Dsp Health System

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation of laboratory reagents and interview with testing personnel (TP) #1, the laboratory failed to ensure that Beckman Coulter bicarbonate calibrators 1+2 (2 of 2 bottles) were not used beyond their expiration date. Findings Include: 1. On the day of survey, 11/21/2019, observation of laboratory reagents revealed the laboratory used Beckman Coulter bicarbonate calibrators 1+2 (2 of 2 bottles) used on the Beckman coulter AU480 for the carbon dioxide test had expired 10/12/2019 and were opened for use on 11/17/2019. 2. TP #1 confirmed the expired calibrators above used on 11/21/2019 around 11:10 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation of laboratory's thermometers and interview with the testing personnel (TP) #1, the laboratory failed perform maintenance/ calibration on 2 of 2 fisher scientific min/max alarm thermometers from 2017 to the date of survey. Findings Include: 1. On the date of survey, 11/21/2019, while on tour of the 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 -- laboratory, 2 of 2 fisher scientific min/max alarm thermometers observed, were due for maintenance/ calibration on: - Large refrigerator: - S/N 6607 - Cat# ACC895REFV - Due July of 2019 - Retains quality controls and calibrators for the Beckman Coulter AcT Diff 2, Access 2 and AU 480. - Mini freezer: - S/N 3285 - Cat# ACC895FREV - August of 2019 - Retains quality controls and calibrators for the Beckman Coulter Access 2 and AU 480. 3. TP #1 confirmed the findings above on 11 /21/2019 around 11:15 am. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on, the review of laboratory quality improvement procedure and interview with testing personnel (TP) #1, the laboratory failed to ensure that quality assessment programs are followed and documented to assure the quality of laboratory from 2018 to the day of survey (16 out of 16 months). Findings Include: 1. The Laboratory Quality Management Plan, page 3 of 4 states, "A total quality improvement report is completed monthly by the laboratory manager and presented at the leadership and quality meeting. 2. On the day of survey, 11/21/2019, TP #1 could not provide documentation of quality improvement reports performed on a monthly basis from: - July 2018 to December 2018 ( 6 of 6 months) - January 2019 to October 2019 (10 of 10 months) 3. TP #1 confirmed the findings above on 11/21/2019 around 11:00 am. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on review of testing personnel qualifcation records, quality control (QC) records and interview with testing personnel (TP) #1, the laboratory failed to have a technical consultant who meets the qualification requirements to review QC records for the Beckman coulter AU 480, Beckman coulter Access 2 chemistry analyzers and the Beckman coulter AcT Diff 2 hematology analyzer from 07/13/2018 to the date of survey. 1. A letter signed by the LD states " I designate TP #1, MLT, who meets technical consultant qualifications, to review all quality control result reports for DSP Health System Laboratory. 2. On the day of survey, 11/21/2019, review of QC records and TP #1 qualification records revealed, TP #1 does not meet requirement of a TC and was not listed as a TC on the Laboratory Personnel Report (CLIA), form CMS- -- 2 of 3 -- 209 signed by the LD on 10/11/2019. 3. TP#1 confirmed they do not meet requirements to perform TC responsibilities on 11/21/2019 around 11:00 am. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records, review of American Proficiency Institute (API) 2018 proficiency testing (PT) records and interview with TP #1, the technical consultant (laboratory director) failed to assess the competency of 1 of 2 TP through internal blind testing samples or external PT samples in 2019. Findings Include: 1. On the day of survey, 11/21/2019, review of TP records and API PT records revealed, the laboratory did not assess the test performance of 1 of 2 TP (TP#2) thorough chemistry PT samples or internal blind testing samples in 2019. 2. TP#1 confirmed the finding above on 11/21/2019 around 9:40 am. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of Beckman Coulter AU 480 Chemistry Analyzer calibration records and interview with testing personnel (TP) #1, the laboratory failed to perform calibration verification (CV) on the Beckman Coulter AU 480 at least every 6 months in 2018. Findings include: 1. On the day of survey, 07/13/2018, review of Beckman Coulter AU 480 CV records, revealed that the laboratory did not perform CV at least every six months. The last CV was performed on 12/18/2018 and was due to be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- performed on 06/18/2018. 2. In 2017: 148 Chemistry tests were analyzed. 3. TP #1 confirmed the finding above on 07/13/2018 around 10:30 am. -- 2 of 2 --