Solvera Healthcare Center Inc

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 lack of documentation and interview with Testing Personnel one (TP1); the laboratory failed to enroll in proficiency testing challenges from March 15, 2022, till the date of the survey, April 5, 2023 for six of six Hematology analytes: Hematocrit, Hemoglobin, Platelet, Red Blood Cell Count, White Blood Cell Count, and automated White Blood Cell Differentials. Findings Include: 1. No documentation was found to confirm the laboratory had enrolled in proficiency testing for six of six regulated analytes: Hematocrit, Hemoglobin, Platelet, Red Blood Cell Count, White Blood Cell Count, and automated White Blood Cell Differentials. 2. During the survey on 04-05- 2023, at 11:06 am, TP1 confirmed the facility had not enrolled in proficiency testing challenges for six of six regulated hematology analytes reported by the laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory records, lack of documentation, and interview with Testing Personnel one (TP1); the laboratory failed to have written procedures for Complete Blood Count (CBC) testing performed in the specialty of hematology. Findings Include: 1. Review of the laboratory's procedure manual found no written procedures for CBC testing performed on the Abbott CELL-DYN Emerald analyzer. 2. On survey date 04-05-2023, at 10:24 am, TP1 confirmed no individual written procedure were available for CBC testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with Testing Personnel three (TP3); the laboratory failed to monitor the laboratory's room temperature and humidity for hematology testing performed on March 15, 2022, through the date of survey on April 5, 2023. Findings Include: 1. Review of Performance Characteristics and Specifications in section four of the CELL-DYN Emerald 22 Operator's Manual stated, "Operating Temperature from 64-9. degrees Fahrenheit and Relative Humidity of 80% maximum at 89.6 degrees Fahrenheit. 2. No documented room temperature and humidity records were found during the survey. 3. On survey date 04-05-2023, at 11:44 am TP3 confirmed the laboratory did not document maintenance or monitor the room temperature or humidity of the laboratory. 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 review of laboratory records, lack of documentation and interview with Testing Personnel three (TP3); the laboratory failed to perform and document maintenance as defined by the manufacturer for hematology testing performed on the CELL-DYN Emerald analyzer from March 15, 2022, through April 5, 2023. Findings include: 1. Review of the manufacturer's operator's manual for the CELL-DYN Emerald analyzer section 9 defines the maintenance procedures and stated "The CELL-DYN Emerald 22 System has been designed to require minimal routine -- 2 of 7 -- maintenance. To ensure optimum performance, the operator is encouraged to routinely perform the scheduled maintenance procedures described in this section. Failure to perform recommended maintenance can result in inaccurate or imprecise results." 2. Review of the manufacturer's operator's manual for the CELL-DYN Emerald analyzer section 9, Preventive Maintenance Schedule stated, a. "Weekly Maintenance, Bleach Cleaning the system with a bleach solution is performed weekly or as needed when a parameter is repeatedly rejected." b. "Quarterly Maintenance, Lubricating the Pistons for optimal operation, the Syringe Pistons should be lubricated every three months." c. "As Needed Maintenance." 3. No records were found to document the weekly, quarterly, and as needed maintenance for the CELL-DYN Emerald analyzer. 4. Interview with TP3 on 04-05-2023 at 11:44 am confirmed the laboratory failed to document/perform all maintenance activities as required by the manufacturer for the CELL-DYN Emerald analyzer. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with Testing Personnel two (TP2); the laboratory failed to identify the Testing Personnel who performed the Complete Blood Count (CBC) testing for nine of nine patient testing records reviewed for the specialty of hematology. Findings Include: 1. Review of laboratory testing records found the laboratory failed to maintain records to identify the testing personnel that had performed the CBC testing for the following patient test records: Testing Date Medical Record Number 04-01-2022 13247 07-01-2022 14353 08-18-2022 16345 09-28-2022 9583 11-25-2022 18833 01-16-2023 55381 03-15- 2023 56333 03-23-2023 56159 03-29-2023 55517 2. On survey date 04-05-2023, at 2: 35 pm, TP3 confirmed that the laboratory does not record or document the Testing Personnel that performs the CBC testing. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel one (TP1); the -- 3 of 7 -- laboratory failed to have a system to ensure results are accurately transferred from the Abbott CELL-DYN Emerald analyzer to the Electronic Medical Record (EMR). Findings Include: 1. No documentation was found to show the laboratory had a system in place to ensure results are accurately transferred from the Abbott CELL- DYN Emerald analyzer to the EMR. 2. On survey date 04-05-2023, at 2:45 pm, TP1 confirmed the laboratory failed to ensure results are accurately transferred from the Abbott CELL-DYN Emerald analyzer to the EMR. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on lack of documentation and interviews with Testing Personnel one (TP1) and Testing Personnel two (TP2); the laboratory director failed to ensure the overall management and direction for the specialty of hematology. Findings Include: 1. The laboratory director failed to ensure the laboratory enrolled in proficiency testing challenges for six of six Hematology analytes: Hematocrit, Hemoglobin, Platelet, Red Blood Cell Count, White Blood Cell Count, and automated White Blood Cell Differentials. See D6015. 2. The laboratory director failed to ensure quality control and quality assessment programs were established and maintained to identify failures in quality as they occur. See D6022. 3. The laboratory director failed to ensure an approved written procedures for Complete Blood Count (CBC) testing performed were available to all personnel. See D6031. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Testing Personnel one (TP1); the laboratory director failed to ensure the laboratory was enrolled in proficiency testing challenges from March 15, 2022, till the date of the survey, April 5, 2023, for six of six Hematology analytes: Hematocrit, Hemoglobin, Platelet, Red Blood Cell Count, White Blood Cell Count, and automated White Blood Cell Differentials. Findings Include: 1. The laboratory failed to enroll in proficiency testing challenges from March 15, 2022, till the date of the survey, April 5, 2023, for six of six Hematology analytes: Hematocrit, Hemoglobin, Platelet, Red Blood Cell Count, White Blood Cell Count, and automated White Blood Cell Differentials. See D2000. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 4 of 7 -- 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 the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of laboratory documentation, and interviews with Testing Personnel one (TP1) and Testing Personnel two (TP2); the laboratory director failed to ensure that the quality control and quality assessment programs were established and maintained to identify failures in quality as they occur. Findings Include: 1. Review of laboratory records found no documented Quality Control (QC) and Quality Assurance (QA) policies. 2. Review of laboratory records found no documented QA monitoring for Complete Blood Count performed from March 15, 2022, to date of survey April 5, 2023. 3. Review of laboratory documents and lack of laboratory documentation showed the laboratory failed to have policies and procedures in place to monitor, assess, and when indicated correct problems when identified. 4. On survey date 04-05-2023, at 11:08 am, TP1 confirmed the laboratory failed to have written policies for QC ad QA. 5. On survey date 04-05-2023, at 2:35 pm, TP2 confirmed the laboratory failed to document