Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Carilion Clinic Family Medicine- Dayton on October 9, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) 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 the review of temperature logs, tour of the lab, phone call with customer service representative, patient testing data, and interviews with the primary testing personnel, office manager and technical consultant, the laboratory failed to ensure the freezer temperatures were within the affiliated testing laboratory's established range of -38 Degrees Celsius for sample storage of patient blood ammonia levels for twenty- one (21) months and seven (7 days) of 21 months and 7 days and two (2) patients reviewed. Findings include: 1. Review of the laboratory temperature logs from January 1, 2018 and up to the date of survey on October 9, 2019 (21 months and 7 days) revealed that the laboratory monitors and documents freezer temperatures. 2. Tour of the laboratory and interview with the primary testing personnel at approximately 12:30 PM revealed that the laboratory collects blood ammonia levels for patients, stores the samples in the freezer, and ships them to their affiliated testing laboratory. 3. A phone call to the affiliated testing laboratory's customer service representative at approximately 1:10 PM revealed that the storage requirements for 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 -- blood ammonia levels are as follows: "specimens must be stored frozen at -38 Degrees Celsius within 30 minutes of collection." 4. The review of the freezer temperatures logs revealed that the freezer temperatures were warmer than -38 Degrees Celsius for the above-specified timeframe. 5. Review of the patient data log from the EPIC Electronic Medical Record (EMR) revealed that 2 patients had blood ammonia levels collected and stored for transportation: Patient #1- 4/26/2018, 1/7 /2019, 6/5/2019 and, 6/21/2018, 1/5/2019, 10/8/2019. 7/26/2018, 3/1/2019, 8/22/2018, 3/20/2019, 10/15/2018, 4/3/2019, 10/17/2018, 4/23/2019, 11/14/2018, 5/15/2019, 12 /31/2018, 5/22/2019, Patient #2- 2/16/2018, 5/20/2018, 9/6/2018, 1/18/2019, 4/29 /2019 and, 9/16/2019. 6. Interviews with the office manager at approximately 1:20 PM and technical consultant at approximately 1:35 PM confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview with the primary TP and the technical consultant (TC), the TC failed to document review of the annual competency assessments for eight (8) of 8 TP in 2018 and 2019. Findings include: 1. Review of the CMS-209 form revealed that there were a total of 8 TP performing patient testing in 2019. See attached TP code sheet. 2. Review of the TP records revealed lack of documentation by the TC of review of the annual competency assessments for all 8 of the TP: Testing Personnel A- no documentation of competency in the calendar year 2018 Testing Personnel B- date documented 12/2018 and September 26, 2019 Testing Personnel C- date documented 12/2018 and September 26, 2019 Testing Personnel D- date documented 12/2018 and September 26, 2019 Testing Personnel E- October 2, 2019 Testing Personnel F- September 26, 2019 Testing Personnel G- date documented 12/2018 and September 26, 2019 Testing Personnel I- September 26, 2019. 3. An interview with the primary TP and TC at approximately 1:35 PM confirmed the 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 the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview with the primary TP and the technical consultant (TC), the TC failed to document review of the semi- annual competency assessments for three (3) of 3 new TP in 2019. Findings include: 1. Review of the CMS-209 form revealed that there were a total of 3 new TP performing patient testing in 2019. See attached TP code sheet. 2. Review of the TP records revealed lack of documentation by the TC of review of the semi-annual -- 2 of 3 -- competency assessments for all 3 of the TP: Testing Personnel E- February 14, 2019 Testing Personnel H- September 26, 2019 Testing Personnel I- February 8, 2019. 3. An interview with the primary TP and TC at approximately 1:35 PM confirmed the findings. -- 3 of 3 --