, level 2 lot #481129, and level 3 lot #491129); (ii) QC testing had been performed using cTnI Calibration Verification Control Set level 1 lot #471129, level 2 lot #481129, and level 3 lot #491129). (b) 03/19/2022 (i) Calibration verification had been performed using cTnI Calibration Verification Control Set (level 1 lot #471137, level 2 lot #481137, and level 3 lot #491137); (ii) QC testing had been performed using cTnI Calibration Verification Control Set (level 1 lot #471137, level 2 lot #481137, and level 3 lot #491137). (c) 09/19/2022 (i) Calibration verification had been performed using cTnI Calibration Verification Control Set (level 1 lot #471155, level 2 lot #481155, and level 3 lot #491155); (ii) QC testing had been performed using cTnI Calibration Verification Control Set (level 1 lot #471155, level 2 lot #481155, and level 3 lot #491155). (d) 03/29/2023 (i) Calibration verification had been -- 3 of 5 -- performed using cTnI Calibration Verification Control Set (level 1 lot #471155, level 2 lot #481155, and level 3 lot #491155); (ii) QC testing had been performed using cTnI Calibration Verification Control Set (level 1 lot #471155, level 2 lot #481155, and level 3 lot #491155). (3) The records were reviewed with the laboratory manager and technical consultant #2. Both stated on 04/19/2023 at 12:10 pm, the laboratory routinely used the calibration verification materials to perform calibration verification and QC testing for Troponin I at the same time. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and technical consultant #2, the laboratory failed to make appropriate reference ranges available for two of two reagent lot numbers implemented for PT (Prothrombin Time) and PTT (Partial Thromboplastin Time) testing. Findings include: (1) On 04/11/2023 at 11:40 am, the laboratory manager stated the following: (a) PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the ACL Elite analyzer; (b) The following lot numbers were put into use when the new analyzer was implemented on 06/27/2022: (i) PT Reagent - Hemosil Recombiplastin 2G lot #N1017425 (ii) PTT Reagent - HemoSIL Synthasil lot #N1117768 (3) A review of the implementation records identified the following: (a) PT - The normal reference interval had been verified as 9.6-12.9 (b) PTT - The normal reference interval had been verified as 24.0-31.0 (4) A review of a patient report with PT and PTT testing performed on 04/14/2023 showed the following normal ranges: (a) PT - 10.0-12.6 (b) PTT - 25.0-34.5 (5) The reports and implementation records were reviewed with the laboratory manager and technical consultant #2. Both stated on 04/19/2023 at 01:42 pm, the laboratory had not updated the normal reference ranges into the laboratory's computer information system. 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 records and interview with the laboratory manager and technical consultant #2, the technical consultant failed to definitively ensure personnel performing moderate complexity testing had been evaluated at least annually for one of six persons. Findings include: (1) On 04/18/2023 a review of personnel records for six persons performing moderate complexity testing during June 2021 through the current date identified the following: (a) Although an annual competency had been documented as completed on 04/27/2022, the competency form had not been signed and dated by the evaluator to definitively determine who performed the assessment. (2) The record was reviewed with the laboratory manager and technical consultant #2. -- 4 of 5 -- Both confirmed on 04/18/2023 at 02:49 pm, technical consultant #2 performed the competency assessment and failed to sign and date as the evaluator. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/12,13,14,2021. The findings were reviewed with technical consultant #2 and general supervisor #3 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.801; D2000: Enrollment and Testing of Samples 493.1447; D6108: Technical Supervisor 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 records and interview with technical consultant #2, the laboratory failed to enroll in a proficiency testing program for qualitative serum pregnancy testing for seven of seven events. Findings include: (1) On 05/12/2021 at 09:45 am, technical consultant #2 stated to the surveyor the laboratory performed serum pregnancy testing using the Beckman Coulter Icon 25 test kit; (2) The surveyor reviewed proficiency testing records for 2019 (First, Second, and Third events), 2020 (First, Second, and Third events), and 2021 (First event). There was no evidence the laboratory was enrolled in proficiency testing for serum qualitative pregnancy testing for seven of seven events; (3) The surveyor reviewed the records with technical consultant #2 who stated on 05/10/2021 at 11:00 am the laboratory was not enrolled in proficiency testing for serum qualitative pregnancy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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 a review of records, written policy, and interview with technical consultant #2, the laboratory failed to have a written technical consultant and general supervisory competency policy based on the position responsibilities as listed in Subpart M for one of one technical consultant. Findings include: (1) On 05/12/2021, the surveyor reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant and the general supervisor; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019, 2020, and 2021. There was no evidence of competencies performed for the technical consultant and general supervisor based on their job responsibilities; (3) The surveyor asked technical consultant #2 if a written policy to evaluate the technical consultant and general supervisor based on job responsibilities was available. Technical consultant #2 stated on 05/12/2021 at 04:45 pm a policy had not been written and competencies had not been performed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2 and general supervisor #3 , the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of seven Chemistry Core events reviewed. Findings include: (1) On 05/12/2021, the surveyor reviewed 2019, 2020, and 2021 proficiency testing records. The following was identified for one of seven Chemistry Core events: (a) First 2021 Chemistry Core Event for ALT (alanine transaminase) - one of two results had not been graded by the proficiency testing program: (i) For one of two results (CH-03), the following was identified: (aa) CH-03 - Under "Performance" it stated, "Not Graded". There was no evidence the laboratory reviewed the Participant Summary Report to evaluate their result. (2) The surveyor reviewed the records with technical consultant #2 and general supervisor #3. Both stated on 05/12/2021 at 05:15 pm, the laboratory had not evaluated the results that were not graded by the proficiency testing program and

Summary Statement of Deficiencies D0000 The recertification survey was performed 03/19/19-03/21/19. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory supervisor and general supervisor #2 during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the laboratory supervisor, the laboratory director failed to sign the proficiency testing attestation form to attest the proficiency testing samples were tested as patient testing using the laboratory's routine methods. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor the laboratory performed Clostridium difficile testing on stool samples using the Alere C. diff Quik Chek test kit; (2) The surveyor reviewed Microbiology proficiency testing records for the Second and Third 2017 Events, and the First, Second, and Third 2018 Events. From the review, the surveyor identified the laboratory director failed to sign the attestation statement for 1 of the 5 testing events reviewed (First 2018 event); (3) The surveyor reviewed the findings with the laboratory supervisor, who stated to the surveyor, the laboratory director failed to sign the attestation statement listed above. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without 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 -- analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to verify the accuracy of proficiency testing results which had not been graded by the proficiency testing program. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor the laboratory performed urine drug screen testing using the BioRad Tox/See Rapid Urine Drug Screen test device; (2) The surveyor then reviewed the Chemistry Miscellaneous proficiency testing records from the Second and Third 2017 Events, and the First, Second, and Third 2018 Events. The surveyor identified in the First event of 2018, the proficiency testing program had not graded the laboratory's result for the analyte Opiates on Sample UDS-02: (a) The laboratory reported "Positive." The proficiency testing program had not graded the result due to "No Consensus" among the participants; (b) In addition, the proficiency testing program's expected response was "See Data Summary." (3) The surveyor reviewed the proficiency testing program's, "Performance Review and