Summary:
Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed retain previous laboratory procedures for the required 2 year period after being discontinued. Findings include: 1. Record review of the laboratory procedures on 11/1/18 for the prior 2 years revealed the previous RapidLab procedure was not available for surveyor review. 2. Staff interview with technical consultant (TC #1) on 11/1/18 at 10:15 AM confirmed the above finding. TC #1 stated: a. The laboratory discontinued use of the RapidLab instrument for blood gas analysis in August 2017 and began using the i-Stat analyzer, Serial Number 378882 in August 2017. b. TC#1 further revealed that the RapidLab procedures had been archived but he/she was unable to provide a copy of the procedure and the exact date patient testing was discontinued. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain analytic records for blood gas analysis testing for at least 2 years. Findings include: 1. Record Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- review of the 'Monthly ABG Review and Unacceptable Specimen Log' on 11/1/18 revealed the following: a. June 2017: Patient #1, 6/9/17: critical low PO2 59.8. b. October 2017: Patient #2, 10/18/17: analysis error: "Reported visible CO2 result edited Cerner for CO2 result on screen." 2. Staff interview with technical consultant (TC) #1 on 11/1/18 at 2:00 PM confirmed the above findings. TC #1 stated the following: a. Patient #1 was performed on the RapidLab instrumentation and instrument records were not available and TC#1 was unaware where the RapidLab records were located. b. From August 2017 to March 3, 2018, i-Stat results went electronically into the patient record through a middle ware program called RALS. c. The 2 OF 2 TCs do not have the ability to access and monitor data captured in the RALS program. d. From March 5, 2018 to November 1, 2018, i-Stat results are manually entered into a comment field in the patient record. e. RapidLab instrument printouts, calibration verifications, and patient results were not available for review from when the instrument was placed into service in August 2017. f. Quality control of G3+ i-Stat cartridges is performed at an offsite location by non-laboratory personnel. 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 record review and staff interview, the laboratory failed to have policies and procedures in place to assess the competency of the technical consultant (TC) and clinical consultant (CC) based on their regulatory responsibilities. Findings include: 1. Record review of the laboratory competency assessment records on 11/1/18 revealed competency documentation for the TC and CC and written competency assessment policies and procedures were not available for review. 2. Staff interview with technical consultant #2 on 11/1/18 at 2:30 PM confirmed confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to provide evidence that it meets the requirements to perform testing for the blood gas analysis testing in the subspecialty of routine chemistry. Refer to citations D5403, D5407, D5409, D5421, D5425, D5427, D5439, D5537, D5539, D5789, D5791, D5801, D5803, D5805, D5807 and D5891. -- 2 of 12 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)