Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on March 7, 2019. The laboratory was found to be NOT IN COMPLIANCE with the CLIA regulations at: 42 CFR 493.1250 CONDITION: Analytic Systems D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on surveyor observation, review of patient final reports, and confirmed in interview of facility personnel, the laboratory failed to ensure confidentiality of patient information. The findings were: 1. Surveyor observation on March 7, 2019 at 13:00 hours revealed that while walking to the laboratory, the surveyor visualized a spiral notebook and loose sheets of paper sitting on the desk in a patient exam room. Upon entering the room, it was revealed the spiral notebook was a log book of notes and patient records with patient names and dates of birth. The loose sheets of paper contained patient names, dates of birth, and CPT codes. Information for Patient 1 (redacted): see patient alias report Information for Patient 2 (redacted): see patient alias report 2. Review of patient final reports for Patient 1 revealed the patient had laboratory testing performed on 05/04/2018, 07/10/2018, 09/13/2018, and 11/29/2018. 3. Review of patient final reports for Patient 2 revealed the patient had laboratory testing performed on 02/07/2017, 02/14/2019, and 02/28,2019. 4. Interview with testing personnel one (as listed on Form CMS 209) on March 7, 2019 at 15:45 hours in the referral office confirmed the findings. She provided laboratory results on each patient. She agreed the information that was found was for patients of the facility. Key: CPT - current procedural terminology CMS - Centers for Medicare and Medicaid Services 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 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted test menu, proficiency testing records and confirmed in interview of facility personnel, the laboratory failed to perform twice annual accuracy for the non-regulated analyte Microalbumin (MAB). The findings were: 1. Review of the laboratory's submitted CMS 116 approved and signed by the laboraotry director on March 7, 2019, revealed the laboratory performs Microalbumin (MAB) testing on the Beckman Coulter AU 480 chemistry analyzer. The facility documented performing 125,000 chemistry tests annually. 2. The analyte of MAB is non-regulated. API provides two events per calendar year. 3. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records from 2017 (events 1 and 2) and 2018 (events 1 and 2) revealed the laboratory received the following scores: a. 2017 Chemistry (event 2) laboratory received an unsuccessful score of 0% b. 2018 Chemistry (event 2) laboratory received an unsuccessful score of 0% 4. Due to the unsuccessful scores, the laboratory failed to perform twice annual accuracy for MAB in 2017 and 2018. 5. An interview with the technical consultant on March 7, 2019 at 10:00 hours in the referral office confirmed the 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 surveyor observations, review of manufacturer's instructions, review of patient results, and confirmed in interview of facility personnel, the laboratory failed to monitor and evaluate overall quality of its analytic systems as evidenced by: 1. The laboratory failed to resolve abnormal flags on CBC (complete blood count) patient results prior to their release to the healthcare provider (this is a repeat deficiency). Refer to D5411 2. The laboratory failed to ensure that expired laboratory supplies were not available for use. Refer to D5417 3. The laboratory failed to ensure calibration verification was performed every six months (this is a repeat deficiency). Refer to D5439 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of review of manufacturer's instructions, review of patient final reports, and confirmed in interview of facility personnel, the laboratory failed to resolve flags on CBC (complete blood count) results. The findings were: 1. This is a repeat deficiency from the survey dated December 8, 2016. 2. A review of the manufacturer's instructions for the Sysmex XP-300 hematology analyzer (Code No. AU553517, Revision July 2013) under the section titled "8.3 Histogram flags" revealed: "When histogram flags are displayed, perform analysis again. If afterwards the flags are still displayed, the sample is considered to correspond to one of the following." The manufacturer then identified histogram flags, probable causes, and