Power Of Change Inc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical supervisor, the laboratory does not have a written step-by-step procedure to ensure positive identification through the testing process. Findings include: 1. Review of "Processing Patient Samples" revealed the procedure does not include instructions to assign numerical identification and label patient samples through the testing phase. 2. Interview with the technical supervisor on February 17, 2020 at 12:18 PM revealed testing personnel assign each sample a number as part of the daily run. Testing personnel also number the specimen and test requisition for the run to correlate with the sample identification on the Mindray BS 200 analyzer. Further interview revealed the procedure had no written step-by-step instructions for this process and testing personnel were not consistently following the process. This is a repeat deficiency from February 20, 2018. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of patient test requisitions, Mindray BS 200 analyzer reports, and interview with the technical supervisor, the laboratory did not enter the date of birth accurately for three of eight patients on January 14, 2020. Findings include: 1. Review of patient test requisitions showed: Patient 1 date of birth: November 30, 1990 Patient 2 date of birth: July 21, 1991 Patient 3 date of birth: May 31, 1965 2. Review of MindRay BS 200 analyzer reports showed: Patient 1 date of birth: January 30, 1990 Patient 2 date of birth: July 12, 1991 Patient 3 date of birth: March 12, 1955 3. Interview with the technical supervisor on February 17, 2020 at 11: 57 AM confirmed the laboratory did not enter the date of birth accurately in the Mindray BS 200 for three of eight patients on January 14, 2020. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on surveyor review of patient test requisitions, analyzer reports and laboratory procedures, observation of patient urine samples and interview with the technical supervisor, the laboratory did not have a mechanism to monitor, assess and correct problems identified in the preanalytic system. Findings include: 1. Review of patient test requisitions and analyzer reports revealed the laboratory did not correct problems identified with inaccurate date of birth on three of eight patients on January 14, 2020. See D5309. 2. Review of "Collection of Patient Sample" procedure showed specimen labels must contain patient's name, date of birth, date of collection and initials of collector. Observation of previously tested patient urine samples on February 17, 2020 at 11:54 AM in the bottom refrigerator showed no collector initials on the specimen label. See D6175. 3. Interview with the technical supervisor on February 17, 2020 at 12:18 PM confirmed the laboratory does not have a mechanism in place to monitor, assess and correct problems identified in the preanalytic processing of patient testing. Further interview confirmed the technical supervisor was aware of inaccurate dates of birth on analyzer reports but had not evaluated or taken steps to resolve the issue. 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)

Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) records and interview with the general supervisor, the laboratory does not have records showing the director attested to the routine integration of the samples into the patient workload using the laboratory's routine methods for two of three PT events in 2017. Findings include: 1. Review of toxicology PT records from 2017 show the laboratory director did not sign the attestation statement for the second event in 2017. The attestation statement for event three is not available. 2. Interview with the general supervisor on February 20, 2018 at 10:45 AM confirmed the laboratory director did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the general supervisor, the samples for event one in 2017 were tested two times while Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- patient samples are routinely tested once. Findings include: 1. Review of PT records for event one of 2017 show two set of laboratory test results for each sample. The test results do not indicate a reason for the repeated analysis. No test records are available for events two and three. 2. Interview with the general supervisor on February 20, 2018 at 10:45 AM confirmed patient samples are routinely tested once and the PT samples were not tested the same number of times as patient samples. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the executive director, the laboratory did not maintain copies of all PT records for two of three events in 2017. Findings include: 1. Review of PT records for 2017 showed records for the second and third events in toxicology are limited to screen prints of results from the PT provider's website for each event and an attestation statement for event two signed by the analyst. 2. Interview with the executive director, staff A, on February 20, 2018 at 3:00 PM revealed the screen prints of the PT records for event two and three had been printed earlier that day when the records for the events were not found in the laboratory, and confirmed the records were not retained for two years. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and test reports, and interview with the general supervisor, testing was limited or discontinued due to insufficient reagents in July, August, and October 2017, and from November 16, 2017 - January 16, 2018. Findings include: 1. Review of calibration records and patient test reports showed no indication testing was performed from November 16, 2017 through January 16, 2018. Test reports from January 17, 2018 show only Ethyl Alcohol and Cannabinoid test results were reported. Review of