Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of Proficiency Testing (PT) records and interview with Laboratory Director (LD) and Laboratory Manager (LM), the laboratory failed to enroll in PT for Parasitology from 6/21/2017 to the day of the complaint investigation. Findings include: 1. During the tour of the Microbiology laboratory on 3/9/18 at approximately 11:00 am, Surveyor A asked if the laboratory performed parasitology tests, and requested to see reference materials. The LD showed the surveyor the reference materials. 2. 2017 PT records were reviewed. There were no records for Parasitology. 3.The LM confirmed that Parasitology testing was performed (Ova and Parasite examinations), but the laboratory was not enrolled in a HHS- approved PT program. 4. The allegation of compliance submitted by the LD in 2017 stated "Parasitology test was discontinued in July 2017". Testing has not been discontinued. This is a repeat deficiency. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 observation, review of Proficiency Testing (PT) records, and interview with the laboratory director (LD) and Laboratory Manager (LM), the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct problems with expired reagents and supplies, reagents not labeled with expiration dates, test system verification, equipment maintenance and control procedures as required in 493. 1251 through 493.1283. Refer to D5415, D5421, D5433, D5445, D5783, and D5791. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation, tour of the laboratory, and interview with Laboratory Director (LD) and Laboratory Manager (LM), the laboratory failed to ensure all reagents, solutions, and other laboratory supplies available for patient testing, were labeled to indicate their expiration dates from June 2017 to the date of complaint investigation. Findings Include: 1. At the time of investigation on 03/09/2018, the Surveyor observed the following reagents and supplies with no expiration dates: 1 bottle of 10% Bleach Aliquot in the Chemistry section. 1 bottle of EKI Low Viscosity Immersion Oil in the Microbiology section. 1 of 1 bottle of J.T. Baker Glycerol 500 ml Lot#K13829 in the Microbiology section. 1 of 1 bottle of Sigma Aldrich Ethanol Lot # SHBB6056V in the Microbiology section. 2. Aliquots of unlabeled liquids were found in the chemistry laboratory refrigerator. According to the LD, they were aliquots for chemistry tests. 3. The LD and LM confirmed the findings above on 03/09 /2018 at approximately 10:30 am. Based on surveyor observation, tour of laboratory, interview with Laboratory Director (LD) and Laboratory Manager (LM) and laboratory policy review, the laboratory failed to ensure 9 of 9 cases of Rainin pipette tips were be labeled to indicate their expiration dates. Findings include: 1. During a tour of the Microbiology Lab, 9 cases of Raining pipette tips used for susceptibility testing, (LTS 250 L 960/10 RT-L250 Batch # 1547 Item # 17002932) were found with no expiration dates (4 in the biosafety cabinet, 5 on the bench). There were scratch marks over the expiration dates observed on each case. 2. The LM, who was interviewed on 3/9/18 at approximately 10:35am, stated that the expiration dates were scratched off as instructed by the LD. He further stated that the pipette tips had expired July, 2014. 3. The laboratory's Policy for Determining Expiration Dates, signed by the LD and accepted 06/28/2011, provided by the LD on 3/9/2018 at the time of survey states, "Supplies without manuafacturer's expiration dates should be dated upon receipt". There were no receipt dates on the Rainin pipette tips. -- 2 of 9 -- 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: A Based on observation, review of the