Summary:
Summary Statement of Deficiencies D0000 An offsite revisit survey was conducted on 8/16/18 for all previous deficiencies cited on 7/18/2018. All deficiencies have been corrected. The facility is in compliance with with all regulations surveyed. 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 proficiency document review and staff interview, the laboratory failed to enroll in profiency testing (PT) for each of the specialties and subspecialties for which it seeks certification. Findings include: 1. Proficiency document review revealed the facility did not enroll in PT for Potassium Hydroxide (KOH) testing and dermatophyte testing in 2016, 2017, and 2018. 2. An interview with the certified medical assistant on 7/18/18 in an office area at approximately 12:00 p.m. confirmed the facility was not enrolled in PT for KOH testing and dermatophyte testing. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to use unexpired reagents for laboratory testing. Findings include: 1. Observation during the laboratory interview on 7/18/18 at approximately 10:45 a.m. revealed the Potassium Hydroxide (KOH) 20 percent solution ( Lot #K147M3), currently used for KOH microscopic testing, expired July, 2017. There were no unexpired replacements available at the time of survey. 2. An interview with the Certified Medical Assistant in the laboratory on 7/18/18 at approximately 10:45 a.m. confirmed the KOH solution currently used for KOH microscopic testing had expired July, 2017, with no unexpired replacements available at the time of survey. 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 document review and staff interview, the laboratory failed to perform and document maintenance on laboratory equipment as required. Findings include: 1. Maintenance document review revealed the laboratory failed to perform and document maintenance on the eyewash equipment for 2017 and 2018 thus far. 2. An interview with the Certified Medical Assistant in the laboratory area on 7/18/18 at approximately 11:00 a.m. confirmed there was no eyewash maintenance log available, for 2017 and 2018 thus far, at the time of survey. -- 2 of 2 --